Outcome Reporting in Surgical Randomized Controlled Trials

Abstract

Background: In September 2005, scientific journals began requiring trial protocol registration to increase transparency and accountability. Objective: My primary objectives were: develop a database of linked protocols and publications for surgical randomized control trials (RCTs); estimate the proportion published; and determine the proportion exhibiting selective outcome reporting. Methods: A systematic search of the clinicaltrials.gov database was conducted identifying surgical RCTs, completed between 2006 and 2012. Protocols were linked with publications. Primary outcomes were compared. Results: We identified a cohort of 743 surgical RCT protocols. The proportion of registered trials which published their primary results was 0.49 (n=364). The proportion of selective outcome reporting was estimated to be 0.244, significantly lower than the previous estimate (p<0.001). Conclusion: More than half of the completed surgical RCTs were unpublished, and one quarter of those published selectively reported their primary outcome. This supports the notion that significant bias is present in the surgical literature.