Upload
others
View
1
Download
0
Embed Size (px)
Citation preview
HEALTH TECHNOLOGY ASSESSMENTVOLUME 20 ISSUE 37 MAY 2016
ISSN 1366-5278
DOI 103310hta20370
A systematic review evidence synthesis and meta-analysis of quantitative and qualitative studies evaluating the clinical effectiveness the cost-effectiveness safety and acceptability of interventions to prevent postnatal depression
C Jane Morrell Paul Sutcliffe Andrew Booth John Stevens Alison Scope Matt Stevenson Rebecca Harvey Alice Bessey Anna Cantrell Cindy-Lee Dennis Shijie Ren Margherita Ragonesi Michael Barkham Dick Churchill Carol Henshaw Jo Newstead Pauline Slade Helen Spiby and Sarah Stewart-Brown
A systematic review evidence synthesisand meta-analysis of quantitative andqualitative studies evaluating the clinicaleffectiveness the cost-effectivenesssafety and acceptability of interventionsto prevent postnatal depression
C Jane Morrell1 Paul Sutcliffe2 Andrew Booth3
John Stevens3 Alison Scope3 Matt Stevenson3
Rebecca Harvey3 Alice Bessey3 Anna Cantrell3
Cindy-Lee Dennis4 Shijie Ren3 Margherita Ragonesi2
Michael Barkham5 Dick Churchill6 Carol Henshaw7
Jo Newstead8 Pauline Slade9 Helen Spiby1
and Sarah Stewart-Brown2
1School of Health Sciences University of Nottingham Nottingham UK2Division of Health Sciences Warwick Medical School University of WarwickCoventry UK
3School of Health and Related Research University of Sheffield Sheffield UK4Lawrence S Bloomberg Faculty of Nursing University of Toronto TorontoON Canada
5Clinical Psychology Unit Department of Psychology University of SheffieldSheffield UK
6School of Medicine University of Nottingham Nottingham UK7Division of Psychiatry Institute of Psychology Health and SocietyUniversity of Liverpool Liverpool UK
8Nottingham Experts Patients Group Clinical Reference Group for PerinatalMental Health Nottingham UK
9Institute of Psychology Health and Society University of LiverpoolLiverpool UK
Corresponding author
Declared competing interests of authors none
Published May 2016DOI 103310hta20370
This report should be referenced as follows
Morrell CJ Sutcliffe P Booth A Stevens J Scope A Stevenson M et al A systematic review
evidence synthesis and meta-analysis of quantitative and qualitative studies evaluating the clinical
effectiveness the cost-effectiveness safety and acceptability of interventions to prevent postnatal
depression Health Technol Assess 201620(37)
Health Technology Assessment is indexed and abstracted in Index MedicusMEDLINE ExcerptaMedicaEMBASE Science Citation Index Expanded (SciSearchreg) and Current ContentsregClinical Medicine
Health Technology Assessment HTAHTA TAR
ISSN 1366-5278 (Print)
ISSN 2046-4924 (Online)
Impact factor 5027
Health Technology Assessment is indexed in MEDLINE CINAHL EMBASE The Cochrane Library and the ISI Science Citation Index
This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (wwwpublicationethicsorg)
Editorial contact nihreditsouthamptonacuk
The full HTA archive is freely available to view online at wwwjournalslibrarynihracukhta Print-on-demand copies can be purchased from thereport pages of the NIHR Journals Library website wwwjournalslibrarynihracuk
Criteria for inclusion in the Health Technology Assessment journalReports are published in Health Technology Assessment (HTA) if (1) they have resulted from work for the HTA programme and (2) theyare of a sufficiently high scientific quality as assessed by the reviewers and editors
Reviews in Health Technology Assessment are termed lsquosystematicrsquo when the account of the search appraisal and synthesis methods (tominimise biases and random errors) would in theory permit the replication of the review by others
HTA programmeThe HTA programme part of the National Institute for Health Research (NIHR) was set up in 1993 It produces high-quality researchinformation on the effectiveness costs and broader impact of health technologies for those who use manage and provide care in the NHSlsquoHealth technologiesrsquo are broadly defined as all interventions used to promote health prevent and treat disease and improve rehabilitationand long-term care
The journal is indexed in NHS Evidence via its abstracts included in MEDLINE and its Technology Assessment Reports inform National Institutefor Health and Care Excellence (NICE) guidance HTA research is also an important source of evidence for National Screening Committee (NSC)policy decisions
For more information about the HTA programme please visit the website httpwwwnetsnihracukprogrammeshta
This reportThe research reported in this issue of the journal was funded by the HTA programme as project number 119503 The contractual start datewas in November 2012 The draft report began editorial review in August 2014 and was accepted for publication in June 2015 The authorshave been wholly responsible for all data collection analysis and interpretation and for writing up their work The HTA editors and publisherhave tried to ensure the accuracy of the authorsrsquo report and would like to thank the reviewers for their constructive comments on the draftdocument However they do not accept liability for damages or losses arising from material published in this report
This report presents independent research funded by the National Institute for Health Research (NIHR) The views and opinions expressed byauthors in this publication are those of the authors and do not necessarily reflect those of the NHS the NIHR NETSCC the HTA programmeor the Department of Health If there are verbatim quotations included in this publication the views and opinions expressed by theinterviewees are those of the interviewees and do not necessarily reflect those of the authors those of the NHS the NIHR NETSCC the HTAprogramme or the Department of Health
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioningcontract issued by the Secretary of State for Health This issue may be freely reproduced for the purposes of private research andstudy and extracts (or indeed the full report) may be included in professional journals provided that suitable acknowledgementis made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating CentreAlpha House University of Southampton Science Park Southampton SO16 7NS UK
Published by the NIHR Journals Library (wwwjournalslibrarynihracuk) produced by Prepress Projects Ltd Perth Scotland(wwwprepress-projectscouk)
Editor-in-Chief
Health Technology Assessment
NIHR Journals Library
Professor Tom Walley Director NIHR Evaluation Trials and Studies and Director of the HTA Programme UK
NIHR Journals Library Editors
Professor Ken Stein Chair of HTA Editorial Board and Professor of Public Health University of Exeter Medical School UK
Professor Andree Le May Chair of NIHR Journals Library Editorial Group (EME HSampDR PGfAR PHR journals)
Dr Martin Ashton-Key Consultant in Public Health MedicineConsultant Advisor NETSCC UK
Professor Matthias Beck Chair in Public Sector Management and Subject Leader (Management Group) Queenrsquos University Management School Queenrsquos University Belfast UK
Professor Aileen Clarke Professor of Public Health and Health Services Research Warwick Medical School University of Warwick UK
Dr Tessa Crilly Director Crystal Blue Consulting Ltd UK
Dr Peter Davidson Director of NETSCC HTA UK
Ms Tara Lamont Scientific Advisor NETSCC UK
Professor Elaine McColl Director Newcastle Clinical Trials Unit Institute of Health and Society Newcastle University UK
Professor William McGuire Professor of Child Health Hull York Medical School University of York UK
Professor Geoffrey Meads Professor of Health Sciences Research Health and Wellbeing Research and
Professor John Norrie Health Services Research Unit University of Aberdeen UK
Professor John Powell Consultant Clinical Adviser National Institute for Health and Care Excellence (NICE) UK
Professor James Raftery Professor of Health Technology Assessment Wessex Institute Faculty of Medicine University of Southampton UK
Dr Rob Riemsma Reviews Manager Kleijnen Systematic Reviews Ltd UK
Professor Helen Roberts Professor of Child Health Research UCL Institute of Child Health UK
Professor Helen Snooks Professor of Health Services Research Institute of Life Science College of Medicine Swansea University UK
Professor Jim Thornton Professor of Obstetrics and Gynaecology Faculty of Medicine and Health Sciences University of Nottingham UK
Please visit the website for a list of members of the NIHR Journals Library Board wwwjournalslibrarynihracukabouteditors
Editorial contact nihreditsouthamptonacuk
Development Group University of Winchester UK
Editor-in-Chief
Professor Hywel Williams Director HTA Programme UK and Foundation Professor and Co-Director of theCentre of Evidence-Based Dermatology University of Nottingham UK
Professor Jonathan Ross Professor of Sexual Health and HIV University Hospital Birmingham UK
NIHR Journals Library wwwjournalslibrarynihracuk
Abstract
A systematic review evidence synthesis and meta-analysisof quantitative and qualitative studies evaluating the clinicaleffectiveness the cost-effectiveness safety and acceptabilityof interventions to prevent postnatal depression
C Jane Morrell1 Paul Sutcliffe2 Andrew Booth3 John Stevens3
Alison Scope3 Matt Stevenson3 Rebecca Harvey3 Alice Bessey3
Anna Cantrell3 Cindy-Lee Dennis4 Shijie Ren3 Margherita Ragonesi2
Michael Barkham5 Dick Churchill6 Carol Henshaw7 Jo Newstead8
Pauline Slade9 Helen Spiby1 and Sarah Stewart-Brown2
1School of Health Sciences University of Nottingham Nottingham UK2Division of Health Sciences Warwick Medical School University of Warwick Coventry UK3School of Health and Related Research University of Sheffield Sheffield UK4Lawrence S Bloomberg Faculty of Nursing University of Toronto Toronto ON Canada5Clinical Psychology Unit Department of Psychology University of Sheffield Sheffield UK6School of Medicine University of Nottingham Nottingham UK7Division of Psychiatry Institute of Psychology Health and Society University of LiverpoolLiverpool UK
8Nottingham Experts Patients Group Clinical Reference Group for Perinatal Mental HealthNottingham UK
9Institute of Psychology Health and Society University of Liverpool Liverpool UK
Corresponding author JaneMorrellnottinghamacuk
Background Postnatal depression (PND) is a major depressive disorder in the year following childbirthwhich impacts on women their infants and their families A range of interventions has been developed toprevent PND
Objectives To (1) evaluate the clinical effectiveness cost-effectiveness acceptability and safety ofantenatal and postnatal interventions for pregnant and postnatal women to prevent PND (2) applyrigorous methods of systematic reviewing of quantitative and qualitative studies evidence synthesis anddecision-analytic modelling to evaluate the preventive impact on women their infants and their familiesand (3) estimate cost-effectiveness
Data sources We searched MEDLINE EMBASE Science Citation Index and other databases (frominception to July 2013) in December 2012 and we were updated by electronic alerts until July 2013
Review methods Two reviewers independently screened titles and abstracts with consensus agreementWe undertook quality assessment All universal selective and indicated preventive interventions forpregnant women and women in the first 6 postnatal weeks were included All outcomes were includedfocusing on the Edinburgh Postnatal Depression Scale (EPDS) diagnostic instruments and infant outcomesThe quantitative evidence was synthesised using network meta-analyses (NMAs) A mathematical modelwas constructed to explore the cost-effectiveness of interventions contained within the NMA forEPDS values
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
vii
Results From 3072 records identified 122 papers (86 trials) were included in the quantitative review From2152 records 56 papers (44 studies) were included in the qualitative review The results were inconclusiveThe most beneficial interventions appeared to be midwifery redesigned postnatal care [as shown by themean 12-month EPDS score difference of ndash143 (95 credible interval ndash400 to 136)] person-centredapproach (PCA)-based and cognitivendashbehavioural therapy (CBT)-based intervention (universal) interpersonalpsychotherapy (IPT)-based intervention and education on preparing for parenting (selective) promotingparentndashinfant interaction peer support IPT-based intervention and PCA-based and CBT-based intervention(indicated) Women valued seeing the same health worker the involvement of partners and access toseveral visits from a midwife or health visitor trained in person-centred or cognitivendashbehavioural approachesThe most cost-effective interventions were estimated to be midwifery redesigned postnatal care (universal)PCA-based intervention (indicated) and IPT-based intervention in the sensitivity analysis (indicated) althoughthere was considerable uncertainty Expected value of partial perfect information (EVPPI) for efficacy datawas in excess of pound150M for each population Given the EVPPI values future trials assessing the relativeefficacies of promising interventions appears to represent value for money
Limitations In the NMAs some trials were omitted because they could not be connected to the mainnetwork of evidence or did not provide EPDS scores This may have introduced reporting or selection biasNo adjustment was made for the lack of quality of some trials Although we appraised a very large numberof studies much of the evidence was inconclusive
Conclusions Interventions warrant replication within randomised controlled trials (RCTs) Several interventionsappear to be cost-effective relative to usual care but this is subject to considerable uncertainty
Future work recommendations Several interventions appear to be cost-effective relative to usual carebut this is subject to considerable uncertainty Future research conducting RCTs to establish whichinterventions are most clinically effective and cost-effective should be considered
Study registration This study is registered as PROSPERO CRD42012003273
Funding The National Institute for Health Research Health Technology Assessment programme
ABSTRACT
NIHR Journals Library wwwjournalslibrarynihracuk
viii
Contents
List of tables xvii
List of figures xxi
List of boxes xxvii
Glossary xxix
List of abbreviations xxxi
Plain English summary xxxiii
Scientific summary xxxv
Chapter 1 Background 1Description of health problem 1
Prevalence 2Impact of health problem 2
Current service provision 3Variation in service and uncertainty about best practice 3Identification of postnatal and antenatal depression 3Current service costs 4
Description of technology under assessment 4Preventive interventions for postnatal depression 4
Evidence of preventive interventions 5Psychological approaches to the prevention and treatment of depression 5Educational interventions 6Social support 6Pharmacological interventions or supplements 7Complementary and alternative medicine 7
Summary 8
Chapter 2 Definition of the decision problem 9Decision problem 9Overall aim and objectives of assessment 9
Service user involvement 10
Chapter 3 Review methods 13Overview of review methods 13Methods for reviewing and assessing clinical effectiveness 13
Search strategies for identification of studies 13Search strategy for randomised controlled trials and systematic reviews 13
Review protocol 16Inclusion and exclusion criteria for quantitative studies 16
Search strategy and outcome summary for the qualitative studies 20Electronic databases 20
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
ix
Study selection 20Study selection criteria and procedures for the quantitative review 20Study quality assessment checklists and procedures for the randomised controlled trials 20Data extraction for randomised controlled trials 20Data synthesis of randomised controlled trials 21
Meta-analysis of randomised controlled trials 21Methods of evidence synthesis 21Methods for the estimation of efficacy 22
Methods for reviewing and assessing qualitative studies 27Study selection criteria and procedures for the effectiveness review 27Inclusion and exclusion criteria for qualitative studies 28Study quality assessment checklists and procedures for qualitative studies 29Data extraction strategy for qualitative studies 29Data synthesis for qualitative studies 29
Synthesis drawing upon realist approaches 29Identification of key potential CLUSTERs 29Searching for CLUSTER documents 30Synthesis and construction of a theoretical model 30
Integrating quantitative and qualitative findings 32
Chapter 4 Overview of results for quantitative and qualitative studies 33Literature search for the quantitative review 33
Quantitative review study characteristics 33Yield of systematic reviews 33Quantitative review study characteristics 33Outcome assessment 35Quality of quantitative studies 35Quality of systematic and other reviews 36
Literature search for the qualitative review 36Qualitative studies level of preventive intervention 36Qualitative review study characteristics 44Qualitative review study characteristics personal and social support strategy studies 44Quality of the qualitative intervention studies 45Certainty of the review findings intervention studies 45Overview of main findings from qualitative intervention studies (all levels) 45Quality of the qualitative personal and social support strategy studies 51Qualitative studies further analysis by level of preventive intervention universalselective and indicated 51
Chapter 5 Results for universal preventive intervention studies 53Characteristics of randomised controlled trials of universal preventive interventions 53
Description of qualitative studies of universal preventive interventions 53Universal preventive interventions psychological interventions 55
Characteristics and main outcomes of randomised controlled trials of universalpreventive interventions of psychological interventions 55Description and findings from qualitative studies of universal preventive interventionsof psychological interventions 55
Universal preventive interventions educational interventions 61Characteristics and main outcomes of randomised controlled trials of universalpreventive interventions of educational interventions 61
CONTENTS
NIHR Journals Library wwwjournalslibrarynihracuk
x
Universal preventive interventions social support 61Characteristics and main outcomes of randomised controlled trials of universalpreventive interventions of social support 61Description and findings from qualitative studies of universal preventive interventionsof social support 61
Universal preventive interventions pharmacological agents or supplements 69Characteristics and main outcomes of randomised controlled trials of universalpreventive intervention of pharmacological agents or supplements 69
Universal preventive interventions midwifery-led interventions 69Characteristics and main outcomes of randomised controlled trials of universalpreventive interventions of midwifery-led interventions 69Description and findings from qualitative studies of universal preventive interventionsof midwifery-led interventions 76
Universal preventive interventions organisation of maternity care 79Characteristics and main outcomes of randomised controlled trials of universalpreventive interventions of organisation of maternity care 79Description and findings from qualitative studies of universal preventive interventionsof organisation of maternity care 79
Universal preventive interventions complementary and alternative medicine or other 85Characteristics and main outcomes of randomised controlled trials of universalpreventive interventions of complementary and alternative medicine or other 85Description and findings of qualitative studies of universal preventive interventions ofcomplementary and alternative medicine or other 85
Results from network meta-analysis for universal preventive interventions for EdinburghPostnatal Depression Scale threshold score 89
Results for universal preventive interventions for Edinburgh Postnatal Depression Scalethreshold score at 6 weeks postnatally 90Results for universal preventive interventions for Edinburgh Postnatal Depression Scalethreshold score at 3 months postnatally 92Results for universal preventive interventions for Edinburgh Postnatal Depression Scalethreshold score at 6 months postnatally 92Results for universal preventive interventions for Edinburgh Postnatal Depression Scalethreshold score at 12 months postnatally 95Summary of results from network meta-analysis for universal preventive interventionsfor Edinburgh Postnatal Depression Scale threshold score 97
Results from network meta-analysis for universal preventive interventions for EdinburghPostnatal Depression Scale mean scores 97
Summary of results from network meta-analysis for universal preventive interventionstudies for Edinburgh Postnatal Depression Scale mean scores 101
Summary of results for universal preventive interventions for Edinburgh PostnatalDepression Scale threshold and Edinburgh Postnatal Depression Scale mean scores 102
Overall summary of results for universal preventive interventions for EdinburghPostnatal Depression Scale threshold and Edinburgh Postnatal Depression Scalemean scores 102
Chapter 6 Results for selective preventive intervention studies 103Characteristics of randomised controlled trials of selective preventive interventions 103
Description of qualitative studies of selective preventive interventions 104Selective preventive interventions psychological interventions 105
Characteristics and main outcomes of randomised controlled trials of selectivepreventive interventions of psychological interventions 105Description and findings from qualitative studies of selective preventive interventionsof psychological interventions 105
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xi
Selective preventive interventions educational interventions 111Characteristics and main outcomes of randomised controlled trials of selectivepreventive intervention of educational interventions 111Description and findings from qualitative studies of selective preventive interventionsof educational interventions 111
Selective preventive interventions social support interventions 117Characteristics and main outcomes of randomised controlled trials of selectivepreventive interventions of social support 117
Selective preventive interventions pharmacological agents or supplements 122Characteristics and main outcomes of randomised controlled trials of selectivepreventive interventions of pharmacological agents or supplements 122
Selective preventive interventions midwifery-led interventions 122Characteristics and main outcomes of randomised controlled trials of selectivepreventive interventions of midwifery-led interventions 122Description and findings from qualitative studies of selective preventive interventionsof midwifery-led interventions 122
Selective preventive interventions organisation of maternity care 127Selective preventive interventions complementary and alternative medicine orother interventions 127Results from network meta-analysis for selective preventive interventions for EdinburghPostnatal Depression Scale threshold score 127
Results from network meta-analysis for selective preventive intervention for EdinburghPostnatal Depression Scale threshold score at 6 weeks postnatally 128Results from network meta-analysis for selective preventive intervention for EdinburghPostnatal Depression Scale threshold score at 3 months postnatally 130Results from network meta-analysis for selective preventive intervention for EdinburghPostnatal Depression Scale threshold score at 6 months postnatally 132Summary of results from network meta-analysis for selective preventive interventionsEdinburgh Postnatal Depression Scale threshold score 132
Results from network meta-analysis for selective preventive interventions for EdinburghPostnatal Depression Scale mean scores 135
Summary of results from network meta-analysis for selective preventive interventionsfor Edinburgh Postnatal Depression Scale mean scores 138
Chapter 7 Results for indicated preventive intervention studies 139Characteristics of randomised controlled trials of indicated preventive interventions 139
Description and findings from qualitative studies of indicated preventive interventions 139Indicated preventive interventions psychological interventions 141
Characteristics and main outcomes of randomised controlled trials of indicatedpreventive interventions of psychological interventions 141
Indicated preventive interventions educational intervention 141Characteristics and main outcomes of randomised controlled trials of indicatedpreventive interventions of educational interventions 141
Indicated preventive interventions social support 141Characteristics and main outcomes of randomised controlled trials of indicatedpreventive interventions of social support 141Description and findings from qualitative studies of indicated preventive interventionsof social support 158
Indicated preventive interventions pharmacological agents or supplements 158Characteristics and main outcomes of randomised controlled trials of indicatedpreventive interventions of pharmacological agents or supplements 158
CONTENTS
NIHR Journals Library wwwjournalslibrarynihracuk
xii
Indicated preventive interventions midwifery-led interventions 158Characteristics and main outcomes of randomised controlled trials of indicatedpreventive interventions of midwifery-led interventions 158
Indicated preventive interventions organisation of maternity care 163Characteristics and main outcomes of randomised controlled trials of indicatedpreventive interventions of organisation of maternity care 163Description and findings of qualitative studies of selective preventive interventions ofthe organisation of maternity care 163
Indicated preventive interventions complementary and alternative medicine orother interventions 165
Characteristics and main outcomes of randomised controlled trials of indicatedpreventive interventions of complementary and alternative medicine orother interventions 165
Results from network meta-analysis for indicated preventive interventions for EdinburghPostnatal Depression Scale threshold score 165
Results from network meta-analysis for indicated preventive intervention forEdinburgh Postnatal Depression Scale threshold scores at 6 weeks postnatally 168Results from network meta-analysis for indicated preventive intervention forEdinburgh Postnatal Depression Scale threshold scores at 3 months postnatally 169Results from network meta-analysis for indicated preventive intervention forEdinburgh Postnatal Depression Scale threshold scores at 4 months postnatally 171Results from network meta-analysis for indicated preventive intervention forEdinburgh Postnatal Depression Scale threshold scores at 6 months postnatally 172Summary of results from network meta-analysis for indicated preventive interventionfor Edinburgh Postnatal Depression Scale threshold scores 174
Results from network meta-analysis for indicated preventive intervention for EdinburghPostnatal Depression Scale mean scores 174
Summary of results from network meta-analysis for indicated preventive interventionfor Edinburgh Postnatal Depression Scale mean scores 177
Chapter 8 Results of realist synthesis what works for whom 179Introduction to Best Fit Realist Synthesis 179Results of the review 179Synthesis drawing upon realist approaches 179
Description of included personal and social support strategy studies 179Study respondents in the personal and social support strategy studies 180Study setting of the personal and social support strategy studies 180
Synthesis of findings across personal and social support strategy studies 180Searching for CLUSTER documents for realist synthesis 181Preliminary synthesis and construction of a theoretical model 181
Identification of provisional lsquobest fitrsquo conceptual framework for realist synthesis 183Population of the conceptual framework 183Identification of existing theory underpinning specific mechanisms 183
Development of a programme theory 191Group-based interventions 191Continuity of care 191Individual-centred interventions 192Considerations shared by group-based and individual-centred interventions 192Support to providers 193Components of the interventions 193Sustainability 194
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xiii
Construction of pathways or chains from lsquoifndashthenrsquo statements 194Mechanisms for improving appropriateness of strategies 194On adverse effects 195
Testing of the programme theory and integrating quantitative and qualitative findings 196Response from the service user group to optimal characteristics identified from thequalitativerealist reviews 197
Modifications to the list 197Additions to the list 197Additional nuances emerging from the consultation 200
Summary of findings from realist synthesis review 200
Chapter 9 Assessment of cost-effectiveness 203Systematic review of existing cost-effectiveness models 203
Identification of cost-effectiveness studies 203Study selection criteria and procedures for the health economics review 204Overview of papers included in the health economics review 204Population considered in the health economics review 204Interventions in the health economics review 209Health-related quality-of-life data in the health economics review 209Costs and health-care resources reported in the health economics review 210Main results reported in the health economics review 218Summary of appropriateness of previously published models 218
The de novo model 218The conceptual model 218Model parameters 220The effectiveness data for each intervention 220The incremental costs associated with each intervention 220The relationship between utility and Edinburgh Postnatal Depression Scale scores 226The relationship between total health costs and Edinburgh Postnatal DepressionScale scores 229The analyses undertaken 231
Results 232The estimated quality-adjusted life-year gain compared with usual care foreach intervention 232Calculating cost per quality-adjusted life-year values 235Producing cost-effectiveness acceptability curves 240Interpretation of the cost-effectiveness results produced 242Interventions for the universal preventive interventions 243Interventions for the selective preventive interventions 243Interventions for indicated preventive interventions 243Assessing the impact of using total health-care costs when these were availablerather than intervention costs 243
Value of information results 244Expected value of perfect information results 244Expected value of partial perfect information results 245Discussion of the assessment of cost-effectiveness of interventions 246
Chapter 10 Discussion 247Introduction 247Description of the interventions 247Levels of preventive intervention 248Conceptualisation of postnatal depression and the potential for prevention 248Focus of the included interventions 248
CONTENTS
NIHR Journals Library wwwjournalslibrarynihracuk
xiv
Network meta-analyses 249Clinical effectiveness of universal preventive interventions 249
Psychological interventions 249Pharmacological or supplements 249Midwifery-led interventions 250Universal preventive interventions not included in the network meta-analysis 250Summary of qualitative findings for universal preventive interventions 251
Clinical effectiveness of selective preventive interventions 251Psychological interventions 251Educational interventions 252Social support 252Summary of qualitative findings for selective preventive interventions 252
Clinical effectiveness of indicated preventive interventions 252Indicated preventive interventions not included in the network meta-analysis 252Social support 253Pharmacological or supplements 253Complementary and alternative medicine or other interventions 253Summary of qualitative findings for indicated preventive interventions 253
Economic analysis 253Limitations of the quantitative evidence base 254
Replication of interventions 254Moderators and mediators 254
Limitations of the included trials 255Quality of the trials 255Heterogeneity of trial participants 255Intervention provider 255Usual care in the UK 255Measures of depression 255Treatment end points 256Infant outcomes 256
Strengths of the review 256Limitations of the review 257Discussion of all qualitative findings 257The implications of the main findings of this review 258
Findings associated with the evidence base methodological implications 258Implications for future research in the prevention of postnatal depression 258
Implications for individual interventions 259
Chapter 11 Conclusion 261Implications from this review for further research 261Implications from this review for service provision 261Suggestions for research priorities 262
Acknowledgements 263
References 265
Appendix 1 Literature search strategies 297
Appendix 2 Randomised controlled trials and systematic reviews number retrieved 319
Appendix 3 Key journals hand-searched via electronic alerts 321
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xv
Appendix 4 Qualitative studies and mixed-methods studies number retrieved 323
Appendix 5 Reason for exclusion of quantitative studies 325
Appendix 6 Data extraction 335
Appendix 7 Synthesis of findings from personal and social support strategy studies 339
Appendix 8 Included systematic reviews 351
Appendix 9 Qualitative review participant characteristics 353
Appendix 10 Studies omitted from the network meta-analysis 369
Appendix 11 Sensitivity analysis of Edinburgh Postnatal Depression Scalethreshold score data using vague prior distribution for the between-studystandard deviation 379
Appendix 12 Similarities and differences between group- and individual-basedapproaches 387
Appendix 13 Findings relating to a potential serviceintervention 389
Appendix 14 CLUSTERs receiving detailed examination 393
Appendix 15 Examples of lsquoifndashthenrsquo propositions used to refine lsquobest fitrsquo analyticframework 395
Appendix 16 TIDieR checklists for focal interventions 401
CONTENTS
NIHR Journals Library wwwjournalslibrarynihracuk
xvi
List of tables
TABLE 1 Risk of bias for included universal preventive intervention RCTssummary judgments about each risk-of-bias item 37
TABLE 2 Risk of bias for included selective preventive intervention RCTssummary judgments about each risk-of-bias item 39
TABLE 3 Risk of bias for included indicated preventive intervention RCTssummary judgements about each risk-of-bias item 40
TABLE 4 Qualitative studies quality assessment of the studies of universalpreventive interventions 45
TABLE 5 Synthesis of findings across all intervention studies what helped 47
TABLE 6 Synthesis of findings across all intervention studies what did not help 48
TABLE 7 Synthesis of findings across all intervention studies service delivery 49
TABLE 8 Synthesis of findings across all intervention studies service deliverybarriers to participation 49
TABLE 9 Synthesis of findings across all intervention studies health-careprofessionalsrsquo views on what helped 49
TABLE 10 Synthesis of findings across all intervention studies health-careprofessionalsrsquo views on what did not help 50
TABLE 11 Synthesis of findings across all intervention studies health-careprofessionalsrsquo views on service delivery 50
TABLE 12 Qualitative studies quality assessment of PSSSs 50
TABLE 13 Universal preventive interventions short-version descriptive labels 54
TABLE 14 Universal preventive interventions characteristics and main outcomesof RCTs of psychological interventions 56
TABLE 15 Qualitative study of universal preventive interventions description ofstudy evaluating a psychological intervention 60
TABLE 16 Universal preventive interventions characteristics and main outcomesof RCTs of educational interventions 62
TABLE 17 Universal preventive interventions characteristics and main outcomesof RCTs of social support 66
TABLE 18 Qualitative studies of universal preventive interventions description ofstudies evaluating social support 68
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xvii
TABLE 19 Universal preventive interventions characteristics and main outcomesof RCTs of pharmacological agents or supplements 70
TABLE 20 Universal preventive interventions characteristics and main outcomesof RCTs of midwifery-led interventions 72
TABLE 21 Qualitative studies of universal preventive interventions description ofstudies evaluating midwifery-led interventions 77
TABLE 22 Universal preventive interventions characteristics and main outcomesof RCTs of organisation of maternity care 80
TABLE 23 Qualitative studies of universal preventive interventions description ofstudies evaluating organisation of maternity care 84
TABLE 24 Universal preventive interventions characteristics and main outcomesof RCTs of CAM or other 86
TABLE 25 Qualitative studies of universal preventive interventions description ofstudies evaluating CAM or other 88
TABLE 26 Universal preventive interventions NMAs overall summary of maineffects of interventions relative to usual care 102
TABLE 27 Selective preventive interventions short-version descriptive labels 104
TABLE 28 Selective preventive interventions characteristics and outcomes ofRCTs of psychological interventions 106
TABLE 29 Qualitative study of selective preventive interventions characteristicsof studies evaluating psychological interventions 110
TABLE 30 Selective preventive interventions characteristics and outcomes ofRCTs of educational interventions 112
TABLE 31 Qualitative studies characteristics of studies evaluatingeducational interventions 116
TABLE 32 Selective preventive interventions characteristics and outcomes ofRCTs of social support interventions 118
TABLE 33 Selective preventive interventions characteristics and outcomes ofRCTs of pharmacological agents or supplements 123
TABLE 34 Selective preventive interventions characteristics and outcomes ofRCTs of midwifery-led interventions 124
TABLE 35 Qualitative studies of selective preventive interventions description ofstudies of midwifery-led intervention 126
TABLE 36 Selective preventive interventions NMAs overall summary of maineffects of interventions relative to usual care 134
LIST OF TABLES
NIHR Journals Library wwwjournalslibrarynihracuk
xviii
TABLE 37 Indicated preventive interventions short-version descriptive labels 140
TABLE 38 Indicated preventive interventions characteristics and outcomes ofRCTs of psychological interventions 142
TABLE 39 Indicated preventive interventions characteristics and outcomes ofRCTs of educational interventions 154
TABLE 40 Indicated preventive interventions characteristics and outcomes ofRCTs evaluating social support 156
TABLE 41 Qualitative studies of indicated preventive interventionscharacteristics of studies evaluating social support 159
TABLE 42 Indicated preventive interventions characteristics and outcomes ofRCTs evaluating pharmacological interventions or supplements 160
TABLE 43 Indicated preventive interventions characteristics and outcomes ofRCTs evaluating midwifery-led interventions 162
TABLE 44 Qualitative studies of indicated preventive interventionscharacteristics of studies evaluating organisation of maternity care 164
TABLE 45 Indicated preventive interventions characteristics and outcomes ofRCTs evaluating CAM or other 166
TABLE 46 Indicated preventive interventions NMAs overall summary of maineffects of interventions relative to usual care 178
TABLE 47 Thirteen focal interventions for exploration by realist review principles 180
TABLE 48 Results for citation searches of index papers for realist synthesis 182
TABLE 49 Dimensions of the featured interventions how it is delivered 183
TABLE 50 Dimensions of the featured interventions who is involved 183
TABLE 51 Specific theories underpinning mechanisms 185
TABLE 52 Programme theories for preventing PND 187
TABLE 53 Mechanisms and underpinning theory for generic group and one-to-oneapproaches 188
TABLE 54 Matrix indicating presence or absence of reported features withoverall assessment of effectiveness 198
TABLE 55 Reasons for exclusion of full papers in the health economics review 204
TABLE 56 Economic evaluations and the cost study included in the healtheconomics review 205
TABLE 57 Economic decision models included in the health economics review 208
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xix
TABLE 58 Costs used in economic evaluations included in the healtheconomics review 211
TABLE 59 Costs by matrices A B and C derived from trial of midwiferyredesigned postnatal care 216
TABLE 60 Staff costs from the Unit Costs of Health and Social Care 221
TABLE 61 Assumed intervention costs for the universal preventive interventions 223
TABLE 62 Assumed intervention costs for the selective preventive interventions 224
TABLE 63 Assumed intervention costs for the indicated preventive interventions 225
TABLE 64 Assumed relationship between EPDS and SF-6D scores used withinthe model 231
TABLE 65 Illustration of EVPI calculation 232
TABLE 66 Cost per QALY values for the universal preventive interventionsbase case 235
TABLE 67 Cost per QALY values for the selective preventive interventions base case 236
TABLE 68 Cost per QALY values for the indicated preventive interventions base case 237
TABLE 69 Cost per QALY values for the universal preventive interventionssensitivity analysis 238
TABLE 70 Cost per QALY values for the selective preventive interventionssensitivity analysis 239
TABLE 71 Cost per QALY values for the indicated preventive interventionssensitivity analysis 240
LIST OF TABLES
NIHR Journals Library wwwjournalslibrarynihracuk
xx
List of figures
FIGURE 1 Overview of review methods 14
FIGURE 2 The Preferred Reporting Items for Systematic Reviews andMeta-Analyses (PRISMA) flow chart of studies included in the quantitative review 34
FIGURE 3 Risk-of-bias graph for all included RCTs authorrsquos judgements abouteach risk-of-bias item 42
FIGURE 4 The Preferred Reporting Items for Systematic Reviews andMeta-Analyses (PRISMA) flow chart of studies included in the qualitative review 43
FIGURE 5 Universal preventive interventions EPDS threshold score at 6 weekspostnatally network of evidence 90
FIGURE 6 Universal preventive interventions EPDS threshold score at 6 weekspostnatally odds ratios for all treatment comparisons 91
FIGURE 7 Universal preventive interventions EPDS threshold score at 6 weekspostnatally probability of treatment rankings (ranks 1ndash6) 91
FIGURE 8 Universal preventive interventions EPDS threshold score at 3 monthspostnatally network of evidence 92
FIGURE 9 Universal preventive interventions EPDS threshold score at 3 monthspostnatally odds ratios for all treatment comparisons 93
FIGURE 10 Universal preventive interventions EPDS threshold score at 3 monthspostnatally probability of treatment rankings (ranks 1ndash5) 93
FIGURE 11 Universal preventive interventions EPDS threshold score at 6 monthspostnatally network of evidence 94
FIGURE 12 Universal preventive interventions EPDS threshold score at 6 monthspostnatally odds ratios all treatment comparisons 94
FIGURE 13 Universal preventive interventions EPDS threshold score at 6 monthspostnatally probability of treatment rankings (ranks 1ndash6) 95
FIGURE 14 Universal preventive interventions EPDS threshold score at 12 monthspostnatally network of evidence 95
FIGURE 15 Universal preventive interventions EPDS threshold score at 12 monthspostnatally odds ratios for all treatment comparisons 96
FIGURE 16 Universal preventive interventions EPDS threshold score at 12 monthspostnatally probability of treatment rankings (ranks 1ndash4) 96
FIGURE 17 Universal preventive interventions EPDS mean scores networkof evidence 98
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xxi
FIGURE 18 Universal preventive interventions EPDS mean scores meandifferences of treatment comparisons vs usual care across all time points 99
FIGURE 19 Universal preventive interventions EPDS mean scores probability oftreatment rankings at 6ndash8 weeks postnatally (ranks 1ndash6) 100
FIGURE 20 Universal preventive interventions EPDS mean scores probability oftreatment rankings at 3ndash4 months postnatally (ranks 1ndash7) 100
FIGURE 21 Universal preventive interventions EPDS mean scores probability oftreatment rankings at 6ndash7 months postnatally (ranks 1ndash8) 101
FIGURE 22 Universal preventive interventions EPDS mean scores probability oftreatment rankings at 12 months postnatally (ranks 1ndash4) 101
FIGURE 23 Selective preventive interventions EPDS threshold score at 6 weekspostnatally network of evidence 128
FIGURE 24 Selective preventive interventions EPDS threshold score at 6 weekspostnatally odds ratios all treatment comparisons 129
FIGURE 25 Selective preventive interventions EPDS threshold score at 6 weekspostnatally probability of treatment rankings (ranks 1ndash4) 130
FIGURE 26 Selective preventive interventions EPDS threshold score at 3 monthspostnatally network of evidence 130
FIGURE 27 Selective preventive interventions EPDS threshold score at 3 monthspostnatally odds ratios all treatment comparisons 131
FIGURE 28 Selective preventive interventions EPDS threshold score at 3 monthspostnatally probability of treatment rankings (ranks 1ndash4) 132
FIGURE 29 Selective preventive interventions EPDS threshold score at 6 monthspostnatally network of evidence 133
FIGURE 30 Selective preventive interventions EPDS threshold score at 6 monthspostnatally odds ratios all treatment comparisons 133
FIGURE 31 Selective preventive interventions EPDS threshold score at 6 monthspostnatally probability of treatment rankings (ranks 1ndash3) 134
FIGURE 32 Selective preventive interventions EPDS mean scores network of evidence 135
FIGURE 33 Selective preventive interventions EPDS mean scores meandifferences of treatment comparisons vs usual care across all time points 136
FIGURE 34 Selective preventive interventions EPDS mean scores probability oftreatment rankings at 6ndash8 weeks postnatally (ranks 1ndash3) 136
FIGURE 35 Selective preventive interventions EPDS mean scores probability oftreatment rankings at 3ndash4 months postnatally (ranks 1ndash3) 137
LIST OF FIGURES
NIHR Journals Library wwwjournalslibrarynihracuk
xxii
FIGURE 36 Selective preventive interventions EPDS mean scores probability oftreatment rankings at 6ndash7 months postnatally (ranks 1ndash3) 137
FIGURE 37 Selective preventive interventions EPDS mean scores probability oftreatment rankings at 12 months (ranks 1ndash4) 138
FIGURE 38 Indicated preventive interventions EPDS threshold score at 6 weekspostnatally network of evidence 168
FIGURE 39 Indicated preventive interventions EPDS threshold score at 6 weekspostnatally odds ratios all treatment comparisons 168
FIGURE 40 Indicated preventive interventions EPDS threshold score at 6 weekspostnatally probability of treatment rankings (ranks 1ndash5) 169
FIGURE 41 Indicated preventive interventions EPDS threshold score at 3 monthspostnatally network of evidence 169
FIGURE 42 Indicated preventive interventions EPDS threshold score at 3 monthspostnatally odds ratios all treatment comparisons 170
FIGURE 43 Indicated preventive interventions EPDS threshold score at 3 monthspostnatally probability of treatment rankings 170
FIGURE 44 Indicated preventive interventions EPDS threshold score at 4 monthspostnatally network of evidence 171
FIGURE 45 Indicated preventive interventions EPDS threshold score at 4 monthspostnatally odds ratios all treatment comparisons 171
FIGURE 46 Indicated preventive interventions EPDS threshold score at 4 monthspostnatally probability of treatment rankings (ranks 1ndash3) 172
FIGURE 47 Indicated preventive interventions EPDS threshold score at 6 monthspostnatally network of evidence 172
FIGURE 48 Indicated preventive interventions EPDS threshold score at 6 monthspostnatally odds ratios all treatment comparisons 173
FIGURE 49 Indicated preventive interventions EPDS threshold score at 6 monthspostnatally probability of treatment rankings (ranks 1ndash4) 173
FIGURE 50 Indicated preventive interventions for EPDS mean scores networkof evidence 174
FIGURE 51 Indicated preventive interventions EPDS mean scores meandifferences of treatment comparisons vs usual care across all time points 175
FIGURE 52 Indicated preventive interventions EPDS mean scores probability oftreatment rankings at 6ndash8 weeks postnatally (ranks 1ndash5) 176
FIGURE 53 Indicated preventive interventions EPDS mean scores probability oftreatment rankings at 3ndash4 months postnatally (ranks 1ndash6) 176
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xxiii
FIGURE 54 Indicated preventive interventions EPDS mean scores probability oftreatment rankings at 6ndash7 months postnatally (ranks 1ndash7) 177
FIGURE 55 Indicated preventive interventions EPDS mean scores probability oftreatment rankings at 12 months (ranks 1ndash4) 177
FIGURE 56 Analytical framework to evaluate group visits 184
FIGURE 57 The ways in which lsquoifndashthenrsquo statements might illuminate pathways forindividual approaches 194
FIGURE 58 The ways in which lsquoifndashthenrsquo statements might illuminate pathways forgroup approaches 195
FIGURE 59 The PRISMA flow chart of studies included in the healtheconomics review 203
FIGURE 60 An illustrative example of calculating the area under the curve whendata for an intervention are available for all time points 219
FIGURE 61 An illustrative example of calculating the area under the curve whendata for an intervention are available only at time point 3 219
FIGURE 62 The relationship between EPDS and SF-6D scores at 6 weeks 227
FIGURE 63 The relationship between EPDS and SF-6D scores at 6 months 227
FIGURE 64 The relationship between EPDS and SF-6D scores at 12 months 228
FIGURE 65 The relationship between EPDS and SF-6D scores using data at both6 and 12 months 228
FIGURE 66 The relationship between EPDS score and total health costs at 6 weeks 229
FIGURE 67 The relationship between EPDS score and total health costs at 6 months 230
FIGURE 68 The relationship between EPDS score and total health costs at12 months 230
FIGURE 69 The estimated incremental QALYs per woman compared with usualcare associated with each universal preventive intervention 233
FIGURE 70 The estimated incremental QALYs per woman compared with usualcare associated with each selective preventive intervention 234
FIGURE 71 The estimated incremental QALYs per woman compared with usualcare associated with each indicated preventive intervention 234
FIGURE 72 The CEAC for the universal preventive interventions 241
FIGURE 73 The CEAC for the selective preventive interventions 241
FIGURE 74 The CEAC for the indicated preventive interventions 242
LIST OF FIGURES
NIHR Journals Library wwwjournalslibrarynihracuk
xxiv
FIGURE 75 The EVPI associated with the universal preventive interventions 244
FIGURE 76 The EVPI associated with the selective preventive interventions 244
FIGURE 77 The EVPI associated with the indicated preventive interventions 245
FIGURE 78 Results of the EVPI and EVPPI analyses 245
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xxv
List of boxes
BOX 1 Symptoms indicating a major depressive episode 1
BOX 2 Population dimension of the PICOS framework for quantitative review 16
BOX 3 Intervention dimension of the PICOS framework for quantitative review 17
BOX 4 Outcome dimension of the PICOS framework for quantitative review 18
BOX 5 Study design dimension of the PICOS framework for quantitative review 19
BOX 6 Population dimension of the PICOS framework for qualitative studies 28
BOX 7 Study design dimension of the PICOS framework for the qualitative studies 28
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xxvii
Glossary
Beck Depression Inventory A 21-item self-report scale used to determine depression severity Items arescored on a 0ndash3 scale giving a total score range of 0ndash63 Total scores within the 1ndash9 range indicateminimal depression 10ndash18 indicate mild depression 19ndash29 indicate moderate depression and 30ndash63indicate severe depression
Center for Epidemiological Studies Depression Scale A short self-report scale designed to measuredepressive symptomology in the general population The 20-item scale has a possible range of scores from0 to 60 with higher scores indicating more symptoms weighted by frequency of occurrence during thepast week
Cognitivendashbehavioural therapy The pragmatic combination of concepts and techniques from cognitiveand behaviour therapies common in clinical practice Cognitivendashbehavioural therapy aims to facilitatethrough collaboration and guided discovery recognition and re-evaluation of negative thinking patternsand practising new behaviours
Edinburgh Postnatal Depression Scale The most widely used self-report scale designed to measurepostnatal depression symptomology The scale consists of a 10-item Likert format relating to depressionand anxiety symptomology Items are scored on a 0ndash3 scale to give a total range of 0ndash30 Total scoreswithin the 12ndash30 range suggest significant depression
Indicated preventive interventions Interventions offered to women at high risk of developing postnataldepression on the basis of psychological risk factors above-average scores on psychological measures orother indications of a predisposition to postnatal depression but who did not meet diagnostic criteria forpostnatal depression at that time
Interpersonal psychotherapy A time-limited structured and psychoeducational therapy which linksdepression to role transitions interpersonal disputes interpersonal sensitivity or losses It facilitatesunderstanding of recent events in these interpersonal terms and explores alternative ways of handlinginterpersonal situations
Multipara A woman who has given birth two or more times
Network meta-analysis An extension of a standard meta-analysis which enables a simultaneouscomparison of all evaluated interventions in a single coherent analysis Thus all interventions can becompared with one another including comparisons not evaluated within individual studies To perform anetwork meta-analysis each study must be linked to at least one other study through having at least oneintervention in common
Postnatal depression (also known as postpartum depression) A non-psychotic depressive episodemeeting standardised diagnostic criteria for a minor or major depressive disorder beginning in orextending into the postnatal period
Selective preventive interventions Interventions offered to women or subgroups of the populationwhose risk of developing postnatal depression was significantly higher than average because they had oneor more social risk factors
Universal preventive interventions Interventions available for all women in a defined population notidentified on the basis of increased risk for postnatal depression
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xxix
List of abbreviations
AMED Allied and ComplementaryMedicine Database
ASSIA Applied Social Sciences Indexand Abstracts
BDI Beck Depression Inventory
CAM complementary and alternativemedicine
CASP Critical Appraisal Skills Programme
CBA cognitivendashbehavioural approach
CBT cognitivendashbehavioural therapy
CEAC cost-effectiveness acceptabilitycurve
CENTRAL Cochrane Central Register ofControlled Trials
CERQual Confidence in the Evidence fromReviews of Qualitative research
CES-D Center for Epidemiologic StudiesDepression scale
CINAHL Cumulative Index to Nursing andAllied Health Literature
CLUSTER Citations Lead authorsUnpublished materials Scholarsearches Theories Early examplesRelated projects
CODA Convergence Diagnostic andOutput Analysis
CORE-OM Clinical Outcomes in RoutineEvaluation-Outcome Measure
CPCI-S Conference Proceedings CitationIndexndashScience
CRCT cluster randomised controlled trial
CrI credible interval
DARE Database of Abstracts of Reviewsof Effects
DHA docosahexaenoic acid
DSM-IV Diagnostic and Statistical Manualof Mental Disorders-Fourth Edition
DSM-V Diagnostic and Statistical Manualof Mental Disorders-Fifth Edition
EP Expert Patient
EPA eicosapentaenoic acid
EPDS Edinburgh Postnatal DepressionScale
EVPI expected value of perfectinformation
EVPPI expected value of partial perfectinformation
GP general practitioner
HADS Hospital Anxiety and DepressionScale
HIV human immunodeficiency virus
HTA Health Technology Assessment
ICD-10 International Classification ofDiseases Tenth Edition
ICER incremental cost-effectiveness ratio
IPT interpersonal psychotherapy
MBE mindndashbody exercise
MCS mental component summary
MDU Midwifery Development Unit
MIDIRS Midwives Information andResource Service
NHS EED NHS Economic Evaluation Database
NICE National Institute for Health andCare Excellence
NMA network meta-analysis
NMB net monetary benefit
PCA person-centred approach
PCS physical component summary
PHQ Patient Health Questionnaire
PICOS population interventioncomparators outcomes studydesigns
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xxxi
PND postnatal depression
PoNDER PostNatal Depression Economicevaluation and Randomisedcontrolled trial
PPI patient and public involvement
PRISM Program of Resources Informationand Support for Mothers
PRISMA Preferred Reporting Items forSystematic Reviews andMeta-Analyses
PSA probabilistic sensitivity analysis
PSI Parenting Stress Index
PSS Perceived Stress Scale
PSSS personal and social supportstrategy
QALY quality-adjusted life-year
RCT randomised controlled trial
ROSE Reach Out Stand strong Essentialsfor new mothers
SCAN Schedule for Clinical Assessmentin Neuropsychiatry
SCID Structured Clinical Interview forDiagnostic and Statistical Manualof Mental Disorders
SD standard deviation
SF-12 Short Form questionnaire-12 items
SF-36 Short Form questionnaire-36 items
SF-6D Short-Form 6-Dimensions
STAI StatendashTrait Anxiety Inventory
TIDieR template for interventiondescription and replication
LIST OF ABBREVIATIONS
NIHR Journals Library wwwjournalslibrarynihracuk
xxxii
Plain English summary
What was the problem
Mental health problems during pregnancy and after childbirth can have an enduring effect on women andtheir developing babies It is important to identify women with mental health problems as early as possiblein order to help them and their children
What did we do
This research reviewed studies which looked at preventing depression in mothers with a baby less than1 year of age The studies examined interventions offered (1) to all women (which we called lsquouniversalrsquo)(2) to women at risk because of social circumstances (lsquoselectiversquo) and (3) to women at higher risk becauseof a link to depression (lsquoindicatedrsquo) We also reviewed what made interventions acceptable to women andwhether or not interventions made the best use of NHS resources Women who had experienceddepression in pregnancy and after childbirth were involved in the research
What did we find
The included studies did not reveal a clear pattern Extra visits from a midwife a health visitor trainedin person-centred approaches (PCAs) or cognitivendashbehavioural therapy (CBT)-based approaches helped inuniversal coverage Education on preparing for parenting or interpersonal therapy-based interventionseemed useful in the selective group Helping parents interact with their baby peer support andapproaches based on CBT or PCA seemed favourable in the indicated group The interventions whichappeared to be most cost-effective were midwifery redesigned postnatal care (universal) education onpreparing for parenting (selective) and PCA-based intervention (indicated)
The research confirmed that women valued seeing the same health-care worker (building trustingrelationships) and their partnersrsquo involvement
What does this mean
It is difficult to conclude on the value of these interventions and further research is necessary We needbetter ways of measuring depression and its costs and need to involve more women in future research
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xxxiii
Scientific summary
Background
Postnatal depression (PND) is a serious public health issue affecting 7ndash13 of women in the yearfollowing childbirth The strongest predictors of PND are antenatal anxiety depression history lack ofsocial support low self-esteem stressful life events poor marital relationship and domestic violenceSevere PND is associated with suicide and infanticide especially when a woman has psychotic symptoms
The prevention of PND is an important neglected area in the UK with NHS effort directed towardstreatment rather than prevention A range of psychological educational pharmacological social supportalternative and other interventions has been explored to minimise the development intensity and durationof maternal depressive symptoms and their potential impact on the infant Previous systematic reviewsprovided conflicting reports about the effectiveness of PND preventive interventions
Preventive approaches relevant to PND are
l universal preventive interventions targeting a population not at increased risk for PNDl selective preventive interventions for women perceived to be at risk for PND because of social factorsl indicated preventive interventions for women at risk of PND because of history predisposition or above
average scores on psychological measures but not meeting diagnostic criteria
Aims and objectives
The aims of this study were to
1 evaluate the clinical effectiveness cost-effectiveness acceptability and safety of antenatal and postnatalinterventions to prevent PND in pregnant and postnatal women
2 apply rigorous methods of systematic reviewing of quantitative and qualitative studies evidencesynthesis and decision-analytic modelling to evaluate the preventive impact on women their infants andtheir families
3 and estimate cost-effectiveness
The objectives were to
(a) determine the clinical effectiveness of antenatal and postnatal interventions for preventing PND(systematic review of quantitative research)
i to identify moderators and mediators of the effectiveness of preventive interventionsii to undertake a network meta-analysis (NMA) of available evidence as appropriate
(b) provide a detailed service user and provider perspective on uptake acceptability and potential harmsof antenatal and postnatal interventions (systematic review of qualitative research)
i to examine the main service models for prevention of PND in relation to the underlying programmetheory and mechanisms focusing on group- and individual-based approaches (realist synthesis)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xxxv
(c) to undertake a systematic review of economic evaluations in the area and identify other evidenceneeded to populate an economic model
(d) to determine the potential value of collecting further data on input parameters (expected value ofinformation analysis)
Clinical effectiveness review methods
Data sourcesA comprehensive search of MEDLINE MEDLINE In-Process amp Other Non-Indexed Citations EMBASE TheCochrane Library (Cochrane Systematic Reviews Database of Abstracts of Reviews of Effects CochraneCentral Register of Controlled Trials NHS Economic Evaluation Database Health Technology Assessmentdatabases) Cumulative Index to Nursing and Allied Health Literature PsycINFO Science Citation Index andConference Proceedings (Web of Science) National Institute for Health Research Health TechnologyAssessment Programme Applied Social Sciences Index and Abstracts Allied and Complementary MedicineDatabase and Midwives Information and Resource Service Reference Database (from inception to July 2013)in December 2012 and electronic alerts update until July 2013 The following trial databases weresearched (from inception to July 2013) Current Controlled Trials ClinicalTrialsgov and the World HealthOrganizationrsquos International Clinical Trials Registry Platform Reference tracking of relevant studies wasperformed Reference lists of relevant reviews were scrutinised Searches were restricted to English-language literature with no restriction by date
