Non-English language validation of patient-reported outcome measures in cancer clinical trials

Stephen R. Grant, Sonal S. Noticewala, Walker Mainwaring, Timothy A. Lin, Austin B. Miller, Amit Jethanandani, Andres F. Espinoza, G. Brandon Gunn, C. David Fuller, Charles R. Thomas, Lorraine Portelance, Ethan B. Ludmir

Research output: Contribution to journalComment/debatepeer-review

7 Scopus citations


Patient-reported outcome measures (PROMs) are increasingly incorporated as endpoints in oncology clinical trials but are often only validated in English. 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.

Original languageEnglish (US)
Pages (from-to)2503-2505
Number of pages3
JournalSupportive Care in Cancer
Issue number6
StatePublished - Jun 1 2020


  • Clinical trials
  • Language
  • Oncology
  • Patient-reported outcome measures

ASJC Scopus subject areas

  • Oncology


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