2025/04/10 by Knoerzer, Dietrich, Kron, Martina, Schüler, Armin +2
#COSMIN criteria #COSMIN-Kriterien #Medicine and health #PRO-CTCAE #Validierung #psychometric quality #psychometrische Qualität #validation
paper · doi:10.3205/mibe000273
Aim: Patient reporting of adverse events (AE) is still rare in oncological drug development. It should however be a crucial part of clinical studies and medical decision making. The PRO-CTCAE instrument has been generated from observer based AE assessment to represent the patients’ view in 124 items. This review examines the psychometric quality of the PRO CTCAE as tested in selected cancer patient groups and published in core papers. Method: A literature review identified 3 league papers describing the original development of the PRO-CTCAE. Using the COSMIN quality criteria for patient-reported outcome measures, the psychometric performance of the PRO-CTCAE was systematically examined. Results: Sufficient information on COSMIN quality standards were only present in 2 of the 10 criteria with EORTC QLQ-C30 used as a validation anchor, providing only limited evidence for reliability or validity. For 5 out of the 10 criteria no information at all is available. Conclusion: PRO-CTCAE is a useful list of items which has been psychometrically tested on individual item level, but not on a scale level. The development of a measurement model and consecutive psychometric testing is recommended to provide information on test-theoretical performance on the aggregate level including scoring and comparison to reference populations. This would transform the PRO-CTCAE items from a list to a tool which can be used in patient-reported AE assessments within and across oncological trials. Future research should focus on explaining potential differences between physicians and patient ratings, on cross-cultural comparability of the tool, and on the impact of PRO-CTCAE as a unique instrument for patient reported outcomes in clinical research and medical decision making.