Sayyid Rashid K, Lokeshwar Soum D, Tella David, Jones Caitlin E, Oberle Michael D, Woodruff Phillip, Klaassen Zachary, Wallis Christopher J D
Section of Urology, Department of Surgery, Medical College of Georgia-Augusta University, Augusta, GA, Georgia.
Department of Urology, Yale New Haven Hospital, New Haven, CT, USA.
Surg Endosc. 2022 Apr;36(4):2600-2606. doi: 10.1007/s00464-021-08550-7. Epub 2021 May 12.
Enrolment of racial/ethnic minorities in randomized controlled trials (RCTs) has historically been poor, despite efforts at improving access to RCTs. Under-representation of racial/ethnic minorities limits the external validity and generalizability of trials. Our objective was to determine to what extent are published RCTs of minimally invasive surgical techniques reporting the racial composition of their study cohorts and to describe the racial composition of patients enrolled in these trials, where data were available.
EMBASE (OvidSP®), MEDLINE (OvidSP®), and Cochrane (Wiley®) databases were systematically searched from inception to December 22, 2017 to identify all RCTs comparing minimally invasive and classical surgical techniques. The Mann-Kendall trend test was used to evaluate reporting trends over the study period. Predictors of racial reporting were evaluated using logistic regression analyses.
Our search strategy yielded 9,321 references of which 496 RCTs met our inclusion/exclusion criteria. Racial information was reported in 20 (4.03%) studies. There was no significant improvement in racial reporting over the study period (p for trend = 0.31). Of the 17 different patient populations accounting for the 20 RCTs, 14 (82.4%) originated from the USA. Multicenter RCTs had significantly increased likelihood of reporting racial composition of the patient cohort (odds ratio 5.10, p = 0.025). White/Caucasian patients accounted for 84.5% of the pooled patient population, with Black/African American, Asian and Latin/Hispanic patients accounting for 7.9%, 1.2%, and 2.1%, respectively.
Among RCTs assessing minimally invasive surgical techniques over the past 30 years, data on included patients' race is poorly reported. In addition to important efforts to improve access to clinical trials for racial and ethnic minorities, efforts aimed at improving reporting and transparency of surgical RCTs are sorely needed.
尽管一直在努力改善种族/族裔少数群体参与随机对照试验（RCT）的机会，但从历史上看，这些群体在RCT中的入组情况一直很差。种族/族裔少数群体的代表性不足限制了试验的外部有效性和可推广性。我们的目标是确定在已发表的关于微创外科技术的RCT中，报告其研究队列种族构成的比例，并在有数据的情况下描述参与这些试验的患者的种族构成。
对EMBASE（OvidSP®）、MEDLINE（OvidSP®）和Cochrane（Wiley®）数据库进行系统检索，检索时间从建库至2017年12月22日，以识别所有比较微创和传统外科技术的RCT。使用Mann-Kendall趋势检验评估研究期间的报告趋势。使用逻辑回归分析评估种族报告的预测因素。
我们的检索策略共获得9321篇参考文献，其中496项RCT符合我们的纳入/排除标准。20项（4.03%）研究报告了种族信息。在研究期间，种族报告情况没有显著改善（趋势p值 = 0.31）。在构成这20项RCT的17种不同患者群体中，14种（82.4%）来自美国。多中心RCT报告患者队列种族构成的可能性显著增加（比值比5.10，p = 0.025）。白人/高加索患者占汇总患者群体的84.5%，黑人/非裔美国人、亚洲人和拉丁裔/西班牙裔患者分别占7.9%、1.2%和2.1%。
在过去30年评估微创外科技术的RCT中，关于纳入患者种族的数据报告不足。除了为改善种族和族裔少数群体参与临床试验的机会做出重要努力外，迫切需要努力提高外科RCT的报告质量和透明度。
