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J Thorac Cardiovasc Surg 1999;118:518-528
© 1999 Mosby, Inc.
GENERAL THORACIC SURGERY |
*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.
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Introduction |
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 Top Introduction OverviewOutcome measuresStudy designTreatments in the NETTStatistical considerationsPatient rights and...ConclusionAppendix: NETT investigatorsReferences |
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Overview |
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TopIntroductionOverviewOutcome measuresStudy designTreatments in the NETTStatistical considerationsPatient rights and...ConclusionAppendix: NETT investigatorsReferences |
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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 
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. 2
Present state of treatment for emphysema.
Guidelines for the diagnosis and management of emphysema have been recently promulgated. 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. 4 Influenza immunization and pneumococcal vaccination are recommended for prevention of intercurrent life-threatening infections. 5,6 As a rule, exacerbations of disease are treated with antibiotics, steroids, and bronchodilators. Although these interventions are believed to shorten the duration of individual episodes and minimize symptoms, there is little evidence that they either alter the natural history of the disease or reduce mortality. 7,8 Bronchodilators improve lung function, exercise capacity, and quality of life in patients with COPD but are of limited benefit to patients without reversible airway disease. 9 Pulmonary rehabilitation, including aerobic exercise conditioning, education, and psychosocial support, improves exercise capacity in patients with COPD and may reduce the rate of hospitalization. 10-13
Long-term domiciliary oxygen therapy in hypoxemic patients is the only treatment for COPD that has been documented to decrease mortality rates. 14,15 Adjunctive forms of therapy, such as mucolytics to control respiratory secretions or narcotics to reduce the sensation of dyspnea, have been used in selected patients with COPD. 16 In patients with 1-protease inhibitor deficiency, protective serum levels of the enzyme may be restored by regular infusions of exogenous 1-protease inhibitor, 17 but it is unclear whether restoring serum levels protects against progression of the disease or prolongs survival. 11 In patients with far-advanced COPD, single or double lung transplantation has been used as a last resort, but this option is limited by the small number of donor organs.
Surgery for emphysema.
The failure of medical treatment to produce prolonged improvement of symptoms has prompted the introduction of various surgical procedures over the past 90 years in an attempt to improve symptoms in patients with emphysema. 18 On the basis of the premise that patients with severe emphysema have lungs that have become too large relative to the size of their chests, several different operative procedures, including pneumoperitoneum, phrenic nerve paralysis, thoracoplasty, or excision of costal cartilage combined with a partial sternotomy, have been tried in uncontrolled series of patients. 18 Other operations have included denervation of the lungs, stabilization and fixation of the trachea, and procedures to correct gastroesophageal reflux disease. These procedures produced minimal or no benefit to the patients. 18
In 1957, Brantigan and Mueller 19 reported the surgical excision of lung tissue to reduce the volume of the hyperinflated lung parenchyma, so-called "lung volume reduction surgery (LVRS)." Although 75% of patients reported clinical improvement, the lack of objective documentation for benefit from the procedure and an operative mortality of 18% prevented widespread acceptance of the procedure.
In more recent years, the concept of reducing lung volume surgically in emphysema has been re-explored. In 1991, Wakabayashi and colleagues 20 reported using the carbon dioxide laser to shrink bullous areas of the lung via a thoracoscopic approach. In 1995, Cooper and associates 21 reported a modification of Brantigan’s volume reduction operation, in which lung tissue was resected from both lungs via a median sternotomy. In the initial 20 cases reported, there was no operative mortality and the operation produced an 82% mean increase in the forced expiratory volume in 1 second and significant improvement in the distance walked in 6 minutes. Moreover, many patients were able to discontinue supplemental oxygen. Subsequent randomized prospective studies suggested that the results with stapled resection were superior to those obtained by laser ablation 22 and that bilateral resection was superior to unilateral resection. 23
Existing data on LVRS.
A number of investigators have reported their results after bilateral LVRS. 23-29 From this combined experience, 738 patients showed a 61% mean improvement in the forced expiratory volume in 1 second and a 45.7% mean improvement in the distance walked in 6 minutes; 62% of the oxygen-dependent patients became oxygen-independent. The operative mortality in these series ranged from 2.5% to 10%, and the mean length of hospital stay ranged from 10.9 to 17 days.
The favorable results reported in the above series contrasted with data collected from 722 Medicare claims that used the LVRS billing code between October 1995 and January 1996. 30 Mortality rates 3 and 12 months after the operation were 14.4% and 23%, respectively. For these patients, acute care hospitalizations and use of long-term care and rehabilitation services were greater after as compared with before the operation (304 stays for 160 patients after the operation vs 197 stays for 123 patients before the operation; the in-patient stay associated with LVRS was excluded from these analyses). Average days hospitalized was greater after than before the operation.