Inclusionexclusion criteria
PopulationThe study population comprised all pregnant women (universal) pregnant women at risk of developingPND because of social factors (selective) pregnant women at risk of developing PND because ofpsychological risk factors above average scores on psychological measures indications of a predispositionto PND (indicated) all postnatal women in their first 6 postnatal weeks (universal) (or first postnatal yearfor the qualitative review) postnatal women at risk of developing PND because of social factors (selective)and postnatal women at risk of developing PND because of psychological risk factors above averagescores on psychological measures and indications of a predisposition to PND but not diagnosed withdepression (indicated)
InterventionsAll interventions suitable for pregnant women and women in the first 6 postnatal weeks were included
ComparatorsAll usual care and enhanced usual-care control and active comparisons were considered
OutcomesIn the review of the quantitative and the qualitative research all outcomes reported were includedKey outcomes were measures of depressive symptoms such as the Edinburgh Postnatal Depression Scale(EPDS) depression diagnostic instruments and infant outcomes
Data extractionThe general principles recommended in the Preferred Reporting Items for Systematic Reviews andMeta-Analyses (PRISMA) statement were used For the quantitative studies two independent reviewersscreened all records and extracted data disagreements were resolved through consensus The risk of biasof included randomised controlled trials (RCTs) was assessed using Cochranersquos risk-of-bias tool For theincluded qualitative studies data extraction was undertaken by one reviewer using a tailored dataextraction framework developed to elicit data extraction elements related directly to the review questionand 20 of extractions were checked by a second reviewer The methodological quality of individual
SCIENTIFIC SUMMARY
NIHR Journals Library wwwjournalslibrarynihracuk
xxxvi
studies was appraised by two reviewers independently using an abbreviated version of the CriticalAppraisal Skills Programme (CASP) quality assessment tool for qualitative studies and the CERQual(Confidence in the Evidence from Reviews of Qualitative research) approach was used to assess the certaintyof the findings
Data synthesisExtracted data and quality assessment variables were presented in tables with narrative descriptionThe evidence was synthesised using a NMA which enabled a simultaneous comparison of all evaluatedinterventions in a single coherent analysis Evidence from RCTs presenting data at any assessment time upto 12 months postnatally was relevant to the decision problem The analysis of the EPDS score data wasconducted in two stages (1) a treatment-effects model in which the effect of each intervention wasestimated relative to usual care and (2) a baseline (ie usual-care) model in which the absolute responseto usual care was estimated The estimates of treatment effects relative to usual care were combined withthe baseline model to provide estimates of absolute responses for each intervention these estimates wereused as inputs to the economic model
Qualitative meta-synthesis was undertaken by highlighting womenrsquos and service providersrsquo issues aroundthe acceptability of interventions elucidating evidence around personal and social support strategies(PSSSs) employed by women using the data extraction framework and thematic synthesis to aggregate thefindings Evidence about interventions from women and from service providers and evidence about PSSSswere presented separately
Clinical effectiveness summary results
For the quantitative studies 3072 records were identified through electronic searches In total 122 papers(representing 86 unique studies of preventive interventions) were included of which 37 studies were ofuniversal preventive interventions 20 were of selective interventions and 30 were of indicated interventions(one study included both indicated and universal preventive interventions) The highest levels of assessedrisk of bias were for selection bias [9 of 86 RCTs (105)] and for attrition andor analysis bias [8 of 86 RCTs(93)] The universal preventive intervention studies had greater risks of bias than the selective andindicated preventive interventions this was most notable for selection bias and attrition bias There was aconsistent lack of clarity about the allocation method the use of a non-random process how the baselinewas defined and how this affected initiation of an intervention
A further 23 relevant systematic reviews were identified which revealed one additional study
Universal preventive interventionsThe results were inconclusive from the set of interventions which formed a network The mostbeneficial interventions at 12 months shown by difference in the mean EPDS score appeared to bemidwifery redesigned postnatal care [ndash143 95 credible interval (CrI) ndash400 to 136] person-centredapproach (PCA)-based intervention (ndash097 95 CrI ndash354 to 171) and cognitivendashbehavioural therapy(CBT)-based intervention (ndash078 95 CrI ndash341 to 191)
Selective preventive interventionsNot all interventions were evaluable and the treatment effects were inconclusive Interpersonalpsychotherapy (IPT)-based intervention appeared to be beneficial as indicated by difference in mean3-month EPDS score (ndash185 95 CrI ndash560 to 214) Education on preparing for parenting appeared to bebeneficial as indicated by the difference in mean 6-month EPDS score (ndash132 95 CrI ndash354 to 110)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xxxvii
Indicated preventive interventionsNot all interventions were evaluable and the NMA showed that in general the treatment effects wereinconclusive The difference in mean 6-month EPDS score was ndash425 (95 CrI ndash778 to 043) for IPT-basedintervention The difference in 12-month mean EPDS score was ndash218 (95 CrI ndash539 to 115) for PCA-basedintervention and ndash218 (95 CrI ndash539 to 115) for CBT-based intervention The difference in the 6-weekmean EPDS score was ndash112 (95 CrI ndash435 to 193) for promoting parentndashinfant interaction for peer supportand the difference in 3-month EPDS score was ndash093 (95 CrI ndash511 to 332)
Cost-effectiveness review methods
A comprehensive search of published economic evaluations was performed One reviewer independentlyscreened titles and abstracts with discussion about uncertainty and consensus agreement A mathematicalmodel was constructed to explore the cost-effectiveness of interventions contained within the NMA versususual care An area under the curve approach was employed alongside mapping from the EPDS valuesto a preference-based utility score Short Form 6-Dimensions (SF-6D) The time horizon was 1 yearamended to 2 years in a sensitivity analysis Expected value of partial perfect information (EVPPI) analyseswere undertaken for efficacy data and for mapping the EPDS values to utility
Cost-effectiveness summary results
No economic evaluations were identified as appropriate for answering the decision problem and hence ade novo model was constructed The cost of the interventions relative to usual care ranged from costsaving to an increase of pound1200 per woman Assuming a willingness to pay of pound20000 per quality-adjustedlife-year (QALY) the most cost-effective interventions were estimated to be midwifery redesigned postnatalcare PCA-based intervention and CBT-based intervention (universal) education on preparing for pregnancy(selective) and PCA-based intervention (indicated) If a benefit of 2 years was assumed then an IPT-basedintervention was the most cost-effective indicated preventive intervention However there wasconsiderable uncertainty in these results The EVPPI for efficacy data was very large in excess of pound150Mfor each population
Qualitative review summary results
For the qualitative studies 2152 records were identified through all searches There were 56 recordsincluded (representing 44 unique studies) which were examined at full text In addition 27 papers(representing 21 unique studies of preventive interventions) were included of which 14 studies were ofuniversal preventive interventions three were of selective interventions and four were of indicatedinterventions The studies varied in quality Only six studies showed evidence of researcher reflexivityNo findings were assessed as being of high certainty by the CERQual approach The remaining 29 papers(23 studies) were concerned with PSSSs to prevent PND
Social support interventions provided emotional and informational support to women and group-basedapproaches may be a useful supplement provided that they do not prove to be too resource intensive orcreate unrealistic expectations of services Continuity of care was confirmed as an important operatoracross several interventions in that it enabled women to build up a relationship of trust with theirhealth-care provider
SCIENTIFIC SUMMARY
NIHR Journals Library wwwjournalslibrarynihracuk
xxxviii
Discussion
We undertook a rigorous systematic review and identified all relevant publications concerning the clinicaleffectiveness and cost-effectiveness interventions to prevent PND Although we appraised and summariseda very large number of studies the results of the review were inconclusive It is possible that usual carecould be the most effective intervention in all three populations
StrengthsThe analysis approach differs from that used in previous Cochrane reviews which did not distinguish betweeninterventions within studies in terms of control comparator or preventive approach Previous reviews usedstandardised effect sizes rather than EPDS values and also tended to not take into account the assessmenttime often taking the latest assessment time The qualitative review identified helpful features from thewomenrsquos and service providersrsquo perspectives as well as preferences for potential improvement
LimitationsThe NMA offers an advance on previous reviews Nevertheless there are some limitations with the currentanalysis (1) some studies were omitted because they did not provide EPDS values which may haveintroduced reporting or selection bias (2) no adjustment was made for the lack of quality associated withsome trials and treatment effects may therefore be overstated (3) the analysis assumed independence ofoutcomes within studies and independence of intervention effects between studies and (4) infantoutcomes were not examined in detail because of insufficient infant outcome data
Limitations with the cost-effectiveness analyses are that (1) interventions that did not report EPDS valueswere omitted from the analyses (2) the incremental costs for each strategy have by necessity beenestimated in a simplistic manner and costs of restructuring services have not been included (3) thepossibility of erroneous grouping of trials as a single intervention within indicated preventive interventionsand (4) simplistic assumptions have been made in estimating the area under the curve when data were notavailable for all time points
Limitations with providing a conclusion regarding the most cost-effective intervention are (1) absoluteQALY gains estimated are small for all interventions and (2) there is considerable uncertainty in thedirection of the estimates of QALY change compared with usual care for all interventions
The values of future research into the relative effectiveness of interventions were shown to be very high inall populations in the order of hundreds of millions of pounds which would be sufficient to cover the costof such research Although the relationship between EPDS values and utility was not shown to influencethe decision given current information future research should include collection of utility data In additiondetailed costing data for each intervention should be recorded
Research recommendationsOwing to the uncertainty associated with the results and the limitations highlighted above our overallresearch recommendations and conclusions are tentative Given the poor quality of the clinicaleffectiveness and cost-effectiveness evidence available replication of some studies is needed withingood-quality RCTs
l as a universal preventive intervention midwifery redesigned postnatal care PCA-based interventionand CBT-based intervention
l as a selective preventive intervention education on preparing for parenting peer support andIPT-based intervention
l as an indicated preventive intervention promoting parentndashinfant interaction peer support(telephone-based and Newpin volunteer support) and CBT- PCA- and IPT-based interventions
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
xxxix
Conclusions
As far as we are aware this is the most comprehensive review of the clinical effectiveness andcost-effectiveness acceptability and safety of antenatal and postnatal interventions for pregnant andpostnatal women to prevent PND Despite this no definitive conclusions can be drawn regarding the mostclinically effective or cost-effective intervention because of the uncertainty about the relative effectivenessof the interventions Several interventions would warrant replication Future RCTs estimating theeffectiveness of interventions considered acceptable to pregnant and postnatal women and the clinicalcommunity should be undertaken using the EPDS Given the EVPPI values future trials assessing therelative efficacies of promising interventions would appear to represent value for money
Study registration
This study is registered as PROSPERO CRD42012003273
Funding
Funding for this study was provided by the Health Technology Assessment programme of theNational Institute for Health Research
SCIENTIFIC SUMMARY
NIHR Journals Library wwwjournalslibrarynihracuk
xl
Chapter 1 Background
This chapter details the background to the report and presents an overview of postnatal depression(PND) the size and importance of the problem the need for prevention current service provision and
the approaches to interventions to prevent the condition
Description of health problem
Depression is a leading cause of life lived with disability PND also termed postpartum depression isdefined using standardised diagnostic criteria as a major depressive disorder in the year followingchildbirth1 PND has a wide range of symptoms measured in clinical practice and in research usingsymptom self-reports as a proxy for clinical assessment1 It is distinguished from the more transientlsquobaby bluesrsquo and the rarer and more acute puerperal psychosis Severe PND is associated with suicide andinfanticide especially when the woman has psychotic symptoms2
The Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V)3 does not recognise PNDas a separate diagnosis so to be diagnosed women must meet the criteria for depression The specifier islsquowith peripartum onsetrsquo (the most recent episode occurring during pregnancy and in the 4 weeks followingdelivery)4 The following symptoms must be present for at least 2 weeks to fulfil the criteria for majordepression a depressed mood or a loss of interest or pleasure in daily activities which represents a changefrom normal mood and a clinically significant distress or impairment in social occupational educational orother important areas of functioning Five or more of the symptoms in Box 1 must also be present for amajor depressive episode to be determined
In contrast the World Health Organizationrsquos International Classification of Diseases Tenth Edition (ICD-10)diagnosis code F53 is for mental disorders associated with the puerperium that is postnatal or postpartumdepression commencing within 6 weeks of delivery that do not meet the criteria for disorders classifiedelsewhere5 ICD-10 also requires several symptoms to be endorsed for a diagnosis of depression and mostcases of PND will meet criteria for disorders classified elsewhere ICD-10 uses key symptoms of persistentsadness or low mood andor loss of interest or pleasure fatigue or low energy at least one of thesesymptoms most days most of the time for at least 2 weeks If any of these are present associatedsymptoms such as disturbed sleep poor concentration or indecisiveness low self-confidence poor orincreased appetite suicidal thoughts or acts agitation or slowing of movements and guilt or self-blamedefine the degree of depression
BOX 1 Symptoms indicating a major depressive episode
1 Depressed mood most of the day almost every day indicated by subjective report or othersrsquo observations
2 Reduced interest or pleasure in all (or nearly all) activities for most of the day almost every day
3 Significant weight loss or weight gain or decrease or increase in appetite almost every day
4 Insomnia or hypersomnia almost every day
5 Psychomotor agitation or retardation almost every day
6 Fatigue or loss of energy almost every day
7 Feelings of worthlessness or excessive or inappropriate guilt almost every day
8 Diminished ability to think or concentrate or indecisiveness almost every day
9 Recurrent thoughts of death recurrent thoughts of suicide without a plan a plan for committing suicide or
a suicide attempt
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
1
PrevalencePostnatal depression is a public health problem46 which occurs in most cultures6ndash8 The prevalence of bothmajor or minor depression during the first postnatal year is 7ndash139 Among a sample of more than8000 women in England 13 scored 13 or more (the threshold to identify women with probable majordepression)2 on the Edinburgh Postnatal Depression Scale (EPDS)10 on at least one postnatal assessment11
Some women recover by the time their infant is 6 months old but in 50 of women depression can lastfor more than 6 months12 Although PND is defined as depression within the 12 months after the birth ofan infant a significant number of women remain depressed for over 1 year13 and some women remaindepressed for 4 years12
Although depression postnatally may not be different from depression occurring in non-pregnant womensome women become depressed for the first time postnatally some experience postnatal recurrence ofprevious depression13 and for others depression begins antenatally and continues postnatally14ndash16
Antenatal depression is the strongest predictor of PND14 being as common as PND with 184 of womenhaving depressive symptoms throughout pregnancy17 Antenatal anxiety is commonly comorbid withantenatal depression and also increases the likelihood of PND141518
Additional factors have consistently been associated with PND Some PND may be biologically mediatedand specifically linked to childbirth1 Some women with PND may be genetically more reactive to theenvironmental trigger for depression19 In other women who have a general vulnerability to depressionPND may occur because childbirth is a stressor1 The strongest predictors of PND are antenatal anxiety andantenatal depression14 lack of social support a history of depression neuroticism low self-esteemstressful life events during pregnancy poor marital relationship and domestic violence12021 Womenthemselves have reported that the causes of their PND were lack of support pressure to do things righttheir personality (prone to mental health problems) pressure (work or money) hormonal changes andresurfaced memories22 As the aetiology is diverse it is difficult to predict accurately which women willdevelop PND
Impact of health problemThe burden of PND can extend in its most severe form to suicide and less frequently infanticide23
The impact of PND on mothers is compounded by impairments to the motherndashinfant interaction24 andimpairments to the infantrsquos longer-term emotional cognitive behavioural and social development2526
The impact of withdrawn behaviour24 and vocally communicated sadness27 appears to be worsened whenwomen live in poorer socioeconomic circumstances and is worse if the infant is a boy2829 or if depressionbecomes a chronic problem3031 Additional later risks for infants are mediated through the effect of chronicdepression on the hypothalamicndashpituitaryndashadrenal axis functioning in offspring into adolescence253233
Depressed pregnant women have a greater risk of delivering a low-birthweight infant34 Antenataldepression is a risk factor for infant mood3335 and for depression in offspring at 18 years of age withhigher risk among offspring whose mothers are less educated1636 There is a potential impact on fathersaround 10 of whom are at risk of depression particularly during the 3ndash6 months after the infant isborn37 This depression is moderately positively correlated with maternal depression but it is unclear ifthere is an association or a causal influence and the direction of the influence if any is unknown37
Furthermore postnatal paternal depression is associated with depression in offspring16
BACKGROUND
NIHR Journals Library wwwjournalslibrarynihracuk
2
Current service provision
Variation in service and uncertainty about best practiceFree maternity care in the UK delivered predominantly by midwives and obstetricians providesopportunities for women to have contact with health-care services The National Institute for Health and CareExcellence (NICE) provides evidence-based guidelines for antenatal intrapartum and postnatal care and forantenatal and postnatal mental health38 Among those at low obstetric and medical risk nine antenatalconsultations are recommended for women expecting their first baby and seven consultations for thoseexpecting a subsequent child39 Most women give birth in hospital maternity units or in free-standing oralongside midwifery units and stay in for less than 2 days fewer than 3 give birth at home40
Traditionally in the UK hospital midwives have provided care in hospital for antenatal labouring and postnatalwomen Community midwifery teams have provided antenatal care in the community and postnatal careduring visits to the womanrsquos home community health centres and childrenrsquos centres for up to 28 days afterbirth Care is usually transferred on postnatal day 10 to the health visiting service and is provided by healthvisitors specially trained public health nurses Most health visitors now offer antenatal visits
National Institute for Health and Care Excellence guidance38 recommends that primary health-careprofessionals should routinely enquire about past and current mental illness and family history of perinatalmental illness at a womanrsquos first appointment in early pregnancy and postnatally (4ndash6 weeks and 3 or4 months) to identify predictive risk factors NICE guidance38 also recommends that midwives enquirewithin the first 24 hours after birth about a womanrsquos experience of her labour In some locationsmidwife-provided services have developed to provide an opportunity for women to discuss their birthexperiences but these do not always include access to formal psychological support
The community midwifersquos role includes an increased focus on improving public health and currentpre-registration midwifery education covers the identification of potential mental health issues forchildbearing women The Maternal Mental Health Pathway41 guidance focuses on the health visitorrsquos rolein maternal mental health and wellbeing during pregnancy and postnatally recognising the contribution ofmidwives mental health practitioners and general practitioners (GPs)
Other maternity support roles include maternity support workers and volunteers such as breastfeedingpeer supporters counsellors and doula support (women who provide support to other women) duringpregnancy labour and birth and the early postnatal period
Infrequently in the UK and more commonly in the USA and a small number of other countriesCenteringPregnancyreg (Centering Healthcare Institute Boston MA USA) is available4243 TheCenteringPregnancy44 approach provides group care to women at similar stages of pregnancy by means ofa health assessment and provision of education and peer support Health-care professionals help womento participate in their own care and to learn from each other about pregnancy and care of the new infant
Identification of postnatal and antenatal depressionThere has been a lack of consistency in the routine approach to the identification of PND94546 by primaryhealth-care professionals47 NICE advocates a case-finding approach for depressive symptoms38 based ontwo questions the Patient Health Questionnaire (PHQ)-2 from the PHQ-9 as follows4849 lsquoOver the last2 weeks how often have you been bothered by any of the following problemsrsquo (1) lsquoLittle interest orpleasure in doing thingsrsquo and (2) lsquoFeeling down depressed or hopelessrsquo49 The EPDS10 the Hospital Anxietyand Depression Scale (HADS)50 and the full PHQ-9 are to be used as follow-up tools as part of a fullerassessment process The EPDS is frequently used as it performs well for major and minor depression45 and isacceptable to women and health-care professionals51 The EPDS is not used systematically throughout theUK to identify depressive symptoms during pregnancy or postnatally partly because it lsquodoes not satisfy theNational Screening Committeersquos criteria for the adoption of a screening strategy as part of nationalhealth policyrsquo52
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
3
Current service costsApart from the distress for women and the potential long-term consequences for infants there areadditional public health social and economic consequences of maternal depression4 The cost of PND tothe UK government is estimated as pound45M53 to pound61M per year4 For each exposed child the estimatedcumulative economic costs of adverse child development linked to a motherrsquos depression is pound819054
The health-care costs associated with postnatal paternal depression have been estimated for fathers withdepression as pound11041 for fathers at high risk of developing depression as pound1075 and for fathers withoutdepression as pound945 at 2008 prices55 In New Zealand the potential value for money of implementation ofa PND screening programme was assessed and the programme was found to be cost-effective56 Incontrast following a cost-effectiveness analysis a system to identify PND in the UK was reported not torepresent value for money based on the assumed cost of false positives57 Little is known about theeconomic consequences of PND or the cost-effectiveness of interventions aiming to prevent or alleviatePND symptoms58 Substantial economic returns have been estimated for investment in the prevention ofmental health problems with potential long-term pay-offs continuing into adulthood59
Despite the lsquocase-findingrsquo approach to identify women at greater risk of PND mainly based on earlierexperience of mental health problems little attention is paid to the prevention of PND and no specificinstruments are available to reliably predict PND among asymptomatic women Some health visitors in theUK use the EPDS but this practice varies nationally It is likely that even less attention is paid to identifyingdepression and anxiety antenatally than postnatally
Description of technology under assessment
Preventive interventions for postnatal depressionThis section provides an overview of the rationale for the prevention of PND and a description ofapproaches that have been explored to prevent PND There is evidence of the effectiveness ofpharmacological60 and psychological interventions61ndash63 to treat PND within four main approaches generalcounselling interpersonal psychotherapy (IPT) cognitivendashbehavioural therapy (CBT) and psychodynamictherapy1 Prevention of a major depressive episode implies reducing the intensity duration and frequencyof depressive symptoms64
NHS England has provided a pound18M budget for public health responsibilities covering screeningimmunisation and health-visiting services65 Less than 5 of NHS funding in England is spent onprevention of all conditions65 The Marmot et al66 review aims to strengthen the role and impact ofill-health prevention prioritising prevention and early detection of mental health conditions and earlyintervention Traditionally primary secondary and tertiary prevention activities are designed respectivelyto reduce the risk of developing health problems to identify and manage pre-symptomatic ill health and toreduce the impact of the disease
Three levels of preventive intervention are relevant to the prevention of PND67
1 Universal preventive interventions are available to all women in a defined population not identified onthe basis of increased risk for PND
2 Selective preventive interventions are offered to women or subgroups of the population whose risk ofdeveloping PND are significantly higher than average because they have one or more social risk factors
3 Indicated preventive interventions are offered to women at high risk of developing PND on the basis ofpsychological risk factors above-average scores on psychological measures or other indications of apredisposition to PND but who do not meet diagnostic criteria for PND at that time
BACKGROUND
NIHR Journals Library wwwjournalslibrarynihracuk
4
Universal preventive approaches may be less stigmatising than selective preventive interventions but littleattention has been paid to universal prevention in pregnant women partly because the cost of a universalprogramme is likely to be high63 compared with a selective approach to identify higher-risk women Forexample 81 of women do not have an EPDS score 13 or more during pregnancy14 However there is arationale for providing a preventive intervention to women with subthreshold symptoms of depression whomay otherwise go on to develop depression1864
The outcomes for a selective intervention depend on how the population and risks are identified anddefined63 Although indicated preventive interventions for PND could be regarded as addressing prodromalsymptoms and therefore are not actually preventive they could be regarded as early intervention68
The rationale for antenatal prevention of PND is based on data from the Avon Longitudinal Study ofParents and Children study14 showing that 437 of women with an EPDS score 13 or more at 32 weeksof pregnancy experienced elevated symptoms postnatally Aiming to prevent identify and treat antenataldepression presupposes that this will lead to a reduction in antenatal maternal morbidity and severitydeleterious effects on the developing infant postnatal maternal morbidity and severity and other adverseoutcomes in the offspring1669 Hence investment during pregnancy and postnatally may yield futurebenefits and financial savings in different areas of health and social care
Evidence of preventive interventions
A wide range of support and treatment approaches have been explored because of the diverse aetiologyof PND (physiological social or psychological) with the aim of changing the mechanisms leading to PND68
Several interventions to prevent PND have been developed as modifications of promising interventions totreat PND These are classified as psychotherapeutic biological pharmacological educational or socialsupport Cochrane and other systematic reviews have provided some contradictory findings about thepotential to prevent PND Not enough is known about the effectiveness of these preventive interventions
Psychological approaches to the prevention and treatment of depressionThe psychological literature attests to the large effort expended on research into differing psychologicalapproaches to the prevention70 and treatment of depression71ndash75 Although depression has often been theinitial target condition for testing psychological approaches it has equally often proved to be a morechallenging condition when attempting to establish mechanisms of change that are specific to particularmodels of therapeutic interventions A review of 101 randomised controlled trials (RCTs) on the treatmentof major depression concluded that IPT CBT and behaviour therapy are effective while brief dynamictherapy and emotion-focused therapy are possibly effective72
A different body of literature suggests relatively small differences between the outcomes of differentpsychological interventions for depression An earlier review which controlled for researcher allegiance(belief in the superiority of a treatment) found small effect sizes from comparisons between specifictherapies73 This finding has been broadly supported in a meta-analysis of 58 outcome studies fordepression which made direct comparisons between specific therapies which yielded similarly small effectsizes74 However arguments suggesting that researcher allegiance bias is related to treatment effects havebeen both supported76 and challenged77
A wide-ranging review of the efficacy and effectiveness of psychological therapies in general concluded thatthey were broadly effective for depression with little difference between theoretically diverse interventions78
Estimates of the proportion of outcome variance attributable to components of therapy comprised thefollowing extra-therapeutic factors 40 (eg delivered individually or in a group or the number of sessions)relationship 30 placeboexpectancy effects 15 and specific techniques 157879 A subsequentmeta-analysis in which common factor control groups were employed supported these estimates80
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
5
Extensive efforts have been afforded in relation to the development of measures81 and the measurementof outcomes82 in psychotherapeutic interventions and the role of non-specific (common) factors such ascongruence positive regard and empathy has long been recognised8384 The account of broadly similaroutcomes despite diverse therapeutic interventions (termed the equivalence paradox)85 has yieldedsophisticated accounts to explain this phenomenon with the existence of common factors persisting asone major explanatory source85 However others have argued that there is no clear evidence supporting acausal link between common factors and therapeutic outcomes86 The debate is not so much focused onthe validity of the concept but rather on the absence of experimental manipulation as a route todetermining which common factors if any impact on therapeutic change The concepts of hope andexpectancy among others have been posited as common factors but the main focus for research hasbeen on the concept of the therapeutic relationship or alliance
Educational interventionsAttention has been paid to developing preventive strategies or interventions that focus on couplecommunication or parenting skills to ease the transition to parenthood87 Antenatal preparation forparenthood has traditionally focused on aspects of the womanrsquos pregnancy and on preparation forchildbirth with less attention paid to what to expect when the infant arrives or to couple communicationor parenting8889 Dyadic relationship quality is adversely affected90 in 67 of new mothers91 and 45 ofnew fathers92 during the first year of parenthood Despite the central role of partner support in maternalmood93 new parent couples have reported being shocked by and unprepared for adverse changes in theirrelationship feeling sad and bemused that no one had talked to them about the changes they wouldexperience in their relationships94
Some preventive educational interventions have been delivered universally to all expectant parents makinguse of the opportunities to access this population through established antenatal care pathways therebyreaching couples who may not otherwise seek such support95 These and more targeted approachescover a variety of levels of intensity and format and timings
Social supportSocial support is a multidimensional concept that incorporates appraisal companionship informationalmotivational and instrumental support that is lsquo information leading the subject to believe that they arecared for and loved esteemed and a member of a network of mutual obligationsrsquo96 Social supportinvolves both social relationships that are embedded such as relationships with family members or friendsand those that are created97
There are several pathways through which social relationships and social support can affect mental healthSocial support can operate to promote health directly by enhancing feelings of well-being or by bufferingthe negative influences of stressful events Integration in a social network might also directly producepositive psychological states including sense of purpose belonging and recognition of self-worth98 Thesepositive states in turn might benefit mental health because of an increased motivation for self-care aswell as the modulation of the neuroendocrine response to stress98 Being part of a social networkenhances the likelihood of accessing various forms of social support which in turn protects againstdistress99 Members of a social network can exert a salutary influence on mental health by role modellinghealth-relevant behaviours100
Several different psychosocial mechanisms link aspects of social relationships to physical and emotionalwell-being social influencesocial comparison social control role-based purpose and meaning (mattering)self-esteem sense of control belonging and companionship and perceived support availability101 Giventhe importance of social support on mental health outcomes enhancing social support has been used as astrategy for both the prevention and treatment of PND
BACKGROUND
NIHR Journals Library wwwjournalslibrarynihracuk
6
Pharmacological interventions or supplementsSome of the earliest interventions for the treatment and prevention of PND were hormonal Uncontrolledstudies used progesterone102ndash104 but no controlled studies have been conducted of progesterone oroestradiol as either a treatment or prevention
Compared with the results of trials supporting antidepressant treatment for major depression there is relativelylittle evidence to guide the clinician in treating or preventing PND The mainstay of treatment has beenantidepressant medication but women are reluctant to take antidepressants60 as they are concerned abouttheir safety when breastfeeding and the potential for side effects to disturb their interaction with their infant105
It has been reported that fish consumption and omega-3 status after childbirth are not associated withPND106 but there is still interest in exploring the role of omega-3 fatty acids in PND alone or combinedwith supportive psychotherapy107
Complementary and alternative medicineThis review adopts a generic definition of complementary and alternative medicine (CAM) lsquoA group ofdiverse medical and health-care systems practices and products that are not presently considered to bepart of conventional medicinersquo108 Although this definition meets with problems in many areas of medicalpractice in that what were once regarded as CAM are now provided as part of conventional medicalservice it works reasonably well in perinatal depression as CAMs are not generally provided inperinatal services
Complementary and alternative medicine is widely used by pregnant women in the Western worldparticularly those who are highly educated and have high incomes109 often to reduce stress and improvemood however their use remains controversial110 Controversy extends beyond the definition of CAM tothe nature of the effects of CAM and to the quality of CAM research CAM is also widely used by thegeneral public particularly women111112 many of whom do not report its use to their doctors It is oftenused to promote wellness in the positive holistic sense as well as in the management of symptoms anddisease CAM has been offered to women with the aim of treating both antenatal depression63113ndash115
and PND63116 alone or in combination
The CAM interventions most commonly explored in these studies include aromatherapy massagehypnosis and other forms of relaxation therapy herbal medicine mindfulness and meditation acupunctureand general traditional Chinese medicine Ayurvedic medicine and homeopathy Acupuncture is a popularform of treatment for depression outside the perinatal period and there is evidence that its effectivenessis equivalent to that of antidepressants117 and that side effects are rare Acupuncture in the context ofantenatal depression was examined by a Cochrane review118 that reported inconclusive evidence
Mindndashbody therapies have also been used to treat depression in general and in the perinatal periodspecifically116119 and for many there is some evidence of effectiveness120 Mindfulness has received specificattention in the context of perinatal depression121 and is supported by an evidence base showing that it iseffective in depression in general122
Yoga and tai chiqi gong are practised both alone and as a component of Ayurvedic and traditionalChinese medicine and are used by pregnant women to improve their health110119 The health effects ofthese traditional medical approaches are held to extend beyond physical fitness suppleness and strengthand they overlap with those of simple physical activity which has also been investigated as an interventionto reduce depressive symptoms in pregnant women123
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
7
Summary
In summary the prevention of PND is an important and somewhat neglected area in the UK in terms ofthe potential impact on women and their infants and families Within the NHS effort is currently directedtowards treating identified depression in perinatal women particularly postnatally A range ofpsychological educational pharmacological social support and CAM interventions have been explored tominimise the development of and the intensity duration and frequency of depressive symptoms The nextchapter defines the decision problem
BACKGROUND
NIHR Journals Library wwwjournalslibrarynihracuk
8
Chapter 2 Definition of the decision problem
Decision problem
The focus of this report is the prevention of PND and optimisation of the mental health of pregnant andpostnatal women and consequently the health of their infants
The population comprised all pregnant women (universal) pregnant women or subgroups whose risk ofdeveloping PND was significantly higher than average because they had one or more social risk factor(selective) and pregnant women at high risk of developing PND on the basis of psychological risk factorsabove-average scores on psychological measures or other indications of a predisposition to PND or diagnoseddepression (indicated) The population also included all postnatal women in their first 6 postnatal weeks(universal) postnatal women or subgroups whose risk of developing PND was significantly higher than averagebecause they had one or more social risk factor (selective) and postnatal women at high risk of developingPND on the basis of psychological risk factors above-average scores on psychological measures or otherindications of a predisposition to PND (indicated) but not postnatal women diagnosed with depression
All interventions suitable for pregnant women and women in the first 6 postnatal weeks were includedAll usual care and enhanced usual-care control and active comparisons were considered In the review ofboth the quantitative and the qualitative research literature all outcomes were considered
Overall aim and objectives of assessment
The overall aim of the report was to evaluate the clinical effectiveness cost-effectiveness acceptability andsafety of antenatal and postnatal interventions to prevent PND The purpose of the study was to applyrigorous methods of systematic reviewing of quantitative and qualitative studies evidence synthesis anddecision-analytic modelling to evaluate the preventive impact on women and their infants and families
The objectives of the review were as follows
1 to determine the clinical effectiveness of antenatal interventions and postnatal interventions to preventPND (systematic review of quantitative research)
a to identify moderators and mediators of the effectiveness of preventive interventionsb to undertake a meta-analysis of available evidence [including a network meta-analysis (NMA)
as appropriate]
2 to provide a detailed service user and service provider perspective on the uptake acceptability andpotential harms of antenatal and postnatal interventions (systematic review of qualitative research)
a to examine the main service models for prevention of PND in relation to the underlying programmetheory and mechanisms with a focus on group- and individual-based approaches (realist synthesis)
3 to undertake an economic analysis including a systematic review of economic evaluations and theidentification of other evidence needed to populate an economic model
4 to determine the potential value of collecting further information on all or some of the inputparameters (expected value of information analysis)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
9
Service user involvementThe Nottingham Expert Patient (EP) committee is a group of women who have experienced the distressingeffects of severe PND Three of the women in the group were admitted to a mother and baby unit and allreceived community psychiatric care The EP committee established in 2009 has acted as the patientsrsquolsquovoicersquo advising the East Midlands Perinatal Mental Health Clinical Network Board on how to develop localservices to meet the needs of women who experience mental health problems in pregnancy and afterchildbirth The EP committee has joined the newly formed National Perinatal Mental Health ClinicalReference Group to ensure that the experiences and views of patients inform and influence the planningand delivery of the specialised service
The EP committee were pleased to be invited to contribute to this review to be involved in thedevelopment of the research proposal and to provide patient and public involvement (PPI) advicethroughout the research The EP committee reviewed the draft research proposal and provided detailedfeedback to the principal investigator The EP committee has maintained involvement through contact withthe principal investigator (JM) ad-hoc meetings having an EP committee member sit on the ExpertClinicalMethodological Group and providing input into this report
Service user feedback on the draft proposalThe EP committee was initially somewhat sceptical that interventions could prevent PND Early detectionand treatment of PND was considered more of a priority than prevention The importance of educatinghealth professionals in the detection of and impact of PND was also highlighted Further discussion andconsideration led to collective acknowledgement that all members of the EP committee had experiencedthe most severe PND which may not have been preventable It was agreed that prevention or at least areduction in severity of moderate or mild PND may be possible and worth investigating
Service user feedback on the proposal and ongoing reviewThe EP committee questioned the meaning of PND especially with regard to the term lsquodepressionrsquo as formany of the women anxiety was the major symptom The research team decided to include maternalanxiety or stress as a secondary outcome with depression as the primary outcome
It was suggested that both infanticide (although rare) and the decision to terminate a pregnancy(if PND had been experienced in a previous pregnancy) should be considered as outcomes Maternalsuicide (no longer the most common cause of maternal death)23 was another potentially preventableoutcome It was agreed to cover these outcomes in the background section of this report Family outcomeswere also emphasised as the entire EP committee reported the impact of their PND on their children andfamily members Of particular note was the impact of their PND on partners who also may becomedepressed or anxious
The group discussed the distinction between prevention and treatment The question was posed lsquoWhen isan intervention considered treatment and when is it preventionrsquo One EP committee member had been onantidepressant medication before conceiving (although symptom free) because she experienced PND withher first child This medication was increased at the end of the first trimester when she developedsymptoms of anxiety This also calls into question the term postnatal depression as many women alsobecome ill in the antenatal period There was some debate around EPDS scores in the literature and thecut-off point for including studies as prevention studies It was decided that trials in which includedwomen had a raised EPDS but no diagnosis of PND would be classed as prevention studies
DEFINITION OF THE DECISION PROBLEM
NIHR Journals Library wwwjournalslibrarynihracuk
10
Service user feedback on acceptability of interventions to preventpostnatal depressionGiven their relatively extreme experiences of PND the EP committeersquos view on potential interventions toprevent PND was very open When faced with a life-changing and potentially life-threatening illnessthey felt the choice of intervention was likely to be focused on proven effectiveness
Medication during pregnancy was perceived to be acceptable to women who have experienced PND in aprevious pregnancy especially severe PND However they felt that preventive medication was probablyundesirable for those women in their first pregnancy who are asymptomatic but deemed lsquoat riskrsquo Othernon-pharmacological interventions such as those being investigated in this review were considered morelikely to be acceptable to the majority of pregnant women
Overall the acceptability of interventions to prevent PND was perceived to be influenced by many factorsnot least whether or not a woman has a history of PND The potential for prevention or lessening theseverity of PND was viewed by the EP committee as a very encouraging and exciting prospect
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
11
Chapter 3 Review methods
Overview of review methods
This chapter details the methods used to identify RCTs systematic and other reviews and qualitativestudies suitable for inclusion in the review Figure 1 illustrates the four phases of the review including thedata extraction analysis and interpretation phases
Methods for reviewing and assessing clinical effectiveness
Search strategies for identification of studiesThe review of effectiveness of interventions to prevent PND constituted the central platform for this reportThe objectives of the individual RCTs and the data available from them determined what NMAs werefeasible The analysis of effectiveness determined the subsequent qualitative synthesis and economicanalyses The leading candidate interventions demonstrated in terms of potential effectiveness becamethe focus for the realist synthesis This filtered approach recognised that it would not be feasible toconduct rich interpretive explorations across the wide heterogeneity of possible interventions andtherefore interpretive resources were focused where they were most likely to yield insights on current andfuture interventions
Search strategy for randomised controlled trials and systematic reviewsSearch activities were as follows
1 searches of electronic databases2 searches of the internet3 searches of specific websites4 citation searches5 reference lists of relevant studies6 hand searches of relevant journals7 scrutiny of references listed in reviews of the prevention of PND8 suggestions from experts and those working in the field
Searches of electronic databasesA comprehensive search of 12 electronic bibliographic databases was undertaken to identify systematicallyclinical effectiveness literature comparing different interventions to prevent PND The literature searchstrategy is presented in Appendix 1 The list of electronic bibliographic databases searched for publishedand unpublished clinical effectiveness research evidence is presented here
l The Cochrane Library including the Cochrane Systematic Reviews Database Cochrane Controlled TrialsRegister Database of Abstracts of Reviews of Effects (DARE) Health Technology Assessment (HTA) andNHS Economic Evaluation Database (NHS EED) 1991 searched on 28 November 2012
l MEDLINE (via Ovid) 1946ndashweek 3 November 2012 searched on 30 November 2012l PreMEDLINE (via Ovid) 4 December 2012 searched on 5 December 2012l EMBASE (via Ovid) 1974ndash4 December 2012 searched on 5 December 2012l Cumulative Index to Nursing and Allied Health Literature (CINAHL via EBSCOhost) 1982 searched on
11 December 2012l PsycINFO (via Ovid) 1806ndashweek 4 November 2012 searched on 5 December 2012l Science Citation Index (via ISI Web of Science) 1899 searched on 5 December 2012l Social Science Citation Index (via ISI Web of Science) 1956 searched on 5 December 2012
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
13
Stre
ams
of
evid
ence
Wer
e th
e in
terv
enti
on
s ef
fect
ive
Ran
do
mis
ed c
on
tro
lled
tri
als
Wer
e th
e in
terv
enti
on
s co
st-e
ffec
tive
Ev
iden
ce f
rom
tri
als
and
iden
tifi
cati
on
of
cost
ele
men
ts
Ho
w d
o t
he
inte
rven
tio
ns
com
par
eM
ixed
tre
atm
ent
com
par
iso
n a
nd
net
wo
rk m
eta-
anal
ysis
Ho
w w
ere
they
imp
lem
ente
d
RC
Ts a
nd
qu
alit
ativ
e st
ud
ies
Wh
at w
ork
ed f
or
wh
om
in
wh
atco
nte
xts
wh
at b
arri
ers
har
ms
An
y st
ud
y d
esig
n o
r ev
iden
ce t
ype
Wer
e in
terv
enti
on
s ac
cep
tab
le
Qu
alit
ativ
e st
ud
ies
(lin
ked
to
RC
Ts)
Wh
at e
lse
mig
ht
hav
e w
ork
ed
Oth
er q
ual
itat
ive
stu
die
s o
n p
erso
nal
and
so
cial
su
pp
ort
str
ateg
ies
Phas
e 1
map
pin
g t
he
lan
dsc
ape
Lite
ratu
re s
earc
hes
incl
usi
on
exc
lusi
on
Qu
alit
y ap
pra
isal
Phas
e 2
sel
ecti
on
an
dp
rio
riti
sati
on
pro
cess
Dat
a ex
trac
tio
n
Phas
e 3
in-d
epth
rev
iew
Ind
ivid
ual
rev
iew
co
mp
on
ents
Phas
e 4
inte
rpre
tati
on
an
dan
alys
is
Nar
rati
ve s
ynth
esis
see
Ch
apte
rs 5
ndash7
Service user consultation
Service user consultation
Ove
rarc
hin
g n
arra
tive
syn
thes
is o
f q
ual
itat
ive
and
qu
anti
tati
ve e
vid
ence
(s
ee C
hap
ter
4) in
clu
din
g
pro
gra
mm
e th
eory
an
d
des
irab
le f
eatu
res
of
inte
rven
tio
ns
(see
Ch
apte
r 8)
Iden
tifi
cati
on
of
cost
effe
ctiv
e o
pti
on
s fo
rU
niv
ersa
l (U
PI)
Sele
ctiv
e (S
PI)
and
Ind
icat
ed (
IPI)
Sce
nar
ios
Imp
licat
ion
s fo
r re
sear
chIm
plic
atio
ns
for
pra
ctic
eD
iscu
ssio
n a
nd
Co
ncl
usi
on
s (s
ee C
hap
ters
10
and
11)
Cla
ssifi
cati
on
as
un
iver
sal p
reve
nti
vein
terv
enti
on
sse
lect
ive
pre
ven
tive
inte
rven
tio
ns
ind
icat
ed p
reve
nti
vein
terv
enti
on
s
Val
ue
of
info
rmat
ion
anal
ysis
Sele
ctio
n o
f st
ud
ies
rep
ort
ing
EPD
S
Iden
tifi
cati
on
of
lsquofo
calrsquo
inte
rven
tio
ns
Exp
lora
tio
n o
f st
ud
yC
LUST
ERs
Exam
inat
ion
of
hig
h-l
evel
th
eori
es a
nd
pro
gra
mm
e th
eori
es
QA
LY g
ain
gra
ph
sse
e C
hap
ter
9
Net
wo
rk
met
a-an
alys
isse
e C
hap
ters
5ndash7
TID
ieR
ch
eckl
ists
see
Ap
pen
dix
16
Rea
list
syn
thes
isse
e C
hap
ter
8
Qu
alit
ativ
e sy
nth
esis
see
Ch
apte
rs 5
ndash7
Qu
alit
ativ
e sy
nth
esis
see
Ch
apte
r 8
FIGURE1
Ove
rview
ofreview
methodsKey
IPIindicated
preve
ntive
interven
tionQ
ALY
quality-ad
justed
life-ye
arS
PIselective
preve
ntive
interven
tionT
IDieRtem
plate
for
interven
tiondescriptionan
dreplicationU
PIu
niversalp
reve
ntive
interven
tionT
hisisan
Open
Accessarticle1
24distributedin
acco
rdan
cewiththeCreativeCommonsAttribution
NonCommercial
(CCBY-N
C30)
licen
sew
hichpermitsothersto
distributerem
ixa
dap
tbuild
uponthiswork
non-commerciallya
ndlicen
setheirderivativeworksondifferent
term
sprovided
theoriginal
work
isproperly
citedan
dtheuse
isnon-commercialS
eeh
ttpcrea
tive
commonsorglicensesby-nc30
REVIEW METHODS
NIHR Journals Library wwwjournalslibrarynihracuk
14
l Applied Social Sciences Index and Abstracts (ASSIA) (via ProQuest) 1987 searched on 19 December 2012l Allied and Complementary Medicine Database (AMED) (via Ovid) 1985ndashDecember 2012 searched on
5 December 2012l Conference Proceedings Citation IndexndashScience (CPCI-S) (via ISI Web of Science) 1990 searched on
5 December 2012l Midwives Information and Resource Service (MIDIRS) Reference Database 1991 searched on 24 July 2013
Further searches for grey literature were conducted from January to March 2013 on additional resourcesA list of the additional resources is presented in Appendix 1
Search strategy search termsThe search strategy was developed using an iterative approach The search used a combination ofthesaurus and free-text terms for postnatal and antenatal depression combined with terms for preventionor risk factors or generic terms for interventions The search comprised four facets
l Facet 1 comprised terms for the population (pregnant and postnatal women)l Facet 2 comprised terms for preventionl Facet 3 comprised terms for known risk factors for PNDl Facet 4 comprised generic terms for interventions
Facet 1 was combined separately with facets 2 3 and 4 The major search refinement was to reduce thenumber of search terms in facet 1 then extra terms were added for facets 2 3 and 4 In addition thesearches were combined with search filters for specific study designs when appropriate All searches wereperformed by an information specialist (AC) from November to December 2012 Copies of The CochraneLibrary and all the other search strategies are presented in Appendix 1
The search strategy was used to search the Cochrane Central Register of Controlled Trials (CENTRAL) andthen to search other databases not indexed by Clinical Trials CENTRAL runs sensitive strategies onMEDLINE and EMBASE to identify relevant published RCTs therefore MEDLINE and EMBASE were notsearched retrospectively Records were retrieved through planned manual searching of a journal orconference proceedings to identify all reports of RCTs and controlled clinical trials125 The search was runwith a systematic reviews filter to find Cochrane and other systematic reviews The number of RCT andsystematic review results obtained for the various databases searched is presented in Appendix 2
Citation searches reference lists relevant journals and clinical expertsReference tracking of all included and relevant studies was performed and reference lists of relevantreviews and systematic reviews were scrutinised to identify additional relevant studies not retrieved by theelectronic search to identify further potentially eligible RCTs Searching of key journals selected followingconsultation with clinical experts was conducted using electronic table of contents alerts from January toJuly 2013 for 33 journals presented in Appendix 3 Clinical advisors were also contacted about furtherpotentially relevant RCTs
Search outcome summary for the randomised controlled trialsSearch result citations were imported and merged into Reference Manager version 12126 (ThomsonResearchSoft San Francisco CA USA) and duplicates were removed by Reference Manager or deletedmanually (by JM and AC)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
15
Review protocol
The population intervention comparators outcomes study designs (PICOS) process was used to breakdown the research question into concepts and search terms Recognising that systems of care differinternationally rather than concentrating solely on UK-based RCTs we were deliberately inclusive in oursearch to capture RCTs of all interventions irrespective of their health-care context The research protocolis registered on PROSPERO (registration number CRD42012003273)
Inclusion and exclusion criteria for quantitative studies
PopulationThe population included women of all ages who were either pregnant or had given birth in the previous6 weeks The population was separated according to level of risk of PND into three levels universalselective or indicated as follows
l Universal all women in a defined population not identified on the basis of increased risk of PNDl Selective women or subgroups of the population whose risk of developing PND was significantly higher
than average because they had one or more social risk factors such as general vulnerability aged lessthan 18 years at risk of violence ethnic minority human immunodeficiency virus (HIV) positive living indeprivation or financial hardship or poverty or single socially disadvantaged or unsupported
l Indicated women at high risk of developing PND on the basis of psychological risk factors above-average scores on psychological measures or other indications of a predisposition to PND but who didnot meet diagnostic criteria for PND at that time such as antenatal depression a raised symptomdepression score and a history of PND or history of major depression
The population dimension for the PICOS framework is presented in Box 2
BOX 2 Population dimension of the PICOS framework for quantitative review
Included
Pregnant women (universal)
Postnatal women with a live baby born within the previous 6 weeks (universal)
Vulnerable pregnant or postnatal women who were aged less than 18 years at risk of violence an ethnic minority HIV
positive living in deprivation financial hardship or poverty or single socially disadvantaged or unsupported (selective)
Pregnant or postnatal women with a raised score on the antenatal risk questionnaire Beck Depression
Inventory Center for Epidemiologic Studies Depression scale the Cooper predictive index depression symptom
checklist EPDS HADS Hamilton Depression Rating Scale Health during pregnancy questionnaire a past history
of PND or major depression (indicated)
Pregnant women with a diagnosis of depression using Research Diagnostic Criteria or DSM-IV criteria (indicated)
Excluded
Postnatal women with a diagnosis of PND
Pregnant women with comorbid psychiatric disorders
Postnatal women with major medical problems
DSM-IV Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition
REVIEW METHODS
NIHR Journals Library wwwjournalslibrarynihracuk
16
InterventionsThe preventive interventions were also separated into three levels of preventive intervention according tothe population for which the intervention was intended
l Universal preventive interventions interventions available for all women in a defined population notidentified on the basis of increased risk of PND
l Selective preventive interventions interventions offered to women or subgroups of the populationwhose risk of developing PND was significantly higher than average because they had one or moresocial risk factors
l Indicated preventive interventions interventions offered to women at high risk of developing PND onthe basis of psychological risk factors above-average scores on psychological measures or otherindications of a predisposition to PND but who did not meet diagnostic criteria for PND at that time
Seven main classes of interventions were also categorised as presented in Box 3
BOX 3 Intervention dimension of the PICOS framework for quantitative review
Included
Pharmacological agents or supplements prescribed antidepressants calcium dietary supplements
hormone therapy thyroid therapy
Psychological the breadth of psychological interventions and approaches which comprise components of a
psychotherapeutic approach
Social support home visits telephone-based peer support doula support social support
Educational educational information booklets and classes
Organisation of maternity care alternative forms of contact with care providers primary care strategies
CAM or other music acupuncture tai chi yoga pregnancy massage aromatherapy exercise and
herbal medicine
Midwifery-led interventions different approaches to antenatal care CenteringPregnancy team midwife
care caseload midwifery
