Department of Gastroenterology and Hepatology, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.
Obes Surg. 2023 Nov;33(11):3699-3702. doi: 10.1007/s11695-023-06854-2. Epub 2023 Oct 6.
Studies have shown that there are multiple disparities in the recruitment for clinical trials across medical specialties, which makes it challenging to translate research findings to the real world. We performed a systematic review of RCTs focused on EBTs and examined the sex, racial, and ethnic background and age of participants.
A systematic search of trials pertaining to EBTs was performed. Demographic details from all trials were abstracted and recorded and compared to real-world demographics of obesity in the United States, as reported in the NHANES 2017-March 2020.
A total of 11 trials were included. Mean age of all patients was 43.50 ± 9.25, which differs from the age distribution of obesity in the population (35% between 40 and 59 years). Mean female representation was 89%, which is higher than real-world estimates (50%). A mean of 74% of participants were white, with underrepresentation of African American (21%) and Hispanic (10%) participants as compared to real-world estimates.
Populations affected by obesity are not equitably reflected in clinical trials focused on endoscopic bariatric therapies.
研究表明，在各医学专业领域的临床试验招募中存在多种差异，这使得将研究结果转化到实际情况中具有挑战性。我们对专注于 EBT 的 RCT 进行了系统回顾，并检查了参与者的性别、种族和民族背景以及年龄。
对所有涉及 EBT 的试验进行了系统搜索。从所有试验中提取并记录人口统计学细节，并与 2017 年 NHANES 至 2020 年 3 月期间美国肥胖的实际人口统计学数据进行比较。
共纳入 11 项试验。所有患者的平均年龄为 43.50±9.25 岁，与肥胖人群的年龄分布不同（40-59 岁之间占 35%）。女性平均占比为 89%，高于实际估计值（50%）。参与者中有 74%为白人，而非裔美国人（21%）和西班牙裔（10%）参与者的代表性不足，与实际估计值相比。
在专注于内镜减肥治疗的临床试验中，受肥胖影响的人群没有得到公平反映。
