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 it includes stories and examples that illustrate different ways that good methodology makes a difference to patients and their care.
Read what key leaders are saying about the report and standards.
The PCORI Methodology Report
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.
Appendix A: PCORI Methodology Standards
This appendix shows PCORI’s set of 47 methodology standards. All research programs need to adhere to best practices in the planning, design, and conduct of every research project for the findings to be considered reliable and worth adoption. The methodology standards specify the minimal requirements for best practices in the design and conduct of patient-centered outcomes research.
Appendix B: Response to Public Comments
PCORI solicited input from stakeholders on a draft of this report from July to September 2012. This appendix acknowledges and incorporates that feedback.
Appendix C: Recommended Actions and Research Recommendations
In conjunction with the creation of the draft methodology report and standards, PCORI’s Methodology Committee developed a set of recommended actions and research. This appendix addresses this data.
Appendix D: The PCORI Methodology Committee’s Approach to the Authorizing Legislation
PCORI’s authorizing legislation directed the Methodology Committee to pursue the creation of a translation table, development of methodological standards for research, and generation of recommendations to promote adherence to the methodological standards. This appendix explores the committee’s commitment to these goals.
Appendix E: Translation Framework
This appendix is an illustration of PCORI’s translation framework.
Appendix F: References
Appendix G: Contributors
Appendix H: Glossary
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 (published November 19, 2013)
- Proposed Revisions to the Methodology Standards by the Methodology Committee (published November 19, 2013)
- PCORI Methodology Committee Research Recommendations (as presented to the Board November 19, 2013, and published December 14, 2013)
Posted: November 19, 2013; Updated: July 15, 2014