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Washington Highlights

AAMC Comments on PCORI’s Draft Methodology Report

September 7, 2012—The AAMC Aug. 27 submitted comments  on the Patient-Centered Outcomes Research Institute (PCORI)’s Draft Methodology Report, “Our Questions, Our Decisions: Standards for Patient-Centered Outcomes Research.” The report was required by the Affordable Care Act (P.L. 111-148, P.L. 111-152), which established PCORI. The report describes methodologies to prioritize the patient’s perspective in all phases of research. This approach is intended to produce trusted information and lead to better healthcare decisions, and ultimately to better health. Future reports will address the perspectives of clinicians, healthcare purchasers, and policy-makers in more detail.

The AAMC congratulates the PCORI Methodology Committee for “generating an exceptional draft first report.” Among its specific comments, the AAMC notes that given the multiple terms applied to research that may be considered patient-centered it would be a great service if the Methodology Committee proposed a formal taxonomy to guide researches and other stakeholders in the appropriate application of terminology.

The comment letter also suggests that subsequent iterations of the report stress that PCORI-funded research is expected to explicitly and fully analyze patterns of missing data to ensure rigor in identifying subgroups of patients (e.g., by gender, race/ethnicity, or socioeconomic status) ― those vulnerable subgroups most likely to attrite from research studies. AAMC also recommends that a specific standard be strengthened so that methodological efforts to ensure the precision and power of a study to reach conclusions about subgroups of interest are incentivized and positively weighted in the review criteria, rather than being optional or only done when “feasible,” unless compelling evidence is presented for excluding such an analysis.

The AAMC specifically supports the inclusion of health equity and disparities as an important content area, but notes that while successful inclusion of diverse patient populations is critical, it is only one approach to reducing disparities. The AAMC encourages future Methodology Reports to focus more specifically on the methodological and theoretical challenges associated with research to narrow and eradicate health disparities.

Comments on the Methodology Committee’s response are due Sept. 14.

Contact:

Philip M. Alberti, PhD
Senior Director, Health Equity Research and Policy
Telephone: 202-828-0522
Email: palberti@aamc.org

Ellen Salkeld, Ph.D.
Senior Lead Specialist for Implementation Science
Telephone: 202-741-6460
Email: esalkeld@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org