Article
A framework for implementing patient-reported outcomes in clinical care: The PROTEUS-practice guide
This Correspondence summarizes the PROTEUS-Practice Guide and its comprehensive guidance on optimizing the use of PROs in clinical practice.
Article
Patient-Reported Outcomes, Digital Health, and the Quest to Improve Health Equity
This article, in support of PROTEUS-Practice, highlights the benefits of ePROs for clinical care and outcomes, and outlines key resources of the PROTEUS Consortium that support implementation of PROs in clinical practice. Citation Information Pritchett JC, Patt D, Thanarajasingam G,…
Article
Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines
This article, in support of “Developing Protocols (Trials),” outlines ethical issues that should be addressed in the design and review of clinical research studies with PRO endpoints.
Article
Listening to the Patient Voice Adds Value to Cancer Clinical Trials
This article, in support of “Applying Findings (Trials),” focuses on how PROs add value to clinical trials by representing the patient voice by employing two previously published descriptive frameworks (addressing how PROs are used in clinical trials and how PROs…
Article
Patient-Reported Outcomes in Randomized Clinical Trials: Development of ISOQOL Reporting Standards
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,…
Article
“Give Us the Tools!” – Development of Knowledge Transfer Tools to Support the Involvement of Patient Partners in the Development of Clinical Trial Protocols with PROs, in Accordance with SPIRIT-PRO
This article, in support of “Developing Protocols (Trials),” adapts the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-Patient-Reported Outcome (PRO) Extension guidance to a user-friendly format for patient partners. Citation Information Cruz Rivera S, Stephens R, Mercieca-Bebber R, Retzer A,…
Article
Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension
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…
Article
Overview Commentary: The PROTEUS-Trials Consortium: Optimizing the Use of Patient-Reported Outcomes in Clinical Trials
This article, in support of “Study Design” and “Study Reporting,” describes the founding of the PROTEUS-Trials Consortium (Patient-Reported Outcomes Tools: Engaging Users and Stakeholders) for the dissemination and implementation of methodologic tools to inform the design, analysis, reporting, and interpretation…
Article
Recommendations for Including or Reviewing Patient-Reported Outcome Endpoints in Grant Applications Article
This article, in support of “Study Design,” provides practical recommendations from an international consortium of experts on patient reported outcomes to inform grant applicants in preparing their research strategies and grant reviewers in evaluating applications.
Article
SPIRIT-PRO Extension Explanation and Elaboration: Guidelines for Inclusion of Patient-Reported Outcomes in Protocols of Clinical Trials
This article, in support of “Developing Protocols (Trials),” provides information to promote understanding of the recommended SPIRIT-PRO items, including a comprehensive protocol template.
Article
International Guidance on the Selection of Patient-Reported Outcome Measures in Clinical Trials: A Review
This resource, in support of “Selecting Measures (Trials),” reviews publications and guidance documents addressing the selection of PRO measures for research studies and evaluates the consistency of their recommendations. Citation Information Crossnohere NL, Brundage M, Calvert MJ, King M, Reeve…
Article
International Standards for the Analysis of Quality-of-Life And Patient-Reported Outcome Endpoints in Cancer Randomized Controlled Trials: Recommendations of the SISAQOL Consortium
This article, in support of “Analyzing Data (Trials),” presents the SISAQOL recommendations for PRO analysis, as well as ongoing developments around these recommendations.