Pacific D
Tools to Standardize Reporting of Patient-Reported Side Effects in Cancer Clinical Trials (307910)
*Duke Butterfield, Mayo ClinicAmylou Dueck, Mayo Clinic
GIna Mazza, Mayo Clinic
Keywords: Adverse events, PRO-CTCAE, cancer clinical trials, SAS tools, R tools
To evaluate safety in cancer clinical trials, clinicians have used the National Cancer Institute’s (NCI’s) Common Terminology Criteria for Adverse Events (CTCAE), originally released in 1982, to record AE grades. However, clinicians generally underreport AEs relative to patients (Basch et al., 2006). To integrate the patient voice in AE reporting, the NCI released for public use in 2016 the Patient-Reported Outcomes (PRO) version of the CTCAE (PRO-CTCAE), a library of 124 items for creating custom questionnaires for patients to report relevant symptomatic AEs. In this presentation, emerging tabular and graphical approaches for PRO-CTCAE data will be reviewed and critiqued. Statistical code in SAS and R will be presented. Code includes options for imputing zeros for electronically skipped items and computation of summary measures with and without adjustment for patients’ pre-existing symptoms. Efforts to standardize reporting of patient-reported outcomes are important to aid in understanding and use. Further exploration of reporting approaches for PRO-CTCAE is needed to identify optimal methods to communicate the side effects of treatment in a usable way for patients, physician