Chair: Kevin Weinfurt, Emily O’Brien
NIH Representatives: Susan Czajkowski, William Riley
Members: Emine Bayman, Arne Beck, M. Fernanda Bellolio, Andrea Cheville, Leslie Crofford, Carol Greco, Erik Hess, Tamara Isakova, Chris Knoepke, Margaret Kuklinski, Amy Loree, William Maixner, Bret Moran, Tuhina Neogi, Pamela Peterson, Karen Sherman, Stacy Sterling, Jon Tilburt, James Tulsky, Doug Zatzick
Project Manager: MariJo Mencini
Patient-reported outcome (PRO) data are defined by the FDA as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” These data are increasingly used to inform and guide patient-centered care, clinical decision-making, and health policy decisions and are an important component of many of the Collaboratory’s Demonstration Projects.
The Patient-Centered Outcomes Core works closely with the Collaboratory to create guidelines and define best practices with respect to
Selecting, compiling, and curating the most appropriate PRO measures (and stimulating the development of new instruments when new solutions are needed)
Creating efficient, high-quality PRO data collection systems compatible with electronic health records and registries
Conducting statistical analyses of PRO endpoints
As part of this work, the Core conducts interviews with clinicians and other investigators using PROs, including Demonstration Project principle investigators, to determine how PROs are currently used in the field, brainstorm solutions to challenges, and monitor progress with PRO implementation and data collection.
The Core has written a PROs Living Textbook chapter, a white paper Strategies for Overcoming Barriers to Patient-Reported Outcomes Measures, and a chapter on including PROs in registries as a part of the AHRQ handbook on registries. It also helped lead the development of an Effectiveness Guidance Document (EGD) for incorporating PROs into comparative effectiveness research in adult oncology and held a workshop to help clinicians implement the NIH Patient Reported Outcomes Measurement Information System (PROMIS). Upcoming publications include a Practical Guide to Initiating and Implementing Patient-Reported Outcomes Measures.
Kevin Weinfurt, PhD, of Duke University, and Kathryn Flynn, PhD, of the Medical College of Wisconsin, discuss patient-reported health measures as endpoints in pragmatic clinical trials.
Products and Publications
Case Studies from the Clinic: Initiating and Implementing Patient-Reported Outcome Measures (Locklear, et al. eGems. 2017)