Reporting and representation of race/ethnicity in published randomixed trials
Reporting and representation of race/ethnicity in published randomixed trials
复制标题
DOI：
10.1016/j.ahj.2009.08.018
复制
发表时间：
2009-11-01
影响因子：
4.8
通讯作者：
Newby, L. Kristin
中科院分区：
文献类型：
--
作者：
Berger, Jeffrey S.;Melloni, Chiara;Newby, L. Kristin
背景：尽管随机对照试验(RCT)中特定亚组(如女性和老年人)的代表性已经受到了严格的审查，但关于种族代表性的数据很少。方法使用2007年美国心脏协会关于女性心血管疾病预防的指南中引用的所有RCT(尽管试验包括是否有女性参与者)，我们探索在基线特征中报告种族信息的程度。种族/民族类别为白人、黑人、亚洲人、西班牙裔和“其他人”。结果总共分析了156项试验。关于种族/族裔的人口统计数据在55次试验中报告(35%)，并随着时间的推移显著增加(1970年代，12.5%；1980年代，25%；1990年代，30.5%；2000年代，46.2%；趋势P=0.011)。在报告了任何种族/民族信息的55项试验中，分别有27%、13%、14%、5%和10%的试验报告了白人、黑人、亚裔、拉美裔和其他人的试验，并随着时间的推移而增加(P代表趋势和0.05)。只在美国或全球(包括美国)招募受试者的试验比没有美国地点的试验更有可能报告种族构成(只有美国的%对全球的62%对非美国的21%，P<；.01)。行业和联邦/基金会资助的RCT报告的种族频率相似(行业36%对联邦34%对两者24%，P=0.44)。当我们单独分析由美国国立卫生研究院资助的试验时，18个随机对照试验中有12个(67%)报告了种族/民族作为基线特征。结论尽管报告的研究人群的种族/民族构成随着时间的推移而增加，但支持最近美国心脏协会()指南的所有随机对照试验中有三分之二没有公布任何关于种族的信息。在将随机对照试验证据翻译给所有种族的患者时，一个必要的首要要求是关于种族人口统计学的信息。应在今后的出版物中大力鼓励这类信息。(《美国心脏杂志》2009；158：742-7。)
Background Although adequate representation of specific subgroups (eg, women and the elderly) in randomized controlled trials (RCTs) has been under intense scrutiny, there are few data on representation by race.Methods Using all RCTs cited by the 2007 American Heart Association guidelines for cardiovascular disease prevention in women (although trials were included whether or not there were female participants), we explored the extent to which information on race was reported in the baseline characteristics. Race/ethnicity categories were whites, blacks, Asians, Hispanics, and "others."Results Overall, 156 trials were analyzed. Demographic data on race/ethnicity were reported in 55 (35%) trials and increased significantly over time (1970s, 12.5%; 1980s, 25%; 1990s, 30.5%; 2000s, 46.2%; P for trend = .011). Among the 55 trials reporting any race/ethnicity information, trial inclusion of whites, blacks, Asians, Hispanics, and "others" was reported in 27%, 13%, 14%, 5%, and 10% of trials, respectively, and increased over time (P for trend < .05 for all). Trials enrolling subjects only in the United States or globally, including the US, were more likely to report race composition than trials that included no US sites (US only 64% vs global 62% vs non-US 21%, P < .01). Industry- and federal/foundation-funded RCTs reported race with similar frequency (industry 36% vs federal 34% vs both 24%, P = .44). When we isolated our analyses to trials that were funded by the National Institutes of Health, 12 (67%) of 18 RCTs reported race/ethnicity as a baseline characteristic.Conclusion Although reporting the race/ethnic composition of study populations is increasing over time, two thirds of all RCTs supporting a recent American Heart Association () guideline failed to publish any information on race. A necessary first requirement in translating RCT evidence to patients of all races is information regarding racial demographics. Such information should be strongly encouraged in future publications. (Am Heart J 2009; 158:742-7.)