Excluded
Treatment trials for women with PND
Interventions initiated preconceptually
Interventions initiated more than 6 weeks postnatally
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
17
ComparatorsAll comparison arms for all eligible studies in all countries were included whether usual care enhancedusual care or an active comparison group
OutcomesThe main outcome was a validated measure of symptoms of maternal depression or a diagnostic measureof depression from 6 weeks to 12 months postnatally Other maternal outcomes of anxiety and well-beingwere included Binary categorical or continuous outcomes were included whether as a single measure orassessed at more than one postbaseline treatment time point The outcomes dimension is presented inBox 4
Study designsThe study designs dimension is presented in Box 5
BOX 4 Outcome dimension of the PICOS framework for quantitative review
Included
Depression symptoms measured on a validated self-completed instrument
Depression diagnosis
Anxiety symptoms
Diagnostic measure of anxiety
Birth outcomes
Infant outcomes
Family outcomes
Excluded
No measure of PND reported in the results
Outcome measurements more than 12 months postnatally
Outcome measurements less than 6 weeks postnatally
Physiological measurement
Unvalidated measures of depression
REVIEW METHODS
NIHR Journals Library wwwjournalslibrarynihracuk
18
BOX 5 Study design dimension of the PICOS framework for quantitative review
Included
RCTs
Economic evaluations alongside RCTs
Systematic reviews of the prevention of PND
Excluded
Before-and-after studies
Casendashcontrol studies
Cohort studies
Commentary or clinical overviews
Cross-sectional surveys
Description of a study
Non-randomised control groups
Non-systematic reviews
Not a PND prevention trial
Ongoing RCTs
Protocols for a RCT
Reviews not about prevention of PND
Secondary analysis of data from a RCT
Studies reported in non-English language
Systematic reviews not about prevention of PND
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
19
Search strategy and outcome summary for the qualitativestudies
Electronic databasesThe search for the clinical effectiveness evidence was run with a qualitative filter to identify qualitativestudies The list of electronic bibliographic databases searched is presented in Appendix 1 The search wasrun again with a mixed-methods filter (devised with AB) to find papers that used quantitative andqualitative methodology The numbers of qualitative studies and mixed-methods studies retrieved for thevarious databases searched are presented in Appendix 4
Study selection
Study selection criteria and procedures for the quantitative reviewTwo reviewers (JM and PS) independently screened the titles and abstracts to identify papers for possibleinclusion If no abstract was available the full paper was retrieved for scrutiny Full papers for RCTs wereobtained if the abstract showed that the study fulfilled the inclusion criteria or it was unclear from theabstract whether or not the inclusion criteria were fulfilled All full papers retrieved were independentlyreviewed by two reviewers Papers were not excluded on quality at this selection stage The full papers hadto fulfil the inclusion criteria presented in Tables 2ndash5 Where there was no consensus following discussionabout inclusion at the full-paper stage a third reviewer or clinical expert (CLD HS or SS-B) was consultedThe reasons for exclusion are presented in Appendix 5
Study quality assessment checklists and procedures for the randomisedcontrolled trials
Risk-of-bias assessmentThe quality of each paper was assessed independently by two reviewers (JM and PS) using the CochraneCollaborationrsquos tool for assessing risk of bias in randomised trials126 Any disagreements about risk of biaswere resolved by a third reviewer The risks assessed were
l risk of selection bias (random sequence generation and allocation concealment)l risk of performance bias (blinding of participants and personnel)l risk of detection bias (blinding of outcome assessors)l risk of attrition bias (incomplete outcome data)l risk of reporting bias (selective reporting of the outcome subgroups or analysis)l risk of other sources of bias (any important concerns about other possible sources of bias such as
funding source adequacy of statistical methods used type of analysis baseline between-groupimbalance in important prognostic factors)
The risks were assessed as low risk of bias high risk of bias or unclear risk of bias For each assessed riskthe reviewers provided a statement description or direct quotation to support their judgement A summaryassessment of risk was made across all the risks to inform the interpretation of plausible bias andsummary risk of bias is presented in Chapter 4 the overview of results for quantitative andqualitative studies
Data extraction for randomised controlled trialsData from the full papers were entered on to a specially designed pre-piloted and tailored data extractionform to summarise the intervention The primary aim of the study was documented (PND preventionantenatal well-being birth outcomes general health general psychological well-being infant outcomes orfamily outcomes) The intervention and comparison arms were described The data extraction formindicating the main RCT characteristics is presented in Appendix 6
REVIEW METHODS
NIHR Journals Library wwwjournalslibrarynihracuk
20
Outcomes were recorded as maternal neonatal and family outcomes using mean [standard deviation (SD)]values when available and numbers and proportions of participants in specific outcome categories Thequality of the extracted data was checked (JM and PS)
Potential moderatorsPotential moderators are variables describing population characteristics for which the intervention mayhave a different effect for different values of the moderator variable127 These were documented whenthere was some basis for believing that the maternal population characteristics might have a moderatingeffect on the outcomes for example maternal age parity being a sole parent history of mental healthproblems and history of PND Baseline depression scores were recorded to estimate the population meandepression score for women who entered the studies
Potential mediatorsPotential mediators are variables that could help explain the process by which an intervention waseffective127 These were documented such as the timing of the intervention the provider the number ofsessions offered and whether the intervention was individual based or group based
Data synthesis of randomised controlled trialsA large number of RCTs and systematic reviews were eligible for inclusion according to our broad inclusioncharacteristics We conducted a narrative description of the studies according to the level of preventiveintervention (universal selective or indicated) class of intervention and the context within which the RCTswere undertaken
Meta-analysis of randomised controlled trials
Methods of evidence synthesisThe extracted data and quality assessment variables were presented for each study in structured tablesand as a narrative description Both conventional RCTs in which individual women were randomised tointerventions and cluster RCTs (CRCTs) were eligible for inclusion Estimates of treatment effect andstandard error of treatment effects from CRCTs were included in the analyses after allowing for thecluster design
The reference treatment for comparative purposes and for estimating intervention effects was defined asusual care Usual care in the UK Australia Canada France Norway and the USA was assumed to besufficiently similar to be interchangeable and was collectively defined as lsquousual carersquo for the purpose ofthe analysis
The evidence was synthesised using a NMA128 A NMA (also known as a mixed-treatment comparison or amultiple treatment comparison) is an extension of a standard (pairwise) meta-analysis It allows evidencefrom RCTs comparing different interventions to be combined to provide an internally consistent set ofintervention effects while respecting the randomisation used in individual studies The NMA enables asimultaneous comparison of all evaluated interventions in a single coherent analysis thus all interventionscan be compared with one another including comparisons not evaluated within individual studies Theonly requirement is that each study must be linked to at least one other study through having at least oneintervention in common The analysis preserves the within-study randomised treatment comparison of eachstudy and assumes that there is consistency across evidence As with standard pairwise meta-analysestreatment effects are assumed to be exchangeable across studies In addition it is assumed that treatmenteffects are transitive such that if the effect of intervention 2 relative to intervention 1 is d21 and the effectof intervention 3 relative to intervention 1 is d31 then the effect of intervention 3 relative to intervention 2is d32= d31 ndash d21 this allows a synthesis of direct and indirect evidence about intervention effects and asimultaneous comparison between interventions Evidence from RCTs presenting data at any assessmenttime up to 12 months were considered relevant to the decision problem
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
21
Methods for the estimation of efficacy
Statistical model for Edinburgh Postnatal Depression Scale threshold scoreThe number of women who had an EPDS score greater than a specified threshold was available fromseveral studies at four different postnatal stages depending on the study (ie 6 weeks 3 months6 months and 12 months) Most studies used one threshold although the thresholds varied across studies(ie threshold score of 10 11 12 and 13) One study129 reported the number of women who had an EPDSscore at two thresholds (ie 10 and 13)
The EPDS threshold scores were regarded as being ordered categorical data with categories 0ndash9 10 1112 13 and 14 or more We assumed an underlying proportional odds model such that
logP(Yle jjx)
1minusP(Yle jjx)
= logit(P(Yle jjx)) = α j + βx j = 1hellip jminus1 x = 0 1 (1)
where αj is the cumulative log-odds for the control intervention (x= 0) and β is the log-odds ratio for theexperimental intervention (x= 1) relative to the control intervention The model assumes that thecumulative log-odds ratios are independent of the threshold so that the effect of treatment does notdepend on the threshold Although this may be a strong assumption it cannot be assessed in studies thatuse only one threshold which are all but one study
Studies were classified as follows
l RCTs randomising women to interventions and reporting data using one thresholdl RCTs randomising women to interventions and reporting data using two thresholdsl CRCTs
Randomised controlled trials randomising women to interventions andreporting data using one thresholdFor RCTs randomising women to interventions and reporting data using one threshold we let rik be thenumber of women with a response greater than the threshold for each arm out of nik women for arm k instudy i We assumed that the data follow a binomial likelihood such that
riksimBinomial(pik nik) (2)
where pik is the probability that a women has a response greater than the threshold in arm k of study iThe pik values are transformed to the real line using a logit link function such that
logit(pik) = microi + δi bkIfkne1g (3)
where
lfug =1 if u is true0 otherwise
(4)
microi is the study-specific baseline log-odds of having a response greater than the threshold in the controlintervention of the study and δibk is the study-specific log-odds ratios of having a response greater than thethreshold in the intervention group compared with the control intervention b
REVIEW METHODS
NIHR Journals Library wwwjournalslibrarynihracuk
22
Randomised controlled trials randomising women to interventions andreporting data using two thresholdsFor RCTs randomising women to interventions and reporting data using two thresholds we fitted aproportional odds model using the freely available software package R (The R Foundation for StatisticalComputing Vienna Austria) using the lsquopolrrsquo function within the MASS package and obtained the sampleestimate of the log-odds ratio yibk and its standard error Vibk for intervention k relative to intervention bin study i We assumed that the sample log-odds ratios arose from a normal likelihood such that
yi bksimN(δi bk Vi bk) (5)
Cluster randomised controlled trialsFor two-arm CRCTs (which reported data using one threshold) the sample estimate of the log-odds ratioyibk and its adjusted standard error Vibk for intervention k relative to intervention b in study i wereextracted and assumed to have arisen from a normal likelihood such that
yi bksimN(δi bk Vi bk) (6)
For three-arm CRCTs (which reported data using one threshold) the two intervention effects are correlatedbecause they are both estimated relative to the same control The likelihood function for study i wasdefined to be bivariate normal such that
yi b2yi b3
simBN
δi b2δi b3
Vi b2 se2i 1
se2i 1 Vi b3
(7)
where yibk and Vibk are as defined before and se2i1 is the variance of the control intervention log-odds
The population standard errors of the log-odds ratios and the population standard error of the controlintervention in a three-arm cluster randomised trial were assumed to be known and equal to thesample estimates
For a random (intervention)-effects model we assumed that the study-specific log-odds ratios arose from acommon population distribution such that
δi bksimN(d1kminusd1b τ2) (8)
where d1k is the population log-odds ratios for intervention k relative to the reference intervention(ie usual care) and τ is the between-study SD We assumed a homogenous variance model in which thebetween-study SD was assumed to be common to all treatment effects For multiarm trials theseunivariate normal distributions are replaced by a multivariate normal distribution to account for correlationbetween treatment effects within a multiarm study
Parameters were estimated using Markov chain Monte Carlo simulation conducted using the freelyavailable software package WinBUGS 143 (MRC Biostatistics Unit Cambridge UK)130
The model was completed by giving the parameters prior distributions
l Vague prior distributions for the trial-specific baselines microisimN(01000)l Vague prior distributions for the treatment effects relative to reference treatment d1tsimN(01000)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
23
Weakly informative prior distribution for the between-study SD of treatment effects τsimHN(0 0322)[in addition as a sensitivity analysis the model was also run using the conventional vague prior distributionτsimU(02)]
Vague prior distributions were used for trial-specific baseline and treatment effect parameters Howevera weakly informative prior distribution was used for the between-study SD because there were insufficientstudies with which to estimate it from the sample data alone this prior distribution was chosen to ensurethat a priori 95 of the study-specific odds ratios were within a factor of 2 from the median odds ratiofor each treatment comparison
Convergence of the Markov chains to their stationary distributions was assessed using the GelmanndashRubinstatistic131 The chains converged within 25000 iterations a burn-in of 30000 iterations was usedWe retained a further 10000 iterations of the Markov chain with which to estimate parameters
Results are presented as odds ratios [and 95 credible intervals (CrIs)] the between-study SD (and its95 CrI) and rankograms (ie the probability of treatment rankings) CrIs provide an x interval such thatthere is a x probability that the true parameter lies within the interval Rankograms provide the probabilitiesof each treatment being ranked as the best second best and so on through to the lowest-ranked treatmentThe between-study SD provides a measure of heterogeneity in treatment effects between studies on thelog-odds scale a between-study SD less than 05 is indicative of mild heterogeneity of between 05 and 1 isindicative of moderate heterogeneity and of greater than 1 is indicative of extreme heterogeneity
Statistical model for Edinburgh Postnatal Depression Scale mean scoresThe analysis of the EPDS score data was conducted in two stages (1) a treatment-effects model in whichthe effect of each intervention was estimated relative to usual care and (2) a baseline (ie usual-care)model in which the absolute response to usual care was estimated The treatment-effects model providesestimates of relative treatment effects which are used to make inferences about the relative effects ofinterventions The estimates of treatment effects relative to usual care were combined with the baselinemodel to provide estimates of absolute responses for each intervention these estimates were used asinputs to the economic model
Treatment-effects modelIn general each study provided data for each intervention in each study at baseline and at least oneon-treatment assessment time We excluded the baseline data from the treatment-effects model theremaining data are longitudinal (ie repeated measures) and are correlated between times
We began by supposing that we have observations yij= (xij Sij) for i= 1 2 I and j= 1 2 Jfor women in study i receiving intervention j that is we suppose that the sample mean EPDS scores forwomen in study i receiving treatment j at times t can be denoted by the vector xij= (xij1 xijT)T and thatthe sample mean variancendashcovariance matrix Sij is
Si j =
S2i j1 Si j1Si j2r12Si
⋯ Si j1Si j Tminus1r1 Tminus1 SiSi j1Si jT r1TSi
Si j1Si j2r12SiS2i j2
⋯ Si j2Si j Tminus1r2 Tminus1 SiSi j2Si jT r2TSi
⋮ ⋮ ⋱ ⋮ ⋮Si j1Si j Tminus1r1 Tminus1 Si
Si jTminus1Si j 2rTminus1 2Si⋯ S2
i jTminus1 Si jTminus1Si j T rTminus1 T Si
Si j1Si jT r1TSiSi jT Si j2rT2Si
⋯ Si jTSi j Tminus1rT Tminus1 SiS2i jT
0BBBB
1CCCCA (9)
where the diagonal elements are the variances of the sample means at each time the off-diagonalelements are the covariances between sample means at different times and the rijSi are the sampleestimates of the within-study correlation coefficients which depend on study si
REVIEW METHODS
NIHR Journals Library wwwjournalslibrarynihracuk
24
Although the woman-specific EPDS scores are discrete in the range 0ndash30 and the underlying distributionof EPDS scores is unlikely to be normal we appeal to the central limit theorem which states that as thesample size approaches infinity for any underlying distribution with finite mean and variance then thedistribution of the sample mean is normal Therefore we assume that the likelihood for the samplesmeans for women in study i receiving treatment j is
x i jjθsimN(v i j si j) (10)
where vij= (vij1 vijT)T represents the study-specific population mean vector of EPDS scores for treatmentj in study i
Published papers provided no information on the correlation between sample means at different timesTherefore we began by assuming that the rijSi is zero We also assumed that the population standarderrors σ i jt= ffiffiffiffiffi
ni jtp were known and equal to the sample standard errors sijt where σijt are the population SDs of
an individual observation for women in study i receiving treatment j at time t
The model for the treatment effects follows that for a NMA of repeated measures as presented by Dakinet al132 We estimate the treatment effects separately for each time such that
vi jt = microit + δi jt (11)
where microit is the population mean EPDS score for the baseline treatment (which is allowed to vary betweenstudies) in study i at time t and δijt is the population mean effect of treatment j in study i at time t
We used an unconstrained baseline model in which the effect of the baseline treatment in each study isfixed at each time thereby preserving the randomisation within each study We assumed that the effectsof treatment j in study i at time t arose from a normal distribution such that
δi jtsimN(dai j bi tminusdai 1 bi t
τ2) (12)
where aik indicates the treatment used in the kth arm of study i We assumed a homogeneous variancemodel in which the between-study SD was assumed to be common to all treatment effects and also acrosstimes For multiarm trials these univariate normal distributions are replaced by a multivariate normaldistribution to account for correlation between treatment effects within a multiarm study
Parameters were estimated using Markov chain Monte Carlo simulation conduction using WinBUGS 143130
The model was completed by giving the parameters prior distributions
l Vague prior distributions for the trial-specific baselines μisimN(01000)l Vague prior distributions for the treatment effects relative to reference treatment d1tsimN(01000)l A weakly informative prior distribution for the between-study SD of treatment effects τsimHN(02)
Vague prior distributions were used for trial-specific baseline and treatment effect parameters However aweakly informative prior distribution was used for the between-study SD because there were insufficientstudies with which to estimate it from the sample data alone this prior distribution has median 095(95 CrI 004 to 317) and was chosen to ensure that a priori 95 of the study-specific differencesbetween interventions in mean EPDS scores were within a range plusmn 31 for each treatment comparison
Convergence of the Markov chains to their stationary distributions was assessed using the GelmanndashRubinstatistic131 The chains converged within 25000 iterations therefore a burn-in of 30000 iterations wasused We retained a further 10000 iterations of the Markov chain to estimate parameters
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
25
Results are presented as differences between intervention in mean EPDS scores and 95 CrIs thebetween-study SD (and its 95 CrI) and rankograms (ie the probability of treatment rankings) at eachtime Crls provide an x interval such that there is a x probability that the true parameter lies within theinterval Rankograms provide the probabilities of each treatment being ranked the best second bestthrough to the lowest-ranked treatment The between-study SD provides a measure of heterogeneity intreatment effects between studies for continuous outcome measures the extent to which the between-study SD indicates mild moderate or extreme heterogeneity depends on the scale of measurement andthe variation within study
Baseline modelIn general studies in which the control intervention was usual care provided data at baseline and at leastone on-treatment assessment time Therefore the data are longitudinal (ie repeated measures) and arecorrelated between times
We began by supposing that we have observations yi= (xiSi) for i= 1 2 I for women in study i thatis we suppose that the sample mean EPDS scores for women in study i receiving usual care at times t canbe denoted by the vector xi= (x1i xiT)T and that the sample mean variancendashcovariance matrix Si is
Si =
S2i1 Si1Si2r12Si
⋯ Si1Si Tminus1r1 Tminus1 SiSi1SiT r1TSi
Si1Si2r12SiS2i2 ⋯ Si2Si Tminus1r2 Tminus1 Si
Si2SiT r2TSi
⋮ ⋮ ⋱ ⋮ ⋮Si1Si Tminus1r1 Tminus1 Si
SiTminus1Si 2rTminus1 2Si⋯ S2
iTminus1 SiTminus1Si T rTminus1 T Si
Si1SiT r1TSiSiTSi2rT2Si
⋯ SiTSi Tminus1rT Tminus1 SiS2iT
0BBBB
1CCCCA (13)
where the diagonal elements are the variances of the sample means at each time the off-diagonalelements are the covariances between sample means at different times and the rijSi are the sampleestimates of the within-study correlation coefficients which depend on study si In practice not all womenprovide data at each time and the covariances depend on the number of women who provide data ateach time as well as the number of women who provide data at both times Therefore the covariancebetween sample means within a study at times t and trsquo is
nttrsquo
ntnsi1rsquo si2rsquo r12si (14)
Although the woman-specific EPDS scores are discrete in the range 0ndash30 and the underlying distributionof EPDS scores is unlikely to be normal we appeal to the central limit theorem which states that as thesample size approaches infinity for any underlying distribution with finite mean and variance then thedistribution of the sample mean is normal Therefore we assume that the likelihood for the samplesmeans for women in study i is
x ijθsimN(v i Si) (15)
where vi= (vi1 viT)T represents the study-specific population mean vector of EPDS scores for women instudy i receiving usual care at times t Studies do not provide data at all times so that the number of timeswith data Ti in study i is such that 1le Tile T
Published papers provided no information on the correlation between sample means at different timesHowever using individual woman-level data from the PoNDER (PostNatal Depression Economic evaluationand Randomised controlled trial) we obtained estimates of the correlation coefficients between sample
REVIEW METHODS
NIHR Journals Library wwwjournalslibrarynihracuk
26
EPDS scores at baseline 6 months and 12 months to be rb6m= 0345 rb12m= 0369 and r6m12m= 0721In the absence of any additional external evidence we made the assumptions as follows
rb6w = rb3m = rb6m = r6w3m = r6w6m = 0345 (16)
rb12m = r6w12m = 0369 (17)
r3m6m = r6m12m = r6m12m = 0721 (18)
The model for the baseline effects follows that presented by Wei and Higgins133 We letυisimMVN(Ximicro XiΩXT
i ) where Xi is a Ti times T design matrix defining which of the T times are included in thestudy micro is a T times 1 vector of underlying mean EPDS scores across studies and Ω is a T times T matrixrepresenting the between study covariance matrix for all T times Thus the studies are linked through theparameters that characterise the distribution of the random effects
All analyses were conducted in WinBUGS 143130 The model was completed by giving the parametersprior distributions
l Vague prior distributions for the treatment effects relative to the reference treatment d1tsimN(01000)l Weakly informative prior distributions for the between-study SD of treatment effects τsimHN(02)l Weakly informative prior distributions for the correlation coefficients U(ndash11)
Vague prior distributions were used for treatment effect parameters However a weakly informative priordistribution was used for the between-study SD because there were insufficient studies with which toestimate it from the sample data alone this prior distribution has a median of 095 (95 CrI 004 to 317)and was chosen to ensure that a priori 95 of the study-specific differences in means lie within a rangeplusmn 31 for each treatment comparison
Convergence of the Markov chains to their stationary distributions was assessed using the GelmanndashRubinstatistic131 The chains converged within 10000 iterations so a burn-in of 10000 iterations was usedWe retained a further 10000 iterations of the Markov chain to estimate parameters after thinning the chainsby retaining every 10th iteration to account for correlation between successive iterations of the Markov chain
Results are presented as means (and 95 CrIs) and the between-study SD (and its 95 CrI) at each time
The mean EPDS scores and the covariance matrix were extracted and were coupled with the treatment-effectsmodel to generate absolute EPDS scores for each treatment as inputs to the economic model Riley134 showedthat in the context of multivariate meta-analyses ignoring the within-study correlation can have substantialimpact on parameter estimates and their correlation expect when the within-study variation is small relative tothe between-study variation Morrell et al61 provided information about usual care cognitivendashbehaviouralapproach (CBA)-based intervention and a person-centred approach (PCA)-based intervention at baseline6 months and 12 months and was used to estimate the within-study correlation coefficients
Methods for reviewing and assessing qualitative studies
Study selection criteria and procedures for the effectiveness reviewA two-stage sifting process for inclusion of studies (title and abstract then full paper sift) was undertaken Titlesand abstracts of the qualitative studies were scrutinised by one assessor (AS) using the inclusion and exclusioncriteria No papers were excluded on the basis of quality at this stage Full papers were obtained for potentiallyincluded studies and for where the abstract provided too little information One-fifth of the total citationsidentified by electronic database searching (n= 2313) were checked for inclusion or exclusion by AB (n= 427)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
27
Inclusion and exclusion criteria for qualitative studiesThe PICOS process was used to clarify the inclusion and exclusion criteria (Box 6)
Population
ComparatorsAll comparators were considered whether they were usual care other controls or specificalternative comparators
OutcomesAll outcome measures were considered All types of data including case studies interview data andobservations were considered
Study designsNo study designs were excluded from the qualitative review (Box 7)
BOX 6 Population dimension of the PICOS framework for qualitative studies
Included
Studies of populations of antenatal women and postnatal women at any point postnatally (but with qualitative
data concerning the first postnatal year) and health-care practitioners involved in delivering preventive
interventions for PND were relevant
Excluded
Studies of pregnant or postnatal women with diagnosed PND or other comorbid psychiatric disorders or major
medical problems
BOX 7 Study design dimension of the PICOS framework for the qualitative studies
Included
l Qualitative studies concerning acceptability to pregnant women and service providers potential harm and
adverse effects were extractedl Studies reporting qualitative research qualitative data elicited via a survey or a mixed-methods study
including qualitative data on the perspectives and attitudes of either (1) those who had received preventive
interventions for PND regardless of modality in order to examine issues of acceptability or (2) from
women who had not experienced PND regarding PSSSs that they believed helped them to avoid the
condition in order to identify promising components of any candidate interventionl Qualitative data embedded in trial reports or in accompanying process evaluations to inform an
understanding of how issues of acceptability were likely to affect the clinical effectiveness of current and
potential interventionsl Qualitative data either from separately conceived research or embedded within quantitative study reports
reporting the acceptability of interventions to health-care practitioners
PSSSs personal and social support strategies
REVIEW METHODS
NIHR Journals Library wwwjournalslibrarynihracuk
28
Study quality assessment checklists and procedures for qualitative studiesStudies meeting the inclusion criteria were evaluated by two reviewers (AS and AB) using the CERQual(Confidence in the Evidence from Reviews of Qualitative research) approach135 which aims to assess howmuch certainty could be placed in the qualitative research evidence and were rated as lsquovery lowrsquo lsquolowrsquolsquomoderatersquo or lsquohighrsquo A summary assessment was made for each study based on the methodologicalquality of each included study and the coherence of the review findings (the extent to which a clearpattern was identifiable across the individual study data) Coherence was assessed by examining whetheror not the review findings were consistent across multiple contexts and incorporated explanations forvariation across individual studies Coherence was strengthened when individual studies contributing to thefindings were drawn from a wide range of settings
The methodological quality of individual studies was appraised using an abbreviated version of the CriticalAppraisal Skills Programme (CASP) quality assessment tool for qualitative studies136 Two reviewers (AS andAB) independently applied the set of quality criteria to each included study
Review findings were subsequently graded as lsquohighrsquo lsquomoderatersquo lsquolowrsquo or lsquovery lowrsquo according to the CASPassessment the number and richness of the data in the studies the consistency of the data within thestudies across study settings and populations and the relevance of the findings to the review question
Data extraction strategy for qualitative studiesData extraction from included studies was undertaken by AS using a data extraction tool adapted andtailored for the qualitative review A 20 sample of data extractions were checked by AB When datafor included studies were missing reviewers attempted to contact the authors at their last knowne-mail address
Selective extraction of findings137 was undertaken when the data were pertaining to an optimalintervention to be delivered antenatally or postnatally to prevent PND A framework for extraction wasdeveloped to elicit data extraction elements related directly to the review question The data extractionelements for the data extraction for the studies are presented in Appendix 6 The level of extractedevidence included information on characteristics of the intervention identified in the results and discussionsections and author comments and interpretation
Data synthesis for qualitative studiesQualitative meta-synthesis was undertaken by highlighting womenrsquos and service providersrsquo issues aroundthe acceptability of interventions and elucidating evidence around regarding personal and social supportstrategies (PSSSs) applied by women using the data extraction framework and thematic synthesis toaggregate the findings138 Evidence about interventions from women and service providers and evidenceabout PSSSs are presented separately (see Appendix 7)
Synthesis drawing upon realist approaches
Identification of key potential CLUSTERsTo exploit the potential of realist synthesis approaches requires rich conceptual and contextual dataReporting limitations and the varied emphases of published reports make it unlikely that all relevant dataare included in a single report of a study However the scale and expense of a RCT increases the likelihoodthat multiple research reports have been produced relating to the study of interest Such reports mayinclude supplementary qualitative work process evaluations student projects pilot studies feasibilitystudies and follow-up studies All such papers may help us to understand the study context mechanismsand outcomes Therefore a key task is to move from analysis of a single study report to a detailedexamination of a cluster of related papers Such forensic examination looks not only for directly relatedlsquosibling studiesrsquo but also for tangentially related lsquokinshiprsquo papers (ie papers that may represent replicationof an existing programme in a different context thus allowing for comparison and contrast)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
29
Finally syntheses analyses and theoretical papers may locate the study within a wider context of exemplarsor case studies thereby expanding the potential for comparison Selection of clusters is necessarily limitedby the resources available for analysis In-depth analysis as typically performed for realist synthesis typicallyprecludes the comprehensive and exhaustive approaches prescribed by systematic review methodsIn selecting focal study clusters the team considered both the likely success of the programme and theavailability of sibling andor kinship study reports At this stage the Preparing for Parenthood cluster wasexcluded as even though it possessed several companion reports the trial did not demonstratepotential effectiveness
Searching for CLUSTER documentsSearching for documents to populate a study cluster has until recently been viewed as essentially anunsystematic and arbitrary procedure Conceptually it draws upon the long-established retrieval practicesoutlined in Batesrsquo seminal paper139 on lsquoberry pickingrsquo including lsquobackward chainingrsquo (following up citedreferences) and lsquoforward chainingrsquo (following up cited articles) Recent years have revealed a prodigiouspotential yield from supplementary documents For example a review by Jagosh et al140 revealed severalclusters with an average of 12 reports per cluster We used systematic methods previously developed byone of the authors of our study (AB) for implementing cluster to become CLUSTER searching for which afull published description of the CLUSTER methods (Citations Lead authors Unpublished materials Scholarsearches Theories Early examples Related projects) is openly available141 In essence the research teamundertook persistent pursuit of study links contextual links and theoretical links from the source study orstudies to other related reports which then themselves initiated a further cause for searching CLUSTERsearching is reliant on relatively rapid judgements on potential links between a referring document and itsreferent141 When papers shared a study identifier or acronym (eg PoNDER) or a RCT identifying numbersuch connections were easy to establish However more typically a sibling relationship between papersrelies on similarities in authorship study context and sponsoring institution However further checksinvolve pursuing cross-citation and co-citation so that a network of studies could be constructed
Synthesis and construction of a theoretical modelFor the synthesis stage we developed a rapid realist review approach provisionally labelled as lsquobest-fitrealist synthesisrsquo This involves
1 identification of a provisional lsquobest-fitrsquo conceptual framework as a starting point for data analysis2 population of the conceptual framework with lsquoifndashthenrsquo statements from the identified articles3 construction of pathways or chains from lsquoifndashthenrsquo statements to surface potential mechanisms by which
outcomes might be achieved4 identification of existing theory underpinning individual mechanisms5 development of a programme theory to explain how PND prevention programmes may work6 testing of the programme theory with contextual data from included studies
Identification of provisional lsquobest fitrsquo conceptual frameworkGiven the prominence of group care approaches among the candidate interventions (eg CenteringPregnancyor IPT) the research team decided to focus initial analytical attempts on the group-care model and then toseek to highlight similarities and differences with behavioural interventions delivered on an individual basiseither via face to face or via telephone A search was conducted on Google Scholar (Google Inc MountainView CA USA) harnessing its extensive full-text searching functionality using the terms lsquogroup carersquo ORlsquogroup visitsrsquo AND lsquohealth educationrsquo AND lsquomodelrsquo OR lsquoframeworkrsquo
Population of the conceptual frameworkIn examining CLUSTER documents the research team sought to identify mechanisms by which outcomeswere achieved in a particular context Mechanisms were operationalised by construction of a series oflsquoifndashthenrsquo statements based on causal relationships advanced by the RCT or hypothesised explanationsproposed by either the qualitative research or derived from the lsquoDiscussionrsquo sections of the associatedstudy reports
REVIEW METHODS
NIHR Journals Library wwwjournalslibrarynihracuk
30
Construction of pathways or chains from lsquoifndashthenrsquo statementslsquoIfndashthenrsquo statements were subsequently constructed into complete pathways or partial chains to form anembryonic basis for a theoretical model that attempted to explain how the intervention works for differentpopulations in different contexts from first action through to ultimate outcome Given the heterogeneityof the interventions present in the initial clusters it is unsurprising to note the presence of differentmechanisms (eg between group- and individual-based approaches) and yet common success factorsfor example the establishment of lsquotrustrsquo whether this be between a woman and a health-care providerbetween a woman and other members in her group or between peers This modelling process providedthe facility to explain both generalisable mechanisms and specific areas of variance
Identification of existing theory underpinning individual mechanismsExamination of mechanisms by which the interventions sought to meet the various needs of the pregnantwomen identified several key concepts In several instances these concepts were explicitly linked withinthe study to specific theory or an implicit connection was readily identifiable (eg by using terminologyassociated with a theory)
Development of a programme theoryBased on the conceptual framework and starting from the premises involved in the group-based modelthe research team constructed a programme theory to explain how such a model might work inpreventing PND This overarching programme theory was then examined in more detail to identify whereindividual-based approaches were unable to meet the same programme requirements and eitherattempted to substitute for them (eg in substituting the resources of the individual peer supporter for thecollective resources of facilitator plus group) or offered features not possible within the constraints of thegroup approach (eg in targeting and making application of strategies to the specific needs of the individual)
Data from included studies quantitative and qualitative were used to examine the evidence in support ofthe programme theory Realist synthesis also accommodates the bringing to bear of a wider evidence baseIn this review more proximate evidence was first accessed identified via a CLUSTER searching approach141
and then expanded where necessary to a wider set of theoretical and empirical papers For examplelsquodirectrsquo qualitative data related to the experience of group-based interventions was used to identify thefeatures of such approaches and this was then supplemented by theoretical understandings of the basisunderpinning the interventions142 and by middle-range theory examining mechanisms for PND143 In thisway the explanatory power of the review was broadened beyond the tight focus prescribed by theinclusion criteria
The supporting data may be limited and may be at a level of abstraction that makes it difficult to identifythe exact mechanism by which cause achieves effect As a consequence synthesis is to a certain extent aninterpretive process which may require the reviewer to identify hypothetical intermediate links in a chain144
by which for example training leads to self-efficacy A further challenge of this method relates to relianceon the detail and quality of reporting while it is legitimate for the reviewer to generate potentialexplanations by which a particular outcome is affected more typically these connections are advanced inthe published literature As a consequence certain explanations may be well rehearsed but poorlysubstantiated whereas others may be novel and consequently unsupported A key stage is therefore thesubsequent validation of the lsquoifndashthenrsquo statements such that they are supported by empirical data or atthe very least they are internally consistent with a range of published data sources To a certain extent theprocess is analogous with brainstorming processes in which idea generation is deliberately divorced fromsubsequent validation In summary a complete explanation is initially privileged over a high-quality onewith the realisation that a poorly constructed study may perversely yield valuable explanatory insightsValidation of lsquoifndashthenrsquo statements therefore follows as an important supplemental stage
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
31
Integrating quantitative and qualitative findings
Methodological work to date has been unable to establish the superiority of conducting the qualitativeand quantitative synthesis in parallel or of conducting quantitative followed by qualitative qualitativefollowed by quantitative or some more iterative approach Our choice of method of combining data hasbeen determined by the needs of this particular review in which the quantitative data are the main focusand the qualitative data are used for their explanatory potential Having initially intended to use methodssimilar to those described by Noyes et al145 to explore an effectiveness review in the light of supportingqualitative research data further examination revealed significant heterogeneity across the types ofbehavioural intervention used within the included studies We therefore decided to expand the explanatorypotential of our study by drawing upon the methods of realist synthesis
Typically realist synthesis explores variation around a single programme type intended to achievepredefined outcomes with much of the variation relating to the population for whom the interventionworks) Early examination revealed that most interventions to be included in the review gravitated primarilyto either group- or individual-based approaches and we therefore decided to start by examining theprogramme theory for group-based approaches and then to re-examine this in the light of individual-basedapproaches As mentioned previously realist synthesis embraces the widest possible range of data sourcesIt therefore becomes a method by which quantitative and qualitative data might potentially be integratedFor example an hypothesis generated by a qualitative report may be substantiated by a trial that formallyestablishes the mechanism of cause and effect Alternatively the qualitative report may enable the reviewto help explain how a particular outcome might be achieved It may also specify aspects of an interventionconsidered important by women that may map to specific components either present in a currentintervention or mooted for inclusion in a future intervention yet to be studied within a trial
REVIEW METHODS
NIHR Journals Library wwwjournalslibrarynihracuk
32
Chapter 4 Overview of results for quantitative andqualitative studies
Literature search for the quantitative review
The electronic searches identified 3072 references following removal of duplicates 2064 remainedA total of 180 additional records were identified from other sources Following removal of duplicatesthere were 2244 records to be screened of which 1910 were excluded at titleabstract level The full textof the remaining 256 records was examined following which 122 (representing 86 unique studies) wereincluded in the review and 134 were excluded The 122 included papers reported 80 conventional RCTs inwhich individual women were randomised to interventions and six CRCTs61146ndash150 The 86 RCTs werereported in multiple publications one study61 included two levels of analysis that were reported in differentpublications151152 Throughout this review these 86 RCTs are cited according to the first author of theircorresponding original publications
The search of ongoing trials in Clinical Trialsgov Current Controlled Trials and UK Clinical ResearchNetwork Portfolio databases (carried out in September 2013) retrieved 47 potentially relevant recordsHowever none of these met the criteria for inclusion in the review
A flow diagram outlining the process of identifying relevant literature and the 86 included RCTs alongwith reasons for exclusion of full-text articles is provided in Figure 2
Quantitative review study characteristicsAn overview of the 86 included RCTs is presented here61121123129146ndash150153ndash229
Yield of systematic reviewsTwenty-three reviews were included (ie Austin et al230 Bennett et al231 Cuijpers et al68 Dale et al232
Dennis and Creedy233 Dennis234 Dennis118 Dennis235 Dennis and Kingston236 Dennis et al237 Dennis238
Dodd and Crowther239 Fontein-Kuipers et al240 Howard et al241 Jans et al242 Lawrie et al243 Leis et al244
Lumley et al245 Marc et al246 Miller et al247 Sado et al248 Shaw et al249 and Sockol et al250) of whichone provided an additional included study not identified in the searches191 The included reviews aresummarised in Appendix 8
Quantitative review study characteristicsSome studies are reported in multiple references for example Armstrong et al 1999164251252 Brugha et al2000188253254 Chabrol et al 2002158255256 Cooper et al 2009153257 Dennis et al 2009205258 Gamble et al2005221259260 Harrison-Hohner et al 2001208261 Ickovics et al 2011222262 Lumley et al 2006147263
MacArthur et al 2002146264 Makrides et al 2010211265 Morrell et al 2000199266 Morrell et al 200961151152
Petrou et al 2006174267 Reid et al 2002200268 Richter et al 2014203269 Rotheram-Borus et al 2011226270
Sen 2006191271 Stamp et al 1995195272 Wisner et al 2001215273 Wisner et al 2004216274 and Wolmanet al 1993204275276 Henceforth studies are referred to by the first identifying reference only
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
33
Iden
tifi
cati
on
Scre
enin
gIn
clu
ded
Elig
ibili
ty
Records identified throughdatabase searching
(n = 3072)
Additional records identifiedthrough other sources
(n = 180)
Records after duplicates removed(n = 2244)
Records screened at titleabstract(n = 2244)
Excluded records at titleabstract(n = 1910)
Full-text articles assessed foreligibility(n = 256)
Articles (n = 122) representing 86unique RCTs included in
quantitative review
Studies included in quantitativesynthesis (meta-analysis)
(n = 35)
Identified reviews(n = 78)
Excluded reviews(n = 55)
bull Commentary or clinical overview n = 2bull No measure of PND reported n = 2bull Non-systematic review n = 29bull Outcome measurement before 6 weeks postnatally n = 6 bull PND treatment trial n = 1bull Protocol for or description of study n = 1bull Systematic review not about prevention of PND n = 7bull Review not about prevention of PND n = 7
Excluded full-text articles(n = 134)
(reasons for exclusions)
bull Commentary or clinical overview n = 15bull Intervention initiated after 6 weeks postnatally n = 18bull No measure of PND reported n = 15bull Non-randomised control group n = 8bull Not a PND prevention trial n = 11bull Outcome measurements after 12 postnatal months n = 7bull Outcome measurement before 6 weeks postnatally n = 31bull PND treatment trial n = 8bull Protocol for or description of study n = 11bull Secondary analysis of data from a RCT n = 5bull Study reported in non-English language n = 5
Included reviews(n = 23)
bull Cochrane review n = 11bull Systematic review n = 2bull Systematic review and meta-analysis n = 3bull Review n = 7
FIGURE 2 The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart of studiesincluded in the quantitative review
OVERVIEW OF RESULTS FOR QUANTITATIVE AND QUALITATIVE STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
34
Level of preventive interventionThe 86 RCTs one reporting both a universal preventive intervention level of analysis and an indicatedpreventive intervention level of analysis61151 comprised
l 37 trials reporting a universal preventive intervention61123129146147150153ndash157180ndash187197ndash200207ndash212217ndash220225ndash228
l 20 trials reporting a selective preventive intervention149158ndash163188ndash192201ndash204213221ndash223
l 30 trials reporting an indicated preventive intervention61121148164ndash179193ndash196205206214ndash216224229
Study locationIn total 15 of the included RCTs were undertaken in the UK61146149150174177188191199ndash201206213219224 31 in theUSA121160161163166ndash173178ndash181187190192197198202208210212214ndash216222227229 18 in Australia123147159164165182184185189195196211217218220221223225 five in South Africa153203204209226 three in the China154157162 two in Canada186205
two in Hong Kong156175 two in the Republic of China (Taiwan)183193 and one each in France158 Germany176
Hungary155 Japan228 Mexico194 the Netherlands207 Norway129 and Pakistan148
ParticipantsA total of 66418 participants were randomised across the 86 trials with the individual trial sample sizesranging from 25 to 18555 participants The mean number of participants was 7723 (SD 2210) The mean(SD) age of participants was 2716 years (SD 406 years)
Intervention classSeven intervention types were identified across the 86 RCTs these were
1 psychological (n= 30)61121148153ndash179
2 educational (n= 17)180ndash196
3 social support (n= 11)149197ndash206
4 pharmacological agents or supplements (n= 10)207ndash216
5 midwifery-led interventions (n= 9)146217ndash224
6 organisation of maternity care (n= 5)147150225ndash227
7 CAM and other (n= 4)123129228229
Outcome assessmentThe studies varied in their duration and assessment times 6ndash8 weeks 10ndash12 weeks 3 or 4 months5 months 6 months 7 months and 12 months postnatally
Following the description of the overall study quality the RCTs are described fully according to the level ofpreventive intervention in Chapters 5ndash7
Quality of quantitative studies
Overall risk of bias of randomised controlled trials
Selection biasOf all the 86 RCTs 64 (744) reported an adequate method for random sequence generation(low risk of bias) 16 (190) were unclear about the allocation method (unclear risk of bias) and six (70)had used a non-random process (high risk of bias) The greatest level of risk was associated with allocationconcealment Furthermore 50 RCTs (581) reported adequate treatment allocation concealment(low risk of bias) 27 (314) were unclear (unclear risk of bias) and nine (105) were at high risk of bias
Performance biasThe nature of most of the interventions made blinding of participants and caregivers not possible but it isunlikely that the lack of blinding could not have affected the results Therefore 73 RCTs (849) wererated as being at low risk of performance bias for the assessment of blinding for participants and staff
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
35
12 (140) were rated as being at unclear risk of bias and one RCT (12) was rated as at high risk ofbias for failing to report blinding status of the women and study personnel In 61 RCTs (71) outcomeassessors were reported to be blinded (low risk of bias) in 24 (280) it was not clear if the outcomeassessors were blinded (unclear risk of bias) and in one RCT the risk of bias was rated as high
Attrition biasThe risk of attrition bias was assessed as low for 51 (593) RCTs and unclear for 27 RCTs (314)eight (93) RCTs were assessed as being at high risk for selective outcome andor analysis bias
Reporting bias and other biasThe risk of reporting bias was assessed as low in 74 RCTs (86) unclear in eight RCTs (93) and high infour RCTs (47)
The risk of other bias (eg funding source or inappropriate analysis) was judged to be low for 54 RCTs(628) unclear for 28 (326) and high for four (47)
Overall the risks of bias were rated as higher for universal preventive intervention studies than for theselective and indicated preventive interventions this was most notable for selection bias and attrition biasThe judgements about each risk of bias domain are presented in Tables 1ndash3 for each included studyaccording to the level of preventive intervention (universal selective or indicated) and summarised inFigure 3 for all included studies
Quality of systematic and other reviewsNo quality assessment was undertaken for the systematic reviews
Literature search for the qualitative review
The electronic searches identified 2131 records after removal of duplicates and a further 20 records thatwere from other sources Overall 2151 records were screened by title and abstract and 1991 wereexcluded The remaining 56 records (representing 44 unique studies) were included and the full textexamined A flow diagram outlining the identification of relevant included qualitative studies and reasonsfor exclusion of full-text articles is provided in Figure 4
Qualitative studies level of preventive interventionAmong the 21 studies (27 citations)
l Fourteen were studies of a universal preventive intervention Twelve studies reported qualitative dataon the perspectives and attitudes of those who had received universal preventive interventions forPND277ndash289 (of these two also reported perspectives and attitudes of service providers on universalpreventive interventions287288 and two studies reported only on the perspectives and attitudes of serviceproviders to preventive interventions)290291
l Four studies presented data from those who had received a selective preventive intervention292ndash298
(with one study additionally presenting data relating to an indicated population)296ndash298 Of these one studyalso reported perspectives and attitudes of service providers on selective preventive interventions296ndash298
l Three studies presented data from those who had received an indicated preventiveintervention253256299300 One study with a separate citation301 additionally reported on the perspectivesof and attitudes of service providers on indicated preventive interventions
These data are synthesised in Chapters 5ndash7 The remaining 29 (23 studies) citations about PSSSs thatwomen believed helped prevent PND are synthesised in Chapter 8 the realist synthesis and are presentedseparately (see Appendix 7)
OVERVIEW OF RESULTS FOR QUANTITATIVE AND QUALITATIVE STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
36
TABLE
1Riskofbiasforincluded
universalpreve
ntive
interven
tionRCTssummaryjudgmen
tsab
outea
chrisk-of-biasitem
Firstau
thorye
ar
reference
number
Selectionbias
Perform
ance
bias
Detectionbias
Attritionbias
Rep
ortingbias
Other
bias
Ran
dom
sequen
cegen
eration
Allo
cation
concealmen
t
Blin
dingof
participan
ts
perso
nnel
Blin
dingof
outcome
assessors
Inco
mplete
outcomedata
Selectivereportingof
theoutcome
subgroups
oran
alysis
Fundingso
urce
adeq
uacyof
statisticalm
ethodsusedtyp
eofan
alysis
(ITT
PP)baseline
imbalan
cein
importan
tch
aracteristics
Christie
20
1115
0Low
Low
Unclear
Low
Low
Low
Low
Coo
per20
0915
3Low
Unclear
Unclear
Low
Low
Low
Low
Doo
rnbo
s20
0920
7Low
Unclear
Low
Low
High
Low
Unclear
Feinbe
rg20
0818
0Unclear
Unclear
Unclear
Low
Low
Low
Low
Fujita
2006
228
Unclear
Unclear
Low
Low
High
Low
Unclear
Gao
20
1015
4Low
Low
Low
Low
Low
Low
Low
Gjerdinge
n20
0218
1Low
Unclear
Unclear
Low
Unclear
High
High
Gun
n19
9822
5Low
Low
Low
Low
Low
Low
Low
Harrison
-Hoh
ner
2001
208
Low
Low
Unclear
Unclear
High
High
High
Hayes20
0118
2Low
Low
Low
Unclear
Low
Low
Unclear
Ho
2009
183
High
High
Low
Low
Low
Low
Unclear
Hod
nett20
0219
7Low
Low
Low
Unclear
Low
Low
Low
Kieffer20
1319
8Low
Low
Low
Low
Low
Low
Low
Kozinsky
2012
155
High
High
Unclear
Unclear
Unclear
High
High
Lawrie
19
9820
9Low
Low
Low
Low
Low
Low
Low
Leun
g20
1215
6Low
Low
Low
Low
Low
Low
Low
Lloren
te20
0321
0Low
Low
Low
Unclear
Unclear
Low
Unclear
Lumley
2006
147
Low
Unclear
Low
Low
Unclear
Low
Low
MacArthu
r20
0214
6Low
Low
Low
Low
Low
Low
Low
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
37
TABLE
1Riskofbiasforincluded
universalpreve
ntive
interven
tionRCTssummaryjudgmen
tsab
outea
chrisk-of-biasitem
(continued
)
Firstau
thorye
ar
reference
number
Selectionbias
Perform
ance
bias
Detectionbias
Attritionbias
Rep
ortingbias
Other
bias
Ran
dom
sequen
cegen
eration
Allo
cation
concealmen
t
Blin
dingof
participan
ts
perso
nnel
Blin
dingof
outcome
assessors
Inco
mplete
outcomedata
Selectivereportingof
theoutcome
subgroups
oran
alysis
Fundingso
urce
adeq
uacyof
statisticalm
ethodsusedtyp
eofan
alysis
(ITT
PP)baseline
imbalan
cein
importan
tch
aracteristics
Makrid
es20
1021
1Low
Low
Low
Low
Low
Low
Low
Mao
20
1215
7Low
Low
Low
Low
Low
Low
Unclear
Matthey20
0418
4Unclear
Unclear
Low
Low
Low
Low
Unclear
Milgrom20
1118
5Low
Low
Low
Unclear
Unclear
Low
Low
Mok
hber20
1121
2Unclear
Unclear
Low
Low
Unclear
Low
Unclear
Morrell
2000
199
Low
Low
Low
Low
Low
Low
Low
Morrell
2009
61Low
Low
Low
Low
Low
Low
Low
Norman
20
1012
3Low
Low
Low
Low
Unclear
Unclear
Unclear
Priest20
0321
7Low
Unclear
Low
Low
Low
Low
Low
Reid20
0220
0Low
Low
Low
Low
Low
Low
Low
Rotheram
-Borus
2011
226
Low
Low
Low
Low
Low
Low
Low
Sealy
2009
186
High
High
Low
Low
Unclear
Low
Unclear
Selkirk
20
0621
8High
High
High
Low
High
Low
Low
Serw
int19
9122
7High
High
Low
Low
Low
Low
Low
Shap
iro20
0518
7Unclear
Unclear
Low
High
High
Low
Unclear
Shields19
9721
9Low
Unclear
Low
Low
Unclear
Unclear
Low
Song
oslashyga
rd20
1212
9Low
Low
Low
Low
Unclear
Unclear
Unclear
Walde
nstrom
20
0022
0Low
Low
Low
Low
Unclear
Low
Low
Keyhigh
high
riskof
biasIDiden
tification
ITT
intentionto
treatlowlow
riskof
biasPPpe
rprotocolun
clearun
clearriskof
bias
OVERVIEW OF RESULTS FOR QUANTITATIVE AND QUALITATIVE STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
38
TABLE
2Riskofbiasforincluded
selectivepreve
ntive
interven
tionRCTssummaryjudgmen
tsab
outea
chrisk-of-biasitem
Firstau
thorye
ar
reference
number
Selectionbias
Perform
ance
bias
Detectionbias
Attritionbias
Rep
ortingbias
Other
bias
Ran
dom
sequen
cegen
eration
Allo
cation
concealmen
t
Blin
dingof
participan
ts
perso
nnel
Blin
dingof
outcome
assessors
Inco
mplete
outcomedata
Selectivereportingof
theoutcome
subgroups
oran
alysis
Fundingso
urce
adeq
uacyof
statisticalm
ethodsusedtyp
eofan
alysis
(ITT
PP)baseline
imbalan
cein
importan
tch
aracteristics
Barnes20
0914
9Unclear
Unclear
Low
Low
Unclear
Low
Unclear
Brug
ha20
0018
8Low
Unclear
Low
Unclear
Low
Low
Low
Buist19
9918
9Unclear
Unclear
Low
Low
Unclear
Unclear
Unclear
Cha
brol20
0215
8Unclear
High
Low
Unclear
Unclear
Low
Unclear
Cup
ples20
1120
1Low
Low
Low
Low
Low
Low
Low
Gam
ble
2005
221
Low
Low
Low
Low
Low
Low
Low
Hag
an20
0415
9Low
Low
Low
Low
Low
Low
Low
Harris20
0221
3Low
Unclear
Low
Low
Unclear
Unclear
Unclear
How
ell20
1219
0Low
Low
Low
Low
Low
Low
Low
Icko
vics20
1122
2Low
Low
Low
Low
Low
Low
Low
Logsdo
n20
0520
2Low
Unclear
Unclear
Low
Unclear
Low
Unclear
Phipps20
1316
0Low
Low
Low
Low
Low
Low
Low
Richter20
1420
3Low
Low
Low
Unclear
High
Unclear
Unclear
Sen
2006
191
Low
Low
Low
Low
Low
Low
Low
Silverstein
2011
161
Low
Low
Low
Low
Low
Low
Low
Small20
0022
3Low
Low
Low
Low
Low
Low
Low
Tam20
0316
2Low
Low
Unclear
Unclear
Unclear
Low
Unclear
Walku
p20
0919
2Low
Low
Low
Low
Unclear
Low
Low
Wolman
19
9320
4Low
Low
Low
Unclear
Unclear
Low
Low
Zlotnick20
1116
3Low
Low
Low
Unclear
Low
Low
Low
Keyhigh
high
riskof
biasIDiden
tification
ITT
intentionto
treatlowlow
riskof
biasPPpe
rprotocolun
clearun
clearriskof
bias
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
39
TABLE
3Riskofbiasforincluded
indicated
preve
ntive
interven
tionRCTssummaryjudgem
ents
aboutea
chrisk-of-biasitem
Firstau
thorye
ar
reference
number
Selectionbias
Perform
ance
bias
Detectionbias
Attritionbias
Rep
ortingbias
Other
bias
Ran
dom
sequen
cegen
eration
Allo
cation
concealmen
t
Blin
dingof
participan
ts
perso
nnel
Blin
dingof
outcome
assessors
Inco
mplete
outcomedata
Selectivereportingof
theoutcomesu
bgroups
oran
alysis
Fundingso
urcead
equacyof
statisticalm
ethodsusedtype
ofan
alysis
(ITT
PP)
baseline
imbalan
cein
importan
tch
aracteristics
Arm
strong
19
9916
4Low
Low
Low
Low
Low
Low
Low
Austin
20
0816
5Low
Unclear
Low
Low
Unclear
Unclear
Unclear
Crockett20
0816
6Unclear
Unclear
Low
Unclear
Low
Low
Unclear
Den
nis20
0920
5Low
Low
Low
Low
Low
Low
Low
El-M
ohan
des20
0816
7Low
Low
Low
Low
Low
Low
Low
Ginsburg
2012
168
Unclear
Unclear
Low
Unclear
Unclear
Low
Unclear
Gorman
19
9716
9Unclear
Unclear
Unclear
Low
Low
Low
Low
Grote20
0917
0Low
Unclear
Low
Unclear
Low
Low
Low
Harris20
0620
6Low
Low
Low
Unclear
Unclear
Unclear
Unclear
Heh
20
0319
3High
High
Low
Low
Low
Low
Unclear
Lara20
1019
4Low
Low
Low
Unclear
High
Low
High
Le20
1117
1Low
Low
Low
Unclear
Low
Low
Low
Man
ber20
0422
9Unclear
Unclear
Unclear
Unclear
Unclear
Low
Unclear
Marks20
0322
4Low
Low
Unclear
Unclear
Low
Low
Unclear
McK
ee20
0617
2Unclear
Unclear
Low
Unclear
High
Low
Unclear
Morrell
2009
61Low
Low
Low
Low
Low
Low
Low
Mozurkewich
2013
214
Low
Low
Low
Low
Low
Low
Low
Mun
oz19
9817
3Low
Low
Low
Unclear
Low
Low
Low
Petrou
20
0617
4Low
Low
