JMIR Publications

ABSTRACT

Background:

The merits of technology have been adopted in capturing patient-reported outcome (PRO) by incorporating PRO 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.

Objective:

This paper aims to introduce a generalised concept that will guide ePRO providers in planning for system-specific validation methods.

Methods:

Since electronic systems are essentially products of software engineering endeavour, electronic systems used to collect ePRO should be viewed from a computer science perspective with consideration to the healthcare environment. On this basis, a testing model was blueprinted and applied to a newly developed ePRO system designed for clinical use in paediatric dentistry (ePAQ-PD) to investigate its thoroughness.

Results:

A behaviour-based model of ePRO system validation was developed based on the principles of User acceptance testing (UAT) and patient-centred 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 13 positive errors (critical= 3; non-critical=10) with one unfavourable response when applied to ePAQ-PD system testing.

Conclusions:

The application of the behaviour-based UAT 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