• Claudia I Henschke, David F Yankelevitz, and William J Kostis.
• Department of Radiology, New York Presbyterian Hospital, Weill Medical College of Cornell University, New York, NY 10021, USA. chensch@med.cornell.edu
• Semin. Ultrasound CT MR. 2003 Feb 1;24(1):23-32.

AbstractThe Early Lung Cancer Action Project (ELCAP) recently demonstrated that earlier diagnosis of lung cancer can be achieved with CT, and these results have led to considerable demand for CT screening. The advisability of screening seems obvious, as screening has been shown to provide for lung cancer treatment at a relatively early stage, leading to a better chance to avert death from lung cancer than when treatment is prompted by symptoms and/or signs. There are, however, countervailing ideas that CT lung cancer screening has not yet been demonstrated to 'save lives.' Further, it has been stated that CT screening has a notable problem of "overdiagnosis," meaning that screening finds lesions that are not life threatening, leading to unnecessary surgery. These concerns have led to the argument that assessing 'lives saved,' as well as the effects of overdiagnosis, can only be achieved with a randomized, controlled trial comparing CT screening with no screening, using a mortality endpoint. To this end, the National Lung Screening Trial (NLST) has been funded. This randomized, controlled trial is the most expensive screening study ever proposed. It compares CT screening with chest X-ray screening, and its designers envision that it will provide an answer about the benefit of CT screening, or lack thereof, in about 10 years. We do not question the value of the randomized design of 'treatment' trials for comparing competing interventions (treatments), but we have serious concerns about the use of randomization in the evaluation of a diagnostic test, such as CT. We feel that randomization is not necessary for evaluating a diagnostic test and may generate misleading results. Rather, we feel that the desired information is how often and how early is the disease diagnosed using that test. The purpose of this article is to raise the general level of concern about the underpinnings of such randomized 'screening' trials, and to convey some of the evidence that led to our pessimism about the NLST.

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