The medication self-management work system of patients and informal carers from a human factors & ergonomics perspective: A scoping review protocol [version 1; peer review: 2 approved]

Background: Healthcare is increasingly delivered closer to the patients’ homes, which increases the level of responsibility that patients and informal carers take for managing their medication-taking, although this is associated with hazards. Medication self-management has been conceptualised as work taking place in non-formal settings (e.g., households), which are complex systems. Human factors and ergonomics (HFE) models provide a framework for studying such systems. The Systems Engineering Initiative for Patient Safety (SEIPS) is one framework that considers work system elements and how they interact with each other to shape processes that lead to outcomes (e.g., safety). Given the increasing amount of diverse research on patient and carer work and on system-shaping factors, the objectives of this review are to: (i) identify available evidence in a structured and systems-oriented way, (ii) explore approaches that have been applied and (iii) highlight research gaps. Methods: An evidence-informed patient, public and carer involvement (PPCI) approach will be implemented at all post-protocol stages to ensure the relevance, uptake and translation of the scoping review. The review will systematically search MEDLINE, Embase, PsycInfo, CINAHL and Web of Science to identify relevant qualitative studies. The methodological approach will be guided by Johanna Briggs Institute methodology and will be reported according to the PRISMA-ScR standards. Data charting and qualitative content analysis directed by SEIPS will explore how the work system and its constituting elements have been described in the literature and identify specific gaps and opportunities for future research. Borrowing from realist approaches, included studies will be assessed in terms of richness and relevance to our review question. Discussion: Strengths of this scoping review include PPCI and a converging focus on medication safety, medication self-management and HFE. Ultimately, this approach will advance our understanding of this complex system and guide opportunities to broaden and strengthen the evidence base