Understanding how a national clinical audit is established, maintained and sustained using the Irish Hip Fracture Database as an exemplar: a realist evaluation protocol.

There is an increasing focus on clinical audit within the Irish Health System to drive quality improvement and standardise care, with many established and emerging clinical audits underway. Since the burden of data collection typically falls to busy clinical staff, understanding the impact of audit is especially crucial. However, the literature rarely explores how audits generate impact, for whom and in what context, despite the considerable effort invested in collecting this valuable data. This study will explore how a national clinical audit is established, maintained and sustained in order to maximise impact using the Irish Hip Fracture Database (IHFD) as an exemplar. The research will be conducted through a realist evaluation lens, which aims to determine what works, for whom, how and to what extent. Realist evaluation is a theory- based approach that uses mixed-methods to explore and answer the research question. Initially programme theories will be formulated through a review of the literature, qualitative interviews, and subsequently refined with an expert panel. The Initial Programme Theories (IPTs) will be refined through iterative rounds of consultation and context-mechanism-outcome configurations. This process will identify demi-regularities, which are semi-predictable patterns that occur often enough to be noticeable, but not universally or consistently across all contexts. These patterns will inform understanding of how the intervention (i.e. the audit) operates or impacts differently across varying contexts. Ultimately, this will inform the development of a middle-range theory to better understand developing and sustaining a clinical audit with meaningful impact. The resulting findings will have relevance and potentially inform and/or enhance the implementation and development of other audits. Ethical approval has been granted by the Research Ethics Committee in the Royal College of Surgeons in Ireland. Results will be disseminated through peer-reviewed publication and at relevant healthcare conferences including patient and public focused conferences.