A comprehensive analysis of health care Inequities in randomized clinical trials following bariatric surgeries. Am J Surg 2024 Jun 08:115796
Date
06/14/2024Pubmed ID
38871550DOI
10.1016/j.amjsurg.2024.115796Scopus ID
2-s2.0-85195847708 (requires institutional sign-in at Scopus site)Abstract
BACKGROUND: Obesity is a global epidemic, leading to an increasing focus on interventions like bariatric surgeries. Despite this, there's a noticeable gap in understanding the demographic distribution of patients in clinical trials for bariatric surgery.
METHODS: We conducted a comprehensive analysis of 117 registered randomized clinical trials related to bariatric surgery on ClinicalTrials.gov. We extracted demographic information, including age, sex, race, and ethnicity, and performed descriptive statistical analyses.
RESULTS: The analysis covered 8,418 participants. The mean age was 43.8 years, with a substantial majority (93.8 %) falling within the 18-65 age group. Females comprised 74.9 % of participants, surpassing real-world estimates. Racially, 65.3 % of participants were White, while African Americans represented 18.5 %, Asians 1.2 %, Native Hawaiians 0.2 %, and American Indians 0.1 %, indicating an underrepresentation of diverse racial groups, notably lower compared to real-world demographic data. In terms of ethnicity, only 17.6 % were Hispanic.
CONCLUSIONS: This study reveals significant demographic disparities in patients undergoing bariatric surgeries in clinical trials. This suggests a lack of generalizability, emphasizing the need for inclusive recruitment strategies to enhance health equity.