During development of the NETT protocol, the historical experience with LVRS at the original 18 clinical centers was reviewed by the Coordinating Center at the request of the NETT Steering Committee. The centers collectively reported 1741 patients who had undergone LVRS by bilateral, unilateral, laser, and excision procedures. The number of patients per center ranged between 13 and 371. Data were requested on baseline prognostic variables (such as age, sex, and pulmonary function tests), pulmonary function tests done 6 months after the operation, the 6-minute walk test, vital status, and duration of survival. Investigators were also asked to make an assessment for each patient of whether the patient had benefited from the LVRS; each investigator could use his or her discretion regarding the criteria for the assessment of benefit or no benefit. Analyses were conducted on all 1741 patients regardless of the type of LVRS procedure.
The analyses showed that considerable historical data were missing, creating difficulty in drawing statistical inferences. For example, only 25% of the 1741 patients had sufficient baseline and follow-up data on prognostic variables for meaningful analyses. Inferences from the historical data were compromised not only by the missing values but also by the potential for strong biases in follow-up and functional assessment. In general, investigators seemed inclined to attribute benefit to the procedure, as seen in the requested subjective assessment of benefit or no benefit. Logistic regression techniques were used on one half of the historical data set to identify baseline covariates predictive of benefit. The other half of the data set was used to determine the sensitivity and specificity of the covariates identified as predictive of benefit. The best sensitivity and specificity for prediction of benefit were approximately 62% and 64%, respectively. In summary, the historical data did not provide convincing evidence for efficacy or reliable characterization of a subset of patients likely to benefit from LVRS.
Rationale for the trial.
As indicated above, published reports on LVRS deal with relatively small numbers of selected patients without long-term follow-up or comprehensive assessment of risks, benefits, and costs. In these reports, there is considerable variability in baseline assessments, types of operations performed, procedures involved in preoperative, intraoperative, and postoperative care, and type and completeness of follow-up evaluations. In addition, although selection criteria were not standardized, only a small proportion of the patients who were evaluated for LVRS actually underwent the procedure. The natural history of these patients, with or without surgery, has not been carefully monitored.
A number of medical centers across the United States tried to reproduce the initial reports of success with LVRS. At several of these sites, mortality rates were inordinately high, raising questions about the risk/benefit ratio of medical therapy versus medical therapy plus surgical intervention. Among the questions were these: How long would the benefit from surgery last? What is the optimal technique for performing the procedure? What are the clinical outcomes beyond the first few postoperative months? Can a subset of patients who would benefit from the procedure be defined?
Thus key questions remain about whether the benefits of LVRS outweigh the associated risks and costs and about issues of efficacy, safety, and patient selection. These questions are particularly pertinent for this group of individuals, who have advanced emphysematous lung disease and who are willing to try any new form of treatment that has the potential of relieving their considerable discomfort in breathing.
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Outcome measures |
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TopIntroductionOverviewOutcome measuresStudy designTreatments in the NETTStatistical considerationsPatient rights and...ConclusionAppendix: NETT investigatorsReferences |
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The other primary measure of outcome, the maximum exercise capacity, was chosen as a measure of integrated cardiopulmonary and physical performance. It is determined by maximal, incremental, symptom-limited exercise with the patient using a cycle ergometer. This test affords several advantages over the 6-minute walk test: it is easier to standardize, it is more reproducible, it is not difficult to administer, and it entails less of a learning effect. Exercise capacity was favored over pulmonary function tests as a primary measure of outcome because studies to date have not documented a consistent relationship between improvement in functional status and changes in pulmonary function, particularly in patients treated medically.
Secondary measures.
The following secondary measures will be used in the assessment of outcomes.
Quality of life and related disease-specific symptoms.
Quality of life and related disease-specific symptoms, possibly the most important outcome measures to the patients participating in the trial, will be measured both by general and disease-specific instruments. General quality of life will be assessed by the Medical Outcomes Study 36-Item Short Form (SF-36) 31 and the utility weighted Quality of Well-Being Scale (QWB). 32 The SF-36 is widely used; its inclusion in the NETT battery will allow comparison of results from NETT with results from other studies. The QWB scale is widely used to provide an estimate of Quality Adjusted Life Years (QALYs), an important measure for the cost effectiveness analysis. Disease-specific quality of life will be assessed with the St George’s Respiratory Questionnaire (SGRQ), 33 an instrument that has been developed and validated in patients with COPD. The University of California, San Diego Shortness of Breath Questionnaire (SOBQ), 34 and the modified Borg Scale for perceived dyspnea 35,36 will be used to assess dyspnea, the most important symptom of chronic lung disease. The SOBQ is sensitive to small changes in perceived breathlessness and provides information about breathlessness with daily activities that can be helpful in the clinical evaluation of patients and their management in rehabilitation. The modified Borg Scale is used at the start and close of the 6-minute walk test and maximum exercise testing to obtain ratings of perceived dyspnea and muscle fatigue before and after exercise. The SF-36, QWB, SGRQ, and SOBQ are self-administered scales that can be completed within 60 minutes.
