The Australian Commission for Safety and Quality in Health Care (the Commission) has identified engagement with patients and consumers across all of its programs and activities as a key area of focus (Priority Program 1) for work in 2008-2009 (ACQSHC 2006). The Commission is specifically interested in how patients and consumers can be more engaged in its work, and in the patient safety work of health care providers. Part of the work plan is the development of a Consumer Engagement Strategy that will describe how the Commission will work with patients, consumers and health care advocates to best achieve its aim of achieving safer care for patients. To support this work the Commission contracted Monash University to undertake a literature review on how patients, consumers and the public can be more effectively involved in patient safety initiatives. The Commission’s focus for the literature review was not on ways in which patients can contribute to their own safer health care, but how, from an organisational perspective, patients, consumers and the public can be more effectively involved in the planning, development and implementation of patient safety initiatives and programs. This report provides a structured evidence-based literature review on the involvement of patients and consumers in patient safety covering Australian and international published articles and reports. The review concentrates on published reports and articles within the last five to ten years. The key questions asked by the Commission, and addressed in this review, were: 1. What are the views of patients, consumers and the public regarding their involvement in patient safety initiatives? 2. What are the different methods and processes that could be used to effectively involve patients, consumers and the public in the planning, development and implementation of patient safety initiatives and programs? a. Have any of these methods or processes been evaluated? b. What are the critical success factors for these methods and processes? c. What are the limitations of these methods and processes? 3. What are the outcomes of involving patients, consumers and the public in the planning, development and implementation of patient safety initiatives and programs? In approaching the identification of literature relevant to the addressing the questions the Commission defined the terms “patient” and “consumer” as: - individual patients who have received or are receiving care; - consumers who have a specific interest in health, but who may not be currently receiving care; - organisations that represent groups of consumers; - members of the public who have an interest in broad decision making or policy regarding patient safety. Literature Review Regarding Patient Engagement in Patient Safety Initiatives 7 This review outlines the methodological approach used, including search methods for identification of published reports and articles, screening methods, assessment of quality and data extraction; synthesis of findings in relation to the questions of interest, followed by a discussion of specific issues of relevance in the Australian setting and recommendations for future policy and research. This review was undertaken in two parts; Part One addressed the first question as it was likely that the majority of research on this area would be qualitative in nature and / or advocacy documents. This was undertaken by an expert in qualitative methods. Part Two incorporated questions likely to be addressed by mixed methods studies and quantitative evaluations and so was undertaken by researchers with expertise in systematic review methodology for both quantitative and qualitative research.