van Hout Ludo, Vriens Patrick W H E, Bökkerink Willem J V
Department of Medical and Clinical Psychology, Tilburg School of Social and Behavioral Sciences, Tilburg University, Warandelaan 2, Tilburg, 5037 AB, The Netherlands.
Department of Surgery, Elisabeth-TweeSteden Hospital (ETZ), Tilburg, The Netherlands.
Hernia. 2024 Dec 12;29(1):45. doi: 10.1007/s10029-024-03238-y.
The Q1.6 Inguinal Hernia application remotely and continuously collects patient-reported outcomes from inguinal hernia patients. Previous research has explored its technical, legal, and ethical aspects, along with face, content, and construct validity assessments. This study aims to examine its concurrent validity by comparing prospective data with that from the ENTREPPMENT trial, a randomised study.
A small cohort of patients participating in the ENTREPPMENT trial were asked to use the Q1.6 application in addition to their standard care. Corresponding prospective data points, in terms of content and timing relative to the operation date, were identified. Correlation coefficients were calculated for matching variables, and a repeated measures model was created to analyse pain and limitation measures during the first two postoperative weeks.
Twenty-eight patients were analysed. Preoperative variables, such as hernia side and painkiller use, demonstrated a predominantly high level of agreement between the two measurement methods, ranging from 'substantial' (0.61-0.8) to 'perfect' (1.0) agreement. Evaluating immediate postoperative outcomes, including pain and limitation scores, revealed a prevalent 'substantial' (0.61-0.8) to 'almost perfect' (0.81-1.0) agreement. In a repeated measures model, the overall within-subjects correlation demonstrated levels of agreement ranging from 'moderate' (0.41-0.6) to 'almost perfect' (0.81-1.0).
This study demonstrates strong agreement between data from the Q1.6 Inguinal Hernia application and the ENTREPPMENT trial, supporting its concurrent validity. This makes the application a reliable tool for collecting PROs before and immediately after inguinal hernia repair, offering a promising alternative to traditional follow-up methods. Future research will focus on enhancing compliance and refining functionality.
Q1.6腹股沟疝应用程序可远程持续收集腹股沟疝患者报告的结局。先前的研究探讨了其技术、法律和伦理方面，以及表面效度、内容效度和结构效度评估。本研究旨在通过将前瞻性数据与随机研究ENTREPPMENT试验的数据进行比较，检验其同时效度。
邀请一小群参与ENTREPPMENT试验的患者在接受标准治疗的同时使用Q1.6应用程序。确定了与手术日期相关的内容和时间方面的相应前瞻性数据点。计算匹配变量的相关系数，并创建重复测量模型以分析术后前两周的疼痛和功能受限指标。
分析了28例患者。术前变量，如疝侧和止痛药使用情况，两种测量方法之间的一致性主要较高，从“实质性”（0.61 - 0.8）到“完美”（1.0）一致。评估术后即时结局，包括疼痛和功能受限评分，发现普遍存在“实质性”（0.61 - 0.8）到“几乎完美”（0.81 - 1.0）的一致。在重复测量模型中，总体受试者内相关性显示一致性水平从“中等”（0.41 - 0.6）到“几乎完美”（0.81 - 1.0）。
本研究表明Q1.6腹股沟疝应用程序的数据与ENTREPPMENT试验的数据高度一致，支持其同时效度。这使得该应用程序成为腹股沟疝修补术前和术后即时收集患者报告结局的可靠工具，为传统随访方法提供了有前景的替代方案。未来的研究将集中在提高依从性和完善功能方面。
