The PCORI Methodology Report

The PCORI Methodology Report provides minimal requirements to follow in the conduct of scientifically valid patient-centered outcomes research. The report addresses two legislative mandates: the development of methodology standards and development of a translation framework to guide the choice of study designs for specific research questions. It details the context and rationale for the PCORI Methodology Standards, published in late 2012, and most recently updated in March 2024. It includes stories and examples that illustrate different ways that good methodology makes a difference to patients and their care.

The PCORI Methodology Report includes an Executive Summary, an Introduction, and four sections:

• Section I: Patient-Centered Outcomes Research reviews the need for methodological standards in patient-centered outcomes research. The standards guide researchers to adopt approaches most likely to produce the high-quality and relevant evidence needed to inform health decisions.
• Section II: Identifying and Addressing Evidence Gaps in PCOR discusses the importance of a systematic process for prioritizing topics and determining which research designs can provide information that is both useful and timely. These activities align a program of patient-centered outcomes research with questions about what works best, for whom, and under what circumstances.
• Section III: PCORI Methodology Standards explains how PCORI developed and updated its set of 54 methodology standards, discusses each group of standards, and summarizes the justifications for the standards. These standards can improve the way research questions are selected and formulated, how studies are designed and analyzed to address these questions, and how findings are reported.
• Section IV: Advancing Understanding and Appropriate Use of Methods for PCOR emphasizes the role of the Methodology Standards in promoting transparency, which is a critical component of good research practices. Transparency enables other researchers to assess the reproducibility and validity of findings. This section also outlines the next steps for PCORI’s continued development of standards to support the design, conduct, analysis, and reporting of high-quality patient-centered outcomes research.

• View the 2017 version of the Methodology Report and Methodology Standards
• View the 2013 version of the Methodology Report and Methodology Standards
• Read what key leaders say about the report and standards

Draft Report and Background Materials

• Draft Methodology Report (Posted July 2012)
• Public comments on the Draft Methodology Report (Received July 23-September 14, 2012)
• Overview of the Methodology Committee’s Response to Public Comment
• Proposed Revisions to the Methodology Standards
  By the Methodology Committee (Published November 19, 2012)
• PCORI Methodology Committee Research Recommendations
  As presented to the Board November 19, 2012, and published December 14, 2012
• PCORI's First Methodology Report (Posted April 2013)

Posted: April 19, 2013; Updated: February 26, 2019