Low
Low
Low
Low
Low
Rahm
an20
0814
8Low
Low
Low
Low
Low
Low
Low
Stam
p19
9519
5Low
Low
Low
Low
Low
Low
Low
OVERVIEW OF RESULTS FOR QUANTITATIVE AND QUALITATIVE STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
40
Firstau
thorye
ar
reference
number
Selectionbias
Perform
ance
bias
Detectionbias
Attritionbias
Rep
ortingbias
Other
bias
Ran
dom
sequen
cegen
eration
Allo
cation
concealmen
t
Blin
dingof
participan
ts
perso
nnel
Blin
dingof
outcome
assessors
Inco
mplete
outcomedata
Selectivereportingof
theoutcomesu
bgroups
oran
alysis
Fundingso
urcead
equacyof
statisticalm
ethodsusedtype
ofan
alysis
(ITT
PP)
baseline
imbalan
cein
importan
tch
aracteristics
Tiwari20
0517
5Low
Low
Low
Low
Low
Low
Low
Vieten
2008
121
Unclear
Unclear
Low
Low
Unclear
High
Unclear
Web
ster20
0319
6Low
Low
Low
Low
Unclear
Low
Low
Weidn
er20
1017
6Low
High
Low
Low
Unclear
Low
Low
Wilson
20
1317
7Low
High
Low
Unclear
Unclear
Low
Low
Wisne
r20
0121
5Low
Low
Low
Low
Low
Low
Low
Wisne
r20
0421
6Low
Low
Low
Low
Low
Low
Low
Zlotnick20
0117
8Unclear
Unclear
Low
Unclear
Low
Low
Low
Zlotnick20
0617
9Low
Unclear
Low
Unclear
Low
Low
Low
Keyhigh
high
riskof
biasIDiden
tification
ITT
intentionto
treatlowlow
riskof
biasPPpe
rprotocolun
clearun
clearriskof
bias
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
41
010
20
30
40
50
60
70
80
90
10
0
Oth
er b
ias
fu
nd
ing
so
urc
e a
deq
uac
y o
f st
atis
tica
l met
ho
ds
use
d t
ype
of
anal
ysis
(IT
TPP
) b
asel
ine
imb
alan
ce in
imp
ort
ant
char
acte
rist
ics
Rep
ort
ing
bia
s s
elec
tive
rep
ort
ing
of
the
ou
tco
me
su
bg
rou
ps
or
anal
ysis
Att
riti
on
bia
s in
com
ple
te o
utc
om
e d
ata
Det
ecti
on
bia
s b
lind
ing
of
ou
tco
me
asse
sso
rs
Perf
orm
ance
bia
s b
lind
ing
of
par
tici
pan
ts a
nd
per
son
nel
Sele
ctio
n b
ias
allo
cati
on
co
nce
alm
ent
Sele
ctio
n b
ias
ran
do
m s
equ
ence
gen
erat
ion
Low
ris
k o
f b
ias
Un
clea
r ri
sk o
f b
ias
Hig
h r
isk
of
bia
sN
A
FIGURE3
Risk-of-biasgraphforallincluded
RCTsau
thorsrsquojudgem
ents
aboutea
chrisk-of-biasitem
Key
ITT
intentionto
trea
tNAn
otap
plicab
lePP
per
protoco
l
OVERVIEW OF RESULTS FOR QUANTITATIVE AND QUALITATIVE STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
42
Scre
enin
gEl
igib
ility
Iden
tifi
cati
on
Records screened by title and abstract(n = 2151)
Full-text articles assessed foreligibility(n = 160)
Full-text articles and abstracts excluded(n = 105)
Reasons for exclusionbull Women with a diagnosis of PND PTSD or psychosis andor not a preventive intervention n = 43bull No qualitative data n = 20bull No datano relevant qualitative data n = 11bull Qualitative data from health professionals but not about an intervention n = 9bull About screeningcare n = 8bull About stressful events during the postnatal year n = 4bull Systematic review n = 1bull Literature review n = 2bull Not in English language n = 3bull Not within 1 year postnatal n = 1bull About treatment for PND n = 1bull About fathersrsquo perceptions only n = 1bull Feasibility study n = 1
Excluded by title and abstract(n = 1991)
Full-text articles and abstracts(citations) included inqualitative syntheses
(n = 55)(relating to 42 studies)
27 citations relating topreventive interventions
29 citations relating to PSSSswomen believed helped
prevent PND
Incl
ud
ed
Records identified throughdatabase searching
(n = 2131)
Additional records identifiedthrough other sources
(n = 20)
FIGURE 4 The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart of studiesincluded in the qualitative reviewKey PTSD post-traumatic stress disorder
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
43
Qualitative review study characteristics
Study locationOf the included studies two were undertaken in the UK253254287 seven in the USA283284286291ndash298 one inSweden277 one in Ireland278279 four in Australia280288289300 three in Canada281285290299301 and onein China282
ParticipantsThe studies contained qualitative data from 940 service users (when reported) and from 29 serviceproviders (when reported) Service provider data came from four clinicians296ndash298 three nurses288 twocertified nurse-midwives and two medical assistants293ndash295 three physicians290 four certified nurse midwivesfive health centre staff and five administrators284 from support workers midwives and health visitors287 andfrom peer volunteers301 The age range of the women was reported in eight studies Age ranged from13 to 45 years Ethnicity was reported in 13 studies280282ndash286290292ndash298300 For further details of participantcharacteristics see Appendix 9
Intervention classA total of 19 qualitative studies corresponded to the seven intervention classes which were identifiedpreviously across the RCTs These were
1 psychological (n= 3 six reports)253254282296ndash298
2 educational (n= 0)3 social support (n= 3 four reports)281287299301
4 pharmacological agents or supplements (n= 0)5 midwifery-led interventions (n= 8 11 reports)277283ndash285289ndash295
6 organisation of maternity care (n= 2)288300
7 CAM and other (n= 3 four reports)278ndash280286
Qualitative review study characteristics personal and social supportstrategy studiesA total of 23 studies (n= 29 citations) reported qualitative data on perspectives and attitudes of women whohad not experienced PND regarding PSSSs that they believe helped them to prevent the condition7302ndash325
This included five citations from three intervention studies which included PSSS evidence286292296ndash298
Study locationTen studies were conducted in the UK304306ndash315319321322324 seven studies were conducted in theUSA286292296ndash298302303318320 one in Switzerland316 one in Canada317 one in Norway323 one in India325 one inChina305 and one in multiple centres7
ParticipantsThe total number of reported participants contributing qualitative evidence was 801 (one study did notprovide the number of participants who contributed to qualitative findings)7 Fifteen studies provided datafrom participants who were part of the general population in the country of study whereas the remainingstudies examined evidence from minority groups within the country of study The minority groups eitherwere a culturally different group based within the country of study (n= 5)304306ndash311314318 or were a selectivegroup (n= 3)292296ndash298315 For details of participant characteristics see Appendix 9
OVERVIEW OF RESULTS FOR QUANTITATIVE AND QUALITATIVE STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
44
Quality of the qualitative intervention studiesAll studies met the requirement to report either qualitative research or qualitative data within mixed-methodsstudies indicated in Table 4 All included studies also adequately described the context and aims of thestudy Few (29) demonstrated evidence of researcher reflexivity (ie awareness of the researcherrsquoscontribution to the construction of meanings throughout the research process and an acknowledgement ofthe impossibility of remaining lsquooutsidersquo onersquos subject matter while conducting research) among those whichdid these descriptions were brief A number of studies illustrated that reflexivity in the research process hadbeen incorporated such as making changes to the interview guide as necessary and responding toparticipantsrsquo wishes All 21 studies provided adequate descriptions of recruitment methods just over half(n= 13) provided adequate descriptions of data collection methods although such descriptions tended tobe brief The study methods used involved interview methods in nine studies supplemented by other methodssuch as focus groups and observation in three studies Qualitative data came from open-ended questions aspart of a questionnaire in three studies Two studies used focus groups and one study used online messagesTwelve studies provided an adequate description of data analysis methods and 13 studies providedsufficiently in-depth detailed and rich data The absence of detail in the remaining studies may have been inpart because of limitations imposed by journal reporting requirements
Certainty of the review findings intervention studiesThe CERQual approach137 was used to assess the certainty of the review findings graded as lsquovery lowrsquolsquolowrsquo lsquomoderatersquo or lsquohighrsquo A summary assessment was based on the CASP quality assessment finding136
the number and richness of the study data the consistency of the data across study settings andpopulations and the relevance of the finding to the review question There were 37 findings in womenrsquosevidence nine were assessed as of moderate certainty 25 as low and three as of very low certainty Forservice providersrsquo evidence there were 25 findings one finding was assessed as being of moderatecertainty 18 as of low certainty and six as of very low certainty No findings were assessed as high certainty
Overview of main findings from qualitative intervention studies (all levels)
PsychologicalWomen reported that IPT served to promote the development of relationships with other group memberswhich had a normalising effect282ndash285 It facilitated gaining support from family members Women alsoreported that they appreciated the support of the midwife as part of the intervention Participants reportedlearning useful and applicable practical strategies282 IPT facilitated the gaining of knowledge and theactive participation of women in their own health care specifically in realistic information about motherhoodand in the empowerment to ask for help
TABLE 4 Qualitative studies quality assessment of the studies of universal preventive interventions
QuestionYessomewhat(n= 21 studies)
1 Is the study qualitative researchor provide qualitative data 2121
2 Is the study context and aims clearly described 2121
3 Is there evidence of researcher reflexivity 621
4 Are the sampling methods clearly described and appropriate for the research question 2121
5 Are the methods of data collection clearly described and appropriate to the research question 1321
6 Is the method of analysis clearly described and appropriate to the research question 1221
7 Are the claims made supported by sufficient evidence That is did the data provide sufficientdepth detail and richness
1321
This table is adapted from the CASP checklist for qualitative studies136 (URL wwwcasp-uknet under Creative Commons licence)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
45
EducationalThe Preparing for Parenthood intervention was aimed at improving womenrsquos knowledge and activeparticipation in their own health care253254 specifically gaining information about sensitive subjects suchas PND Although appearing to want information about PND women who attended the Preparationof Parentedhood intervention were reluctant to ask for information because of the fear of stigmaOther women appeared to avoid information about PND authors interpreted this as a belief that lack ofknowledge could operate as a protective factor Although most women reported benefits of the groupenvironment a few did not want to join because of privacy concerns Most participants valued theopportunity provided for their partner to join the group and were interested in the partnerinvolvement session
Social supportThe qualitative review demonstrated that both women and service providers felt the support group andsupport intervention adequately provided emotional and informational support reassurance and validationParticipants of the support worker intervention287 reported that the intervention would have been morebeneficial if it were more intensive Concerns articulated by service providers included worries about theirown ability to deal with unpredictable situations and womenrsquos overdependence on the service287288
Midwifery-led interventionsPeer support partner support and support from health professionals were particularly helpful aspects ofthe CenteringPregnancy intervention277283285289ndash294 Specifically a supportive environment and theopportunity to share experiences were appreciated However some women reported a dislike for thegroup environment and the inclusion of partners because of concerns regarding privacy277 Some partnersalso felt uncomfortable with their own inclusion for similar reasons277 Women felt the health professionalswere able to pay more attention to their own concerns and offer them more solutions285 although the skillof the midwife was an important factor in the success of the intervention277 Service providers felt theintervention promoted better communication between providers and users and between health providersThey were able to develop better relationships with the intervention recipients and the enhancedcommunication served to facilitate information exchange290 Education and information about pregnancyand the postnatal period were valued283284293294 However the evidence indicated283289 that some womenwanted more and more intensive education on issues relating to labour birth and parenting particularlyabout the early weeks of parenting
Organisation of maternity careThe support women received from the health professionals delivering the service was felt to behelpful288300 although a lack of understanding of the role of the maternal and child health nurse created apotential barrier to accessing the service288 Women reported that they felt able to rely on the serviceparticularly if they needed the service urgently300 However concerns included feeling intimidated by thethought of referral to the specialist perinatal and infant mental health service300 worries about stigmaassociated with using the service288 and concerns about being ready to be discharged300
Complementary and alternative medicine or other interventionWomen reported that the CAM interventions provided peer support specifically by the sharing ofexperiences and birth stories and the facilitation of family support278ndash280286 They reported the practicaluse of strategies learned during the intervention278279286 However some difficulty in being able to applylearned techniques in practice was expressed286 together with a concern that the use of the learnedstrategies could result in unexpected emotional responses278279 The interventions facilitated preparation forbirth both emotionally278ndash280 and physically280
Tables 5ndash12 provide a synthesis of the qualitative evidence across all types of intervention
OVERVIEW OF RESULTS FOR QUANTITATIVE AND QUALITATIVE STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
46
TABLE 5 Synthesis of findings across all intervention studies what helped
Meta-theme Subtheme Mechanism (with examples)Evidencesource CASPa
Certainty inCERQual137
Support Peer support Peer support providing reassurancenormalisation of experiences emotionalsupport practical advice and informationaladvice Achieved through reading aboutpeer experiences281 sharing experiences277283
and through the development of friendshipand relationships and forming a connectionwith others280
Moderate(times 6)low
Moderate
Family support Practical and emotional support from thefamily facilitated by educating familymembers through provision formenpartners to join the group to besupported283 and partners beingencouraged to be actively involved inintervention289 through family joining thegroup and participants teaching theirpartner or mother the song learned in thegroup278279
Moderate(times 3)low
Moderate
Educating the intervention recipients aboutlsquodoing the monthrsquo served to facilitatedevelopment of a relationship with themother-in-law leading to her providingpractical support282
Moderate Moderate
Health professionalsupport
Health professionals leading theintervention were seen as having concernfor participants providing emotional andpractical support Specifically discussionswith nurses288 support workers287 or socialsupport from the midwife throughtelephone follow-up282 were reported asbeing helpful
Moderate(times 3)low (times 2)
Moderate
Partner support Partnersrsquo support in applying techniqueslearned through the intervention whichwent on to facilitate better communicationbetween the partners286289
Highlow Low
Empowerment Educationactiveparticipation inown health care
Participants empowered by being allowedto weigh themselves283 providing educationand information280282284
Moderate Moderate
Learning practicalstrategiesskillsknowledge
Learning practical strategies such assinging278279 problem-solving skillsmindndashbody exercises and techniques286 tobe applied during pregnancy or in thepostpartum period These included theability to calm the infant278279 the gainingof information about sensitive subjects suchas PND282 and realistic information aboutmotherhood thus helping participantsaccept the reality of early motherhood282
Moderatehighmoderate
Moderate
Self-esteem Yoga provided emotional preparation forbirth280
Moderate Low
Interventions promoted abilities in dealingwith offers of support and asking forsupport and developing a goodrelationship with mother-in-law to beempowered to ask for help282
Moderate Low
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
47
TABLE 6 Synthesis of findings across all intervention studies what did not help
An intervention for the prevention of PND was unhelpful when it resulted in aperception of
Evidencesource CASP
Certainty inCERQual137
Lack of support as a result of partners feeling uncomfortable with discussions and thusdisengaging283
Moderate Moderate
Inability to implement learned strategies without the support of the group286 High Moderate
Difficult to raise questions with partners present at group intervention84283 Moderate Moderate
An unexpected emotional response because of the application of the strategies learnedin the group (singing) resulting in a lsquoprofoundrsquo emotional response85279
Moderate Low
Feeling rushed by health professionals during the intervention90 Moderate Low
Lack of privacy during the intervention90 Moderate Low
Lack of consideration for workload specific to a service in a military setting90 Moderate Low
Midwife being too controlling and not asking about the wishes of the group84 Moderate Low
Service was not family centred and older children were not welcome at the service90 Moderate Low
Service providers were scrimping and cost-saving on care (women were asked to delivertheir own samples to the laboratory)90
Moderate Low
Not being able to implement strategies because of forgetfulness3 High Low
Format of the sessions was not ideal because a 2-hour session was too long96 Low Low
A long interval between first and second group meetings84 Moderate Moderate
Group format was disliked84 Moderate Low
TABLE 5 Synthesis of findings across all intervention studies what helped (continued )
Meta-theme Subtheme Mechanism (with examples)Evidencesource CASPa
Certainty inCERQual137
Time outrelaxationsocialisation
ndash Reduction of stress and anxiety andcountering isolation by the provision ofsocialisation in a group278279 or via aone-to-one intervention287
Moderatemoderatelow
Physicalpreparationrecovery
ndash Yoga practice as part of the groupintervention promoted preparation for birthand quicker physical recovery from birth280
Moderate Low
Reducedwaiting times
ndash A group rather than individual formatresulted in reduced waiting times289
Low Very low
Continuity ofcare
ndash Group intervention promoted continuity ofcare277
Moderate Low
Connectingwith the baby
ndash Yoga aspect of group interventionpromoted connection with unborn baby280
Moderate Low
Safe space ndash Group intervention provided a safe space280 Moderate Low
a Multiple ratings indicate that the results have been synthesised from two or more studiesNoteCertainty is based on quality of individual studies rated as lsquovery lowrsquo lsquolowrsquo lsquomoderatersquo or lsquohighrsquo
OVERVIEW OF RESULTS FOR QUANTITATIVE AND QUALITATIVE STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
48
TABLE 7 Synthesis of findings across all intervention studies service delivery
An intervention for prevention of PND should have includedEvidencesource CASP
Certainty inCERQual137
Education specifically about the early weeks of parenting289 Low Very low
More intensive intervention more visits and longer visits287 Low Very low
Something different from the mainstream (CAM)280 Moderate Low
Structure to the group aspect280 Moderate Low
More drinksrefreshments283 Moderate Low
TABLE 8 Synthesis of findings across all intervention studies service delivery barriers to participation
Barriers to participation includedEvidencesource CASPa
Certainty inCERQual137
Poor access to the service including practical difficulties in getting to appointmentsand physical limitations (bleeding) which hindered attendance283
Moderate Low
Unhelpful front-desk staff long waits and lsquobrush-offsrsquo283 Moderate Low
Not understanding role of the service provider288 Moderate Low
Not associating the depression with pregnancypostpartum period286288 Moderatehigh Moderate
Perceived stigma related to the admission of not being able to cope286288 Moderatehigh Moderate
Being unable to see use of strategies learned during pregnancy for the postpartum period286 High Low
Being unable to find the time to implement strategies learned286 High Low
a Multiple ratings indicate that the results have been synthesised from a number of studies
TABLE 9 Synthesis of findings across all intervention studies health-care professionalsrsquo views on what helped
Things helpful for the intervention recipientsEvidencesource CASPa
Certainty inCERQual137
Peer support through sharing experiences providing reassurance normalisation ofexperiences emotional support practical support and informational advice287290291
Moderatemoderatelow
Moderate
Education group environment provided more opportunity for teaching284291 Moderate Low
Womenrsquos active participation in their own health care (empowerment) the groupenvironment allowed more time to be allocated to this284290
Moderate Low
Better communication between provider and user facilitating information exchange inthe group setting290
Moderate Low
Health professional developed better relationships with service users in the group setting290 Moderate Low
Provision of richer care provided in a group setting290291 Moderate Low
Womenrsquos enthusiasm about a group setting served to increase participation284 Moderate Low
Group setting allowed more women to be seen in same amount of time therebyaddressing waiting time issues284
Moderate Low
Sensitivity to the women and a subtle and non-threatening manner in approach to issues288 Moderate Low
Things helpful for the health professionals delivering the intervention
Group setting resulted in more efficient use of time290 Moderate Low
Health professionals found delivering the group intervention enjoyable satisfying anda rewarding experience290291
Moderate Low
Delivering an innovative (group) intervention brought recognition to the site (health centre)284 Moderate Low
a Multiple ratings indicate that the results have been synthesised from a number of studies
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
49
TABLE 10 Synthesis of findings across all intervention studies health-care professionalsrsquo views on what did not help
Things that health professionals thought did not help prevent PNDEvidencesource CASPa
Certainty inCERQual137
Restricting service to selective groups through staff and provider bias for example onlyfor teens291
Moderate Low
Difficulties in funding the service284291 Moderate Low
Difficulties in facilitating access to the service because of work conflicts for serviceproviders and transportation difficulties for women attending groups and also forsupport workers travelling to womenrsquos homes to deliver the one-to-one intervention287291
Moderatelow Low
Womenrsquos resistance to the intervention or discontinuation of the intervention because ofparticipantsrsquo resistance to a group format291 or the individual support worker visit wasanxiety inducing287
Moderatelow Low
Group interventions result in provider having less opportunity for one-to-one care284 Moderate Low
Inability to address deeply personal issues in group setting Service providers felt thatdeeper issues were not appropriate to be discussed in a group setting284
Moderate Low
Scheduling difficulties as while one provider was doing group care the other had to dealwith everything else284
Moderate Low
Potential for participants to become dependent on the intervention287 Low Very low
Potential conflicts or threats to provider roles287 Low Very low
Potential for invasion of participant privacy287 Low Very low
Being unable to deal with unpredictable situations or those for which they wereunqualified Anxieties about their own abilities skills and helpfulness287
Low Very low
a Multiple ratings indicate that the results have been synthesised from a number of studies
TABLE 11 Synthesis of findings across all intervention studies health-care professionalsrsquo views on service delivery
Health professionalsrsquo thought an intervention for prevention of PNDshould include
Evidencesource CASP
Certainty inCERQual
Closer integration with other service providers (primary care team)287 Low Very low
Target vulnerable groups287 Low Very low
TABLE 12 Qualitative studies quality assessment of PSSSs
QuestionYessomewhat(n= 23 studies)
1 Is the study qualitative researchor does it provide qualitative data 2323
2 Is the study context and are the aims clearly described 2323
3 Is there evidence of researcher reflexivity 1623
4 Are the sampling methods clearly described and appropriate for the research question 2123
5 Are the methods of data collection clearly described and appropriate to the research question 2123
6 Is the method of analysis clearly described and appropriate to the research question 1823
7 Are the claims made supported by sufficient evidence ie did the data provide sufficient depthdetail and richness
2023
This table is adapted from CASP checklist for qualitative studies136 (URL wwwcasp-uknet under Creative Commons licence)
OVERVIEW OF RESULTS FOR QUANTITATIVE AND QUALITATIVE STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
50
Quality of the qualitative personal and social support strategy studiesAs shown in Table 12 all included studies reported either qualitative research or qualitative data withinmixed-methods studies All included studies adequately described the context and aims of the studySixteen of the 23 studies demonstrated evidence of researcher reflexivity As in the intervention studiesfew PSSS studies made explicit reference to researcher reflexivity and in those which did descriptions wereoften brief Most studies adequately described recruitment methods (n= 21) and data collection methods(n= 21) although such descriptions tended to be brief Eighteen studies used interview methods fourused focus groups and one study used an online survey Eighteen of 23 of studies provided an adequatedescription of data analysis methods and 20 of the 23 studies provided sufficiently in-depth detailed andrich data
Certainty of the review findings personal and social support strategy studiesThe CERQual approach137 was applied to assess the certainty of the review findings graded as lowmoderate or high In each case a summary assessment was made of the CASP quality assessment findingthe number of studies contributing to the finding the consistency of study setting and the populationThe PSSS data yielded 19 findings one assessed as high certainty 11 assessed as moderate certainty andseven assessed as low certainty
The findings were used to inform the realist synthesis and are presented in Chapter 8
Qualitative studies further analysis by level of preventive interventionuniversal selective and indicatedFurther quantitative and qualitative results are presented in Chapter 5 (37 universal preventive interventionstrials 14 qualitative studies) Chapter 6 (20 selective preventive interventions trials four qualitative studies)and Chapter 7 (30 indicated preventive interventions trials three qualitative studies) One study presentedtwo levels of intervention and analysis61
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
51
Chapter 5 Results for universal preventiveintervention studies
Characteristics of randomised controlled trials of universalpreventive interventions
There were 37 RCTs included in the universal preventive interventionsgroup61123129146147150153ndash157180ndash187197ndash200207ndash212217ndash220225ndash228266287 in the seven intervention classes defined as
1 psychological (n= 6)61153ndash157
2 educational (n= 8)180ndash187
3 social support (n= 4)197ndash200266287
4 pharmacological agents or supplements (n= 6)207ndash212
5 midwifery-led interventions (n= 5)146217ndash220
6 organisation of maternity care (n= 5)147150225ndash227
7 CAM or other (n= 3)123129228
The results are presented in this order for the RCTs of universal preventive interventions There was limitedreplication of interventions across the trials The 37 universal preventive intervention trials are describedfirst by their intervention context mechanisms and measured outcomes within the seven classes
Description of qualitative studies of universal preventive interventionsThere were 14 studies relating to 15 citations reporting qualitative data on universal preventiveinterventions for PND277ndash291 Twelve studies relating to 13 citations reported the perspectives and attitudesof women who had received an intervention277ndash289 Four studies reported perspectives and attitudes ofservice providers of universal preventive interventions286287290291
The qualitative studies related to five of the seven intervention classes
1 psychological (n= 1)282
2 social support (n= 2)281287
3 midwifery-led interventions (n= 7)277283ndash285289ndash291
4 organisation of maternity care (n= 1)288
5 CAM or other (n= 3)278ndash280286
For ease of reference the universal preventive interventions have been given short-version descriptive labels(Table 13)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
53
TABLE 13 Universal preventive interventions short-version descriptive labels
First author yearreference number
Short-versiondescriptive label Fuller description
Gunn 1998225 Early contact with careprovider
A postnatal check-up with a GP 1 week after hospital discharge
Harrison-Hohner2001208261
Calcium 2000mg of elemental calcium per day during pregnancy
Hodnett 2002197 Support in labour Continuous labour support by a specially trained nurse
Lumley 2006147263 Primary care- andcommunity-basedstrategies
Complex multifaceted primary care- and community-basedstrategies
MacArthur 2002146
2003264Midwifery redesignedpostnatal care
Redesigned midwifery-led community postnatal care
Makrides 2010211265 DHA 800mg of DHA in DHA-rich fish oil capsules in pregnancy
Matthey 2004184 Baby play A session focused on the importance of play with a baby withvideotapes and discussion on how parents can play with infants
Matthey 2004184 Education on preparingfor parenting
A session focusing on postpartum psychosocial issues related tobecoming first-time parents
Mokhber 2011212 Selenium 100 microg of selenium as selenium yeast daily during pregnancy
Morrell 2000199266
2002287Social support Up to 10 home visits in the first postnatal month by a community
postnatal support worker
Morrell 200961151152326 CBT-based intervention HV training in the assessment of postnatal women with CBAsessions for eligible women
Morrell 200961151152326 PCA-based intervention HV training in the assessment of postnatal women combined withPCA sessions for eligible women
Norman 2010123 Exercise An 8-week lsquoMother and Babyrsquo programme of specialised exerciseprovided by a physical therapist combined with parenting education
Norman 2010123 Educational information An 8-week lsquoMother and Babyrsquo programme with parentingeducation
Sealy 2009186 Booklet on PND An educational pamphlet lsquoWhy is everyone happy but mersquo mailedat 4-weeks postpartum that explained the symptoms of PPD andidentified local services for PPD
Shields 1997219 Midwife-managed care A new programme of midwife-managed care (MidwiferyDevelopment Unit)
Songoslashygard 2012129 Exercise A 12-week exercise programme of aerobic and strengtheningexercises during pregnancy a weekly physiotherapy-led groupsession and home exercises encouraged twice a week
Waldenstrom 2000220 Midwifery team care Team midwife care eight midwives who provided antenatal andintrapartum care and follow-up visits to the postnatal ward
Key DHA docosahexaenoic acid HV health visitor PPD postpartum depression
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
54
Universal preventive interventions psychological interventions
Characteristics and main outcomes of randomised controlled trials ofuniversal preventive interventions of psychological interventionsOf the 37 universal preventive interventions six studies evaluated a psychological intervention61153ndash157
including promotion of parentndashinfant interaction153 psychoeducation155 IPT154157 CBT-basedinterventions61157 and PCA Comparators included usual care in specific countries61153154156157 andeducational information155 Three studies provided the intervention using a group format154ndash156 whereastwo involved individual sessions61153 and one combined both group and individual sessions157 Two trialsprovided interventions in the home setting61153 whereas in the other four trials the intervention wasprovided in the antenatal setting154ndash157 Three trials provided the intervention in the antenatal periodonly155ndash157 whereas one trial initiated the intervention postnatally61 and two trials provided the interventionacross the perinatal period both during pregnancy and following childbirth153154 The interventions wereprovided by different health-care providers including community workers153 midwives154 health visitors155
psychologists156 and obstetricians157 with the number of intervention contacts ranging from two154 to 16153
and with the duration of contact ranging from 1 to 2 hours
A summary of the characteristics and main outcomes is provided in Table 14 In the psychologicalintervention trials PND was assessed using various measures including the EPDS61153154156157 GeneralHealth Questionnaire154 Leverton Questionnaire155 the Short Form questionnaire-36 items (SF-36) mentalcomponent summary (MCS)328 the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM)151
the PHQ-9157 and the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders(SCID)157 The StatendashTrait Anxiety Inventory (STAI) was the only anxiety outcome reported151 and the PerceivedStress Scale (PSS) the only stress outcome156 Family outcomes included the Dyadic Adjustment Scale61 theParenting Stress Index (PSI)151 the Relationship Efficacy Measure156 the Satisfaction with InterpersonalRelationships Scale154 and motherndashinfant interaction (maternal sensitivity and intrusiveness)153 The three infantoutcomes reported were the Ainsworth Strange Situation Assessment of Infant Attachment153 the BehaviourScreening Questionnaire61 and the Checklist for Autism in Toddlers61 General health and other outcomesincluded the Short Form questionnaire-12 items (SF-12) the SF-36 physical component summary (PCS) theShort-Form questionnaire-6 Dimensions (SF-6D)61 and the Subjective Happiness Scale156
Description and findings from qualitative studies of universal preventiveinterventions of psychological interventionsA description of the qualitative study evaluating a psychological intervention is provided in Table 15
SupportThe qualitative study of a psychological intervention was IPT based and was conducted in China282
Data from participants demonstrated that the intervention promoted the development of relationships andconnection with other group members normalised their experience282 helped them to harness supportfrom family members282 and educated them about the Chinese cultural ritual known as lsquodoing the monthrsquo(which they had felt was unscientific and out of date) and how it could help them to develop a betterrelationship and elicit support from their mother-in-law282 Women appreciated the social support theyreceived from the midwife through a telephone follow-up282
Learning practical strategiesParticipants learned useful and applicable practical strategies as part of the intervention282 gainingknowledge and skills to cope with the postpartum period282
Educationactive participation in own health careThe intervention promoted knowledge gain and active participation in their own health care282 Specificallyparticipants reported that they were able to gain realistic information about motherhood that it helpedthem to accept the reality of early motherhood282 and that they felt empowered to ask for help282
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
55
TABLE 14 Universal preventive interventions characteristics and main outcomes of RCTs of psychologicalinterventions
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
CBT-basedintervention
Mao 2012157 China 204 Antenatalsetting
Antenatal Individuallyand group
Obstetrician
CBT-basedintervention andPCA-basedintervention
Morrell200961151152326
UK 2241 Homevisits
Postnatal Individually Health visitor
IPT-basedintervention
Gao 2010154
2012327China 194 Antenatal
settingAntenataland postnatal
Group Midwife
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
56
Comparisongroup(s)
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Overallrisk ofbias
Usual care inChina
4 90 EPDS meanscore (Chineseversion) PHQ-9score (Chineseversion) SCID
ndash On completion of theprogram IG reportedsignificantly lower meanPHQ-9 and EPDS scoresthan CG157
Unclear
The mean EPDS score at6 weeks postnatally was lowerin the intervention group(mean 645 SD 109) than inthe control group (mean 923SD 291) (t= 195 p= 004)
Fewer participants from theIG were diagnosed ashaving PND using theSCID for DSM-IV157
Usual care inthe UK
1 ndash EPDS score 12or more SF-12MCS scoreCORE-OMscore
STAI DASPSI BSQCHATSF-12 PCSSF-6D
At 6 months among all ofthe women who hadreturned both a 6-week anda 6-month questionnaire164 in CG scored 12 ormore on the EPDS versus117 in IG Absolutedifference was 47(95 CI 07 to 86)(p= 0003)61
Low
Mean EPDS score was 64(SD 52) in CG and 55(SD 47) in IG Differencewas statistically significant(p= 0001)61
Usual care inChina
2 90 EPDS score13 or more(Chineseversion) GHQscore 4 ormore
SWIRS (devisedby first author)
Women receiving thechildbirth psychoeducationprogramme had significantlybetter psychologicalwell-being (t = ndash333p= 0001) fewer depressivesymptoms (t= ndash376p= 0000) and betterinterpersonal relationships(t= 325 p= 0001) at6 weeks postpartumcompared with those whoreceived only routinechildbirth education152
Low
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
57
TABLE 14 Universal preventive interventions characteristics and main outcomes of RCTs of psychologicalinterventions (continued )
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
IPT-basedintervention
Leung 2012156 China(HongKong)
156 Antenatalsetting
Antenatal Group Psychologist
Promotingparentndashinfantinteraction
Cooper 2009153 SouthAfrica
449 Homevisits
Antenataland postnatal
Individually Communityworker (Lay)
Psychoeducationalintervention
Kozinsky2012155
Hungary 1762 Antenatalsetting
Antenatal Group Hungarianhealthvisitors
Key ASSA Ainsworth Strange Situation Assessment of Infant Attachment BSQ Behaviour Screening QuestionnaireCG control group CHAT Checklist for Autism in Toddlers CI confidence interval DAS Dyadic Adjustment Scaledf degrees of freedom GHQ General Health Questionnaire high high risk of bias IG intervention group low low risk ofbias OR odds ratio REM Relationship Efficacy Measure SHS Subjective Happiness Scale SWIRS Satisfaction withInterpersonal Relationships Scale unclear unclear risk of biasEffect statistically significant at a conventional p-value of plt 005
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
58
Comparisongroup(s)
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Overallrisk ofbias
Usual care inHong Kong
2 or more ndash EPDS score 13or more
PSS(four-items)REM SHS
Intention-to-treat analysisshowed IG had significantlylower perceived stress andgreater happiness than CGimmediately after theintervention (in pregnancy)Effects not sustained atpostnatal follow-up156
Low
Usual care inSouth Africa
16 60 EPDS meanscore SCID(DSM-IV)
Motherndashinfantinteractionmaternalsensitivity andintrusivenessASSA
At 6 months and 12 monthspostnatally the SCID indicatednon-statistically significantdifferences in depression in theintervention and control group(χ2= 085 df= 1 p= 036 at6 months χ2= 116 df= 1p= 021 at 12 months)
Unclear
With regard to maternaldepressive symptoms (thecontinuous EPDS) the meanscores for those in the IGwere lower at bothassessments than werethose for the CG but thebenefit of treatment wassignificant only at6 months (z= 205p= 0041 at 6 monthsz= 024 p= 0813 at12 months)153
Educationalinformation
4 180 LevertonQuestionnairescore
ndash Leverton scores appeared toindicate a reduction in therisk of depression in theintervention group (OR= 069)The risk was reduced byaround 18 among womenwho were depressed inpregnancy and 05in women not depressed inpregnancy
High
At 6 weeks postnatally theprevalence of depression was127 in the intervention groupand 175 in the control group(χ2 plt001 OR 068) Levertonscores were 943 (plusmn2168) vs1012 (plusmn3632) in theintervention and control groupsrespectively
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
59
TABLE
15Qualitativestudyofuniversalp
reve
ntive
interven
tionsdescriptionofstudyev
aluatingapsych
ological
interven
tion
Firstau
thor
CASP
quality
grading
Country
Interven
tiondetails
Nam
eSe
tting
Delivered
antenatal
postnatal
Group
individual
Numbers
ingroup
Number
of
sessions
Durationof
session(m
inutes)
Facilitatorservice
provider
Gao
282
Mod
erate
China
IPT-oriented
prog
ramme
Second
ary
care
ndashteaching
hospita
l
Anten
atal
and
postna
tal
Group
and
individu
alNR
Twoclasses
anda
postna
tal
follow-up
teleph
onecall
90Midwife
KeyNR
notrepo
rted
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
60
Universal preventive interventions educational interventions
Characteristics and main outcomes of randomised controlled trials ofuniversal preventive interventions of educational interventionsEight included studies evaluated an educational intervention for the universal prevention of PND none ofwhich were conducted in the UK180182ndash187 Two main types of educational interventions were identifiededucation on preparing for parenting180181184185187 and various advisory booklets on PND182183186
Comparisons were made with usual care in specific countries180ndash184186 and educational information185
Four trials provided the educational intervention via group format180181184187 while the remaining four trialsinvolved individual sessions182183185186 Only one trial provided the intervention in the home setting186
Four trials provided the intervention in the antenatal period only181182185187 whereas two trials initiated theintervention postnatally183186 and two trials provided the intervention across the perinatal period bothduring pregnancy and following childbirth180184 The interventions were provided by psychologists180181184185
midwives182 and nurses183186 The number of contacts ranged from two to eight and the duration of contactranged from 30 minutes to 4 hours
A summary of the characteristics and main outcomes is provided in Table 16 No qualitative studies werefound for educational interventions as a universal preventive intervention
Universal preventive interventions social support
Characteristics and main outcomes of randomised controlled trials ofuniversal preventive interventions of social supportOf the 37 RCTs of universal preventive interventions four (11) evaluated a social supportintervention197ndash200 two of which were conducted in the UK199200 Several types of social support wereidentified including support in labour197 and self-help support200 Comparisons were made with usual carein specific countries197199200 and educational information198 One intervention involved a group session200
two studies involved individual sessions197199 and one involved both group and individual sessions198
One study took place in the home setting199 None of the studies were undertaken in the antenatal periodonly two were in the postnatal period only199200 two were in a combination of both antenatal andpostnatal periods198 and one was at the stage of labour197 As with other types of included interventionsthese were provided by different health-care providers community workers198 midwives200 nurses197
and support workers198 The number of contacts ranged from one to 14 but duration of contact(10ndash378 minutes) was reported in only one study199
A summary of the characteristics and main outcomes is provided in Table 17
Description and findings from qualitative studies of universal preventiveinterventions of social supportOf the two qualitative studies of social support included in the universal preventive interventions categoryone was conducted in the UK287 and one in Canada281 One intervention was an online discussion group281
and the other a postnatal support worker intervention287 Further details are provided in Table 18
Findings from qualitative studies of universal preventive interventions ofsocial support
SupportParticipants reported that helpful aspects of the intervention were emotional and informational supportthe development of relationships with peers281287 reassurance and validation (appraisal support)normalisation of their feelings practical advice281 and practical support287
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
61
TABLE 16 Universal preventive interventions characteristics and main outcomes of RCTs of educationalinterventions
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
Booklet on PND Hayes 2001182
2004329Australia 188 Antenatal
settingAntenatal Individually Midwife
Booklet on PND Ho 2009183 Taiwan 200 Primary care Postnatal Individually Postpartumward nurse
Booklet on PNDand availableservices
Sealy 2009186 Canada 256 Home visits Postnatal Individually Nurse
Education onpreparing forparenting
Feinberg2008180
USA 169 Antenatalsetting
Antenatalandpostnatal
Group Psychologist
Education onpreparing forparenting
Gjerdingen2002181
USA 151 Antenatalsetting
Antenatal Group Psychologist
Education onpreparing forparenting
Matthey2004184
Australia 268 Antenatalsetting
Antenatalandpostnatal
Group Psychologist
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
62
Comparisongroup(s)
Numberofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Usual care inAustralia
1 ndash POMS NSSQ Significant and steadyreduction in scores (overalland on the subscales) wasobserved over time for bothgroups that showedsignificant improvement insymptoms of depression Nodifference when comparingIG vs CG182
Unclear
Usual care inTaiwan
1 ndash EPDS score10 or more(Chineseversion)
ndash No significant difference forIG vs CG at 6 weeks(χ2= 190 df= 1 p= 017)and 3 months postpartum(χ2= 102 df= 1 p= 031)183
High
Usual care inCanada
1 ndash EPDS score12 or more
The Parkyntool
Women in IG had EPDSscores significantly lowerthan women in CG IG 414CG 501 t= 2180df= 254 p= 0030186
High
Usual care inthe USA
8 ndash CES-D (subsetof 7 items)
ndash Intent-to-treat analysesindicated significant programeffects on coparentalsupport maternal depressionand anxiety distress in theparentndashchild relationshipand several indicators ofinfant regulation180
Unclear
Results indicate a significantintervention effect onmaternal depressionand anxiety180
Usual care inthe USA
2 30 SF-36 5-itemmental healthscale
Partnersatisfactionand caringSF-365-items
No significant groupdifferences on postpartumhealth or work outcomes181
High
Usual care inAustralia
7 120 CES-D DIS(DSM-IV)EPDS POMS
SOS CSEI No significant effects wereobtained for either measureof caseness at 6 monthspostpartum184
Unclear
Findings point strongly todifferential effects of anintervention dependent uponthe womanrsquos level ofself-esteem184
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
63
TABLE 16 Universal preventive interventions characteristics and main outcomes of RCTs of educationalinterventions (continued )
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
Education onpreparing forparenting
Milgrom2011185
Australia 143 Telephone Antenatal Individually Psychologist
Education onpreparing forparenting
Shapiro 2005187 USA 38 Antenatalsetting
Antenatal Group Psychologist
Key BDI Beck Depression Inventory CES-D Center for Epidemiologic Studies Depression scale CG control groupCSEI Coopersmithrsquos Self-Esteem Inventory DASS Depression Anxiety Stress Scale-short form DIS Diagnostic InterviewSchedule df degrees of freedom DSM-IV Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition highhigh risk of bias IG intervention group low low risk of bias NSSQ Norbeck Social Support Questionnaire POMS Profileof Mood States RAC Risk Assessment Checklist SCL Symptom Checklist SOS Significant Others Scale unclear unclearrisk of biasEffect statistically significant at a conventional p-value of plt 005
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
64
Comparisongroup(s)
Numberofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Educationalinformation
8 ndash BDI DASSscore EPDSscore 13 ormore
RAC Significantly fewer casesscoring above threshold formild to severe depressionanxiety symptoms postnatallyvs routine care185
Unclear
IG reported significantlylower levels of depression(BDI-II) post-treatment thanparticipants in routine care(F186= 782 plt 001 Cohenrsquosd= 06)185
Usual care inthe USA
2 420 SCL score (dataextracted usingdigitisingsoftware)
MaritalAdjustmentTest
In general intervention waseffective compared to CG forwife and husband maritalquality for wife and husbandpostpartum depression187
High
The major change inpostpartum depression wasfrom 3 months to 1 year CGincreased and IG decreasedt(32)= 213 plt 005187
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
65
TABLE 17 Universal preventive interventions characteristics and main outcomes of RCTs of social support
Interventionsummary
First authoryearreferencenumber Country
Totalnumberof womenrandomised Place Timing
Type ofsession Provider
Self-helpsupport
Reid2002200268
UK 1004 Primarycare
Postnatal Group Midwifegroupfacilitator
Social support Kieffer 2013198 USA 278 Antenatalsetting
Antenataland postnatal
Individuallyand group
Communityhealth worker
Social support Morrell2000199266287
UK 623 Home visits Postnatal Individually Postnatalsupportworker
Support inlabour
Hodnett2002197
Canada 6915 Labourward
Labour Individually Nurse
Key CES-D Center for Epidemiologic Studies Depression scale CG control group CI confidence interval DUFSS DukeFunctional Social Support Scale high high risk of bias IG intervention group LAS Labor Agentry Scale low low riskof bias LSQ Labour Support Questionnaire MOMs Mothers on the Move SSQ6 Social Support Questionnaireunclear unclear risk of biasEffect statistically significant at a conventional p-value of plt 005
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
66
Comparisongroup(s)
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Overallrisk ofbias
Usual care inthe UK
2 or more ndash EPDS score12 or more
ndash There were no significantdifferences in EPDS scoresbetween the control andtrial arms at 3 and6 months nor were theredifferences in the SF-36and the SSQ6 scores
Low
Educationalinformation
14 ndash CES-D score16 or more
ndash IG less likely than CG to beat risk for depression atfollow-up198
Low
From baseline topostpartum the meanCES-D score of the MOMsgroup decreased145 points more than themean CES-D score ofthe CG although thisdifference in overallchange scores was notsignificant (95 CI ndash326037 p= 012)198
Usual care inthe UK
10 Range10ndash378
EPDS score12 or more
BreastfeedingSF-36 DUFSSresource usecosts
At 6 weeks no significantimprovement in health statusamong the women in the IG
Low
Usual care inthe USA
1 ndash EPDS score13 or more
Caesareandelivery LASLSQ
No significant differences inwomenrsquos perceived controlduring childbirth or indepression measured at6ndash8 weeks postpartum A totalof 245 women in IG (87)had evidence of postpartumdepression vs 277 women(101) in CG (p=008)
Unclear
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
67
TABLE
18Qualitativestudiesofuniversalpreve
ntive
interven
tionsdescriptionofstudiesev
aluatingsocial
support
Firstau
thor
yearreference
number
CASP
Quality
Grading
Country
Interven
tiondetails
Nam
eSe
tting
Delivered
antenatalpostnatal
Groupindividual
Number
ingroup
Number
of
sessions
Duration
ofsession
Facilitatorservice
providers
Evan
s20
1228
1Mod
erate
Can
ada
Onlinediscussion
supp
ortgrou
pOnlineforum
Postna
tal
Virtua
lgroup
(onlineforum)
NA
NA
NA
Peers
Morrell
2000
199
266
2002
287
Low
UK
Postna
talsup
port
worker
interven
tion
Hom
evisits
Postna
tal
Individu
alNA
Upto
10sessions
Upto
3ho
urs
Supp
ortworkers
traine
dto
NVQ
level2
fortherole
KeyNAno
tap
plicab
leNVQNationa
lVocationa
lQua
lification
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
68
I would just like to say the support worker who came to help me was fantastic I had twins bycaesarean so I couldnrsquot move around too good She sent me off to bed and when Irsquod get up the housewould be straight ironing done babies bathed and my 3-year-old amused J was brilliant I think thesupport worker is good and hope you can carry it on
Participant287
Providers of the support worker intervention reported that it provided women with emotionalinformational and appraisal support287 However one concern about the interventions was whether or notwomen would become overdependent on the additional support287
Service deliveryParticipants287 reported that the intervention would be more beneficial if it were more intensive forexample if visits were longer andor more frequent Midwives raised concern about the support workerrsquosrole threatening their own role Service providers were concerned that the intervention represented aninvasion of the womenrsquos privacy287 and were worried that they would be unable to deal with unpredictablesituations which they were not qualified to address In the study the authors suggested that serviceproviders wanted closer integration with other service providers such as the primary care team and thatthe intervention should be targeted at vulnerable groups287
Universal preventive interventions pharmacological agentsor supplements
Characteristics and main outcomes of randomised controlled trials of universalpreventive intervention of pharmacological agents or supplementsOf the six trials that evaluated a specific supplement or drug for the universal prevention of PND nonewere conducted in the UK207ndash212 Several types of pharmacological agents or supplements were identifiedincluding docosahexaenoic acid (DHA) at different doses207210211 calcium208 norethisterone ethanate209 andselenium212 All six studies compared the interventions with usual care in specific countries207ndash212 All sixstudies involved individual sessions207ndash212 Three studies took place in the antenatal period208211212 and twoin the postnatal period209210 one combined both antenatal and postnatal periods207 Included interventionswere all delivered by the provider A summary of the characteristics and main outcomes is provided inTable 19 No qualitative studies were identified of pharmacological agents or supplements aimed at auniversal population
Universal preventive interventions midwifery-ledinterventions
Characteristics and main outcomes of randomised controlled trials of universalpreventive interventions of midwifery-led interventionsOf the five studies146217ndash220 evaluating midwifery-led interventions for the universal prevention of PND twowere conducted in the UK146219 Several types of midwifery-led interventions were identified includingmidwifery redesigned postnatal care146 midwife-led debriefing or counselling after childbirth217218
midwife-managed care219 and team midwife care220 Comparisons were made with usual care in specificcountries146217ndash220 All six trials involved individual sessions146217ndash220 None of the trials provided theintervention only antenatally three initiated the intervention postnatally146217264 and two trials initiated theintervention during the pregnancy and continued it postnatally219220 The provision of the midwifery carevaried in the number of contacts with duration ranging from 15 minutes to 1 hour A summary of thecharacteristics and main outcomes is provided in Table 20
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
69
TABLE 19 Universal preventive interventions characteristics and main outcomes of RCTs of pharmacological agentsor supplements
Interventionsummary
First authoryear referencenumber Country
Totalnumberof womenrandomised Place Timing
Type ofsession Provider
Calcium Harrison-Hohner2001208261
USA 468 Antenatalsetting
Antenatal Individually Prescriber
DHA Doornbos2009207
TheNetherlands
119 Antenatalsetting
Antenatalandpostnatal
Individually Prescriber
DHA 200mgday Llorente 2003210 USA 89 Postnatalsetting
Postnatal Individually Prescriber
DHA 800mg Makrides2010211265
Australia 2399 Antenatalsetting
Antenatal Individually Prescriber
Norethisteroneethanate 200mgadministeredintramuscularly
Lawrie 1998209 SouthAfrica
180 Postnatalsetting
Postnatal Individually Prescriber
Selenium Mokhber 2011212 Iran 166 Antenatalsetting
Antenatal Individually Prescriber
Key BDI Beck Depression Inventory BSID Bayley Scales of Infant Development CG control group CI confidence intervalhigh high risk of bias low low risk of bias MADRS MontgomeryndashAringsberg Depression Rating Scale OOS Obstetric OptimalityScore SCID-CV Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders clinician versionunclear unclear risk of biasEffect statistically significant at a conventional p-value of plt 005
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
70
Comparisongroup
Number ofcontacts
Depressionoutcomes Other outcomes Main findings
Overallrisk ofbias
Usual care inthe USA
2 or more EPDS score14 or more
Norbeckrsquos modifiedSarasonrsquos LifeEvents Survey
There was a trend among293 women who scored 14on more on the 6-week EPDStowards less depressionin the intervention groupAt 12 weeks postnatally theintervention group were lessdepressed (p= 004)
High
The authors suggested thatcalcium supplementationcould have had a preventiveeffect at one centre but noeffect at another and thatthese outcomes were difficultto explain
Usual carein theNetherlands
2 or more EPDS score12 or more(Dutch version)
OOS IG did not differ in mean EPDSscores or changes in EPDSscores nor in incidence orseverity of postpartum blues
High
Usual care inthe USA
2 or more BDI EPDS meanscore SCID-CV
Plasmaphospholipid DHAacid content
After 4 months no differencebetween groups in eitherself-rating or diagnosticmeasures of depression
Unclear
Usual care inAustralia
2 or more EPDS score13 or more
BSID The percentage of womenwith high levels of depressivesymptoms during the first6 months postpartum did notdiffer for IG vs CG (967 vs1119 adjusted relative risk085 95 CI 070 to 102p= 009)
Low
Usual care inSouth Africa
1 EPDS score12 or moreMADRS
Breastfeedingvaginal bleedingsomatic complaints
Mean depression scoressignificantly higher in IGvs CG at 6 weekspostpartum (mean MADRSscore 83 vs 49p= 00111 mean EPDSscore 106 vs 75p= 00022)209
Low
Usual care inIran
2 or more EPDS score 13 ormore (Iranianversion)
ndash Mean EPDS score in seleniumgroup significantly lower thanin CG (plt 005)
Unclear
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
71
TABLE 20 Universal preventive interventions characteristics and main outcomes of RCTs of midwifery-ledinterventions
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
Midwife-leddebriefing orcounselling afterchildbirth
Priest 2003217
Henderson1998330
Australia 1745 Postnatalsetting
Postnatal Individually Midwife
Midwife-leddebriefing orcounselling afterchildbirth
Selkirk 2006218 Australia 149 Postnatalsetting
Postnatal Individually Midwife
Midwife-managed care
Shields 1997219 UK 1299 Antenatalsetting
Antenataland postnatal
Individually Midwife
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
72
Comparisongroup
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Usual care inAustralia
1 Range15ndash60
EPDS score13 or moreSCID SADs
IoE Scale(revised)(psychologicaltrauma)
No significant differences forCG vs IG in scores on IoEScale or EPDS at 2 6 or12 months postpartum or inthe proportions of womenwho met diagnostic criteria fora stress disorder (intervention06 vs control 08p= 058) or major or minordepression [intervention178 vs control 182relative risk 099 (95 CI087 to 111)] during thepostpartum year Nodifferences in median time toonset of depression[intervention 6 (interquartilerange 4ndash9) weeks vs control43ndash8 weeks p= 084] orduration of depression(intervention 2412ndash46 weeks vscontrol 2210ndash52 weeksp= 098)
Unclear
Usual care inAustralia
1 Range30ndash60
EPDS meanscore SCL-90
STAI IESDAS FADPSI IIS POBS
No significant differencesfor IG vs CG on measuresof personal informationdepression anxietytrauma perception of thebirth or parenting stressat any assessment pointspostpartum218
High
Usual care inthe UK
2 or more ndash EPDS meanscore (question10 on self-harmwas excluded)
Infant feeding EPDS has not beenvalidated as a 9-itemscale It was not possibleto give a lsquotruersquo measure ofpoint prevalence of PND219
Unclear
The mean scores for womenin the MDU were lower thanthose for the traditional caregroup (81 SD 49 vs 90SD 49) 167 of women inthe MDU vs 232 womenin usual care had an EPDSscore 13 or more (95 CIndash121 to ndash09)
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
73
TABLE 20 Universal preventive interventions characteristics and main outcomes of RCTs of midwifery-ledinterventions (continued )
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
Midwifery-redesignedpostnatal care
MacArthur2002146 2003264
UK 2064 Postnatalsetting
Postnatal Individually Midwife
Team midwifecare
Waldenstrom2000220
Australia 1000 Antenatalsetting
Antenataland postnatal
Individually Midwife
Key CI confidence interval DAS Dyadic Adjustment Scale FAD Family Assessment Device high high risk of biasIES Impact of Events Scale IoE Impact of Events scale IIS Intrapartum Intervention Scale low low risk of biasMDU Midwifery Development Unit POBS Perception of Birth Scale SADs Schedule for Affective Disorders SCL-90Symptom Checklist-90 SD standard deviation unclear unclear risk of biasEffect statistically significant at a conventional p-value of plt 005
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
74
Comparisongroup
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Usual care inthe UK
2 or more ndash EPDS score13 or moreSF-36 MCS
SF-36 PCS Womenrsquos mentalhealth measures weresignificantly better in theIG (MCS 303 [95 CI153ndash452] EPDS ndash192[ndash255 to ndash129] EPDS13+ odds ratio 057[043ndash076]) than incontrols but the physicalhealth score didnot differ146
Low
Usual care inAustralia
2 or more ndash EPDS score13 or more
ndash Team midwife careassociated with increasedsatisfaction Differencesbetween groups mostnoticeable for intrapartumcare and least noticeablefor postpartum care Nodifferences for teammidwife care vs standardcare in medicalinterventions or inwomenrsquos emotionalwell-being 2 months afterthe birth220
Unclear
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
75
Description and findings from qualitative studies of universal preventiveinterventions of midwifery-led interventionsSeven qualitative reports were identified of womenrsquos experiences of midwifery-ledinterventions277283ndash285289ndash291 All seven reports related to the CenteringPregnancy initiative (Table 21)
