Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York, USA.
J Card Surg. 2022 May;37(5):1311-1316. doi: 10.1111/jocs.16371. Epub 2022 Mar 2.
Racial minorities account for 39.9% of the population in the United States, but are often underrepresented in clinical research. Results from studies predominantly enrolling White patients may not apply to racial minorities. The aim of this analysis is to assess the representation of racial minorities in cardiac surgery randomized clinical trials (RCTs).
A systematic search of the literature was performed. All RCTs published from 2000 to 2020 including at least 100 patients and comparing two or more adult cardiac surgery procedures were included. Meta-analytic estimates were calculated.
Among 51 cardiac surgery RCTs published between 2000 and 2020, only 9 (17.6%) reported the race of patients and were included in the final analysis. All of them were multicentric, with a mean of 33 centers included. Six RCTs enrolled patients undergoing coronary artery bypass grafting (66.7%), while the remaining three were on valve surgery (33.3%). Overall, 9193 patients were included; of them, 8034 (87.4%) were White and 1026 (11.2%) nonWhite (386 [4.2%] Black, 191 [2.1%] Hispanic, 274 [3.0%] from other races, and 175 [1.9%] nonWhite patients of unspecified race). The proportion of nonWhite patients did not change over time.
Only 9 (17.6%) of the 51 cardiac surgery RCTs published between 2000 and 2020 reported the race of the patients enrolled and only 11.2% of them were nonWhite patients. Given the association between race and clinical outcomes, future RCTs should either guarantee a balanced inclusion of racial minorities or be designed to specifically enroll them.
在美国，少数民族占总人口的 39.9%，但在临床研究中往往代表性不足。主要纳入白人患者的研究结果可能不适用于少数民族。本分析旨在评估种族少数群体在心脏手术随机临床试验（RCT）中的代表性。
系统地检索文献。纳入 2000 年至 2020 年发表的所有纳入至少 100 例患者且比较两种或多种成人心脏手术的 RCT。计算了荟萃分析估计值。
在 2000 年至 2020 年发表的 51 项心脏手术 RCT 中，仅有 9 项（17.6%）报告了患者的种族，并纳入最终分析。它们均为多中心研究，平均纳入 33 个中心。6 项 RCT 纳入接受冠状动脉旁路移植术（CABG）的患者（66.7%），其余 3 项为瓣膜手术（33.3%）。共纳入 9193 例患者；其中 8034 例（87.4%）为白人，1026 例（11.2%）为非白人（386 例[4.2%]黑人，191 例[2.1%]西班牙裔，274 例[3.0%]其他种族，175 例[1.9%]非白人患者未指明种族）。非白人患者的比例没有随时间变化。
在 2000 年至 2020 年发表的 51 项心脏手术 RCT 中，仅有 9 项（17.6%）报告了纳入患者的种族，其中只有 11.2%是非白人患者。鉴于种族与临床结局之间的关联，未来的 RCT 应保证少数民族的均衡纳入，或专门设计纳入他们。
