A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice

Abstract

IntroductionIncident reports contain descriptions of errors and harms that occurred during clinical care delivery. Few observational studies have characterised incidents from general practice, and none of these have been from the England and Wales National Reporting and Learning System. This study aims to describe incidents reported from a general practice care setting.Methods and analysisA general practice patient safety incident classification will be developed to characterise patient safety incidents. A weighted-random sample of 12 500 incidents describing no harm, low harm and moderate harm of patients, and all incidents describing severe harm and death of patients will be classified. Insights from exploratory descriptive statistics and thematic analysis will be combined to identify priority areas for future interventions.Ethics and disseminationThe need for ethical approval was waivered by the Aneurin Bevan University Health Board research risk review committee given the anonymised nature of data (ABHB R&D Ref number: SA/410/13). The authors will submit the results of the study to relevant journals and undertake national and international oral presentations to researchers, clinicians and policymakers.

Patient Safety Incidents Involving Sick Children in Primary Care in England and Wales: A Mixed Methods Analysis

“…Reports can also be submitted directly to the NRLS online [26–28]. Each report captures structured categorical information such as patient age, incident location, incident date, and severity of harm outcome (no harm, low harm, moderate harm, severe harm, or death) [26–28].…”

“…Reports can also be submitted directly to the NRLS online [26–28]. Each report captures structured categorical information such as patient age, incident location, incident date, and severity of harm outcome (no harm, low harm, moderate harm, severe harm, or death) [26–28]. In addition, each report contains three unstructured free-text fields where reporters can describe what happened, why they think it happened, and how they think it could have been prevented [26–28].…”

“…This involved systematically coding data using multiple coding frameworks to describe the incident, quantitatively exploring coded data to identify important patterns, and thematically analyzing a purposive sample of reports containing new theoretical insights. This methodology has been accepted by the international literature [23,25,28]. …”

“…Each incident report underwent data coding using multi-axial frameworks to describe incident types (primary and contributory), potential contributory factors, incident outcomes, and harm severity (S2–S4 Texts) [23,25,28]. Primary incidents included those proximal (chronologically) to the patient outcome, whereas contributory incidents included those that contributed to the occurrence of another incident.…”

“…This permitted modeling of the steps preceding and leading to primary incidents, e.g., contributory incidents and factors, which, in turn, resulted in patient outcomes (S1 Fig). The incident type, contributory factor, and incident outcome frameworks were developed in house [28]. Each incident report in the NRLS comes with a reporter-allocated harm severity; however, where the free-text descriptions conflicted with the reporter-allocated harm severity, harm severity was reclassified using WHO International Classification for Patient Safety definitions (see Table 1 for WHO definitions of harm severity) [3,23,25,30].…”