ISOQOL (International Society for Quality of Life Research) 31st Annual Conference

Session information:

Title: Have we truly progressed with optimizing the collection of patient-reported outcomes in clinical trials?

Dates: Sunday, October 13, 2024

Time: 6:00 p.m. – 7:30 p.m. CET

Abstract title (Clario): Comparability testing: Turning the tide

Aims:

With the adoption of electronic patient reported outcomes (ePRO) came the need to perform comparability testing to ensure the psychometric properties of the measures were not altered given the change in mode from paper to electronic. While historically most studies used a single provisioned device when using ePRO, many studies are now using multiple device types within a study, in part due to changes in global supply market, advances in hardware technology, country-specific import rules, implementation of web-based solutions, and the adoption of Bring-Your-Own-Device (BYOD). A more device agnostic approach to data collection in clinical trials is therefore becoming more common. Whether continued comparability testing between paper and electronic PROs and between various electronic device types is needed has been called to question given the abundance of ePRO comparability studies conducted. We aimed to determine if and when comparability testing is still required when implementing ePRO.

Methods:

We conducted a review of the literature and industry best practices to determine the need for continued comparability testing when implementing PROs across different electronic modalities.

Result:

There is mounting evidence in the literature that supports comparability of PRO measures between paper and electronic and across device types. Industry best practices conclude that we can start relaxing the need to routinely conduct comparability testing as long as eCOA best practices are followed and user experience properties have been assessed in a representative group.

Speaker