Knowledge translation concerns for the CONSORT-PRO extension reporting guidance: a review of reviews

Rebecca Mercieca-bebber; Olalekan Lee Aiyegbusi; Madeleine T. King; Michael Brundage; Claire Snyder; Melanie Calvert

doi:10.1007/s11136-022-03119-w

Knowledge translation concerns for the CONSORT-PRO extension reporting guidance: a review of reviews

Rebecca Mercieca-bebber, Olalekan Lee Aiyegbusi, Madeleine T. King, Michael Brundage, Claire Snyder, Melanie Calvert

Applied Health Research

Research output: Contribution to journal › Review article › peer-review

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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
Pages (from-to)	2939-2957
Number of pages	19
Journal	Quality of Life Research
Volume	31
Issue number	10
DOIs	https://doi.org/10.1007/s11136-022-03119-w
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

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Mercieca-BebberR2022KnowleFinal published version, 696 KBLicence: Creative Commons: Attribution (CC BY)

Cite this

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title = "Knowledge translation concerns for the CONSORT-PRO extension reporting guidance: a review of reviews",

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{\textquoteright}s release did not report recommended CONSORT-PRO items, which may lead to misinterpretation and consequently to research waste.",

keywords = "CONSORT-PRO, Patient-reported outcomes, Quality of life, Reporting, Research methodology, Research waste",

author = "Rebecca Mercieca-bebber and Aiyegbusi, {Olalekan Lee} and King, {Madeleine T.} and Michael Brundage and Claire Snyder and Melanie Calvert",

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: {\textcopyright} 2022, The Author(s).",

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AU - Brundage, Michael

AU - Snyder, Claire

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N1 - 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).

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N2 - 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.

AB - 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.

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Knowledge translation concerns for the CONSORT-PRO extension reporting guidance: a review of reviews

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

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