当被要求为研究共享健康记录时，互动式增强信任的电子知情同意是否能改善患者体验？一项随机试验。
Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial.
机构信息
Department of Health Policy and Management, Indiana University, Indianapolis, Indiana, USA.
Regenstrief Institute Center for Biomedical Informatics, Indianapolis, Indiana, USA.
出版信息
J Am Med Inform Assoc. 2019 Jul 1;26(7):620-629. doi: 10.1093/jamia/ocz015.
OBJECTIVE
In the context of patient broad consent for future research uses of their identifiable health record data, we compare the effectiveness of interactive trust-enhanced e-consent, interactive-only e-consent, and standard e-consent (no interactivity, no trust enhancement).
MATERIALS AND METHODS
A randomized trial was conducted involving adult participants making a scheduled primary care visit. Participants were randomized into 1 of the 3 e-consent conditions. Primary outcomes were patient-reported satisfaction with and subjective understanding of the e-consent. Secondary outcomes were objective knowledge, perceived voluntariness, trust in medical researchers, consent decision, and time spent using the application. Outcomes were assessed immediately after use of the e-consent and at 1-week follow-up.
RESULTS
Across all conditions, participants (N = 734) reported moderate-to-high satisfaction with consent (mean 4.3 of 5) and subjective understanding (79.1 of 100). Over 94% agreed to share their health record data. No statistically significant differences in outcomes were observed between conditions. Irrespective of condition, black participants and those with lower education reported lower satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers, as well as spent more time consenting.
CONCLUSIONS
A large majority of patients were willing to share their identifiable health records for research, and they reported positive consent experiences. However, incorporating optional additional information and messages designed to enhance trust in the research process did not improve consent experiences. To improve poorer consent experiences of racial and ethnic minority participants and those with lower education, other novel consent technologies and processes may be valuable. (An Interactive Patient-Centered Consent for Research Using Medical Records; NCT03063268).
目的
在患者对其可识别健康记录数据的未来研究用途进行广泛同意的背景下，我们比较了增强互动信任的电子知情同意、仅互动式电子知情同意和标准电子知情同意（无互动、无信任增强）的效果。
材料和方法
进行了一项随机试验，涉及进行常规初级保健就诊的成年参与者。参与者被随机分配到 3 种电子知情同意条件之一。主要结果是患者对电子知情同意的满意度和主观理解的报告。次要结果是客观知识、感知自愿性、对医学研究人员的信任、同意决定以及使用应用程序所花费的时间。在使用电子知情同意后立即以及在 1 周随访时评估结果。
结果
在所有条件下，参与者（N=734）报告对同意（平均 4.3 分中的 4.3 分）和主观理解（100 分中的 79.1 分）的满意度较高。超过 94%的参与者同意分享他们的健康记录数据。在结果方面，各条件之间没有观察到统计学上的显著差异。无论条件如何，黑人参与者和受教育程度较低的参与者报告的满意度、主观理解、知识、感知自愿性和对医学研究人员的信任较低，并且花费更多的时间同意。
结论
绝大多数患者愿意分享其可识别的健康记录用于研究，并且他们报告了积极的同意体验。然而，纳入旨在增强对研究过程信任的可选附加信息和消息并没有改善同意体验。为了改善种族和民族少数参与者以及受教育程度较低的参与者较差的同意体验，可能需要其他新颖的同意技术和流程。（使用医疗记录进行互动式以患者为中心的研究同意；NCT03063268）。
Zotero 插件