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- Title
Non-English language validation of patient-reported outcome measures in cancer clinical trials.
- Authors
Grant, Stephen R.; Noticewala, Sonal S.; Mainwaring, Walker; Lin, Timothy A.; Miller, Austin B.; Jethanandani, Amit; Espinoza, Andres F.; Gunn, G. Brandon; Fuller, C. David; Thomas Jr, Charles R.; Portelance, Lorraine; Ludmir, Ethan B.; Thomas, Charles R Jr
- Abstract
Patient-reported outcome measures (PROMs) are increasingly incorporated as endpoints in oncology clinical trials but are often only validated in English. ClinicalTrials.gov was queried for cancer-specific randomized control trials (RCTs) addressing a therapeutic intervention and enrolling primarily in the USA. Peer-reviewed validation of Spanish and Chinese versions of each PROM was assessed. Of 103 eligible trials, a PROM was used as a primary endpoint in 25 RCTs (24.3%) and as a secondary endpoint in 78 RCTs (75.7%). A total of 61 of the 103 eligible trials (59.2%) and 17 of the 25 trials with a PROM primary endpoint (68.0%) used a PROM with either no Spanish or Chinese validation. The absence of validated PROM translations may diminish the voices of non-English language speaking trial participants. With an increasingly diverse US population, validation of non-English PROM translations may decrease disparities in trial participation and improve generalizability of study results.
- Subjects
CLINICAL trials; CANCER; PATIENT reported outcome measures; TRANSLATIONS; TUMOR treatment; RESEARCH evaluation; LANGUAGE &; languages; RANDOMIZED controlled trials; CULTURAL competence; STATISTICAL sampling
- Publication
Supportive Care in Cancer, 2020, Vol 28, Issue 6, p2503
- ISSN
0941-4355
- Publication type
journal article
- DOI
10.1007/s00520-020-05399-9