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Systematic review of the use of translated patient-reported outcome measures in cancer trials

Systematic review of the use of translated patient-reported outcome measures in cancer trials
Systematic review of the use of translated patient-reported outcome measures in cancer trials

Background: Patient-reported outcomes (PROs) are used in clinical trials to assess the effectiveness and tolerability of interventions. Inclusion of participants from different ethnic backgrounds is essential for generalisability of cancer trial results. PRO data collection should include appropriately translated patient-reported outcome measures (PROMs) to minimise missing data and sample attrition. 

Methods: Protocols and/or publications from cancer clinical trials using a PRO endpoint and registered on the National Institute for Health Research Portfolio were systematically reviewed for information on recruitment, inclusion of ethnicity data, and use of appropriately translated PROMs. Semi-structured interviews were conducted with key stakeholders to explore barriers and facilitators for optimal PRO trial design, diverse recruitment and reporting, and use of appropriately translated PROMs. 


Results: Eighty-four trials met the inclusion criteria, only 14 (17%) (n = 4754) reported ethnic group data, and ethnic group recruitment was low, 611 (13%). Although 8 (57%) studies were multi-centred and multi-national, none reported using translated PROMs, although available for 7 (88%) of the studies. Interviews with 44 international stakeholders identified a number of perceived barriers to ethnically diverse recruitment including diverse participant engagement, relevance of ethnicity to research question, prominence of PROs, and need to minimise investigator burden. Stakeholders had differing opinions on the use of translated PROMs, the impact of trial designs, and recruitment strategies on diverse recruitment. Facilitators of inclusive research were described and examples of good practice identified.

 Conclusions: Greater transparency is required when PROs are used as primary or secondary outcomes in clinical trials. Protocols and publications should demonstrate that recruitment was accessible to diverse populations and facilitated by trial design, recruitment strategies, and appropriate PROM usage. The use of translated PROMs should be made explicit when used in cancer clinical trials.

Patient-reported outcomes (PROs), Patient-reported outcome measures (PROMs), Ethnicity, Recruitment, Cross-cultural translation, Clinical trials, Trial protocols, Primary outcomes, Secondary outcomes
1745-6215
306
Slade, A. L.
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Retzer, A.
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Ahmed, K.
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Kyte, D.
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Keeley, T.
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Armes, J.
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Brown, J. M.
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Calman, L.
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Gavin, A.
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Glaser, A. W.
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Greenfield, D. M.
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Lanceley, A.
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Taylor, R. M.
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Velikova, G.
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Turner, G.
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Calvert, M. J.
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Slade, A. L.
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Retzer, A.
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Ahmed, K.
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Kyte, D.
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Keeley, T.
ceb9ee0d-105d-44dd-b3cf-6e69cf41c630
Armes, J.
162c2c72-239b-425d-af92-77c0b5c7a432
Brown, J. M.
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Calman, L.
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Gavin, A.
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Glaser, A. W.
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Greenfield, D. M.
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Lanceley, A.
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Taylor, R. M.
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Velikova, G.
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Turner, G.
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Calvert, M. J.
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Slade, A. L., Retzer, A., Ahmed, K., Kyte, D., Keeley, T., Armes, J., Brown, J. M., Calman, L., Gavin, A., Glaser, A. W., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Turner, G. and Calvert, M. J. (2021) Systematic review of the use of translated patient-reported outcome measures in cancer trials. Trials, 22 (1), 306, [306]. (doi:10.1186/s13063-021-05255-z).

Record type: Review

Abstract

Background: Patient-reported outcomes (PROs) are used in clinical trials to assess the effectiveness and tolerability of interventions. Inclusion of participants from different ethnic backgrounds is essential for generalisability of cancer trial results. PRO data collection should include appropriately translated patient-reported outcome measures (PROMs) to minimise missing data and sample attrition. 

Methods: Protocols and/or publications from cancer clinical trials using a PRO endpoint and registered on the National Institute for Health Research Portfolio were systematically reviewed for information on recruitment, inclusion of ethnicity data, and use of appropriately translated PROMs. Semi-structured interviews were conducted with key stakeholders to explore barriers and facilitators for optimal PRO trial design, diverse recruitment and reporting, and use of appropriately translated PROMs. 


Results: Eighty-four trials met the inclusion criteria, only 14 (17%) (n = 4754) reported ethnic group data, and ethnic group recruitment was low, 611 (13%). Although 8 (57%) studies were multi-centred and multi-national, none reported using translated PROMs, although available for 7 (88%) of the studies. Interviews with 44 international stakeholders identified a number of perceived barriers to ethnically diverse recruitment including diverse participant engagement, relevance of ethnicity to research question, prominence of PROs, and need to minimise investigator burden. Stakeholders had differing opinions on the use of translated PROMs, the impact of trial designs, and recruitment strategies on diverse recruitment. Facilitators of inclusive research were described and examples of good practice identified.

