Review: Lack of Specificity Seen in Outcome Measurement Instruments Used for AE Reporting in Cancer Trials


Some common measurement instruments of patient-reported outcomes in skin cancer trials lack specificity and rigorous validation, according to a new systematic review.

"Assessment of type, severity, and impact of dermatologic adverse events (DAEs) necessitates well-developed and validated clinician-reported outcome measures (ClinROMs) and patient-reported outcome measures (PROMs) that evaluate concepts specific to mucocutaneous toxic effects and that allow appropriate interpretation and comparison of DAEs across trials," the authors wrote. 

To assess the quality and diversity of ClinROMs and PROMs used to evaluate dermatologic adverse events (DAEs) induced by systemic cancer therapy, the researchers conducted a study through searches in PubMed and Embase databases. Among the 395 studies included in the analysis, the Common Terminology Criteria for Adverse Events (CTCAE) was predominant (featured in 83.8% of trials) while skin-related PROMs were less utilized, appearing in only 20% of systemic chemotherapy trials.

The authors reported that limited specificity was prevalent. Many studies reported DAEs with nondescript terms like "rash," lacking morphologic detail. Moreover, the evaluation of measurement properties such as content validity, intrarater reliability, and measurement error for prominent tools like CTCAE, Dermatology Life Quality Index (DLQI), and Skindex-16 were also absent. There was seldom an assessment of interrater reliability and responsiveness, and significant gaps in construct validity for DLQI and Skindex were reported.

"In this systematic review, there was a narrow spectrum of ClinROMs and PROMs with limited validity for the measurement of DAEs in the context of systemic chemotherapy interventions in clinical trials," the authors wrote. "Report of trial DAEs often had low morphologic specificity and meaning. Based on existing gaps in measurement and report of DAEs, a frequent and impactful adverse event to chemotherapy, the framework for evaluating cutaneous toxic effects in oncology trials may need collaborative reevaluation."

Source: Shaigany S, Mastacouris N, Tannenbaum R, et al. Outcome Measurement Instruments Used to Evaluate Dermatologic Adverse Events in Cancer Trials. JAMA Dermatology. Published online March 20, 2024. doi:

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