Exclusion of Families Who Speak Languages Other than English from Federally Funded Pediatric Trials.
Exclusion of Families Who Speak Languages Other than English from Federally Funded Pediatric Trials.
复制标题
将使用英语以外语言的家庭排除在联邦资助的儿科试验之外。
DOI：
10.1016/j.jpeds.2023.113597
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发表时间：
2023
期刊：
影响因子：
--
通讯作者：
Yun,Katherine
中科院分区：
文献类型：
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作者：
Anwar,Ayesha;Dawson-Hahn,Elizabeth;Lion,KCasey;Jimenez,ManuelE;Yun,Katherine
目的确定在美国讲英语以外语言的个体（LOE）是否被排除在联邦资助的儿科临床试验之外，以及这些试验是否遵守美国国立卫生研究院关于纳入少数群体成员的政策。研究设计使用ClinicalTrials.gov，我们确定了截至2019年6月18日所有已完成的、联邦资助的、美国的试验，包括≤17岁的儿童，重点关注4种常见慢性儿童疾病（哮喘、心理健康、肥胖和龋齿）中的一种。我们回顾了ClinicalTrials.gov的在线内容，以及与ClinicalTrials.gov条目相关的已发表的手稿，以提取与语言相关的排除标准的信息。如果在研究方案或已发表的手稿中有明确的排除声明，则认为试验排除了LOE参与者/护理人员。结果189项试验符合纳入标准。三分之二（67%）没有解决多语种招生问题。在62项这样做的试验中，82%排除了失恋者。没有试验涉及非英语、非西班牙语个体的入组。在93项没有缺失种族数据的试验中，拉丁美洲人在包括LOE个体的试验中占31%，在不包括LOE个体的试验中占14%。结论：在美国，联邦资助的儿科试验没有充分解决多语言注册问题，这似乎违反了联邦和合同要求，即接受联邦资助的实体要适应语言障碍。
ObjectiveTo determine whether individuals in the United States who speak languages other than English (LOE) are excluded from federally funded pediatric clinical trials and whether such trials adhere to the National Institutes of Health policy regarding inclusion of members of minority groups.Study designUsing ClinicalTrials.gov, we identified all completed, federally funded, US-based trials inclusive of children ≤17 and focused on one of 4 common chronic childhood conditions (asthma, mental health, obesity, and dental caries) as of June 18, 2019. We reviewed ClinicalTrials.gov online content, as well as published manuscripts linked to ClinicalTrials.gov entries, to abstract information about language-related exclusion criteria. Trials were deemed to exclude LOE participants/caregivers if explicit statements regarding exclusion were identified in the study protocol or published manuscript.ResultsOf total, 189 trials met inclusion criteria. Two-thirds (67%) did not address multilingual enrollment. Of the 62 trials that did, 82% excluded LOE individuals. No trials addressed the enrollment of non-English, non-Spanish-speaking individuals. In 93 trials with nonmissing data on ethnicity, Latino individuals comprised 31% of participants in trials that included LOE individuals and 14% of participants in trials that excluded LOE individuals.ConclusionsFederally funded pediatric trials in the United States do not adequately address multilingual enrollment, a seeming violation of federal and contractual requirements for accommodation of language barriers by entities receiving federal funding.