ness research and achieving health care practice change require not only identifying research priorities, but also determining how to conduct the studies and implement the results. The new PatientCentered Outcomes Research Institute (PCORI) is a nonprofit entity charged with prioritizing and supporting studies and improvement in the methods of comparative effectiveness research.1 By 2014, the PCORI budget may increase to more than $500 million. It is funded by Medicare, private health insurers, and self-insured plans.
Laying the FoundationEven though the PCORI is a new entity, it is rooted in recommendations made a decade ago by members of the Clinical Research Roundtable (CRR) at the Institute of Medicine of the National Academies.2 The CRR focused on the critical challenges facing the nation's clinical research enterprise and how they might be resolved.One challenge was the translation of new research findings into clinical practice. In a frequently cited article, 3 the CRR identified 2 translational blocks: bench to bedside and bedside to clinical practice, each requiring specific attention. Notably, the CRR, with regard to bedside to clinical practice, argued for increased efforts focused on effectiveness research.
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CRR's FindingsThe CRR expressed concern that the research enterprise did not focus enough on effectiveness. Recent analyses of the level of evidence used by organizations to develop guidelines for infectious diseases showed that the recommendations in the guidelines largely relied upon expert opinion and consensus statements.8 Members of the CRR concluded that new mechanisms were needed to enhance the output of effectiveness research, and that all public and private stakeholders should be involved in the planning, conduct, and dissemination of the research.Members of the CRR proposed and discussed several alternative mechanisms and focused on a recommendation to create a public-private cooperative for health care improvement research. 5 The model identified by the CRR is similar to the long-standing cooperative research programs of the National Academies' Transportation Research Board.5,9 These programs focus on applied research, development of research priorities, and sponsorship and monitoring of research studies. The research priorities are developed through public information requests and a committee of public and private stakeholders. Specific requests for proposals are then developed by the National Academies of Science in collaboration with expert review panels. Peer review by scientific panels and monitoring of contract mechanisms ensure that specific goals are met. The PCORI model draws from these recommendations; however, the mechanism for implementing its research priorities is left unclear. For instance, how will the PCORI review and fund research? Will it use existing public-sector mechanisms or will it develop new approaches?Clinical implementation of research findings can be hindered by issues such as experimental design and perceived generalizability of the study approach. Perce...