New framework for cancer patient side effects to help assess quality of life
An online resource that logs side effects in cancer patients to help assess their quality of life will benefit from a new framework, thanks to researchers.
The European Organisation for Research and Treatment of Cancer (EORTC) has an Item Library that offers coverage of side effects – also called adverse events, AEs - important to cancer patients and the impact they have on their quality of life and emotional wellbeing.
Researchers from the University of Leeds’ School of Medicine and the EORTC have now created a new framework to systematically classify and improve searchability and item selection for relevant AEs in the Item Library after clinicians, researchers and regulatory authorities highlighted an increasing need for a patient-centred approach in measuring AEs and their burden on patients.
The framework developed by study, published in the Journal of Clinical Oncology, will now be integrated into the Item Library’s online searchable database.
Gold standard for side effects reporting
The gold standard for the classification of side effects reporting in cancer clinical trials is the Common Terminology Criteria for Adverse Events (CTCAE). Used by clinicians, it includes more than 835 different side effects, including using laboratory and imaging findings.
Patient-reported outcomes (PROs) complement clinician reporting by directly capturing the patient perspective. The EORTC Item Library supplements the standard PRO questionnaires and modules developed by the EORTC QLG to assess quality of life for cancer patients. The Item Library allows for more flexibility through customised lists of questions (item lists) that can be used to better cover new disease and treatment contexts.
It covers symptoms and treatment-related burden, emotional functioning and overall quality of life.
The EORTC Item Library provides considerable coverage of side effects important to cancer patients.
The study assessed the coverage of AEs within the Item Library on the basis of the gold standard CTCAE. The authors linked Item Library items - questions – to corresponding side effects and found that out of the 950 EORTC questions, 625 (65.8%) were linked to 208 different side effects.
The study found that the Item Library provides good coverage of many common side effects. Future work could explore mapping symptomatic AEs from the CTCAE to the Item Library, to ensure it has comprehensive coverage of all symptomatic side effects.
Framework to optimise questions for patients
Co-author Dr Alexandra Gilbert, an EORTC Quality of Life Group (QLG) member based at the University of Leeds, said: “The EORTC Item Library provides considerable coverage of side effects important to cancer patients, along with many other complementary issues, such as impact on emotional wellbeing.”
Co-author Claire Piccinin, of the EORTC in Belgium, said the framework will help optimise side effect questions patients are asked.
She said: “This framework provides researchers and clinicians with details on which questions are most relevant for specific side effects. This will optimise their use in clinical trials and routine care.”
The EORTC QLG strives to improve health-related quality of life for cancer patients through dedicated research and measures within cancer clinical trials and clinical practice.
For more information, visit the EORTC website.
