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Slade, A.L., Ahmed, K., Kyte, Derek 
ORCID: https://orcid.org/0000-0002-7679-6741, 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.
p. 306.
ISSN 1745-6215
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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.
| Item Type: | Article |
|---|---|
| Additional Information: | This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. A pdf file of this article is available to download from this WRaP record. |
| Uncontrolled Discrete Keywords: | Patient-reported outcomes (PROs), Patient-reported outcome measures (PROMs), Ethnicity, Recruitment, Cross-cultural translation, Clinical trials, Trial protocols, Primary outcomes, Secondary outcomes |
| Divisions: | College of Health, Life and Environmental Sciences > School of Allied Health and Community |
| Related URLs: | |
| Copyright Info: | Open Access article |
| Depositing User: | Derek Kyte |
| Date Deposited: | 27 Aug 2021 08:18 |
| Last Modified: | 27 Aug 2021 08:18 |
| URI: | https://worc-9.eprints-hosting.org/id/eprint/11296 |
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