Development of programme theory for integration of service user and caregiver involvement in mental health system strengthening: protocol for realist systematic review

Background: There is international recognition of the need for service user and caregiver involvement in mental health system strengthening. However, little is known about how best to integrate this approach into the mental healthcare system; what works to advance involvement, under what conditions, how and when does involvement bring added value, and how can it work in resource-poor settings in low and middle-income countries. Objective: To describe the methodology for a realist systematic review protocol to synthesise the evidence to explain the contexts, outcomes, and underlying mechanisms for involvement of service users with severe mental health problems and their caregivers in mental healthcare policy-making and planning, advocacy, service development, monitoring and improvement. Methods/designs: The proposed realist systematic review will involve five steps: (i) clarifying the review scope, (ii) a systematic search for evidence, (iii) evidence appraisal and data extraction, (iv) data analysis, (v) synthesis of evidence and formation of revised programme theory. Inputs from a formative qualitative study, consultative Theory of Change meetings with key stakeholder groups, and scoping reviews will be used to identify candidate theory/theories that will guide the selection, appraisal and analysis of studies, and refine the Theory of Change model that will be piloted and evaluated. Synthesis of data will be undertaken using realist logic, constant comparison and thematic analysis. In a consultative meeting with stakeholders the Theory of Change model will then be situated with respect to relevant programme theories and adapted to incorporate the synthesized evidence of relevance to the local context. The finalized Theory of Change model will be piloted and evaluated in a primary health care setting in rural Ethiopia. Discussion: Realist review methodology has not been applied to the area of mental health service user involvement in low-and middle-income country settings. In this protocol, we describe how this contextualized approach will be applied to identify and refine a theory-driven and transferable model of involvement of service users, embedded in ongoing work in Ethiopia.