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Special Communication
Clinician's Corner
April 18, 2012

Methodological Standards and Patient-Centeredness in Comparative Effectiveness Research: The PCORI Perspective

Author Affiliations

Members of the Methodology Committee of PCORI: Ethan Basch, MD, MSc (Memorial Sloan-Kettering Cancer Center, New York, New York); Naomi Aronson, PhD (Blue Cross Blue Shield Association, Chicago, Illinois); Alfred Berg, MD, MPH (University of Washington, Seattle); David Flum, MD, MPH (University of Washington, Seattle); Sherine Gabriel, MD, MSc (chair, Mayo Clinic, Rochester, Minnesota); Steven N. Goodman, MD, MHS, PhD (Stanford University, Stanford, California); Mark Helfand, MD, MS, MPH (Portland VA Medical Center, Portland, Oregon); John P. A. Ioannidis, MD, DSc (Stanford University, Stanford, California); Michael Lauer, MD (National Heart, Lung, and Blood Institute, Bethesda, Maryland); David Meltzer, MD, PhD (University of Chicago, Chicago, Illinois); Brian Mittman, PhD (Department of Veterans Affairs, Sepulveda, California); Robin Newhouse, PhD, RN (University of Maryland, Baltimore); Sharon-Lise Normand, MSc, PhD (vice chair, Harvard Medical School and Harvard School of Public Health, Boston, Massachusetts); Sebastian Schneeweiss, MD, ScD (Harvard Medical School, Boston, Massachusetts); Jean Slutsky, PA, MSPH (Agency for Healthcare Research and Quality, Rockville, Maryland); Mary Tinetti, MD (Yale University, New Haven, Connecticut); and Clyde Yancy, MD, MSc (Northwestern University, Chicago, Illinois).

JAMA. 2012;307(15):1636-1640. doi:10.1001/jama.2012.466

Rigorous methodological standards help to ensure that medical research produces information that is valid and generalizable, and are essential in patient-centered outcomes research (PCOR). Patient-centeredness refers to the extent to which the preferences, decision-making needs, and characteristics of patients are addressed, and is the key characteristic differentiating PCOR from comparative effectiveness research. The Patient Protection and Affordable Care Act signed into law in 2010 created the Patient-Centered Outcomes Research Institute (PCORI), which includes an independent, federally appointed Methodology Committee. The Methodology Committee is charged to develop methodological standards for PCOR. The 4 general areas identified by the committee in which standards will be developed are (1) prioritizing research questions, (2) using appropriate study designs and analyses, (3) incorporating patient perspectives throughout the research continuum, and (4) fostering efficient dissemination and implementation of results. A Congressionally mandated PCORI methodology report (to be issued in its first iteration in May 2012) will begin to provide standards in each of these areas, and will inform future PCORI funding announcements and review criteria. The work of the Methodology Committee is intended to enable generation of information that is relevant and trustworthy for patients, and to enable decisions that improve patient-centered outcomes.

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