Outcomes Derail Study on Educated Consumers

Educating consumers might not be the way toward better outcomes after all, suggests a study of COPD self-management that’s raising some eyebrows. Patients in an intervention group were given four 90-minute seminars designed to help them spot

the symptoms of a COPD flare-up. They were also given an action plan on how best to respond. The problem: More people (27) died in the intervention group than the usual-care group (10). When monitors spotted this, the study was discontinued. “A Comprehensive Care Management Program to Prevent Chronic Obstructive Pulmonary Disease Hospitalizations” is in the May 15 issue of Annals of Internal Medicine.

Enrollment, which took place at Veterans Administration medical centers, began in January 2007 at six sites and eventually expanded to 20 sites. But enrollment had not reached even half of the target number when the study was ended in February 2009, although patients were followed for another six months.

Researchers and others immediately began to consider what might have gone wrong. They noted that two similar studies (by Bourbeau et al. and Rice et al.) showed that educating patients does help in the management of COPD.

“We cannot explain the unexpected increase in mortality … but we believe that the threats to internal validity, such as biased group assignment or biased outcome assessment, were not contributors,” the study states.

Jonathan Whiteson, MD, director of cardiopulmonary rehabilitation at NYU Langone Medical Center, told HealthDay News Service, “If you flip a coin, the odds are 50–50 that you’ll get heads, but, if you flip it just 20 times, you might only get heads a few times. If you keep flipping the coin, however, it will eventually even out. That could be what was going on here.”

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