Comparison of a Voluntary Safety Reporting System to a Global Trigger Tool for Identifying Adverse Events in an Oncology Population.

Abstract

There is a lack of research on adverse event (AE) detection in oncology patients, despite the propensity for iatrogenic harm. Two common methods include voluntary safety reporting (VSR) and chart review tools, such as the Institute for Healthcare Improvement's Global Trigger Tool (GTT). Our objective was to compare frequency and type of AEs detected by a modified GTT compared with VSR for identifying AEs in oncology patients in a larger clinical trial. Patients across 6 oncology units (from July 1, 2013, through May 29, 2015) were randomly selected. Retrospective chart reviews were conducted by a team of nurses and physicians to identify AEs using the GTT. The VSR system was queried by the department of quality and safety of the hospital. Adverse event frequencies, type, and harm code for both methods were compared. The modified GTT detected 0.90 AEs per patient (79 AEs in 88 patients; 95% [0.71-1.12] AEs per patient) that were predominantly medication AEs (53/79); more than half of the AEs caused harm to the patients (41/79, 52%), but only one quarter were preventable (21/79; 27%). The VSR detected 0.24 AEs per patient (21 AEs in 88 patients; 95% [0.15-0.37] AEs per patient), a large plurality of which were medication/intravenous related (8/21); more than half did not cause harm (70%). Only 2% of the AEs (2/100) were detected by both methods. Neither the modified GTT nor the VSR system alone is sufficient for detecting AEs in oncology patient populations. Further studies exploring methods such as automated AE detection from electronic health records and leveraging patient-reported AEs are needed.