Preventable and mitigable adverse events in cancer care: Measuring risk and harm across the continuum

Cancer. 2017 Dec 1;123(23):4728-4736. doi: 10.1002/cncr.30916. Epub 2017 Aug 17.

Abstract

Background: Patient safety is a critical concern in clinical oncology, but the ability to measure adverse events (AEs) across cancer care is limited by a narrow focus on treatment-related toxicities. The objective of this study was to assess the nature and extent of AEs among cancer patients across inpatient and outpatient settings.

Methods: This was a retrospective cohort study of 400 adult patients selected by stratified random sampling who had breast (n = 128), colorectal (n = 136), or lung cancer (n = 136) treated at a comprehensive cancer center in 2012. Candidate AEs, or injuries due to medical care, were identified by trained nurse reviewers over the course of 1 year from medical records and safety-reporting databases. Physicians determined the AE harm severity and the likelihood of preventability and harm mitigation.

Results: The 400-patient sample represented 133,358 days of follow-up. Three hundred four AEs were identified for an overall rate of 2.3 events per 1000 patient days (91.2 per 1000 inpatient days and 0.9 per 1000 outpatient days). Thirty-four percent of the patients had 1 or more AEs (95% confidence interval, 29%-39%), and 16% of the patients had 1 or more preventable or mitigable AEs (95% confidence interval, 13%-20%). The AE rate for patients with breast cancer was lower than the rate for patients with colorectal or lung cancer (P ≤ .001). The preventable or mitigable AE rate was 0.9 per 1000 patient days. Six percent of AEs and 4% of preventable AEs resulted in serious harm. Examples included lymphedema, abscess, and renal failure.

Conclusions: A heavy burden of AEs, including preventable or mitigable events, has been identified. Future research should examine risk factors and improvement strategies for reducing their burden. Cancer 2017;123:4728-4736. © 2017 American Cancer Society.

Keywords: adverse events; harm; medical error; oncology; patient safety.

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Drug-Related Side Effects and Adverse Reactions / diagnosis
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Drug-Related Side Effects and Adverse Reactions / prevention & control*
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Medical Errors / prevention & control*
  • Medical Oncology*
  • Middle Aged
  • Neoplasms / drug therapy*
  • Patient Safety
  • Prognosis
  • Quality Improvement
  • Retrospective Studies
  • Risk Factors