使用智能手表的无站点数字临床试验中的种族和族裔代表性及研究参与情况：苹果心脏研究的结果
Racial and Ethnic Representation and Study Engagement in a Siteless Digital Clinical Trial Using a Smartwatch: Findings From the Apple Heart Study.
作者信息
Nguyen Kaylin T, Yu Jingzhi, Hedlin Haley, Phillips Adam T, Desai Sumbul, Cheung Lauren, Kowey Peter R, Jain Sneha S, Rumsfeld John S, Russo Andrea M, Granger Christopher B, Hills Mellanie True, Desai Manisha, Mahaffey Kenneth W, Turakhia Mintu P, Perez Marco V
机构信息
Division of Cardiovascular Medicine, Olive View-UCLA Medical Center, Sylmar, CA.
Quantitative Sciences Unit, Stanford University, Stanford, CA.
出版信息
Mayo Clin Proc Digit Health. 2025 Jun 3;3(3):100232. doi: 10.1016/j.mcpdig.2025.100232. eCollection 2025 Sep.
OBJECTIVE
To evaluate differences in study engagement in diverse racial/ethnic groups that have been significantly underrepresented in atrial fibrillation and digital clinical trials.
PATIENTS AND METHODS
This was a secondary analysis of participants from the Apple Heart Study, a prospective, siteless, single-arm pragmatic clinical trial from November 29, 2017, to January 31, 2019. Black, Hispanic, Asian, and White participants were monitored using an irregular rhythm notification algorithm designed to detect atrial fibrillation on a smartwatch. Logistic regression was performed to evaluate the relationship between race/ethnicity and completion of the first study visit after an irregular rhythm notification, adjusting for demographic characteristics and comorbidities.
RESULTS
Of the 419,297 participants, 393,396 (93.8%) individuals self-identified as White, Black, Hispanic, or Asian. Overall, participants were 57% men and had a mean (SD) age of 41 (13) years. Among 2044 (0.52%) participants who received an irregular rhythm notification, non-White participants had lower odds of completing the initial virtual study visit compared with White participants (Black: OR, 0.61; 95% CI, 0.39-0.94; Hispanic: OR, 0.62; 95% CI, 0.40-0.95; Asian: OR, 0.40; 95% CI, 0.23-0.66) after multivariate adjustment. Among those who completed the initial study visit, there was no statistically significant difference in the odds of returning the electrocardiogram patch in the non-White groups compared with that of the White group.
CONCLUSION
Despite successful recruitment of racially and ethnically diverse participants, there were differences in subsequent engagement by non-White compared with that by White participants. Equitable representation and engagement of diverse racial and ethnic groups in digital clinical studies requires further study.
TRIAL REGISTRATION
Clinicaltrials.gov Identifier: NCT03335800.
目的
评估在心房颤动和数字临床试验中代表性严重不足的不同种族/族裔群体在研究参与度方面的差异。
患者与方法
这是对苹果心脏研究参与者的二次分析，该研究是一项从2017年11月29日至2019年1月31日的前瞻性、无站点、单臂实用临床试验。使用一种不规则心律通知算法对黑人、西班牙裔、亚洲人和白人参与者进行监测，该算法旨在通过智能手表检测心房颤动。进行逻辑回归以评估种族/族裔与不规则心律通知后首次研究访视完成情况之间的关系，并对人口统计学特征和合并症进行调整。
结果
在419,297名参与者中，393,396名（93.8%）自我认定为白人、黑人、西班牙裔或亚洲人。总体而言，参与者中男性占57%，平均（标准差）年龄为41（13）岁。在2044名（0.52%）收到不规则心律通知的参与者中，与白人参与者相比，非白人参与者完成首次虚拟研究访视的几率较低（黑人：比值比，0.61；95%置信区间，0.39 - 0.94；西班牙裔：比值比，0.62；95%置信区间，0.40 - 0.95；亚洲人：比值比，0.40；95%置信区间，0.23 - 0.66），经过多变量调整。在完成首次研究访视的参与者中，非白人组返回心电图贴片的几率与白人组相比无统计学显著差异。
结论
尽管成功招募了不同种族和族裔的参与者，但与白人参与者相比，非白人参与者在后续参与度方面存在差异。不同种族和族裔群体在数字临床研究中的公平代表性和参与度需要进一步研究。
试验注册
Clinicaltrials.gov标识符：NCT03335800。
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