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母语非英语的人群参与临床试验招募:儿童肿瘤协作组报告。

Clinical trial recruitment of people who speak languages other than English: a Children's Oncology Group report.

机构信息

Division of Research and Scholarship, Columbia University School of Nursing, New York, NY, USA.

Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY, USA.

出版信息

JNCI Cancer Spectr. 2024 Jul 1;8(4). doi: 10.1093/jncics/pkae047.

Abstract

BACKGROUND

Persons who speak languages other than English are underrepresented in clinical trials, likely in part because of inadequate multilevel resources. We conducted a survey of institutions affiliated with the Children's Oncology Group (COG) to characterize current research recruitment practices and resources regarding translation and interpretation services.

METHODS

In October 2022, a 20-item survey was distributed electronically to institutions affiliated with COG to assess consent practices and resources for recruiting participants who speak languages other than English to COG trials. Descriptive statistics were used to summarize responses; responses were compared by institution size and type as well as respondent role.

RESULTS

The survey was sent to 230 institutions, and the response rate was 60% (n = 139). In total, 60% (n = 83) of those respondents had access to short-form consent forms. Full consent form translation was required at 50% of institutions, and 12% of institutional review boards restricted use of centrally translated consent forms. Forty-six percent (n = 64) of institutions reported insufficient funding to support translation costs; 19% (n = 26) had access to no-cost translation services. Forty-four percent (n = 61) were required to use in-person interpreters for consent discussions; the most frequently cited barrier (56%) to obtaining consent was lack of available in-person interpreters. Forty-seven percent (n = 65) reported that recruiting persons who speak languages other than English to clinical trials was somewhat or very difficult.

CONCLUSIONS

Institutions affiliated with COG face resource-specific challenges that impede recruitment of participants who speak languages other than English for clinical trials. These findings indicate an urgent need to identify strategies aimed at reducing recruitment barriers to ensure equitable access to clinical trials.

摘要

背景

讲英语以外语言的人在临床试验中代表性不足,部分原因可能是多层次资源不足。我们对与儿童肿瘤学组 (COG) 有关联的机构进行了一项调查,以描述目前与翻译和口译服务有关的研究招募实践和资源。

方法

2022 年 10 月,向 COG 附属机构发送了一份 20 项的调查,以评估将讲英语以外语言的参与者招募到 COG 试验中的同意实践和资源。使用描述性统计数据总结答复;根据机构规模和类型以及答复者的角色比较答复。

结果

该调查发送给了 230 个机构,回应率为 60%(n=139)。总体而言,60%(n=83)的答复者可以获得简短同意书。50%的机构需要完整的同意书翻译,12%的机构审查委员会限制使用集中翻译的同意书。46%(n=64)的机构报告说没有足够的资金来支付翻译费用;19%(n=26)没有免费的翻译服务。44%(n=61)需要为同意讨论使用现场口译员;获得同意的最常见障碍(56%)是缺乏可用的现场口译员。47%(n=65)报告说,招募讲英语以外语言的人参加临床试验有些或非常困难。

结论

与 COG 有关联的机构面临特定的资源挑战,这阻碍了讲英语以外语言的参与者参加临床试验的招募。这些发现表明迫切需要确定旨在减少招募障碍的策略,以确保公平获得临床试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb3e/11272047/1aa3d037e3c0/pkae047f1.jpg

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