Innovative treatments and procedures are essential to the advancement of surgery. Outcomes research provides the mechanism to analyze these new treatments as they enter clinical practice and evaluate them against established therapies. Information gained through this methodology is essential because new techniques and innovations often gain rapid acceptance before clinical trials can be conducted to assess them. Increasing national emphasis is placed on comparative effectiveness as health care costs rise. Surgeons must take the lead in surgical outcomes and comparative effectiveness research, with the goal of identifying the most efficient and effective treatment for our patients. The authors show how to structure and design a research project involving pediatric surgical outcomes. The model consists of the following 3 phases: (1) study design, (2) data preparation, and (3) data analysis. The model we present provides the reader with a basic format and research structure to serve as a guide to performing high-quality surgical outcomes research.
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