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.
Surgical endoscopy. 2021 May 12 [Epub ahead of print]
Rashid K Sayyid, Soum D Lokeshwar, David Tella, Caitlin E Jones, Michael D Oberle, Phillip Woodruff, Zachary Klaassen, Christopher J D Wallis
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., Department of Urology, University of Virginia, Charlottesville, VA, USA., Department of Surgery, Medical College of Georgia-Augusta University, Augusta, GA, Georgia., Department of Urologic Surgery, Vanderbilt University Medical Center, A1302 Medical Center North, Nashville, TN, 37232-2765, USA. .