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 Guidelines Washington, DC May 10, 2011 Steven H. Woolf, MD, MPH Center on Human Needs Department of Family Medicine Virginia 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 issues o “Strength of the evidence”-- conflating effect size (magnitude) and scientific certainty o Dealing with insufficient evidence o Generalizability (external validity) o Subgroup differences o Harms o Costs o Tradeoffs: the tension between clear guidance and shared decision-making

Persistent Challenges (Continued) Hierarchy of evidence and the RCT Bias o Composition and sponsorship o 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