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The Comprehensive Complication Index: A Novel and More Sensitive Endpoint for Assessing Outcome and Reducing Sample Size in Randomized Controlled Trials

Wednesday, October 8, 2014

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Slankamenac, Ksenija; Nederlof, Nina; Pessaux, Patrick; de Jonge, Jeroen; Wijnhoven, Bas PL; Breitenstein, Stefan; Oberkofler, Christian E; Graf, Rolf; Puhan, Milo A; Clavien, Pierre-Alain

The Comprehensive Complication Index (CCI) was compared to more standard methods of categorizing complications for their utility in assessing outcomes after randomized surgical trials.  The CCI outperformed standard methods in 2 of 3 published randomized trials (pancreatic and esophageal surgery), demonstrating significant differences in outcomes whereas none was reported in the original trials.  The sample sizes needed to demonstrate differences using CCI are an order of magnitude lower than for traditional endpoints.

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