Findings from the qualitative studies of universal preventive interventions ofmidwifery-led interventions
Peer supportSeveral respondents in the seven studies277283ndash285289ndash291 reported gaining support particularly in theCenteringPregnancy intervention Service providers were positive about their experience and thought theintervention facilitated peer support290291 In addition the women felt that they had benefited from asupportive environment and from sharing experiences277283289
I really enjoyed having others who were at the same stage of pregnancy as me to talk to and comparefeelings and symptoms
Participant289
Women talked about building relationships with peers283289 receiving reassurance and normalisation oftheir experiences during the pregnancy during birth and postnatally289 Women also valued the emotionalinformational and appraisal support received from peers289 One woman did not find the groupenvironment helpful
It wasnrsquot a good idea in the beginning of the pregnancy I would not want the pregnancy be open tothe public
Participant277
PartnersRespondents felt that their partners needed and appreciated the support from the intervention283289
It was good for the husbands They all came and it was nice [that] they were included my husbandliked it because before he had to wait in the waiting room and now he was involved
Participant283
Some women felt more of the intervention focus should be on partners277 although one womanwas ambivalent277283
I think itrsquos good if they can come but when they were present there were things you did not want toask in front of others I did not want to raise questions in front of them
Participant277
Authorsrsquo interpretations277283 revealed either that partners had difficulty contributing to the group becauseof shyness277 or that women felt that partners were uncomfortable with intimate discussions283
Service providersrsquo skillsParticipants found the midwivesrsquo support and group skills in running the intervention helpful277285289
because they were able to pay attention to womenrsquos concerns and offer women solutions277285 althoughsome midwives required more training to lead groups
I was disappointed that the midwife did not ask about the wishes of the groupParticipant277
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
76
TABLE
21Qualitativestudiesofuniversalpreve
ntive
interven
tionsdescriptionofstudiesev
aluatingmidwifery-ledinterven
tions
Nam
eCASP
quality
grading
Firstau
thor
yearreference
number
Country
Setting
Delivered
antenatal
postnatal
Group
individual
Number
of
women
ingroup
Number
of
sessions
Duration
ofsession
(hours)
Facilitatorservice
providers
Cen
terin
gPregn
ancy
Mod
erate
And
ersson
20
1227
7Sw
eden
Second
arycare
ndash
antena
talclinic
Anten
atal
and
postna
tal
Group
and
individu
al6ndash
8NR
NR
Midwives
Cen
terin
gPregn
ancy
Mod
erate
Ken
nedy20
0928
3USA
Second
arycare
ndash
airforceba
se
USNavyho
spita
l
Anten
atal
(one
postna
talreu
nion
)from
12ndash16
weeks
ofpreg
nancy
Group
and
individu
al8ndash
1210
2Midwivesnurse
Cen
terin
gPregn
ancy
Mod
erate
Klim
a20
0928
4USA
Second
arycare
ndash
antena
talclinic
Anten
atal
and
postna
tal
Group
and
individu
al4ndash
10NR
NR
Certifiednu
rse-
midwives
Cen
terin
gPregn
ancy
Mod
erate
McN
eil20
1228
5Can
ada
Second
arycare
ndash
antena
talclinic
Anten
atal
and
postna
tal
Group
and
individu
al8ndash
1210
2Family
physician
andape
rinatal
educator
Cen
terin
gPregn
ancy
Mod
erate
McN
eil20
1329
0Can
ada
Second
arycare
ndash
antena
talclinic
Anten
atal
and
postna
tal
Group
and
individu
al8ndash
1210
2Family
physician
andape
rinatal
educator
Cen
terin
gPregn
ancy
Low
Teate
2011
289
Australia
Second
arycare
ndash
antena
talclinic
commun
ityhe
alth
centres
Anten
atal
and
postna
tal
Group
and
individu
al8ndash
12NR
NR
Midwivesstud
ent
midwivessocial
workers
Cen
terin
gPregn
ancy
Mod
erate
Tann
er-Smith
20
1229
1USA
Second
arycare
ndash
antena
talclinic
commun
ityhe
alth
centresndashmultisite
Anten
atal
and
postna
tal
Group
and
individu
al8ndash
12NR
NR
NR
KeyNR
notrepo
rted
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
77
Participants felt midwives should focus more on their partners277 Others appreciated the midwifersquos skillsknowledge warmth providing suggestions for group discussion and allowing unstructured discussion277 Serviceproviders felt the intervention improved communication between them and participants which promoted abetter relationship and facilitated information exchange290 Service providers said they enjoyed delivering theintervention and found it a satisfying and rewarding experience in that it provided richer care to women290291
Active participationeducationAnother important theme related to how participants might actively participate in their own health careincluding the provision of education and the gaining of information and knowledge283ndash285289 Severalrespondents said that they valued receiving education and information about pregnancy and the postnatalperiod283284 The women felt empowered by being allowed to undertake certain health monitoring tasks suchas weighing themselves and taking their own blood pressure283 In two studies283289 the women wanted moreand more intensive education on issues relating to labour birth and parenting and the early weeks of parenting
At the time we were given ample information I was very well informed for my birth Moreinformation about coping with a newborn would be helpful
Participant289
Group settingService providers in two studies reported that compared with individual care the group environmentprovided more opportunity for teaching and enhanced education284291 Providers across studies felt that theintervention encouraged women to be active participants in their own health care284290 They reported thatwomen were enthusiastic about the group setting and this enthusiasm served to increase participation284
Service delivery and barriers to participationPractical aspects relating to how the service is delivered has important implications regarding interventionup-take Participants reported the format reduced waiting times285289 and promoted continuity of care277
In a study in a US military setting283 participants found lsquofront-desk staffrsquo unhelpful
You would have to wait for a really long time on the phone or for them to call back And then it feltlike they just brushed you off
Participant283
They complained about the lack of child care and consideration for children283 Participants reported theyfelt they had few assessments and that they experienced lsquoscrimping and cost savingrsquo as they were asked toundertake tasks such as taking samples to the laboratory They felt they would not have had to undertakethese activities if their care been delivered in a civilian setting283
Suggested improvementsWays suggested to improve the service were to reduce the period of time between first and second groupmeetings277 to reduce the 2-hour session289 to address the rushed feeling283 to improve the lack ofprivacy277283 to address the lack of healthy snacks283 and to add individual appointments
As a first-time mom you need more reassurance to talk with a caregiver Or perhaps have an opentime where you can go in ndash perhaps before or after to talk with them
Participant283
Service providers reported the group intervention helped to address waiting time issues in one study284 andsuggested that the intervention was a more efficient use of time290
I canrsquot impart everything Irsquove learned from 20 years of delivering babies in five 7-minute visits but I can get more of that across in all their 2-hour groups
Participant290
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
78
The intervention was still restricted to groups such as teenagers because of provider bias291 There weredifficulties gaining funding to keep the intervention running284291 and attendance difficulties because oftransport or work conflict issues Some women were resistant to the group format291 which serviceproviders felt did not allow lsquodeeper issuesrsquo to be addressed284 Service providers reported concerns that thegroup intervention took a provider away from one-to-one care284 and that they experienced difficultieswith scheduling
There is no system for scheduling While one provider does the group the other provider getsdumped on
Participant284
Universal preventive interventions organisation of maternity care
Characteristics and main outcomes of randomised controlled trials of universalpreventive interventions of organisation of maternity careOf the five studies147150225ndash227 evaluating the organisation of maternity care for the universal prevention ofPND only one was conducted in the UK150 Several types of organisation of maternity care interventionswere identified including planned health visitor visits150 early contact with care provider225 primary careand community care strategies147 programmes for HIV alcohol and mental health226 and early contact withcare provider227 Comparisons were made with usual care in specific countries147225ndash227 All five studiesinvolved individual contacts147150225ndash227
None of the studies were undertaken in only the antenatal period three in only the postnatal period150225227
and two used a combination of both antenatal and postnatal periods226227 The interventions were providedby different health-care providers including health visitors150 GPs225 primary care nurses communitydevelopment workers147 community health workers peer mentors226 paediatric house officer or nursepractitioners227 The number of contacts varied greatly A summary of the characteristics and main outcomesis provided in Table 22
Description and findings from qualitative studies of universal preventiveinterventions of organisation of maternity careOne qualitative study288 reported womenrsquos experiences of interventions aimed at a universal populationinvolving the organisation of maternity care (Table 23)
Findings from qualitative studies of universal preventive interventions of organisationof maternity care
SupportWomen found the service providerrsquos support helpful288 and appreciated the infant welfare sisterrsquos concernexpressed for them and the baby They also talked about the nurse as maternal figure for themselves
Shersquos a supplement to my own mother Shersquos easy to talk to I depend on her Shersquos not just there totake care of the baby but for the mothers too She started a group for us new mothers
Participant288
However this positive effect may have become a barrier to effective service use in situations in whichwomen reported that they did not understand the role of the maternal and child health nurse288 Onewoman reported
I never thought I had a right to talk about emotional problems as I was never told what the role ofthe nurse covers
Participant288
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
79
TABLE 22 Universal preventive interventions characteristics and main outcomes of RCTs of organisation ofmaternity care
Interventionsummary
First authoryear referencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
Early contact withcare provider
Gunn 1998225 Australia 475 Primarycare
Postnatal Individually GP
Early contact withcare provider
Serwint 1991227 USA 251 Postnatalsetting
Postnatal Individually Paediatrichouse officeror nursepractitioner
Primary care andcommunity carestrategies
Lumley2006147263
Australia 18555 Primarycare
Antenatalandpostnatal
Individually Primary carenurse andcommunitydevelopmentworker
Program for HIValcohol mentalhealth
Rotheram-Borus2011226 le Roux2013270
SouthAfrica
1144 Antenatalsetting
Antenatalandpostnatal
Individually Communityhealth worker(peer mentors)
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
80
Comparisongroup
Number ofcontacts
Durationof contact
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Usual care inAustralia
1 ndash EPDS score13 or more
BreastfeedingSF-36
No significant differencesbetween groups in EPDSand SF-36 scores numberof problems breastfeedingrates or satisfaction withgeneral practitioner careIG less likely to attend fortheir check-up (764 vs884 p= 0001)225
Low
Usual care inthe USA
1 ndash CES-D Maternalknowledgeuse of services
No differences for IG vs CGfor emergency roomutilisation percentage whoreceived immunisations by90 days of age maternalknowledge of infant carematernal anxiety orpostpartum depression
High
Usual care inAustralia
2 or more ndash EPDS score13 or moreSF-36 MCS
SF-36 PCS There were no differences inmean scores for the MCS orEPDS There were nodifferences in the proportionof women scoring 13 or moreon the EPDS There were alsono differences in the meanPCS scores
Unclear
The combination ofprimary care andcommunity basedstrategies did not reducethe symptoms ofdepression or improve thephysical health of womenat 6 months postnatally
Usual care inSouth Africa
11 ndash EPDS score14 or moreGHQ
ndash PIP is a model forcountries facing significantreductions in HIV fundingwhose families facemultiple health risksHealthcare maternaldepression social supportand of motherssecuring the child grantwere similar acrossconditions270
Low
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
81
TABLE 22 Universal preventive interventions characteristics and main outcomes of RCTs of organisation ofmaternity care (continued )
Interventionsummary
First authoryear referencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
Six plannedhealth visitorvisits
Christie 2011150 UK 295 Homevisits
Postnatal Individually Health visitor
Key CES-D Center for Epidemiologic Studies Depression scale CI confidence interval GHQ General Health Questionnairehigh high risk of bias low low risk of bias OR odds ratio PES Parenting Expectations Survey PIP Philani InterventionProgramme unclear unclear risk of biasEffect statistically significant at a conventional p-value of plt 005
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
82
Comparisongroup
Number ofcontacts
Durationof contact
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Health visitorsingle visit
6 ndash EPDS PSI rolerestrictionattachmentself-efficacyPES babynurturebreastfeedinguse of servicessatisfaction
There were no differences inoutcomes for the interventiongroup compared with thecontrol group apart from theEPDS score which was higher(indicating more symptoms ofdepression) in the interventiongroup at 8 weeks postnatallyCompared with the controlgroup women in theintervention group reportedhigher levels of satisfactionand lower use of emergencyservices up to 8 weekspostnatally
Unclear
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
83
TABLE
23Qualitativestudiesofuniversalpreve
ntive
interven
tionsdescriptionofstudiesev
aluatingorgan
isationofmaternitycare
Firstau
thor
yearreferen
cenumber
Country
Interven
tiondetails
CASP
quality
grading
Nam
eSe
tting
Delivered
antenatalpostnatal
Groupindividual
Number
of
women
ingroup
Number
of
sessions
Duration
ofsession
Facilitatorservice
providers
Scott19
8728
8Australia
Materna
lan
dchild
health
nurses
Second
arycare
ndash
materna
land
child
health
centres
Postna
tally
Individu
alNA
Multip
lecontact
NA
Nurses
Mod
erate
KeyNAno
tap
plicab
le
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
84
Service delivery and barriers to participationWomen reported that they did not understand that depression was associated with the baby andtherefore did not talk to the nurse about their feelings or they were worried about stigma if theyapproached the nurse for emotional support288
Universal preventive interventions complementary and alternativemedicine or other
Characteristics and main outcomes of randomised controlled trials of universalpreventive interventions of complementary and alternative medicine or otherNone of the three studies123129228 evaluating the CAMs for the universal prevention of PND wereconducted in the UK Several types of CAMs interventions were identified including baby massage228 andexercise123129 Comparisons were made with usual care in specific countries129228 and educationalinformation123 All three studies involved individual sessions One was undertaken in the antenatal periodonly129 and two in the postnatal period only123228 The provider of these interventions was a massageinstructor228 or physical therapist123129 The number of contacts varied and the length of contact was1 hour in two studies123129 A summary of the characteristics and main outcomes is provided in Table 24
Description and findings of qualitative studies of universal preventiveinterventions of complementary and alternative medicine or otherThree qualitative studies278ndash280286288 reported womenrsquos experiences of interventions aimed at a universalpopulation involving the CAMs or other intervention (Table 25)
SupportSupport was an important theme in studies of a group mindndashbody exercise (MBE) intervention286 a singinglullabies group intervention278279 and a yoga and discussion group280 In two studies278ndash280 the benefit ofpeer support was reported by participants especially the sharing of experiences and birth stories and in thedevelopment of connections with their fellow group members
(when I was giving birth) I thought of all the women in the lullaby project having their babies
it just connected me and I didnrsquot feel so nervous Participant278279
Women who took part in the MBE techniques reported that when partners supported them in applyingthe MBE techniques this facilitated communication between them and their partners286 Participantsreported that family support was also facilitated by teaching the songs learned in the lullabyintervention278279 The study author reported that participants found it difficult to apply MBE techniqueslearned during the intervention without group support286
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
85
TABLE 24 Universal preventive interventions characteristics and main outcomes of RCTs of CAM or other
Interventionsummary
First authoryear referencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
Baby massage Fujita 2006228 Japan 57 Postnatalsetting
Postnatal Individually Massageinstructor
Exercise Norman 2010123 Australia 161 Postnatalsetting
Postnatal Group Physicaltherapist
Exercise Songoslashygard2012129
Norway 855 Antenatalsetting
Antenatal Group Physiotherapist
Key high high risk of bias low low risk of bias PABS Positive Affect Balance Scale POMS Profile of Mood Statesunclear unclear risk of biasEffect statistically significant at a conventional p-value of plt 005
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
86
Comparisongroup
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Usual care inJapan
2 or more ndash POMS(Japaneseversion)
Salivarycortisol
Significant differences inthe POMS score seen indepression and vigorbetween two groups at3 months No significantdifferences in the salivarycortisol levels 3 monthsafter delivery scores hadimproved more positively indepression and vigor in IGvs CG (D t= ndash257p= 02 V t= 239p= 02)228
High
Educationalinformation
8 60 EPDS score13 or more
PABS There was a reduction in meanEPDS score in the Mother andBaby Program interventiongroup at 8 weeks comparedwith the education-only groupmaintained for 4 weeks
Unclear
Usual care inNorway
12 60 EPDS score10 or moreEPDS score13 or more
ndash 14379 (37) women inIG and 17 of 340 (50) inCG had an EPDS score of10 or more (p= 046) and4379 (12) women in IGand 8340 (24) in CGhad an EPDS score of13 or more (p= 025)129
Unclear
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
87
TABLE
25Qualitativestudiesofuniversalpreve
ntive
interven
tionsdescriptionofstudiesev
aluatingCAM
orother
Nam
e
CASP
quality
grading
Firstau
thor
year
reference
number
Country
Setting
Delivered
antenatalpostnatal
Groupindividual
Number
of
women
ingroup
Number
of
sessions
Duration
ofsession
(minutes)
Facilitatorservice
providers
Sing
ing
lullabies
Mod
erate
Carolan
20
1227
8 27
9Ire
land
Second
arycare
ndash
antena
talclinic
Anten
atally
Group
64
45Musicians
Yog
aan
ddiscussion
grou
p
Mod
erate
Doran
20
1328
0Australia
Second
arycare
ndash
commun
ityba
sed
feministno
n-go
vernmen
twom
enrsquoshe
alth
centre
Anten
atallyan
dpo
stna
tally
Group
NR
Ong
oing
fle
xible
NR
Midwife
anda
yoga
teache
r
Mindndash
body
exercise
techniqu
es
High
Migl20
0928
6USA
Second
arycare
ndash
pren
atal
supp
ort
grou
p
Anten
atally
Group
NR
5weekly
sessions
NR
NR
KeyNR
notrepo
rted
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
88
Learning practical strategiesBeneficial aspects of the interventions were reported by participants as the practical use of strategieslearned during the intervention278279286 Participants reported that they served to prevent panic attackscombat physical symptoms of stress and could be used in combination with existing strategies286
Participants in one study286 reported that they valued techniques that were easy to use in any setting andfor a short period and being able to take the specific parts of the intervention they needed
[MBE was] something new and easy to use in almost any setting and for period a short period of time Participant286
However in one study278279 it was reported that the use of the learned strategies could result inunexpected emotional responses
I was told yoursquore going to get blue so I was expecting that I didnrsquot expect [what happened] At first Irsquod start crying was when I was singing that song I was crying at the time It was so strong
Participant278279
In one study286 the authors reported that the women found it difficult to allocate time to use the practicalstrategies learned forgot to implement the strategies or were resistant to using techniques because ofstigma in that they felt certain MBE techniques were not accepted by wider society One woman reportedthat she could not see the value in the use of the techniques during the postpartum period286
Empowerment (self-esteem)Women in two interventions reported that the intervention facilitated preparation for birth278ndash280 This was bothemotionally through stress reduction and confidence building278ndash280 and physically through yoga techniques280
Results from network meta-analysis for universal preventiveinterventions for Edinburgh Postnatal Depression Scalethreshold score
A NMA is an extension of a standard meta-analysis that enables a simultaneous comparison of allevaluated interventions in a single coherent analysis In this way all interventions can be compared withone another including comparisons not evaluated within individual studies The only requirement is thateach study must be linked to at least one other study through having at least one intervention in common
Among the trials excluded because they could not be connected to the main network (see Appendix 10Table of universal preventive intervention studies omitted from network meta-analysis) three were conducted inSouth Africa153209226 three in China154156157 one in Japan228 one in the Republic of China (Taiwan)183 and onein Hungary155 Three of these trials were at high risk of bias155183228 and two were of uncertain risk of bias153157
Among the other excluded trials three had no usual-care comparator150185198 Six trials did not report anEPDS score180ndash182187227329 and in two the EPDS score was unusable200268 Two trials of social support oneconducted in the UK200 and one in the USA198 were at low risk of bias and found no evidence of an effectThere were five studies at high risk of bias181187207218227 In all of the other studies the risk of bias wasunclear Three of these studies did not have negative results150180185 A US trial of education on preparingfor parenting found lsquoa [statistically] significant intervention effect on maternal depression and anxietyrsquo180
using a subset of seven items from the Center for Epidemiologic Studies Depression (CES-D) scaleAn Australian trial of education on preparing for parenting found lsquoparticipants in the intervention reportedsignificantly lower levels of depression [Beck Depression Inventory (BDI-II)] post-treatment than participantsin routine carersquo185 A UK-based trial of six planned health visitor visits150 found that the lsquointervention had noimpact on most outcomes however it was associated with an increased EPDS score at eight weeks (beforeaccounting for outliers) but not at seven monthsrsquo
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
89
Results for universal preventive interventions for Edinburgh PostnatalDepression Scale threshold score at 6 weeks postnatallyData were available from five studies presenting the EPDS threshold score at 6 weeks postnatally197208211219220
The results for the five universal preventive intervention trials presenting an EPDS threshold score arecombined here A NMA compared the effects of support in labour197 midwife-managed care219 DHA211
calcium208 and team midwife care220 relative to usual care on EPDS threshold Figure 5 presents the networkof evidence There were five intervention effects (relative to usual care) to estimate from five studies
Figure 6 presents the odds ratios of each intervention relative to usual care and Figure 7 presents theprobabilities of treatment rankings The total residual deviance was 1004 which is compared with thetotal number of data points 10 included in the analysis This implies a good fit of the model to the dataThe between-study SD was estimated to be 026 (95 CrI 001 to 072) which implies mild heterogeneityof intervention effects between studies
For all interventions except midwifery team care the odds ratio was less than 1 suggesting a beneficialeffect compared with usual care However none of the comparisons were statistically significant at aconventional 5 level (see Figure 6) The interventions with the highest probabilities of being the bestwere midwife-managed care and calcium (probability 043 and 036 respectively)
Midwifery team care was associated with an increased odds ratio compared with usual care(139 95 CrI 065 to 301) and had a 74 chance of being the least effective among the six interventions(see Figure 7)
Harrison-Hohner 2001 208
Hodnett 2002 197
Makrides 2010 211
Shields 1997 219
Waldenstrom 2000 220
Usual care
Calcium
Support in labour
DHA
Midwife-managed care
Midwifery team care
FIGURE 5 Universal preventive interventions EPDS threshold score at 6 weeks postnatally network of evidence
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
90
005 018 063 225 800
Midwife-managed care
Midwifery team care
Calcium
DHA
Support in labour
Midwifery team care
Calcium
DHA
Support in labour
Calcium
DHA
Support in labour
DHA
Support in labour
Support in labour
066 (030 to 140)
139 (065 to 301)
070 (029 to 164)
087 (041 to 183)
085 (040 to 174)
212 (074 to 639)
106 (033 to 325)
131 (046 to 383)
129 (045 to 381)
050 (015 to 152)
063 (022 to 178)
061 (021 to 175)
124 (042 to 391)
122 (041 to 381)
098 (034 to 283)
vs DHA
vs calcium
vs midwifery team care
vs midwife-managed care
vs usual care
Treatment comparison OR (95 CrI)
FIGURE 6 Universal preventive interventions EPDS threshold score at 6 weeks postnatally odds ratios for alltreatment comparisons Key OR odds ratio
100
075
050
025
Pro
bab
ility
000
Usual
care
Mid
wife-m
anag
ed ca
re
Mid
wifery
team
care
Calciu
mDHA
Support
in la
bor
FIGURE 7 Universal preventive interventions EPDS threshold score at 6 weeks postnatally probability of treatmentrankings (ranks 1ndash6)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
91
Results for universal preventive interventions for Edinburgh Postnatal DepressionScale threshold score at 3 months postnatallyA NMA was used to compare the effects of calcium208 booklet on PND186 exercise129 and early contactwith care provider225 relative to usual care on EPDS threshold Data were available from four studiescomparing five interventions Figure 8 presents the network of evidence There were four interventioneffects to estimate from four studies129186208225
Figure 9 presents the odds ratios of each intervention relative to usual care and Figure 10 presents theprobabilities of treatment rankings The total residual deviance was 704 which is compared with the totalnumber of data points seven included in the analysis This implies a good fit of the model to the dataThe between-study SD was estimated to be 023 (95 CrI 000 to 074) which implies mild heterogeneitybetween studies in intervention effects
The odds ratios of calcium a booklet on PND and exercise were less than 1 suggesting a beneficial effectcompared with usual care Early contact with care provider had an odds ratio greater than 1 suggestinga worsening effect (see Figure 9) However only the effect of calcium was statistically significant at aconventional 5 level The interventions with the highest probabilities of being the best were calcium andbooklet on PND (probability 048 and 045 respectively)
Results for universal preventive interventions for Edinburgh PostnatalDepression Scale threshold score at 6 months postnatallyA NMA was used to compare the effects of DHA211 CBT-based intervention61 PCA-based intervention61
primary care and community care strategies147 and early contact with care provider225 relative to usual careon EPDS threshold Data were available from four studies comparing six interventions Figure 11 presentsthe network of evidence There were five intervention effects to estimate from four studies61147211225
Figure 12 presents the odds ratios of each intervention relative to usual care and Figure 13 presents theprobabilities of treatment rankings The total residual deviance was 704 which is compared with the totalnumber of data points seven included in the analysis This implies a good fit of the model to the dataThe between-study SD was estimated to be 022 (95 CrI 000 to 071) which implies mild heterogeneityof intervention effects between studies
Gunn 1998 225
Harrison-Hohner 2001 208
Sealy 2009 186
Songoslashygard 2012 129
Usual care
Early contact with care provider
Calcium
Booklet on PND
Exercise
FIGURE 8 Universal preventive interventions EPDS threshold score at 3 months postnatally network of evidence
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
92
005 022 100 447 2000
Calcium
Booklet on PND
Early contact with care provider
Exercise
Booklet on PND
Early contact with care provider
Exercise
Early contact with care provider
Exercise
Exercise
032 (009 to 094)
034 (006 to 138)
130 (057 to 301)
071 (026 to 186)
106 (016 to 663)
419 (105 to 1812)
223 (051 to 1097)
391 (072 to 2425)
211 (035 to 1507)
054 (015 to 202)
vs early contact with care provider
vs booklet on PND
vs calcium
vs usual care
Treatment comparison OR (95 CrI)
FIGURE 9 Universal preventive interventions EPDS threshold score at 3 months postnatally odds ratios for alltreatment comparisons Key OR odds ratio
100
075
050
025Pro
bab
ility
000
Usual
care
Calciu
m
Booklet
on P
ND
Early
conta
ct w
ith ca
re p
rovid
er
Exer
cise
FIGURE 10 Universal preventive interventions EPDS threshold score at 3 months postnatally probability oftreatment rankings (ranks 1ndash5)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
93
Gunn 1998 225
Lumley 2006 147
Makrides 2010 211
Morrell 2009 61
Usual care
Early contact with care provider
Primary care and community care strategies
DHA
CBT-based intervention
PCA-based intervention
FIGURE 11 Universal preventive interventions EPDS threshold score at 6 months postnatally network of evidenceDashed lines represent three-arm trials
005 018 063 225 800
DHACBT-based intervention
PCA-based interventionEarly contact with care provider
Primary care and community care strategies
CBT-based interventionPCA-based intervention
Early contact with care providerPrimary care and community care strategies
PCA-based intervention
Early contact with care providerPrimary care and community care strategies
Early contact with care provider
Primary care and community care strategies
Primary care and community care strategies
085 (039 to 174)067 (030 to 146)069 (032 to 146)
089 (039 to 212)106 (052 to 221)
079 (027 to 234)
082 (029 to 236)106 (035 to 351)
125 (045 to 375)
104 (049 to 222)134 (041 to 452)160 (057 to 480)
129 (042 to 426)154 (053 to 458)
118 (037 to 365)vs early contact with care provider
vs PCA-based intervention
vs CBT-based intervention
vs DHA
vs usual care
Treatment comparison OR (95 CrI)
FIGURE 12 Universal preventive interventions EPDS threshold score at 6 months postnatally odds ratios alltreatment comparisons Key OR odds ratio
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
94
For all interventions except primary care and community care strategies the odds ratio compared withusual care was less than 1 suggesting a beneficial effect However none of the comparisons werestatistically significant at a conventional 5 level (see Figure 12) The interventions with the highestprobabilities of being the best were CBT-based intervention and PCA-based intervention (probabilities 038and 029 respectively) (see Figure 13)
Results for universal preventive interventions for Edinburgh Postnatal DepressionScale threshold score at 12 months postnatallyA NMA was used to compare the effects of CBT-based intervention61 PCA-based intervention61 andmidwifery redesigned postnatal care146 relative to usual care on EPDS threshold Data were available fromtwo studies comparing four interventions Figure 14 presents the network of evidence There were threeintervention effects to estimate from two studies61146
Usual
care
DHA
CBT-bas
ed in
terv
entio
n
PCA-b
ased
inte
rven
tion
Early
conta
ct with
care
pro
vider
Prim
ary c
are a
nd com
munity
care
stra
tegies
100
075
050
025Pro
bab
ility
000
FIGURE 13 Universal preventive interventions EPDS threshold score at 6 months postnatally probability oftreatment rankings (ranks 1ndash6)
MacArthur 2002 146
Morrell 2009 61
Usual care
Midwifery redesigned postnatal care
CBT-based intervention
PCA-based intervention
Morrell 200961
FIGURE 14 Universal preventive interventions EPDS threshold score at 12 months postnatally network of evidence
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
95
All three interventions were associated with a beneficial effect although the results were statisticallyinconclusive (Figure 15) The probability of the intervention being the best was 043 032 and 025 formidwifery redesigned postnatal care146 CBT-based intervention61 and PCA-based intervention61
respectively (Figure 16)
005 018 063 225 800
Midwifery redesigned postnatal care
CBT-based intervention
PCA-based intervention
CBT-based intervention
PCA-based intervention
PCA-based intervention
057 (027 to 121)
058 (027 to 130)
061 (029 to 136)
103 (034 to 308)
107 (037 to 309)
105 (047 to 229)
vs CBT-based intervention
vs midwifery redesigned postnatal care
vs usual care
Treatment comparison OR (95 CrI)
FIGURE 15 Universal preventive interventions EPDS threshold score at 12 months postnatally odds ratios for alltreatment comparisons Key OR odds ratio
000
025
050
075
100
Pro
bab
ility
Usual
care
Mid
wifery
redes
igned
postn
atal
care
CBT-bas
ed in
terv
entio
n
PCA-b
ased
inte
rven
tion
FIGURE 16 Universal preventive interventions EPDS threshold score at 12 months postnatally probability oftreatment rankings (ranks 1ndash4)
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
96
Summary of results from network meta-analysis for universal preventive interventionsfor Edinburgh Postnatal Depression Scale threshold scoreIn general the intervention effects were inconclusive although calcium was associated with a statisticallysignificant benefit relative to usual care at 3 months Intervention effects tended to vary over timeThe interventions most likely to be the best among those evaluable at each assessment were
l at 6 weeks postnatally midwife-managed care219 and calcium208 (the included studies were of unclearand high risk of bias respectively)
l at 3 months postnatally booklet on PND186 and calcium208 (the included studies were both at high riskof bias)
l at 6 months postnatally CBT-based intervention61 and PCA-based intervention61
l at 12 months postnatally midwifery redesigned postnatal care146 CBT-based intervention61 andPCA-based intervention61
However there was considerable uncertainty associated with the results and none of the probabilities ofbeing the best intervention exceeded 05
A weakly informative prior distribution was used for the between-study SD because there were insufficientstudies with which to estimate it from the sample data alone This prior distribution was chosen to ensurethat a priori 95 of the study-specific odds ratios were within a factor of 2 of the median odds ratiofor each treatment comparison The sensitivity analysis is presented for completeness in Appendix 11
Results from network meta-analysis for universal preventiveinterventions for Edinburgh Postnatal Depression Scalemean scores
A NMA was used to compare the effects of baby play184 booklet on PND186 calcium208 CBT-basedintervention61 early contact with care provider225 education on preparing for parenting184 educationalinformation123 exercise129 midwife-managed care219 midwifery redesigned postnatal care146 PCA-basedintervention61 primary care and community care strategies147 selenium212 and social support199 relative to usualcare on EPDS mean scores Data were available from 12 studies comparing 15 interventions so that therewere 14 intervention effects (relative to usual care) to estimate from 12 studies61123129146147184186199208212219225
Figure 17 presents the network of evidence
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
97
Figure 18 presents the differences in EPDS mean scores of each intervention relative to usual careThe between-study SD was estimated to be 081 (95 CrI 004 to 261) which implies moderateheterogeneity of intervention effects between studies
The interventions associated with the greatest reduction in EPDS mean score were selenium212
(ndash190 95 CrI ndash483 to 138 at 6ndash8 weeks) and midwifery redesigned postnatal care146 (ndash164 95 CrIndash407 to 107 at 3ndash4 months ndash143 95 CrI ndash400 to 136 at 12 months) None of the comparisonsagainst usual care were statistically significant at a conventional 5 level
Figures 19ndash22 present the probabilities of treatment rankings at 6ndash8 weeks 3ndash4 months 6ndash7 months and12 months respectively
The intervention with the highest probability of being the best at 6ndash8 weeks postnatally was selenium212
(probability 059) at 3ndash4 months postnatally the intervention with the highest probability of being the bestwas midwifery redesigned postnatal care (probability 055) while at 6ndash7 months postnatally CBT-basedintervention and PCA-based intervention were equally likely to be the best (probability 030 in each case)and at 12 months postnatally the highest probabilities were associated with midwifery redesignedpostnatal care146 and PCA-based intervention (probability 058 and 025 respectively)
Gunn 1998 225
Harrison-Hohner 2001 208
Lumley 2006 147
MacArthur 2002 146
Mokhber 2011 212
Morrell 2000 199
Norman 2010 123 Sealy 2009 186
Shields 1997 219
Songoslashygard 2012 129
Matthey 2004 184
Morrell 2009 61
Usual care
Early contact with care provider
Calcium
Primary care and community care strategies
Midwifery redesigned postnatal care
Selenium
Social support
Educational information
Exercise
Booklet on PND
Midwife-managed care
Education on preparing for parenting
Baby play
CBT-based intervention
PCA-based intervention
FIGURE 17 Universal preventive interventions EPDS mean scores network of evidence Dashed lines representthree-arm trials
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
98
ndash 500 ndash 250 000 250 500
6 ndash 8 weeks
3 ndash 4 months12 months
3 ndash 4 months
6 ndash 8 weeks
6 ndash 8 weeks6 ndash 7 months
6 ndash 7 months12 months
6 ndash 7 months12 months
6 ndash 8 weeks6 ndash 7 months
3 ndash 4 months
6 ndash 8 weeks6 ndash 7 months
3 ndash 4 months
3 ndash 4 months6 ndash 7 months
6 ndash 7 months
3 ndash 4 months
ndash 089 (ndash 349 to 184)
ndash 164 (ndash 407 to 107)ndash 143 (ndash 400 to 136)
ndash 090 (ndash 356 to 185)
ndash 190 (ndash 483 to 138)
ndash 073 (ndash 370 to 225) 048 (ndash 261 to 354)
ndash 091 (ndash 341 to 176)ndash 078 (ndash 341 to 191)
ndash 090 (ndash 332 to 174)ndash 097 (ndash 354 to 171)
068 (ndash 200 to 333)ndash 011 (ndash 278 to 264)
ndash 087 (ndash 331 to 189)
056 (ndash 245 to 343) 143 (ndash 166 to 442)
184 (ndash 205 to 566)
ndash 009 (ndash 273 to 258)ndash 020 (ndash 291 to 250)
009 (ndash 246 to 270)
001 (ndash 241 to 267)Exercise
Primary care and community care strategies
Early contact with care provider
Educational information
Education on preparing for parenting
Booklet on PND
Social support
PCA-based intervention
CBT-based intervention
Baby play
Selenium
Calcium
Midwifery redesigned postnatal care
Midwife-managed care
Treatment comparison EPDS difference (95 CrI)
FIGURE 18 Universal preventive interventions EPDS mean scores mean differences of treatment comparisons vsusual care across all time points
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
99
000
025
050
075
100
Pro
bab
ility
Usual
care
Mid
wifery
redes
igned
postn
atal
care
Calciu
m
Booklet o
n PND
Educa
tional
info
rmat
ion
Early
conta
ct with
care
pro
vider
Exer
cise
FIGURE 20 Universal preventive interventions EPDS mean scores probability of treatment rankings at 3ndash4 monthspostnatally (ranks 1ndash7)
000
025
050
075
100
Pro
bab
ility
Usual
care
Mid
wife-m
anag
ed ca
re
Selen
ium
Baby p
lay
Socia
l support
Educa
tion o
n pre
parin
g for p
aren
ting
FIGURE 19 Universal preventive interventions EPDS mean scores probability of treatment rankings at 6ndash8 weekspostnatally (ranks 1ndash6)
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
100
Summary of results from network meta-analysis for universal preventiveintervention studies for Edinburgh Postnatal Depression Scale mean scoresNot all studies provided information about intervention effects at each time making it difficult to drawinferences across all interventions at each time In general the intervention effects were inconclusive andthe CrIs were wide Intervention effects tended to vary over time The interventions most likely to be thebest among those evaluable at each assessment were
l 6ndash8 weeks postnatally selenium212 (the risk of bias for this study was unclear so the benefit of seleniumestimated in this NMA should be treated with some caution)
l 3 months postnatally midwifery redesigned postnatal care146
l 6 months postnatally CBT-based intervention61 and PCA-based intervention61
l 12 months postnatally midwifery redesigned postnatal care146 CBT-based intervention61 andPCA-based intervention61
000
025
050
075
100
Pro
bab
ility
Usual
care
Baby p
lay
CBT-bas
ed in
terv
entio
n
PCA-b
ased
inte
rven
tion
Socia
l support
Educa
tion o
n pre
parin
g for p
aren
ting
Early
conta
ct with
care
pro
vider
Prim
ary c
are a
nd com
munity
care
stra
tegies
FIGURE 21 Universal preventive interventions EPDS mean scores probability of treatment rankings at 6ndash7 monthspostnatally (ranks 1ndash8)
000
025
050
075
100
Pro
bab
ility
Usual
care
Mid
wifery
redes
igned
postn
atal
care
CBT-bas
ed in
terv
entio
n
PCA-b
ased
inte
rven
tion
FIGURE 22 Universal preventive interventions EPDS mean scores probability of treatment rankings at 12 monthspostnatally (ranks 1ndash4)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
101
Summary of results for universal preventive interventions forEdinburgh Postnatal Depression Scale threshold and EdinburghPostnatal Depression Scale mean scores
Overall summary of results for universal preventive interventions for EdinburghPostnatal Depression Scale threshold and Edinburgh Postnatal DepressionScale mean scoresTable 26 indicates the results of the NMAs for the EPDS threshold scores and EPDS mean scores at allassessment times The results indicate that the universal preventive intervention with the best-qualityevidence and the most enduring effect were midwifery redesigned postnatal care146 CBT-basedintervention61 and PCA-based intervention61
The qualitative data indicated that women appreciated the benefits from IPT the reassurance andnormalisation of social support and the support received from peers while taking part in midwifery-ledinterventions and group-based CAM interventions
TABLE 26 Universal preventive interventions NMAs overall summary of main effects of interventions relative tousual care
Time postnatally
EPDS mean score EPDS threshold score
Overallrisk ofbias
Difference in mean(95 CrI)
Probabilityof beingthe besta
Odds ratio(95 CrI)
Probabilityof beingthe besta
6 weeks postnatally
Midwife-managed care219ndash089 (ndash349 to 184) 017 066 (030 to 140) 043b Unclear
Calcium208 NE NE 070 (029 to 164) 036b High
3 months postnatally
Midwifery redesignedpostnatal care146
ndash164 (ndash407 to 107) 055c NE NE Low
Calcium208ndash090 (ndash356 to 185) 019 032 (009 to 094) 048d High
Booklet on PND186ndash087 (ndash331 to 189) 015c 034 (006 to 138) 045d High
6 months postnatally
CBT-based intervention61ndash091 (ndash341 to 176) 030e 067 (030 to 146) 038b Low
PCA-based intervention61ndash090 (ndash332 to 174) 030e 069 (032 to 146) 029b Low
12 months postnatally
Midwifery redesignedpostnatal care146
ndash143 (ndash400 to 136) 058f 057 (027 to 121) 043f Low
PCA-based intervention61ndash097 (ndash354 to 171) 025f 061 (029 to 136) 025f Low
CBT-based intervention61ndash078 (ndash341 to 191) 015f 058 (027 to 130) 032f Low
Key high high risk of bias low low risk of bias NE not evaluable unclear unclear risk of biasa Probability of being the best among interventions with evaluable data at each assessmentb Best among six interventionsc Best among seven interventionsd Best among five interventionse Best among eight interventionsf Best among four interventionsNotesFor difference in mean lt ndash075 or odds ratio lt 070Not evaluable data were data not available on this outcome measure for this intervention
RESULTS FOR UNIVERSAL PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
102
Chapter 6 Results for selective preventiveintervention studies
Characteristics of randomised controlled trials of selectivepreventive interventions
There were 20 RCTs in the selective preventive interventions group in five of the seven intervention classesdefined as
l psychological (n= 6)158ndash163
l educational (n= 5)188ndash190192271
l social support (n= 5)149201ndash204
l pharmacological agents or supplements (n= 1)213
l midwifery-led interventions (n= 3)221ndash223
l organisation of maternity care (n= 0)l CAM or other (n= 0)
Results are presented in this order for the RCTs of selective preventive interventions There was limitedreplication of interventions across the trials The 20 selective preventive intervention trials are described bytheir intervention context mechanisms and measured outcomes within the seven classes The results of theNMAs are presented for the EPDS threshold score and EPDS mean scores followed by the findings ofthe qualitative data
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
103
Description of qualitative studies of selective preventive interventionsThe qualitative synthesis identified four studies in the selected preventive interventions group within threeof the seven intervention classes
1 psychological (n= 1)296ndash298
2 educational (n= 1)253254
3 midwifery-led interventions (n= 2)292ndash294
For ease of reference the selective preventive interventions have been given short-version descriptive labels(Table 27)
TABLE 27 Selective preventive interventions short-version descriptive labels
First author yearreference number
Short-version descriptivelabels Fuller description
Barnes 2009149 Peer support Home-Start UK volunteer visits
Brugha 2000188 Education on preparing forparenting
Preparing for Parenthood is a series of six structured 2-hour longantenatal classes These are preceded by an initial introductorymeeting with the woman and her partner The classes are designedto increase social support and problem-solving skills
Buist 1999189 Education on preparing forparenting
Ten classes in pregnancy and postpartum focusing on parentingand coping strategies Sessions covered physical preparing forparenting but focused on emotional issues and highlighted thereality of parenting Didactic teaching was combined with interactivegroup work films and experiential exercises
Chabrol 2002158 CBT-based intervention One cognitivendashbehavioural prevention session during hospitalisation
Gamble 2005221 Midwife-led debriefing orcounselling after childbirth
Face-to-face counselling within 72 hours of birth and again viatelephone at 4ndash6 weeks postpartum for women who report adistressing birth experience
Harris 2002213 Thyroxine 100 microg of thyroxine tablets daily in thyroid antibody-positive women
Sen 2006191 Education on preparing forparenting
A twin midwife advisor invitation to attend a series of educationsessions additional home visits and attendance at an antenatal twinclinic for women with twins
Small 2000223 Midwife-led debriefing orcounselling after childbirth
Midwife-led debriefing after operative childbirth before dischargefrom hospital
Zlotnick 2011163 IPT-based intervention An interpersonally based intervention for low-income pregnantwomen with intimate partner violence
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
104
Selective preventive interventions psychological interventions
Characteristics and main outcomes of randomised controlled trials ofselective preventive interventions of psychological interventionsOf the six included selective preventive intervention trials evaluating a psychological intervention158ndash163
none were conducted in the UK Three types of psychological interventions were evaluatedpsychoeducational therapy162 IPT160163 and CBT158159161 Comparisons were made with usual care inspecific countries158159161ndash163 and educational information160 One trial provided the intervention in a groupformat159 and five trials incorporated individual sessions158160ndash163 None of the interventions were providedin the home setting One trial provided the intervention in the antenatal period only160 whereas three trialsinitiated the intervention postnatally159161162 and two trials provided the intervention across the perinatalperiod from pregnancy to after childbirth158163 Interventions were provided by a variety of serviceproviders The number of contacts ranged from one to six (mean 43) and contact duration ranged from25 minutes to 2 hours
A summary of the characteristics and main outcomes is provided in Table 28
Description and findings from qualitative studies of selective preventiveinterventions of psychological interventionsThere was one US-based study reporting qualitative data on selective preventive interventions forPND296ndash298 The IPT intervention for teenagers promoted support from peers and clinicians and participantswere able to gain practical skills and felt empowered (Table 29)
Findings from qualitative studies of selective preventive interventions ofpsychological interventions support learning practical strategiesand empowermentParticipants reported that the intervention promoted the development of relationships and connection withother group members and that it was a normalising experience296ndash298 Service providers said gainingpractical skills was an important aspect of the intervention and that the intervention was beneficial whenthe group was supportive and when the group members could share experiences and give advice296ndash298
Clinicians raised the importance of supporting the women and the validation of the pregnancy as part ofan IPT intervention for teenagers296ndash298
That we honored the arrival of motherhood supported it as valid and no less valid even though theywere young and poor
Participant296ndash298
Helping them to think about whatrsquos next how to get the child care how to find a school for the childhow to negotiate with the difficult people in their lives to get what they need
Participant296ndash298
Being able to self-advocate and establish personal boundaries was interpreted by the authors as twobenefits of IPT296ndash298
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
105
TABLE 28 Selective preventive interventions characteristics and outcomes of RCTs of psychologicalinterventions
Interventionsummary
First authoryearreferencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
CBT-basedintervention
Chabrol2002158255256
France 258 Antenatalsetting
Antenatalandpostnatal
Individually Psychologist
CBT-basedintervention
Hagan 2004159 Australia 199 Postnatalsetting
Postnatal Group Midwife
CBT-basedintervention
Silverstein2011161
USA 50 Postnatalsetting
Postnatal Individually Social worker
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
106
Comparisongroup
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Overallrisk ofbias
Usual care inFrance
1 60 BDI EPDSscore 11 ormore HDRSMINI SIGH-D
ndash Compared with the controlgroup women in theprevention group hadsignificant reductions in thefrequency of probabledepression (30plusmn 2 vs48plusmn 2) Recovery ratesbased on HDRS scores oflt 7 and BDI scores of lt 4were also significantlygreater in the treated groupthan in the control group158
High
The study suggests that thisprogramme for preventionand treatment of post-partum depression isreasonably well-acceptedand efficacious158
Usual care inAustralia
6 120 BDI DSM-IVEPDS median(interquartilerange) GHQSADs
ndash Fifty-four mothers (27) inthe trial were diagnosedwith minor or majordepression in the 12 monthsfollowing very pretermdelivery 29 (29) in theintervention group and 25(26) in the control group[relative risk 11 (95 CI080ndash15)]159
Low
There were no differences inthe time of onset or theduration of the episodes ofdepression between thegroups159
Our intervention programdid not alter the prevalenceof depression in thesemothers159
Usual care inthe USA
4 25ndash60 QIDS ndash Forty-four per cent ofcontrol group mothersexperienced an episode ofmoderately severedepression symptoms overthe follow-up periodcompared to 24 of PSEmothers Control mothersexperienced an average119 symptomatic episodesover the 6 months offollow-up compared to052 among PSE mothers161
Low
PSE appears feasible and maybe a promising strategy toprevent depression amongmothers of preterm infants161
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
107
TABLE 28 Selective preventive interventions characteristics and outcomes of RCTs of psychologicalinterventions (continued )
Interventionsummary
First authoryearreferencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
IPT-basedintervention
Phipps 2013160 USA 106 Antenatalsetting
Antenatal Individually Psychologist
IPT-basedintervention
Zlotnick2011163
USA 54 Antenatalsetting
Antenatalandpostnatal
Individually Interventionist
Psychoeducationalintervention
Tam 2003162 China 516 Postnatalsetting
Postnatal Individually Nurse
Key CGI Clinical Global Impressions CI confidence interval CTS Conflict Tactics Scale DTS Davidson Trauma ScaleGHQ General Health Questionnaire HDRS Hamilton Depression Rating Scale high high risk of bias IPV Intimate PartnerViolence KID-SCID childhood version of the Structured Clinical Interview for Diagnostic and Statistical Manual of MentalDisorders LIFE Longitudinal Interval Follow-up Examination low low risk of bias MINI Mini International NeuropsychiatricInterview PSE Problem Solving Education PTSD post-traumatic stress disorder QIDS Quick Inventory of DepressiveSymptoms SADs Schedule for Affective Disorders SCIDNP Structured Clinical Interview for Diagnostic and StatisticalManual of Mental Disordersndash non-patient edition SIGH-D Structured Interview Guide for the 17-item version of theHamilton Depression Rating Scale unclear unclear risk of bias WHO-QOL World Health Organization Quality of Life scale
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
108
Comparisongroup
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Overallrisk ofbias
Educationalinformation
6 60 KID-SCID ndash The overall rate ofdepression in theintervention group (125)was lower than the controlgroup (25) with a hazardrate ratio of 044 (95confidence interval017ndash115) at 6 monthsafter delivery160
Low
An intervention that isdelivered during theprenatal period has thepotential to reduce the riskfor postpartum depressionin primiparous adolescentmothers160
Usual care inthe USA
5 60 EPDS meanLIFE SCIDNP
DTS CriterionA of PTSDmodule ofSCID-NPCTS2
The intervention was notassociated with a reduction inmajor depressive episodesPTSD or IPV in pregnant orpostnatal women There wassome effect in loweringsymptoms of PTSD anddepression among pregnantwomen For women up to3 months postnatally there was alarger effect for PTSD symptoms
This study suggests someinitial support for ourintervention Largerrandomized trials areneeded to further examinethe intervention both duringand after pregnancy163
Low
Usual care inChina
4 ndash CGI GHQHADS
WHO-QOL(Chineseversion)
There was no significantdifference in psychologicalmorbidity quality of life orclient satisfaction betweenthe counselling group andthe control group162
Unclear
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
109
TABLE
29Qualitativestudyofselectivepreve
ntive
interven
tionsch
aracteristicsofstudiesev
aluatingpsych
ological
interven
tions
Firstau
thor
yearreferen
cenumber
Country
Interven
tiondetails
Nam
eSe
tting
Delivered
antenatalpostnatal
Groupindividual
Number
of
women
ingroup
Number
of
sessions
Duration
ofsession
Facilitatorservice
providers
Shan
ok20
0729
6ndash29
8
Mod
erateCASP
quality
USA
IPT(n=14
curren
tde
pressive
disorder)
n=28
no
inclusion
exclusioncrite
ria
Second
ary
carescho
olforpreg
nant
parenting
teen
agers
Majority
antena
tal
Group
712
weekly
75minutes
Clinical
psycho
logist
andco-the
rapist
with
training
inIPT
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
110
Selective preventive interventions educational interventions
Characteristics and main outcomes of randomised controlled trials ofselective preventive intervention of educational interventionsOf five included trials of a selective preventive intervention evaluating an educational intervention188ndash190192271
two were conducted in the UK188191 Two main types of interventions were identified education on preparingfor parenting188189192271 and a booklet on PND and social worker telephone call190 Comparisons were madewith usual care in specific countries188189192271 One study evaluated the effect of group sessions188
two studies evaluated the effect of individual sessions only190192 and two studies evaluated a combination ofindividual and group sessions189191 One trial provided the intervention in a home setting192 Three trialsprovided the intervention in the antenatal period only188189191 whereas one trial initiated the intervention inthe postnatal period190 and one trial provided the intervention across the antenatal and postnatal periods192
The interventions were provided by a variety of service providers with the number of contacts rangingfrom 1 to 25 (mean 96 contacts) and the duration varying between 1 and 2 hours A summary of thecharacteristics and main outcomes is provided in Table 30
Description and findings from qualitative studies of selective preventiveinterventions of educational interventionsOne qualitative study of an educational intervention was included in the indicated preventive interventionscategory253254 This study was linked to the trial of education on preparing for parenting188 Further detailsare provided in Table 31
Findings from the qualitative review
SupportData from participants of the group intervention demonstrated that the intervention promoted thedevelopment of relationships and connection with other group members and that it was a normalisingexperience253256 One participant refused to take part in the intervention and said the idea of being inroom full of people who did not know each other was lsquostrangersquo253254
Recipients reported that the intervention helped them to harness support from family members253254
Authorsrsquo interpretations indicated that participants valued the provision for their partner to join the groupand that they were most interested in the session that included partner involvement Participants found ithelpful having another person with them to hear information that was provided253254
Learning practical strategiesParticipants reported that they had learned useful practical strategies as part of the intervention253254
Specifically participants learned and were then able to apply the SODAS (situation optionsdisadvantages advantages solution) problem-solving system253254
Educationactive participation in own health careThe intervention promoted the gaining of knowledge and active participation in their own healthcare253254 Specifically the recipients reported that they were able to gain information about sensitivesubjects such as PND253254
Service delivery and barriers to participationAlthough the majority of service user perspectives on psychological interventions were positive a numberof suggestions for improvement were provided Authors of one study253254 reported participants wantedmore time for sharing of experiences The women reported that they wanted to keep groups intimate
And then when there were four of us there was more trust you could be honest it became like alittle family
Participant253254
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
111
TABLE 30 Selective preventive interventions characteristics and outcomes of RCTs of educationalinterventions
Interventionsummary
First authoryearreferencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
Booklet on PNDand social workercall
Howell 2012190 USA 540 Postnatalsetting
Postnatal Individually Social worker
Education onpreparing forparenting
Brugha2000188254331
UK 209 Antenatalsetting
Antenatal Group Nurse andoccupationaltherapist
Education onpreparing forparenting
Buist 1999189 Australia 44 Antenatalsetting
Antenatal Individuallyand group
Midwifepsychologistnurse
Education onpreparing forparenting
Sen 2006191271 UK 162 Antenatalsetting
Antenatal Individuallyand group
Midwife
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
112
Comparisongroup
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Educationalinformation
1 ndash EPDS score10 or morePHQ-9
An intention-to-treatrepeated measures analysisfor up to 6 months offollow-up demonstratedthat mothers in theintervention group were lesslikely to screen positive fordepression versus enhancedusual care (odds ratio of067 95 CI 047ndash097number needed to treat16 95 CI 9ndash112)190
Low
For black and Latina postnatalwomen the action orientedbehavioural educationalintervention was associatedwith fewer depressivesymptoms
Usual care inthe UK
6 120 EPDS score11 or moreGHQ-DSCAN
Assignment to the IG didnot significantly impact onPND [odds ratio for GHQ-Depression 122 (95 CI063 to 239) p= 055] oron risk factors fordepression188
Unclear
Attenders benefited nomore than non-attenders188
Usual care inAustralia
10 ndash BDI EPDSscore 13 ormore
STAI DAS SSS Postpartum nodifferences in depressionscores however anxietyless at 6 weeks in IG189
Unclear
Usual care inthe UK
6 90 EPDS score13 or moreHADS
HADS subscalefor anxietyPSI maritalrelationshipmotherndashinfantattachmentsocial support
Non significant differenceswere noted at 6 weeks(8 vs 20 p= 052)12 weeks (11 vs 22p= 020) and 26 weekspostnatal (9 vs 19p= 008) but not at52 weeks postnatal(18 vs 20 p= 068)191
Low
Future provision of care fortwin pregnancy birth andparenting requires carefulconsideration Theintervention resulted inimproved psychologicalbenefit other thandepression191
