PCORI Issues Updated Standards Guiding Methods Used in Patient-Centered Outcomes Research

WASHINGTON, DC — The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today adopted the newest version of the PCORI Methodology Standards.

The updates include new standards on analysis of clustered data, inclusion of a formal study protocol in public data, and approaches to selection and usage of data networks, among other changes. The revised standards, which now total 48 covering 12 topic areas, are available here.

The PCORI Methodology Standards provide minimal requirements for the conduct of scientifically valid patient-centered outcomes research (PCOR). They address study design, analytic methods, and other critical practices in the conduct and reporting of PCOR studies and help to ensure that these studies generate trustworthy findings that patients, clinicians, and other healthcare stakeholders can rely on. 

“These standards provide critical direction to PCORI staff, PCORI-funded researchers, and the larger research community on advancing high-quality, patient-centered outcomes research,” said PCORI Executive Director Joe Selby, MD, MPH. “We remain committed to continuously reviewing these standards to reflect advances in the field of patient-centered comparative clinical effectiveness research.”

“Methods matter. Ensuring that PCORI-funded research produces valid and reliable results is an essential part of patient-centered outcomes research,” added Robin Newhouse, PhD, RN, Chair of PCORI’s Methodology Committee. “PCORI is committed to providing evidence that helps patients and their caregivers make healthcare decisions that work for them, it all starts with making sure the research methods are sound.”

In other business, the Board approved topics for new PCORI funding opportunities; more information is available here.