Methodologies validated for the causal analysis of adverse events of clinical relevance in biomedicine

Abstract

Introduction: Causal analysis of adverse events requires validated methodologies to determine the origin of incidents affecting patient safety in health care settings.

Objective: Describe the conceptual and methodological bases of the systems for the causal analysis of adverse events of clinical relevance in biomedicine.

Methods: A document review was conducted of updated national and international bibliography. The search was carried out in the search engine Google Scholar, and open access papers were consulted in the databases PubMed and SciELO from March 2019 to March 2020. The key words used were “adverse events”, “root cause analysis” and “patient safety”, obtained from Health Sciences Descriptors (DeCS). A total 25 papers were selected (20 in Spanish and 5 in English), of which 18 (72.0%) had been published in the last five years.

Data analysis and integration: Root-cause analysis methodologies, the ANCLA score, the failure modes and effects analysis (FMEA) and the London Protocol share the common purpose of using events or errors to reveal gaps that weaken patient safety and inappropriate aspects of the health care process.

Conclusions: Systems for the causal analysis of adverse events are tools to enhance patient safety culture, for they detect failures and errors latent in the system whose correction is essential to implement prevention strategies.