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Defining adverse events in manual therapies Dawn Carnes a, * , Martin Underwood b a Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Centre for Health Sciences, 2 Newark St, London. E1 2AT, Tel: 00 44 20 7882 2546 b Warwick Medical School, Clinical Trials Unit, Gibbetts Hill, Warwick. UK Background: Defining what an adverse event is in manual therapy is complex as perceptions may differ between practitioners and patients. Aim: To understand and identify constructs that provide meaning and describe adverse events in manual therapy and seek a consensus definition. Method: Firstly, an expert focus group was convened to identify issues surrounding the definition of adverse events and to generate constructs that may give meaning and description. Secondly, a modified Delphi consensus study was conducted with an expert panel (50) and patients (30) to seek an agreement about a pragmatic definition of adverse events for use by manual therapy practitioners. Results: There was a 50% response rate from experts for round one, 56% responded to round two and 60% of those responding to round 2 replied to round 3. Patients completed round one and round two only response rates were 90% and 80% respectively. Consensus at 75% or more, described major/moderate adverse events as severe, unacceptable, unexpected, requires further interven- tion, serious, distressing. Minor and not adverse events were described as expected, non serious, function remains in tact, transient/ reversible, short term duration, no treatment alterations required, short term consequences and contained. Additionally patients used the terms mild and acceptable. Using a cut off of 75% consensus or over, major adverse events were long term (weeks) and medium or severe in intensity, or medium term (days) and severe in intensity. Moderate adverse events were described as long term and mild in intensity, or medium term and moderate severity. Short term (hours) and mild intensity reactions were regarded as mild adverse events or not adverse at all. Conclusions: There were no major differences in consensus agreements between patients and experts. Participants found classifying adverse events difficult without context or detail. Classifying reactions to treatment may be improved by used the defining criteria identified in this study. Acknowledgements: National Centre for Osteopathic Research, UK for funding, Brenda Mullinger, European School of Osteopathy (collaborator) and to the Expert panel. doi:10.1016/j.ijosm.2008.08.003 Attitudes towards research in Australian and New Zealand osteopaths Cameron Gosling a,b , Robert Moran c , Steven Vogel d a Centre for Ageing, Rehabilitation and Exercise Science, Victoria University, Melbourne, Australia b Osteopathic Medicine Unit, School of Biomedical & Health Sciences, Victoria University, Melbourne, Australia c School of Health Science, Unitec NZ, Auckland, New Zealand d The British School of Osteopathy, London, United Kingdom Introduction: To assist future improvements in both quality and volume of research and the use of research derived evidence as a clinical tool in an Australasian setting, a baseline must first be established that records the current attitudes and experiences of osteopaths. The aim of the current study was to investigate the attitudes towards research in a population of Australian and New Zealand osteopaths. Design: Postal survey of osteopathic practitioners. Methods: All registered osteopaths in Australia (n ¼ 1012) and New Zealand (n ¼ 417) were mailed a questionnaire that recorded information about their attitude to and experience of research. The questionnaire was adapted from the ‘Barriers and Attitudes to Research in the Therapies’ (BART) questionnaire and modified for the osteopathy setting. The questionnaire is divided into four key sections, however, only two sections are reported here: 154 Abstracts ICAOR 7, Bradenton, FL, USA, September 2008 / International Journal of Osteopathic Medicine 11 (2008) 149e168

Attitudes towards research in Australian and New Zealand osteopaths

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154 Abstracts ICAOR 7, Bradenton, FL, USA, September 2008 / International Journal of Osteopathic Medicine 11 (2008) 149e168

Defining adverse events in manual therapies

Dawn Carnes a,*, Martin Underwood b

a Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Centre for Health Sciences, 2 Newark St,

London. E1 2AT, Tel: 00 44 20 7882 2546b Warwick Medical School, Clinical Trials Unit, Gibbetts Hill, Warwick. UK

Background:Definingwhat anadverse event is inmanual therapy is complexasperceptionsmaydifferbetweenpractitioners andpatients.Aim: To understand and identify constructs that provide meaning and describe adverse events in manual therapy and seek

a consensus definition.Method: Firstly, an expert focus group was convened to identify issues surrounding the definition of adverse events and to generateconstructs that may give meaning and description. Secondly, a modified Delphi consensus study was conducted with an expert panel

(50) and patients (30) to seek an agreement about a pragmatic definition of adverse events for use by manual therapy practitioners.Results: There was a 50% response rate from experts for round one, 56% responded to round two and 60% of those responding toround 2 replied to round 3. Patients completed round one and round two only response rates were 90% and 80% respectively.Consensus at 75% or more, described major/moderate adverse events as severe, unacceptable, unexpected, requires further interven-

tion, serious, distressing. Minor and not adverse events were described as expected, non serious, function remains in tact, transient/reversible, short term duration, no treatment alterations required, short term consequences and contained. Additionally patientsused the terms mild and acceptable. Using a cut off of 75% consensus or over, major adverse events were long term (weeks) and

medium or severe in intensity, or medium term (days) and severe in intensity. Moderate adverse events were described as longterm and mild in intensity, or medium term and moderate severity. Short term (hours) and mild intensity reactions were regardedas mild adverse events or not adverse at all.

Conclusions: There were no major differences in consensus agreements between patients and experts. Participants found classifyingadverse events difficult without context or detail. Classifying reactions to treatment may be improved by used the defining criteriaidentified in this study.

