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J Thorac Cardiovasc Surg 2003;125:784-786
© 2003 The American Association for Thoracic Surgery

Editorials

Optimizing lung transplant immunosuppression: Beyond calcineurin inhibition

From the Section of Thoracic Surgery, University of Washington, Seattle, Wash.

Received for publication July 1, 2002. Accepted for publication July 15, 2002. Address for reprints: Michael S. Mulligan, MD, Surgical Director, Lung Transplantation, Division of Cardiothoracic Surgery, University of Washington, Box 356310, 1959 NE Pacific St, Box 356310, AA-115, Seattle, WA 98195-6310.

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

See related article on page 891.

It is often difficult, or even impossible, for surgeons to answer some important questions in the context of a prospective, randomized clinical trial. Although the randomized trial is the gold standard for comparing two therapeutic interventions, a number of statistical, practical, and ethical considerations, combined with our own preconceived ideas, usually prevent the contemplation of a randomized trial. A common problem may be that limited patient numbers or small differences between treatments may prevent a large enough trial to provide a valid statistical power to detect legitimate treatment differences. In fact, the majority of randomized surgical trials are flawed by this very lack of a power calculation in the original trial design. ¹

In other cases, a preponderance of phase II clinical trial data may make it appear unethical to assign patients to one of the arms of a randomized study. This is often difficult to disconnect from the separate problem of surgeon bias. However, these are distinct and should not be confused or intertwined. When a preponderance of the informed medical community believes that one treatment is better on the basis of clinical experience and scientific outcomes, random treatment assignment becomes unethical. However, if a given physician, or group of physicians, believes strongly in treatment efficacy, yet is balanced by an informed but skeptical group of physicians, this creates the setting of clinical equipoise, a condition of legitimate professional uncertainty about the optimal treatment. We as surgeons have been quick to accept simple case series, often from a single institution, as adequate proof of efficacy, limiting our ability or willingness to subject these questions to the more rigorous examination of a randomized clinical trial. ¹

Dr Zuckermann and his colleagues ² are . . . [Full Text of this Article]

Related Article

Cyclosporine A versus tacrolimus in combination with mycophenolate mofetil and steroids as primary immunosuppression after lung transplantation: One-year results of a 2-center prospective randomized trial

Andreas Zuckermann, Hermann Reichenspurner, Tudor Birsan, Henrick Treede, Elena Deviatko, Bruno Reichart, and Walter Klepetko
J. Thorac. Cardiovasc. Surg. 2003 125: 891-900. [Abstract] [Full Text] [PDF]