Schneiderheinze Hauke, Prokosch Hans-Ulrich, Apel Hendrik, Bellut Laura, Wullich Bernd, Trollmann Regina, Schüttler Christina
Friedrich-Alexander-Universität Erlangen-Nürnberg.
Department of Urology and Paediatric Urology, University Hospital Erlangen.
Stud Health Technol Inform. 2019 Sep 3;267:297-303. doi: 10.3233/SHTI190841.
More and more medical data is being stored digitally in routine care. The secondary use of patient data is only possible to a limited extent for data protection reasons. In order to enable a long-term and far-reaching use of secondary data, a possible approach is to obtain "broad consent" from patients, e.g. on research projects whose purpose is still unknown at the time of consent.
To develop and evaluate an interactive eConsent prototype that presents the extensive contents of the "broad consent" in multimedia form for the purpose of a successful and resource-efficient information and consent process.
The eConsent prototype was designed on basis of a literature review and in accordance with the goals of the German medical informatics initiative. User tests and subsequent questionnaire surveys using the System Usability Scale (SUS) were carried out with patients from a university hospital to assess the prototype's usability. The study was conducted in a quasi-experimental, one-group posttest-only design.
The created interactive prototype can present the contents acoustically and visually and offers the possibility to retrieve additional information. With a SUS score of 84,1/100 the results indicate a very good usability of the prototype.
The next steps will include further refinements of the prototype based on the feedback received and a subsequent study with a broader user group aimed at introducing an eConsent tool as part of a patient portal.
在日常医疗中，越来越多的医学数据以数字形式存储。出于数据保护的原因，患者数据的二次使用仅在有限程度上可行。为了实现对二次数据的长期和广泛使用，一种可能的方法是获得患者的“广泛同意”，例如对那些在同意时目的仍不明确的研究项目。
开发并评估一个交互式电子同意书原型，该原型以多媒体形式呈现“广泛同意”的丰富内容，以实现成功且资源高效的信息告知和同意流程。
电子同意书原型基于文献综述并根据德国医学信息学倡议的目标进行设计。使用系统可用性量表（SUS）对一家大学医院的患者进行用户测试及后续问卷调查，以评估该原型的可用性。该研究采用准实验、单组仅后测设计。
创建的交互式原型能够以听觉和视觉方式呈现内容，并提供获取额外信息的可能性。SUS 评分为 84.1/100，结果表明该原型具有非常好的可用性。
接下来的步骤将包括根据收到的反馈对原型进行进一步完善，以及随后针对更广泛用户群体的研究，旨在引入电子同意书工具作为患者门户的一部分。
