The PROTEUS-Trials Consortium: optimizing the use of patient-reported outcomes in clinical trials

Claire Snyder, Norah L. Crossnohere, Madeleine King, Bryce B. Reeve, Andrew Bottomley, Melanie Calvert, Elissa Thorner, Albert W Wu, Michael Brundage, PROTEUS-Trials Consortium

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Background: The assessment of patient-reported outcomes (PROs) in clinical trials has enormous potential to promote patient-centered care, but for this potential to be realized, the PROs must be captured effectively and communicated clearly. Over the past decade, methodologic tools have been developed to inform the design, analysis, reporting, and interpretation of PRO data from clinical trials. We formed the PROTEUS-Trials Consortium (Patient-Reported Outcomes Tools: Engaging Users & Stakeholders) to disseminate and implement these methodologic tools.
Methods: PROTEUS-Trials is engaging with patient, clinician, research, and regulatory stakeholders from 27 organizations in the US, Canada, Australia, the UK, and Europe to develop both organization-specific and cross-cutting strategies for implementing and disseminating the methodologic tools. Guided by the Knowledge-to-Action framework, we conducted Consortium-wide webinars and meetings, as well as individual calls with participating organizations, to develop a workplan, which we are currently executing.
Results: Six methodologic tools serve as the foundation for PROTEUS-Trials dissemination and implementation efforts: the SPIRIT-PRO Extension for writing protocols with PROs, the International Society for Quality of Life Research Minimum Standards for selecting a PRO measure, SISAQOL Consortium recommendations for PRO data analysis, the CONSORT-PRO extension for reporting clinical trials with PROs, recommendations for the graphic display of PRO data, and a Clinician’s Checklist for reading and using an article about PROs. The PROTEUS-Trials website ( serves as a central repository for the methodologic tools and associated resources. To date, we have developed (1) a roadmap to visually display where each of the six methodologic tools applies along the clinical trial trajectory, (2) web tutorials that provide guidance on the methodologic tools at different levels of detail, (3) checklists to provide brief summaries of each tool’s recommendations, (4) a handbook to provide a self-guided approach to learning about the tools and recommendations, and (5) publications that address key topics related to PROs in clinical trials. We are also conducting organization-specific activities, including meetings, presentations, workshops, and webinars to publicize the existence of the methodologic tools and the PROTEUS-Trials resources. Work to develop communications strategies to ensure that PROTEUS-Trials reaches key audiences with relevant information about PROs in clinical trials and PROTEUS-Trials is ongoing.
Discussion: The PROTEUS-Trials Consortium aims to help researchers generate PRO data from clinical trials to (1) enable investigators, regulators, and policy-makers to take the patient perspective into account when conducting research and making decisions; (2) help patients understand treatment options and make treatment decisions; and (3) inform clinicians’ discussions with patients regarding treatment options. In these ways, the PROTEUS Consortium promotes patient-centered research and care.

Original languageEnglish
JournalClinical Trials
Publication statusAccepted/In press - 6 Jan 2022


  • patient-reported outcomes
  • clinical trials
  • reporting methods
  • protocols
  • measure selection
  • data visualization


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