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

Slade, A L, Retzer, Ameeta, Ahmed, K, Kyte, Derek, 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, Grace M and Calvert, M J (2021) Systematic review of the use of translated patient-reported outcome measures in cancer trials. Trials, 22 (1). p. 306. ISSN 1745-6215. This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs

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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 available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
Subjects: QW Microbiology. Immunology
QZ Pathology. Oncology
W Public health. Health statistics. Occupational health. Health education
WA Patients. Primary care. Medical profession. Forensic medicine
Divisions: Ambulatory Care > Outpatients
Related URLs:
Depositing User: Jamie Edgar
Date Deposited: 05 May 2021 15:02
Last Modified: 05 May 2021 15:02
URI: http://www.repository.uhblibrary.co.uk/id/eprint/4277

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