Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA
Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
BMJ Health Care Inform. 2023 Jul;30(1). doi: 10.1136/bmjhci-2022-100726.
Digital technologies create opportunities for improvement of consenting processes in clinical care. Yet little is known about the prevalence, characteristics or outcomes of shifting from paper to electronic consenting, or e-consent, in clinical settings. Thus questions remain around e-consent's impact on efficiency, data integrity, user experience, care access, equity and quality. Our objective was to scope all known findings on this critical topic.
Through an international, systematic scoping review, we identified and assessed all published findings on clinical e-consent in the scholarly and grey literatures, including consents for telehealth encounters, procedures and health information exchanges. From each relevant publication, we abstracted data on study design, measures, findings and other study features.
Metrics describing or evaluating clinical e-consent, including preferences for paper versus e-consenting; efficiency (eg, time, workload) and effectiveness (eg, data integrity, care quality). User characteristics were captured where available.
A total of 25 articles published since 2005, most from North America or Europe, report on the deployment of e-consent in surgery, oncology and other clinical settings. Experimental designs and other study characteristics vary, but nearly all focus on procedural e-consents. Synthesis reveals relatively consistent findings around improved efficiency and data integrity with, and user preferences for, e-consent. Care access and quality issues are less frequently explored, with disparate findings.
The literature is nascent and largely focused on issues that are immediate and straightforward to measure. As virtual care pathways expand, more research is urgently needed to ensure that care quality and access are advanced, not compromised, by e-consent.
数字技术为改善临床护理中的知情同意过程创造了机会。然而，对于从纸质同意书到电子同意书（e 同意书）在临床环境中的转变的普遍性、特征或结果知之甚少。因此，围绕 e 同意书对效率、数据完整性、用户体验、护理获取、公平性和质量的影响仍存在疑问。我们的目标是对这一关键主题的所有已知发现进行范围界定。
通过国际系统的范围界定审查，我们在学术和灰色文献中确定并评估了所有关于临床电子同意书的已发表发现，包括远程医疗就诊、程序和健康信息交换的同意书。从每篇相关出版物中，我们提取了关于研究设计、措施、发现和其他研究特征的数据。
描述或评估临床电子同意书的指标，包括对纸质与电子同意书的偏好；效率（例如，时间、工作量）和效果（例如，数据完整性、护理质量）。在可用的情况下，还记录了用户特征。
自 2005 年以来，共发表了 25 篇文章，其中大部分来自北美或欧洲，报告了电子同意书在手术、肿瘤学和其他临床环境中的部署情况。实验设计和其他研究特征各不相同，但几乎所有研究都集中在程序性电子同意书上。综合结果表明，电子同意书在提高效率和数据完整性方面具有一致性，且用户对此具有偏好。护理获取和质量问题探讨较少，结果也不一致。
文献尚处于初期阶段，主要集中在那些易于测量的直接问题上。随着虚拟护理途径的扩展，迫切需要开展更多研究，以确保护理质量和获取不会因电子同意书而受到影响。
