Research institute promotes records use in clinical studies

The Patient-Centered Outcomes Research Institute (PCORI) is not widely known. Yet this year-old, nonprofit organization, established by the Patient Protection and Affordable Care Act, is tasked with funding and setting the agenda for comparative effectiveness research (CER), which will have a major impact on future healthcare by influencing medical practice and insurance coverage.

In a recent commentary in the New England Journal of Medicine, PCORI's leaders lay out the organization's goals and plans. With $3 billion to spend between now and 2020, PCORI has an ambitious agenda. What's directly relevant to health IT are the methods that will be used to gather data for CER studies.

Among the current methods of patient-centered outcomes research that PCORI will examine, according to the NEJM piece, is "the use of clinical data systems, including those covering usual practice settings." That means the use of electronic health records and registries to generate data for studies about which tests and treatments work best in everyday practice.

Furthermore, the authors state that they expect PCORI-funded investigators "to deploy a full research arsenal, including randomized trials, observational outcomes studies based in registries or databases derived primarily from clinical care, and data syntheses."

The Agency for Healthcare Research and Quality (AHRQ), with which PCORI will collaborate, has long favored the use of "practical clinical trials" to answer certain questions about clinical effectiveness. And Carolyn Clancy, AHRQ's longtime director, has called for the use of EHRs in medical research.

If PCORI does sponsor these kinds of trials for some types of research, EHR vendors may have to modify their products to produce the requisite kinds of data. Or perhaps they will create special versions of their EHRs for physicians and institutions that wish to engage in clinical trials. In any case, this research could help answer questions--especially about subgroups of patients and comorbidities--that conventional research rarely looks at.

Meanwhile, the Centers for Medicare and Medicaid Research (CMS) recently proposed the creation of a multi-payer claims database to do comparative effectiveness research from a different angle.

To learn more:
- read the NEJM paper on PCORI
- see an independent analysis of PCORI's goals
- check out this study on practical clinical trials
- see Clancy's paper on the use of EHRs in research

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