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In this chapter, we identify three distinct transformational performance improvement (TPI) approaches commonly used to redesign work processes in health care organizations. We describe the unique components or tools that each approach uses to improve the delivery of health services. We also summarize what is empirically known about the effectiveness of each TPI approach according to systematic reviews and recent studies published in the peer-reviewed literature. Based on examination of this research, we discuss what knowledge is still needed to strengthen the evidence for whole system transformation. This involves the use of conceptual frameworks to assess and guide implementation efforts, and facilitators and barriers to change as revealed in a recent evaluation of one major initiative, the Lean Enterprise Transformation (LET) at the Veterans Health Administration. The analysis suggests ways in which TPI facilitators can be developed and barriers reduced to improve the effectiveness and sustainability of quality initiatives. Finally, we discuss appropriate study designs to evaluate TPI interventions that may strengthen the evidence for their effectiveness in real world practice settings.