A group of researchers published in the February 2020 issue of the Annals of Oncology about process of updating and testing of the European Organization for Research and Treatment of Cancer (EORTC) questionnaire to assess quality of life (QoL) in breast cancer patients. The final updated module contains a total of 45 items from which 22 are new. These new items contain two multi-item scales: a target symptom scale and a satisfaction scale. The EORTC QLQ-BR45 is now available for use in research and clinical practice. It provides a more accurate and comprehensive assessment of the impact of new treatments on patients' QoL.
The researchers from the EORTC Quality of Life Group and Breast Cancer Group wrote in the background that EORTC QLQ-BR23 was one of the first disease-specific questionnaires developed in 1996 to assess QoL in patients with breast cancer. However, since 1996 major changes in breast cancer treatment have occurred and it was needed to update the module related to breast cancer.
In their paper, the EORTC investigators present the results of the phase I–III update of the QLQ-BR23 questionnaire. The update of the module followed standard EORTC guidelines. A systematic literature review revealed 83 potential relevant QoL issues during phases I and II. After shortening the issues list and following interviews with patients and health care providers, 15 relevant issues were transformed into 27 items. The preliminary module was pretested in an international, multicentre phase III study to identify and solve potential problems with wording comprehensibility and acceptability of the items. Analyses were qualitative and quantitative.
The phase I and II results indicated the need to supplement the original QLQ-BR23 module with additional items related to newer therapeutic options. The phase III study recruited 250 patients from 12 countries.
The final updated phase III module contains a total of 45 items, 23 items from the QLQ-BR23 and 22 new items. The new items contain two multi-item scales, a target symptom scale and a satisfaction scale. The target symptom scale can be divided into three subscales: 1. endocrine therapy, 2. endocrine sexual and 3. skin/mucosa scale.
The authors concluded that their work has led to the development of a new EORTC QLQ-BR45 module which provides a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients' QoL. The final version of the EORTC QLQ-BR45 is now available for use in clinical practice. The final phase IV study is underway to confirm psychometric properties of the module.
Bjelic- Radisic V, Cardoso F, Cameron D, et al. An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45. Annals of Oncology 2020; 31(2):283-288. doi: 10.1016/j.annonc.2019.10.027.