NHLBI tests controversial lung procedure
Eighteen centers collaborate to develop pathway
The Bethesda, MD-based National Heart, Lung, and Blood Institute (NHLBI) is set this month to initiate a clinical trial to study the efficacy of a controversial surgical procedure for patients with emphysema.
The randomized trial, which will be conducted at 18 different sites across the country, will attempt to measure the risks and benefits of lung volume reduction surgery compared to medical management alone in 4,700 emphysema sufferers, says Gail Weinman, MD, medical officer at NHLBI.
Sponsored in cooperation with the Baltimore-based Health Care Financing Administration, the agency that oversees Medicare, the trial could pave the way for future Medicare reimbursement for the procedure. Medicare and some private insurers have so far shied away from paying for the procedure because of concerns over a potentially high mortality.
"Medicare patients represent an older population," Weinman explains. "Not only are the majority of them over 65, but they are desperately ill. Before thy are subjected to a major intervention, we need to know if the intervention works."
Several recent studies have reported generally positive results regarding functional status and quality of life of patients who’ve undergone the procedure. "The problem with those assessments," Weinman says, "is that there’s no control group. You’re taking a very sick population, doing a really major intervention on them, and then asking if they feel better. People don’t want to go through major thoracic surgery without thinking they’ve benefited from it."
Weinman adds that long-term survival among patients undergoing the procedure is only one focus of the trial. "One perfectly conceivable outcome is that [lung volume reduction surgery] doesn’t affect survival at all, but that the quality of life is so vastly improved while the patients are alive that the surgery is acceptable." Other factors to be studied include the patients’ ability to exercise, and improvement in their activities of daily living, Weinman says.
As part of the trial, all 18 participating medical centers will share a data system coordinated by Johns Hopkins University Hospital in Baltimore. They will also use similar techniques with regard to the medical management of patients randomized to the control. In addition, each center will use a single, standardized clinical pathway.
The pathway, as well as certain aspects of the medical management component and outcomes assessment procedure, were hammered out by principal investigators from the institutions during the course of a series of two-day meetings in Washington, DC. "By letting people choose which parts of the protocol they wanted to write in, they were able to bring in some of their own expertise and experience," Weinman says. "And then they compromised."
The trial is scheduled to run until 2003, but it could be terminated earlier based on preliminary results, Weinman says. NHLBI is expected to release the critical pathway by the end of this year.
For more information on the lung volume reduction surgery trial, contact the National Heart, Lung, and Blood Institute, Division of Lung Diseases, Two Rockledge Center, MSC 7952, 6701 Rockledge Dr., Bethesda, MD 20892-7952. Telephone: (301) 496-7332.
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