Integrating the patient voice with clinician reports to identify a hepatocellular carcinoma-specific subset of treatment-related symptomatic adverse events.

ABSTRACT:

Background

Incorporating patient reporting of symptomatic adverse events (AEs) is important in evaluating safety and tolerability in cancer clinical trials. The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed to assess the frequency, severity, and/or interference of patient-reported symptomatic AEs. The objective of this study was to identify, based on oncologist and patient interviews, a relevant subset of symptomatic AEs from the PRO-CTCAE that can be used to optimize patient reporting of symptomatic AEs in hepatocellular carcinoma (HCC) clinical trials.

Methods

Qualitative and quantitative data on HCC diagnosis, treatment, symptoms, and side effects were collected from patients. Using a numerical rating sca

SUBMITTER: Speck RM 

PROVIDER: S-EPMC6104407 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature