The objective of the study is to improve the accuracy of clinician-reported adverse event (AE) information based on CTCAE ratings by providing clinicians with EORTC PRO data. Having patients EORTC PRO data available, clinicians’ ratings are supposed to be more sensitive regarding the detection of AEs and more concordant between medical raters.
This way of data collection enables drawing a more precise picture of the patients’ health status, as AEs are more likely to be detected and the AE rating becomes more consistent across clinicians. In the context of clinical trials, this promotes the integration of the patient’s perspective for the development of more accurate AE profiles, whilst in routine care such data can be beneficial for the provision of patient-centered treatment options.
Ethical approval obtained, CHES software for data collection is set up, patient recruitment in ongoing in 4 active centres (France, Germany, Jordan, Japan)
The study explores whether two different clinicians assess more accurately the symptom burden of a patient, if they previously receive a standardized summary of how the patient himself perceives his symptoms. This is necessary, as sometimes symptoms go unnoticed and two independent clinicians rate the symptoms of one single patient very differently. If the patient’s answers to special questionnaires are used to guide the ratings by clinicians, this can influence e.g. which side effects are listed in drug package inserts and if patients receive treatment for these side effects as part of their routine care.
Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial,Trials. 2020 Oct 13;21(1):849. doi: 10.1186/s13063-020-04745-w.