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Slide 1
Translating Research into Clinical
Lactation Practice
Karen Wambach,PhD, RN, IBCLC, FILCA
University of Kansas School of Nursing
Slide 2
Objectives
• Define Evidence Based Practice (EBP)• Formulate EBP questions using the PICOT
acronym as a guide: P (population), I (intervention or issue), C (comparison of interest), O (outcome)
• Review and synthesize the evidence from published research or reviews of research
• Prepare a systematic plan for applying research findings to improve lactation practice and evaluating outcomes.
Slide 3
Research Utilization (RU)
• Older and narrower concept - nursing 1970s, 1980s, early 1990s
• Demonstration projects – CURN, NCAST, WICHEN
• Refers to the review and critique of scientific research, and then the application of the findings to clinical practice (Polit & Beck, 2012).
• Starting point is the research itself! How can I use this knowledge/evidence?
Slide 4
Evidence Based Practice (EBP)
• Based in definitions posed by Sackett for evidence based medicine (1996)
• “conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients”
• Broader than RU – considers patient preferences and values, as well as the context of application
• Starts with the clinical problem!
Slide 5
Research Utilization and EBP Models
• Stetler Model of Research Utilization (Stetler, 2001)
▫ Preparation, validation, decision-making, translation/application, evaluation
• The Iowa Model of Evidence-Based Practice to Promote Quality Care (Titler et al., 2001)
▫ Starts with a knowledge focused or problem focused trigger
Slide 6 The Iowa Model of Evidence-Based
Practice to Promote Quality Care
Slide 7 Triggers
Slide 8
Process
Slide 9
Step one: Formulate PICO Question
• P = patient or problem
• I = intervention
• C = comparison intervention
• O = outcomes
• Use a PICO or PIO Format when the goal is to evaluate the best outcome, or use a PI format when the goal is to understand the meaning or process
Slide 10
Example PICO Formats
• Example (PICO): In ………(population), how effective is ……. versus …….(intervention plus comparison) in the prevention of …….(outcome)?
• Example (PIO): For………(population), the use of……….(intervention) leads to ………….(outcome)?
• Example (PI): What is it like for…….(population) to live with………(Interest area)?
Slide 11
Example PICO Question
• In first-time breastfeeding teenage mothers, how effective is peer counselor support versus lactation consultant support in the prevention of early weaning (before 2 weeks)?
Slide 12 Step Two: Find and Appraise the
Levels of Evidence
• Level I: Systematic review or meta-analysis of all relevant RCTs. Systematic review of nonrandomized trials. Evidence-based clinical practice guidelines based on systematic reviews of RCTs.
• Level II: Single RCT; single nonrandomized trial.
• Level III: Systematic review of correlational/observational studies
• Level IV: Single correlational/observational study (case-control and cohort)
Slide 13
Levels of Evidence - Continued
• Level V: Systematic review of descriptive/qualitative/physiologic studies.
• Level VI: Single descriptive/qualitative/physiologic study
• Level VII: Opinion of authorities and/or reports of expert committees
Slide 14
How to search the literature
• PubMed/Medline
• CINAHL
• PsychInfo
• COCHRANE Collaboration
Slide 15
How to Search
Subject search
Search for topics or key words in the databasepostpartum depression
postpartum depression, breastfeeding
Textword search
Search for specific words in text fields of the database record
Author search
Search for a specific researcherWambach K
Slide 16
Slide 17
Conducting the Literature Review
• Objective▫ To describe the research on the problem▫ To identify what is known and not known▫ To synthesize the evidence for an EBP protocol
Slide 18
Guidelines as Sources of Evidence and
Protocols
Slide 19
Slide 20
Slide 21
Slide 22
Slide 23 Step Three: Synthesize for
Implications for Practice
• Formulate guidelines for care
• Test in practice
• Evaluate the outcomes
Slide 24
What is EBP in Lactation Care?
• Problem solving process
• Evaluation of research in clinical application
• Best and highest level of evidence
• Aims for excellence and quality care
• Aims to incorporate patient and family preferences
• Consideration of culture
Slide 25
Let’s do a quick review on a
common lactation issue!
Slide 26 Where it Starts? A Clinical or
Practice Problem
• Should LCs encourage that pacifiers be avoided as recommended by the 10 Steps and BFHI?
• Should pacifiers be encouraged at sleep time to protect from SIDS?
Slide 27
PICO Question
• For first time breastfeeding mothers of full term infants, the use of patient education to encourage pacifier avoidance in the hospital leads to increased exclusive breastfeeding at hospital discharge, one month and three months?
Slide 28
Slide 29
Looking at the Evidence!
