Ann Thorac Surg 2006;82:1173-1174
© 2006 The Society of Thoracic Surgeons
Editorial
"Surgical Research or Comic Opera" Redux
Robert M. Sade, MD*
Institute of Human Values in Health Care, Medical University of South Carolina, Charleston, South Carolina
* Address correspondence to Dr Sade, Department of Surgery, 96 Jonathan Lucas St, Suite 409, PO Box 250612, Charleston, SC 29425 (Email: sader@musc.edu).
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Introduction
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The gold standard of clinical research is the randomized controlled trial (RCT). Yet, only 6–10% of studies published in the cardiothoracic surgery literature are RCTs, less than half the rate of RCTs published in medical journals [1, 2]. More than half of surgical research studies are retrospective chart reviews, mostly clinical series of operations, which have been decried by some of our medical colleagues as little better than a collection of anecdotal experiences, the weakest scientific evidence, or as hopelessly invalid because of uncontrolled bias and other confounding, potentially lethal flaws [3]. Some comments have gone beyond mere criticism to outright ridicule: "I should like to shame [surgeons] out of the comic opera performances which they suppose are statistics of operations" [3].
It is not often recognized, however, that RCTs can reach valid and useful conclusions only if they address procedures or treatments in which the study interventions can be easily standardized, the skill of the treating physician is of minimal importance, subjects are available in sufficient numbers to allow reliable statistical analysis, and blinding of relevant participants can be easily accomplished. Given those requirements, we can appreciate why RCTs are more common in medical research than in surgical, particularly surgical operations: placebo controls or no treatment controls are often either undesirable or unethical; blinding of all relevant participants is not practical or not possible because surgeons must know what they are doing (blinding of patients, assessors, and analysts often can be done); and patients needing specific procedures are often too few in number for reliable statistical analysis. Standardization of treatment is particularly difficult to accomplish because, unlike 20-milligram tablets, no two operations are the same. Surgical techniques vary among surgeons, and also vary in the same surgeon from one operation to the next; . . . [Full Text of this Article]
Copyright © 2006 by The Society of Thoracic Surgeons.
