Developing and improving the science and methods of patient-centered outcomes research (PCOR) is a central part of PCORI’s work. Better methods will produce more valid, trustworthy, and useful information that will lead to better healthcare decisions and, ultimately, to improved patient outcomes.
PCORI's Methodology Committee, in accordance with PCORI’s authorizing legislation, submitted to the Board of Governors on May 10, 2012, the first draft PCORI Methodology Report. After a 54-day public comment period, the report’s draft Methodology Standards were revised and adopted by the Board on November 19, 2012, then published on December 14, 2012. At its November 18, 2013, meeting, the Board of Governors approved minor editorial revisions to the standards. See the standards here.
PCORI considers the accomplishment of developing, refining, and finalizing these standards to be a critical step in advancing the field of PCOR. We look forward to working with our many stakeholders to see that these standards become a useful and valued resource for the entire healthcare community.
Proposed studies are required to adhere to relevant PCORI methodology standards, as published in December 2012. If a proposed study uses an approach or elements not covered by those standards, it should adhere to other currently accepted best practices. A variety of study designs and analytic methods may contribute valid new knowledge.
During its November 18, 2013, meeting, PCORI’s Board of Governors accepted the report presented by PCORI’s Methodology Committee, which was revised to address extensive feedback received from the healthcare community during a public comment period that followed the July 2012 release of a draft. To view the revised report and its appendixes, click on the titles below:
- The PCORI Methodology Report
- Appendix A: PCORI Methodology Standards
- Appendix B: Response to Public Comments
- Appendix C: Recommended Actions and Research Recommendations
- Appendix D: The PCORI Methodology Committee’s Approach to the Authorizing Legislation
- Appendix E: 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
- 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)
Articles of Interest
- Getting the Methods Right — The Foundation of Patient-Centered Outcomes Research, Sherine E. Gabriel, M.D., and Sharon-Lise T. Normand, Ph.D., New England Journal of Medicine, Aug. 30, 2012
- Toward Patient-Centered Drug Development in Oncology, Ethan Basch, MD, New England Journal of Medicine, Aug. 1, 2013.
- The Randomized Registry Trial — The Next Disruptive Technology in Clinical Research?, Michael S. Lauer, MD, and Ralph B. D'Agostino, Sr., PhD, New England Journal of Medicine, Sept. 1, 2013.
Posted September 21, 2013; Updated April 28, 2014