Analysis of applying a patient safety taxonomy to patient and clinician-reported incident reports during the COVID-19 pandemic: a mixed methods study.

BACKGROUND: The COVID-19 pandemic resulted in major disruption to healthcare delivery worldwide causing medical services to adapt their standard practices. Learning how these adaptations result in unintended patient harm is essential to mitigate against future incidents. Incident reporting and learning system data can be used to identify areas to improve patient safety. A classification system is required to make sense of such data to identify learning and priorities for further in-depth investigation. The Patient Safety (PISA) classification system was created for this purpose, but it is not known if classification systems are sufficient to capture novel safety concepts arising from crises like the pandemic. We aimed to review the application of the PISA classification system during the COVID-19 pandemic to appraise whether modifications were required to maintain its meaningful use for the pandemic context. METHODS: We conducted a mixed-methods study integrating two phases in an exploratory, sequential design. This included a comparative secondary analysis of patient safety incident reports from two studies conducted during the first wave of the pandemic, where we coded patient-reported incidents from the UK and clinician-reported incidents from France. The findings were presented to a focus group of experts in classification systems and patient safety, and a thematic analysis was conducted on the resultant transcript. RESULTS: We identified five key themes derived from the data analysis and expert group discussion. These included capitalising on the unique perspective of safety concerns from different groups, that existing frameworks do identify priority areas to investigate further, the objectives of a study shape the data interpretation, the pandemic spotlighted long-standing patient concerns, and the time period in which data are collected offers valuable context to aid explanation. The group consensus was that no COVID-19-specific codes were warranted, and the PISA classification system was fit for purpose. CONCLUSIONS: We have scrutinised the meaningful use of the PISA classification system's application during a period of systemic healthcare constraint, the COVID-19 pandemic. Despite these constraints, we found the framework can be successfully applied to incident reports to enable deductive analysis, identify areas for further enquiry and thus support organisational learning. No new or amended codes were warranted. Organisations and investigators can use our findings when reviewing their own classification systems.

Defining avoidable healthcare-associated harm in prisons: A mixed-method development study.

BACKGROUND: Reducing avoidable healthcare-associated harm is a global health priority. Progress in evaluating the burden and aetiology of avoidable harm in prisons is limited compared with other healthcare sectors. To address this gap, this study aimed to develop a definition of avoidable harm to facilitate future epidemiological studies in prisons. METHODS: Using a sequential mixed methods study design we first characterised and reached consensus on the types and avoidability of patient harm in prison healthcare involving analysis of 151 serious prison incidents reported to the Strategic Executive Information System (StEIS) followed by in-depth nominal group (NG) discussions with four former service users and four prison professionals. Findings of the NG discussions and StEIS analysis were then synthesised and discussed among the research team and study oversight groups to develop an operational definition of avoidable harm in prison healthcare which was subsequently tested and validated using prison patient safety incident report data derived from the National Reporting and Learning System (NRLS). RESULTS: Analysis of StEIS incident reports and NG discussions identified important factors influencing avoidable harm which reflected the unique prison setting, including health care delivery issues and constraints associated with the secure environment which limited access to care. These findings informed the development of a new working two-tier definition of avoidable harm using appropriate and timely intervention, which included an additional assessment of harm avoidability taking into the account the prison regime and environment. The definition was compatible with the NRLS incident report narratives and illustrated how the prison environment may influence identification of avoidable harm and judgements of avoidability. CONCLUSIONS: We have developed a working definition of avoidable harm in prison health care that enables consideration of caveats associated with prison environments and systems. Our definition enables future studies of the safety of prison healthcare to standardise outcome measurement.