Background and aims
There is growing interest in customising patient-reported outcome measures (PROMs) by selecting specific subscales/domains that focus on the key health-related quality of life (HRQoL) outcomes most relevant to a particular trial or clinical trial context and omitting others – called the ‘modular approach’. This approach has sparked ongoing debate, focusing on balancing the collection of data that is important from the patient perspective with minimising respondent burden. The aim of this presentation is to explore various perspectives for and against adopting a modular approach for PROM inclusion.
Methods
This presentation will examine the arguments for and against a modular approach. Key considerations, such as ensuring the inclusion of sufficient domains for economic evaluation purposes, will also be discussed.
Results
TROG investigators are invited to learn about the modular approach, weighing both its advantages and limitations, to support decision making regarding PROM inclusion in their studies. On one hand, including fewer items reduces respondent burden and allows for flexible assessment of different HRQoL constructs at specific frequencies or timepoints that are meaningful. On the other hand, this approach may overlook unknown HRQoL issues affecting patients and make comparability with other studies challenging. The Cancer Quality of Life Expert Service Team (CQUEST) can work collaboratively with investigators, assisting in the choice of PROMs and/or PROM subscales after key HRQoL concepts of interest have been identified.
Conclusion
CQUEST invites TROG members to engage with our presentation to inform decisions about the selection of PROMs in cancer clinical trials. This will ensure the trial objectives are directly addressed while considering participant burden and yielding results that are optimally informative for stakeholder needs.