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
113
TABLE 30 Selective preventive interventions characteristics and outcomes of RCTs of educationalinterventions (continued )
Interventionsummary
First authoryearreferencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
Education onpreparing forparenting
Walkup2009192
USA 167 Homevisits
Antenatalandpostnatal
Individually Communitywomen
Key CI confidence interval DAS Dyadic Adjustment Scale GHQ General Health Questionnaire high high risk of biasHOME Home Observation for Measurement of the Environment ITSEA Infant Toddler Social Emotional Assessmentlow low risk of bias SCAN Schedule for Clinical Assessment in Neuropsychiatry SSS Sarason Social Support Scaleunclear unclear risk of bias
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
114
Comparisongroup
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Educationalinformation
25 60 CES-D PSI Parentingknowledgetest HOMEParentinvolvementITSEA SocialSupportself-reportmeasuresubstance use
No between-groupdifferences found formaternal involvementhome environment ormothersrsquo stress socialsupport depressionor substance use192
Unclear
Supports efficacy ofparaprofessional-deliveredFamily Spirit home-visitingintervention for youngAmerican Indian motherson maternal knowledgeand infant behavioroutcomes192
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
115
TABLE
31Qualitativestudiesch
aracteristicsofstudiesev
aluatinged
ucational
interven
tions
Firstau
thor
year
reference
number
Country
Interven
tiondetails
Nam
eSe
tting
Delivered
antenatalpostnatal
Groupindividual
Numbers
ingroup
Number
ofsessions
Duration
ofsession
Facilitatorservice
providers
Whe
atley
1999
253
2003
256
UK
Prep
aringfor
parentho
odSecond
arycare
ndash
antena
talclinic
Anten
atal
Group
10ndash15
One
introd
uctory
meetin
gsixgrou
psessions
andon
epo
stna
talreu
nion
2ho
urs
NR
NR
notrepo
rted
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
116
Participants also reported that they would have liked written information such as handouts to be able tore-read them at a later point253254
The authors253254 also raised the point that when women were provided with information about theintervention they were told that only some women would be invited to take part At the same time theywere told the primary aim of the intervention was to reduce the likelihood of PND The authors concludedthat the selected women may have made the assumption that they were considered as of increasedvulnerability for PND but as it was never confirmed it may have left them with unresolved questions andanxieties This may have implications for how information about interventions is presented to women
A participant in one study253254 reported difficulties in accessing the service
I mean I wish I hadnrsquot missed the others you know what I mean to carry on really but just whatwith getting there as well and my bleeding ndash so like you know I was upset that I missed quite afew sessions
Participant253254
Other barriers were less visible and concerned how women approached the taboo subject of PND Theauthors of one study253254 reported that women appeared to want information about PND but wereresistant to ask for this information in fear that they would be thought of as lsquogoing madrsquo Other womenappeared to actively avoid information about PND when one woman was asked if she had found outabout PND from health professionals she replied
Well no not really I just didnrsquot want to know I think I thought if I didnrsquot know about it itwouldnrsquot happen
Participant253254
The authors concluded that some participants avoided information about PND as they believed a lack ofknowledge could operate as a protective factor When this information about PND was provided to themin the context of the intervention it appeared most were receptive to it
Selective preventive interventions social support interventions
Characteristics and main outcomes of randomised controlled trials ofselective preventive interventions of social supportOf the five included trials149201ndash204 evaluating social support interventions for the selective preventionof PND only two were conducted in the UK149201 Peer support was the main type of social supportintervention identified booklet on PND149201203 as well as support in labour204 and a booklet plus video202
One trial provided the intervention using a group format203 whereas the remaining four trials providedindividual sessions149201202204 Two trials provided the intervention in a home setting149201 One trialprovided the intervention in the antenatal period only202 and no trial initiated the intervention postnatallyThree trials provided the intervention in both the antenatal and postnatal time periods149201203 One trialprovided the intervention during labour204 As in the other included trials the interventions were providedby a variety of lay and professional service providers The number of contacts varied greatly with durationof contact (300 minutes) reported in only one trial204
A summary of the characteristics and main outcomes is provided in Table 32
No qualitative studies provided data on social support interventions
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
117
TABLE 32 Selective preventive interventions characteristics and outcomes of RCTs of social supportinterventions
Interventionsummary
First authoryear referencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
Booklet plusvideo
Logsdon 2005202 USA 128 Antenatalsetting
Antenatal Individually Nurse
Peer mentorsliving with HIV
Richter 2014203
Rotheram2014269
SouthAfrica
262 Primarycare
Antenatalandpostnatal
Group Peer mentors
Peer support Barnes 2009149 UK 527 Homevisits
Antenatalandpostnatal
Individually Home-Startvolunteers
Peer support Cupples 2011201 UK 343 Homevisits
Antenatalandpostnatal
Individually Peer mentors
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
118
Comparisongroup
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Usual care inthe USA
1 ndash CES-D PSQ RSE No significant differencesfound in Center forEpidemiological Trials ofDepression instrumentscores among groups at6 weeks postpartum202
Unclear
No significant difference
Usual care inSouth Africafor womenwith HIV
8 ndash EPDS score13 or moreGHQ
Infant healthweight-for-agez-score health-care utilisationsocial supportHIVtransmission-relatedbehaviours
Compared to standard carewomen living with HIVEnhanced Intervention womenwere less likely to reportdepressed mood (OR= 255p= 0003)
High
Adherence to clinicintervention groups waslow yet there werebenefits for maternal andinfant health at 15 monthspost birth203
Significant difference
Usual care inthe UK
2 or more ndash EPDS score13 or moreSCID
PSI ICQ MSSI Volunteer support had noidentifiable impact on theemergence of maternaldepression from 2 to12 months or ondepression symptomswhen infants were12 months149
Unclear
Informal support initiatedfollowing screening fordisadvantage in pregnancydid not reduce thelikelihood of depressionfor mothers with infants149
No significant difference
Usual care inthe UK
2 or more ndash SF-36 BSID-II IG and CG did not differin BSID-II psychomotor(mean difference 16495 CI minus094 to 421) ormental (minus081 minus278 to116) scores nor SF-36physical functioning (minus54minus116 to 07) or mentalhealth (minus18 minus61 to26)201 scores
Low
No benefit for infantdevelopment or maternalhealth at 1 year201
No significant difference
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
119
TABLE 32 Selective preventive interventions characteristics and outcomes of RCTs of social supportinterventions (continued )
Interventionsummary
First authoryear referencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
Support inlabour
Wolman 1993204
Trotter 1992276
Nikodem 1998275
SouthAfrica
189 Labourward
Labour Individually Supportivelabourcompaniondoula
Key BSID Bayley Scales of Infant Development CG control group CI confidence interval CSEI Coopersmithrsquos Self-EsteemInventory GHQ General Health Questionnaire HDRS Hamilton Depression Rating Scale high high risk of bias ICQ InfantCharacteristics Questionnaire IG intervention group low low risk of bias MSSI Maternal Social Support IndexPDI Pitt Depression Inventory PSQ Postpartum Support Questionnaire RSE Rosenberg Self-Esteem scaleSEM standard error of the mean unclear unclear risk of bias
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
120
Comparisongroup
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Usual care inSouth Africa
1 300 EPDS meanscore HDRSPDI
STAI CSEI The mean depressionscore of control groupmothers was 2327 (SEM128) and of supportedmothers 104 (SEM 077)(plt 0001)204
Unclear
The group receivingsupport attained higherself-esteem scores andlower postpartumdepression and anxietyratings 6 weeks afterdelivery204
According to the dataanalysis the presence of asupportive labourcompanion resulted in asignificant decrease indepression 3 months afterbirth t(61) = 218plt 005276
There were no differencesin postpartum depressionscores between twogroups at 1 year275
Mixed results
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
121
Selective preventive interventions pharmacological agentsor supplements
Characteristics and main outcomes of randomised controlled trials of selectivepreventive interventions of pharmacological agents or supplementsOnly one trial was identified that evaluated a pharmacological agent or supplement intervention for theprevention of PND213 This trial was conducted in the UK and evaluated the administration of thyroxine duringthe postnatal period The number of contacts involved was two or more but duration length of contact wasnot reported A summary of the characteristics and main outcomes is provided in Table 33
No qualitative studies provided data on studies of pharmacological agents or supplement interventions
Selective preventive interventions midwifery-led interventions
Characteristics and main outcomes of randomised controlled trials ofselective preventive interventions of midwifery-led interventionsOf the three trials221ndash223 included in the selective preventive interventions evaluating midwifery-ledinterventions none were conducted in the UK The types of midwifery-led interventions that were identifiedincluded midwife-led debriefing after childbirth221223 and CenteringPregnancy Plus222 Comparisons weremade with usual care in Australia221223 and the USA222 Two studies evaluated individual sessions221223 andone study was undertaken in the antenatal period only222 Midwives provided the interventions The numberof contacts varied and duration of contact ranged from 1 to 2 hours A summary of the characteristics andmain outcomes is provided in Table 34
Description and findings from qualitative studies of selective preventiveinterventions of midwifery-led interventionsTwo US-based studies292ndash295 included in the selective preventive interventions reported on midwifery-ledinterventions Details of these CenteringPregnancy interventions are presented in Table 35
Findings from the qualitative review
SupportWomen reported gaining support of various kinds such as peer support as a particularly helpful aspect ofthe CenteringPregnancy intervention292ndash295 Women talked about building relationships with peers293ndash295
receiving reassurance and normalising their experiences of pregnancy birth and the postpartumperiod293ndash295 Women reported how they valued the emotional support informational support and practicaladvice they gained from peers293ndash295
Service providers were positive about their experience in delivering CenteringPregnancy They echoedservice user views suggesting that the intervention facilitated peer support293ndash295
Women in two studies felt the intervention encouraged family and partner support and increased familyawareness of difficulties in pregnancy292ndash295 Participants in one study felt health professionalsrsquo support washelpful292 Service providers reported the intervention facilitated improved communication between healthproviders such as between community mental health teams and obstetric providers293ndash295
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
122
TABLE
33Se
lectivepreve
ntive
interven
tionsch
aracteristicsan
doutcomes
ofRCTs
ofpharmacological
agen
tsorsupplemen
ts
Interven
tion
summary
Firstau
thor
year
reference
number
Country
Total
number
of
women
randomised
Place
Timing
Typeof
session
Provider
Comparison
group(s)
Number
of
contacts
Duration
ofco
ntact
(minutes)
Dep
ression
outcomes
Other
outcomes
Mainfindings
Riskof
bias
Thyroxine
Harris
2002
213
UK
341
Postna
tal
setting
Postna
tal
Individu
ally
Prescriber
Usual
care
intheUK
2or
more
ndashEPDSscore
13or
more
GHQM
ADRS
RD
C
ndashNoeviden
cethat
thyroxineha
dan
yeffect
onoccurren
ceof
depression
213
Unclear
KeyGHQGen
eral
Health
Que
stionn
airehigh
high
riskof
biaslowlow
riskof
biasMADRS
Mon
tgom
eryndashAringsbergDep
ressionRa
tingScale
unclearun
clearriskof
bias
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
123
TABLE 34 Selective preventive interventions characteristics and outcomes of RCTs of midwifery-led interventions
Interventionsummary
First authoryear referencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
CenteringPregnancyPlus
Ickovics 2011222
Ickovics 2007262USA 1047 Antenatal
settingAntenatal Group Midwife
Midwife-leddebriefing afterchildbirth
Gamble2005221259260
Australia 103 Postnatalsetting
Postnatal Individually Midwife
Midwife-leddebriefing afterchildbirth
Small 2000223 Australia 1041 Postnatalsetting
Postnatal Individually Midwife
Key CI confidence interval DAS Dyadic Adjustment Scale high high risk of bias low low risk of bias MINI Mini InternationalNeuropsychiatric Interview MSSS Maternity Social Support Scale PTSD post-traumatic stress disorder RR relative riskSRS Social Relationship Scale unclear unclear risk of bias
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
124
Comparisongroup(s)
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Risk ofbias
Usual care inthe USA
10 120 CES-D PSS SRS socialsupportsubscale itemsseven SRSsocial conflictsubscale items
Using intention-to-treatmodels there were nosignificant differences inpsychosocial function yetwomen in the top tertile ofpsychosocial stress at studyentry did benefit fromintegrated group care222
Low
Scores for high-stress women inthe CenteringPregnancy Plusarm were higher for self-esteemand lower for stress and socialconflict in the third trimesterand depression was lower at1 year postnatally
No significant difference
Usual care inAustralia
2 or more ndash EPDS score13 or moreDASS-21
MINI-PTSDMSSS
At 3-month follow-upintervention group womenreported decreased traumasymptoms low relative riskof depression low relativerisk of stress and lowfeelings of self-blame221
Low
The midwifery-led interventionfor women following adistressing birth experience wasassociated with a reduction insymptoms of stress traumadepression and self-blame
Four women in the interventiongroup and 17 women in thecontrol group had an EPDSscore 12 or more at 3 monthspostnatally (RR 025 95 CI009 to 069)
Significant difference
Usual care inAustralia
1 60 EPDS score13 or more
SF-36 subscales More women allocated to IGscored as depressed 6 monthsafter birth than womenallocated to usual postpartumcare [81 (17) vs 65 (14)]although this difference wasnot significant (odds ratio 12495 CI 087 to 177)
Low
No significant difference
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
125
TABLE
35Qualitativestudiesofselectivepreve
ntive
interven
tionsdescriptionofstudiesofmidwifery-ledinterven
tion
First
author
year
reference
number
CASP
Quality
Grading
Country
Interven
tiondetails
Nam
eSe
tting
Delivered
antenatalpostnatal
Groupindividual
Number
ofin
group
Number
of
sessions
Duration
ofsession
Facilitatorservice
providers
Lehm
an
2012
292
Mod
erate
USA
Cen
terin
gPregn
ancy
Second
ary
care
ndash
faith
-based
commun
ityhe
alth
centre
Anten
atal
and
postna
tal
Group
and
individu
alNR
10(the
first
four
mon
thly
andthen
the
last
six
fortnigh
tly)
2ho
urs
NR
Novick
2012
293
2013
294 29
5
High
USA
Cen
terin
gPregn
ancy
Second
ary
care
ndashan
tena
tal
clinic
Anten
atal
and
postna
tal
Group
and
individu
al8ndash
12One
individu
al
then
8ndash10
grou
p
2ho
urs
Certifiednu
rse-
midwife
anda
med
ical
assistan
t
KeyNR
notrepo
rted
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
126
Active participationeducationOne study highlighted how participants might actively participate in their own health care including theprovision of education and gaining information and knowledge293ndash295 Several respondents in one studyreported that they valued receiving education and information about pregnancy and the postnatalperiod293ndash295 Providers across several studies felt that the intervention encouraged women to be activeparticipants in their own health care293ndash295
Service delivery and barriers to participationService providers said that the group intervention was a more efficient use of their time293ndash295
The review showed that peer support was an important aspect of the intervention The intervention alsoappeared to promote and facilitate support from the womanrsquos family and partner Women found thesupport received from health professionals helpful Service providers felt that the intervention facilitatedimproved communication between health providers Women valued receiving education and informationabout pregnancy and the postnatal period Providers felt that the intervention encouraged activeparticipation by the women Service providers also felt that the intervention was an efficient use of timecompared with other models
Selective preventive interventions organisation ofmaternity care
No selective preventive intervention for PND was identified concerning the organisation of maternity careNo qualitative studies provided data on selective preventive interventions of organisation of maternity care
Selective preventive interventions complementary andalternative medicine or other interventions
No selective preventive intervention for PND was identified concerning CAMs or other interventionsNo qualitative studies provided data on selective preventive interventions of CAMs or other interventions
Results from network meta-analysis for selective preventiveinterventions for Edinburgh Postnatal Depression Scalethreshold score
Of the 20 selective preventive intervention trials nine were included in the NMA150160188190213215221223225
Among the 11 trials excluded because they could not be connected to the main network (see Appendix 10Table of selective preventive intervention studies omitted from network meta-analysis) two were conductedin South Africa203204269270275276 and one in China162 Three trials were excluded because they could not beconnected to the main network of evidence160190192
Five trials were excluded because of a lack of EPDS data159161201202222262 and three trials because there wasno usual-care comparator160190192
Three of the trials at low risk of bias found no benefit of CenteringPregnancy Plus for young ethnicminority women of low socioeconomic status222262 of CBT-based intervention for mothers following verypreterm delivery159 or of peer mentors for first-time mothers in socioeconomically deprived communities
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
127
Of the other three trials at low risk of bias one found that a CBT-based intervention was associated with areduction in depressive symptoms for women living in financial hardship161 one found that an IPT-basedintervention was associated with an overall lower rate of depression among primiparous adolescentmothers160 and one found that a booklet on PND and social worker call was associated with a reducedlikelihood of screening positive for depression among black and Latina mothers postpartum190
Results from network meta-analysis for selective preventive intervention forEdinburgh Postnatal Depression Scale threshold score at 6 weekspostnatallyA NMA was used to compare the effects of thyroxine213 a CBT-based intervention158 and midwife-leddebriefing following childbirth221 relative to usual care on EPDS threshold data Data were available fromthree trials comparing three interventions158213221 Figure 23 presents the network of evidence158213221
Harris 2002 213
Gamble 2005 221
Chabrol 2002 158
Usual care
Thyroxine
Midwife-led debriefing or counselling after childbirth
CBT-based intervention
FIGURE 23 Selective preventive interventions EPDS threshold score at 6 weeks postnatally network of evidence
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
128
Figure 24 presents the odds ratios of each intervention relative to usual care and Figure 25 presents theprobabilities of treatment rankings The total residual deviance was 600 compared with the totalnumber of data points six included in the analysis This implies a good fit of the model to the dataThe between-study SD was estimated to be 021 (95 CrI 001 to 072) which implies mild heterogeneityof intervention effects between trials
008 025 078 240 739
Midwife-led debriefing or counselling after childbirth
Thyroxine
CBT-based intervention
Thyroxine
CBT-based intervention
CBT-based intervention
095 (033 to 257)
127 (056 to 305)
046 (018 to 110)
135 (037 to 539)
050 (013 to 188)
036 (010 to 119)
vs thyroxine
vs midwife-led debriefing or counselling after childbirth
vs usual care
Treatment comparison OR (95 CrI)
FIGURE 24 Selective preventive interventions EPDS threshold score at 6 weeks postnatally odds ratios all treatmentcomparisons Key OR odds ratio
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
129
Cognitivendashbehavioural therapy-based intervention had the biggest effect relative to usual care (odds ratio046 95 CrI 018 to 110) although this was not statistically significant at a conventional 5 level(see Figure 24) CBT-based intervention had the highest probability of being the best (probability 084)(see Figure 25)
Results from network meta-analysis for selective preventive intervention forEdinburgh Postnatal Depression Scale threshold score at 3 monthspostnatallyA NMA was used to compare the effects of midwife-led debriefing after childbirth221 education onpreparing for parenting188 and thyroxine213 relative to usual care on EPDS threshold Data were availablefrom three trials comparing four interventions188213221 Figure 26 presents the network of evidenceThree treatment effects were estimated from three trials188213221
000
025
050
075
100Pr
ob
abili
ty
Usual
care
Mid
wife-le
d deb
riefing o
r counse
lling
afte
r child
birth
Thyr
oxine
CBT-bas
ed in
terv
entio
n
FIGURE 25 Selective preventive interventions EPDS threshold score at 6 weeks postnatally probability of treatmentrankings (ranks 1ndash4)
Brugha 2000 188
Gamble 2005 221
Harris 2002 213Usual care
Education on preparing for parenting
Midwife-led debriefing or counselling after childbirth
Thyroxine
FIGURE 26 Selective preventive interventions EPDS threshold score at 3 months postnatally network of evidence
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
130
Figure 27 presents the odds ratios of each intervention relative to usual care and Figure 28 presents theprobabilities of treatment rankings The total residual deviance was 616 compared with the totalnumber of data points six included in the analysis This implies a good fit of the model to the dataThe between-study SD was estimated to be 022 (95 CrI 001 to 073) which implies mild heterogeneityof intervention effects between trials
008 032 128 508 2009
Midwife-led debriefing or counselling afterchildbirthThyroxine
Education on preparing for parenting
Thyroxine
Education on preparing for parenting
Education on preparing for parenting
018 (004 to 065)
143 (059 to 326)
083 (030 to 223)
803 (162 to 4227)
469 (087 to 2734)
058 (015 to 216)
vs thyroxine
vs midwife-led debriefing or counselling after childbirth
vs usual care
Treatment comparison OR (95 CrI)
FIGURE 27 Selective preventive interventions EPDS threshold score at 3 months postnatally odds ratios alltreatment comparisons Key OR odds ratio
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
131
For the selective preventive interventions at 3 months postnatally midwife-led debriefing or counsellingafter childbirth had the biggest effect relative to usual care (odds ratio 018 95 CrI 004 to 065)(see Figure 27) Midwife-led debriefing or counselling after childbirth had the highest probability of beingthe best (probability 096) (see Figure 28)
Results from network meta-analysis for selective preventive intervention forEdinburgh Postnatal Depression Scale threshold score at 6 monthspostnatallyA NMA was used to compare the effects of thryoxine213 and midwife-led debriefing after childbirth223
relative to usual care on EPDS threshold Data were available from two trials comparing threeinterventions213223 Figure 29 presents the network of evidence There were two treatment effects toestimate from two trials213223
Figure 30 presents the odds ratios of each intervention relative to usual care and Figure 31 presents theprobabilities of treatment rankings The total residual deviance was 399 compared with the totalnumber of data points four included in the analysis This implies a good fit of the model to the dataThe between-study SD was estimated to be 022 (95 CrI 002 to 074) which implies mild heterogeneityof intervention effects between trials
There was insufficient evidence of a difference in effect between interventions (see Figures 30 and 31)
Summary of results from network meta-analysis for selective preventiveinterventions Edinburgh Postnatal Depression Scale threshold scoreTable 36 indicates the results of the NMAs for the EPDS threshold scores and mean scores at allassessment times In general the intervention effects were inconclusive although midwife-led debriefingafter childbirth was associated with a statistically significant benefit at 3 months When interventions wereevaluated at more than one assessment the effects tended to vary over time
100
075
050
Pro
bab
ility
025
000
Usual
care
Mid
wife-le
d deb
riefing o
r counse
lling
afte
r child
birth
Thyr
oxine
Educa
tion o
n pre
parin
g for p
aren
ting
FIGURE 28 Selective preventive interventions EPDS threshold score at 3 months postnatally probability oftreatment rankings (ranks 1ndash4)
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
132
Harris 2002 213
Small 2000 223
Usual care
Thyroxine
Midwife-led debriefing or counselling after childbirth
FIGURE 29 Selective preventive interventions EPDS threshold score at 6 months postnatally network of evidence
005 018 063 225 800
Midwife-led debriefing or counselling after childbirth
Thyroxine
Thyroxine
126 (057 to 278)
095 (038 to 242)
074 (023 to 265)
vs midwife-led debriefing or counselling after childbirth
vs usual care
Treatment comparison OR (95 CrI)
FIGURE 30 Selective preventive interventions EPDS threshold score at 6 months postnatally odds ratios alltreatment comparisons Key OR odds ratio
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
133
100
075
050
Pro
bab
ility
025
000
Usual
care
Mid
wife-le
d deb
riefing o
r counse
lling
afte
r child
birth
Thyr
oxine
FIGURE 31 Selective preventive interventions EPDS threshold score at 6 months postnatally probability oftreatment rankings (ranks 1ndash3)
TABLE 36 Selective preventive interventions NMAs overall summary of main effects of interventions relative tousual care
Time postnatally
EPDS mean score EPDS threshold score
Overallrisk ofbias
Difference inmean (95 CrI)
Probabilityof beingthe besta
Odds ratio(95 CrI)
Probabilityof beingthe besta
6 weeks postnatally
CBT-based intervention Chabrol2002158
ndash175(ndash425 to 071)
075b 046(018 to 110)
084c High
Education on preparing for parentingSen 2006191 Buist 1999189
ndash081(ndash310 to 134)
023 3 NE NE Lowuncleard
3 months postnatally
Education on preparing for parentingSen 2006191 Buist 1999189
ndash108(ndash383 to 165)
035b 083(030 to 223)
003c Lowuncleard
IPT-based intervention Zlotnick2011163
ndash185(ndash560 to 214)
062b NE NE Unclear
6 months postnatally
Education on preparing for parentingSen 2006191 Buist 1999189
ndash132(ndash354 to 110)
083b NE NE Lowuncleard
Key high high risk of bias low low risk of bias NE not evaluable unclear unclear risk of biasa Probability of being the best among interventions with evaluable data at each assessmentb Best among three interventionsc Best among four interventionsd When there were two studies the risk of bias is indicated in the order in which the studies are citedNotesFor difference in mean lt ndash075 or odds ratio lt 070Not evaluable data were data not available on this outcome measure for this intervention
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
134
Results from network meta-analysis for selective preventiveinterventions for Edinburgh Postnatal Depression Scalemean scores
A NMA was used to compare the effects of CBT-based intervention158 education on preparing forparenting189191 IPT-based intervention163 midwife-led debriefing after childbirth223 and peer support149
relative to usual care on EPDS mean scores Data were available from six trials comparing fiveinterventions Figure 32 presents the network of evidence There were five intervention effects to estimate(relative to usual care) from six trials149158163189191223
Figure 33 presents the difference in EPDS mean scores of each intervention relative to usual care andFigures 34ndash37 present the probabilities of treatment rankings at 6ndash8 weeks 3ndash4 months 6ndash7 months and12 months respectively The between-study SD was estimated to be 068 (95 CrI 003 to 246) whichimplies moderate heterogeneity of intervention effects between trials The interventions associated withthe greatest reduction in EPDS mean score were the IPT-based intervention (ndash185 95 CrI ndash560 to2144 at 3ndash4 months) and CBT-based intervention (ndash175 95 CrI ndash425 to 071 at 6ndash8 weeks) None ofthe comparisons against usual care were statistically significant at a conventional 5 level
The intervention with the highest probabilities of being the best at 6ndash8 weeks was the CBT-basedintervention (probability 075) The intervention with the highest probability of being the best at3ndash4 months was the IPT-based intervention (probability 062) The intervention with the highest probabilityof being the best at 6ndash7 months was education on preparing for parenting (probability 083) Theintervention with the highest probability of being the best at 12 months was education on preparing forparenting (probability 057)
Barnes 2009 149
Buist 1999 189
Chabrol 2002 158
Sen 2006 191
Small 2000 223
Zlotnick 2011 163
Usual care
Peer support
Education onpreparing for parenting
CBT-based intervention
Midwife-led debriefing or counselling after childbirth
IPT-based intervention
FIGURE 32 Selective preventive interventions EPDS mean scores network of evidence
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
135
ndash 500 ndash 250 000 250 500
6 ndash 7 months
6 ndash 8 weeks
3 ndash 4 months
12 months
6 ndash 8 weeks
3 ndash 4 months
6 ndash 7 months
12 months
045 (ndash 202 to 302)
ndash 175 (ndash 425 to 071)
ndash 185 (ndash 560 to 214)
073 (ndash 196 to 341)
ndash 081 (ndash 310 to 134)
ndash 108 (ndash 383 to 165)
ndash 131 (ndash 354 to 110)
ndash 040 (ndash 321 to 238)
Education on preparing for parenting
Peer support
IPT-based intervention
CBT-based intervention
Midwife-led debriefing or counselling after childbirth
Treatment comparison EPDS difference (95 CrI)
FIGURE 33 Selective preventive interventions EPDS mean scores mean differences of treatment comparisons vsusual care across all time points
000
025
050
075
100
Pro
bab
ility
Usual
care
CBT-bas
ed in
terv
entio
n
Educa
tion o
n pre
parin
g for p
aren
ting
FIGURE 34 Selective preventive interventions EPDS mean scores probability of treatment rankings at 6ndash8 weekspostnatally (ranks 1ndash3)
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
136
000
025
050
075
100
Pro
bab
ility
Usual
care
IPT-b
ased
inte
rven
tion
Educa
tion o
n pre
parin
g for p
aren
ting
FIGURE 35 Selective preventive interventions EPDS mean scores probability of treatment rankings at 3ndash4 monthspostnatally (ranks 1ndash3)
000
025
050
075
100
Pro
bab
ility
Usual
care
Mid
wife-le
d deb
riefing o
r counse
lling
afte
r child
birth
Educa
tion o
n pre
parin
g for p
aren
ting
FIGURE 36 Selective preventive interventions EPDS mean scores probability of treatment rankings at 6ndash7 monthspostnatally (ranks 1ndash3)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
137
Summary of results from network meta-analysis for selective preventiveinterventions for Edinburgh Postnatal Depression Scale mean scoresNot all interventions provided information about intervention effects at each time making it difficult todraw inferences across all interventions at each time In general the intervention effects were inconclusiveand the CrIs were wide The most beneficial interventions appeared to be the CBT-based interventionsIPT-based interventions and education on preparing for parenting However the evidence for the effect ofCBT-based intervention came from the study by Chabrol et al158 which was judged to be at high risk ofbias As such the benefit of that CBT-based intervention estimated in this NMA should be treated withsome caution In addition the evidence for the effect of IPT-based interventions at 3ndash4 months came froma trial which was a small pilot study by Zlotnick et al163 and as such the results should be treatedwith caution
The evidence from the qualitative review demonstrated that the IPT as a selective intervention wasacceptable to women and they reported benefiting from gaining realistic information about motherhoodand from being empowered to ask for help The educational intervention lsquoPreparing for parenthoodrsquoprovided participants with an additional opportunity to learn about PND while avoiding the stigma ofasking for this information Benefits of the CenteringPregnancy intervention included facilitation ofsupport particularly peer support for selective groups
000
025
050
075
100
Pro
bab
ility
Usual
care
Peer
support
Educa
tion o
n pre
parin
g for p
aren
ting
FIGURE 37 Selective preventive interventions EPDS mean scores probability of treatment rankings at 12 months(ranks 1ndash4)
RESULTS FOR SELECTIVE PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
138
Chapter 7 Results for indicated preventiveintervention studies
Characteristics of randomised controlled trials of indicatedpreventive interventions
There were 30 RCTs in the indicated preventive interventions group in six of the seven intervention classesdefined as
1 psychological (n= 19)61121148164ndash179
2 educational (n= 4)193ndash196
3 social support (n= 2)205206
4 pharmacological agents or supplements (n= 3)214ndash216
5 midwifery-led interventions (n= 1)224
6 organisation of maternity care (n= 0)7 CAM or other interventions (n= 1)229
Results are presented in this order for the RCTs of indicated preventive interventions There was limitedreplication of interventions across the studies The 30 indicated preventive intervention studies aredescribed by their intervention context mechanisms and measured outcomes within the seven classes
Description and findings from qualitative studies of indicatedpreventive interventionsThere were three qualitative studies in the indicated preventive interventions group in two of the sevenintervention classes
l social support (n= 2)299301
l organisation of maternity care (n= 1)300
One study reported on the perspectives and attitudes of service providers to indicated preventiveinterventions298 For ease of reference indicated preventive interventions were given short-versionindicative labels (Table 37)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
139
TABLE 37 Indicated preventive interventions short-version descriptive labels
First authoryear referencenumber
Short-versionindicative label Fuller description
Armstrong1999164
Promotingparentndashinfantinteraction
A structured home-visiting programme of weekly nurse home visiting supportedby a social worker and paediatrician when the child was at great risk of poorhealth and developmental outcomes
Austin 2008165 CBT-basedintervention
An antenatal cognitivendashbehavioural group intervention in a primary care settingfor pregnant women identified with mild to moderate symptoms in pregnancyandor at risk of developing depression or anxiety in the perinatal period
Austin 2008165 Educationalinformation
Information booklet for pregnant women identified with mild to moderatesymptoms in pregnancy andor at risk of developing depression or anxiety in theperinatal period
Dennis 2009205 Peer support Telephone-based volunteer peer support for women at high risk of PND
Ginsburg 2012168 CBT-basedintervention
An eight-lesson cognitivendashbehavioural-based programme Living in Harmonyfor reservation-based American Indians
Ginsburg 2012168 Educationalinformation
An eight-lesson education programme Education-Support programmefor reservation-based American Indians
Gorman 1997169 IPT-basedintervention
A preventive intervention adapted from IPT for depression for women at highrisk of PND and adjustment problems
Grote 2009170 Educationalinformation
Written educational materials about depression and strong encouragement toseek treatment at the behavioural health centre for low-income pregnantwomen scoring 13 or more on the EPDS
Grote 2009170 IPT-basedintervention
Culturally relevant enhanced brief IPT-B consisting of an engagement sessionfollowed by eight acute IPT-B sessions before birth and maintenance IPT up to6 months postpartum for low-income pregnant women scoring 13 or more on theEPDS
Marks 2003224 Midwiferycontinuous care
Continuous midwifery care of a named midwife who as far as possible followedthe women through the pregnancy delivery and postnatally for women with ahistory of major depressive disorder
Morrell 200961 CBT-basedintervention
HV training in the assessment of postnatal women combined withcognitivendashbehavioural approach sessions for eligible women who scored 12 ormore on the EPDS
Morrell 200961 PCA-basedintervention
HV training in the assessment of postnatal women combined withPerson-Centred Approach sessions for eligible women who scored 12 or moreon the EPDS
Munoz 2007173 CBT-basedintervention
Mamaacutes y BebeacutesMothers and Babies Course developed in Spanish and Englishthat uses a cognitivendashbehavioural mood management framework andincorporates social learning concepts attachment theory and sociocultural issuesfor low-income predominantly Latina women who screened positive for a majordepressive episode andor who scored 16 or more on CES-D
Petrou 2006174 Promotingparentndashinfantinteraction
Home visits from research health visitors to enhance maternal sensitivity to infantcommunicative signals and infant responsiveness and to encourage women toexpress their feelings for women at raised risk for PND
Stamp 1995195 Education onpreparing forparenting
Two antenatal groups and one postnatal group with a practical and emotionalemphasis on planning for and expectations of life changes precipitated by thearrival of a new baby for women vulnerable to developing PND A non-directivepractical and supportive programme was developed underpinned by aphilosophy that acknowledged the abilities and resourcefulness of the womenthemselves Its focus was on access to information preparation and support theextension and development of womenrsquos existing networks and goal setting
Webster 2003196 Booklet on PND Providing women in the intervention group with a booklet about PND and a listof the phone contacts of PND resources for pregnant women with risk factorsfor PND
IPT-B Interpersonal Psychotherapy ndash brief HV health visitor
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
140
Indicated preventive interventions psychological interventions
Characteristics and main outcomes of randomised controlled trials of indicatedpreventive interventions of psychological interventionsOf the 19 included studies reporting psychological interventions for the indicated prevention ofPND61121148164ndash179 only three61174177 were conducted in the UK Six types of psychological interventionswere identified CBT-based interventions61148165167168171ndash173 empowerment training175 IPT-basedinterventions166169170178179 mindfulness-based intervention121 promoting parentndashinfant interaction164174177
and psychoeducational interventions176 Comparisons were made with usual care in specificcountries61121148164166167169ndash179 and educational information165168 Seven studies evaluated groupsessions121165171173177ndash179 11 evaluated individual sessions61148164167ndash170172174ndash176 and one evaluated bothgroup and individual sessions166 Five studies took place in the home setting61164168172174 Six studies wereundertaken in the antenatal period only121168173175ndash177 two in the postnatal period only61164 and 11 in acombination of both antenatal and postnatal periods148165ndash167169ndash172174178179 The interventions wereprovided by different health-care providers (nurse social worker paediatrician psychologist counsellorhealth visitor community health workers) and group facilitators171177 The number of contacts varied andlength of contact ranged from 30 minutes168 to 2 hours121165171177 A summary of the characteristics andmain outcomes is provided in Table 38
There were no qualitative studies of indicated preventive interventions of psychological interventions
Indicated preventive interventions educational intervention
Characteristics and main outcomes of randomised controlled trials of indicatedpreventive interventions of educational interventionsNone of the four included studies193ndash196 reporting educational interventions for the indicated prevention ofPND were conducted in the UK Two main types of educational interventions were identified a booklet onPND193194196 and education on preparing for parenting195 Comparisons were made with usual care inspecific countries and educational information Two studies evaluated group sessions194195 and twoevaluated individual sessions only193196 No study took place in the home setting Two studies wereundertaken in the antenatal period only194196 one in the postnatal period only193 and one in a combinationof both antenatal and postnatal periods195 The interventions were provided by different health-careproviders (nurse midwife) with the number of contacts ranging from one to eight (mean 325) andduration of contact ranging from 1 to 2 hours (mean 15 hours) A summary of the characteristics andmain outcomes is provided in Table 39
There were no qualitative studies of indicated preventive interventions of educational interventions
Indicated preventive interventions social support
Characteristics and main outcomes of randomised controlled trials of indicatedpreventive interventions of social supportOnly one of the included studies206 evaluating social support for the indicated prevention of PND wasconducted in the UK Peer support was the main type of social support intervention identified a bookleton PND205206 Comparisons were made with usual care in specific countries (ie Canada205 and the UK206)Both included studies evaluated individual sessions only205206 One study took place in the home setting206
and one intervention was by telephone205 One study was undertaken in the postnatal period only205 andone in a combination of both antenatal and postnatal periods206 Both interventions were provided bydifferent peer volunteers the number of contacts varied and the length of contact was not specifiedA summary of the characteristics and main outcomes is provided in Table 40
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
141
TABLE 38 Indicated preventive interventions characteristics and outcomes of RCTs of psychologicalinterventions
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
CBT-basedintervention
Austin 2008165 Australia 277 Antenatalsetting
Antenatalandpostnatal
Group Psychologist
CBT-basedintervention
El-Mohandes2008167
USA 1070 Antenatalsetting
Antenatalandpostnatal
Individually Counsellor
CBT-basedintervention
Ginsburg 2012168 USA 47 Homevisits
Antenatal Individually Paraprofessionals
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
142
Comparisongroup(s)
Number ofcontacts
Duration ofcontact(minutes)
Depressionoutcomes Other outcomes Main findings
Overallrisk ofbias
Educationalinformation
6 120 EPDS meanscore (dataextractedusingdigitisingsoftware)MINI
STAI (notreported)
Intention-to-treat analysesrevealed relatively low meanbaseline EPDS scores [range 688(SD 443) 816 (SD 447)] withno reduction in EPDS scores ineither group MINI depressioncriteria were fulfilled by 19of all participants at time 1but there was no reductionin depression in either group incontrast those with MINI anxietydiagnoses reduced from 28 inlate pregnancy to 16 at4 months postpartum in theCBT group with similarreductions in the control group
Unclear
No significant difference
Usual care inthe USA
2 or more 36 BDI-IIHopkinssymptomchecklist
CTS ETSE Depression at postpartuminterview was 255 in theintervention group and 290in the control group p= 0303
Low
An integrated multiple riskfactor interventionaddressing psychosocialand behavioral risksdelivered mainly duringpregnancy can havebeneficial effects in riskreduction postpartum167
No significant difference
Educationalinformation
8 30ndash60 CES-D CGASDISC EPDSmean score
SSI At all post interventionassessments mothers inboth groups showedsimilar reductions indepressive symptoms andsimilar rates of MDD Bothgroups of participantsalso showed similarimprovements in globalfunctioning No changesin either group werefound on the measure ofsocial support168
Unclear
No significant difference
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
143
TABLE 38 Indicated preventive interventions characteristics and outcomes of RCTs of psychologicalinterventions (continued )
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
CBT-basedintervention
Le 2011171 USA 217 Antenatalsetting
Antenatalandpostnatal
Group Group Facilitators
CBT-basedintervention
McKee 2006172 USA 90 Homevisits
Antenatalandpostnatal
Individually Psychologist
CBT-basedintervention andPCA-basedintervention
Morrell 200961 UK 595 Homevisits
Postnatal Individually Health visitors
CBT-basedintervention
Munoz 2007173 USA 41 Antenatalsetting
Antenatal Group Psychologist
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
144
Comparisongroup(s)
Number ofcontacts
Duration ofcontact(minutes)
Depressionoutcomes Other outcomes Main findings
Overallrisk ofbias
Usual care inthe USA
11 120 BDI-II score21 or moreMoodScreener
Mood Screener The cumulative incidenceof major depressiveepisodes was notsignificantly differentbetween the intervention(78) and UC(96) groups171
Unclear
A CBT intervention forlow-income high-riskLatinas reduced depressivesymptoms duringpregnancy but not duringthe postpartum period171
No significant difference
Usual care inthe USA
8 ndash BDI-II IRS NSSQ The two interventionconditions were equallyeffective in reducingdepression172
High
No significant difference
Usual care inthe UK
up to 8 60 CORE-OMEPDS score12 or moreand meanSF-36 MCS
PSI DASSF-6D SF-36 PCS
At 6 months postnatally 93 ofthe 271 (34) women in the IGand 67 of the 147 women in theCG (46) had an EPDS score12 or more The OR for a score12 or more at 6 monthspostnatally was 062 (95 CI040 to 097 p=0036) forwomen in the IG vs CG
Low
Training health visitors toassess women identifysymptoms of PND anddeliver psychologicallyinformed sessions wasclinically effective at 6 and12 months postnatallycompared with usualcare61
Significant difference
Usual care inthe USA
12 ndash CES-D EPDSmean scoreMMS for MDE
ndash Differences in terms ofdepression symptom levelsor incidence of MDEsbetween the two groupsdid not reach statisticalsignificance in this pilottrial However the MDEincidence rates of 14 forthe intervention conditionversus 25 for thecomparison conditionrepresent a small effectsize (h= 028)173
Unclear
No significant difference
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
145
TABLE 38 Indicated preventive interventions characteristics and outcomes of RCTs of psychologicalinterventions (continued )
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
CBT-basedintervention
Rahman 2008148 Pakistan 903 Antenatalsetting
Antenatalandpostnatal
Individually Community healthworkers
Empowermenttraining
Tiwari 2005175 HongKong
110 Antenatalsetting
Antenatal Individually Midwife
IPT-basedintervention
Crockett 2008166 USA 36 Antenatalsetting
Antenatalandpostnatal
Individuallyand group
Counsellor
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
146
Comparisongroup(s)
Number ofcontacts
Duration ofcontact(minutes)
Depressionoutcomes Other outcomes Main findings
Overallrisk ofbias
Usual care inPakistan
16 ndash HDRS Weight-for-ageZ scores height-for-age Z scoresMSPSS BDQGAFS
At 6 months 97 of the 418(23) women in the IG and211 of the 400 womenin the CG (53) had majordepression The OR was 022(95 CI 014 to 036plt 00001) At 12 months27 in the IG (111 out of 412)vs 59 in the CG (226 outof 386) had major depressionThe OR was 023 (95 CI 015to 036 plt 00001)
Low
This psychologicalintervention delivered bycommunity-based primaryhealth workers has thepotential to be integratedinto health systems inresource-poor settings148
Significant difference
Usual care inHong Kong
1 30 EPDS score10 or more
CTS SF-36 Twenty-five women fromthe control group hadEPDS scores of 10 or morecompared with 9 from theexperimental group(relative risk 036015ndash088)175
Low
The experimental groupreported less psychologicalabuse and minor physicalviolence and their depressionsymptom scores were lowerthan the those for the CG
Significant difference
Usual care inthe USA
4 90 DSM-IV EPDSscore 10 ormore SCID
PPAQ PSI SASself-reportquestionnaire
At 3 months postpartumthe study found no significantdifferences between the twoconditions in degree ofdepressive symptoms or level ofparental stress
Unclear
No significant difference
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
147
TABLE 38 Indicated preventive interventions characteristics and outcomes of RCTs of psychologicalinterventions (continued )
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
IPT-basedintervention
Gorman 1997169 USA 45 Antenatalsetting
Antenatalandpostnatal
Individually Psychologist
IPT-basedintervention
Grote 2009170 USA 53 Antenatalsetting
Antenatalandpostnatal
Individually Psychologist
IPT-basedintervention
Zlotnick 2001178 USA 35 Antenatalsetting
Antenatalandpostnatal
Group Psychologist
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
148
Comparisongroup(s)
Number ofcontacts
Duration ofcontact(minutes)
Depressionoutcomes Other outcomes Main findings
Overallrisk ofbias
Usual care inthe USA
5 ndash BDI EPDSscore13 or morePANAS SCIDSCL-90-R
DAS PPAQ No significant differencesbetween the two groupswere found on self-reportmeasures of depressivesymptomatology generalpsychiatric symptomatologymarital satisfaction orgeneral postpartumadjustment at either 1 or6 months postpartum169
Unclear
No significant difference
Educationalinformation
8 ndash BDI DISEPDS score13 or moreSCID (DSM-IV)
BAI PPAQ newbaby subscale(not reported)SAS (Social andLeisure Domain)
At 6 months postnatallyno women in the IPT-B groupshad major depressioncompared with 16 of 23 (70)in the UC group At 6 monthspostnatally the EPDS scoresindicated a response totreatment in 22 of 25 women inthe IPT-B group (88) vs 7 of28 (25) in the CG with a largeeffect size (χ2= 2116 df= 1plt 001 Cohenrsquos h= 117)170
Unclear
Findings suggest thatenhanced IPT-Bameliorates depressionduring pregnancy andprevents depressiverelapse and improvessocial functioning up to6 months postpartum170
Significant difference
Usual care inthe USA
4 60 BDI SCID At 3 months postnatallynone of the 17 women in theintervention group comparedwith 6 of 18 women in thecontrol group (33) had majordepression There was a greaterreduction in BDI scores in the 17IG women than in the 18 CGwomen (t=350 df=33p=0001) Four antenatalsessions of IPT for financiallydisadvantaged women appearedto prevent major PND
Unclear
Significant difference
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
149
TABLE 38 Indicated preventive interventions characteristics and outcomes of RCTs of psychologicalinterventions (continued )
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
IPT-basedintervention
Zlotnick 2006179 USA 99 Antenatalsetting
Antenatalandpostnatal
Group Nurse
Mindfulness-basedintervention
Vieten 2008121 USA 34 Antenatalsetting
Antenatal Group Clinicalpsychologistyoga instructor
Promotingparentndashinfantinteraction
Armstrong1999164
Australia 181 Homevisits
Postnatal Individually Nurse socialworkerpaediatrician
Promotingparentndashinfantinteraction
Petrou 2006174
Cooper 2014267UK 151 Home
visitsAntenatalandpostnatal
Individually Health visitor
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
150
Comparisongroup(s)
Number ofcontacts
Duration ofcontact(minutes)
Depressionoutcomes Other outcomes Main findings
Overallrisk ofbias
Usual care inthe USA
5 60 BDI RIFT At 3 months postnatally2 of the 50 women in theintervention group (4)compared with 8 of 40 womenin the control group (20) hadmajor PND A brief antenatalIPT-based intervention forfinancially disadvantagedwomen appeared to preventmajor PND
Unclear
Significant difference
Usual care inthe USA
8 120 CES-DPANAS-X
STAI PSS ARMMAAS
Differences observedbetween treatment andwait-list controls at3-month follow-up werenot statistically significant121
High
No significant difference
Usual care inAustralia
6 ndash EPDS score13 or more
PSIbreastfeedingaccidental injuryChild AbusePotentialInventory HOMEnewly-developedmeasure ofpreventive infanthealth carePSQ-18 use ofhealth services
At 6 weeks women receivingthe home-based programmehad significant reduction in PNDscreening scores as well asimprovements in theirexperience of the parental roleand improvement in the abilityto maintain their own identityEPDS in intervention group was567 (SD 414) vs 790 (SD 589)comparison group p= 0004
Low
Significant difference
Usual care inthe UK
2 or more ndash EPDS meanscore SCIDfor DSM-IVdiagnoses
ASSA BSID IIMDI BSQ
The index intervention hadno discernible impact onmaternal mood or thequality of maternalparenting behavioursneither did it benefit theinfant outcomesassessed174267
Low
No significant difference
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
151
TABLE 38 Indicated preventive interventions characteristics and outcomes of RCTs of psychologicalinterventions (continued )
Interventionsummary
First authoryear referencenumber Country
Total numberof womenrandomised Place Timing
Type ofsession Provider
Promotingparentndashinfantinteraction
Wilson 2013177 UK 31 Antenatalsetting
Antenatal Group Group facilitators
Psychoeducationalintervention
Weidner 2010176 Germany 238 Antenatalsetting
Antenatal Individually Psychologist
Key ARM Affect Regulation Measure ASSA Ainsworth Strange Situation Assessment of Infant Attachment AWS AdultWellbeing Scale BAI Beck Anxiety Inventory BDQ Brief Disability Questionnaire BSID Bayley Scales of Infant DevelopmentBSQ Behaviour Screening Questionnaire CG control group CGAS Childrenrsquos Global Assessment Scale CI confidenceinterval CTS Conflict Tactics Scale DAS Dyadic Adjustment Scale df degrees of freedom DIS Diagnostic InterviewSchedule DISC Diagnostic Interview Schedule for Children-Computer Version DSM-IV Diagnostic and Statistical Manualof Mental Disorders-Fourth Edition ETSE Environmental Tobacco Smoke Exposure GAFS Global Assessment of FunctioningScale high high risk of bias HOME Home Observation for Measurement of the Environment HDRS Hamilton DepressionRating Scale IG intervention group IRS Interaction Rating Scale ITP-B Interpersonal Psychotherapy ndash brief low low riskof bias MAAS Mindful Attention Awareness Scale MDD major depressive disorder MDE Major Depressive EpisodesMDI Mental Development Index MINI Mini International Neuropsychiatric Interview MMS Maternal Mood ScreenerMSPSS Multidimensional Scale for Perceived Social Support NSSQ Norbeck Social Support Questionnaire OR odds ratioPANAS Positive and Negative Affect Schedule PPAQ postpartum adjustment questionnaire PSQ Postpartum SupportQuestionnaire RIFT Range of Impaired Functioning Tool SAS Social Adjustment Scale SCL-90-R SymptomChecklist-90-Revised SSI Social Support Index UC usual care unclear unclear risk of bias
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
152
Comparisongroup(s)
Number ofcontacts
Duration ofcontact(minutes)
Depressionoutcomes Other outcomes Main findings
Overallrisk ofbias
Usual care inthe UK
6 120 EPDS meanscore
AWS Salivarycortisol
For a small number of womenvulnerable in pregnancyrepresenting a hard-to-reachpopulation the Mellow BumpsGroup and the Chill-out inPregnancy group both appearedto have positive effects on thewomenrsquos mental healthand well-being overall at8ndash12 weeks postnatally
High
No significant difference
Usual care inGermany
22 ndash HADS GiessenSubjectiveComplaints list(physicalsymptoms)
The psychosomaticintervention had asignificant effect onanxiety scores (pndash0006)but not on depressionscores physical complaintsand characteristics oflabour and delivery176
High
No significant difference
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
153
TABLE 39 Indicated preventive interventions characteristics and outcomes of RCTs of educational interventions
Interventionsummary
First authoryear referencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
Booklet onPND
Heh 2003193 Taiwan 70 Postnatalsetting
Postnatal Individually Nurse
Booklet onPND
Lara 2010194 Mexico 377 Antenatalsetting
Antenatal Group Group facilitators
Booklet onPND andcontactnumbers
Webster2003196
Australia 600 Antenatalsetting
Antenatal Individually Leaflet (unclear)
Education onpreparing forparenting
Stamp 1995195 Australia 144 Antenatalsetting
Antenatalandpostnatal
Group Midwife
Key CI confidence interval high high risk of bias low low risk of bias SCL-90 Symptom Checklist-90 unclear unclear risk of bias
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
154
Comparisongroup(s)
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Overallrisk ofbias
Usual care inTaiwan
1 60 EPDS score10 or more(Chineseversion)
At 3 months postnatallyTaiwanese women who receivedinformation at around 6 weekspostnatally had lower EPDSscores (mean 108 SD 44) thana control group (mean 121SD 300) (p= 002)
High
Significant difference
Usual care inMexico
8 120 BDI-II SCID SCL-90 anxietysubscale
At 6 months postnatally 6 of56 women in the interventiongroup (107) had majordepression vs 15 of 60 womenin the control group (25) butthere was no significant effect
High
Available data are consistentwith the possibility that theincidence of depression mayhave been reduced by theintervention but differentialattrition makes interpretationof the findings difficult194
Mixed results
Usual care inAustralia
1 ndash EPDS score13 or more
The proportion of womenwho reported an EPDS scoreof 13 or more was 26There were no significantdifferences betweenintervention (46192 24)and control groups (50177282) on this primaryoutcome measure (OR 08095 CI 050ndash128)196
Unclear
No significant difference
Usual care inAustralia
3 ndash EPDS score13 or more
At 6 weeks postnatally 8 out of64 women in the interventiongroup (13) scored 13 or more onthe EPDS compared with 11 out of64 women in the control group(17)
Low
At 12 weeks postnatally7 out of 63 women in theintervention group (11) scored13 or more compared with 10out of 65 women in the controlgroup (15)
At 6 months postnatally 9 out of60 women in the interventiongroup (15) scored 13 or morecompared with 6 out of61 women in the controlgroup (10)
No significant difference
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
155
TABLE 40 Indicated preventive interventions characteristics and outcomes of RCTs evaluating social support
Interventionsummary
First authoryear referencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
Peer support Dennis 2009205 Canada 701 Telephone Postnatal Individually Peer volunteers
Peer support Harris 2006206 UK 65 Homevisits
Antenatalandpostnatal
Individually Newpin volunteer
Key high high risk of bias low low risk of bias SCAN PSE Schedule for Clinical Assessment in Neuropsychiatry Present StateExamination UCLA University of California Los Angeles unclear unclear risk of biasStatistically significant difference is assumed at the conventional value of lt 005
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
156
Comparisongroup(s)
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Overallrisk ofbias
Usual care inCanada
8 ndash EPDS score13 or moreSCID
STAI UCLAloneliness scale
At 12 weeks postnatally40 out of 297 women in theintervention group (14)scored 13 or more on the EPDScompared with 78 out of315 women in the controlgroup (25) (χ2= 125plt 0001) The number neededto treat was 88 (95 CI 59to 196) The relative riskreduction was 046 (95 CI024 to 062)
Low
Significant difference
Usual care inthe UK
2 or more ndash SCAN PSE ndash The onset of perinatal majordepression was 27 (830) forthe Newpin befriender groupand 54 (1935) for thecontrol group (χ2= 400p= 0045 two-tailed test)206
Unclear
Significant difference
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
157
Description and findings from qualitative studies of indicated preventiveinterventions of social supportTwo qualitative studies of social support interventions were included in the indicated preventiveinterventions category299301 one relating to womenrsquos perceptions and one relating to service providerperceptions of the same intervention Further details are provided in Table 41
Findings from the qualitative review
SupportEmotional support informational support and the development of relationships with peers were reportedby participants as beneficial aspects of the telephone support intervention299
Service deliveryService providers301 were concerned that the intervention represented an invasion of the recipientsrsquo privacyand also that they would not be able to deal with unpredictable situations for which they were notqualified One peer volunteer301 reported that providing the service had resulted in the recurrence of herown past emotions and anxieties Peer volunteers felt uncomfortable discussing emotional issues with therecipients Some felt they would have benefited from further training supervision and information to sharewith the service users The peer volunteers reported that they would have liked more time to devote tothe role301
Indicated preventive interventions pharmacological agentsor supplements
Characteristics and main outcomes of randomised controlled trials ofindicated preventive interventions of pharmacological agents or supplementsAll three included studies214ndash216 evaluating pharmacological agents or supplements for the indicatedprevention of PND were conducted in the USA Four types of pharmacological agents or supplements wereidentified eicosapentaenoic acid (EPA) plus DHA214 nortriptyline273 and sertraline216 One study wasundertaken in the antenatal period only214 and two studies were undertaken in the postnatal periodonly215216 A summary of the characteristics and main outcomes is provided in Table 42
There were no qualitative studies of indicated preventive interventions of pharmacological agentsor supplements
Indicated preventive interventions midwifery-ledinterventions
