Center for Clinical Epidemiology and Methodology, Guangdong Second Provincial General Hospital, Guangzhou, China.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.
Diabetologia. 2022 Sep;65(9):1461-1472. doi: 10.1007/s00125-022-05736-z. Epub 2022 Jun 16.
AIMS/HYPOTHESIS: Ethnic representativeness of participant enrolment in diabetes RCTs involving multiple ethnicities remains unknown. The aims of this study were to evaluate the status and temporal trend of ethnic representativeness in enrolment to diabetes RCTs, and to assess under-enrolment of non-white ethnic groups and explore trial characteristics associated with under-enrolment.
We conducted a chronological survey by systematically searching the literature to include eligible RCTs published between January 2000 and December 2020. We assessed temporal trends in enrolment of ethnic groups in the included trials. Univariable logistic regression was used to explore the association between trial characteristics and under-enrolment of non-white groups, using a participant to prevalence ratio of <0.8 to define under-enrolment. This study was registered in PROSPERO (CRD42021229100).
We included 405 RCTs for analysis (327 multi-country trials, 69 conducted in the USA and nine conducted in the UK). The median enrolment rate of all non-white groups was 24.0% in the overall RCTs. Trials conducted in the USA and the UK had median enrolment rates of 29.0% and 12.0% for all non-white groups, respectively. There was a temporal trend towards increased participation of non-white ethnic groups in the overall RCTs; however, no significant improvement over time was found in the US or UK trials. Non-white groups were under-enrolled in most included trials: 62.3% (43/69) in US trials and 77.8% (7/9) in UK trials. The US trials with a high female proportion were associated with lower odds of under-enrolment of all non-white groups (OR 0.22; 95% CI 0.07, 0.65), while trials receiving funding from industry showed increased odds of under-enrolment (OR 4.64; 95% CI 1.50, 14.35). Outpatient enrolment and intervention duration were significantly associated with under-enrolment of Black participants. Only a small proportion of trials reported subgroup results or explored the effect modification by ethnicity.
CONCLUSIONS/INTERPRETATION: A temporal trend towards increased non-white ethnic enrolment was found in diabetes RCTs globally, but not in the USA or the UK. Non-white ethnic groups were under-represented in the majority of diabetes trials conducted in the USA and the UK. Some trial characteristics may be associated with non-white under-enrolment in diabetes trials. These findings provide some evidence for non-white ethnic representativeness in diabetes trials over the past two decades, and highlight the need for more effective strategies and endeavours to alleviate under-enrolment of non-white ethnic groups.
目的/假设：参与涉及多种族的糖尿病 RCT 的参与者中，种族代表性仍不清楚。本研究的目的是评估入组糖尿病 RCT 中种族代表性的现状和时间趋势，并评估非白人种族群体的入组不足情况，并探讨与入组不足相关的试验特征。
我们通过系统搜索文献进行了一项时间顺序调查，纳入了 2000 年 1 月至 2020 年 12 月期间发表的合格 RCT。我们评估了纳入试验中种族群体入组的时间趋势。使用参与者与患病率的比例<0.8 来定义入组不足，采用单变量逻辑回归来探讨试验特征与非白人组入组不足的关系。本研究已在 PROSPERO（CRD42021229100）注册。
我们纳入了 405 项 RCT 进行分析（327 项多国家试验，69 项在美国进行，9 项在英国进行）。在所有 RCT 中，所有非白人种族群体的中位入组率为 24.0%。在美国和英国进行的试验中，所有非白人种族群体的中位入组率分别为 29.0%和 12.0%。在整体 RCT 中，非白人种族群体的参与呈现出随时间增加的趋势；然而，在美国或英国的试验中，并没有发现随时间的显著改善。在大多数纳入的试验中，非白人种族群体入组不足：美国试验中为 62.3%（43/69），英国试验中为 77.8%（7/9）。女性比例较高的美国试验与所有非白人种族群体入组不足的几率较低相关（OR 0.22；95%CI 0.07，0.65），而接受工业界资助的试验显示出入组不足的几率增加（OR 4.64；95%CI 1.50，14.35）。门诊入组和干预持续时间与黑人参与者的入组不足显著相关。只有少数试验报告了亚组结果或探讨了种族对效果的修饰作用。
结论/解释：在全球范围内，糖尿病 RCT 中发现了非白人种族入组增加的时间趋势，但在美国或英国没有发现。在美国和英国进行的大多数糖尿病试验中，非白人种族群体代表性不足。一些试验特征可能与糖尿病试验中非白人入组不足有关。这些发现为过去二十年来糖尿病试验中种族代表性提供了一些证据，并强调需要采取更有效的策略和努力，以减轻非白人种族群体的入组不足。
