Methodological standards and patient-centeredness in comparative effectiveness research: The PCORI perspective

Ethan Basch, Naomi Aronson, Alfred Berg, David Flum, Sherine Gabriel, Steven N. Goodman, Mark Helfand, John P.A. Ioannidis, Michael Lauer, David Meltzer, Brian Mittman, Robin Newhouse, Sharon Lise Normand, Sebastian Schneeweiss, Jean Slutsky, Mary Tinetti, Clyde Yancy

Research output: Contribution to journalReview articlepeer-review

200 Scopus citations


Rigorous methodological standards help to ensure that medical research produces information that is valid and generalizable, and are essential in patientcentered 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.

Original languageEnglish (US)
Pages (from-to)1636-1640
Number of pages5
Issue number15
StatePublished - Apr 18 2012
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)


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