ATLANTA, Ga. (Nov. 19, 2013) – The Patient-Centered Outcomes Research Institute (PCORI) today issued its revised PCORI Methodology Report, which offers minimal requirements for following best practices in the conduct of scientifically valid patient-centered outcomes research (PCOR).

During its latest public meeting in Atlanta yesterday, 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. The report provides context for PCORI’s Methodology Standards, which set forth baseline requirements for clinical comparative effectiveness research centered on questions and results that matter most to patients, clinicians, and other end-users of research findings. The report includes stories and examples that illustrate different ways that good methodology makes a difference to patients and their care.

The Board also approved minor editorial revisions to the standards, which had previously been revised in response to the public comments and published in December 2012. Applicants for PCORI funding have been required to follow the standards starting with the August 2013 cycle of PCORI Funding Announcements.

"The publication of this report, which benefited greatly from the comments received from across the healthcare community, is a major achievement,” said PCORI Executive Director Joe Selby, MD, MPH. “The members of the Committee, the PCORI staff who supported them, and all of those who offered useful comments, have provided not just the research community but the healthcare system as a whole with a valuable reference. We owe all of them our thanks.”

Both PCORI and its Methodology Committee expect the Methodology Standards to evolve over time based on ongoing input from the healthcare community.

“The report and standards establish a foundation for best practices for the conduct of patient-centered outcomes research, outlining why methods matter,” said Committee Chair Robin Newhouse, PhD, RN, Professor and Chair of Organizational Systems and Adult Health at the University of Maryland School of Nursing. “We encourage all who support, develop, and conduct health research to adopt them as their own. And we are committed to efforts to expand and refine the standards over time to address the full spectrum of patient-centered research inquiries and approaches.”

As part of that effort, Committee members and PCORI staff will start working with organizations and institutions across the healthcare community to seek input on how to most effectively promote wider use of the standards through the development of training, implementation tools, and other resources. The hope is that the community, as it makes use of the report and standards, will regularly suggest ways to improve them. At the same time, the Committee and PCORI staff will continue working to identify areas where new standards might be needed or where current standards need revision.

The standards provide a common set of expectations about the characteristics of high-quality PCOR. The 47 standards include several that guide researchers on the inclusion of relevant patients and other stakeholders in the research process and the use of outcomes that are meaningful to these end-users of study results. Development of the standards and Methodology Report drew on the expertise of dozens of individuals and organizations, including the National Institutes of Health and the Agency for Healthcare Research and Quality, both of which have representatives on the Methodology Committee and whose directors serve on PCORI’s Board of Governors.

Additional Resources for More Information

• Full Report and Report Appendices
• What Key Leaders Are Saying About the PCORI Methodology Report and Standards

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About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.