Knowing What Works in Health Care : A Roadmap for the Nation

1. Knowing What Works in Health Care: A Roadmap for the Nation Alliance for Health Reform April 4, 2008 Wilhelmine Miller, MS, PhD GWU SPHHS

2. Charge toCommittee: To Recommend… • Approach to identifying highly effective clinical services • Process to evaluate evidence about clinical effectiveness • Organizational framework for using evidence reports to make recommendations

3. Outside Committee Scope • Considerations of cost, specifically use of cost-effectiveness analyses • Organizational locus of any new program • Recommendations regarding funding for clinical effectiveness research or program

4. Body of evidence Systematicreview • Policy • Practice guidelines • Performance measures • Insurance coverage Evidence-Based Practice Centers Proprietary firms • USPSTF • ACP • NIH • BC • CMS • ACC/AHA

5. Strengths of U.S. Activities and Capacity • Well-developed systematic review methods • A network of professionals skilled in systematic reviews • Pluralistic, close to the ground • Some excellent models for transparent, rigorous guideline development • Influential users of guidelines (e.g., coverage decisions, performance measures)

6. Problems with the Status Quo • Extensive duplication of efforts by insurers and private groups • Potential conflicts of interest in assessing evidence and promulgating guidelines • Systematic reviews and guidelines often lack scientific rigor • Difficult for users to see the connection between the evidence and clinical recommendations

9. Duplication of Efforts Of 20 services* - 14 evaluated by all 7 groups - 17 evaluated by 5 of 7 groups - 5 evaluated by AHRQ * 2006 activities

10. Building a Foundation for Knowing What Works • Create a single entity with authority, overarching responsibility, sustained resources, and adequate capacity to ensure credible, unbiased information about clinical effectiveness is produced. • The program should: - set priorities for, fund, and manage systematic reviews of clinical effectiveness and related topics - develop a common language and standards for conducting systematic reviews of evidence and generating clinical guidelines and recommendations - provide a forum for addressing conflicting guidelines and recommendations - report to Congress annually

11. Building a Foundation for Knowing What Works • The Secretary of HHS should appoint a Clinical Effectiveness Advisory Board to oversee the Program. • Advisory Board should be constituted to minimize bias due to conflict of interest and should represent diverse public and private sector expertise and interests. • Program should develop standards to minimize bias due to conflicts of interest for • priority setting • evidence assessment • guidelines development

12. Setting Priorities The Program should appoint a standing Priority Setting Advisory Committee (PSAC) to identify high priority topics for systematic reviews of clinical effectiveness • Priority setting process should be open, transparent, efficient, and timely • Priorities should reflect • the potential to improve health across the life span • reduce the burden of disease and health disparities • eliminate undesirable variation • consider economic factors, such as costs of treatment and economic burden of disease • Membership of the PSAC should include a broad mix of expertise and interests and be chosen to minimize bias due to conflicts of interest

13. Assessing Evidence • Develop evidence-based methods standards for systematic reviews, including a common language for characterizing the strength of evidence • Fund reviewers only if they commit to and consistently meet these standards • Invest in advancing the scientific methods underlying the conduct of systematic reviews and update standards for funded reviews as appropriate • Assess the capacity of the research workforce to meet the needs for systematic reviews • Expand training opportunities in systematic review and comparative effectiveness research methods as appropriate

14. Developing Clinical Practice Guidelines • Groups developing clinical guidelines or recommendations should • adhere to the program’s standards • document their adherence • make documentation publicly available • Panels should include a balance of competing interests and diverse stakeholders, publish conflict of interest disclosures, and prohibit voting by members with material conflicts to minimize bias

15. Using Clinical Practice Guidelines • Who should preferentially use guidelines developed according to these standards? • Clinicians and providers • Public and private insurers • Purchasers • Accrediting organizations • Performance measurement groups • Patients and consumers