Improving the evidence‐base in surgery: evaluating surgical effectiveness

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Abstract
This second of two articles about clinical epidemiology reviews the generation and synthesis of evidence for the effectiveness of surgical procedures. While well‐designed randomized controlled trials of surgical procedures are considered the ‘gold standard’ of evaluation design, they may achieve high internal validity at the expense of external validity (generalizability). Improving the ­evidence‐base in surgery likely will require a comprehensive approach to surgical outcomes assessment, involving both improvements in the quality and quantity of randomized controlled trials as well as recognition of the complementary role of alternate study designs.