Background: Patients and clinicians value information regarding the impact of disease and treatment from the perspective of patients, so patient-reported outcome (PRO) assessments are a critical aspect of clinical trials. However, the PRO results from clinical trials can only be used by patients and their clinicians if they are measured appropriately and reported clearly. With funding from PCORI and others, methodologic tools to improve the assessment and interpretation of PROs in clinical trials have been developed. These tools require a coordinated and stakeholder-driven implementation and dissemination strategy to ensure that they are fully applied in practice.

Proposed Solution to the Problem: The project team proposes to form the PROTEUS Consortium (Patient-Reported Outcomes Tools: Engaging Users & Stakeholders). The PROTEUS Consortium aims to partner with key patient, clinician, research, and regulatory groups from the United States and around the world to promote the application of the methodologic tools developed to optimize the assessment and reporting of PROs in clinical trials.

Objectives: The long-term objective of PROTEUS is to ensure that patients and their clinicians have the information they need from the patient perspective to make the best decisions they can about treatment options. To accomplish this objective, PROTEUS will engage key stakeholder groups to promote the implementation and dissemination of methodologic tools that have been developed to optimize the assessment and reporting of PROs in clinical trials.

Activities: PROTEUS will engage key stakeholder organizations and will work with each consortium partner individually (primarily by conference call) to develop specific strategies for disseminating and implementing the PRO tools in its particular context. The PROTEUS Consortium will then meet in person to develop general strategies for disseminating and implementing the PRO tools across stakeholders.

Outcomes and Outputs (projected): PROTEUS is expected to promote the optimal design and reporting of clinical trials that produce the information from the patient perspective patients and clinicians need to make healthcare decisions. It will accomplish this objective by bringing together the diverse stakeholders engaged in the design, implementation, and use of PROs in clinical trials, and working with these consortium members to develop individualized and general strategies for implementation and dissemination of the methodologic tools developed to guide PRO assessment and reporting.

Patient and Stakeholder Engagement plan: The key stakeholders for this project are patients (end users of PRO data from clinical trials), clinicians (who counsel patients about the PRO impacts of different treatments), researchers (who conduct clinical trials), and other healthcare decision makers. The project team includes a patient advocate, a cancer clinician, and PRO researchers who have been involved in developing the methodologic tools PROTEUS will disseminate.

The project team stakeholders will partner with the consortium members to promote patient-centered clinical trials through the application of these tools.

Project Collaborators: The project team will work with key cancer patient groups, clinician groups, research groups, and government groups.