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J Thorac Cardiovasc Surg 1999;118:518-528
© 1999 Mosby, Inc.


GENERAL THORACIC SURGERY

RATIONALE AND DESIGN OF THE NATIONAL EMPHYSEMA TREATMENT TRIAL (NETT): A PROSPECTIVE RANDOMIZED TRIAL OF LUNG VOLUME REDUCTION SURGERY

, The National Emphysema Treatment Trial Research Group*

*Members of the National Emphysema Treatment Trial Research Group are listed in the appendix.

The National Emphysema Treatment Trial (NETT) is supported by the National Heart, Lung, and Blood Institute (NHLBI), the Health Care Financing Administration (HCFA), and the Agency for Health Care, Policy and Research (AHCPR).

Address for reprints: Steven Piantadosi, MD, PhD, NETT Coordinating Center, Johns Hopkins Center for Clinical Trials, Room 5010, Johns Hopkins School of Hygiene and Public Health, 615 North Wolfe St, Baltimore, MD 21205.


    Introduction
 
The purpose of this article is to present the design for the National Emphysema Treatment Trial (NETT). This trial is a collaborative effort of 17 clinical centers, a study coordinating/statistical center, the National Heart, Lung, and Blood Institute (NHLBI), and the Health Care Financing Administration (HCFA). The study protocol and procedures were finalized in 1997-1998. Screening began in October 1997 and randomization began in January 1998.


    Overview
 
Terminology.
Emphysema is a condition of the lung characterized by abnormal permanent enlargement of air spaces distal to the terminal bronchiole, accompanied by destruction of their walls in the absence of obvious fibrosis.Go 1 The cardinal physiologic defect in emphysema is a decrease in elastic recoil. This decrease in elastic recoil results in the principal physiologic abnormalities of emphysema: decreased maximum expiratory air flow, hyperinflation, and air trapping. The destruction of the alveolar-capillary membrane surface leads to a reduction in diffusing capacity. Emphysema is usually the result of cigarette smoking, although it can occur occasionally without this exposure, notably in {alpha}1-antitrypsin deficiency. It is a chronic progressive disorder that ultimately leads to disability and early death. Emphysema is estimated to be present in 2 million adults in the United States and, along with other forms of chronic obstructive pulmonary disease (COPD), accounts for more than 90,000 deaths annually.Go 2

Present state of treatment for emphysema.
Guidelines for the diagnosis and management of emphysema have been recently promulgated.Go Go 1,3 The goals of therapy in emphysema, as in other forms of COPD, are to halt the progressive decline in lung function, prevent and shorten exacerbations of the disease, improve exercise capacity and quality of life, and prolong survival. The only treatment that has been shown to alter the rate of progression of COPD is cessation of smoking.Go 4 Influenza immunization and pneumococcal vaccination are recommended for prevention of intercurrent life-threatening infections.Go Go 5,6 As a rule, exacerbations of disease . . . [Full Text of this Article]




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