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J Thorac Cardiovasc Surg 2006;132:245-246
© 2006 The American Association for Thoracic Surgery

Statistics for the Rest of Us

Reports of clinical trials: Ethical aspects

Robert M. Sade, MD *

Department of Surgery and the Institute of Human Values in Health Care, Medical University of South Carolina, Charleston, SC.

Received for publication October 25, 2005; accepted for publication March 3, 2006.

* Address for reprints: Robert M. Sade, MD, Medical University of South Carolina, Department of Surgery, 96 Jonathan Lucas St, Suite 409, PO Box 250612, Charleston, SC 29425 (Email: sader@musc.edu).

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

GoTiruvoipati and colleagues 1 Go have shown us glaring deficiencies in the reporting of randomized controlled trials (RCTs) in the cardiothoracic surgery (CTS) literature. The CONSORT statement, a checklist and flowchart used in writing reports of RCTs, is a tool that can be used to improve RCT reports; it is endorsed by most major medical journals but by none of the major cardiothoracic journals. Why is this? One reason might be that RCTs are not as applicable to surgical as to medical disciplines. Indeed, the authors observe that RCTs are only half as prevalent in our journals as they are in general medical journals, and therefore CTS journal editors might be less inclined to pay attention to quality of reporting of low-incidence articles.

RCTs, the gold standard of clinical investigation, are less common in CTS journals than in medical journals for several reasons. Surgical clinical trial protocols that use no-treatment or placebo control groups . . . [Full Text of this Article]


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