Cost effectiveness analysis.
Cost effectiveness will be analyzed with incremental QALYs used as the denominator and incremental costs in the numerator. Costs will include resources consumed during the course of care; values or prices will be assigned to each resource. Costs of therapy include medical and surgical care, non-medical care related to the treatment, family or friends’ time (valued to dollars) for caring for the patient, and the value of the patient’s time obtaining treatment. The analysis will be completed both from this general societal perspective and from the Medicare perspective. The latter includes only the costs that Medicare covers. Details about the cost effectiveness analysis will be published elsewhere.
Pulmonary function and gas exchange.
Pulmonary function and gas exchange will be assessed in all patients at the time of the initial evaluation and at all follow-up visits. Tests will include spirometry, plethysmographic determination of the functional residual capacity, the single-breath diffusing capacity, arterial blood gases at rest, and the maximal inspiratory and expiratory mouth pressures. Selected clinics will assess pulmonary mechanics in greater detail, including determinations of lung elastic recoil pressures, flow-volume relationships, pulmonary resistance, respiratory muscle function, and arterial blood gases during maximum exercise.
Radiologic studies.
Radiologic studies will include standard chest radiographs, volumetric and high-resolution computed tomographic scans, and nuclear perfusion scans. Chest radiographs and computed tomographic scans will be performed at the time of initial evaluation and at 2 follow-up visits; perfusion scans will be performed at the initial evaluation only. Computed tomographic scans will be used to verify the presence of emphysema and to assess the distribution and severity of the disease.
Oxygen requirement.
The requirement of patients for supplemental oxygen will be assessed on entry into the study and in follow-up. This will be done by adjusting the oxygen concentration of inspired air to maintain the oxygen saturation of arterial blood at greater than 90% while the patient walks on a treadmill, at level grade, at 1 mile per hour.
Six-minute walk distance.
This exercise parameter is included largely because of its widespread use by investigators who have previously reported on the results of LVRS. However, it has been designated as a secondary, rather than a primary, measure of outcome because the test is difficult to standardize. 37 The test will be performed initially and during follow-up.
Cardiovascular measures.
All patients will undergo echocardiographic studies during the initial assessment. All patients with evidence of abnormally high pulmonary arterial pressures will undergo right heart catheterization as part of their evaluation for inclusion in the trial. Patients with pulmonary hypertension are ineligible because of the possibility of increased surgical risk. All patients will undergo at least 1 follow-up echocardiographic study. At selected clinics, patients will undergo initial and follow-up right heart catheterization.
Attention and psychomotor functioning.
The Trail Making Test 38,39 will be used at baseline and annual follow-up visits to evaluate changes in cognitive ability or performance over time. The test is included because it is informative, simple to administer, and sensitive to hypoxia.
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Study design |
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TopIntroductionOverviewOutcome measuresStudy designTreatments in the NETTStatistical considerationsPatient rights and...ConclusionAppendix: NETT investigatorsReferences |
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The trial has 3 components:
Patient participation.
The recruitment goal for the trial is 2500 patients; 6% of these are expected to be of minority background and 30% are expected to be female. The study duration is set at 4.5 years with a 6-month close-out period.
Patients with moderate to severe emphysema, who have been nonsmokers for 6 months before randomization and are judged to be free of other diseases, disabilities, or circumstances likely to interfere with therapy and/or data collection for the duration of the trial, will be offered the opportunity to enroll in the NETT.
At all clinical centers, participants, after enrollment and pulmonary rehabilitation, will be randomized to a program of medical therapy or to a program of medical therapy plus LVRS in a 1:1 ratio. At those clinical centers that offer LVRS by both median sternotomy and video-assisted thoracoscopic surgical (VATS) procedures, those randomized to the surgical arm will participate in a second randomization between the 2 surgical approaches, also in a 1:1 ratio.
Screening process.
Patients may either self-refer for evaluation at a NETT clinical center or be referred by a physician. Patients or their physicians, or both, will be asked to provide a brief history, chest radiograph, electrocardiographic report, and the results of spirometry. These data will be reviewed at the clinical center. Those without identifiable contraindication will be invited to the clinical center for evaluation and testing. All patients who initiate screening at a NETT clinic are included in the NETT registry. Patients who are found to be ineligible for randomization remain in the registry and will be observed for vital status.
Patients invited for further evaluation will undertake a process designed to (1) establish eligibility to be enrolled in the NETT and (2) provide the baseline assessments that will serve as reference data for the duration of the trial. The evaluation process is outlined inTable I and the post-rehabilitation assessment inTable II.
