The PROTEUS Consortium is partnering with key patient, clinician, research, and regulatory groups from the U.S. and internationally to promote systematic use of methodologic tools developed to optimize the design, analysis, reporting, and interpretation of PROs in clinical trials. These methodologic tools are found in links below. Each link provides a brief overview of the tool, provides a link to its source, and provides additional resources (where available) to help apply the tool in practice.
Standard Protocol Items: Recommendations for Interventional Trials-PRO Extension (SPIRIT-PRO)
The SPIRIT-PRO Extension recommends best practices for writing the PRO aspects of randomized controlled trial protocols. It is an extension of the general 2013 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidance that identified the minimum elements required in clinical trial protocols, generally [https://www.spirit-statement.org/]. The SPIRIT-PRO Extension builds on the general SPIRIT guidance by addressing the minimum elements related to PROs that should be included in clinical trial protocols.
Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT; the SPIRIT-PRO Group. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: The SPIRIT-PRO Extension. JAMA. 2018;319:483-494.
View Checklist for using SPIRIT-PRO
ISOQOL Minimum Standards for PRO Measures in Patient-Centered and Comparative Effectiveness Research
In 2013, the International Society for Quality of Life Research (ISOQOL) conducted a project to recommend minimum standards for PRO measures to be used in patient-centered outcomes and comparative effectiveness research. These standards can inform the selection of the PRO measures for these research studies.
Reeve BB, Wyrwich KW, Wu AW, Velikova G, Terwee CB, Snyder CF, Schwartz C, Revicki D, Moinpour CM, McLeod LD, Lyons JC, Lenderking WR, Hinds PS, Hays RD, Greenhalgh J, Gerson R, Feeny D, Fayers PM, Cella D, Brundage M, Ahmed S, Aaronson NK, Butt Z. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Quality of Life Research. 2013;22:1889-1905.
Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) Consortium
The European Organization for the Research and Treatment of Cancer (EORTC) formed the SISAQOL Consortium to set international standards in analyzing patient-reported outcomes and quality of life endpoint data. SISAQOL provides a taxonomy of research objectives, outlines appropriate statistical methods for each objective, and advises on handling missing data.
Coens C, Pe M, Dueck AC, Sloan J, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro J, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn M, Velikova G, Bottomley A. International standards for the analysis of quality of life and patient reported outcomes endpoints in cancer randomised controlled trials: Recommendations based on critical reviews of the literature and international multi-expert, multi-stakeholder collaborative process. The Lancet Oncology. 2020;21:e83-96.
Consolidated Standards of Reporting Trials-PRO Extension (CONSORT-PRO)
The CONSORT guidance (Consolidated Standards of Reporting Trials) provides recommendations for publications reporting clinical trial results [http://www.consort-statement.org/]. In 2013, a PRO-specific extension was published that addresses the specific elements related to PRO endpoints that should be included in clinical trials publications.
Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309:814-822.
Stakeholder-Driven, Evidence-Based Standards for Presenting PROs in Clinical Practice
A specific issue related to the reporting of PRO clinical trial results is the best way to graphically report the findings so that patients and clinicians can easily and accurately interpret the PRO findings. To address this issue, stakeholder-driven, evidence-based recommendations for how to display PRO data to promote understanding and use have been developed.
View Primary Reference Article (see reference below)
Snyder C, Smith K, Holzner B, Rivera YM, Bantug E, Brundage M; PRO Data Presentation Delphi Panel. Making a picture worth a thousand numbers: Recommendations for graphically displaying patient-reported outcomes data. Quality of Life Research. 2019;28:345-356.
Clinicians Checklist for Reading and Using an Article about PROs
The Clinician’s Checklist for reading and using an article about PROs provides clinicians who are not expert in PRO research with guidance on how to use PRO findings in their practice.
Wu AW, Bradford AN, Velanovich V, Sprangers MAG, Brundage M, Snyder C. Clinician’s checklist for reading and using an article about patient-reported outcomes. Mayo Clinic Proceedings. 2014;89:653-661.
View Advanced Video: “Applying the PRO Findings in Practice – Advanced Clinician’s Guide”