of the level of funding, all sponsors of SRs of CER should adopt standards for the planning, conducting, and reporting of SRs to ensure that a minimal level of quality is met, and should make the adopted standards publicly available. The committee recognizes that its recommended standards are provisional, subject to change as the science of SRs advances and lessons are learned from applying the standards in real-world situations. Also, its standards and elements of performance are at the “exacting” end of the continuum, some of which are within the control of the review team whereas others are contingent on the SR sponsor’s compliance. However, high-quality reviews require adequate time and resources to reach reliable conclusions. The recommended standards are an appropriate starting point for publicly funded reviews in the United States (including PCORI, federal, state, and local funders) because of the heightened attention and potential clinical impact of major reviews sponsored by public agencies. The committee also recognizes that a range of SRs are supported by public funds derived from nonfederal sources (e.g., state public health agencies) and private sources where these standards will be seen as an aspiration rather than as a minimum bar. Application of the standards to reviews embedded within other programs that may be publicly funded (e.g., highly focused reviews conducted by individual investigators as part of research grants) also presents difficult operational issues. On the whole, however, the committee feels strongly that the standards (and their successor standards) should serve as a benchmark for all SRs of CER. They could even, for example, be used to inform other topic areas (e.g., risk assessment, epidemiologic research) where standards are also being developed. SRs that significantly deviate from the standards should clearly explain and justify the use of different methods.

Recommendation 2: PCORI and the Department of Health and Human Services (HHS) agencies (directed by the Secretary of HHS) should collaborate to improve the science and environment for SRs of CER. Primary goals of this collaboration should include

  • Developing training programs for researchers, users, consumers, and other stakeholders to encourage more effective and inclusive contributions to SRs of CER;

  • Systematically supporting research that advances the methods for designing and conducting SRs of CER;

  • Supporting research to improve the communication and use of SRs of CER in clinical decision making;



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