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Exclusion of patients at high risk for perioperative morbidity or mortality, as well as patients unlikely to be able to complete the trial.
Inclusion criteria.
The inclusion criteria were designed to enroll patients with severe obstructive lung disease primarily due to emphysema. The criteria were formulated to include patients with a diverse distribution of emphysema to examine the effect of the anatomic distribution of disease on the response to therapy. The inclusion criteria include (1) radiographic evidence of bilateral emphysema, (2) studies demonstrating severe air-flow obstruction and hyperinflation, and (3) participation in pulmonary rehabilitation with the attainment of preset performance goals(Table III).
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Treatments in the NETT |
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TopIntroductionOverviewOutcome measuresStudy designTreatments in the NETTStatistical considerationsPatient rights and...ConclusionAppendix: NETT investigatorsReferences |
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1 The NETT pulmonary physician will provide recommendations for medical therapy for each participant in the trial. Overall responsibility for medical management will remain with the patient’s primary care physician. Medical treatment will include the following:
Smoking cessation.
Although eligibility for participation in NETT requires smoking cessation for at least 6 months before randomization and biochemical validation at the time of screening, it is anticipated that some participants may resume smoking during the NETT. Relapses will be treated in line with the AHCPR guidelines, including counseling, referral to group programs, and nicotine replacement therapy.
Regular inhaled bronchodilators.
In general, treatment will include both an anticholinergic bronchodilator and a ß2-agonist. The preferred route of administration is by metered-dose inhaler.
Oxygen therapy.
Oxygen will be administered on a long-term basis to maintain the arterial oxygen saturation at 90% or higher during activities of daily living.
Immunization.
Influenza immunization and pneumococcal vaccination are to be used in accord with guidelines of the Centers for Disease Control.
Additional measures.
Additional measures will be tailored to individual needs. These may include bronchodilators such as theophylline administered orally, corticosteroids by inhalation or orally, and antibiotics for treatment of respiratory infections.
Pulmonary rehabilitation.
The rehabilitation program in NETT is designed to optimize the ability of the patient to perform the activities of daily living and to understand and manage the chronic disease. For participants undergoing medical therapy alone, the goal of the NETT rehabilitation program is to optimize exercise capacity. For participants undergoing medical therapy plus LVRS, the goals are to achieve as much physical fitness as possible before the operation to effect early postoperative mobilization and to provide a baseline of optimized preoperative exercise capacity for comparison with the postoperative exercise capacity.
All participants will engage in pulmonary rehabilitation, which will be conducted in 3 phases: pre-randomization (16-20 sessions over 6-10 weeks); post-randomization (10 sessions over 8-9 weeks); and long-term maintenance (duration of the trial). The rehabilitation programs will be supervised by a NETT clinical center; portions of the program may be carried out at a NETT-certified rehabilitation facility closer to the participant’s home. The long-term maintenance program will be conducted at home or at a fitness center with continued monitoring by a NETT clinical center.
Components of the pulmonary rehabilitation program include the following:
Surgical treatment.
On the basis of the consensus that excision of lung tissue at LVRS is more effective than laser ablation or lung plication in relieving symptoms and improving pulmonary function, and to ensure consistency among participating centers, only stapled LVRS with excision will be used in the trial. In addition, all patients treated surgically will undergo bilateral LVRS because of the evidence that the bilateral procedure affords greater and more consistent benefits than do unilateral operations.
The surgical approach will not be uniform at all the centers: 8 of the 17 centers will perform the operation via median sternotomy, 3 will use bilateral VATS procedures, and 6 will randomize patients to either median sternotomy or VATS. Patients will be scheduled for surgery within 2 weeks of randomization. If exacerbation of their underlying disease or other illness causes delay beyond this limit, surgery will be postponed until after the acute illness has subsided. Further pulmonary rehabilitation and additional testing may be required to ensure that candidates continue to satisfy inclusion criteria.
The surgical procedure is directed at excising functionally useless lung tissue. The areas to be resected are identified by preoperative computed tomographic images and perfusion scans. On the basis of published experience, most patients can be expected to have heterogenous disease that is most severe in the upper lobes; in relatively few, emphysema will predominate in the lower lobes. The surgical procedure entails removal of approximately 25% to 30% of the total lung tissue from each side. Surgeons are permitted to reinforce the staple lines with buttress material to minimize the incidence and severity of air leaks. Removed tissue will be weighed and portions will be stored for possible future studies. For each patient, details of the operation will be recorded, with special attention paid to the extent of adhesions, intraoperative difficulties, and problems with intraoperative hemodynamics.
