Abstract
BackgroundSelection of specific patient-reported outcomes (PROs) for cancer patients requires careful consideration to the purpose and population at aim. Here we report the process of choosing which items to include in a bladder cancer population in chemo- or immunotherapy based on the Patient-Reported Outcomes Version of the Common Terminology Criteria of Adverse Events (PRO-CTCAE).MethodsInitial PRO-CTCAE symptoms were chosen through 1) medical record audit 2) patient interviews 3) summary of product characteristics from European Medicines Agency and Food and Drug Administration for the applied chemotherapies, and 4) toxicity reporting from Phase 2 and 3 trials for immunotherapies applied in patients with urothelial cancer. The selected questions were applied in a prospective cohort of 78 bladder cancer patients receiving chemo- or immunotherapy at Rigshospitalet and Herlev Hospital, Denmark. Symptoms tested in this population were selected for the final module if they appeared in ≥3 of the following groupings a) the most prevalent PRO-CTCAE symptoms grade ≥ 2 overall during treatment b) the PRO-CTCAE symptoms reported in conjunction with hospital admissions or mentioned in focus group interviews discussing which symptoms were prevalent in this patient group with specialized c) nurses or d) physicians. The authors also included symptoms in the final module if they were present in two of the above groups and defined as actionable by clinicians.ResultsFrom the initial selection of PRO-CTCAE symptoms, a total of 45 PRO-CTCAE symptoms explored by 84 PRO-CTCAE questions were retrieved. Through the second selection process based on the described criteria, the study group agreed on 15 PRO-CTCAE symptoms explored by 30 PRO-CTCAE items to be appropriate and relevant for the bladder population during medical oncological treatment.ConclusionsThe selection of disease specific PROs in a bladder cancer population was feasible. The process revealed several steps of selection needed in order to reach a final module for clinical application.
Highlights
Selection of specific patient-reported outcomes (PROs) for cancer patients requires careful consideration to the purpose and population at aim
Symptoms explored by 84 PRO-Common Terminology Criteria of Adverse Events (CTCAE) items, as many PRO-CTCAE symptoms are explored by single items on frequency, severity and interference with daily activities
The symptoms not corresponding to a PRO-CTCAE symptom were found not to do so primarily because of the symptom not being assessable by the patient her/ himself, e.g. hyponatremia
Summary
Selection of specific patient-reported outcomes (PROs) for cancer patients requires careful consideration to the purpose and population at aim. Despite the FDA recommendation, the NCI initiative and the reporting of clinical benefits, the use of the PROCTCAE or other PRO tools for symptom monitoring is not a standard along with the CTCAE reporting in daily clinical practice The reasons for this may be multiple. For cancer patients with comorbidities and limited treatment options implementation of PROs can be a safe and toxicity-free way of improving survival [5, 9]. One such population is bladder cancer patients known to deal with several comorbidities [12, 13]. Patient-reported outcomes may increase patient awareness towards symptoms and their management, thereby affecting treatment adherence and in this way be an option for these patients to improve clinical outcomes
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