This article, in support of “Developing Protocols (Trials),” aims to improve the completeness of trial protocols by providing recommendations for the PRO-specific information that should be addressed. Citation Information Calvert M, Kyte D, Mercieca-Bebber R, et al. Guidelines for Inclusion…
The PROTEUS Guide to Implementing Patient-Reported Outcomes in Clinical Practice: A Synthesis of Resources (the PROTEUS-Practice Guide) can help you design, implement, and manage patient-reported outcome (PRO) systems and related data in clinical care settings. The information in the PROTEUS-Practice…
This resource, in support of “Developing Protocols (Trials),” aims to promote implementation and use of the SPIRIT- PRO Extension for trials where PROs are a primary or key secondary outcome. The template is also recommended for use where PROs are…
This resource, in support of “Reporting Data (Trials),” aims to promote implementation and use of the CONSORT-PRO Extension for trials where PROs are primary or key secondary outcomes. The template is also recommended for use where PROs are exploratory outcomes.
This video, in support of “PROTEUS Trials” and “PROTEUS Practice,” offers an overview of the goals and resources offered by The PROTEUS Consortium. Co-PI’s Claire Snyder and Michael Brundage describe the core resources and unique tools available to support the…
Illustrates how PROs add value to clinical trials according to previously published descriptive frameworks. (JNCI 2022)
This powerpoint, a resource supporting “Study Design (Trials)” provides information particularly relevant for biostatisticians when designing studies, analyzing data, and reporting results related to PROs in clinical trials. Prepared by: Madeleine King, PhD
This resource, developed by the International Society for Quality of Life Research and in support of Reporting Data (Trials), provides information on standards for reporting health-related quality of life outcomes in randomized clinical trials. Citation Information: Brundage M, Blazeby J,…
This powerpoint, in support of “Reporting Data (Trials),” describes the recommended information about PRO endpoints to include in clinical trial publications. Presented by: Melanie Calvert, PhD; Michael Brundage, MD, MSc
This website, established by the CERTAIN initiative and supporting “PROTEUS-Practice,” provides evidence-based guidelines and tools that facilitate the successful integration of electronic patient-reported outcomes (ePROs) and electronic health record (EHR) data to inform clinical care.
The “Applying Findings (Trials): Handbook Chapter” is an excerpt of the PROTEUS-Trials Handbook summarizing the checklist items for clinicians to consider when evaluating articles with PROs. View the entire Handbook here (US version) or here (UK version).
The “Displaying Results: Handbook Chapter” is an excerpt of the PROTEUS-Trials Handbook summarizing the recommendations for visualization of PRO data to promote understanding and use by patients and clinicians. View the entire Handbook here (US version) or here (UK version).
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