Intraoperative anesthetic management has been standardized. Preoperatively, in patients undergoing median sternotomy, thoracic epidural catheters will be placed for intraoperative and postoperative pain control. Extubation within 2 hours is expected either in the operating room or in the recovery area. Patients will be admitted either to the intensive care unit or to another designated unit in line with the standard of care for patients undergoing major thoracic procedures at the respective institution. Starting on the first postoperative day, patients will receive vigorous chest respiratory therapy and physical therapy to enhance mobilization.
On the basis of previous experience, the most significant postoperative complication is expected to be air leaks that last longer than 7 days. This problem is likely to affect up to 40% of surgical patients regardless of the technique used for LVRS. Other significant complications to be anticipated include respiratory failure, especially if re-intubation is necessary, cardiac arrhythmia, and gastrointestinal complications.
Individual centers may choose to discharge patients with air leaks controlled by the use of Heimlich valves on the chest tube(s). The date of discharge from the surgical facility, as well as the disposition of the patient (eg, home, another in-patient facility), will be recorded.
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Statistical considerations |
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TopIntroductionOverviewOutcome measuresStudy designTreatments in the NETTStatistical considerationsPatient rights and...ConclusionAppendix: NETT investigatorsReferences |
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The primary treatment comparisons will be between medical therapy and LVRS of either type (median sternotomy or VATS). However, the structure and size of the trial will also permit important subset analyses to be conducted, as well as comparisons of morbidity, mortality, and other outcomes within the surgery group. These differences will be assessed with lower power than the primary comparison but should permit clinically important differences to be detected. An important objective of the trial is to gather information to characterize any subset of patients who might receive disproportionate benefit (or risk) from the surgical procedure.
Power and sample size.
This trial is designed primarily to determine the difference in survival between the medical therapy and LVRS groups. The required sample size has been calculated to be 2500 patients, that is, 1250 per group. 41 The accrual rate required to reach the target of 2500 patients in 4.5 years is 2.7 patients per clinic per month. Overall, the trial will have high power to meet other objectives such as detecting a difference in maximum exercise capacity (or other continuously distributed random variables).
Analyses.
In the initial analysis for any variable, patients will be counted in the treatment group to which they were randomly assigned without regard to drop-outs, drop-ins, or course of therapy (intention-to-treat principle). All events occurring from randomization on will be counted in the treatment group to which the patient was randomly assigned. Analyses will be conducted to assess whether any observed treatment effect is consistent across subsets of patients (defined by baseline characteristics, eg, age, race, sex). Analyses will be conducted separately in the prospectively defined subset of patients who are thought most likely to benefit. This approach will be taken for analyses of mortality, complications, and functional outcomes.
Attempts will be made to define a subset of patients who benefit from treatment (either LVRS or medical therapy). Benefit will be defined objectively by a quantitative algorithm based on functional capacity, and all patients will be classified accordingly. The association between benefit and baseline prognostic factors will be assessed with the use of a multiple logistic regression model. The model will be built on a random subset of patients (50%) and validated on the remaining patients. The sensitivity and specificity of the "best" such model will be calculated from the logistic classification method by means of standard methods. A similar procedure will be used to identify subsets of patients who may be at high short-term risk from treatment. These analyses will be conducted separately in medical and surgical patients, as well as in the combined group.
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Patient rights and responsibilities |
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TopIntroductionOverviewOutcome measuresStudy designTreatments in the NETTStatistical considerationsPatient rights and...ConclusionAppendix: NETT investigatorsReferences |
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Participation in NETT and impact on participation in the transplant program.
Participation in the trial does not preclude a patient from undergoing lung transplantation or remaining on the active list. Although individual patients may be asked by the NETT staff to consider delaying transplantation at certain times during the protocol, the final choice will be made by the patient in consultation with his or her private physician and will be directed by his or her clinical situation.
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Conclusion |
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TopIntroductionOverviewOutcome measuresStudy designTreatments in the NETTStatistical considerationsPatient rights and...ConclusionAppendix: NETT investigatorsReferences |
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The NETT represents a novel paradigm for evaluating new medical and surgical treatments. The agreement between NHLBI and HCFA to co-sponsor NETT specifies for NHLBI to provide scientific and administrative leadership and monitoring (and associated costs) and for HCFA to bear the costs of the clinical services associated with the protocol. AHCPR contributes support for the cost effectiveness analysis. NETT could serve as a model for evaluating the benefit and appropriate use of new therapies.
