What do “none,” “mild,” “moderate,” “severe” and “very severe” mean to patients with cancer? Content validity of PRO-CTCAE™ response scales∗

Accurate capture of the symptom experience is essential to gauging efficacy, safety, and tolerability of cancer treatments (1). The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™); (2) was developed by the National Cancer Institute to allow direct patient self-reporting of symptomatic adverse events in cancer clinical trials (3-5). Its content validity has been established in accordance with recommended practices for novel patient-reported outcome (PRO) instruments (6, 7).

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