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.
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The authors report no financial disclosures or conflicts of interests related to this work. Drs. Grant and Ludmir had full access to all the data in the study, take responsibility for the integrity of the data and the accuracy of the data analysis, and agree to allow the journal to review the data if requested.
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The authors report no financial disclosures or conflicts of interests related to this work. Dr. Fuller receives research funding from NIH, Elekta, GE Healthcare, and National Science Foundation, all outside the submitted work.
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Grant, S.R., Noticewala, S.S., Mainwaring, W. et al. Non-English language validation of patient-reported outcome measures in cancer clinical trials. Support Care Cancer 28, 2503–2505 (2020). https://doi.org/10.1007/s00520-020-05399-9
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DOI: https://doi.org/10.1007/s00520-020-05399-9