Characteristics and main outcomes of randomised controlled trials ofindicated preventive interventions of midwifery-led interventionsThere was one indicated preventive intervention evaluating midwifery-led interventions conducted in theUK224 A summary of the characteristics and main outcomes is provided in Table 43
There were no qualitative studies of indicated preventive interventions of midwifery-led interventions
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
158
TABLE
41Qualitativestudiesofindicated
preve
ntive
interven
tionsch
aracteristicsofstudiesev
aluatingsocial
support
Firstau
thor
year
reference
number
Country
Interven
tiondetails
Nam
eSe
tting
Delivered
Antenatalpostnatal
Groupindividual
Number
of
sessions
Durationofsession
Facilitatorservice
providers
Den
nis
2009
205
Can
ada
Teleph
one-ba
sed
peer
supp
ort
Teleph
one
supp
ort
Postna
tal
Individu
alMeancontacts
88(SD6
contacts)
Meanleng
thof
contact14
1minutes
(SD18
5minutes)
rang
e1ndash
180minutes
Peer
volunteers
ndashmothe
rsfrom
thecommun
itywith
resolved
historyof
PND
who
participated
ina
4-ho
urtraining
session
KeyNAno
tap
plicab
le
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
159
TABLE 42 Indicated preventive interventions characteristics and outcomes of RCTs evaluating pharmacologicalinterventions or supplements
Interventionsummary
First authoryear referencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
EPA and DHA Mozurkewich2013214
USA 126 Antenatalsetting
Antenatal Individually Prescriber
Nortriptyline Wisner 2001215 USA 51 Postnatalsetting
Postnatal Individually Prescriber
Sertraline Wisner 2004216 USA 25 Postnatalsetting
Postnatal Individually Prescriber
Key BRMS BechndashRafaelsen Mania Scale HAM-D Hamilton Rating Scale for Depression HDRS Hamilton Depression RatingScale high high risk of bias low low risk of bias MINI Mini International Neuropsychiatric Interview unclear unclear riskof bias
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
160
Comparisongroup(s)
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Overallrisk ofbias
Usual care inthe USA
2 or more ndash BDI MINI ndash No differences betweengroups in BDI scoresor other depressionendpoints at any of thethree time points aftersupplementation214
Low
EPA-rich fish oil andDHA-rich fish oilsupplementation didnot prevent depressivesymptoms duringpregnancy or postpartum214
No significant difference
Usual care inthe USA
2 or more ndash HDRS(HAM-D)
BRMS 6 out of the 26 women in thenortriptyline intervention group(23) compared with 6 out ofthe 25 women in the controlgroup (24) had a postnatalrecurrence of depression
Low
No significant difference
Usual care inthe USA
2 or more ndash HDRS SCID Asberg SideEffects rating
Recurrences in the 17-weekpreventive treatment periodoccurred in four of theeight women takingplacebo (proportion 05095 CI 016ndash084) and inone of the 14 womentaking sertraline(proportion 007 95 CI000ndash034) (p= 004Fisherrsquos exact test)216
Low
Significant difference
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
161
TABLE
43Indicated
preve
ntive
interven
tionsch
aracteristicsan
doutcomes
ofRCTs
evaluatingmidwifery-ledinterven
tions
Interven
tion
summary
First
author
year
reference
number
Country
Total
number
of
women
randomised
Place
Timing
Typeof
session
Provider
Comparison
group(s)
Number
of
contacts
Duration
ofco
ntact
(minutes)
Dep
ression
outcomes
Other
outcomes
Mainfindings
Ove
rall
risk
of
bias
Midwife
rycontinuo
uscare
Marks
2003
224
UK
98Anten
atal
setting
Anten
atal
and
postna
tal
Individu
ally
Midwife
Usual
care
intheUK
22NR
EPDSmean
score
SCID
CAME
MSQ
At3mon
ths
postna
tallythe
EPDSmean
scoreforthe43
wom
enin
the
controlg
roup
was
749
(SD
533
)an
dforthe
42wom
enin
theinterven
tion
grou
pwas
748
(SD654
)
Unclear
Nosign
ificant
differen
ces
KeyCAME
Con
textua
lAssessm
entof
Maternity
Expe
rience
MSQ
Maternity
ServiceQue
stionn
aireNR
notrepo
rted
un
clearun
clearriskof
bias
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
162
Indicated preventive interventions organisation ofmaternity care
Characteristics and main outcomes of randomised controlled trials ofindicated preventive interventions of organisation of maternity careNo indicated preventive intervention for preventing PND was identified concerning the organisation ofmaternity care
Description and findings of qualitative studies of selective preventiveinterventions of the organisation of maternity careOne qualitative study of an intervention evaluating the organisation of maternity care was included in theindicated preventive intervention category300 Further details are provided in Table 44
SupportRecipients of the intervention300 reported the support they received from the health professionals deliveringthe service as helpful and the relationship with the service provider appeared to be of great importanceWomen reported that they were able to rely on the service and that if they needed the service urgently itwas available to them
the service was closing and I just rang up and was like lsquoI really need some helprsquo and they calledme straight back the next day (M)y clinical nurse immediately started seeing me within a weekbecause they could see how desperate I was for some help
Participant300
They also valued a close relationship they were able to form with their clinician and reported on their kindapproach which enabled a feeling of safety300
Empowerment (self-esteem)The authors reported that the women learned to cope without the service and that it allowed them togain confidence in themselves300
Service delivery and barriers to participationWomen reported feeling intimidated by the thought of referral to the specialist perinatal and infant mentalhealth service300 The authors reported that those who did feel able to access the service fully said that theywould have liked the service to be extended beyond the infantrsquos first birthday and felt that they were notready to be discharged which caused them stress and anxiety300
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
163
TABLE
44Qualitativestudiesofindicated
preve
ntive
interven
tionsch
aracteristicsofstudiesev
aluatingorgan
isationofmaternitycare
Firstau
thor
yearreferen
cenumber
Country
Interven
tiondetails
Nam
eSe
tting
Delivered
antenatalpostnatal
Groupindividual
Numbers
ingroup
Number
of
sessions
Duration
ofsession
Facilitatorservice
providers
Myors20
1430
0Australia
Specialistpe
rinatal
and
infant
men
talh
ealth
service
Second
arycare
ndash
locatio
nno
trepo
rted
Anten
atal
and
postna
tal
Individu
alNA
Multip
lecontact
NA
Nursepsychiatrist
psycho
logistsocial
workers
KeyNAno
tap
plicab
le
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
164
Indicated preventive interventions complementary andalternative medicine or other interventions
Characteristics and main outcomes of randomised controlled trials ofindicated preventive interventions of complementary and alternativemedicine or other interventionsThe only included study evaluating CAMs or other interventions for the indicated prevention of PND wasconducted in the USA229 A summary of the characteristics and main outcomes is provided in Table 45
There were no qualitative studies of indicated preventive interventions of CAM or other interventions
Results from network meta-analysis for indicated preventiveinterventions for Edinburgh Postnatal Depression Scalethreshold score
Of the indicated preventive intervention trials 12 were included in the NMA (see Appendix 10 Table ofindicated preventive intervention studies omitted from network meta-analysis) Four trials were excludedbecause they could not be connected to the main network of evidence148177229 and 12 were excluded as aresult of lack of available EPDS data121166167171172176178179206214ndash216
The four trials excluded because they could not be connected to the main network were undertaken inChina (Hong Kong)175 Mexico194 Pakistan148 and Taiwan193
Of the 14 trials excluded as a result of lack of available EPDS data four were at high risk of bias and noneof these were associated with significant differences in depression121172176177 The UK-based trial was small(n= 31) and the results suggested that psychoeducational interventions in pregnancy may benefit womenwith major psychosocial needs177
Of the 14 trials excluded as a result of lack of available EPDS data six were at unclear risk ofbias166171178179206229 Five of these trials were small with fewer than 100 participants166178179206229
The largest of these trials with 217 participants concluded lsquoA CBT intervention for low-income high-riskLatinas reduced depressive symptoms during pregnancy but not during the postpartum periodrsquo171 Two ofthe three trials examining IPT-based intervention found a significant effect using the BDI or DSM-IV[Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)] criteria178179 but the otherdid not166 In the active acupuncture study there were only 20 participants in each group229 and theUK-based Newpin trial found a significant reduction in the onset of perinatal major depression using theSchedule for Clinical Assessment in Neuropsychiatry (SCAN)206
One of the four trials at low risk of bias found that EPA- and DHA-rich fish oil supplementation did notprevent depressive symptoms214 No difference was found in the rate of recurrence in women treated withnortriptyline compared with those treated with placebo215 There were significantly fewer recurrencesof depression in women taking sertraline preventive treatment compared with women taking placebo216
A CBT-based intervention that integrated multiple risk interventions delivered mainly during pregnancyhad a non-significant effect in reducing risks for smoking depression and intimate partner violencebut there was a difference in favour of the intervention group167
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
165
TABLE 45 Indicated preventive interventions characteristics and outcomes of RCTs evaluating CAM or other
Interventionsummary
First authoryear referencenumber Country
Totalnumber ofwomenrandomised Place Timing
Type ofsession Provider
Acupuncturefor depression
Manber 2004229 USA 61 Antenatalsetting
Antenatalandpostnatal
Individually Acupuncturespecialist
Key BDI Beck Depression Inventory HDRS Hamilton Depression Rating Scale high high risk of bias low low risk of biasunclear unclear risk of bias
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
166
Comparisongroup(s)
Number ofcontacts
Durationof contact(minutes)
Depressionoutcomes
Otheroutcomes Main findings
Overallrisk ofbias
Acupuncturenon-specific
12 30 BDI HDRS ndash At 10 weeks postnatallythe mean BDI score in the16 women in the acupuncturegroup was 69 (SD 77) In the19 women in the active controlit was 108 (SD 98) and in the19 women in the massagegroup it was 102 (SD 66)There was no pure control
Unclear
Limited by small sample
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
167
Results from network meta-analysis for indicated preventive intervention forEdinburgh Postnatal Depression Scale threshold scores at 6 weekspostnatallyA NMA was used to compare the effects of education on preparing for parenting and promotingparentndashinfant interaction relative to usual care on EPDS threshold Data were available from two studiescomparing three interventions166197 Figure 38 presents the network of evidence There were twointervention effects to estimate from two studies
Figure 39 presents the odds ratios of each intervention relative to usual care and Figure 40 presents theprobabilities of treatment rankings The total residual deviance was 412 compared with the total numberof data points four included in the analysis This implies a good fit of the model to the data Thebetween-study SD was estimated to be 023 (95 CrI 001 to 074) which implies mild heterogeneity ofintervention effects between studies
Armstrong 1999 164
Stamp 1995 195
Usual care
Promoting parent ndash infant interaction
Education on preparing for parenting
FIGURE 38 Indicated preventive interventions EPDS threshold score at 6 weeks postnatally network of evidence
005 018 063 225 800
Promoting parent ndash infant interaction
Education on preparing for parenting
Education on preparing for parenting
021 (006 to 063)
071 (021 to 225)
348 (066 to 2013)
vs promoting parent ndash infant interaction
vs usual care
Treatment comparison OR (95 CrI)
FIGURE 39 Indicated preventive interventions EPDS threshold score at 6 weeks postnatally odds ratios alltreatment comparisons
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
168
Promoting parentndashinfant interaction and education on preparing for parenting reduced the odds of highEPDS scores compared with usual care although the effect was statistically significant only for promotingparentndashinfant interaction at a conventional 5 level (see Figure 39)
Promoting parentndashinfant interaction had the highest probability of being the best (probability 084)(see Figure 40)
Results from network meta-analysis for indicated preventive intervention forEdinburgh Postnatal Depression Scale threshold scores at 3 monthspostnatallyA NMA was used to compare the effects of peer support and education on preparing for parentingrelative to usual care on EPDS threshold Data were available from two studies comparing threeinterventions197207 Figure 41 presents the network of evidence There were two intervention effects toestimate from three studies
000
025
050
075
100
Pro
bab
ility
Usual
care
Prom
oting p
aren
t ndash infa
nt inte
racti
on
Educa
tion o
n pre
parin
g for p
aren
ting
FIGURE 40 Indicated preventive interventions EPDS threshold score at 6 weeks postnatally probability oftreatment rankings (ranks 1ndash5)
Dennis 2009 205
Stamp 1995 195
Usual care
Peer support
Education on preparing for parenting
FIGURE 41 Indicated preventive interventions EPDS threshold score at 3 months postnatally network of evidence
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
169
Figure 42 presents the odds ratios of each intervention relative to usual care and Figure 43 presents theprobabilities of treatment rankings The total residual deviance was 405 compared with the total numberof data points four included in the analysis This implies a good fit of the model to the data Thebetween-study SD was estimated to be 021 (95 CrI 001 to 072) which implies mild heterogeneity ofintervention effects between studies
Both peer support and education on preparing for parenting have reduced odds of high EPDS scorescompared with usual care However the effects were not statistically significant at a conventional 5 level(see Figure 42) Peer support has the highest probability of being the best (probability 069) (see Figure 43)
005 018 063 225 800
Peer support
Education on preparing for parenting
Education on preparing for parenting
047 (021 to 103)
067 (018 to 237)
144 (033 to 637)
vs peer support
vs usual care
Treatment comparison OR (95 CrI)
FIGURE 42 Indicated preventive interventions EPDS threshold score at 3 months postnatally odds ratios alltreatment comparisons
000
025
050
075
100
Pro
bab
ility
Usual
care
Peer
support
Educa
tion o
n pre
parin
g for p
aren
ting
FIGURE 43 Indicated preventive interventions EPDS threshold score at 3 months postnatally probability oftreatment rankings
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
170
Results from network meta-analysis for indicated preventive intervention forEdinburgh Postnatal Depression Scale threshold scores at 4 monthspostnatallyA NMA was used to compare the effects of booklets on PND and promoting parentndashinfant interactionrelative to usual care on EPDS threshold Data were available from two studies comparing threeinterventions166198 Figure 44 presents the network of evidence There were two intervention effects toestimate from two studies
Figure 45 presents the odds ratios of each intervention relative to usual care and Figure 46 presents theprobabilities of treatment rankings The total residual deviance was 397 compared with the totalnumber of data points four included in the analysis This implies a good fit of the model to the dataThe between-study SD was estimated to be 022 (95 CrI 001 to 070) which implies mild heterogeneityof intervention effects between studies
Armstrong 1999 164
Webster 2003 196
Usual care
Promoting parent ndash infant interaction
Booklet on PND
FIGURE 44 Indicated preventive interventions EPDS threshold score at 4 months postnatally network of evidence
005 018 063 225 800
Promoting parent ndash infant interaction
Booklet on PND
Booklet on PND
067 (024 to 174)
079 (036 to 170)
120 (034 to 418)
vs promoting parent ndash infant interaction
vs usual care
Treatment comparison OR (95 CrI)
FIGURE 45 Indicated preventive interventions EPDS threshold score at 4 months postnatally odds ratios alltreatment comparisons
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
171
The odds ratio for both promoting parentndashinfant interaction and booklet on PND was less than 1suggesting a beneficial effect compared with usual care although the results were not statisticallysignificant at a conventional 5 level (see Figure 45) Promoting parentndashinfant interaction has the highestprobability of being the best (probability 060) (see Figure 46)
Results from network meta-analysis for indicated preventive intervention forEdinburgh Postnatal Depression Scale threshold scores at 6 monthspostnatallyA NMA was used to compare the effects of CBT-based intervention PCA-based intervention andeducation on preparing for parenting relative to usual care on EPDS threshold Data were available fromtwo studies comparing four interventions61197 Figure 47 presents the network of evidence There werethree intervention effects to estimate from two studies
000
025
050
075
100
Pro
bab
ility
Usual
care
Prom
oting p
aren
t ndash infa
nt inte
racti
on
Booklet o
n PND
FIGURE 46 Indicated preventive interventions EPDS threshold score at 4 months postnatally probability oftreatment rankings (ranks 1ndash3)
Stamp 1995 195
Morrell 2009 61
Usual care
Education on preparing for parenting
CBT-based intervention
PCA-based intervention
FIGURE 47 Indicated preventive interventions EPDS threshold score at 6 months postnatally network of evidence
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
172
Figure 48 presents the odds ratios of each intervention relative to usual care and Figure 49 presents theprobabilities of treatment rankings The total residual deviance was 412 compared with four data pointsincluded in the analysis This implies a good fit of the model to the data The between-study SD wasestimated to be 022 (95 CrI 001 to 073) which implies mild heterogeneity of intervention effectsbetween studies
005 018 063 225 800
CBT-based intervention
PCA-based intervention
Education on preparing for parenting
PCA-based intervention
Education on preparing for parenting
Education on preparing for parenting
059 (026 to 138)
065 (028 to 157)
170 (048 to 717)
110 (047 to 257)
287 (065 to 1528)
263 (057 to 1443)
vs PCA-based intervention
vs CBT-based intervention
vs usual care
Treatment comparison OR (95 CrI)
FIGURE 48 Indicated preventive interventions EPDS threshold score at 6 months postnatally odds ratios alltreatment comparisons
000
025
050
075
100
Pro
bab
ility
Usual
care
CBT-bas
ed in
terv
entio
n
PCA-b
ased
inte
rven
tion
Educa
tion o
n pre
parin
g for p
aren
ting
FIGURE 49 Indicated preventive interventions EPDS threshold score at 6 months postnatally probability oftreatment rankings (ranks 1ndash4)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
173
The CBT- and PCA-based interventions had reduced odds of high EPDS scores compared with usual careEducation on preparing for parenting had an increased odds of a high EPDS score at 6 months comparedwith usual care However none of the odds ratios were statistically significant at a conventional 5 level(see Figure 48) The CBT-based intervention has the highest probability of being the best (probability 056)(see Figure 49)
Summary of results from network meta-analysis for indicated preventiveintervention for Edinburgh Postnatal Depression Scale threshold scoresIn general the intervention effects were inconclusive although promoting parentndashinfant interaction wasassociated with a statistically significant benefit at 6 weeks Intervention effects tended to vary over timewith the most beneficial treatments being promoting parentndashinfant interaction at 6 weeks peer supportat 3 months promoting parentndashinfant interaction at 4 months and CBT- and PCA-based interventionsat 6 months
Results from network meta-analysis for indicated preventiveintervention for Edinburgh Postnatal Depression Scalemean scores
A NMA was used to compare the effects CBT-based intervention educational information IPT-basedintervention midwifery continuous care peer support PCA-based intervention and promotingparentndashinfant interaction relative to usual care on EPDS mean scores Data were available from 10 studiescomparing eight interventions61166167170ndash172175176207226 There were seven intervention effects to estimate(relative to usual care) from 10 studies Figure 50 presents the network of evidence
Armstrong 1999 164
Austin 2008 165
Dennis 2009 205
Ginsburg 2012 168
Gorman 1997 169
Grote 2009 170
Marks 2003 224
Munoz 2007 173
Petrou 2006 174
Morrell 2009 61
Usual care
Promoting parent ndash infant interaction
Educational information
CBT-based intervention
Peer support
IPT based
Midwifery continuous care
PCA-based intervention
FIGURE 50 Indicated preventive interventions for EPDS mean scores network of evidence Dashed lines representthree-arm trials
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
174
Figure 51 presents the differences in EPDS mean scores of each intervention relative to usual careThe between-study SD was estimated to be 195 (95 CrI 069 to 355) which implies moderateheterogeneity of intervention effects between studies However there is considerable uncertainty aboutthe between-study SD because of the relatively small number of studies that provided data relative to thenumber of intervention effects being estimated The interventions associated with the greatest reduction inEPDS mean score were IPT-based intervention (ndash425 95 CrI ndash787 to 043 at 6ndash7 months) CBT-basedintervention (ndash218 95 CrI ndash539 to 115 at 12 months) and PCA-based intervention (ndash205 95 CrIndash590 to 212 at 12 months) None of the comparisons with usual care were statistically significant at aconventional 5 level Figures 52ndash55 present the probabilities of treatment rankings at 6ndash8 weeks3ndash4 months 6ndash7 months and 12 months respectively
The interventions with the highest probabilities of being the best at 6ndash8 weeks were the IPT-basedintervention and promoting parentndashinfant interaction (probability 060 and 032 respectively)
The interventions with the highest probabilities of being the best at 3ndash4 months were educationalinformation (probability 024) CBT-based intervention (probability 021) promoting parentndashinfantinteraction (probability 020) and peer support (probability 020)
The intervention with the highest probability of being the best at 6ndash7 months was IPT-based intervention(probability 077)
The interventions with the highest probabilities of being the best at 12 months were CBT- and PCA-basedinterventions (probability 043 and 041 respectively)
ndash 500 ndash 250 000 250 500
3 ndash 4 months
3 ndash 4 months6 ndash 7 months12 months
6 ndash 7 months
6 ndash 7 months12 months
6 ndash 8 weeks3 ndash 4 months6 ndash 7 months12 months
3 ndash 4 months6 ndash 7 months
3 ndash 4 months6 ndash 7 months
ndash 004 (ndash 483 to 486)
ndash 138 (ndash 607 to 387)ndash 034 (ndash 306 to 301)ndash 218 (ndash 539 to 115)
ndash 425 (ndash 787 to 043)
ndash 121 (ndash 501 to 293)ndash 205 (ndash 590 to 212)
ndash 112 (ndash 435 to 193)ndash 086 (ndash 527 to 364) 014 (ndash 427 to 447)ndash 012 (ndash 433 to 424)
ndash 093 (ndash 511 to 332)ndash 060 (ndash 475 to 361)
ndash 119 (ndash 657 to 504) 218 (ndash 220 to 700)
Educational information
Peer support
Promoting parent ndash infant interaction
PCA-based intervention
IPT-based intervention
CBT-based intervention
Midwifery continuous care
Treatment comparison EPDS difference (95 CrI)
FIGURE 51 Indicated preventive interventions EPDS mean scores mean differences of treatment comparisons vsusual care across all time points
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
175
000
025
050
075
100
Pro
bab
ility
Usual
care
CBT-bas
ed in
terv
entio
n
IPT-b
ased
inte
rven
tion
Prom
oting p
aren
tndashin
fant i
ntera
ction
Educa
tional
info
rmat
ion
FIGURE 52 Indicated preventive interventions EPDS mean scores probability of treatment rankings at 6ndash8 weekspostnatally (ranks 1ndash5)
000
025
050
075
100
Pro
bab
ility
Usual
care
Mid
wifery
contin
uous car
e
CBT-bas
ed in
terv
entio
n
Prom
oting p
aren
tndashin
fant i
ntera
ction
Peer
support
Educa
tional
info
rmat
ion
FIGURE 53 Indicated preventive interventions EPDS mean scores probability of treatment rankings at 3ndash4 monthspostnatally (ranks 1ndash6)
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
176
Summary of results from network meta-analysis for indicated preventiveintervention for Edinburgh Postnatal Depression Scale mean scoresNot all interventions provided information about intervention effects at each time making inferencesacross all treatments at each time difficult In general the intervention effects were inconclusive and theCrIs were wide The most beneficial treatments appeared to be IPT-based intervention educationalinformation CBT-based intervention and PCA-based intervention A summary of the results for thethreshold and the EPDS mean scores is presented in Table 46
The qualitative evidence suggested that the social support intervention adequately provided emotional andinformational support to women Women reported that they felt able to rely on a perinatal and infantmental health service if they needed to access them urgently and appreciated the support of the healthprofessionals delivering the service However barriers to accessing the service included a feeling ofintimidation around being referred to such a service stigma and concerns about being discharged beforethey felt ready
000
025
050
075
100
Pro
bab
ility
Usual
care
CBT-bas
ed in
terv
entio
n
PCA-b
ased
inte
rven
tion
Prom
oting p
aren
tndashin
fant i
ntera
ction
FIGURE 55 Indicated preventive interventions EPDS mean scores probability of treatment rankings at 12 months(ranks 1ndash4)
000
025
050
075
100
Pro
bab
ility
Usual
care
CBT-bas
ed in
terv
entio
n
IPT-b
ased
inte
rven
tion
PCA-b
ased
inte
rven
tion
Prom
oting p
aren
tndashin
fant i
ntera
ction
Peer
support
Educa
tional
info
rmat
ion
FIGURE 54 Indicated preventive interventions EPDS mean scores probability of treatment rankings at 6ndash7 monthspostnatally (ranks 1ndash7)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
177
TABLE 46 Indicated preventive interventions NMAs overall summary of main effects of interventions relative tousual care
Time postnatally
EPDS mean score EPDS threshold score
Overall riskof bias
Difference in mean(95 CrI)
Probability ofbeing the besta
Odds ratio(95 CrI)
Probability ofbeing the besta
6 weeks postnatally
Promotingparentndashinfantinteraction164
ndash112 (ndash435 to 193) 060b 021 (006 to 063) 084c Low
3 months postnatally
CBT-basedintervention173
ndash138 (ndash607 to 387) 021d NE NE Unclear
Educationalinformation168
ndash119 (ndash657 to 504) 024d NE NE Unclear
Peer support205 ndash093 (ndash511 to 332) 020d 047 (021 to 103) 069c Low
Education onpreparing forparenting195
NE NE 067 (018 to 237) 030c Low
Promotingparentndashinfantinteraction164
ndash086 (ndash527 to 364) 020d NE NE Low
4 months postnatally
Promotingparentndashinfantinteraction164
NE NE 067 (024 to 174) 060c Low
6 months postnatally
IPT-basedintervention169170
ndash425 (ndash787 to 043) 077e NE NE Unclear
PCA-basedintervention61
ndash121 (ndash501 to 293) 010e 065 (028 to 157) 037f Low
CBT-basedintervention61
ndash034 (ndash306 to 301) 001e 059 (026 to 138) 056f Low
12 months postnatally
PCA-basedintervention61
ndash205 (ndash590 to 212) 041f NE NE Low
CBT-basedintervention61173
ndash218 (ndash539 to 115) 043f NE NE Lowunclearg
Key high high risk of bias low low risk of bias NE not evaluable unclear unclear risk of biasa Probability of being the best among interventions with evaluable data at each assessmentb Best among two interventionsc Best among three interventionsd Best among six interventionse Best among seven interventionsf Best among four interventionsg Where there were two studies the risk of bias is indicated in the order in which the studies are citedFor difference in mean lt ndash075 or odds ratio lt 070 Not evaluable data were data not available on this outcome measurefor this intervention
RESULTS FOR INDICATED PREVENTIVE INTERVENTION STUDIES
NIHR Journals Library wwwjournalslibrarynihracuk
178
Chapter 8 Results of realist synthesis what worksfor whom
Introduction to Best Fit Realist Synthesis
Having characterised the principal seven classes of intervention and having identified focal interventionsfrom among the group- and individual-based approaches the team sought to examine the main servicemodels for prevention of PND in relation to the underlying programme theory and mechanisms
Results of the review
The lsquoBest Fit Realist Reviewrsquo engaged with 96 studies relating to 13 separate interventionprogrammes7842ndash4461146148151152154160163164166170178179184190205206208219221222224236251252262264277ndash340
CenteringPregnancy was the most represented in the literature (with 22 studies)61146148151154164170179190205208219221251252262264327335ndash338 Next came telephone peer support and IPT plus telephone (nine studies each)followed by midwifery redesigned postnatal care (eight) Then followed IPT-brief (seven) midwife-managedcare (seven) midwife-led brief counselling (six) the Newpin Project (six) Health Visitor PoNDER Training(six) Thinking Healthy Programme (five) and the two-step behavioural educational intervention (five)Finally home-based intervention and IPT plus Reach Out Stand strong Essentials for new mothers (ROSE)were both covered by three studies
Eleven trials were from the effectiveness review 25 of the studies represented the views of womenreceiving an intervention and five represented the views of service providers One study collected the viewsof both women and service providers Two represented a cost study or economic evaluation One studycollected measures of womenrsquos satisfaction and costs339 Eleven studies were either reviews or evidencesyntheses The remaining 40 studies were study reports but were not RCTs qualitative studies or economicevaluations Eight of the qualitative studies were already included in the qualitative synthesis ofintervention studies (See Appendix 9)
Synthesis drawing upon realist approaches
The realist review began by engaging with the spreadsheet-based matrices of intervention classes andtheir relative effectiveness and with the qualitative synthesis of intervention study findings The dearth ofqualitative intervention studies further required that the realist synthesis engage with wider qualitative datafrom beyond the group of intervention studies These studies are characterised from here onwards as PSSSstudies Such studies identify strategies used by women who had not experienced PND that they believehelped to prevent the condition Although such data must be treated with caution given that they reflectwomenrsquos anticipation of a hypothetical situation the team believed that this perspective would providea counterpoint to interventions in which content and delivery had been primarily devised by healthprofessionals The PSSS studies allow comparison between what women feel is helpful and what is actuallybeing delivered by the interventions themselves
Description of included personal and social support strategy studiesIn total 23 studies (n= 29 citations) were identified reporting qualitative data on the perspectives andattitudes of women who had not experienced PND regarding PSSSs that they believe helped to prevent thecondition (see Appendix 9 Personal and social support strategy studies population characteristics)
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
179
Study respondents in the personal and social support strategy studiesThe number of participants contributing qualitative evidence across all studies where reported wassummed and totalled 801 (one study7 did not provide the number of participants who contributed to thequalitative findings) Fifteen studies provided data from participants from a general population in thecountry of study7286302303305312313316ndash325 while the remaining studies examined evidence from minoritygroups within the country of study The minority groups were either a culturally different group basedwithin the country of study (n= 6)292306ndash311314315318 or a selective group (n= 2)296ndash298304 For details ofparticipant characteristics see Appendix 9
Study setting of the personal and social support strategy studiesTen studies were conducted in the UK304306ndash315319321322324 seven studies were conducted in theUSA286292296ndash298302303318320 one in Switzerland316 one in Canada317 one in Norway323 one in India325
one in China305 and one in multiple centres7
Synthesis of findings across personal and social support strategystudies
Several themes relating to the PSSSs which helped women prevent PND were identified across theincluded studies Included studies focused on either general population women minority groups whichwere culturally different from the general population of the country of study or in a small number ofcases selective groups (low-socioeconomic status or vulnerable groups) Two studies305325 focused on thegeneral population of the country of study but highlighted findings related to particular cultural practices
Based on an actual or promising assessment of effectiveness the review team specified thirteeninterventions requiring further in-depth analysis These 13 interventions became the focus for subsequentinvestigation of study clusters (Table 47)
TABLE 47 Thirteen focal interventions for exploration by realist review principles
Intervention category Initiative Target population Setting
Psychological Health Visitor PoNDER Training Universal and indicated UK
Psychological Home-based intervention Indicated Australia
Psychological IPT plus telephone follow-up Universal China
Psychological IPT standard antenatal careplus the ROSE programme
Indicated USA
Psychological IPT ndash Brief Indicated USA
Educational Two-step behaviouraleducational intervention
Selective USA
Social Support Telephone peer support Indicated Canada
Social Support The Newpin Project Indicated UK
Social Support Thinking Healthy Programme Indicated Pakistan and developing world
Midwifery-led interventions CenteringPregnancy Selective USA and Australia
Midwifery-led interventions Midwife-led brief counselling Selective Australia
Midwifery-led interventions Midwife-managed care332 Universal UK
Midwifery-led interventions Midwifery redesignedpostnatal care
Universal UK
RESULTS OF REALIST SYNTHESIS WHAT WORKS FOR WHOM
NIHR Journals Library wwwjournalslibrarynihracuk
180
Examination of the RCTs in conjunction with searches for qualitative research revealed 22 published trialreports associated with the 13 interventions (see Table 48) These reports became the lsquoindex papersrsquo forour study clusters
Searching for CLUSTER documents for realist synthesis
Google Scholar citation searches (lsquoforward chainingrsquo) were conducted for each of the 22 published studyreports141 A total of 1888 citations were identified (including duplicates) The mean number of citationswas 86 (range 0ndash232) Lists of results for articles citing an index paper were examined carefully for sharedauthorship a common study identifier or for other common study-level denominators (eg setting orinstitution) When a directly connected (lsquosiblingrsquo) report was identified this was used to populate synthesisof the findings from PSSS studies Appendix 7
In addition when a similar intervention study (eg differing in setting population etc) was identifiedthis was recorded as a kinship study Finally systematic reviews narrative reviews and qualitative evidencesyntheses on the topic were also identified The reference lists of all 22 original published reports(Table 48) as well as the reference lists of all lsquosiblingrsquo studies were scrutinised (lsquobackward chainingrsquo) forearlier sibling studies (eg protocols pilot studies feasibility studies etc) or related lsquokinship studiesrsquo(eg studies sharing a common intervention or underpinning theory)
Preliminary synthesis and construction of a theoretical model
A formative stage of the synthesis required becoming familiar with the focal interventions to sensitise tothe study data and to broadly characterise the different programmes against their defining dimensionsTable 49 attempts to locate the included programmes against the following dimensions
l whether the programme is delivered at an individual or group level or it has elements of both (lsquomixedapproachrsquo) or whether it is not directly targeting the women but reaching them indirectly throughhealth professional training
l whether the programme is delivered face to face whether it is delivered remotely or whether it usesboth methods (lsquohybrid deliveryrsquo)
l whether the programme is delivered by health professionals or by lay support or it is delivered by both(lsquojoint deliveryrsquo)
This formative analysis helped in looking for similarities and differences across programmes for examplein characterising the different mechanisms by which lay support might work compared with delivery byhealth professionals
Although specific components of one-to-one or group types of approach are determined by the reviews ofeffectiveness and acceptability these two types of approach are underpinned by discernibly differentassumptions Consequently the mechanisms by which such approaches might operate also carry importantdifferences These are best illustrated by placing the two types of approach in juxtaposition Howeverinterventions may blend both approaches For example CenteringPregnancy an essentially group-basedapproach offers the opportunity for individual consultation with health professionals IPT is initiallyconducted in a group environment but is followed up by one-to-one telephone contact (Table 50)
Subsequent synthesis involved detailed itemisation of programme components from each cluster of relatedstudy reports use of multiple reports was essential as not all study reports provided a full description of theintervention The descriptions of the interventions often lacked sufficient detail to allow replication beyondthe original programme341 The innovative template for intervention description and replication (TIDieR)framework was used as a template for elicitation of relevant programme components342 Appendix 16 containsthe TIDieR templates for all thirteen focal interventions with as complete details as cluster reporting allowed
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
181
TABLE 48 Results for citation searches of index papers for realist synthesis
Study report (first author year reference number) Number of Google Scholar citations
Psychological
Health Visitor PoNDER Training
1 Morrell 200961 44
2 Morrell 2009151 105
Home-based intervention
3 Armstrong 1999164 169
4 Armstrong 2000251 97
5 Fraser 2000252 93
IPT standard antenatal care plus the ROSE programme
6 Zlotnick 2006179 117
IPT plus telephone follow-up
7 Gao 2010154 15
8 Gao 2012327 10
IPT-brief
9 Grote 2009170 75
Educational
Two-step behavioural educational intervention
10 Howell 2012190 9
11 Howell 2014335 1
12 Martin 2013336 0
Social support
Telephone peer support
13 Dennis 2009205 102
The Newpin Project
14 Harris 2008206 0
Thinking Healthy Programme
15 Rahman 2008148 209
Midwifery-led interventions
CenteringPregnancy
16 Ickovics 2007262 199
Midwife-led brief counselling
17 Gamble 2005221 105
Midwife-managed care
18 Shields 1997219 37
19 Shields 1998337 43
20 Turnbull 1996338 232
Midwifery redesigned postnatal care
21 MacArthur 2002146 168
22 MacArthur 2003264 58
Total references 1888
RESULTS OF REALIST SYNTHESIS WHAT WORKS FOR WHOM
NIHR Journals Library wwwjournalslibrarynihracuk
182
Identification of provisional lsquobest fitrsquo conceptual framework forrealist synthesisSearches of Google Scholar identified two outputs from a single Veteran Affairs project on group-basedapproaches343344 In line with the lsquobest fit frameworkrsquo345346 these study reports were sufficiently generic tobe used as a source of an lsquoanalytical frameworkrsquo (Figure 56) for examining group care approaches duringthe perinatal period
Population of the conceptual frameworkElements of the analytical conceptual framework (see Figure 56) were deconstituted into fields on a dataextraction form Two fields were modified a priori in recognition of the topic mortality (re-interpreted assuicide ideation) and biophysical markers (re-interpreted as physical signs and symptoms) The Best FitFramework approach provides for inclusion of additional inductive elements once the deductive stage ofthe synthesis is completed
Identification of existing theory underpinning specific mechanismsFive main bodies of theory seemed to underpin the specific mechanisms of featured interventions
l social cognitivelearning theory and self-efficacyl social supportsocial exchange theory (eg Brugha et al152)l locus of control (eg Brugha et al152)l empowerment (eg CenteringPregnancy)l attachment theory (eg home-based intervention and IPT interventions)
TABLE 49 Dimensions of the featured interventions how it is delivered
Dimension Individual Mixed approach Group Training
Face to face Midwife-managed caremidwifery redesignedpostnatal care
IPT standard antenatalcare plus ROSEprogramme
CenteringPregnancyThinking Healthy Programme
Health VisitorPoNDER Training
Hybrid delivery Midwife-led briefcounselling plustelephone postpartumthe Newpin Projecttwo-step behaviouraleducational intervention
ndash IPT plus telephone follow-up ndash
Remote Telephone peer support ndash ndash ndash
TABLE 50 Dimensions of the featured interventions who is involved
Dimension Individual Mixed approach Group Training
Healthcareprofessional
Midwife-managed caremidwifery redesignedpostnatal caremidwife-led briefcounselling plustelephone postpartumtwo-step behaviouraleducational intervention
IPT standard antenatalcare plus the ROSEprogramme
IPT plus telephone follow-up Health VisitorPoNDER Training
Joint delivery ndash ndash CenteringPregnancy ndash
Lay support The Newpin Projecttelephone peer support
ndash Thinking Healthy Programme ndash
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
183
Pop
ula
tio
nA
du
lts
wit
h
bull T2
DM
bull H
TNbull
CH
FC
AD
bull C
OPD
Ast
hm
abull
Art
hri
tis
bull C
hro
nic
pai
nbull
His
tory
of
falls
Dis
tal O
utc
om
esbull
Lon
g-t
erm
sym
pto
m
man
agem
ent
bull Fu
nct
ion
al s
tatu
sbull
Qu
alit
y o
f lif
ebull
ED v
isit
sbull
Reh
osp
ital
izat
ion
sbull
Un
pla
nn
ed o
ffice
vi
sits
bull M
ort
alit
ybull
Co
sts
Gro
up
Vis
it m
od
els
bull Le
d b
y n
on
-pre
scri
bin
g f
acili
tato
rsbull
Gro
up
siz
e (
pat
ien
ts)
bull D
iag
no
sis
rec
ency
dia
gn
osi
sbull
Vis
it c
om
po
nen
tsbull
Vis
it f
req
uen
cy d
ura
tio
n
nu
mb
er o
f fo
llow
-up
sbull
Peer
su
pp
ort
bull Te
am c
om
po
siti
on
bull O
ther
car
e p
atie
nts
are
rec
eivi
ng
Pro
xim
al O
utc
om
esbull
Ad
her
ence
bull B
iop
hys
ical
mar
kers
bull Se
lf-e
ffica
cybull
Pati
ent
par
tici
pat
ion
Usu
al c
are
bull In
div
idu
al v
isit
fo
r ch
ron
ic
care
bull O
ther
qu
alit
y im
pro
vem
ents
Ad
vers
e O
utc
om
esbull
Pati
ent
con
fid
enti
alit
ybull
Pati
ent
par
tici
pat
ion
bull M
isse
d a
pp
oin
tmen
ts
Mo
difi
ers
bull Pa
tien
t ch
arac
teri
stic
sa
bull B
uilt
en
viro
nm
ent
bull So
cial
su
pp
ort
bull H
ealt
h c
are
syst
em
KQ
2K
Q2
KQ
1K
Q3
KQ
1K
Q3
FIGURE56
Analytical
fram
ework
toev
aluategroupvisitsRep
roducedwithpermissionfrom
Quinones
etal343Notea
Includes
gen
derraceethnicity
age
educationhea
lth
literacy
ruralitygeo
graphy
chronic
conditionsmorbidityan
dother
patientdem
ographicsNotesocioeconomic
influen
cessuch
asfinan
cial
strain
(egprice
ofgas)directly
affect
patientpopulationKey
CHFCADco
ngestive
hea
rtfailu
recoronaryartery
disea
seC
OPD
ch
ronic
obstructivepulm
onarydisea
seHTN
hyp
ertensionKQk
eyquestion
EDe
mergen
cydep
artm
entT2
DMtype2diabetes
mellitus
RESULTS OF REALIST SYNTHESIS WHAT WORKS FOR WHOM
NIHR Journals Library wwwjournalslibrarynihracuk
184
The theories underpinning the mechanisms for each study are provided in Table 51 Table 52 indicatesthe theories relevant for the prevention of PND Table 53 indicates the mechanism of application of thetheories according to the approach used for example one-to-one or group approach
TABLE 51 Specific theories underpinning mechanisms
Initiative Implicitexplicit presence of theory
CenteringPregnancy CenteringPregnancy was developed and piloted by a certified nurse-midwifeafter experience with successful family-centred approaches to prenatal careand in recognition of repetitiousness [sic] of one-on-one prenatal care forproviders Uses a model of empowerment
Health Visitor PoNDER training Health visitors were trained to deliver psychologically informed sessionsbased on distinct psychological theories either cognitivendashbehaviouralprinciples347 or person-centred principles348
Home-based intervention Attachment theory349 states that parentsrsquo bonding with their own childrenand treatment of them is affected by their own earlier attachment historyand internal working models Attachment theory emphasises theimportance of consistency in relationships and sensitive understandingof reactions to separation loss and rejection The theory of resilience350
recognises personal resilience factors (eg positive orientation toproblem-solving) and environmental factors (eg the help of a supportiveadult)351352 Although some factors are relatively fixed others can bemodified such as access to support By exploring individual and familystrengths positive experiences and resources are built upon and enhanced
IPT standard antenatal care plus ROSEprogramme IPT plus telephone follow-upIPT-brief
IPT353 is grounded in interpersonal theories354 and attachment theories355
It is based on the hypothesis that clients who experience social disruptionare at increased risk of depression IPT specifically targets interpersonalrelationships and is designed to assist clients in modifying either theirrelationships or their expectations about relationships IPT could help newmothers in
l role transitions in which clients have to adapt to a change in lifecircumstances IPT aims to help to re-appraise the old and new roleto identify sources of difficulty in the new role and fashion solutions forthese roles
l interpersonal disputes these occur in marital family social or worksettings Clients may have diverging expectations of a situation and thisconflict is excessive enough to lead to significant distress IPT aims toidentify sources of dispute faulty communication or unreasonableexpectations It intervenes by communication training problem-solvingor other techniques that aim to facilitate change in the situation
l interpersonal deficits in which clients report impoverished interpersonalrelationships in terms of both number and quality of the relationshipsIPT aims to identify problematic processes such as dependency orhostility and aims to modify these processes
Midwife-led brief counselling The intervention was based on two theoretical perspectives relating toviolence and maternal distress356357 focus group discussions withchildbearing women and midwives and reviews of the literature
Midwife-managed care The predominant model of shared care ndash divided among midwives hospitaldoctors and GPs (family physicians) ndash has been called into question Thisinitiative was designed to address the hypothesis that midwife-managedcare would result in fewer interventions similar (or more favourable)outcomes similar complications plus greater satisfaction with care andenhanced continuity of care and carer
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
185
TABLE 51 Specific theories underpinning mechanisms (continued )
Initiative Implicitexplicit presence of theory
The Newpin Project340 A lifespan model of psychosocial origins of depression in women358
pinpoints the role of stressful life eventsdifficulties (often involvinghumiliating losses) in bringing on depressionfresh-start events (promisinghope of a new beginning) in promoting remission
Midwifery redesigned postnatal care No explicit theory The intervention was based on UK government reportsstating that there was a need for wide-ranging changes to maternityservices emphasising poor assessment and frequently inappropriate deliveryof postnatal care A service led by midwives with continuity of care andinvolvement of women which is supportive and sensitive to individualneeds and preferences is at the centre of the maternity carerecommendations
Telephone peer support The intervention was based on research related to maternal dissatisfactionwith peer support Lazarus and Folkman (1984)359 theorised that copingincorporates problem-resolution and emotion-regulation while employingaffective cognitive and behavioural response systems Bandura (1977)360
and Bandura (1986)361 social cognitive theory peer support influences healthoutcomes by (1) decreasing isolation and feelings of loneliness (2) swayinghealth practices and deterring maladaptive behaviours or responses(3) promoting positive psychological states and individual motivation(4) providing information regarding access to medical services or thebenefits of behaviours that positively influence health and well-beingand (5) preventing risk for progression of and promoting recovery fromphysical illness
Thinking Healthy Programme Holistic approach designed to counter lsquodefunct theory of ldquomindndashbodyrdquodualismrsquo
362
Two-step behavioural educationalintervention
Prior research suggests that postpartum physical symptoms overload fromdaily demands and poor social support play a major role in generation ofdepressive symptoms
RESULTS OF REALIST SYNTHESIS WHAT WORKS FOR WHOM
NIHR Journals Library wwwjournalslibrarynihracuk
186
TABLE 52 Programme theories for preventing PND
Programmetheory Label
Programme theory ndash PND willbe prevented if Relevant theory Elements
By activity
PT1 Developing trust Women develop meaningfulrelationships with other womenin the group and withhealth-care providers285363
Social cognitivetheory
Group interaction
PT1 Asking for help Women are made aware that itis legitimate to ask for help364
and can identify whom to ask365
Social norms Modelling withingroup
PT2 Learning by doing Women acquire practical366 andcommunication skills367 thatequip them for their new roles366
Social learning theorylocus of controlself-efficacy
Practical sessionsdemonstrationsrole play
PT3 Feeling supported Women feel supported by theirpartner health professionalspeer supporters or groupmembers to help them feelcomfortable reduce their anxietyand help them cope withchallenges283285364368
Social support Group sessionstelephoneindividual sessions
PT4 Accessing information Women are able to accessinformation not before or afterbut when they need it369
Social learning theorylocus of control
Group or individualinformation sessions
PT5 Sharing information Women are able to harvestresources to support coping184
from their health-care provider370
or from other group members
Social exchangetheory
Group orinformation sessions
Symbolic
PT6 Feeling normal Women come to realise thattheir experience is notuncommon and that otherwomen come through it364369
Social norms Group sessionsor individualinteraction withpeer or professional
PT7 Dispelling the myth ofthe ideal motherbirthbaby
Women come to realise that thenarratives of the idealmother316371 birth372 and babyare social constructions
Social norms Group sessionsor individualinteraction withpeer or professional
PT8 Making time for self Women discover that it islegitimate to make time forthemselves320371 within ababy-centric situation373
Social norms Group sessionsor individualinteraction withpeer or professional
PT programme theory
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
187
TABLE 53 Mechanisms and underpinning theory for generic group and one-to-one approaches
Mechanism
Underpinningtheory (whenidentified) Group approaches One-to-one approaches
Appraisal support(functionalsupport)
Social exchangetheory374375
Positive even where facilitatorappears unsupportive other groupmembers may compensate
Positive individuals may developrapport and trust with theirnominated contact
Negative individuals may feelinhibited within a group setting
Negative individuals may perceivenominated contact as judgementalor unsympathetic
Emotional support(functionalsupport)
Social exchangetheory374375
Positive even where facilitatorappears unsupportive other groupmembers may compensate
Positive individuals may developrapport and trust with and feelable to confide in their nominatedcontact
Negative individuals may feelinhibited within a group setting
Negative individuals may not beappropriately matched withnominated contact
Informationalsupport (functionalsupport)
Social exchangetheory374375
Positive facilitator may validateinformation quality on behalf of thegroup
Positive health professionalpeersupporter may validate informationquality and provide tailoredinformation
Positive other group members mayask a question of relevance to amore reticent member
Positive individuals may feelcomfortable in asking sensitivequestions
Positive reticent individuals maygrow in confidence to askquestions
Negative health professionalpeersupporter may provideinappropriate unhelpful or factuallyincorrect information
Negative group members mayprovide unfiltered informationleading to incorrect decision orincomplete picture
Negative individuals may leavepersonalised concerns unexpressed
Negative individualspartners mayfeel uncomfortable in askingsensitive questions
Instrumentalsupport (functionalsupport)
Social exchangetheory374375
Positive women may share ideasfor sources of practical aid
Positive facilitator may share ideasfor sources of practical aid
Negative individual women mayexperience increased frustration ifsources are not forthcoming
Negative facilitator may not havefull understanding of practicalrealities
Support-seekingstrategies
Attachmenttheory355
Positive group members accesswidest range of suggestedstrategies
Positive health professionalpeersupporter may be able to tailorsuggested strategies
Negative others in group may havea limited repertoire of strategies toshare
Negative health professionalpeersupporter may have limitedrepertoire of strategies to share
Interpersonalrelationships
Interpersonaltheory354
Positive other group members mayact as buffer or sounding board forrelationship difficulties
Positive health professionalpeersupporter may become confidantfor relationship difficulties
Negative group may have limitedtime to address specific individualrelationship difficulties
Negative individual may feelinhibited from sharing relationshipdifficulties with health professionalpeer supporter
Negative individuals may feelinhibited from sharing relationshipdifficulties with others
RESULTS OF REALIST SYNTHESIS WHAT WORKS FOR WHOM
NIHR Journals Library wwwjournalslibrarynihracuk
188
TABLE 53 Mechanisms and underpinning theory for generic group and one-to-one approaches (continued )
Mechanism
Underpinningtheory (whenidentified) Group approaches One-to-one approaches
Normalisation Normalisingthroughconnectiontheory376
Positive other group members mayaffirm validity of individualrsquos feelingor experience
Positive health professionalpeersupporter may validate individualrsquosfeeling or experience based onprevious caseload or professionalknowledge
Positive facilitator may validateindividualrsquos feeling or experiencebased on previous caseload orprofessional knowledge
Negative health professionalpeersupporter may communicatefrequently experiencedphenomenon as routine andappear to minimise individualrsquospersonalised experience
Negative others in group may nothave experienced same feeling orevent Individual may feel strangeor isolated
Negative health professionalpeersupporter may perpetuateunrealistic expectations
Negative others in group mayperpetuate or amplify unrealisticexpectations
Coping Coping theory359 Positive individual is exposed todifferent models of coping and canselect resources appropriately
Positive health professionalpeersupporter may identify mostappropriate coping resources tomatch to individual
Negative individual may comparethemselves unfavourably to othergroup members
Negative health professionalpeersupporter may privilege their ownpreferred strategies
Self-efficacy Self-efficacytheory377
Positive group members may helpto normalise rationalisations fortheir symptoms
Positive care provider may help tonormalise rationalisations for theirsymptoms
Negative group members mayaffirm belief that PND isunpreventableuntreatable
Negative care provider may affirmbelief that PND is unpreventableuntreatable
Continuity of care Not identified Positive group facilitation andmembership may be relativelystable
Positive individual receivescoherent and cohesive care from asole provider
Negative group facilitation andmembership may be inconsistent
Negative individual may becomeoverly dependent upon soleprovider
Modellingbehaviours
Social learningtheory360
Positive other group members maybe appropriate and realistic rolemodels
Positive individuals may rehearseappropriate behaviours in a safeenvironment
Negative group may promoteunhelpful norms thatcounterbalance positive behaviours
Negative individual may notperceive health professionalpeersupporter as appropriate or realisticrole model
Preparing forparenting
Not identified Positive facilitator and other groupmembers may contribute to realisticexpectations
Positive health professionalpeersupporter may help to activelymanage expectations
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
189
The social cognitive theory of depression proposes that lsquowomen for whom motherhood is a highly valuedrole may be particularly vulnerable to depression if events or difficulties threaten this rolersquo378 Interventionsthat address this theory therefore seek to equip the woman with self-efficacy so that she is better able tomanage such events or difficulties or has multiple strategies by which she might attempt to address themIncreased self-efficacy may be seen in the management of her own symptoms or more generally in beingable to cope with the practical aspects of motherhood that might otherwise be viewed as difficult orproblematic A further aspect to this theory is the modification of the womanrsquos understanding of themotherhood role so that she is less likely to fall victim to unrealistic expectations of either herself orof others
The social support theory of depression is underpinned by social exchange theory Social support has beenfound to facilitate the adaptation to and transition to motherhood and facilitates the flow of emotionalconcern instrumental aid information and appraisal between people including partners and mothersInterventions that address this theory therefore seek to reduce the psychological stress of the transition tomotherhood379 Strategies include the building up of social support networks prior to the birth and beingbetter able to mobilise such support when needed Group-based interventions may serve to extend socialsupport again in preparation for the birth or as a resource to be accessed after childbirth Social exchangetheory requires a structure through which an interactive process might occur and preventive strategies mayhelp in both the identification of and mobilisation of such structures for interaction378
The idea of the locus of control that is lsquowhether a person perceives what happens to her as being withinher own control or in the hands of external forcesrsquo380 is believed to be an important aspect ofpsychological functioning Clearly this is closely linked with self-efficacy as discussed above Howeversome commentators caution380 that in a childbirth context this may not necessarily translate into greaterinvolvement in decision-making as for some women such involvement may actually increase feelings ofanxiety Interventions that engage with the idea of locus of control provide a woman with an opportunityto discuss all aspects of the motherhood experience fully with staff The woman receives the right amountof information that they personally require Receiving the right amount of information both lsquopreloadedrsquo(ie prior to the birth) and subsequently lsquoon demandrsquo reduces their anxiety about aspects of themotherhood experience and increases their satisfaction with aspects of the birth experience Againthe mechanism of modifying expectations to make them more realistic is present in such interventions
TABLE 53 Mechanisms and underpinning theory for generic group and one-to-one approaches (continued )
Mechanism
Underpinningtheory (whenidentified) Group approaches One-to-one approaches
Negative facilitator and othergroup members may focus onlabour rather than parenthood
Negative health professionalpeersupporter may base advice solelyon their own experience
Negative health professionalpeersupporter may focus on labourrather than parenthood
Targetingdepressivesymptoms
Vulnerability-stress theory358
Positive even though not everyindividual experiences everysymptom there is an increasedlikelihood that at least one memberexperiences a symptom
Positive health professionalpeersupporter may be able to tailorsupportadvice to specific needs ofindividual
Targeting anxietysymptoms
Vulnerability-stress theory358
Positive not every individualexperiences every symptom butthere is an increased likelihood thatat least one member experiences asymptom
Positive health professionalpeersupporter may be able to tailorsupportadvice to specific needs ofindividual
RESULTS OF REALIST SYNTHESIS WHAT WORKS FOR WHOM
NIHR Journals Library wwwjournalslibrarynihracuk
190
The empowerment model of prevention of depression is based on the assumption that women are likelyto experience negative partner support and therefore need information and coping resources by which tohandle this Interventions that address this theory therefore seek to provide information to help womento identify particular strategies that may be helpful to them Community resources are identified fromwhich women may draw as appropriate Empowerment approaches often allow an individualised focus foran intervention so that support can focus on areas of particular need for each woman
The attachment theory of depression proposes that postpartum depression develops when a motherrsquosattachment needs are not being satisfied by her partner whom she feels is irresponsive or inaccessible toher381 Although attachment theory originally focused on the importance developing a strong emotionalbond between an infant and their mother more recently this has been extended to include adultrelationships such as the partner and the mother or mother-in-law Attachment provides a useful resourceduring times of uncertainty such as characterise the anxiety-filled birth and postnatal periods Attachmenttheory attempts to explain why some women seek to be close to their partner or significant othersbut fear being rejected by them and why others seek to avoid closeness Interventions that address theattachment theory seek to develop attachment typically with the partner so that social support may bereadily accessed as and when required They seek to develop mechanisms by which need for support maybe communicated and recognised
