PURPOSE: With the growing emphasis on patient-centeredness, patient-reported outcomes (PROs) are taking on increasing importance in research studies, clinical care, and policy-making. The PROTEUS Consortium (Patient-Reported Outcomes Tools: Engaging Users & Stakeholders) promotes rigorous PRO methods by partnering with stakeholders to disseminate and implement PRO methodologic guidance documents ("Tools"). This workshop will focus on the use of PROs in clinical research. It will describe PROTEUS and the relevant methodologic Tools, and provide industry, regulatory, and health technology assessment perspectives regarding the importance of PROs and how the PROTEUS Tools can promote patient-centered research and decision-making.

DESCRIPTION: The workshop will have four 12-minute presentations, followed by an interactive discussion with audience polling and questions-and-answers, and will be relevant to industry and academic researchers, policy-makers, and methodologists. Dr. Snyder will describe how PROTEUS and the Tools can be used to inform PRO methods for protocol writing, measure selection, analysis, reporting, and application in practice. She will also introduce the resources (e.g., checklists, web tutorials, handbook) that have been developed to facilitate dissemination and implementation of the PRO methodologic Tools. Ms. Nelsen will provide an industry perspective on how the PROTEUS Tools and resources can help address the challenges of incorporating PROs in clinical trials. Drs. Bhatnagar and Jonsson will discuss the evaluation of PRO data from the regulatory and health technology assessment perspectives, respectively, and how high-quality PRO data, as promoted by the PROTEUS Tools and resources, can inform decision-making. The workshop will conclude with a 12-minute interactive session with audience polling regarding the usefulness of the current PROTEUS Tools and resources and priorities for future resource development, as well as questions from the audience. After the session, attendees will be better positioned to conduct rigorous PRO research, thereby producing PRO data decision-makers can use to promote patient-centered care.