Selecting a PRO-CTCAE-based subset for patient-reported symptom monitoring in prostate cancer patients: a modified Delphi procedure.

Background: Clinician-based reporting of adverse events leads to underreporting and underestimation of the impact of adverse events on prostate cancer patients. Therefore, interest has grown in capturing adverse events directly from patients using the Patient-Reported Outcomes (PROs) version of the Common Terminology Criteria for Adverse Events (CTCAE). We aimed to develop a standardized PRO-CTCAE subset tailored to adverse event monitoring in prostate cancer patients.

Materials And Methods: We used a mixed-method approach based on the 'phase I guideline for developing questionnaire modules' by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life group, including a literature review, and interviews with patients (n = 30) and health care providers (HCPs, n = 16). A modified Delphi procedure was carried out to reach consensus on the final subset selected from the complete PRO-CTCAE item library.

Results: Fourteen multidisciplinary HCPs and 12 patients participated in the Delphi rounds. Ninety percent agreed on the final subset, consisting of: 'ability to achieve and maintain erection', 'decreased libido', 'inability to reach orgasm', 'urinary frequency', 'urinary urgency', 'urinary incontinence', 'painful urination', 'fecal incontinence', 'fatigue', 'hot flashes', 'feeling discouraged', 'sadness', and 'concentration'. From 16 articles identified in the literature review, the following adverse events for which no PRO-CTCAE items are available, were included to the recommendation section: 'nocturia', 'blood and/or mucus in stool', 'hemorrhoids', 'hematuria', 'cystitis', 'neuropathy', and 'proctitis'.

Conclusions: The obtained PRO-CTCAE-subset can be used for multidisciplinary adverse event monitoring in prostate cancer care. The described method may guide development of future PRO-CTCAE subsets.