MD-NETT:
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The Maryland Center for the
National Emphsema Treatment Trial (NETT)
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In 1997, the University of Maryland, in collaboration with Johns Hopkins University,
was awarded a National Institutes of Health (NIH) grant to become one of the
17 centers of excellence in the National Emphysema Treatment Trial (NETT).
This national clinical trial is designed to determine what is the best treatment
for people with severe emphysema: medical management alone, which typically
involves medication and rehabilitation or medical management plus lung volume
reduction surgery (LVRS), in which damaged portions of each lung are removed.
This surgical treatment has shown promise in recent years by improving lung
function and quality of life for many patients. However, there are still questions
about whether its long-term benefits actually outweigh those of medical therapy
and rehabilitation without surgery.
The study, which is funded by the Health Care Financing Administration and managed
by the National Heart Lung and Blood Institute, will compare the addition of
LVRS to medical therapy in patients with severe emphysema. Each participant
will be assigned at random to either a surgical or nonsurgical course of treatment.
NETT is scheduled to run through the year 2003. The MD-NETT is a collaboration
between the University of Marylands Division of Thoracic Surgery and Pulmonary
Medicine, and the Division of Pulmonary and Critical Care at Johns Hopkins University.
Participation in the trial is offered as a treatment option for people with
advanced emphysema.
Who can participate?
The trial is open to people with emphysema who meet the following basic criteria:
- They have severe, disabling emphysema.
- They are not currently smoking and havent done so within the past
4 months.
- They have no major heart problems.
- They have had no extensive prior chest surgery or lung resection.
- They are able to perform pulmonary rehabilitation.
- They are willing to being randomized to surgery or medical management and
agree to comply with the randomization.
- They have no other serious illnesses that could limit benefits of the surgery.
Medicare beneficiaries are the usual candidates because 80 percent of any patient
care costs associated with participation are covered. Patients or their
secondary insurance are responsible for the usual co-pay and deductibles. Some
private insurers are also participating in NETT, so other people who may be
interested should check with their insurers about coverage of services.
What does participation involve?
People are first identified as candidates for the trial based on information
provided by their physician, including medical history, chest x-ray, and results
of spirometry and EKG tests (which evaluate the condition of the lungs and heart,
respectively). Each center uses this information to determine preliminary eligibility.
If eligible, selected participants must undergo a series of tests to ensure
that they meet all eligibility criteria and to provide baseline data about their
condition. If eligible for NETT, they then enter a course of rigorous pulmonary
rehabilitation for 6 to 10 weeks, during which they participate in a program
of exercise and education. Once this period is over, points are reassessed.
They are randomly assigned either to continue with this treatment or to have
Lung Volume Reduction Surgery in addition to it. The surgery involves removing
the damaged portions of both lungs, typically 20 to 30 percent of each.
After treatment, participants take part in post-randomization rehabilitation
and will be followed closely for the duration of the trial (up to five years).
They will undergo periodic tests of exercise tolerance and pulmonary and cardiovascular
function, laboratory and radiologic tests, and psychosocial and quality-of-life
assessments.
How can I get more information?
If you are a patient or health professional who is interested in NETT at Maryland,
you may contact the principal investigator, Dr. Mark Krasna, at 410-328-8473
(phone) or 410-328-8578 (fax), or Dr. Henry Fessler, co-principal investigator
at 410-614-5920 or 410-955-0036 (fax).
Participants can choose to have most of their screening and follow-up at either
the University of Maryland Medical Center or Johns Hopkins Hospital. However,
all surgery for the trial is performed by Dr. Krasna at the University of Maryland
and all pulmonary appointments are at Johns Hopkins Hospital.
The National Heart Lung and Blood Institute, NHLBI, provides general information
about the NETT, including a press release. Medicares policy letter on
the NETT is available through the Health Care Financing Administration.
If you need additional information or would like to schedule a consultation
in our clinic, please contact us at 410-328-8473 or 1-800-492-5538.
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