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J Thorac Cardiovasc Surg 2006;132:241-242
© 2006 The American Association for Thoracic Surgery

Statistics for the Rest of Us

Randomized clinical trials in surgery: Why do we need them?

Departments of Surgery and Oncology, Johns Hopkins Medical Institutions, Baltimore, Md.

Received for publication December 28, 2005; accepted for publication March 3, 2006.

(Email: balchch@jhmi.edu).

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

Randomized clinical trials (RCTs) are a fundamental tool for surgical investigators to validate new therapies, but they are still used sparingly, and the results are reported in an inconsistent format. This conclusion is highlighted by the provocative article by Tiruvoipati and colleagues, ¹ who report in this issue on the use of the CONSORT statement, a checklist and flowchart used in reporting results of RCTs, in the cardiothoracic surgery literature. This important statement is endorsed by many medical journals but not by most surgical journals. I strongly agree with the authors' major conclusion that

It is therefore important that RCTs are reported in a high quality manner so the readers could have a clear view on why the study was conducted, how it was conducted and how it was analyzed. This would be helpful not only in the immediate appraisal of trials, but also in the long term, when performing further analyses such as in systematic reviews and meta-analyses. ¹

They also make the important point that a uniform reporting format about the design and methodology of a trial is vital, so that results of subsequent trials can be compared with those of previously published reports or so that trial results can be appropriately . . . [Full Text of this Article]

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J. Thorac. Cardiovasc. Surg. 2006 132: 229-232. [Extract] [Full Text] [PDF]