Representation in robotic surgery randomised controlled trials: a systematic review.

Introduction: Robotic surgery has been widely adopted across surgical specialties since its introduction in the 1980s, making it important to assess the representation of patients from varying demographic backgrounds in clinical trials. The objective of this study was to evaluate the demographic representativeness of randomised controlled trials (RCTs) on robotic surgery. Research Design and Methods: This systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. PubMed, Embase and Web of Science databases were searched for English-language RCTs conducted between January 2000 and December 2022. Only RCTs that enrolled participants of both sexes and compared robotic surgery with a non-robotic comparator were included. Primary outcomes included the reporting of participants' demographic information, specifically sex, age, race and ethnicity, the inclusion of subgroup analyses based on these demographics and the distribution of demographics within each study. Results: Out of 75 RCTs, 71 (95%) trials reported participant sex, 73 (97%) RCTs reported age and four (5%) RCTs reported race or ethnicity. Six (8%) RCTs provided sex-specific results, three (4%) RCTs provided age-specific outcomes and no RCTs reported outcomes based on race or ethnicity. The average percentage of female patients per RCT was 47.1% and the average age was 59.7 (SD=9) years. Of the RCTs that reported race or ethnicity, 59.5% of the population was Caucasian, 25.0% was Hispanic, 13.9% was African American and 1.6% was Asian/Pacific Islander/other. Conclusions: There was underreporting of demographic data, especially race and ethnicity of participants, a lack of demographic-specific study outcomes and underrepresentation of women and non-white participants across RCTs. This study highlights the need for greater efforts to improve diversity in robotic surgery clinical trials.