Development of the Cancer Patient-reported Symptomatic Adverse Events Inventory (EORTC-PRO-AE) using the EORTC Item Library

EORTC Item Library (EORTC-IL) is an online, interactive platform currently composed of 1059 unique items from the EORTC QLG’s portfolio of questionnaires. It enables more flexible usage of the static questionnaires by allowing users to create customised item lists, thereby increasing flexibility to cover different disease and treatment contexts. The EORTC-IL measures cover symptomatic adverse events related to cancer and its treatment, 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 (e.g., measurement of baseline symptoms and responsiveness to change). For each symptomatic AE, multiple EORTC-IL items are available. 

The main objective of this project is to develop a comprehensive list of symptomatic adverse events measured in the EORTC Item Library and determine the ‘best’ library item to accompany each adverse event. Additionally, we aim to develop items to measure adverse events for which no EORTC items are currently available, drawing on module development guidelines. 

• Written study protocol 

• Prepared and submitted ethics applications 

• Updated mapping of 1159 library items 

Current status:

WP1 ongoing: updating the mapping of library items against using the CTCAE classification 

• Completing and publishing results of WP1  

• Obtaining ethics approval for WP2 and WP3 

• WP2: Delphi survey to determine ‘best’ EORTC library item for each adverse event, Recruitment will start as soon as ethics approval is granted. 

• WP3: qualitative interview study to develop new items. Recruitment will start after completion of data collection for WP2. 

• Project is expected to be completed by October 2026 

The objective of this project is to summarise the symptoms measured in the EORTC Item Library and choose one preferred item to measure each symptom. The EORTC Item Library is a database which contains all the questions developed by the EORTC Quality of Life Group to measure symptoms and functional problems related to cancer and its treatment. It currently includes 1159 different questions and multiple questions are available to measure each symptom. This project aims to summarise the symptoms included in the item library and select the best question to measure each symptom.