Goldschmitt Mascha, Gleim Patricia, Mandelartz Sekina, Kellmeyer Philipp, Rigotti Thomas
Department of Work, Organizational, and Business Psychology, Johannes Gutenberg University Mainz, Wallstr. 3, Mainz, 55122, Germany.
Department of Neurosurgery, University of Freiburg- Medical Center, Breisacher Str. 64, Freiburg I.B, 79106, Germany.
BMC Health Serv Res. 2025 Jul 2;25(1):893. doi: 10.1186/s12913-025-12964-7.
Traditional paper-based informed consent for medical procedures poses a number of challenges, such as low comprehensibility, lack of customization, and limited time for discussion with medical staff. Digitalization, especially in light of the rapid development of AI-based technologies, could provide a solution.
This scoping review explores the digitalization of the consent process, focusing on the types of technologies used, their role in the consent process, evaluation results, and success factors for implementation. Following the guidance of the Joanna Briggs Institute (JBI) Manual for Evidence Synthesis for scoping reviews, we searched various databases and platforms (Web of Science, EBSCOHost, PubMed and PubPsych) for eligible articles published between January 2012 and June 2024.
Title and abstract screening of 4287 records resulted in the inclusion of 27 studies for analysis. The findings suggest that digitalizing the consent process can enhance recipients' understanding of clinical procedures, potential risks and benefits, and alternative treatments. Mixed evidence exists on patient satisfaction, convenience, and perceived stress. The limited research on healthcare professionals indicates that time savings are the major benefit. AI-based technologies seem to be not yet suitable for use without medical oversight.
Overall, few interactive technologies have been evaluated in the patient consent process, and only recently have studies started to examine the use of AI technologies. This indicates an early stage of the digitalization of patient consent for medical diagnosis and treatment. However, there is great potential to optimize the consent process for both patients and healthcare professionals. Methodologically sound studies are needed to validate these findings.
The scoping review was initially preregistered with PROSPERO (CRD42023397681) as a systematic review. The reasons for the change to a scoping review are outlined in the registration, while the systematic approach to data extraction and analysis was maintained.
传统的基于纸质的医疗程序知情同意书面临诸多挑战，如理解性低、缺乏定制性以及与医护人员讨论的时间有限。数字化，尤其是鉴于基于人工智能的技术的快速发展，可能提供一种解决方案。
本范围综述探讨了同意过程的数字化，重点关注所使用的技术类型、它们在同意过程中的作用、评估结果以及实施的成功因素。遵循乔安娜·布里格斯研究所（JBI）证据综合手册中范围综述的指导，我们在多个数据库和平台（科学网、EBSCOHost、PubMed和PubPsych）中搜索了2012年1月至2024年6月期间发表的符合条件的文章。
对4287条记录进行标题和摘要筛选后，纳入了27项研究进行分析。研究结果表明，将同意过程数字化可以增强接受者对临床程序、潜在风险和益处以及替代治疗的理解。关于患者满意度、便利性和感知压力存在混合证据。对医疗保健专业人员的有限研究表明，节省时间是主要益处。在没有医疗监督的情况下，基于人工智能的技术似乎尚不适合使用。
总体而言，在患者同意过程中很少有交互式技术得到评估，而且直到最近才有研究开始考察人工智能技术的使用。这表明医疗诊断和治疗患者同意的数字化尚处于早期阶段。然而，对于患者和医疗保健专业人员来说，优化同意过程有很大潜力。需要方法学上合理健全的研究来验证这些发现。
该范围综述最初作为系统综述在PROSPERO（CRD42023397681）上进行了预注册。注册中概述了改为范围综述的原因，并保持了数据提取和分析的系统方法。
