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J Thorac Cardiovasc Surg 2006;132:247-248
© 2006 The American Association for Thoracic Surgery

Statistics for the Rest of Us

Improving the quality of clinical trials in surgery

Johns Hopkins Center for Clinical Trials, NETT Coordinating Center, Baltimore, Md.

Received for publication December 21, 2005; accepted for publication March 3, 2006.

^_* Address for reprints: Steven Piantadosi, MD, Johns Hopkins Center for Clinical Trials, NETT Coordinating Center, 615 N. Wolfe St, Room 5010, Baltimore, MD 21205-2011 (Email: spiantad@jhmi.edu).

The first 20% of the full text of this article appears below.

The current work by Tiruvoipati and colleagues ¹ measures substantive deficiencies in the reporting of randomized trials in the surgical literature. Among other things, the authors of that report indicate that lack of awareness of the CONSORT guidelines ² contributes to the deficiencies they observed. We cannot know for sure whether the problems in the surgical literature are worse than in other contexts, but we think they are because of the general underapplication of rigorous experimental design methods for clinical questions in surgery. ³

The Tiruvoipati study ¹ is a review of problems relatively near the end of the evidentiary pipeline. However, I believe it is helpful to reflect on the whole culture and process of therapeutic inference in surgery to understand how the literature might be improved and, in turn, how the literature might improve the science. This means examining investigators' attitudes and beliefs, the mindset of peer reviewers, the role of surgical journals, and the demands of readers.

With regard to attitudes . . . [Full Text of this Article]

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