Reference values data

Principal investigator(s)
Andrew Bottomley
Brussels, Belgium
Project coordinator(s)
Justyna Mierzynska
Brussels, Belgium

Project summary

The objectives of the Reference values data project are to determine reference values for EORTC-QLQ-C30 for Hodgkin’s Lymphoma and Breast cancer patients. It will help to support the interpretation of EORTC instrument scores in these specific oncology tumour types in single arm trials. This Project aims to provide a more evidence-based approach to interpreting HRQOL scores of the QLQ-C30, using data from existing Phase II and III EORTC clinical trials.

Determining reference values in HRQOL scores is useful to researchers because it can be used as a benchmark for assessing the success of a health care intervention (e.g., a new treatment) in single arm treatment settings. Moreover, reference values are useful for the design of a clinical trial since it provides information to determine the sample size and conduct power calculations. The outcome of this Project could be useful for pharmaceutical industry users of the EORTC’s tools to better interpret patient-reported data via the EORTC instruments (Fayers et al., 1998). Finally, reference values are also interesting for regulators, clinicians and patients as they allow a better evaluation of the treatment effect of a new therapy on a patient.

For patients

the reference values data project has the aim to define a benchmark of the quality of life assessed by a questionnaire. This benchmark is useful to assess the average quality of life in comparison with other stages of the disease, other patients and other treatments. Indeed, it allows a better evaluation of the treatment effect of a new therapy on a patient.