The differentiating characteristic between observational and experimental study designs is that in the latter, the presence or absence of undergoing an intervention defines the groups. The goal of analytic studies is to identify and evaluate causes or risk factors of diseases or health-related events. Observational studies fall under the category of analytic study designs and are further sub-classified as observational or experimental study designs ( Figure 1). 4, 5 Observational studies can also complement RCTs in hypothesis generation, establishing questions for future RCTs, and defining clinical conditions. However, recent work has challenged this notion, showing comparable results between observational studies and RCTs. Results from observational studies are often criticized for being vulnerable to influences by unpredictable confounding factors. 3 Instead, well-designed observational studies, recognized as level II or III evidence, can play an important role in deriving evidence for plastic surgery. However, RCT methodology, which was first developed for drug trials, can be difficult to conduct for surgical investigations. 1 Well-designed randomized controlled trials (RCTs) have held the pre-eminent position in the hierarchy of EBM as level I evidence ( Table 1). Because of the innovative nature of the specialty, plastic surgeons are frequently confronted with a spectrum of clinical questions by patients who inquire about “best practices.” It is thus essential that plastic surgeons know how to critically appraise the literature to understand and practice evidence-based medicine (EBM) and also contribute to the effort by carrying out high-quality investigations.
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