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Additional file 4. SPIRIT 2013 Checklist

Additional file 1. DSMB Charter, Version Dated September 14, 2021. Description: Charter outlining the roles, responsibilities, practices, and procedures of the EMO Trial Data and Safety Monitoring Board.

Additional file 3. CONSORT 2010 checklist

Additional file 2. Dissemination plan for results of the EMO Trial. Description: Description of the plan for disseminating results and products of the EMO trial. This document was also submitted with the EMO Trial grant proposal.

The mixed results of success among QI initiatives may be due to differences in the context of these initiatives.The business and health care literature was systematically reviewed to identify contextual factors that might influence QI success; to categorize, summarize, and synthesize these factors; and to understand the current stage of development of this research field.Forty-seven articles were included in the final review. Consistent with current theories of implementation and organization change, leadership from top management, organizational culture, data infrastructure and information systems, and years involved in QI were suggested as important to QI success. Other potentially important factors identified in this review included: physician involvement in QI, microsystem motivation to change, resources for QI, and QI team leadership. Key limitations in the existing literature were the lack of a practical conceptual model, the lack of clear definitions of contextual factors, and the lack of well-specified measures.Several contextual factors were shown to be important to QI success, although the current body of literature lacks adequate definitions and is characterized by considerable variability in how contextual factors are measured across studies. Future research should focus on identifying and developing measures of context tied to a conceptual model that examines context across all levels of the health care system and explores the relationships among various aspects of context.