Underreporting and Underrepresentation of Racial and Ethnic Minority Patients in Lymphedema Clinical Trials: A Systematic Review.

Pub Date : 2024-04-14 DOI:10.2458/lymph.6064

M. J. Escobar-Domingo, V. P. Bustos, J. E. Fanning, J. Foppiani, E. Kim, A. Hernandez-Alvarez, S. J. Lin, D. Singhal, B. T. Lee

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Abstract

The generalizability of findings from Clinical Trials (CTs) investigating lymphedema treatment modalities requires an accurate representation of the target population. This study aims to evaluate racial and ethnic reporting and representation in lymphedema CTs. A comprehensive systematic literature search was conducted during May 2023 using multiple databases, following the PRISMA guidelines. All CTs published from 2018 to 2023 were included. A total of 84 articles were included in this review, from which 6,546 participants were included in the analysis. Seventy-four (88.1%) articles addressed secondary lymphedema, of which 60 (81.1%) were related to breast cancer. Only 12 (13%) of CTs reported at some extend race or ethnicity. Of these, five (41.6%) reported race and two (16.6%) reported ethnicity according to FDA guidelines. White race had the highest pooled prevalence (80%; 95% CI 72-86%; I2=90%), followed by Black (7%; 95% CI 2- 15%; I2= 94.3%) and Asian (4%; 95% CI 1-8%; I2= 89.9%). In studies reporting ethnicity, participants were predominantly non-Hispanic (92.1%; 95% CI 90 - 94%). There is an underreporting and underrepresentation of racial and ethnic minorities among lymphedema CTs, limiting their generalizability. It is imperative to future development of strategies to enhance diversity in the study sample.

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淋巴水肿临床试验中少数种族和族裔患者的报告不足和代表性不足：系统回顾。

淋巴水肿治疗方法临床试验（Clinical Trials，CT）研究结果的推广性需要目标人群的准确代表性。本研究旨在评估淋巴水肿临床试验中的种族和民族报告及代表性。2023 年 5 月期间，我们按照 PRISMA 指南使用多个数据库进行了全面的系统文献检索。纳入了 2018 年至 2023 年间发表的所有 CT。本综述共纳入 84 篇文章，其中 6546 名参与者被纳入分析。74篇（88.1%）文章涉及继发性淋巴水肿，其中60篇（81.1%）与乳腺癌有关。只有 12 篇（13%）CT 报告了部分种族或民族。其中，5 篇（41.6%）根据 FDA 指南报告了种族，2 篇（16.6%）根据 FDA 指南报告了民族。白种人的汇总流行率最高（80%；95% CI 72-86%；I2=90%），其次是黑人（7%；95% CI 2-15%；I2=94.3%）和亚裔（4%；95% CI 1-8%；I2=89.9%）。在报告种族的研究中，参与者主要为非西班牙裔（92.1%；95% CI 90 - 94%）。在淋巴水肿 CT 中，少数种族和少数族裔的报告和代表性不足，限制了其普遍性。今后必须制定策略，提高研究样本的多样性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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