This discussion demonstrates that these theories are not distinct but frequently operate in close proximityCollectively they explain many intervention components for individual-based and group-centredapproaches Other interventions derive their imperative not from an explicit theoretical basis but frompolitical or social drivers such as the agendas of the UK government264 or of the World HealthOrganization148 For a fuller discussion of principal theories underpinning strategies for treatment and byimplication prevention see the useful summary by Beck381
Development of a programme theory
A key issue in developing a programme theory with regard to two different modes of delivery that isgroup-based (one-to-many) and individual-based (one-to-one) approaches relates to whether they offercompeting alternatives to meet the same needs or they seek to address different sets of needs The tables ofcomponents (see Appendix 7) assist in identification of important mechanisms that are common to bothapproaches those that can substitute for each other or those that are unique to one of the two approaches
Group-based interventionsIn the case of the group under a lsquoresource-based modelrsquo (ie the idea that a group is identifyingsharing and subsequently using its collective emotional and experiential resources) members of a groupmay provide aspects of information experience or support beyond the resources of a singlefacilitator302312313321 However this relies on the existence of mechanisms for releasing the resources foruse by the whole group There is evidence of facilitators being aware of resources or experience within agroup that the individuals themselves felt unable or unwilling to share293 Consequently the facilitators feltpowerless to offer such experiences without the approval of the individual themselves Use of group-basedmechanisms places additional requirements for group coherence382 the development of trust with a largernumber of individuals and the existence of ground rules that minimise the chance of harmfulgroup behaviours
Continuity of careContinuity of care may be present through the ongoing participation of one or more group co-ordinatorsThe CenteringPregnancy programme identifies lsquostability of group leadershiprsquo as an lsquoessential elementrsquo ofthe approach383 Continuity is also sought within team midwifery-based support approaches224 but thatdoes not necessarily translate into the personalised and tailored care required for the building ofconfidence trust and satisfaction with care If a facilitator does not function well with or relate well
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
191
personally to several or indeed all of the group then this may potentially cause more harm than aproblematic one-to-one approach However this may be partially compensated for through a form ofsubstitution by good relationships within the group
Individual-centred interventionsWith regard to individual interventions it is perhaps unhelpful to focus on the lsquoindividualrsquo part as theintervention (in contrast to the acknowledged effect of the lsquogrouprsquo) The individual approach offerspotential benefits that may or may not be realised For example under a resource-based model aparticular supporter whether professional or lay may not have experience to draw upon and mobilise forthe benefit of the individual Continuity of care a claimed advantage of individual-based interventionsmay not be realised if staff changes or team processes interfere with this This may explain why Denniset al384 found a non-significant effect for continuity of care in their systematic review There may not bea rapport between supporter and woman If an individual relationship is not built up then trust andrelationships are impaired Other benefits such as sharing of confidential personalised information arenot realised Dennis et al384 refer to this in the specific context of revealing PND to a health professionalHowever this may be equally important in prevention when seeking to broach the subject of potentialsymptoms or causative factors385 It is helpful to highlight the personalised targeted nature of theindividual-based approaches not the fact of the individual relationship per se
Considerations shared by group-based and individual-centred interventionsThe analysis has revealed the shared importance of three preparatory stages in the intervention Principallythese concern (1) recruitment whether of health professionals or of lay supporters (2) training againirrespective of whether professionals or lay supporters and (3) the process of targeting or matching theneeds of those requiring support to those delivering support In addition mechanisms for sustainabilitywithin a programme also surface as being important considerations
RecruitmentRecruitment is a key intervention in relation to lay support Lay supporters are typically volunteers and areoften motivated by a desire to help or to give something back301
TrainingClinical staff must make a considerable investment of time to supplement their clinical expertise withfacilitation counselling or support skills Midwives to create a favourable impression within aCenteringPregnancy intervention have to be sufficiently skilled knowledgeable and warm to providesuggestions for group discussion and to allow unstructured discussion all of which were appreciated by groupmembers277 The intervention by Morrell287 compared training for health visitors in assessment and two differentmethods of psychological support Deficiencies in delivery of care sometimes imply a need for further training
For lay supporters the potential training burden is substantial For example it may include experientialtraining such as role-playing and supervision information on peer support strategies and topic-specificinformation about PND and medications as well as organisations or further sources to which they couldrefer386 Dennis386 describes the use of a 121-page training manual
MatchingBehavioural interventions require creation of a rapport between service provider and recipients of careThose delivering group interventions must be viewed as accessible and welcoming by members of thegroup Indeed effective facilitation requires that the facilitator progressively suppresses his or her own roleso that the group becomes functional with minimum and judicious input In the individual telephonecounselling intervention participants were matched with peer volunteers lsquoif the mother desiredrsquo205
However this so-called matching was based on residency and ethnicity and was performed by theco-ordinator The Newpin Intervention saw young befrienders being matched with younger parents206387
However demographic lsquomatchingrsquo may not be sufficient and numerous other variables could beconsidered when seeking to establish compatibility
RESULTS OF REALIST SYNTHESIS WHAT WORKS FOR WHOM
NIHR Journals Library wwwjournalslibrarynihracuk
192
Support to providersA further ongoing requirement for both approaches is supervision of or at least support to thosedelivering support (whether professionals or lay supporters) This is particularly the case for formalpsychological approaches such as IPT which often require supervision as a component of interventiondelivery The availability of such support may have a subsequent effect on retention of the facilitatorssupporters the sustainability of the overall programme and indeed on further recruitment
Another consideration for both group and individual approaches that is not determined exclusively by typeof intervention delivery relates to the convenience of the intervention sessions Delivery of sessions at homeor over the telephone and integration with routine health-care visits may help to increase the acceptabilityand feasibility of intervention delivery as well as adherence327388 Hybrid models may seek to optimise thepattern of home visits and regular visits to a health-care provider Opportunities for improved co-ordinationare offered by using such visits to give advice on nutrition child health child development programmespositive parenting programmes vaccination programmes routine childbirth education sessions andcommunity health programmes389 Group interventions can seek to achieve improved acceptability andfeasibility by being offered in conjunction with individual health-care appointments as in theCenteringPregnancy model
Components of the interventionsSeveral features recurred frequently in the qualitative syntheses of interventions and of personal and socialstrategies as either actual or suggested components for the intervention irrespective of the chosenmethod of delivery In some cases the feature is implicit within suggestions of what might have helpedFor example the value of family support or of instrumental support translates into a requirement forintervention content that both affirms the validity of help-seeking and provides practical strategiesfor eliciting such support A useful intervention when time and resources permit includes the following
l make provision for continuity of carel legitimise help-seeking without framing this as an inability to copel offer strategies for identifying supportl equip women to delegate tasks without surrendering mother rolel offer strategies for eliciting emotional spiritual and instrumental supportl identify coping strategies to allow self-helpl help women to access information as and when requiredl feel able to share feelings and experiences without experiencing premature closurel facilitate normalisation of feelingsl create realistic expectations about the birthl create realistic expectations about motherhood rolesl create realistic expectations about health professional support and roles and health servicesl challenge social norms of the ideal birth the ideal baby or the ideal motherl anticipate baby-centric focus of family and health professionalsl identify strategies for acknowledging and meeting motherrsquos own needsl prepare women for emotional labilityl anticipate fatigue pain and slow recovery from labourl help women adjust their routines to motherhoodl widen focus beyond delivery and birthl gain strengthjoy from babyl develop attachment with infantl acquire practical skills (breastfeeding changing nappies bottle feeding bathing)l understand appropriate use of medication alternative medicine and counselling servicesl acknowledge and build upon cultural variationl adjust to cultural barriers regarding communication or provision of support
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
193
SustainabilityA further key consideration relates to the sustainability of the intervention or programme Unlike otherself-management or peer support programmes primarily within the domain of chronic diseases pregnancyis a time-limited condition with definable antenatal and postnatal periods Sustainability cannot be offeredby continuity of group membership Sustainability may be offered by structural components for examplea common venue or ongoing facilitators or by process elements such as training manuals and programmesor a standard curriculum There is some evidence within the reviewed studies of a cohort approach whichseeks to engage a group of mothers to be at a common point and then take them together through theantenatal birth and postnatal period Certainly group membership seems less of an issue under a cohortmodel than with an escalator model in which mothers can enter or exit at any point in the programmeHowever the cohort model is in turn predicated upon having sufficient critical mass of women atapproximately the same point in their pregnancy for the group to be viable Here considerations of optimalgroup size need to be considered against what is feasible and practicable
Recruitment of the next generation of peer supporters could in theory be achieved from within eachcohort although timing is an issue as a recent mother adjusting to such a significant life event does notcorrespond to the typical model of one likely to volunteer Therefore some mechanism for medium-termfollow-up may be needed to keep in touch with potential future peer supporters
Construction of pathways or chains from lsquoifndashthenrsquo statements
The subsequent stage to production of lsquoifndashthenrsquo statements is to seek to integrate these into causalpathways or chains
Mechanisms for improving appropriateness of strategiesFigures 57 and 58 present schema demonstrating the way in which lsquoifndashthenrsquo statements might illuminateparticular paths or dependencies290
These representations illustrate that a key point in the delivery of interventions whether group orindividual based is the establishment of a relationship with a care provider whether professional or a layhelper Matching of care provider to women whether individually or collectively becomes a key factor inthe success of such interventions Building up such a relationship allows the establishment of trust whichthen allows open and frank information exchange285 When such communication is present it leads inturn to a better understanding of the needs of the expectant mother The establishing of relationshipsexplains at least in part why continuity of care283 figures prominently in discussions of the requirementsfor good-quality antenatal care
Trust
Confidingin care
provider
Identificationof personalised
strategiesby provider
Continuityof care
Relationshipwith careprovider
FIGURE 57 The ways in which lsquoif-thenrsquo statements might illuminate pathways for individual approachesData source McNeil et al 2013290
RESULTS OF REALIST SYNTHESIS WHAT WORKS FOR WHOM
NIHR Journals Library wwwjournalslibrarynihracuk
194
In group-based interventions the requirement for a successful relationship is further compoundedRelationships need to be built up between mother and care provider and between mother and othersin the group283289 However this element of lsquoriskrsquo to the functioning of the group may potentially becompensated for by the likelihood that support for the group may compensate for inadequacies in thefacilitation and also that the group has more resources in terms of experience to share and a lsquolike mindrsquo390
to offer in support of each individual mother When support is being provided by care provider andor bywomen in a group this may take away some of the pressure on the relationship with fathers or significantothers (such as in-laws)
That women need to build up relationships in order for the intervention to work is seen in the experiencethat groups may initially struggle285 Subsequently they typically weather initial periods of individual anxiety
On adverse effectsSome women do not welcome the group approach and so in quantitative terms are lost to trials prior torandomisation Similarly most of the qualitative studies recruited women who had agreed to participate ina group-based approach This represents an important area of potential methodological bias Likewiseparticipation tends to be described in very forgiving terms for example in the number of women attendingone or more sessions Theoretically this means that the women are likely to be being delivered a suboptimallsquodosersquo of care In practical terms there is the possibility that health provider resources are not used effectivelyor women may be unable to access groups because available slots are occupied by non-attenders In additionthere was some evidence that discomfort experienced by partners over the nature of discussions may havecaused them to disengage with a subsequent perception of lack of support from the viewpoint of the womenthemselves283 A further complication relates to the potential inclusion of fathers Fathers may experiencedifficulty in contributing to the group277 either because of their own shyness or because women felt that menwere uncomfortable with intimate discussions283 Alternatively women may feel reticent in bringing uptopics when in a mixed group that includes fathers If women themselves fail to maintain an adequateattendance level and thus experience a consequent lack of group support they may perceive an inability toimplement strategies that they have learned286
Communication with a care provider andor with a group should not be viewed simply in positive termsGroups or care providers may albeit unwittingly create expectations that become difficult or impossiblefor an individual mother to fulfil371 A failure to meet either perceived or actual norms may contributeto a feeling of inadequacy Social comparison may also be unfavourable if others in the group are handlingchallenging situations with more ease even if this reflects individual proficiency rather than the benchmarklevel for the group as a whole There was some evidence that established group members would takesignificant steps to avoid upsetting other group members by creating expectations (eg in their supportrelationships material circumstances or the pregnancy experience) that they might be unable subsequentlyto fulfil293
Diversityof group
Relationshipwith careprovider
Trust
Sharing ofpersonalstrategies
(provider andgroup)
Self-identificationof personalised
strategies
Relationshipwith group
FIGURE 58 The ways in which lsquoif-thenrsquo statements might illuminate pathways for group approaches
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
195
Although much is made of the benefits of bringing together women who are facing the commonchallenges associated with pregnancy labour and childbirth it should be recognised that this is notwithout risk Given the recognised susceptibility of these women to emotional feelings it can be seen tobe potentially volatile to bring together women when the response of another might well attenuatethe emotional effect A further consideration within a group context is that a lack of privacy during theintervention may result in a mother feeling that her individual care has been sacrificed to the requirementsof the group The very structured CenteringPregnancy protocol also poses specific logistic problems ifwomen perceive that the format of the sessions is not ideal with a 2-hour session being too long289 orthere being too long a period of time between first and second group meetings277
A shared concern for both individual- and group-based approaches relates to the fact that any type ofservice provision raises expectations from the service If these expectations are subsequently unrealisedthen this can be an additional source of frustration to women who already feel unsupported Improvedaccess to a caregiver through a targeted intervention may subsequently raise expectations that might notbe met either in individual follow-up care from the provider or by front-desk support staff in theirinteractions with mothers283 Qualitative research revealed specific logistic concerns related to the fact thatthe choreographed and structured nature of group sessions may induce a feeling of being rushed by ahealth professional during the intervention Specifically within a military setting CenteringPregnancy wasseen to neglect consideration of the associated workload and resource constraints So although theCenteringPregnancy Intervention appears to be generally well received constraint of available resourcescould have a disproportionate that is non-symmetrical effect if service providers are seen to be scrimpingand saving on costs of care Women may therefore feel that their care is not perceived as a priority
Other considerations relate to specific facilitation difficulties in which a health professional is perceived asbeing too controlling or not suitably facilitative in engaging with the wishes of the group A tensionbetween encouraging women to bring their family in some cases when this facilitates their access andattendance but acknowledging the disruption this may pose in other instances can lead to the perceptionthat the service is not family centred and that older children are not welcome
Testing of the programme theory and integrating quantitativeand qualitative findings
Having identified hypothesised components for successful inclusion in an intervention or programmeenabled us to re-examine their presence or absence in the featured interventions Although this approachis necessarily limited by the quality of reporting of each intervention this effect was minimised by using allavailable published reports of each intervention not solely the primary trial report It was assumed thatthe emphasis of the reporting would largely reflect the corresponding emphasis of particular featureswithin an intervention That is if a feature is mentioned it is more likely to be considered important to aninterventionrsquos mechanisms of action whereas if a feature is unclear or omitted particularly given word limitconstraints it is correspondingly unlikely to be considered a key feature although not necessarily absentA further limitation relates to the limited ability of an approach based on reporting to establish whethera feature was deliberately planned in the conception of an intervention or was implemented fortuitously oropportunistically Nevertheless its presence would indicate that it is feasible both as a feature of theexisting intervention and as part of any planned enhancement
RESULTS OF REALIST SYNTHESIS WHAT WORKS FOR WHOM
NIHR Journals Library wwwjournalslibrarynihracuk
196
Finally consideration of desired qualitative features alone is not sufficient for exploration of the candidateinterventions At some point these features must be correlated with data on the effectiveness of eachintervention Table 54 makes an initial link between the presence or absence of reported features and anoverall assessment of effectiveness However it is important to recognise that this simply represents acorrelation and cannot be considered evidence of a cause and effect relationship
Response from the service user group to optimal characteristicsidentified from the qualitativerealist reviews
Consultation with the PPI group revealed that many characteristics listed resonated with group membersrsquoown experience and feelings One informant commented that they felt that lsquothe list was meaningful andshows good insight into the pregnancy experience and early motherhoodrsquo while another stated that lsquoitcaptures the main concernsrsquo and a third agreed that it was meaningful They did identify that the wordingof the list would need careful attention if it is to be translated into use with women themselves asopposed to health professionals
Modifications to the listOne informant endorsed the need to equip woman to delegate tasks without surrendering the motherrole She made an implicit connection with challenging the concept of the lsquoideal motherrsquo in stressing towomen that lsquohelp with mothering could be necessary and to avoid making this shameful or neglectfulrsquoMembers of the PPI group offered specific observations on the timing of some of the suggested strategiesPractical skills (such as breastfeeding changing nappies bottle feeding bathing) were considered lsquoveryimportant skills that need to be acknowledged before the birthrsquo It was felt that these should beemphasised because as also revealed by the literature reviews lsquotoo much focus is on the birthrsquo It was alsoimportant that womenrsquos own needs be acknowledged before the birth
I would add also to tell mothers to look after themselves before and after the birth by doing one thinga day they enjoy five minutes of filing nails eating something they really enjoy and simple everydaypleasures which are achievable
PPI group member
Finally information on PND needs to be available from the start for example at antenatal classes
Additions to the listIn addition members of the PPI group volunteered observations that triangulated with findings identifiedelsewhere in the review processes In particular the involvement of and role of partners was essentialwith a need to educate partners regarding symptoms and a requirement to lsquokeep them involved and tohelp them understand what is going onrsquo Comments resonated with the strategies offered by IPT namelylsquoto avoid potential possible relationship difficultiesbreakdown which obviously wouldnrsquot be helpful to thewomen with PNDrsquo The importance of attachment extends beyond the mother and baby requiring thatpartners enjoy lsquosome level of involvement to encourage the later bonding process with baby ndash or it couldbecome very much just the womanrsquos experiencersquo
Other findings from the review reflected by participant responses included the importance of the need tolegitimise help-seeking without framing this as an inability to cope given that women may lsquofear theirchildren may be taken away from them if they open up as to how they are feelingrsquo The key role ofcontinuity of care was affirmed particularly in the context of the caregiver being able to identify changesin the woman and therefore offer personalised strategies for eliciting emotional spiritual and instrumental(ie practical) support
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
197
TABLE 54 Matrix indicating presence or absence of reported features with overall assessment of effectiveness
Element from qualitativefindings Two-step CenteringPregnancy
Midwife-ledbrief counselling
Midwife-managed care
Mid-routineprimary care
Continuity of care ndash ndash
Legitimise help-seeking ndash ndash ndash ndash
Identify support ndash ndash ndash
Delegate without surrender ndash ndash ndash ndash ndash
Strategies for elicitingsupport
ndash ndash
Coping strategies ndash ndash ndash ndash ndash
Access information asrequired
ndash ndash
Able to share feelingswithout experiencingpremature closure
ndash ndash ndash ndash ndash
Normalisation of feelings ndash ndash ndash ndash
Realistic expectations aboutbirth
ndash ndash ndash ndash ndash
Realistic expectations aboutmotherhood roles
ndash ndash ndash ndash ndash
Realistic expectations ofprofessionals and healthservices
ndash ndash ndash
Challenge lsquoidealrsquo ndash ndash ndash ndash ndash
Anticipate baby-centricfocus
ndash ndash ndash ndash ndash
Acknowledge motherrsquosown needs
ndash ndash ndash ndash
Acknowledge emotionallability
ndash ndash ndash ndash ndash
Anticipate fatigue painand recovery from labour
ndash ndash ndash ndash
Adjust routines ndash ndash ndash ndash
Focus beyond delivery andbirth
ndash ndash ndash ndash ndash
Gain strengthjoy frombaby
ndash ndash ndash ndash ndash
Develop attachment withinfant
ndash ndash ndash ndash ndash
Acquire practical skills ndash ndash ndash ndash
Use of medicationalternative medicine andcounselling
ndash ndash ndash ndash ndash
Cultural variation ndash ndash ndash ndash ndash
Cultural barriers regardingcommunication or support
ndash ndash ndash ndash ndash
RESULTS OF REALIST SYNTHESIS WHAT WORKS FOR WHOM
NIHR Journals Library wwwjournalslibrarynihracuk
198
PoNDER Home based IPT phone IPT Rose IPT-brief Telephone support Newpin Thinking Healthy
ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash
ndash ndash ndash
ndash ndash ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash
ndash ndash ndash
ndash ndash
ndash ndash ndash ndash
ndash ndash ndash
ndash ndash ndash ndash ndash ndash ndash
ndash ndash
ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash ndash ndash ndash ndash
ndash ndash ndash
ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash ndash ndash ndash ndash
ndash ndash ndash ndash ndash
ndash ndash ndash ndash ndash ndash
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
199
Other important features felt to help avoid PND included
l being informed about and prepared for the risks of reccurrence with subsequent pregnanciesl having a supportive GPl not being put under pressure to breast feed if a woman feels uncomfortable doing sol providing access to other new mums for example groups
An observation not identified in the literature related to lsquohelp with identifying babyrsquos criesrsquo A womandescribed how she lsquofelt anxious and found it hard to trust and to connect with [her] babyrsquo She suggestedthat help in interpreting babyrsquos cries might be based on the work of an Australian musician who haslsquoobserved babiesrsquo cries and discovered how we can interpret them before they become fully fledgedit is called Dunstanrsquos baby language391
Additional nuances emerging from the consultationOne informant while recognising that the strategies listed were important highlighted practical difficultiesin implementing the strategies For example triggering asking for help may prove problematic becauselsquowhat a woman experiences is ldquonormalrdquo for her and therefore she might not know that she is depressedand therefore not ask for helprsquo Similarly equipping a woman with strategies for identifying support is alsodependent on a woman herself recognising that she needs support
Delegation of tasks will not always be possible if a woman has no one to help her or if a partner is of nohelp and only increases her anxiety Individual ability to lsquomanage everything themselvesrsquo varies fromwoman to woman and this needs to be recognised by health-care providers Other comments alsohighlighted the individualised nature of response to help advice and support
Anything that is said to an anxious or depressed woman can have a negative effect but also a positiveeffect Her ability to cope must not be doubted I think professionals need to be very aware
Summary of findings from realist synthesis review
When planning a group-based intervention an intervention is
l more likely to succeed if a facilitator has been trained in group leadership and facilitationl more likely to succeed if a facilitator has personal resources that they can bring to the groupl more likely to succeed if a facilitator creates a rapport with the groupl more likely to succeed if the group creates a favourable group dynamicl less likely to succeed if the facilitator is seen as controlling or not responding to the wishes of
the group
When planning a one-to-one peer-based intervention an intervention is more likely to succeed
l if a peer has been matched on other than simple demographic variablesl when peers are recruited based on extroversion and good communication skills
When planning a one-to-one professional mediated intervention an intervention is more likely tosucceed if
l a relationship of trust is built up between the woman and the care providerl the health-care provider has significant personal resources on which to draw
A face-to-face intervention is more likely to be successful if a health-care provider responds to visual verbaland non-verbal cues that reflect how a woman is feeling
RESULTS OF REALIST SYNTHESIS WHAT WORKS FOR WHOM
NIHR Journals Library wwwjournalslibrarynihracuk
200
An intervention delivered at a distance is more likely to be successful if a supporter makes more contactshas more conversations and leaves messages
Training interventions for health professionals or peer supporters are more likely to be successful if they
l include problem-solving strategies such as role playl include demonstrations of practical skills that can subsequently be modelled with individuals and
groups of womenl are relevant to the community as they equip health professionals or peer supporters with appropriate
skills to deal with the range of people who receive services within a multicultural society
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
201
Chapter 9 Assessment of cost-effectiveness
Systematic review of existing cost-effectiveness models
Identification of cost-effectiveness studiesA comprehensive search was undertaken to identify systematically cost-effectiveness literature comparingthe costs of different interventions to prevent PND The search used a combination of thesaurus andfree-text terms The search comprised four facets combined together Facet 1 comprised terms for thepopulation (pregnant and postnatal women) Facet 2 comprised terms for prevention Facet 3 comprisedterms for known risk factors of PND Facet 4 was generic terms for interventions To retrievecost-effectiveness literature the four facets of the searches were combined with an economic evaluationssearch filters The searches were performed by an information specialist (AC) in November and December2012 The search strategy is reported in Appendix 1 The economic evaluations filter for MEDLINE isprovided in Appendix 1 Search strategy used for cost-effectiveness studies with economic evaluations filterfor MEDLINE The list of electronic bibliographic databases searched for cost-effectiveness literature ispresented in Appendix 1 Electronic databases searched for the cost-effectiveness literature All citationswere imported into Reference Manager version 12 and duplicates deleted The Preferred Reporting Itemsfor Systematic Reviews and Meta-Analyses (PRISMA) flow chart for the studies included in the healtheconomics review is presented in Figure 59
Potentially relevant papersscreened and identified
for retrieval(n = 2420)
Studies excluded at title andabstract sift (n = 2401)
Studies excluded at full paper sift
(n = 4)
Studies excluded abstract only (n = 5)
Total studies screened (n = 19)
Total full papers screened (n = 14)
Additional papers (n = 3)
Total included full papers (n = 13)nine economic evaluations
alongside trials three decisionmodel and one cost study
FIGURE 59 The PRISMA flow chart of studies included in the health economics review
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
203
Study selection criteria and procedures for the health economics reviewPapers were eligible for inclusion if they included costs or health-related quality-of-life measurements ofPND that could be used in an economic decision model As only a limited number of studies addressingprevention only were found the inclusion criteria were kept broad to include papers evaluating screeningfor and treatment of PND as well as prevention of PND in order to minimise the risk of potentially usefuldata being excluded When multiple papers of the same studies were published the most detailed or mostrecent (as appropriate) were selected as recorded in Table 55
There were 2420 papers were identified in the search The reasons for exclusion at the full paper stageare shown in Table 55 There were two studies for which multiple papers for the same study werefound4557392393 and in both cases the more detailed paper was selected45392 An additional paper that waspublished after the search was completed was identified by a member of the project team who was anauthor on the paper and the paper was included396 It was not identified in a systematic way and otherpapers that were published after the search was conducted will have been missed A second paper wasidentified by a member of the project team during the search for quantitative studies and was included inthis health economic review56 This paper had been excluded at the title and abstract stage on the basis ofthe paper title A further paper was identified during the economic modelling process397 It had beenexcluded at the title and abstract stage as PND or associated terms were not included in the title orabstract Of the 13 papers identified61174199264392ndash394398ndash400 nine described an economic evaluation thatwas conducted alongside a trial5361174199264299392393400 three papers described an economic decisionmodel4556394 and one paper described a cost study398
Overview of papers included in the health economics reviewAlthough all included papers described an economic evaluation of a PND intervention they wereheterogeneous in many aspects including the population intervention comparator and outcomesevaluated The nine economic evaluations5361174199264299392393400 and the one cost study398 are described inTable 56 and the three economic decision models4556392 are described in Table 57
Population considered in the health economics reviewThe population under consideration differed between studies Two of the studies evaluating treatmentinterventions included only women diagnosed with PND392399 The other two studies that evaluatiedthe incremental cost of PND included women regarded as having PND400 and women at risk of PND51
In the Dagher et al400 study women were regarded as having PND if they scored 13 or more on the EPDSat 5 weeks postpartum The Petrou et al174 study included high-risk women identified antenatally at26ndash28 weeksrsquo gestation using the Cooper predictive index401 including both psychological and social riskfactors Women were diagnosed with PND using the Structured Clinical Interview for the Diagnostic andStatistical Manual of Mental Disorders-Third Edition Revised diagnoses at 8 weeks 18 weeks 12 monthsand 18 months postpartum The population in the screening papers4556 was all postnatal women Forthe papers broadly evaluating the prevention of PND the population differed with some studies includingall postnatal women61199264397 and three studies evaluating women who had been identified as atincreased risk of developing PND61174396
TABLE 55 Reasons for exclusion of full papers in the health economics review
First author year reference number Reason for exclusion
Stevenson 2010392 Two papers on same study392393 the more detailed paper was selected392
Paulden 200957 Two papers on same study4557 the more detailed paper was selected45
Buist 2002394 Non-economic evaluation neither costs nor health-related quality of lifereported
Darcy 2011395 Non-economic evaluation neither costs nor relevant health-related quality oflife reported
ASSESSMENT OF COST-EFFECTIVENESS
NIHR Journals Library wwwjournalslibrarynihracuk
204
TABLE
56Economic
evaluationsan
dtheco
ststudyincluded
inthehea
ltheconomicsreview
Study(first
authorye
ar
reference
number)
Country
Interven
tion
Population
Sample
size
Outcomes
mea
sured
Maineconomic
outcomereported
Quality-of-life
mea
sure
Timehorizo
nResult
App
leby20
0339
8En
glan
dHealth
visitors
giving
cogn
itivendashbe
haviou
ral
coun
selling
Allpo
stna
tal
wom
en97
health
visitors
Num
berof
health
visitorcontacts
per
depressedwom
anprean
dpo
sttraining
cost
ofhe
alth
visitor
timeprean
dpo
sttraining
Cha
ngein
health
visitorcosts
ndash6mon
ths
Ano
n-sign
ificant
decrease
inmean
costsoccurred
overall
Boath
2003
399
Englan
dPN
Dtreatm
entin
aspecialised
PBDU
compa
redwith
routineprim
arycare
Wom
enwith
PND
60wom
en(30in
theinterven
tion
and30
inthe
controlg
roup
)
Meancostsfor
wom
enusingPB
DU
androutineprim
ary
carenu
mbe
rof
wom
ende
pressed
at6mon
ths
Increm
entalcost
persuccessfully
treatedwom
an
ndash6mon
ths
Amovefrom
routine
prim
arycare
toPB
DU
wou
ldincuran
additio
nalcostof
pound194
5pe
rsuccessfullytreated
wom
en
Dag
her20
1240
0USA
ndashEm
ployed
postna
talw
omen
31de
pressed
607
non-de
pressed
Totalh
ealth
-care
resourcesused
at11
weeks
Differen
cein
health-care
resourcesused
SF-12
11weeks
Themeantotalcost
forhe
alth-care
resourcesused
was
US$
681high
erin
the
depressedgrou
pthan
intheno
n-de
pressed
grou
p
Duk
hovny
2013
396
Can
ada
Volun
teer
teleph
one-ba
sedpe
ersupp
ortcompa
red
with
usua
lcarefor
thepreven
tion
ofPN
D
High-riskwom
en(screene
dpo
stna
tally)
610wom
en(296
intheinterven
tion
and31
4in
the
controlg
roup
)
Cases
ofPN
Daverted
at12
weeks
(EPD
S)
health-service
use
cost
ofinterven
tion
volunteerop
portun
itycosthired
housew
orkchild
care
andpa
rtne
rtim
eof
work
ICER
(per
case
ofPN
Daverted)
ndash12
weeks
AnICER
ofCA$1
000
9pe
rcase
ofPN
Davoide
d continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
205
TABLE
56Economic
evaluationsan
dtheco
ststudyincluded
inthehea
ltheconomicsreview
(continued
)
Study(first
authorye
ar
reference
number)
Country
Interven
tion
Population
Sample
size
Outcomes
mea
sured
Maineconomic
outcomereported
Quality-of-life
mea
sure
Timehorizo
nResult
Gold
2007
397
Australia
Prim
arycare
and
commun
ity-based
interven
tions
toprom
otethehe
alth
ofne
wmothe
rs
Allpo
stna
tal
wom
enin
stud
yareas
16interven
tion
areaseigh
tin
the
interven
tionan
deigh
tin
the
controlg
roup
Costof
the
interven
tionan
dhe
alth-careresource
use
Costpe
rwom
anof
theinterven
tion
andcost
perarea
SF-36(but
value
notrepo
rted
inpa
per)
24mon
ths
Average
cost
per
wom
anof
AU$1
29in
rurala
reas
and
AU$1
72in
urba
nareasNosign
ificant
differen
cesin
health-careresource
usewhe
ninterven
tionareas
compa
redwith
controla
reas
MacArthu
r20
0326
4En
glan
dDesigne
dto
enab
lemidwife
rycare
incommun
itysettings
tobe
tailoredto
wom
enrsquosindividu
alne
edswith
afocus
ontheiden
tification
andman
agem
ent
ofph
ysical
and
psycho
logicalh
ealth
rather
than
onroutineob
servations
Allpo
stna
tal
wom
enin
the
selected
GP
clusters
1042
(485
inthe
controlg
roup
and55
7in
the
interven
tion
grou
p)
Num
beran
ddu
ratio
nof
health-service
use
EPDSscores
Totalh
ealth
-care
resourcesused
Costpe
rcase
ofprob
able
depression
avoide
d
ndash12
mon
ths
Anincrem
entalcost
ofpound7
00pe
rcase
ofprob
able
depression
preven
ted
Morrell
2000
199
Englan
dAdd
ition
alpo
stna
tal
care
bytraine
dcommun
itypo
stna
tal
supp
ortworkers
Postna
talw
omen
623(311
inthe
interven
tiongrou
pan
d31
2in
the
controlg
roup
)
Num
berof
contacts
with
health
services
SF-36
Duk
efunctio
nalsocial
supp
ortscalescores
EPDSscoresothe
rmeasuresof
health
outcom
es
Cha
ngein
health
servicecosts
SF-36
6weekan
d6mon
ths
Nosign
ificant
differen
cesin
NHS
resource
use(excep
tforthesupp
ort
workerservice)
ASSESSMENT OF COST-EFFECTIVENESS
NIHR Journals Library wwwjournalslibrarynihracuk
206
Study(first
authorye
ar
reference
number)
Country
Interven
tion
Population
Sample
size
Outcomes
mea
sured
Maineconomic
outcomereported
Quality-of-life
mea
sure
Timehorizo
nResult
Morrell
2009
61En
glan
dHealth
visitor
psycho
logically
inform
edtraining
interven
tion
At-riskwom
en(screene
dpo
stna
tally)an
dallp
ostnatal
wom
en
At-riskwom
en41
8allw
omen
2659
Costof
health
visitor
training
he
alth
servicecontacts
for
interven
tions
and
controlEPDSscores
Increm
entalcosts
andQALY
sSF-6D
6an
d12
mon
ths
Psycho
logical
approa
ches
dominated
control
grou
pndashlower
mean
cost
andhigh
ermean
QALY
gain
Petrou
20
0617
4En
glan
dAdd
ition
alhe
alth
visitorvisits
At-riskwom
en(screene
dan
tena
tally)
151(74in
interven
tiongrou
pan
d77
incontrol
grou
p)
Num
berof
contacts
with
health
services
leng
thof
PND
Increm
entalcost
permon
thof
PND
avoide
d
ndash18
mon
ths
Increm
entalcostpe
rmon
thof
PND
avoide
dof
pound4310
Petrou
20
0253
Englan
dndash
High-riskwom
en20
6Num
berof
contacts
with
health
services
Increm
entalcostof
treatin
gPN
Dndash
18mon
ths
Meancost
per
wom
enwith
PND
pound241
9meancost
perwom
enwith
out
PNDpound2
027
KeyICER
increm
entalcost-effectiven
essratio
PB
DUpsychiatric
parent
andba
byda
yun
itQALY
qu
ality-adjustedlife-year
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
207
TABLE
57Economic
decisionmodelsincluded
inthehea
ltheconomicsreview
Study(first
authorye
ar
reference
number)
Country
Interven
tion
Population
Costsused
Quality-of-life
mea
sure
Outcomemea
sure
Model
time
horizo
nResults
Hew
itt20
0945
Englan
dScreen
ingforPN
D(EPD
San
dBD
I)Allpo
stna
tal
wom
enCostof
screen
ing
cost
oftreatin
gPN
D
Mod
eratePN
DICER
increm
ental
costsan
dincrem
entalQ
ALY
s
1year
EPDS(cut-offscoreof
6)ICER
pound4110
3pe
rQALY
Th
eICER
for
othe
rstrategies
rang
edfrom
pound2319
5to
pound814
623
Steven
son
2010
392
Englan
dGroup
CBT
for
wom
enwith
PND
Wom
enwith
PND
Costof
grou
pCBT
SF-6D(m
appe
dfrom
EPDS)
Meancost
per
QALY
1year
Meancost
perQALY
ofpound4
646
2(pound36
062
PSA)
Cam
pbell20
0856
New
Zealan
dScreen
ingforPN
D(three-que
stion
questio
nnaire)
Allpo
stna
tal
wom
enCostof
screen
ing
cost
oftreatin
gPN
D
Revickia
ndWoo
dge
neral
depression
values
ICER
increm
ental
costsincrem
ental
QALY
sincrem
ental
PNDcasesde
tected
increm
entalP
ND
casesresolved
1year
ICER
NZ$
3461
per
QALY
NZ$
287pe
rad
ditio
nalcaseof
PNDde
tected
NZ$
400pe
rad
ditio
nal
case
ofPN
Dresolved
KeyICER
increm
entalcost-effectiven
essratio
PSAprob
abilisticsensitivity
analysisQALY
qu
ality-adjustedlife-year
ASSESSMENT OF COST-EFFECTIVENESS
NIHR Journals Library wwwjournalslibrarynihracuk
208
The methods used to identify higher-risk women also varied between studies The Dukhovny et al396 andMorrell et al61 studies both used the EPDS but at different cut-off points (score greater than 9 and scoregreater than 11 respectively) and at different time points (24ndash48 hours after hospital discharge and at6 weeks postnatally respectively) Both the 2002 and the 2006 Petrou et al papers53174 identified womenantenatally at 26ndash28 weeksrsquo gestation using the Cooper predictive index401
Interventions in the health economics reviewOf the 13 included papers
l Six were broadly concerned with the prevention of PND61174199264396397
l Four evaluated different strategies for treating PND53392399400 and of these four two were concernedwith the additional cost of treating PND53400
l Two evaluated screening for PND4556
l One focused on the impact on health visitorsrsquo time before and after they were given training incognitivendashbehavioural counselling398
The health impact of the intervention on PND was measured in 10 of the studies455661174199264392ndash394399 themeasure used differed between studies and included the number of cases of or duration of PND and theEPDS scores The Appleby et al398 study did not report the impact of the intervention on PND as it wasfocused on the impact on health visitors and their time spent per depressed woman The Petrou et al53
study and the Dagher et al400 study did not contain an intervention as they were focused on theincremental cost of treating PND in a high-risk population and among employed women respectively
Health-related quality-of-life data in the health economics reviewSeven of the papers used a measure of health-related quality of life455661199392397400 Five of these papersused a generic measure61199392397400 whereas the other two used a patient-generated utility value4556
Of those that used a generic measure two used the SF-6D61392 two used the SF-36199397 and one usedthe SF-12400 The SF-36 and SF-12 cannot be used in their basic form to estimate quality-adjusted life-year(QALY) values but can be converted into the SF-6D which provides values that can be used to estimateQALY values for use in an economic decision model Only the mean and SD were reported for the SF-12PCS and MCS at 5 postnatal weeks400
The remaining two papers45401 used patient-generated utility values from a study by Revicki and Wood402
in which patients diagnosed with depression valued hypothetical depression-related states using a standardgamble approach From this study402 Hewitt et al45 used the value given for moderate depression andapplied this to women suffering with PND in their decision model In contrast Campbell et al56 usedvalues for severe symptoms mild or moderate symptoms subthreshold symptoms drug and psychologicaltreatment response and response without drug-associated disutility for different health states within theirmodel There are several issues with using the utility values from the Campbell et al56 study First thehealth state valued was a general depression health state and not a specific PND health state Secondthe sample size reported of 70 patients was relatively small and made up of patients suffering withdepression and not specifically PND Third the health-state values were estimated using a patientpopulation although the preferred approach is to use a general population sample to value health states403
The PoNDER trial61 collected SF-6D data using the UK tariff at a baseline of 6 weeks and then at 6 12and 18 months postnatally and these scores were used in the economic evaluation to calculate QALYsThe PoNDER trial61 also collected data on the EPDS at the same time points The paired data on thechange in SF-6D and EPDS scores were used by Stevenson et al392 to map change in EPDS to change inSF-6D which was then used in the decision model392
Comparison between the QALY estimates used in the three papers is not possible because of the way theywere calculated and presented Hewitt et al45 and Campbell et al56 used utility values from the Revicki andWood study402 Hewitt et al45 used values of 063 for women with PND and 086 for women without PND
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
209
and Campbell et al56 used values of 030 for severe symptoms 063 for mild or moderate symptoms 080 forsubthreshold symptoms and response with drug and psychological treatment and 086 for response withoutdrug-associated disutility Whereas Morrell et al61 presented the mean difference in QALY values at 6 monthsfor women in the control and intervention groups Stevenson et al392 presented the mean QALY gain
Costs and health-care resources reported in the health economics reviewAll included studies reported health-service use for interventions evaluating the prevention or treatment ofPND The nine economic evaluations alongside trials and the one cost study all reported costs associatedwith the resource use reported during the trials or study whereas the decision models used estimates fromthe literature and expert opinion Costs were inflated using the hospital and community health servicesindex for studies based in England404 Canadian costs were inflated using the Canadian ConsumerPrice Index health and personal care index405 US costs were inflated using the medical care Consumer PriceIndex406 Australian costs were inflated using the Australian Total Health Price Index407 and the New Zealandcosts were inflated using the average of the US and English indexes The costs used in the economicevaluations identified in the literature review are presented in Table 58
In their economic decision model Hewitt et al45 included costs for screening using the EPDS and BDIbased on 5 minutes of health visitorsrsquo time plus the licence fee for the BDI screening tool The costs oftreatment of PND were based on NICE clinical guidelines for the treatment of PND and were costed usingrelevant NHS reference costs The cost for an undiagnosed woman with depression was estimated as oneadditional GP visit Stevenson et al392 included costs for an intervention group CBT which were based onresource use reported in a RCT and from expert opinion408 Campbell et al56 included the cost of screeningand the cost of treatment based on unit costs of health staff and prescriptions Screening was assumed totake 5 minutes using the EPDS and 3 minutes using the brief three PHQ questions49 A further 30-minuteappointment with a GP was assumed for all women who screened positive Half of the women who wereseverely depressed and did not respond to treatment were assumed to have 1 day of inpatient care inhospital and a further GP appointment Treatment costs were adjusted for non-compliance with 10of the total treatment costs applied to these women
For their economic evaluations alongside trials Petrou et al53 estimated the health-care resources usedfrom delivery to 18 months by the population of high-risk women and differentiated between those whodeveloped PND and those who did not Women diagnosed with PND had higher overall resource usea reported difference of pound392 which inflated at 20123 prices increased to pound601404 Part of the Petrouet al53 2002 sample included women who were taking part in the Petrou et al174 2006 RCT The report of2006 trial174 described resource use for the intervention group additional health visitor visits and thecontrol group routine primary care and not for women who developed PND and those that did notMother and infant costs were included in both studies
A broader perspective was taken in the Dukhovny et al396 study which included both health-care andnon-health-care costs For the intervention the public health cost and the opportunity cost of thevolunteersrsquo time was included Costs for the intervention group and the usual-care group were reportedat 12 weeks These included health-care costs as well as costs for hired housework hired child care andfamilyfriend and partner time off work Mother and infant costs were included
The 2009 Morrell et al61 paper collected health-care resource use for women in their trial Total resourceuse estimates were split into control and intervention groups over periods of 6 and 12 months Theprimary analysis was carried out using the 6-month data which included the costs incurred by the motherA further analysis on the 12-month data was also carried out which included the costs incurred by themother and also the baby The total resource use was further split into an analysis of at-risk women andan analysis of all women and additionally split between the two intervention approaches of CBA and PCAThe study also collected data on the additional training that would be required for health visitors to beable to provide the psychologically informed intervention sessions and estimated that the additionaltraining would increase the health visitorsrsquo cost per hour of client time by pound2 from pound77 to pound79
ASSESSMENT OF COST-EFFECTIVENESS
NIHR Journals Library wwwjournalslibrarynihracuk
210
TABLE 58 Costs used in economic evaluations included in the health economics review
First authoryear referencenumber
Resource userecorded in study
Category ofcost Cost Base year
Inflated cost(201213) Perspective
Appleby 2003398 Health visitor timepre-training
Per woman pound81 1998 pound135 Health-care system(NHS) perspective ndash
health visitor timePer depressedwoman
pound116 pound193
Per treatedwoman
pound107 pound178
Health visitor timepost-training
Per woman pound79 pound132
Per depressedwoman
pound108 pound180
Per treatedwoman
pound109 pound182
Boath 2003399 Mean cost PBDUpatient
PBDU cost pound991 19923 pound1905 Health-care system(NHS) and widersocietal costsperspective ndash
health-care resourceuse Mother andinfant costs included
GP and healthvisitor
pound203 pound390
Secondary care pound0 pound0
Cost to client pound302 pound581
Medication pound44 pound85
Total pound1540 pound2960
Total excludingcost to client
pound1238 pound2380
Mean cost perroutine primarycare patient
PBDU cost pound0 19923 pound0
GP and healthvisitor
pound266 pound511
Secondary care pound309 pound594
Cost to client pound25 pound48
Medication pound32 pound62
Total pound632 pound1215
Total excludingcost to client
pound607 pound1167
Dagher 2012400 Mean cost perwoman with PND
Emergencydepartmentvisits
US$84 2001 US$131 Health-care systemperspective(USA) ndash health-careresource useUnclear if infantcosts included
Inpatienthospital stays
US$607 US$949
Outpatientsurgeries
US$93 US$145
Physicianrsquosofficeurgentcare centrevisits
US$124 US$194
Mental healthcounselling
US$138 US$216
Total US$1046 US$1636
pound984a
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
211
TABLE 58 Costs used in economic evaluations included in the health economics review (continued )
First authoryear referencenumber
Resource userecorded in study
Category ofcost Cost Base year
Inflated cost(201213) Perspective
Mean cost perwoman withoutPND
Emergencydepartmentvisits
US$13 2001 US$20
Inpatienthospital stays
US$80 US$125
Outpatientsurgeries
US$138 US$216
MD officeurgent carecentre visits
US$12 US$189
Mental healthcounselling
US$13 US$20
Total US$365 US$571
pound343a
Dukhovny2013396
Telephone-basedpeer support group
Public healthcosts
CA$667 2011 CA$674 Health-care systemand wider societalcosts perspective(Canada) ndashhealth-care resourceuse and wider costsincluded Motherand infant costsincluded
Volunteeropportunitycosts
CA$126 CA$127
Hiredhousework
CA$234 CA$236
Hired child care CA$194 CA$196
Familyfriendand partnertime of work
CA$2374 CA$2398
Health-careutilisation total
CA$901 CA$910
Nursing visits CA$252 CA$255
Provider visits CA$371 CA$375
Mental healthvisits
CA$43 CA$43
Inpatientadmissions total
CA$227 CA$229
Mother CA$42 CA$42
Infant CA$185 CA$187
Ambulance CA$8 CA$8
Total CA$4497 CA$4543
pound2474a
ASSESSMENT OF COST-EFFECTIVENESS
NIHR Journals Library wwwjournalslibrarynihracuk
212
TABLE 58 Costs used in economic evaluations included in the health economics review (continued )
First authoryear referencenumber
Resource userecorded in study
Category ofcost Cost Base year
Inflated cost(201213) Perspective
Routine primarycare
Public healthcosts
NA 2011 NA
Volunteeropportunitycosts
NA NA
Hiredhousework
CA$180 CA$182
Hired child care CA$137 CA$138
Familyfriendand partnertime of work
CA$1983 CA$2003
Health-careutilisation total
CA$1080 CA$1091
Nursing visits CA$256 CA$259
Provider visits CA$373 CA$377
Mental healthvisits
CA$57 CA$58
Inpatientadmissions total
CA$389 CA$393
Mother CA$73 CA$74
Infant CA$316 CA$319
Ambulance CA$6 CA$6
Total CA$3380 CA$3415
pound1860a
Gold 2007397 Cost of theintervention
Rural cost perwoman
AU$172 2002 pound127a Cost of theintervention andhealth-care resourceuse (Australia)Urban cost per
womanAU$129 pound95a
Rural cost perarea
AU$272490 pound200959a
Urban cost perarea
AU$313900 pound231499a
MacArthur2003264
Control group Total costs pound542 1998 pound902 Health-care system(NHS) perspective ndash
health-care resourceuse Infant costs notincluded
Postnatal carecost
pound126 pound209
Intervention group Total costs pound470 pound783
Postnatal carecosts
pound190 pound317
continued
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
213
TABLE 58 Costs used in economic evaluations included in the health economics review (continued )
First authoryear referencenumber
Resource userecorded in study
Category ofcost Cost Base year
Inflated cost(201213) Perspective
Morrell 2000199 Cost ofinterventionadditional supportworker visits
ndash pound160 1996 pound279 Health-care system(NHS) perspective ndash
cost of theintervention andhealth-care resourceuse Mother andinfant costs included
Total resourcesintervention(6 months)
ndash pound815 pound1420
Total resourcescontrol (6 months)
ndash pound639 pound1113
Morrell 200961 Total resourcesused all women(6 months)
Control pound272 20034 pound350 Health-care system(NHS) perspective ndash
health-care resourceuse Mother andinfant costs included
CBA pound253 pound326
PCA pound250 pound322
Total resourcesused at-riskwomen(12 months)
Control pound374 pound481
CBA pound329 pound423
PCA pound353 pound454
Petrou 2006174 Cost of additionalhealth visitor visits
ndash pound121 2000 pound185 Health-care system(NHS) perspective ndash
health-care resourceuse Mother andinfant costs included
Petrou 200253 Total resourcesused women withPND
ndash pound2419 2000 pound3710 Health-care system(NHS) perspective ndash
health-care resourceuse Mother andinfant costs includedTotal resources
used womenwithout PND
ndash pound2027 pound3109
Hewitt 200945 Cost ofintervention
EPDS (5 minuteshealth visitortime)
pound8 20067 pound9 Health-care system(NHS) perspective ndash
cost of screeningand treatment
BDI (5 minuteshealth visitortime andlicense fee)
pound9 pound10
Cost of treatmentof PND
Structuredpsychologicaltherapy
pound447 pound517
Supportive care pound414 pound479
Stevenson2010392
Group CBT Onesession per weekfor 8 weeks2-hour longgroups of four tosix women
ndash pound1500 20078 pound1687 Health-care system(NHS) perspective ndash
cost of interventiontreatment
ASSESSMENT OF COST-EFFECTIVENESS
NIHR Journals Library wwwjournalslibrarynihracuk
214
TABLE 58 Costs used in economic evaluations included in the health economics review (continued )
First authoryear referencenumber
Resource userecorded in study
Category ofcost Cost Base year
Inflated cost(201213) Perspective
Campbell200856
Psychologicaltherapy (IPT- orCBT-basedintervention)eight sessions(50 minutes each)provided by aclinical psychologist
ndash NZ$268 20067 NZ$318 Health-care systemperspective (NewZealand) ndash cost ofscreening andtreatment
pound166a
Social supportthree groupsessions (fivewomen) and threetelephone contactsby a qualifiedcounsellor(30 minutes each)
ndash NZ$59 NZ$70
pound37a
Combinationtherapy16 sessions(50 minutes each)of psychologicaltherapy by aclinical psychologistand 12 weeksrsquoantidepressanttherapy
ndash NZ$561 NZ$666
pound347a
Key GBP Great British pounds PBDU psychiatric parent and baby day unit NA not applicablea Costs converted using XE Currency Convertor (wwwxecom) exchange rates correct as of 11 March 2014 1 AU$= 055
GBP 1 USD= 06 GBP 1 CAD= 0545 GBP and 1 NZ$= 052 GBP
DOI 103310hta20370 HEALTH TECHNOLOGY ASSESSMENT 2016 VOL 20 NO 37
copy Queenrsquos Printer and Controller of HMSO 2016 This work was produced by Morrell et al under the terms of a commissioning contract issued by the Secretary of State forHealth This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising Applications for commercial reproduction should beaddressed to NIHR Journals Library National Institute for Health Research Evaluation Trials and Studies Coordinating Centre Alpha House University of Southampton SciencePark Southampton SO16 7NS UK
215
The Morrell et al199 paper reported the cost of the intervention under study (additional care by trainedcommunity postnatal support workers) and the total health-care resources used by the intervention andcontrol groups Total health-care resource use was reported at 6 weeks and 6 months Mother and infantcosts were included
MacArthur et al264 collected total health-care resources used for the intervention and control groups inthree matrices (presented in Table 59) A subset of the total health-care resources referred to as postnatalcare costs was also presented These costs included the standard community services offered to postnatalwomen including midwife home visits GP home visits and the postnatal check For all matrices total costswere lower in the intervention group than in the control group while postnatal care costs were higher inthe intervention group than in the control group for matrices A and B and lower for matrix C Costs formatrix A were estimated based on crude data from midwivesrsquo diaries and GPsrsquo records A further analysiswas conducted that included replacement data from womenrsquos health diaries when estimates frommidwives were unavailable (matrix B) Using this approach the total costs for the control group decreasedfrom pound542 to pound479 whereas the cost of postnatal care increased slightly from pound126 to pound134 A thirdanalysis using the womenrsquos health diaries to estimate the frequency of midwivesrsquo and GP appointmentswas undertaken (matrix C) Using this approach the total costs decreased compared with matrix A to pound509and the costs of postnatal care also increased compared with both matrices A and B to pound161 The totalcost for the intervention group also fell from pound470 to pound457 and the costs for postnatal care decreasedfrom pound190 to pound152 (see Table 66) As the intervention was not intended to impact on health visitorshealth visitor costs were not included in the total resource use Costs incurred by the babies were alsonot included
Boath et al399 reported the median and mean of total cost for women receiving treatment in a specialisedpsychiatric parent and baby day unit and for women receiving routine primary care Costs to the motherand baby were included in the analysis
TABLE 59 Costs by matrices A B and C derived from trial of midwifery redesigned postnatal care
Matrix Category of cost
Mean of cluster means
Control (pound) Intervention (pound)
Matrix A Total costs 542 470
Postnatal care costs 126 190
Matrix B Total costs 479 469
Postnatal care costs 134 190
Matrix C Total costs 509 457
Postnatal care costs 161 152
Data source MacArthur et al264
ASSESSMENT OF COST-EFFECTIVENESS
NIHR Journals Library wwwjournalslibrarynihracuk
216