opers of CPGs. The focus is on the development and reporting of comprehensive, publicly funded SRs of the comparative effectiveness of therapeutic medical or surgical interventions. The recent health reform legislation underscores the imperative for establishing standards to ensure the highest quality SRs. The Patient Protection and Affordable Care Act of 2010 (ACA) created the nation’s first nonprofit, public–private Patient-Centered Outcomes Research Institute (PCORI). PCORI will be responsible for establishing and implementing a research agenda—including SRs of CER—to help patients, clinicians and other healthcare providers, purchasers, and policy makers make informed healthcare decisions. As this report was being developed, planning for PCORI was underway. An initial task of the newly appointed governing board of the institute is to establish a standing methodology committee charged with developing and improving the science and methods of CER.
The IOM committee undertook its work with the intention to inform the PCORI methodology committee’s own standards development. The IOM committee also views other public sponsors of SRs of CER as key audiences for this report, including the Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program, the Centers for Medicaid and Medicare Coverage Advisory Committee, the Drug Effectiveness Research Project, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the U.S. Preventive Services Task Force.
Organizations establish standards to set performance expectations and to promote accountability for meeting these expectations. For SRs in particular, the principal objective of setting standards is to minimize bias in identifying, selecting, and interpreting evidence. For the purposes of this report, the committee defined an SR “standard” as a process, action, or procedure that is deemed essential to producing scientifically valid, transparent, and reproducible SRs. A standard may be supported by scientific evidence, by a reasonable expectation that the standard helps achieve the anticipated level of quality in an SR, or by the broad acceptance of the practice by authors of SRs.
The evidence base for many of the steps in the SR process is sparse, especially with respect to linking characteristics of SRs to clinical outcomes, the ultimate test of quality. The committee developed its standards and elements of performance based on available research evidence and expert guidance from the AHRQ Effective