 Conclusions: Greater transparency is required when PROs are used as primary or secondary outcomes in clinical trials. Protocols and publications should demonstrate that recruitment was accessible to diverse populations and facilitated by trial design, recruitment strategies, and appropriate PROM usage. The use of translated PROMs should be made explicit when used in cancer clinical trials.

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More information

Accepted/In Press date: 8 April 2021
Published date: 26 April 2021
Additional Information: Funding Information: JMB report grants from the National Institute for Health Research and Yorkshire Cancer Research. Funding Information: DK was supported by project funding from Macmillan Cancer Support and reports grants from Innovate UK, the National Institute For Health Research, Birmingham Biomedical Research Centre, and National Institute For Health Research Surgical Reconstruction and Microbiology Research Centre at the University of Birmingham and University Hospitals Birmingham National Health Service Foundation Trust, and personal fees from Merck and GlaxoSmithKline outside the submitted work. Funding Information: This work was supported by funding from the National Institute for Health Research, Clinical Research Network funding (Grant number RHJK20013), and Macmillan Cancer Support (Grant number 5592105). This paper presents independent research supported by the National Institute of Health Research Birmingham Biomedical Research Centre at the University Hospitals Birmingham National Health Service Foundation Trust and the University of Birmingham. The study funders did not have any role in the study design; the collection, analysis, and interpretation of the data; the writing of the report; or the decision to submit the article for publication. Funding Information: GT is funded by the National Institute for Health Research Postdoctoral Fellowship programme (PDF-2017-10-047) and reports funding by the National Institute for Health Research Birmingham Biomedical Research Centre and National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre at the University of Birmingham and University Hospitals Birmingham National Health Service Foundation Trust outside the submitted work. Funding Information: GV reports grants from Pfizer, Breast Cancer NOW, Yorkshire Cancer Research, and European Organisation for Research and Treatment of Cancer and personal fees from Roche, Eisai, and Novartis. Funding Information: AWG reports research grant funding from Macmillan Cancer Support, Prostate Cancer UK, Yorkshire Cancer Research. He is a member of the Teenage and Young Adult Clinical study Group. Funding Information: MC is a National Institute for Health Research Senior Investigator and receives funding from the National Institute for Health Research Birmingham Biomedical Research Centre, the National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre, and National Institute for Health Research Applied Research Collaboration West Midlands at the University of Birmingham and University Hospitals Birmingham National Health Service Foundation Trust, Health Data Research United Kingdom, Innovate United Kingdom (part of United Kingdom Research and Innovation), Macmillan Cancer Support, Health Foundation, UCB Pharma and GSK. MC has received personal fees from Astellas, Takeda, Merck, Daiichi Sankyo, Glaukos, GlaxoSmithKline, and the Patient-Centred Outcomes Research Institute (PCORI) outside the submitted work. Funding Information: ALS was supported by funding from Macmillan Cancer Support and reports funding by British Heart Foundation, National Institute for Health Research Invention for Innovation, Medical Research Council, National Institute for Health Research MedTech and INvitro diagnostics Co-operative – Trauma management, Eye Hope Foundation, Association du Syndrome de Wolfram, Snow Foundation; Pfizer Health Research Foundation; National Institute for Health Research Clinical Research Network; and National Institute For Health Research Birmingham Biomedical Research Centre and National Institute For Health Research Surgical Reconstruction and Microbiology Research Centre at the University of Birmingham and University Hospitals Birmingham National Health Service Foundation Trust outside the submitted work. Funding Information: AR was supported by funding from Macmillan Cancer Support and reports funding by the National Institute for Health Research Clinical Research Network and Innovate UK (part of UK Research and Innovation) outside the submitted work. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
Keywords: Patient-reported outcomes (PROs), Patient-reported outcome measures (PROMs), Ethnicity, Recruitment, Cross-cultural translation, Clinical trials, Trial protocols, Primary outcomes, Secondary outcomes

Identifiers

Local EPrints ID: 450811
URI: http://eprints.soton.ac.uk/id/eprint/450811
ISSN: 1745-6215
PURE UUID: 6abbabfd-e09a-4765-b184-910d7d34ebcc
ORCID for L. Calman: ORCID iD orcid.org/0000-0002-9964-6017

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Date deposited: 12 Aug 2021 16:31
Last modified: 18 Mar 2024 03:20

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Contributors

Author: A. L. Slade
Author: A. Retzer
Author: K. Ahmed
Author: D. Kyte
Author: T. Keeley
Author: J. Armes
Author: J. M. Brown
Author: L. Calman ORCID iD
Author: A. Gavin
Author: A. W. Glaser
Author: D. M. Greenfield
Author: A. Lanceley
Author: R. M. Taylor
Author: G. Velikova
Author: G. Turner
Author: M. J. Calvert

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