Development of a program theory for shared decision-making: a realist review protocol.

Background: The practicality of applying evidence to healthcare systems with the aim of implementing change is an ongoing challenge for practitioners, policy makers, and academics. Shared decision- making (SDM), a method of medical decision-making that allows a balanced relationship between patients, physicians, and other key players in the medical decision process, is purported to improve patient and system outcomes. Despite the oft-mentioned benefits, there are gaps in the current literature between theory and implementation that would benefit from a realist approach given the value of this methodology to analyze complex interventions. In this protocol, we outline a study that will explore: "In which situations, how, why, and for whom does SDM between patients and health care providers contribute to improved decision making?"

Methods: A seven step iterative process will be described including preliminary theory development, establishment of a search strategy, selection and appraisal of literature, data extraction, analysis and synthesis of extracted results from literature, and formation of a revised program theory with the input of patients, physicians, nurse navigators, and policy makers from a stakeholder session.

Discussion: The goal of the realist review will be to identify and refine a program theory for SDM through the identification of mechanisms which shape the characteristics of when, how, and why SDM will, and will not, work.

Systematic Review Registration: PROSPERO CRD42017062609.