Development of an interpretation guideline for the EORTC PRO measures

Project summary

The assessment of PRO data in oncological practice and research has proved to be beneficial for patient outcomes. By offering guidance on interpretation, the EORTC QLG aims to support the use of PRO data assessed with its measures. To meet the need for practical guidelines on how to differentiate and use the various ways of interpreting EORTC PRO data, we aim to develop a guideline including best practice recommendations on interpreting PROs assessed with EORTC PRO measures for scientific as well as clinical use. The recommendations in the guideline will be based on existing evidence and consensus between PRO experts in the field, including buy-in from relevant stakeholders (i.e. patient representatives, clinicians, researchers, pharma representatives). Guideline development will follow the procedure established by the National Institute of Care and Health Excellence and the GIN-McMaster Guideline Development Checklist.


  • Online survey inviting experts and stakeholders (from the EORTC QLG, EORTC disease-oriented groups and beyond) to share their perspective on current practice and information needs completed
  • Systematic literature review on guidance documents on the topic of (EORTC) PRO data interpretation to be
  • Systematic scoping assessment of the current practice in the interpretation of EORTC PRO data in randomised clinical trials and observational studies in patients with breast cancer completed.


Future plans

  • The systematic literature search/ review on current practice of EORTC PRO data interpretation in clinical trials and observational studies from 2019 to 2022 in six major cancer entities is ongoing.
  • A sub-study to assess the patient perspective on EORTC PRO data interpretation to inform the development of the plain language version of the guideline is
  • A survey on the perspective of pharma stakeholder regarding EORTC PRO data interpretation is open.
  • Comprehensive results of Phase I and draft scope document will be available end of April 2023.



Interested in the project or want to tell us your opinion on EORTC PRO data interpretation?

You are cordially invited to contact the PI ( for more information on the project and possibilities for future collaboration.

We are looking forward to hearing from you!

For patients

Up to date, the EORTC Quality of Life Group offers guidance on how to develop its PRO questionnaires, how to translate and how to migrate them into electronic platforms for assessing PROs in clinical trials and in clinical practice.

What is currently missing is a guideline for the interpretation of PRO data, assessed with EORTC PRO questionnaires. The emerging guideline aims to support researchers, as well as patients and clinicians, in interpreting PRO scores correctly and evaluate the results’ clinical relevance. The final guideline will include the expertise of estimated colleagues in the field as well as from researchers, clinicians, and patients working in and with the EORTC Quality of Life Group.


Presented at the ISOQOL Conference 2022