患者在数字健康背景下对知情同意的观点和偏好：最新文献综述。

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review.

机构信息

Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.

Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.

出版信息

J Med Internet Res. 2023 Feb 10;25:e42507. doi: 10.2196/42507.

DOI:10.2196/42507

PMID:36763409

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9960046/

Abstract

BACKGROUND

The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Although privacy legislation governs how entities may collect, use, or share PHI, such legislation has not kept pace with digital health innovations, resulting in a lack of guidance on implementing meaningful consent. Understanding patient perspectives when implementing meaningful consent is critical to ensure that it meets their needs. Consent for research in the context of digital health is limited.

OBJECTIVE

This state-of-the-art review aimed to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives were to explore what is known about the patient perspective and experience with digital health consent and provide recommendations on designing and implementing digital health consent based on the findings.

METHODS

A structured literature search was developed and deployed in 4 electronic databases-MEDLINE, IEEE Xplore, Scopus, and Web of Science-for articles published after January 2010. The initial literature search was conducted in March 2021 and updated in March 2022. Articles were eligible for inclusion if they discussed electronic consent or consent, focused on the patient perspective or preference, and were related to digital health or digital PHI. Data were extracted using an extraction template and analyzed using qualitative content analysis.

RESULTS

In total, 75 articles were included for analysis. Most studies were published within the last 5 years (58/75, 77%) and conducted in a clinical care context (33/75, 44%) and in the United States (48/75, 64%). Most studies aimed to understand participants' willingness to share PHI (25/75, 33%) and participants' perceived usability and comprehension of an electronic consent notice (25/75, 33%). More than half (40/75, 53%) of the studies did not describe the type of consent model used. The broad open consent model was the most explored (11/75, 15%). Of the 75 studies, 68 (91%) found that participants were willing to provide consent; however, their consent behaviors and preferences were context-dependent. Common patient consent requirements included clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured.

CONCLUSIONS

There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. There is evidence suggesting that many patients are willing to consent for various purposes, especially when there is greater transparency on how the PHI is used and oversight mechanisms are in place. Providing this transparency is critical for fostering trust in digital health tools and the innovative uses of data to optimize health and system outcomes.

摘要

背景

数字健康工具越来越多地融入医疗服务，可能导致患者和提供者之间个人健康信息（PHI）的流动增加。尽管隐私法规规定了实体机构可以如何收集、使用或共享 PHI，但这些法规并未跟上数字健康创新的步伐，导致在实施有意义的同意方面缺乏指导。了解患者在实施有意义的同意时的观点对于确保其满足他们的需求至关重要。数字健康背景下的研究同意权有限。

目的

本研究旨在了解与患者对数字健康同意的观点相关的当前研究状况。其目的是探讨患者对数字健康同意的观点和体验，以及根据研究结果就数字健康同意的设计和实施提出建议。

方法

制定并在 4 个电子数据库（MEDLINE、IEEE Xplore、Scopus 和 Web of Science）中进行了结构化文献检索，以检索 2010 年 1 月以后发表的文章。初始文献检索于 2021 年 3 月进行，并于 2022 年 3 月进行了更新。如果文章讨论了电子同意或同意，重点是患者的观点或偏好，并且与数字健康或数字 PHI 相关，则符合纳入标准。使用提取模板提取数据，并使用定性内容分析进行分析。

结果

共有 75 篇文章符合分析条件。大多数研究发表于最近 5 年（75 篇中的 58 篇，77%），在临床护理环境中进行（75 篇中的 33 篇，44%），且在美国进行（75 篇中的 48 篇，64%）。大多数研究旨在了解参与者分享 PHI 的意愿（75 篇中的 25 篇，33%）和参与者对电子同意通知的感知可用性和理解性（75 篇中的 25 篇，33%）。超过一半（75 篇中的 40 篇，53%）的研究未描述所使用的同意模型类型。最广泛的开放同意模型是研究最多的（75 篇中的 11 篇，15%）。在这 75 项研究中，有 68 项（91%）研究发现参与者愿意提供同意；然而，他们的同意行为和偏好取决于具体情况。患者常见的同意要求包括详细说明谁可以访问 PHI、PHI 将用于什么目的以及如何确保隐私的清晰易懂的信息。