Reworking the QLG guidelines for assessing Quality of Life in EORTC clinical trials – updating and rewriting by incorporating cutting-edge advice on PROs and input from relevant QLG projects (REQUALIFY)
Project summary
The current edition of ‘’Guidelines for assessing Quality of Life in EORTC clinical trials’’ is over two decades old. The guidance given in this “blue book” has become obsolete in several respects.
Therefore, this Quality of Life Group (QLG) research project aims at updating the guidelines based on recent publications and initiatives on best practices in implementing, assessing, and interpreting quality of life (QoL) data in cancer clinical trials. Furthermore, the expertise and data from other QLG projects will be used to update the guidelines.
Additionally, a structured liaison process will be developed and included in the guidelines, including liaisons’ expected duties and responsibilities, eligibility criteria, time frame and funding.
This project consists of three phases:
Phase 1. Review of the current ‘Guidelines for assessing Quality of Life in EORTC clinical trials’ and updating the QoL liaison process.
Phase 2. Update and revision of the guidelines.
Phase 3. Dissemination and development of a training program and sustainability plan.
Achievements
QoL liaisons have been appointed for each EORTC DOG and Council. The QoL liaison Terms of Reference were finalized. A first liaison meeting was held in March 2025; regular gatherings are planned at future QLG meetings.
In parallel, existing guidelines for assessing QoL in clinical trials were reviewed. The blue book is being drafted drawing on a number of resources including ongoing EORTC QLG research projects, external collaborations such as SISAQOL, and consultations with experts relevant for each chapter.
Drafting of the bluebook is in progress.
Future plans
Semi-structured interviews and brainstorming meetings are planned to refine the scope and inform recommendations for the Blue Book.
Drafted chapters will be reviewed by collaborators.
Training materials will be developed to support implementation.
The aim is to finish the project by mid-2028.
For patients
It is important that quality of life data obtained in cancer clinical trials is collected, analyzed and reported properly. Therefore, over two decades ago a guideline entitled ‘‘’Guidelines for assessing Quality of Life in EORTC clinical trials’’ was developed. Since the development of these guidelines, new initiatives and research have been conducted on collecting and reporting of quality of life data from clinical trials. Therefore, the aim of this project is to update the guidelines with the latest information from recent research and initiatives. The guidelines will help designing clinical trials and educate staff at the EORTC on conducting clinical trials that collect quality of life data.