Principles for the Consideration of the Full Range of Outcomes Data

 , October 05, 2020

The Society of General Internal Medicine (SGIM) is a member-based internal medical association of more than 3,300 of the world’s leading academic general internists dedicated to improving the access to care for all populations, eliminating healthcare disparities and enhancing medical education. SGIM's mission is to cultivate innovative educators, researchers, and clinicians in academic  general internal medicine, leading the way to better health for everyone. The members of the Society advance the practice of medicine through their commitment to
providing comprehensive, coordinated and cost-effective care to adults, educating the next generation of outstanding physicians, and conducting cutting-edge research to improve qualityof care and clinical outcomes of all patients.

SGIM supports the proposed principles, specifically the addition of economic analyses to clinical studies. For many patients the costs and economic consequences of their medical care are important considerations as they work with their physicians to choose treatments and evaluate the likely outcomes of those choices. Including these elements in PCORI-sponsored studies will  allow the portfolio to be more patient-centered over time by providing patients and other stakeholders with rigorous analyses of these highly relevant outcomes. We understand that the original statute supporting PCORI continues to restrict support for costeffectiveness analyses or the use of quality-adjusted-life-years as outcomes, and that these proposed principles would not allow for economic outcomes to be the primary outcomes for PCORI-supported research. Nevertheless, the principles as developed will improve what is already a high-quality portfolio.

We would suggest that PCORI add economic elements to the current methods portfolio, seeking to support studies of the most accurate ways to assess cost, economic burden, or economic benefit in a patient-centered manner. These new studies would be consistent with PCORI’s revised mandate and could also yield a better understanding of the types of economic analyses which PCORI will support in the future.

The Society of General Internal Medicine, which advocated for PCORI during its initial ten-year authorization and, again, in its recent reauthorization, is pleased to support these principles and pledges to continue to work with the Board and staff to advance patient-centered research in the years ahead.