Representation of women and historically underserved populations in hypertension and diabetes clinical trials at Federally Qualified Health Centers: A systematic review and meta-analysis.

IF 2.7 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Journal of Clinical and Translational Science Pub Date : 2026-06-06 eCollection Date: 2026-01-01 DOI:10.1017/cts.2026.10759

Rifath Ara Alam Barsha, Samuel Byiringiro, Thomas Hinneh, Emmanuel Uwiringiyimana, Juliana Garcia, Kimesha Grant, Oluwatosin Tomiwa, Khadijat Adeleye, Brenda Owusu, Yuling Chen, Diana-Lyn Baptiste, Ashwag Alhabodal, Serina Gbaba, Payam Sheikhattari, Hailey N Miller, Cheryl R Dennison Himmelfarb

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Abstract

Introduction: Federally Qualified Health Centers (FQHCs) serve diverse populations and may enhance participant diversity in clinical trials; however, their engagement in trials remains understudied. The objective of the current study was to examine participant diversity in hypertension (HTN) and type-2 diabetes (T2D) clinical trials.

Methods: We searched PubMed, Cochrane, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Web of Science, Embase, and Scopus for clinical trials of medical interventions addressing HTN or T2D among adults (≥18), engaging one or multiple FQHCs, and published between 2013 and 2023. We reported pooled proportions of representation of underserved populations in clinical trials.

Results: Of 4552 articles identified, 26 clinical trials were included. The pooled proportion was 0.35 (95% CI: 0.26, 0.45) for Hispanic, 0.36 (95% CI: 0.23, 0.48) for Black/African American, 0.03 (95% CI: 0.02, 0.05) for Asian, 0.58 (95% CI: 0.54, 0.63) for female, and 0.25 (95% CI: 0.07, 0.43) for uninsured participants, and 0.54 (95% CI: 0.36, 0.72) for people with limited education (≤high school).

Conclusion: Trials involving FQHCs demonstrated high inclusion of historically underrepresented than typical trial populations. This underscores the potential of FQHCs to improve clinical trial representativeness and to enhance the generalizability of research findings.

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联邦合格医疗中心高血压和糖尿病临床试验中女性和历史上服务不足人群的代表性：系统回顾和荟萃分析

简介：联邦合格健康中心（FQHCs）服务于不同的人群，可以提高临床试验参与者的多样性；然而，他们参与试验的情况仍未得到充分研究。本研究的目的是检查高血压（HTN）和2型糖尿病（T2D）临床试验的参与者多样性。方法：我们检索PubMed、Cochrane、CINAHL（护理和相关健康文献累积索引）、Web of Science、Embase和Scopus，检索2013年至2023年间发表的针对成人（≥18岁）HTN或T2D的医疗干预措施的临床试验，涉及一个或多个fqhc。我们报告了临床试验中服务不足人群的汇总比例。结果：在纳入的4552篇文献中，纳入了26项临床试验。西班牙裔的合并比例为0.35 (95% CI: 0.26, 0.45)，黑人/非裔美国人为0.36 (95% CI: 0.23, 0.48)，亚洲人为0.03 (95% CI: 0.02, 0.05)，女性为0.58 (95% CI: 0.54, 0.63)，未参保者为0.25 (95% CI: 0.07, 0.43)，受教育程度有限（高中以下）者为0.54 （95% CI: 0.36, 0.72）。结论：涉及fqhc的试验显示，与典型试验人群相比，历史上代表性不足的受试者纳入率较高。这强调了fqhc在提高临床试验代表性和增强研究结果的普遍性方面的潜力。

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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