NHLBI And CMS将启动大型的针对慢性阻塞性肺病的家
NHLBI And CMS Launch Large Study Of Home Oxygen Therapy For COPD
The National Heart, Lung, and Blood Institute (NHLBI), one of the National Institutes of Health (NIH), and the Centers for Medicare & Medicaid Services (CMS) is launching the largest randomized clinical trial of the effectiveness and safety of long-term, home oxygen therapy for COPD (chronic obstructive pulmonary disease). The six-year, $28 million project will study patients with moderate disease.
COPD, a lung disease that over time makes it hard to breathe, is the fourth leading cause of death in the United States. In the Long-term Oxygen Treatment Trial, researchers at 14 clinical centers across the United States will study approximately 3,500 patients with moderate COPD to determine whether supplemental oxygen will help them lead longer, more active, and better quality lives. The results will help Medicare decide whether to extend coverage for home oxygen treatment to patients with moderate disease. Currently, Medicare limits coverage of home oxygen therapy to beneficiaries with severe COPD (very low blood oxygen levels while resting).
NHLBI will administer and oversee the study, and Medicare will cover the costs of items and medical services that are generally available through that program to beneficiaries enrolled in the trial. NIH and CMS are agencies of the U.S. Department of Health and Human Services (HHS).
"COPD is a devastating, highly disabling disease. The prospect that home oxygen therapy could lessen the disability of COPD and perhaps even prolong life when given earlier during the course of the disease is enticing, but we need more information to determine the risks and benefits," said NHLBI Director Elizabeth G. Nabel, M.D. "This study will provide important information to help patients and their health providers decide whether home oxygen treatment is a good choice for them."
About 12 million adults in the United States have been diagnosed with COPD, and another 12 million are believed to be undiagnosed. Approximately one million COPD patients currently receive supplemental oxygen treatment. Although oxygen therapy has been shown to improve survival in patients with severe COPD, the effects of treatment have not been adequately studied in patients with less severe disease.
The decision to undertake the study evolved from a scientific working group convened in May 2004 by NHLBI in cooperation with CMS and HHS' Agency for Healthcare Research and Quality. The group called for more research on the safety and efficacy of long-term oxygen therapy in patients with COPD. In March, Medicare announced that it will extend coverage of home oxygen treatment to Medicare-eligible patients enrolled in the study, who would not otherwise be covered.
"Medicare is committed to ensure that beneficiaries have access to the most appropriate treatments based on the best available science," commented CMS Chief Clinical Officer Barry Straube, M.D. "The results of this study will improve our understanding of the effects of oxygen treatment in a broader group of COPD patients and will help guide our policy decisions."
Patient recruitment for the Long-term Oxygen Treatment Trial is expected to begin in late 2007. Participants will be randomly selected to receive or not to receive supplemental oxygen for approximately three years. All participants will be periodically monitored; those who are not initially selected to receive oxygen will be prescribed oxygen if their blood oxygen levels worsen during the trial.
The 14 field study sites awarded contracts are
* Brigham & Women's Hospital (John Reilly, M.D., Principal Investigator)
* Cleveland Clinic Foundation (James Stoller, M.D., M.S., Principal Investigator)
* Denver Health Medical Center (Rick Albert, M.D., Principal Investigator)
* Duke University (Neil MacIntyre, M.D., Principal Investigator)
* Kaiser Permanente Northwest (Thomas Stibolt, M.D., Principal Investigator)
* Los Angeles Biomedical Research Institute (Richard Casaburi, M.D., Principal Investigator)
* Ohio State University (Philip Diaz, M.D., Principal Investigator)
* Temple University (Gerard Criner, M.D., Principal Investigator)
* University of Alabama at Birmingham (J. Allen Cooper, Jr., M.D., Principal Investigator)
* University of Michigan (Fernando J. Martinez, M.D., M.S., Principal Investigator)
* University of Pittsburgh (Frank Sciurba, M.D., Principal Investigator)
* University of Utah (Richard Kanner, M.D., Principal Investigator)
* University of Washington (David Au, M.D., M.S., Principal Investigator)
* Washington University (Roger Yusen, M.D., M.P.H., Principal Investigator)
NHLBI awarded the contract for the study's data coordinating center to Johns Hopkins University (Steven Piantadosi, MD, PhD, Principal Investigator).
作者:admin@医学,生命科学 2011-02-24 05:11