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Appendix: NETT investigators |
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TopIntroductionOverviewOutcome measuresStudy designTreatments in the NETTStatistical considerationsPatient rights and...ConclusionAppendix: NETT investigatorsReferences |
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The members of the NETT Research Group as of February 1999 are as follows:
Clinical centers
Baylor College of Medicine, Houston, Texas:
Rafael Espada, MD (Principal Investigator); Joseph Rodarte, MD (Co-Principal Investigator); Charles Miller III, PhD (Principal clinic coordinator); Peter Barnard, PhD, RPFT; John Carter, MD; Kimberly DuBose, RRT; Tonya Flanigan, RN; Pam Fox, MD; John Haddad, MD; Kathryn Hale, MD; Everett Hood, RRT; Amy Jahn, RRT; Karen King, RPFT; Chinh Nguyen, RPFT; Sherl Norman, PTA; Todd Officer, MS; Michael Reardon, MD; Jeannie Ricketts; Steven Sax, MD; Michael Tucker, RRT; Kedren Williams.
Brigham and Women’s Hospital, Boston, Massachusetts:
John Reilly, MD (Principal Investigator); David Sugarbaker, MD (Co-Principal Investigator); Carol Fanning (Principal clinic coordinator); Karyn Birkenmaier, MS; Simon Body, MD; Carolyn Catanzano; Sabine Duffy, MD; Vladmir Formanek, MD; Anne Fuhlbrigge, MD; Philip Hartigan, MD; Andetta Hunsaker, MD; Francine Jacobson, MD; Linda Mark; Roger Russell, MD; Diane Saunders; Gloria Simons; Scott Swanson, MD.
Cedars-Sinai Medical Center, Los Angeles, California:
Rob McKenna, MD (Principal Investigator); Zab Mohsenifar, MD (Co-Principal Investigator); Carol Geaga, RN (Principal clinic coordinator); Denise Aberle, MD; Jane Brown, RN, MPH; Susan Clark, RN, MN; Christopher Cooper, MD; Rogel Ferrill, RCPT, RCP; Robert Frantz, MD; Arthur Gelb, MD; Jonathan Goldin, MbChb, PhD, FRCR; Jane Gordon, MA, MFCC; David Head, MD; Milton Joyner, BA; Peter Julien, MD; Michael Levine, MD; Michael Lewis, MD; Marcia Pendio, LCSW; Jeffrey Silverman, MD; Peggy Walker, RRT, RCP; Brenda Williams, RN; Valentina Yegyan, BS, CPFT; Charles Yoou, CRTT, CPFT, RCP.
Cleveland Clinic Foundation, Cleveland, Ohio:
Janet Maurer, MD (Principal Investigator); Malcolm DeCamp, MD (Co-Principal Investigator); Yvonne Meli, RNC (Principal clinic coordinator); Luisa Aviv; Charles Hearn, DO; Erik Kraenzler, MD; Scott Marlow; Kevin McCarthy; Atul Mehta, MD; Moulay Meziane, MD; Peter O’Donovan, MD; Robert Schilz, DO; Eugene Sullivan, MD.
Columbia University, New York, New York:
Mark Ginsburg, MD (Principal Investigator); Steven Scharf, MD, PhD (Co-Principal Investigator); Patricia Jellen, MSN, RNC (Principal clinic coordinator); Asnake Asegu, BS, RRT, RPFT; John Austin, MD; Matthew Bartels, MD; Yahya Berkman, MD; Patricia Berkoski, BS, RRT; Francis Brogan, MSN, RN; Elise Delphin, MD; Glenda Demercado; Angela DiMango, MD; Lisa DePrisco, BS, CRTT, CPFT; John Gonzales, RT; Jill Gotthelf, BS, CRTT; Peter Herman, MD; Arfa Khan, MD; Mike Mantinaos, MD; Kerri McKeon, BS, RRT, RN; Berend Mets, MD; Gregory Pearson, MD; Jacqueline Pfeffer, MPH, PT; Leonard Rossoff, MD; Arlene Sunshine, MD; Paul Simonelli, MD; Kim Stavrolakes, MS, PT; Byron Thomashow, MD; Denise Vilotijevic, MS, PT; Chun Yip, MD.
Duke University Medical Center, Durham, North Carolina:
Neil MacIntyre, MD (Principal Investigator); R. Duane Davis, MD (Co-Principal Investigator); John Howe, RN (Principal clinic coordinator); Rebecca Crouch, RPT; Katherine Grichnik, MD; David Harpole, Jr, MD; Abby Krichman, RRT; Brian Lawlor; Holman McAdams, MD; Jennifer Norten, PhD; Susan Rinaldo-Gallo, MED; Mark Steele, MD; Victor Tapson, MD.
Mayo Foundation, Rochester, Minnesota:
Rolf Hubmayr, MD (Principal Investigator); Claude Deschamps, MD (Co-Principal Investigator); Sara Bartling, BA, RN (Principal clinic coordinator); Gregory Aughenbaugh, MD; Kristin Bradt; Marlene Edgar; Beth Elliott, MD; Eric Edell, MD; James Garrett; Karen Hanson; Lori Hanson; Gordon Harms, MD; Tom Hartman, MD; Sanjay Kalra, MD; Philip Karsell, MD; David Midthun, MD; Daniel Miller, MD; Carl Mottram; Kari Odenbrett; Stephen Swensen, MD; Anne-Marie Sykes, MD; Norman Torres, MD; James Utz, MD.
