A strategic framework for selecting adverse events in healthcare for investigation to improve patient safety

Aims This paper aims to address the research question: What is an effective framework to strategically select nationally reported serious adverse events in healthcare for investigation to improve patient safety? Background The healthcare system is globally under strain due to an aging population with increasing co-morbidities. Serious adverse events remain a consistent challenge. Patient safety can be improved by investigating cases and addressing underlying systemic risks. However, due to resource limitations, only a limited number of cases can be investigated. This necessitates a strategic selection of cases with the greatest potential for improving patient safety. This paper aims to develop a theoretical framework that identifies the key strategic issues that should be addressed when setting up a new national healthcare safety investigative body to select adverse events for investigation. Methods This study will primarily draw on semi-structured interviews with senior stakeholders in key healthcare regulatory agencies in Norway. For comparative purposes, a stakeholder from a key United Kingdom healthcare agency was also interviewed. The interview template is developed based on insights from a literature review and develop existing safety frameworks such as the Framework for Managing Risk. The paper also draws on selected tools from Strategy Management. Results A novel theoretical framework was developed to help set up case selection mechanism in a new national investigative body. The framework consists of four strategic themes that should be considered both sequentially and cyclically. Within each theme several key policy questions were identified. (1) Governance: role and powers, independence, and stakeholder engagement (2) Monitoring risk: adverse events, quality indicators, and unexplained variation (3) Strategic portfolio: broad coverage, vulnerable groups, and underreporting (4) Individual case selection: outcome, systemic risk, and learning potential Conclusions Policy makers should carefully consider the themes and questions in the proposed theoretical framework when setting up a new national safety investigative agency. In turn, this can ensure that the implemented selection mechanism identifies cases with the greatest potential to improve patient safety.