The More Things Change, the More They Stay the Same: A Study to Evaluate Compliance With Inclusion and Assessment of Women and Minorities in Randomized Controlled Trials
The More Things Change, the More They Stay the Same: A Study to Evaluate Compliance With Inclusion and Assessment of Women and Minorities in Randomized Controlled Trials
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DOI：
10.1097/acm.0000000000002027
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发表时间：
2018-04-01
影响因子：
7.4
通讯作者：
Carnes, Molly
中科院分区：
文献类型：
--
作者：
Geller, Stacie E.;Koch, Abigail R.;Carnes, Molly
目的1993年《美国国立卫生研究院(NIH)振兴法案》要求由NIH资助的临床试验纳入妇女和少数民族作为参与者，并按性别、种族或民族评估结果。这项研究的目的是调查目前NIH资助的随机对照试验(RCT)中纳入、分析和报告这些指南的水平，并将结果与作者先前报告的2009和2004年的结果进行比较。方法作者通过PubMed搜索确定了2015年发表在美国14种主要医学期刊上的782篇随机对照试验。其中，142份是由美国国立卫生研究院资助的随机对照试验的主要报告，符合分析条件。作者审阅了每个符合条件的研究的摘要、文本和表格以及任何后续发表的评论，以确定是否符合NIH指南。结果35项研究限制了一种性别的登记。在其余107项研究中，女性参与者的中位数为46%，但有16项(15.0%)女性参与者的比例低于30%。在107名受试者中，28人(26%)报告了至少一种性别结果，或在统计分析中明确将性别作为协变量。在142项研究中，19项(13.4%)按种族或民族分析或报告了结果。与之前的研究相比，在纳入、分析或按性别、种族或民族报告方面没有统计学上的显著变化。结论NIH政策没有导致按性别、种族或民族报告结果的显著增加。作者建议采取强有力的期刊政策，以增加对NIH政策的遵从性。
Purpose The National Institutes of Health (NIH) Revitalization Act of 1993 requires NIH-funded clinical trials to include women and minorities as participants and assess outcomes by sex and race or ethnicity. The objective of this study was to investigate current levels of compliance with these guidelines for inclusion, analysis, and reporting in NIH-funded randomized controlled trials (RCTs) and compare the results with those from 2009 and 2004, which the authors reported previously.Method The authors identified 782 RCTs published in 14 leading U.S. medical journals in 2015 with a PubMed search. Of those, 142 were the primary report of an NIH-funded RCT, conducted in the United States, and eligible for analysis. The authors reviewed abstract, text, and tables of each eligible study as well as any follow-up published commentary to determine compliance with NIH guidelines.Results Thirty-five studies limited enrollment to one sex. The median enrollment of women in the remaining 107 studies was 46%, but 16 (15.0%) enrolled less than 30% women. Twenty-eight of the 107 (26%) reported at least one outcome by sex or explicitly included sex as a covariate in statistical analysis. Of the 142 studies, 19 (13.4%) analyzed or reported outcomes by race or ethnicity. There were no statistically significant changes in inclusion, analysis, or reporting by sex, race, or ethnicity compared with the previous studies.Conclusions NIH policies have not resulted in significant increases in reporting results by sex, race, or ethnicity. The authors recommend strong journal policies to increase compliance with NIH policies.