National Jewish Medical and Research Center, Denver, Colorado:
Reuben Cherniack, MD (Principal Investigator); Barry Make, MD, FACP, FCCP, FAACVPR (Co-Principal Investigator); Mary Gilmartin, RN, RRT (Principal clinic coordinator); Bonnie Buquor, RN; Joyce Canterbury; Martin Carlos; Paul Chetham, MD; Enrique Fernandez, MD; Lisa Geyman, MSPT; David Lynch, MD; John Newell, MD; Marvin Pomerantz, MD; Cynthia Raymond, MS; Beth Safilian; Rickey Tolliver, MPH; Jane Whalen-Price, PT; Kathy Winner, OTR; Martin Zamora, MD.
Ohio State University, Columbus, Ohio:
Philip Diaz, MD (Principal Investigator); Patrick Ross, MD (Co-Principal Investigator); Moira Kelsey, RN, MS (Principal clinic coordinator); Stephanie Dinant; Mark King, MD; Ronald Harter, MD; Elisa Mikelinich; David Rittenger; Scott Shaffer.
Saint Louis University, Saint Louis, Missouri:
Keith Naunheim, MD (Principal Investigator); Cesar Keller, MD (Co-Principal Investigator); Joan Osterloh, RN, BSN (Principal clinic coordinator); Francisco Alvarez, MD; Susan Borosh; Charles Bowen, MD; Sally Frese; James Glockner, MD; Elisabeth Heiberg, MD; Alan Hibbett; Mary Ellen Kleinhenz, MD; Dinah McCain; Gregg Ruppel; W. Sherman Turnage, MD.
Temple University, Philadelphia, Pennsylvania:
Gerard Criner, MD (Principal Investigator); Satoshi Furukawa, MD (Co-Principal Investigator); Anne Marie Kuzma, RN, MSN (Principal clinic coordinator); Roger Barnette, MD; Phillip Boiselle, MD; Neil Brester, MD; Gilbert D’Alonzo, DO; Mary Gilmartin, RN, BSN; Michael Keresztury, MD; Linda Kish; Kathy Lautensack, RN, BSN; Edward Leonard, MD; Vadim Leyenson, MD; Madelina Lorenzon, CPFT; Gerald O’Brien, MD; Timothy O’Grady, MD; Peter Rising, MS; Scott Schartel, MD; John Travaline, MD.
University of California, San Diego, San Diego, California:
Andrew Ries, MD, MPH (Principal Investigator); Robert Kaplan, PhD (Co-Principal Investigator); Catherine Ramirez, BS, RCP (Principal clinic coordinator); Nancy Brewer, RVT; Henri Colt, MD; Stephen Crawford, MD; David Frankville, MD; Paul Friedman, MD; Jeffery Johnson; David Kapelanski, MD; Catherine Larsen, MPH; Trina Limberg, RRT; Michael Magliocca, RN, CNP; Linda Olson, MD; Frank J. Papatheofanis, MD, PhD; Lela Prewitt; Pamela Resnikoff, MD; Dawn Sassi-Dambron, RN.
University of Maryland at Baltimore, Baltimore, Maryland:
Mark Krasna, MD (Principal Investigator); Jonathan Orens, MD (Co-Principal Investigator); Iris Moskowitz (Principal clinic coordinator); Michele Altemus, PT; Daniel Bochicchio, MD; E. James Britt, MD; Laura Cook, RN, MS; Henry Fessler, MD; Dino Gaetani; Ileana Gheorghiu, MD; Timothy Gilbert, MD; Jawad Hasnain, MD; Ava Kearney; Sandra Kim, PT; Karen King, RN; Susan Markus, RN; Naomi Miller, PT; Ron Schneider; David Shade; Kenneth Silver, MD; Karen Smith; Cynthia Turner; Clarence Weir; Jane Wheeler, MD; Charles White, MD.
University of Michigan, Ann Arbor, Michigan:
Fernando Martinez, MD (Principal Investigator); Mark Iannettoni, MD (Co-Principal Investigator); Catherine Meldrum, RN (Principal clinic coordinator); Joy Alexander; William Bria, MD; Kelly Campbell; Paul Christensen, MD; Catherine Foss; Paramjit Gill, RN; Paul Kazanjian, MD; Ella Kazerooni, MD; Vivian Knieper; Nancy Lowenbergh, RN; Mary Meldrum; Rebecca Miller; Tammy Ojo, MD; Diana Piergentili; Lewis Poole; Leslie Quint, MD; Paul Rysso; Michael Spear; Mercedes True; Brian Woodcock, MD.
