JAMA: Theme Issue – Comparative Effectiveness Research

JAMA   
April 18, 2012, Vol 307, No. 15, pp 1555-1657
http://jama.ama-assn.org/current.dtl

Theme Issue: Comparative Effectiveness Research
Viewpoints
The Patient-Centered Outcomes Research Institute (PCORI) National Priorities for Research and Initial Research Agenda
Joe V. Selby, Anne C. Beal, Lori Frank
JAMA. 2012;307(15):1583-1584.doi:10.1001/jama.2012.500

Extract
The Patient Protection and Affordable Care Act of 2010 created the Patient-Centered Outcomes Research Institute (PCORI) to fund and promote comparative clinical effectiveness research (CER) that will “assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis.”1 CER is not a new concept,2,3 but appreciation of its potential for providing patients and their clinicians with uniquely valuable information on what works, tailored to the clinical situation and to patient priorities, has increased rapidly in recent years.

The research institute founded by this legislation was named to emphasize the critical importance of a patient-centered perspective in conducting this research.4 The PCORI Board of Governors determined early on that taking this …

Special Communication
Methodological Standards and Patient-Centeredness in Comparative Effectiveness Research: The PCORI Perspective
Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI)
JAMA. 2012;307(15):1636-1640.doi:10.1001/jama.2012.466

Abstract
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.

Editorials
Is It Time for Medicine-Based Evidence?
John Concato

Comparative Effectiveness Research: Relative Successes
Robert M. Golub, Phil B. Fontanarosa