A Medical Device Daily

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health and the Centers for Medicare & Medicaid Services reported launch of the largest randomized clinical trial of the effectiveness and safety of long-term, home oxygen therapy for chronic obstructive pulmonary disease (COPD) in a six-year study.

In the Long-term Oxygen Treatment Trial (LOTT), researchers at 14 U.S. clinical centers will study about 3,500 patients with moderate COPD to determine whether supplemental oxygen will help them lead longer, more active 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, defined as very low blood oxygen levels while resting (LVRS). Medicare will cover the costs of items and medical services generally available through that program to beneficiaries enrolled in the trial.

About 12 million adults in the U.S. have been diagnosed with COPD; another 12 million are thought to be undiagnosed. About 1 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 agencies said that the decision to undertake the study developed from a scientific group convened in May 2004 by NHLBI in cooperation with CMS and the Agency for Healthcare Research and Quality (AHRQ; Washington). The group called for more research on long-term oxygen therapy. In March, Medicare said that it will extend coverage of home oxygen treatment to Medicare-eligible patients enrolled in the study, not otherwise covered.

Patient recruitment for LOTT is expected to begin in late 2007. Participants will be randomized either to receive or not receive supplemental oxygen for about three years. All participants will be periodically monitored; those not initially selected to receive oxygen will be prescribed oxygen if their blood oxygen levels worsen during the trial.

NHLBI and CMS previously collaborated on the study that determined which patients with severe COPD are most likely to benefit from or suffer complications from LVRS. Findings from the National Emphysema Treatment Trial were reported in May 2003, and Medicare subsequently began coverage of the procedure based on the results.

November is National COPD Awareness Month.

Genetics reference portal launched

Under a new program, practitioners are being encouraged to refer their patients to Genetics Home Reference, a free web site of the NIH, at http://ghr.nlm.nih.gov. Under this program, doctors can request free "Information Rx" pads, enabling them to write "prescriptions," pointing patients to the site which provides explanation of newborn screening. All states screen newborns for certain genetic disorders, though the number of tests varies from state to state.

These conditions are usually not apparent in the newborn, but can cause physical problems, mental retardation and, in some cases, death. Most babies receive a clean bill of health, but early diagnosis and treatment can make the difference between lifelong disabilities and optimal development.

The effort is a collaboration between the National Library of Medicine (NLM) and the National Institute of Child Health and Human Development and four medical associations that have agreed to encourage physicians to point patients to the NLM database.

Genetics Home Reference includes over 500 topics on genetic conditions and related genes.

$75 million awarded for informatics training

The National Library of Medicine (NLM) said it is awarding 18 five-year grants, totaling more than $75 million, for research training in biomedical informatics, the discipline that seeks to apply computer and communications technology to the field of health.

Donald Lndeberg, head of NLM, said specialists in informatics "are vital for research in such key areas as the human genome, application of genomics to treatment and diagnosis, and the use of electronic health records to improve care and reduce error."

At its current group of 18 informatics programs, NLM supports nearly 300 pre-doctoral and post-doctoral trainees each year. Informatics requires knowledge of biology and medicine as well as of computer and information sciences, engineering, and human behavior. Many trainees have two mentors guiding their research. Trainees come to these programs with a range of educational and professional backgrounds; the group includes physicians, biologists, computer scientists, and engineers.

NLM's informatics training programs provide graduate degrees and in-depth research experience in several areas, such as: patient care; genomics, proteomics, cheminformatics, systems biology and simulation/modeling of biological systems; and "bench to bedside" translational research.