• Systematic Review (O’Connor et al., 2009)
▫ 4 RCT, 20 Cohort Studies, 5 Cross-Sectional Studies – Level of evidence I and V
▫ Results from the 4 RCT showed no difference in breastfeeding outcomes
▫ Results from most observational studies reported a negative association between pacifier use and duration of breastfeeding
Slide 30
Cochrane Review – Jafar et al., 2011
• Review of randomised and non-randomised (quasi-experimental) trials comparing pacifier use versus no pacifier use in healthy full-term newborns
• Three trials found
• Two studies – meta –analysis (N=1302) – (Jenik2009 and Kramer 2001)
• No significant effect on exclusive breastfeeding at 3 months or 4 months
• No significant effect on partial breastfeeding at 3 months and 4 months
Slide 31
Evidence From Newer Studies!
• Multicenter, randomized, non-inferiority, controlled trial – Level of Evidence II (Jenik et al 2009)
• N = 1021 – Exclusive well established BF (2 weeks), intended to EBF 3 months, not using pacifier
• Argentina – 5 tertiary medical centers (2 BFHI)
• Intervention – Encourage Pacifier or No Pacifier
Slide 32
New Evidence- continued
• Telephone contacts monthly 1 – 10 months and 12 months or until breastfeeding stopped
• Outcomes – Exclusive BF at 3 months
• Results: 3 months - 85.8% in pacifier versus 86.2% in no pacifier group – non-significant difference
Slide 33
More Evidence – Level IV
• Brazilian Cohort study of 1,309 mother-child pairs (Vieira et al. 2010)
• Data - in hospital and home visits first month
• What predicted discontinuation of exclusive breastfeeding at 1 month?
▫ Lack of prior breastfeeding experience
▫ Cracked nipples
▫ Use of fixed breastfeeding schedules
▫ Pacifier use
Slide 34
Synthesize the Evidence
• RCTs point to no differences in breastfeeding outcomes but observational studies, of lower evidence level, point to negative association of pacifier use and breastfeeding outcomes!
• Early breastfeeding outcomes (1 month) may be more influenced as suggested by some evidence (e.g. Howard et al., 2003)
• Conclude that encouragement to avoid pacifier use in the hospital may be beneficial in short term outcomes, but evidence is mixed!
Slide 35
Evidence Table
Author (Year) Location
Design Sample
Level of Evidence
Interven-tion/IV
Depen-dent Variable
Measures of Outcome
Results
Jenik et al (2009)Brazil
RCT N = 1021
II Encourage Pacifier --No Pacifier
Exclusive BF at 3 months
Self-report
No difference between groups
Slide 36
Summary
• Evidence can provide direction for practice
• Evidence can be contradictory depending on study design
• State of breastfeeding and lactation knowledge is growing
• Continued research is often needed but must use best evidence available now
Slide 37 Systematic plan for applying research
findings in lactation practice
• Pilot the Change In Practice▫ Select Outcomes▫ Collect Baseline Data ▫ Design EBP Guidelines▫ Implement EBP – Pilot Setting▫ Evaluate Process And Outcomes ▫ Modify the Practice Guidelines As Needed
• Is Change Appropriate? • Institute the Change• Monitor and Analyze Structure, Process, and
Outcomes Data
Slide 38 Published Example of EBP
Implementation
Implementing Skin-To-Skin Contact at Birth Using the Iowa Model: Applying Evidence to Practice
Haxton, Doering, Gingras, & Kelly (2012)
Slide 39
Background and Purpose
• Early SSC is beneficial (based in evidence from RCTs) for mothers and babies
• Implement use of SSC in L & D unit
• Minimum of 1 hour immediately after birth
• Iowa Model
Slide 40
Step 1 – Trigger Identification
• Knowledge Focused Trigger
▫ Many nurses not aware of benefits of SSC
▫ Many did not regularly engage in the practice
▫ Recent guidelines had been published
▫ 30 mothers were interviewed and 10 (30%) had discussed with nurse
▫ 15 had been offered SSC
▫ 12 engaged is SSC between 1 and 20 minutes
▫ None for longer than 20 minutes
Slide 41
Step 2: Endorsement of SSC as Facility
Priority• Goals of the birthing center were consistent with the
Healthy People goals relative to breastfeeding
• Baseline – 74% breastfeeding initiation rate; 45% supplementation rate; 31% exclusive breastfeeding at discharge
• Presented the SSC proposal, initial evidence table detailing most current/relevant evidence, and pilot results on SSC to the Best Practice Committee and the unit and hospital leadership
• Endorsed the project
Slide 42
Step 3: Form a Team
• Development, implementation and evaluation tasks
