Patient-Reported Outcomes

Our PRO Core will work closely with the PRO Workgroup and the Collaboratory Network to create guidelines and define best practices with respect to 1) selecting, compiling and curating the most appropriate PRO measures (and stimulating the development of new instruments when new solutions are needed); 2) providing guidance for the creation efficient, high-quality PRO data collection systems compatible with electronic health records (EHRs) and registries; and 3) conducting statistical analyses of PRO endpoints. These guidelines and practices will be harmonized and disseminated via the relevant Collaboratory Work Groups, including the Design/Statistical, Health Systems Interaction and Phenotype/Outcome Description groups.

Two important national efforts involving Drs. Abernethy and Weinfurt are already underway and will serve as immediate material for this aim. Together with Dr. Sean Tunis and others, Dr. Abernethy has helped lead the development of an Effectiveness Guidance Document (EGD) for incorporating PROs into comparative effectiveness research in adult oncology. EGDs provide clinical researchers and product developers with guidance on how to design clinical studies that will produce the evidence needed for decision making by the healthcare community. Payers and policymakers use EGDs as evidence standards that can be used when making reimbursement and coverage decisions. In addition, EGDs provide a research framework for researchers and funding agents in the area of promising medical technologies. Product developers, payers, clinicians, patient representatives, researchers, and other relevant experts participate directly in the development of EGDs through a multi-stakeholder workgroup process. A summary manuscript formalizes a broad-based recommendation for inclusion of PROs into CER trials including pragmatic clinical trials.

The other important addition is a new chapter on including PROs into registries as a part of the AHRQ handbook on registries. Led by Dr. Abernethy‟s team, this practical “how-to” guide translates guidelines and lessons learned into summary steps that can be incorporated by researchers. It demonstrates how our proposed Collaboratory Coordinating Center has day-to-day experience in supporting researchers as they develop trials and registries that include PROs, including those from the NIH PROMIS Network, the Center for Medical Technology Policy (CMTP; led by Sean Tunis), and the Agency for Healthcare Research and Quality (AHRQ). We will also draw on the FDA‟s guidance on PRO development and analysis in clinical trials, as well as the forthcoming report (May 2012) from the Patient-Centered Outcomes Research Institute (PCORI) on methodological standards for conducting patient-centered outcomes research.

Collaboratory Core and Working Group Members

​Core/Working Group ​Members ​Administrative Contacts
Patient-Reported Outcomes​ Amy Abernethy, Co-Chair
Kevin Weinfurt, Co-Chair
Susan Czajkowski, NIH Representative
Wiliam Riley, NIH Representative

Betsy Chrischilles
Gloria Coronado
Rick Deyo
Kathryn Flynn
Frank Keefe
Tracie Locklear
Dana Miskulin
Laura Criscione

Tracie Locklear

Naomi Pratt

Tammy Reece