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

Area of Science:

• Surgical innovation
• Digital health
• Patient-reported outcomes

Background:

• The Q1.6 Inguinal Hernia application collects patient-reported outcomes (PROs) remotely.
• Previous studies assessed its technical, legal, ethical, and validity aspects.
• This study focuses on concurrent validity against a randomized trial.

Purpose of the Study:

• To examine the concurrent validity of the Q1.6 Inguinal Hernia application.
• To compare prospective data from the Q1.6 app with data from the ENTREPPMENT trial.
• To establish the reliability of the Q1.6 app for collecting PROs in inguinal hernia patients.

Main Methods:

• A cohort from the ENTREPPMENT trial used the Q1.6 application alongside standard care.
• Prospective data points were identified and matched with trial data.
• Correlation coefficients and a repeated measures model were used to analyze agreement.

Main Results:

• High agreement (substantial to perfect) was found for preoperative variables.
• Substantial to almost perfect agreement was observed for immediate postoperative outcomes.
• The repeated measures model showed moderate to almost perfect within-subjects correlation.

Conclusions:

• The Q1.6 Inguinal Hernia application demonstrates strong concurrent validity.
• The app is a reliable tool for collecting PROs before and after inguinal hernia repair.
• This digital tool offers a promising alternative to traditional follow-up methods.