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Patient-reported outcomes item selection for bladder cancer patients in chemo- or immunotherapy.


ABSTRACT:

Background

Selection 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).

Methods

Initial 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 prosp

SUBMITTER: Taarnhoj GA 

PROVIDER: S-EPMC6706489 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature