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