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

doi:10.1007/s00520-020-05399-9

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

Radiation Medicine

Research output: Contribution to journal › Comment/debate › peer-review

8 Scopus citations

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.

Original language	English (US)
Pages (from-to)	2503-2505
Number of pages	3
Journal	Supportive Care in Cancer
Volume	28
Issue number	6
DOIs	https://doi.org/10.1007/s00520-020-05399-9
State	Published - Jun 1 2020

Keywords

Clinical trials
Language
Oncology
Patient-reported outcome measures

ASJC Scopus subject areas

Oncology

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Grant, S. R., Noticewala, S. S., Mainwaring, W., Lin, T. A., Miller, A. B., Jethanandani, A., Espinoza, A. F., Gunn, G. B., Fuller, C. D., Thomas, C. R., Portelance, L., & Ludmir, E. B. (2020). Non-English language validation of patient-reported outcome measures in cancer clinical trials. Supportive Care in Cancer, 28(6), 2503-2505. https://doi.org/10.1007/s00520-020-05399-9

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title = "Non-English language validation of patient-reported outcome measures in cancer clinical trials",

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.",

keywords = "Clinical trials, Language, Oncology, Patient-reported outcome measures",

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

note = "Publisher Copyright: {\textcopyright} 2020, Springer-Verlag GmbH Germany, part of Springer Nature.",

year = "2020",

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doi = "10.1007/s00520-020-05399-9",

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AU - Grant, Stephen R.

AU - Noticewala, Sonal S.

AU - Mainwaring, Walker

AU - Lin, Timothy A.

AU - Miller, Austin B.

AU - Jethanandani, Amit

AU - Espinoza, Andres F.

AU - Gunn, G. Brandon

AU - Fuller, C. David

AU - Thomas, Charles R.

AU - Portelance, Lorraine

AU - Ludmir, Ethan B.

PY - 2020/6/1

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N2 - 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.

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

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