Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities
Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities
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DOI：
10.1016/s0895-4356(03)00031-3
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发表时间：
2003-05-01
影响因子：
7.2
通讯作者：
Ransohoff, DF
中科院分区：
文献类型：
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作者：
Corbie-Smith, G;St George, DMM;Ransohoff, DF
尽管联邦倡议要求将少数民族更广泛地纳入对种族和族裔之间存在健康差异的疾病的临床研究，但尚不清楚这些倡议是否影响了试验结果的报告。本研究的目的是检查在已知的健康差异领域（即糖尿病、心血管疾病、艾滋病毒/艾滋病和癌症）的临床试验报告中种族/民族的报告，并确定哪些因素与结果中种族/民族的报告有关。我们对1989年1月至2000年10月期间的Medline进行了检索，以确定在内科医学年鉴、JAMA和新英格兰医学杂志上发表的糖尿病、心血管疾病、艾滋病毒/艾滋病和癌症的临床试验。主要的结果测量是参与者的参与情况和试验参与者的种族/民族结果的报告。在253个符合条件的试验中，40% （n = 102）不是以种族为中心的，但没有报道。种族，而2% （n = 4）不以性别为中心，没有报告性别。46%报告了样本的种族/民族的试验只报告了一个或两个种族/民族类别，在43%的试验中，每个种族/民族类别报告的个人总数不等于报告的总样本量。只有两项试验报告了按种族/民族分析结果，只有三项试验报告了按性别分析结果。在已知存在种族和民族差异的疾病中，许多临床试验没有报告研究参与者的种族/民族，几乎没有报告按种族/民族进行分析。尽管联邦政府的倡议要求将少数群体纳入研究，但这种纳入并没有转化为可能的结果报告。指导治疗决策。(C) 2003 Elsevier Inc.版权所有。
Although federal initiatives have mandated broader inclusion of minorities in clinical research on diseases that have disparities in health by race and ethnicity, it is not clear whether these initiatives have affected reporting of trial results. The objective of,this-study was to examine the reporting of race/ethnicity in clinical trials reports in areas of known disparities in health (i.e., diabetes, cardiovascular disease, HIV/AIDS, and cancer) and to determine what factors were associated with reporting of race/ethnicity in,results. We,performed a Medline search covering the period January 1989 to Oct 2000 to identify clinical trials of diabetes, cardiovascular disease, HIV/AIDS, and cancer published in the Annals of Internal Medicine, JAMA, and New England Journal of Medicine. The main outcome measure, was the reporting of participation and of results by race/ethnicity of trial participants. Of 253 : eligible trials, 40% (n = 102) were non race-focused yet did not report. race, while 2% (n = 4) were non gender-focused and did not report gender. Forty-six percent of trials' that reported the race/ethnicity of the sample reported only one or two racial/ethnic categories, and in 43% of these trials the total number of individuals reported in each race/ethnicity category, did not equal the total reported sample size. Analysis of results by race/ethnicity was reported in only two trials, and by gender in only three trials. In diseases With known racial and,ethnic disparities, many clinical trials do not report the race/ethnicity of the study participants, and almost none report analyses by race/ethnicity. Although federal initiatives mandate inclusion of minority groups in research, that inclusion has not translated to reporting of results that might. guide therapeutic decisions. (C) 2003 Elsevier Inc. All rights reserved.