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)
PowerPoint
Insights for Biostatisticians on PRO Data in Clinical Trials
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
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,…
PowerPoint
Reporting the PRO Results Clearly – The CONSORT PRO Extension: Overview
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
Website
ePROs in Clinical Care
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.
Handbook Chapter
Applying Findings (Trials): Handbook Chapter
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).
Handbook Chapter
Displaying Results (Trials): Handbook Chapter
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).
Handbook Chapter
Reporting Data (Trials): Handbook Chapter
The “Reporting Data (Trials): Handbook Chapter” resource is an excerpt of the PROTEUS-Trials Handbook summarizing the recommendations for reporting PRO components of research studies. View the entire Handbook here (US version) or here (UK version).
Handbook Chapter
Analyzing Data (Trials): Handbook Chapter
The “Analyzing Data (Trials): Handbook Chapter” resource is an excerpt of the PROTEUS-Trials Handbook summarizing the preliminary SISAQOL recommendations for PRO data analysis; work is continuing via the SISAQOL-IMI initiative. View the entire Handbook here (US version) or here (UK version).
Handbook Chapter
Selecting Measures (Trials): Handbook Chapter
The “Selecting Measures (Trials): Handbook Chapter” resource is an excerpt of the PROTEUS-Trials Handbook summarizing the recommendations for selecting PRO measures in research studies. View the entire Handbook here (US version) or here (UK version).
Handbook Chapter
Developing Protocols (Trials): Handbook Chapter
The “Developing Protocols (Trials): Handbook Chapter” is an excerpt of the PROTEUS-Trials Handbook that describes the SPIRIT-PRO guidance for addressing the minimum elements related to PROs that should be included in clinical trial protocols. View the entire Handbook here (US version) or here (UK…
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,…