The Challenges and Larger Significance of Implementing Standards for Clinical Practice
Guidelines
Institute of Medicine Workshop: Next Steps: Implementation Workshop on Standards for
Systematic Reviews and Clinical Practice GuidelinesWashington, DC
May 10, 2011
Steven H. Woolf, MD, MPHCenter on Human Needs
Department of Family MedicineVirginia Commonwealth University
Disclaimers
• No longer a guideline producer• Coauthor of commissioned background
paper
Laudable Progress Since the 1980s
• Broader acceptance of need for evidence-based practice guidelines
• Greater sophistication in critical appraisal, grading of evidence, and systematic reviews
• Greater attention to bias and conflicts of interest
• Larger presence of evidence-based guidelines in practice and policy
Persistent Challenges
• Assessing the evidence: methodologic issueso “Strength of the evidence”-- conflating effect size
(magnitude) and scientific certaintyo Dealing with insufficient evidenceo Generalizability (external validity)o Subgroup differenceso Harmso Costso Tradeoffs: the tension between clear guidance and
shared decision-making
Persistent Challenges (Continued)
• Hierarchy of evidence and the RCT• Bias
o Composition and sponsorshipo Developers’ concerns about medicolegal
implications, insurance coverage, or political backlash
• Communicating recommendations to the public, practitioners, and policymakersba
Studying Guideline Methodology
“Even though the evidence may be in doubt in the minds of some scientists, the practical sense conclusion is that there is very, very substantial evidence to show that mammograms are helpful.”
Sen. Arlin Specter, February 4, 1997
Are Guidelines Implementable?
• Clarity and precision• Feasibility• Measurability• Adaptability to information technology and
quality improvement tools
“Further testing for some patients may be indicated at appropriate intervals.”
Do Guidelines Make a Difference?
• Health outcomes• Practice variation• Cost inflation
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