儿科研究中持续存在的非英语使用者排除情况:一项使用ClinicalTrials.gov的全国性分析。
Persistent exclusion of non-English speakers in Pediatric research: a national analysis using ClinicalTrials.gov.
作者信息
Muthukumar Akila V, Shah Kavya M, Glynn Robert J, Bierer Barbara E
机构信息
Harvard College, Cambridge, MA, USA.
Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Boston, MA, USA.
出版信息
Pediatr Res. 2025 Jan 22. doi: 10.1038/s41390-025-03845-0.
Over one-fifth of US households speak a language other than English. While some studies have documented language-based disparities in pediatric clinical research, they are limited in scope and not representative of all US pediatric trials. Because language-based exclusion, if extensive, would limit the generalizability of the results of the research, we performed a systematic analysis of language-based eligibility criteria across all 4982 US pediatric interventional clinical trials registered on ClinicalTrials.gov from 2019 to 2022. We found that 70.0% [95% CI: 68.8-71.3%] of trials did not include any information about language while 23.4% [22.2-24.5%] had explicit English language requirements, of which only a minority (14.4%) included justifications for the limitation. Conversely, 6.6% [5.9-7.3%] of trials accommodated non-English languages. Trials with a posted protocol were more likely than all registered trials to include English language requirements (P < 0.00001). Trials with a federal sponsor, a behavioral intervention, or a focus on prevention or supportive care were more likely to report information about language when compared to all registered trials (P < 0.001), while trials with industry sponsors, drug or biological interventions, or a focus on treatment were less likely to do so (P < 0.001). Although modest, the percentage of trials requiring English decreased and the percentage offering language services increased from 2019 to 2022. IMPACT STATEMENT: Of 4982 US pediatric interventional studies registered on ClinicalTrials.gov from 2019 to 2022, 70.0% did not include any information about language while 23.4% explicitly included English language requirements. Of the trials requiring English, only 14.4% provided a justification for the requirement. Trials with a posted protocol were more likely to require English than all registered trials. Trials with industry sponsors, drug-based/biological interventions, or a treatment focus were less likely to mention language information than all registered trials.
超过五分之一的美国家庭说英语以外的语言。虽然一些研究记录了儿科临床研究中基于语言的差异,但这些研究范围有限,并非所有美国儿科试验都具有代表性。由于基于语言的排除(如果广泛存在)会限制研究结果的普遍性,我们对2019年至2022年在ClinicalTrials.gov上注册的所有4982项美国儿科介入性临床试验中基于语言的纳入标准进行了系统分析。我们发现,70.0%[95%置信区间:68.8 - 71.3%]的试验未包含任何关于语言的信息,而23.4%[22.2 - 24.5%]有明确的英语语言要求,其中只有少数(14.4%)对该限制给出了理由。相反,6.6%[5.9 - 7.3%]的试验接受非英语语言。有发布方案的试验比所有注册试验更有可能包含英语语言要求(P < 0.00001)。与所有注册试验相比,有联邦赞助商、行为干预或侧重于预防或支持性护理的试验更有可能报告语言信息(P < 0.001),而有行业赞助商、药物或生物干预或侧重于治疗的试验则不太可能这样做(P < 0.001)。尽管幅度不大,但从2019年到2022年,要求使用英语的试验百分比下降,提供语言服务的试验百分比上升。影响声明:在2019年至2022年在ClinicalTrials.gov上注册的4982项美国儿科介入性研究中,70.0%未包含任何关于语言的信息,而23.4%明确包含英语语言要求。在要求使用英语的试验中,只有14.4%为该要求提供了理由。有发布方案的试验比所有注册试验更有可能要求使用英语。有行业赞助商、基于药物/生物的干预或侧重于治疗的试验比所有注册试验更不可能提及语言信息。