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 model for creating translation tables. It details the context and rationale for the PCORI Methodology Standards, published in late 2012, and updated in May 2017. It includes stories and examples that illustrate different ways that good methodology makes a difference to patients and their care.
On May 8, 2017, the PCORI Board of Governors adopted a major revision of our Methodology Standards, including the addition of a 12th category of standards. See the updated PCORI Methodology Standards. The PCORI Methodology Report is undergoing final revisions to reflect the updated standards.
The 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 lead to valuable conclusions.
Section II: Prioritizing Research Questions and Development of the Translation Table describes a systematic process to 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 its set of 47 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 to address these questions, and how findings are reported.
Section IV: The Context for Implementing the Methodology Standards and Next Steps considers transparency as the core of implementing the methodology standards. It enables other researchers to verify findings and protects against variables that could distort or misrepresent results. This section also explains the next steps for PCORI’s continued development of standards to support the design and conduct of patient-centered outcomes research.
Draft report and background materials:
- Draft Methodology Report (Posted July 23, 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)
Posted: November 19, 2013; Updated: May 8, 2017