The University of Texas MD Anderson Cancer Center, 1400 Pressler St, Unit 1422, Houston,, TX, 77030, USA.
Baylor College of Medicine, Houston, TX, USA.
Support Care Cancer. 2020 Jun;28(6):2503-2505. doi: 10.1007/s00520-020-05399-9. Epub 2020 Mar 18.
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.
患者报告的结局测量（PROMs）越来越多地被纳入肿瘤学临床试验的终点，但通常仅在英语中进行验证。在 ClinicalTrials.gov 上查询了针对治疗干预措施并主要在美国招募的癌症特定随机对照试验（RCT）。评估了每个 PROM 的西班牙语和中文版本的同行评审验证。在 103 项合格试验中，25 项 RCT（24.3%）将 PROM 用作主要终点，78 项 RCT（75.7%）将 PROM 用作次要终点。在 103 项合格试验中，有 61 项（59.2%）和 25 项具有 PROM 主要终点的试验中有 17 项（68.0%）使用了未经西班牙语或中文验证的 PROM。缺乏经过验证的 PROM 翻译可能会降低非英语语言试验参与者的声音。随着美国人口的日益多样化，验证非英语 PROM 翻译可能会减少试验参与的差异，并提高研究结果的普遍性。
