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 February 2019. 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 PCORI Methodology Report

Draft report and background materials:

PCORI’s First Methodology Report

Reports to Support the Development of the First Report

All statements in these reports, including their findings and conclusions, are solely those of the authors and do not necessarily represent the views of PCORI, its Board of Governors, or Methodology Committee. PCORI has not peer-reviewed or edited this content. The report is being made available free of charge for the information of the scientific community and general public as part of PCORI’s ongoing research programs. Questions or comments about this report may be sent to PCORI at [email protected].

Review of Guidance Documents for Selected Methods in Patient-Centered Outcomes Research

Review and Synthesis of Evidence for Eliciting the Patient's Perspective in Patient-Centered Outcomes Research

Expert Stakeholder Interviews to Identify Evidence for Eliciting the Patient’s Perspective in Patient-Centered Outcomes Research

Methods for Setting Priorities in Research

*The PCORI Methodology Standards were updated February 26, 2019, and are available here.
An updated Methodology Report will be posted in later in 2019.

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

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