Abstract
Abstract: This review of reviews aimed to appraise the use of the CONSORT-PRO Extension as an evaluation tool for assessing the reporting of patient-reported outcome (PROs) in publications, and to describe the reporting of PRO research across reviews. We also outlined how variation in such evaluations impacts knowledge translation and may lead to potential misuse of the CONSORT-PRO Extension. We systematically searched Medline, Pubmed and CINAHL from 2013 to 2025 March 2021 for reviews of the completeness of reporting of PRO endpoints according to CONSORT-PRO criteria. Two reviewers extracted details of each review, the percentage of included studies that addressed each CONSORT-PRO item, and key recommendations from each review. Fourteen reviews met inclusion criteria, and only six of these used the full CONSORT-PRO checklist with minimal justified modifications. The remaining eight studies made significant or unjustified adjustments to the CONSORT-PRO Extension. Review studies also varied in how they scored multi-component CONSORT-PRO items. CONSORT-PRO items were often unreported in trial reports, and certain CONSORT-PRO items were reported less often than others. The reporting of statistical approaches to dealing with missing PRO data were poor in RCTs included in all 14 review articles. Studies reviewing PRO publications often omitted recommended CONSORT-PRO items from their evaluations, which may cause confusion among readers regarding how best to report their PRO research according to the CONSORT-PRO extension. Many trials published since CONSORT-PRO’s release did not report recommended CONSORT-PRO items, which may lead to misinterpretation and consequently to research waste.
Original language | English |
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Pages (from-to) | 2939-2957 |
Number of pages | 19 |
Journal | Quality of Life Research |
Volume | 31 |
Issue number | 10 |
DOIs | |
Publication status | Published - 26 Mar 2022 |
Bibliographical note
Funding Information:Open Access funding enabled and organized by CAUL and its Member Institutions. RMB is supported by an NHMRC Early Career Fellowship, App1138100. OLA receives funding from the NIHR Birmingham Biomedical Research Centre (BRC), NIHR Applied Research Centre (ARC), West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation, Innovate UK (part of UK Research and Innovation), Gilead Sciences Ltd, and Janssen Pharmaceuticals, Inc. OLA declares personal fees from Gilead Sciences Ltd, GlaxoSmithKline (GSK) and Merck outside the submitted work. MC is Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient Reported Outcomes Research and is a National Institute for Health Research (NIHR) Senior Investigator. She receives funding from the NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR ARC West Midlands at the at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UK Research and Innovation), Macmillan Cancer Support, UCB and GSK Pharma. MC has received personal fees from Astellas, Takeda, Merck, Daiichi Sankyo, Glaukos, GSK and the Patient-Centered Outcomes Research Institute (PCORI) outside the submitted work. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, or the Department of Health and Social Care. CS has received consulting fees from Janssen, via Health Outcomes Solutions. PROTEUS previously received funding from the Patient-Centered Outcomes Research Institute (PCORI) and has continued funding from Genentech and Pfizer. CS and MB receive support for their leadership of the PROTEUS consortium; MC (PCORI, Genentech, Pfizer) and MK (PCORI, Genentech) receive honoraria for participating on the PROTEUS steering committee; MK has a subcontract from Johns Hopkins for PROTEUS-related work.
Publisher Copyright:
© 2022, The Author(s).
Keywords
- CONSORT-PRO
- Patient-reported outcomes
- Quality of life
- Reporting
- Research methodology
- Research waste
ASJC Scopus subject areas
- Public Health, Environmental and Occupational Health