Academic Unit of Oral Health Dentistry and Society, University of Sheffield, Sheffield, United Kingdom.
Department of Preventive Dentistry, College of Dentistry, University of Hail, Hail, Saudi Arabia.
JMIR Form Res. 2024 Sep 17;8:e56370. doi: 10.2196/56370.
The merits of technology have been adopted in capturing patient-reported outcomes (PROs) by incorporating PROs into electronic systems. Following the development of an electronic system, evaluation of system performance is crucial to ensuring the collection of meaningful data. In contemporary PRO literature, electronic system validation is overlooked, and evidence on validation methods is lacking.
This study aims to introduce a generalized concept to guide electronic patient-reported outcome (ePRO) providers in planning for system-specific validation methods.
Since electronic systems are essentially products of software engineering endeavors, electronic systems used to collect PRO should be viewed from a computer science perspective with consideration to the health care environment. On this basis, a testing model was blueprinted and applied to a newly developed ePRO system designed for clinical use in pediatric dentistry (electronic Personal Assessment Questionnaire-Paediatric Dentistry) to investigate its thoroughness.
A behavior-based model of ePRO system validation was developed based on the principles of user acceptance testing and patient-centered care. The model allows systematic inspection of system specifications and identification of technical errors through simulated positive and negative usage pathways in open and closed environments. The model was able to detect 15 positive errors with 1 unfavorable response when applied to electronic Personal Assessment Questionnaire-Paediatric Dentistry system testing.
The application of the behavior-based model to a newly developed ePRO system showed a high ability for technical error detection in a systematic fashion. The proposed model will increase confidence in the validity of ePRO systems as data collection tools in future research and clinical practice.
通过将患者报告的结局（PROs）纳入电子系统，技术的优势已被用于捕获 PROs。在开发电子系统之后，评估系统性能对于确保收集有意义的数据至关重要。在当代 PRO 文献中，电子系统验证被忽视，缺乏关于验证方法的证据。
本研究旨在引入一个通用概念，以指导电子患者报告结局（ePRO）提供者规划特定于系统的验证方法。
由于电子系统本质上是软件工程努力的产物，因此应从计算机科学的角度来看待用于收集 PRO 的电子系统，并考虑医疗保健环境。在此基础上，蓝本设计了一个测试模型，并将其应用于新开发的用于儿科牙科临床使用的电子 PRO 系统（电子个人评估问卷-儿科牙科），以调查其全面性。
基于用户接受测试和以患者为中心的护理原则，开发了一种基于行为的 ePRO 系统验证模型。该模型允许通过模拟开放和封闭环境中的正向和负向使用路径，对系统规范进行系统检查，并识别技术错误。该模型在应用于电子个人评估问卷-儿科牙科系统测试时，能够检测到 15 个阳性错误和 1 个不利反应。
将基于行为的模型应用于新开发的 ePRO 系统，以系统的方式展示了对技术错误检测的高能力。该模型的应用将增加对 ePRO 系统作为未来研究和临床实践中数据收集工具的有效性的信心。
