Article
Listening to the Patient Voice Adds Value to Cancer Clinical Trials
Illustrates how PROs add value to clinical trials according to previously published descriptive frameworks. (JNCI 2022)
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
Describes the founding of PROTEUS and its work to guide and strengthen the use of PROs in clinical trials. (Clin Trials 2022)
Article
Recommendations for Including or Reviewing Patient-Reported Outcome Endpoints in Grant Applications
Provides practical recommendations for grant applicants and grant reviewers about the key information that should be included in applications that include PROs. (BMJ 2021)
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
Addresses the selection of patient-reported outcome measures for research studies by reviewing relevant publications and guidance documents. (Qual Life Res 2021)
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.
Article
Engaging Patients and Other Non-Researchers in Health Research: Defining Research Engagement
This article, in support of “PROTEUS-Practice,” provides measurable actions for defining research engagement amongst patient populations for use in PROs. Citation Information Frank L, Morton SC, Guise JM, Jull J, Concannon TW, Tugwell P; Multi Stakeholder Engagement (MuSE) Consortium. Engaging…
Article
Engaging Stakeholders to Improve Presentation of Patient-Reported Outcomes Data in Clinical Practice
This article, in support of “Displaying Results (Trials),” describes a stakeholder engaged process to develop improved formats for visualizing individual-level PRO data (for patient monitoring) and group-level PRO data (for reporting comparative clinical studies) in clinical practice.
Article
In Proportion: Approaches for Displaying Patient-Reported Outcome Research Study Results as Percentages Responding to Treatment
This article, in support of “Displaying Results (Trials),” reports the results of the pivotal study evaluating accuracy of interpretation and clarity of PRO formats for visualizing the proportions responding to treatment in educational materials and decision aids for patients. Citation…