• Birth Center CNS; L&D nurses (greatest membership and from all shifts); physicians; certified nursing assistants; and lactation consultants
• Champion – director of patient safety and quality for the Department of Obstetrics and Gynecology
Slide 43
Step 4: Assemble Research &
Literature• CNS led the effort and distributed work load
• Cochrane Review and meta-analysis of SSC
• Practice guidelines and position statements from AAP, AABM, and AWHONN
• Selected Quality Outcomes:
▫ Breastfeeding initiation rates
▫ Breastfeeding exclusivity at hospital discharge
▫ Maternal satisfaction levels
Slide 44
Step 5: Critique and Synthesize
Research for Practice• Evidence was strong and SSC immediately after
birth for all healthy term infants should be available to stable newborns and their parents
• Current practice was a major issue
• Back to the literature to find evidence for delaying newborn interventions – AAP Breastfeeding and the Use of Human Milk (Gartner et al, 2005)
Slide 45 Step 5: Critique and Synthesize Research
for Practice – Protocol Development
• Information and consent for mother prior to birth
• Infant placed on warm blanket on mother’s abdomen during cord clamp/cut
• Infant then placed directly on mother’s chest with diaper and cap – warm blanket to cover both mom/babe
Slide 46 Step 5: Critique and Synthesize Research
for Practice – Protocol Development
• APGAR and ID bands placed. Weight could be done quickly
• Self-latch allowed unless mother requested
• Formula feeding mothers encouraged to do SSC for temperature and blood sugar benefits to infant
• Those refusing SSC given baby as done previously
Slide 47
Step 6: Pilot Change & Evaluate
• Order sets modified for SSC
• Documentation system (electronic) altered for SSC
• 4 educational sessions for L&D staff
• Discussions on potential barriers to implementation by nurses
Slide 48
Step 7: Evaluation for Decision to Fully
Implement & Follow-Up• Actual offering of SSC (5 weeks after pilot)
• Medical record review – random audit of 30 healthy newborn records 2 weeks post intervention
• Nurses anecdotally reported no increased workload or delay in transfers to mother-baby
• Prenatal education incorporated SSC flyer
Slide 49
Outcome Evaluation
• Breastfeeding initiation increased from 74% to 84% in the 2 quarters following implementation
• Challenges
▫ Assuring staff that SSC would not take more time/common tasks can be safely delayed
▫ Documentation system changes
▫ Order set changes
▫ Scheduling conflicts for team meetings
▫ Providing education to 100% of staff
Slide 50
Questions on Example EBP Project?
Slide 51
Thank You!!
Slide 52
References
• Haxton, D., Doering, J., Gingras, L., & Kelly, L. (2012). Implementing Skin-To-Skin Contact at Birth Using the Iowa Model: Applying Evidence to Practice. Nursing and Women’s Health, 16, 220-229.
• Howard, Howard, Lanphear, et al.,(2003). Randomized clinical trial of pacifier use and bottle-feeding or cup-feeding and their effect on breastfeeding. Pediatrics, 111, 511-518.
• Jenik, Vain, Gorestein, & Jacobi, Pacifier and Breastfeeding Trial Group. (2009). Does the recommendation to use a pacifier influence the prevalence of breastfeeding? Journal of Pediatrics, 155, 350-354.
Slide 53
References
• O’Connor, Tanabe, Stadaty, & Hauk (2009). Systematic Review of Evidence on Pacifier use and Breastfeeding Outcomes . Archives of Pediatric and Adolescent Medicine, 163, 378-382.
• Polit, D. & Beck, C.T. (2012).Nursing research: Generating and assessing evidence for nursing practice (9th ed.). Philadelphia: Lippincott Williams & Wilkins.
• Sackett, D.L., Rosenberg, W., Muir Gray, J.A., Haynes, R., & Richardson, W. (1996) Evidence-Based medicine: What it is and what it isn’t. British Medical Journal, 312, 71-72.
Slide 54
References
• Stetler, C.B. (2001). Updating the Stetler model of research utilization to facilitate evidence-based practice. Nursing Outlook, 49, 272-279.
• Titler, M.G., Kleiber, G., Steelman, Vlk Rakel, B., Burdreau, G., Everett, L., Buckwalter, K., Tripp-Reimer, T., & Goode, C. (2001). The Iowa model of evidence-based practice to promote quality care. Critical Care Nursing Clinics of North America, 13, 497-509.
• Viero, Martins, Vieira, de Oliveira, & Sylvia. Factors predicting early discontinuation of exclusive breastfeeding in the first month of life. J Pediatr(Rio J). 2010 Aug 23;86(5).
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