University of Pennsylvania, Philadelphia, Pennsylvania:
Larry Kaiser, MD (Principal Investigator); John Hansen-Flaschen, MD (Co-Principal Investigator); Angela Wurster, MSN, CRNP (Principal clinic coordinator); Abass Alavi, MD; Theresa Alcorn; Judith Aronchick, MD; Selim Arcasoy, MD; Stanley Aukberg, MD; Bryan Benedict, RRT; Susan Craemer, BS, RRT, CPFT; Jeffery Edelman, MD; Warren Gefter, MD; Laura Kotler-Klein, MSS; Robert Kotloff, MD; Scott Manaker, MD; James Mendez, RN, BSN; Wallace Miller, Jr, MD; Wallace Miller, Sr, MD; Harold Palevsky, MD; William Russell, RPFT; Rodney Simcox, BSRT, RRT; Susanne Snedeker, RRT, CPFT; Gregory Tino, MD.
University of Pittsburgh, Pittsburgh, Pennsylvania:
Robert Keenan, MD (Principal Investigator); Frank Sciurba, MD (Co-Principal Investigator); Elisabeth George, RN, MSN (Principal clinic coordinator); Gerald Ayres; Gerene Bauldoff, RN, MSN; Manuel Brown, MD; Philip Costello, MD; Michael Donahoe, MD; Carl Fuhrman, MD; Robert Hoffman, MD; Michael Holbert, MD; Pamela Johnson; Theodore Kopp, MS; Joan Lacomis, MD; Joan Sexton; Laurie Silfies; William Slivka; Diane Strollo, MD; Erin Sullivan, MD; William Tullock, MD.
University of Washington, Seattle, Washington:
Joshua Benditt, MD (Principal Investigator), Douglas Wood, MD (Co-Principal Investigator); Margaret Snyder, MN (Principal clinic coordinator); Kymberley Anable; Nancy Battaglia; Louie Boitano; Andrew Bowdle, MD; Leighton Chan, MD; Cindy Chwalik; Bruce Culver, MD; David Godwin, MD; Susan Golden; Andra Ibrahim, MD; Diane Lockhart; Stephen Marglin, MD; Patricia McDowell; Katrice Nellum; Gail Van Norman, MD.
Other participants
Agency for Health Care, Policy and Research, Rockville, Maryland:
Lynn Bosco, MD, MPH; Yen-Pin Chiang, PhD; Carolyn Clancy, MD; Harry Handelsman, DO.
Coordinating Center, The Johns Hopkins University, Baltimore, Maryland:
Steven Piantadosi, MD, PhD (Center Director); James Tonascia, PhD (Co-Investigator); Patricia Belt; Karen Collins; Betty Collison; Christopher Dawson; Dawn Dawson; Michele Donithan, MHS; Vera Edmonds; Judith Harle; Rosetta Jackson; Shing Lee, MSc; Charlene Levine; Jill Meinert; Deborah Nowakowski; Daniel Reshef, MD; Michael Smith; Brett Simon, MD; Alice Sternberg, ScM; Mark Van Natta, MHS; Robert Wise, MD.
Cost Effectiveness Subcommittee:
Robert M. Kaplan, PhD (Chair); Yen-Pin Chiang, PhD; Marianne C. Fahs, PhD; A. Mark Fendrick, MD; Alan Jay Moskowitz, MD; Dev Pathak, PhD; Scott D. Ramsey, MD, PhD; Elizabeth Richter, MA; J. Sanford Schwartz, MD; Steven Sheingold, PhD; A. Laurie Shroyer, PhD; Judith Wagner, PhD; Roger Yusen, MD.
Data and Safety Monitoring Board:
John Waldhausen, MD (Chair); Gordon Bernard, MD; David DeMets, PhD; Eddie Hoover, MD; Robert Levine, MD; Donald Mahler, MD; A. John McSweeney, PhD; Jeanine Wiener-Kronish, MD; O. Dale Williams, PhD; Magdy Younes, MD.
Health Care Financing Administration, Baltimore, Maryland:
Steven Sheingold, PhD; Karen McVearry; Claude Mone; Joan Proctor-Young.
Office of the Chair of the Steering Committee, University of Pennsylvania, Philadelphia, Pennsylvania:
Alfred P. Fishman, MD (Chair).
Project Office, National Heart, Lung, and Blood Institute, Bethesda, Maryland:
Gail Weinmann, MD (Project Officer); Joanne Deshler, MS (Contracting Officer); Paul Albert, PhD; Suzanne Hurd, PhD; James Kiley, PhD; Margaret Wu, PhD.
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TopIntroductionOverviewOutcome measuresStudy designTreatments in the NETTStatistical considerationsPatient rights and...ConclusionAppendix: NETT investigatorsReferences |
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