Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician.

Real-world studies have become increasingly important in providing evidence of treatment effectiveness in clinical practice. While randomized clinical trials (RCTs) are the "gold standard" for evaluating the safety and efficacy of new therapeutic agents, necessarily strict inclusion and exclusion criteria mean that trial populations are often not representative of the patient populations encountered in clinical practice. Real-world studies may use information from electronic health and claims databases, which provide large datasets from diverse patient populations, and/or may be observational, collecting prospective or retrospective data over a long period of time. They can therefore provide information on the long-term safety, particularly pertaining to rare events, and effectiveness of drugs in large heterogeneous populations, as well as information on utilization patterns and health and economic outcomes. This review focuses on how evidence from real-world studies can be utilized to complement data from RCTs to gain a more complete picture of the advantages and disadvantages of medications as they are used in practice.Funding: Sanofi US, Inc

Knowledge, capacity and readiness: translating successful experiences in community-based participatory research for health promotion

Capacity building is a guiding principle of community-based participatory research (CBPR). This paper explores the interrelationship between capacity building and the concepts of readiness and intercommunity knowledge translation. A five-year study examined two long-standing projects for the primary prevention of type 2 diabetes in Aboriginal communities, to translate the lessons learned from those experiences into capacity for diabetes prevention in a third Aboriginal community. Reviewing external factors with the PRECEDE-PROCEED model of health promotion reveals that readiness for change requires both intra- and extra-community enabling factors including expertise from other communities, national and international organizations, federal health service funding, available research and intervention funding, and availability of external partners. These resources do not address the community health issue directly, but rather build capacity, objective and environmental, for the community to address the issue itself. It was found that a community that is internally ready, and situated within an external enabling environment rich in appropriate resources, can translate the knowledge from other successful community experiences to develop the capacity to initiate community health promotion for diabetes prevention