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

Research output: Contribution to journalArticlepeer-review

Authors

  • Thomas Keeley
  • Jo Armes
  • J. M. Brown
  • Lynn Calman
  • A. Gavin
  • A. W. Glaser
  • D. M. Greenfield
  • A. Lanceley
  • R. M. Taylor
  • Galina Velikova
  • Melanie Calvert

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.

Bibliographic note

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.

Details

Original languageEnglish
Article number306
JournalTrials
Volume22
Issue number1
Publication statusPublished - 26 Apr 2021

Keywords

  • Patient-reported outcomes (PROs), Patient-reported outcome measures (PROMs), Ethnicity, Recruitment, Cross-cultural translation, Clinical trials, Trial protocols, Primary outcomes, Secondary outcomes

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