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

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.

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.

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'.

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.

ESMO open. 2023 Jan 16 [Epub ahead of print]

E Feldman, F J Pos, R J Smeenk, H van der Poel, P van Leeuwen, J M de Feijter, M Hulshof, T Budiharto, R Hermens, K M de Ligt, I Walraven

Department for Health Evidence, Radboud University Medical Center, Nijmegen., Department of Radiation Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam., Department of Radiation Oncology, Radboud University Medical Center, Nijmegen., Department of Urology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam; Department of Urology, Amsterdam University Medical Centers, Amsterdam., Department of Urology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam., Department of Internal Medicine, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam., Department of Radiation Oncology, Academical Medical Center, University of Amsterdam, Amsterdam., Department of Radiation Oncology, Catharina Hospital, Eindhoven., Scientific Institute for Quality in Healthcare, Radboud Institute for Health Sciences, Radboud University Medical Center, Radboud University Nijmegen, Nijmegen., Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, the Netherlands., Department for Health Evidence, Radboud University Medical Center, Nijmegen. Electronic address: .