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Ann Thorac Surg 2001;72:330-333
© 2001 The Society of Thoracic Surgeons
a Division of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri, USA
Address reprint requests to Dr Cooper, Division of Cardiothoracic Surgery, Washington University School of Medicine, 3108 Queeny Tower, One Barnes Hospital Plaza, St. Louis, MO 63110
e-mail: cooperj@msnostes.wustl.edu
Two articles in this volume relating to lung volume reduction surgery (LVRS) address a critical issue for surgeons and patients: namely, how can innovative surgical procedures be ethically introduced in a timely and responsible fashion, while protecting patients and payors from abuse? The review by Stirling and coauthors [1] concludes that in selected cases LVRS is safe and effective with sufficient data available to verify benefit at least out to 2 years. The authors conclude, however, that "higher level evidence is required in the form of randomized control trials comparing LVRS with medical management to establish the worth of this technique in clinical practice." The second article, by Berger and coworkers [2], cites extensive evidence as to the efficacy of LVRS and concludes that there is no justification for continuing to deny the procedure to Medicare patients, whose only current option for coverage is enrollment in the National Emphysema Treatment Trial (NETT), which consigns half of the eligible LVRS Medicare patients to a controlled, nonsurgical arm for an indefinite period, the very type of trial recommended by Stirling and associates. They conclude that "the nonpayment policy [of HCFA] is no longer justifiable."
The two groups present the same data yet with differing conclusions. One recommendation represents the epidemiologists quest for measurement of the true "worth" of an effective procedure. The other recommendation seeks to eliminate barriers to the provision of promising new procedures to patients.
At the core of the issue is the role of what is known as evidence-based medicine and its application to new surgical procedures. There are at least three components: When, and under what circumstances should a payor provide access for its beneficiaries to a new procedure? How should scientific validation of new interventions be obtained? How important is it to determine the true "value"
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