Acknowledgements: National Centre for Osteopathic Research, UK for funding, Brenda Mullinger, European School of Osteopathy(collaborator) and to the Expert panel.

doi:10.1016/j.ijosm.2008.08.003

Attitudes towards research in Australian and New Zealandosteopaths

Cameron Gosling a,b, Robert Moran c, Steven Vogel d

a Centre for Ageing, Rehabilitation and Exercise Science, Victoria University, Melbourne, Australiab Osteopathic Medicine Unit, School of Biomedical & Health Sciences, Victoria University, Melbourne, Australia

c School of Health Science, Unitec NZ, Auckland, New Zealandd The British School of Osteopathy, London, United Kingdom

Introduction:To assist future improvements in both quality and volume of research and the use of research derived evidence as a clinicaltool in an Australasian setting, a baseline must first be established that records the current attitudes and experiences of osteopaths. The

aim of the current study was to investigate the attitudes towards research in a population of Australian and New Zealand osteopaths.Design: Postal survey of osteopathic practitioners.Methods: All registered osteopaths in Australia (n ¼ 1012) and New Zealand (n ¼ 417) were mailed a questionnaire that recorded

information about their attitude to and experience of research. The questionnaire was adapted from the ‘Barriers and Attitudes toResearch in the Therapies’ (BART) questionnaire and modified for the osteopathy setting. The questionnaire is divided into four keysections, however, only two sections are reported here:

155Abstracts ICAOR 7, Bradenton, FL, USA, September 2008 / International Journal of Osteopathic Medicine 11 (2008) 149e168

1. Demographic, education and practice.2. Research in osteopathy section, consisting of 16 statements about research.

Each item was scored from -2 (strongly disagree) to +2 (strongly agree) Data was analysed using descriptive analysis, factor anal-ysis, t-tests for normally distributed data and Mann-Whitney U for non-normally distributed data.

Results: Overall response rate was 33.8% (483/1429) with 311 from Australia (response rate ¼ 30.7%; 138 male, 160 female, 13incomplete data) and 172 from New Zealand (response rate ¼ 41.2%; 92 male, 76 female, 4 incomplete data). New Zealand respon-dents were mainly UK trained (59.9%) to a diploma level qualification (30.2%) while the Australian respondents were mainly

trained in Australian universities (67.3%) to a Master’s degree level (50.3%). The NZ respondents were older (NZ mean age:41.9y � 11.2; Aus mean age 35.4y � 10.3; P<0.001) and been practicing longer (NZ mean: 11.3y � 8.2; Aus mean: 9.7y � 8.4;P¼0.011) than their Australian colleagues, however, no difference was reported for hours worked per week, and proportion of

work time allocated to each of patient care, practice management, teaching and research. Factor analysis on the 16 statements iden-tified four factors that accounted for 50.64% of the variance and reliability was above 0.65 for each factor. There was no total scoredifference for opinions on research in osteopathy between groups (Aus median score 5.5 IQR 3-8; NZ median 6 IQR 2-9; Z ¼ 0.0 P

¼ 1). Australian (90.5%) and New Zealand respondents (89.6%) both disagreed or strongly disagreed with the statement that‘‘Research is pointless, because what we do cannot be measured’’ and 87.8% and 76.1% respectively, disagreed that ‘‘Researchis not a priority for osteopathy at the moment’’. There were significant differences between countries for six items (Z: -2.085 to-5.125; P: < 0.001 to 0.037) related to the focus of osteopathy related research.

Conclusions: The Australian and New Zealand osteopaths sampled in this survey differ in their beliefs about the key research needsof the profession, but there appears to be underlying support for the notion that research is important.

doi:10.1016/j.ijosm.2008.08.009

Pilot clinical study of osteopathic manipulative treatmentin pregnant patients with acute low back pain

James D. Leiber, Pei-Yuen Tang, Christopher Caragan, Michael Slack,Jason Koskinen, Don Zust, Timothy Cragun

Family Medicine Department, Malcolm Grow Medical Centre, Andrews Air force Base, Maryland

Introduction: Acute low Back pain is a common complaint of women during pregnancy. Physicians and patients desire non-medi-cation treatment options.

Design: Prospective, non-controlled clinical intervention pilot studyMethods: Thirty-one women with pregnancy related low back pain (LBP) were screened for study inclusion at Malcolm GrowMedical Center from December 2004 to April 2005 and January 2007 to April 2007. Twenty patients met all inclusion and exclusion

criteria. 11 patients completed all four weeks of the study protocol .Standardized OMT techniques targeting the soft tissue/muscular restriction and bony alignment of the lumbar, sacral, and pelvicregion were performed. Patients were expected to complete three OMT sessions at weekly intervals. Outcomes were assessed usingthe Visual Analog Scale (VAS), Roland-Morris Low Back Pain and Disability questionnaire andSF-36v2 Health Survey. VAS was

completed both before and after each OMT session in addition to one week after the final treatment (week four).The questionnaire and survey were completed prior to each appointment (weeks one, two and three) in addition to one week afterthe final appointment.

Results: Paired Sample t-tests were performed on VAS scores pre- and post- treatment pain levels at each patient contact. Resultssuggest immediate back pain improvement following each treatment session.Paired Sample t-tests were also completed on the Roland-Morris Low Back Pain Disability questionnaire and the physical and

bodily pain components of the SF-36v2 Health Survey comparing pre-intervention (weekone) to completed intervention cycle(week four) scores. Results of both analyses show improvement in functional capacity and relative burden of LBP after completionof three weekly OMT sessions.

Conclusions: Preliminary data is encouraging related to the potential of OMT as an effective adjunct in the treatment of LBP in preg-nancy. From this small pilot study, OMTappears to be an effective therapy for immediate relief of pregnancy related low back pain andsuggests a possible longer term effect on improving functional capacity and bodily pain after three serial weekly treatments. FutureOMT research to expand on this pilot study is recommended to further explore the clinical benefit of OMT in pregnancy related LBP.

doi:10.1016/j.ijosm.2008.08.010