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A comprehensive analysis of health care Inequities in randomized clinical trials following bariatric surgeries. Am J Surg 2024 Jun 08:115796

Date

06/14/2024

Pubmed ID

38871550

DOI

10.1016/j.amjsurg.2024.115796

Scopus 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.

Author List

Ghusn W, Mosleh KA, Hage K, Salame M, Gala K, Edwards MA, Kindel TL, Ghanem OM

Author

Tammy Lyn Kindel MD, PhD Associate Professor in the Surgery department at Medical College of Wisconsin