The Department of Veterans Affairs (VA) has been studying chronic obstructive pulmonary disease (COPD) and how to manage the disease for some time. A randomized trial in 2009 resulted in a series of deaths and put an end to the research program, which was to last 4 years. Nobody however, saw fit to alert anyone outside the VA that the trials were no longer being performed.
The trial was named BREATH (Bronchitis and Emphysema Advice and Training to Reduce Hospitalizations). Researchers had hoped to establish if educating patients and providing tailored disease management would result in fewer hospitalizations and hospital re-admissions for COPD.
At the time the VA stopped the research, they had less than 50% of the amount of participants they hoped to enroll. They also made no public announcement that they were halting the program. Started in 2006 and originally slated as a 1 year pilot study,the COPD study was extended to cover 22 states within 12 months.
After 2 years of study participation, it was discovered the patients receiving comprehensive case management along with standard care suffered from “higher all-cause mortality and possibly other ‘indicators of safety.’” Those issues lead to the committee monitoring the study to recommend and end further interventions and new enrollments in February, 2009.
Many VA on-site researchers were not told why the disease management intervention was ending. The VA apparently cited “safety concerns,” but did not go into detail as to what those concerns were. According to the VA, this is standard operating procedure as their findings have yet to be published.
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