Institute for Precision Health, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States.
Center for SMART Health, Institute for Precision Health, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States.
J Med Internet Res. 2021 Dec 8;23(12):e31121. doi: 10.2196/31121.
Obtaining explicit consent from patients to use their remnant biological samples and deidentified clinical data for research is essential for advancing precision medicine.
We aimed to describe the operational implementation and scalability of an electronic universal consent process that was used to power an institutional precision health biobank across a large academic health system.
The University of California, Los Angeles, implemented the use of innovative electronic consent videos as the primary recruitment tool for precision health research. The consent videos targeted patients aged ≥18 years across ambulatory clinical laboratories, perioperative settings, and hospital settings. Each of these major areas had slightly different workflows and patient populations. Sociodemographic information, comorbidity data, health utilization data (ambulatory visits, emergency room visits, and hospital admissions), and consent decision data were collected.
The consenting approach proved scalable across 22 clinical sites (hospital and ambulatory settings). Over 40,000 participants completed the consent process at a rate of 800 to 1000 patients per week over a 2-year time period. Participants were representative of the adult University of California, Los Angeles, Health population. The opt-in rates in the perioperative (16,500/22,519, 73.3%) and ambulatory clinics (2308/3390, 68.1%) were higher than those in clinical laboratories (7506/14,235, 52.7%; P<.001). Patients with higher medical acuity were more likely to opt in. The multivariate analyses showed that African American (odds ratio [OR] 0.53, 95% CI 0.49-0.58; P<.001), Asian (OR 0.72, 95% CI 0.68-0.77; P<.001), and multiple-race populations (OR 0.73, 95% CI 0.69-0.77; P<.001) were less likely to participate than White individuals.
This is one of the few large-scale, electronic video-based consent implementation programs that reports a 65.5% (26,314/40,144) average overall opt-in rate across a large academic health system. This rate is higher than those previously reported for email (3.6%) and electronic biobank (50%) informed consent rates. This study demonstrates a scalable recruitment approach for population health research.
获得患者明确同意,使用其剩余生物样本和去识别临床数据进行研究,对推进精准医学至关重要。
本研究旨在描述一种电子通用同意流程的实施和可扩展性,该流程用于为大型学术健康系统中的机构精准健康生物库提供动力。
加州大学洛杉矶分校(UCLA)实施了创新的电子同意视频的使用,作为精准健康研究的主要招募工具。这些同意视频针对年龄≥18 岁的门诊临床实验室、围手术期和医院环境中的患者。这些主要领域中的每一个都有略微不同的工作流程和患者群体。收集了社会人口统计学信息、合并症数据、健康利用数据(门诊就诊、急诊就诊和住院)和同意决策数据。
该同意方法在 22 个临床地点(医院和门诊环境)中具有可扩展性。在 2 年的时间内,每周有 800 到 1000 名患者完成了同意流程。参与者代表了成年的加州大学洛杉矶分校健康人群。围手术期(16500/22519,73.3%)和门诊诊所(2308/3390,68.1%)的选择加入率高于临床实验室(7506/14235,52.7%;P<.001)。医疗急症较高的患者更有可能选择加入。多变量分析显示,非裔美国人(比值比[OR]0.53,95%置信区间[CI]0.49-0.58;P<.001)、亚洲人(OR0.72,95%CI0.68-0.77;P<.001)和多种族人群(OR0.73,95%CI0.69-0.77;P<.001)参与的可能性低于白人个体。
这是为数不多的大规模、基于电子视频的同意实施计划之一,报告了在大型学术健康系统中平均总体选择加入率为 65.5%(26314/40144)。这一比率高于之前报告的电子邮件(3.6%)和电子生物库(50%)知情同意率。本研究展示了一种可扩展的人群健康研究招募方法。