Start date: April 2024
Expected end date: October 2026
Background:
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaires are among the most used PROs in cancer clinical trials. These questionnaires were developed by the EORTC Quality of life Group (EORTC QLG) and are complemented by the issue of the EORTC Item Library (EORTC-IL). This online, interactive platform is currently composed of 1059 unique items. The EORTC-IL items cover patient-reported symptomatic adverse events (AEs) in cancer, in addition to many other domains related to quality of life (e.g. functioning and activities of daily living (ADL), body image, emotional impact of a symptom, diagnosis, or treatment, communication, and satisfaction with care). These are available in multiple languages and have demonstrated robust psychometric properties.
The aim of this research is to summarise the contents of the EORTC-IL and develop a comprehensive inventory of symptomatic AEs that can be measured using the EORTC-IL items, accompanied by a recommended item to measure each AE.
Study aims:
The study covers three main work packages:
- WP1: Identify all items in the EORTC-IL which could map onto a list of AEs, updating previous work that mapped the EORTC-IL with the CTCAE and PRO-CTCAE libraries.
- WP2: Select adverse events from the EORTC-IL to be included in the AEs inventory. Select the ‘best’ EORTC item from the EORTC-IL for each of the included symptomatic AE items.
- WP3: Develop new items, drawing on module development guidelines, for the missing AEs and produce a finalised list.
Study outcomes:
A comprehensive inventory of the symptomatic adverse events covered in the EORTC Item Library and their corresponding EORTC Item Library items.
Research team:
Dr Hayat Hamzeh
Dr Alexandra Gilbert (PI)