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Introduction: National Emphysema Treatment Trial

The State-of-the-Art of the Evaluation and Treatment of Emphysema

Temple University School of Medicine
Philadelphia, Pennsylvania

Alice L. Sternberg, Sc.M.

Johns Hopkins University Bloomberg
School of Public Health
Baltimore, Maryland

The National Emphysema Treatment Trial (NETT) is a multicenter, randomized, controlled trial comparing optimal medical treatment, including pulmonary rehabilitation, with optimal medical treatment plus lung volume reduction surgery. A total of 1,218 patients were randomized to one of the two treatment arms and then followed for a minimum of 6 months (maximum of 5 yr). Resources permitted patient follow-up to continue for an additional 1.5 years to capture additional long-term survival and quality-of-life data, and data analysis to continue for 3 years after that, thus extending the duration of NETT operation to more than a decade. As a result, the NETT is the largest, longest, and most comprehensive examination of the evaluation and treatment of emphysema ever conducted. Over its period of operation, the NETT has had many unique features as follows:

• The NETT compiled and reported the largest and most complete collection of demographic, clinical, physiologic, and radiographic data at baseline and longitudinally over time in patients with severe emphysema. Ancillary studies broadened this data collection to include DNA samples and lung tissue samples for a subset of patients.
  
• Because the NETT was designed as a parallel treatment trial, it was able to examine the effects of optimal medical management alone and optimal medical management plus lung volume reduction surgery on short- and long-term survival, as well as lung function, exercise performance, and quality of life.
  
• Because the NETT was designed with survival as one of its two primary outcomes, the power of the trial was sufficient to reach conclusions regarding the effects of the two treatments on many secondary patient outcomes, such as lung function, exercise performance, and quality of life.
  
• The NETT was large enough and had sufficient heterogeneity in patient baseline characteristics to determine which clinical features predispose patients with emphysema to increased morbidity and mortality.
  
• The NETT was the first collaboration of three federal agencies—the National Institutes of Health, the Centers for Medicare and Medicaid Services (CMS), and the Agency for Healthcare Research and Quality—on a health research study.
  
• Because the costs of clinical care, surgery, and rehabilitation were retrievable from CMS billing records, a cost-effectiveness analysis was planned and conducted in parallel with the trial.
  

The NETT also provided many lessons regarding the care of the patient with emphysema as follows:

• Established that physiologic and radiographic phenotype in severe emphysema can predict patient survival as well as response to treatment.
  
• Demonstrated that static and dynamic hyperinflation have devastating consequences on symptoms, exercise performance, quality of life, and survival in severe emphysema.
  
• Established the optimum management of the preoperative, perioperative, and postoperative care of the patient with severe emphysema undergoing thoracotomy.
  
• Elucidated techniques of pain control that are safe and effective in the postoperative treatment of the patients with severe emphysema.
  
• Demonstrated the importance of multidisciplinary care provided by an ancillary team to address nonpulmonary issues, such as nutritional intervention, cardiac assessment, and the treatment of anxiety and depression in severe emphysema.
  
• Recognized the complexities of performing long-term trials in patients with severe emphysema where multiple comorbidities, frequent exacerbations of chronic obstructive pulmonary disease, and the severity of the underlying disease complicate patient participation and the collection of data.
  

This issue of the Proceedings of the American Thoracic Society is a comprehensive compendium of state-of-the-art care of emphysema by the NETT investigators based on their experience managing patients enrolled in the NETT. The information goes well beyond our knowledge gained about lung volume reduction surgery or pulmonary care, and includes the lessons learned about the total overall care of the patients with emphysema. Our intent is that this information will be a useful resource for clinicians who care for patients with severe emphysema and serve as a reference to those who plan to conduct future clinical investigation in this extremely impaired and complexly ill patient group.

The success of the NETT was due to the combined efforts of dedicated teams of physicians, coordinators, nurses, therapists, researchers, and expanded ancillary staff from a variety of medical institutions across the country. The NETT Data Coordinating Center and the project officers from the National Heart, Lung, and Blood Institute, the CMS, and the Agency for Healthcare Research and Quality led these teams in NETT study design and operation. We recognize the extreme dedication and cooperation of the patients who enrolled into the NETT. It is to our patients that we dedicate this supplement.

ACKNOWLEDGMENTS

The editors of this supplement would also like to acknowledge the editorial contributions of Susan Tonascia, Sc.M., in helping us complete this work.

FOOTNOTES

Conflict of Interest Statement: G.J.C. has had grant support from Emphasys and Aeris Therapeutics. A.L.S. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript.

This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Google Scholar Articles by Criner, G. J. Articles by Sternberg, A. L. PubMed PubMed Citation Articles by Criner, G. J. Articles by Sternberg, A. L.