1 The U.S. Preventive Services Task Force: The Challenge of Transparency Dr. Albert Siu New York Academy of Medicine

2 Background The U.S. Preventive Services Task Force… Established in 1984 Makes recommendations on clinical preventive services for primary care The USPSTF scope for clinical preventive services includes: screening tests counseling services preventive medications Services offered in a primary care setting or referable from primary care Applicable to adults & children with no signs or symptoms Recommendations based on a rigorous analysis of peer-reviewed evidence

3 Who is the USPSTF? Experts in primary care, prevention, research methods Congressionally mandated and government supported, by AHRQ, but independent Represent family medicine, internal medicine, pediatrics, obstetrics/gynecology, nursing, behavioral medicine Scientific support from Evidence-based Practice Centers (EPCs) Non-member liaisons (“Partners”) from primary care clinician associations, Federal agencies

4 Topic Selection & Prioritization Anyone can nominate a topic for the USPSTF to consider via its Web site Nominated topics are prioritized to balance the overall portfolio of recommendations by populations, types of services (screening, counseling, preventive medications), and disease types Scope (i.e., asymptomatic population, primary care setting) Health burden Expected effectiveness of the preventive service to reduce that burden Potential for a Task Force recommendation to affect clinical practice (based on existing controversy or the belief that a gap exists between evidence and practice)

5 Steps the USPSTF Takes to Solicit Public Input and Make a Recommendation

6 Steps the USPSTF Takes to Solicit Public Input and Make a Recommendation: Step 1

7 Analytic Framework for Lung Cancer Screening

8 Analytic Framework for Hepatitis C Screening

9 Steps the USPSTF Takes to Solicit Public Input and Make a Recommendation: Step 2

10 Evidence Review: Define & Retrieve Relevant Evidence For each Key Question developed from Analytic Framework: Create inclusion/exclusion criteria based on the key questions defined from the analytic framework PubMed, Cochrane, and Other database search (CINAHL, etc.) References from key articles, editorials, review articles Expert consultation (others, TF members)

11 Steps the USPSTF Takes to Solicit Public Input and Make a Recommendation: Step 3

12 Synthesize & Judge Overall Strength of Evidence Convincing: Well-designed, well-conducted studies in representative populations that directly assess effects on health outcomes Adequate: Sufficient to determine effects on health outcomes, but limited by number, quality, or consistency of studies, generalizability to routine practice, or indirect nature of the evidence Inadequate: Insufficient due to limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes

13 Assessment of Net Benefit & Recommendation Likelihood that the assessment of the net benefit of a preventive service is correct Net benefit is defined as benefit minus harm of the preventive service as implemented in a primary care population The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service

14 Level of Certainty High Certainty: The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations, using health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies. Moderate Certainty: The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by limitations in the research. As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion. Low Certainty: The available evidence is insufficient to assess effects on health outcomes.

15 Grade Recommendations Certainty of Net BenefitMagnitude of Net Benefit SubstantialModerateSmallZero/negative HighABCD ModerateBBCD Low Insufficient (I Statement)

16 Patient Protection and Affordable Care Act: Investment in prevention… A group health plan and a health insurance issuer offering group or individual health insurance coverage shall provide coverage for and shall not impose any cost sharing requirements for Evidence-based items or services that have … a rating of ‘A’ or ‘B’ in the current recommendations of the United States Preventive Services Task Force

17 Steps the USPSTF Takes to Solicit Public Input and Make a Recommendation: Step 4

18 External Review of Draft Recommendation Statement Consideration of Public Comment & Revision of Draft Recommendation Statement — Ratification of Final Recommendation Statement Publication of Final Recommendation Statement Draft Evidence Report External Review of Draft Evidence Report by Experts USPSTF Topic Workgroup Reviews Evidence & Prepares Preliminary Recommendation Full USPSTF Reviews Evidence & Debates Preliminary Recommendation Topic Workgroup Prepares Full Draft Recommendation Statement Final Evidence Report & Manuscript Published External Review of Draft Research Plan Approval of External-reviewed Final Research Plan Opportunities for Public Input Engagement Opportunity for Public Comment Topic Nomination Topic Selection Draft Research Plan Development Opportunity for Public Comment FUTURE Opportunity for Public Comment

19 Important Considerations for Success The commitment to evidence is what makes the USPSTF recommendations the “gold standard” for clinical preventive services Recommendations are used for national performance measures and policy Public-private partnership is valuable model The USPSTF is an INDEPENDENT entity, but our work is made possible through the partnership with AHRQ AHRQ convenes the USPSTF and provides scientific, technical, administrative, and dissemination support

20 Important Considerations for Success Rigorous, systematic and TRANSPARENT processes USPSTF Procedure Manual is available online Explicit conflict of interest procedures Analytic frameworks, draft reports, and draft recommendation statements are available for public comment Expanded dissemination (plain language fact sheets) Efforts to engage the media Engaging stakeholders in the process through briefings and other activities

21 Public Input on Hepatitis C Screening – 11/28/12 “Advocates for wider screening for hepatitis C criticized a government panel Tuesday for not issuing a stronger recommendation that all baby boomers get a test to make sure they aren’t infected with the deadly virus. The National Viral Hepatitis Roundtable, a coalition of groups that battle viral hepatitis, said that the task force recommendation doesn’t match up with Centers for Disease Control guidelines that everyone born between 1945 and 1965 be tested. “We’ll miss a tremendous opportunity to save lives,” said the executive director of the group.” “I'd still argue that the magnitude of benefit is less than either the CDC or Task Force say it is... there's no direct evidence that screening for hepatitis C saves lives. New treatments are more likely to lead to SVR, but there's no evidence that they save lives.”

22 Benefits and “Harms” of Public Engagement Benefits Corrections to analytic framework Improved wording of recommendation statement Changed recommendation grade based on new evidence Better articulated critical evidence gaps “Harms” Longer timeline Additional resources More time from task force “volunteers” in activities outside of comfort zone

23 Thank you for your interest

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