There is growing concern among international stakeholders that the cancer clinical trial community has often relied on specific full-length questionnaires, which may not always measure the QoL issues relevant for specific studies, contexts, populations, and stakeholders.
The potential to reduce questionnaire burden while improving the relevance of questions in a more flexible manner has also been a key area of interest for both CCTG investigators and consumers alike.
In response, there has been recent interest in a “modular approach”, where only a subset of domains (i.e. subscales) from multi-scaled questionnaires are administered. In CQUEST’s latest publication, we build upon recent guidance from the Food and Drug Administration (FDA) and questionnaire developers regarding the use of PROMs, as well as position statements from various international stakeholders. We also provide practical examples of how to apply the modular approach and demonstrate how it can improve PRO data quality.
This article has been published by the Medical Journal of Australia and can be assessed at Using patient-reported outcome measures in clinical trials: perspectives for and against a modular approach.
We are also presenting this topic at various CTG conferences. View our poster, which contains practical examples. (PDF 455 kB)