Article

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.

Illustrates how PROs add value to clinical trials according to previously published descriptive frameworks. (JNCI 2022)

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 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,…

This article, in support of “Developing Protocols (Trials),” provides information to promote understanding of the recommended SPIRIT-PRO items, including a comprehensive protocol template.

Addresses the selection of patient-reported outcome measures for research studies by reviewing relevant publications and guidance documents. (Qual Life Res 2021)

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…

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.