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Report: PCORI Needs More Focus on Effectiveness Research

Joe Selby

Joe Selby, Executive Director, PCORI (A. Kotok)

24 January 2014. A report released today by Center for American Progress, a progressive think tank in Washington, D.C., calls for the organization formed to study comparative effectiveness of treatment options to focus more on the research for which it was created. The Patient-Centered Outcomes Research Institute (PCORI) was established in a provision of the 2010 health care reform law, known as the Affordable Care Act.

PCORI is a not-for-profit organization, whose mission is to conduct comparative effectiveness research, defined as research providing evidence for patients and health care providers to make more informed decisions about prevention, treatment, and care options, and the science behind those options. The Center’s report, whose authors include Ezekiel Emanuel, a professor of medical ethics at University of Pennsylvania and an author of the Affordable Care Act, says PCORI in the first four years of its existence spent too much of its resources on other tasks, and not generating the comparative effectiveness data needed by patients and clinicians.

PCORI, says the report, devoted less than 40 percent of its research funding on comparative effectiveness research. The organization, according to the report, started only a few studies comparing the effectiveness of drugs, and not one study of medical devices.

In addition, PCORI’s studies so far address barely half of the top priorities reported in a 2009 Institute of Medicine list of 100 issues for comparative effectiveness research to address. In its first four years, says the report, PCORI funded 34 studies addressing 12 of the top 25 issues listed by Institute of Medicine. Those 34 studies represent about 12 percent of the total 284 studies supported by PCORI.

More than 6 in 10 of PCORI’s dollars, says Center for American Progress, are so far going to studies of methodology and dissemination (38%) and communication tools and educational initiatives (25%). That leaves 37 percent for studies comparing two or more medical interventions, the primary purpose of comparative effectiveness research.

More than just research

At a meeting today at Center for American Progress to discuss the report, Joe Selby, PCORI’s executive director, defended the organization’s priorities. He said PCORI’s mandate is to “assist stakeholders in making informed decisions, through research, evidence, and dissemination of information,” thus more than just the conduct of studies.

To get the parties involved in health care to adopt the findings of comparative effectiveness research, said Selby, requires synthesizing the results of multiple studies and disseminating that information. Selby noted that a big part of that effort is engaging all the stakeholders through panels established by PCORI of patients, clinicians, and payers.

Selby also challenged the report’s calculations of PCORI’s distribution of resources. PCORI, said Selby, to date committed 62 percent of its research funding to comparative effectiveness studies, with 11 percent spent of methodological studies, 9 percent of communication and dissemination research, and 18 percent on studies of infrastructure.

Much of the infrastructure spending went to establishing PCORnet, a national network of clinical outcomes research. Selby said PCORnet is expected to collect data from clinical studies conducted by health care providers, as well as groups of patients who band together to share data on clinical outcomes, stored in a common data format. PCORI says it is funding 29 data collections so far — 11 from health care providers and 18 from patient groups — and a PCORnet coordinator.

In addition, Selby noted, PCORI — whose budget is expected to double this year — plans to fund 12 to 18 major studies, with each study expected to receive $10 to $15 million. The new research topics will be posted on the PCORI Web site on 8 February.

In a panel discussion to discuss the report, Emanuel said the goal of PCORI is not to change the research process, but “to get evidence and disseminate that evidence to change behavior.” He noted that the synthesis of data is important, but “the need for data is most important.”

Emanuel cited economic analyses showing 50 to 60 percent of health care costs over and above the rate of inflation are due to technology, which is a more important factor in accounting for the rise of costs than the aging of the population or increasing access to health care. “The goal of PCORI is to address technology,” Emanuel added.

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