The ultimate objective of this project is to construct a standardized RECIST-type endpoint based on the QLQ-C30 questionnaire for use in the longitudinal evaluation of HRQoL in oncology RCTs at the international level. The development of the so-called Q-RECIST criteria for HRQoL is thus the primary intermediary objective. Further work will focus on the validation of the proposed metric and to propose refinements according to specific needs. These may involve local adaptations based on cancer site or population. Furthermore, a robust methodology will be developed to supplement the responder definition so that its implementation into RCTs and analysis/reporting is simplified and harmonized. R and SAS macros will be developed to facilitate and standardize the Q-RECIST criteria estimation.
The first step of this project is ongoing (literature review).
The literature review will be done in September and results could be available in late 2018.
The objective of this project is to propose a single metric to summarize all information collected regarding the quality of life level over time for patients. Knowing all this information, this metric will be able to simplify the interpretation of the results by reporting if the patient is deteriorated, stable, or improved in terms of quality of life over time.