Validating the Q1.6 Inguinal Hernia application using prospective data from a randomised clinical trial

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.