Development of recommendations for use of EORTC QLG-C30 summary score in cancer clinical trials and clinical practice

The EORTC QLQ-C30 summary score is a single score of ‘overall health-related quality of life’ of cancer patients, based on 27 of 30 questions of the QLQ-C30 questionnaire. This questionnaire comprises multiple domains, assessing different aspects of the patients’ functioning and wellbeing. The use of the EORTC QLQ-C30 Summary score has become widespread since its publication. Despite the possible advantages, there is an ongoing debate within the EORTC Quality of Life Group about the settings in which the summary score is appropriate. Moreover, regulatory agencies have raised concerns that a summary score may not be specific enough for research aimed at establishing labelling claims, and some clinicians question the value of a summary score for clinical practice, as it may be difficult to act upon. Therefore, more understanding is needed of the value of the EORTC QLQ-C30 summary score in both cancer clinical trials and clinical practice settings, which can subsequently be used in the development of guidelines. This project aims to provide recommendations for the use of the EORTC QLQ-C30 summary score in cancer clinical trials and clinical practice.

A systematic review and comparative analysis of the literature has been published in the European Journal of Cancer. The analyses of the prognostic value of the summary score for overall survival have been submitted to the European Journal of Cancer. The analyses of responsiveness and relative validity are almost finished, and the manuscript has been partly written.

The third manuscript on the responsiveness to change over time and relative validity of the summary score is underway, and will be finalized when the last analyses have been performed. We have planned phase IV of the project, drafting recommendations on the use of the Summary Score in clinical trials, and started drafting. In May, I will work on Phase IV intensively during a research visit in Innsbruck supervised by Johannes Giesinger.  Phase IV is expected to finish in September 2026.

The EORTC QLQ-C30 summary score is a single score of overall health-related quality of life, which is based on multiple questions on functioning and wellbeing from the QLQ-C30 questionnaire. This summary score has certain advantages, but it is still unclear in which situations the summary score can best be used. Therefore, this project aims to provide recommendations for the use of the summary score in randomized cancer studies.