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    Put to the test

    A possible role for clinical trials in modifying U.S. healthcare system

    i have an idea. The idea is based upon what seems to be an almost-universally accepted belief that before there should be widespread use of surgical or medical therapies to treat patients with diseases, those therapies should first be vetted in controlled clinical trials involving a limited sample of the afflicted population.

    When it comes to our entire healthcare system, however, there is sometimes the tendency to widely implement a new policy or strategy, and then only after it has been mandated do we bother to examine the impact.

    Here are some examples. The Affordable Care Act of 2010 established the Hospital Readmissions Reduction Program (HRRP) to publicly report 30-day readmission rates for patients with heart failure, heart attack, and pneumonia. Hospitals with higher re-admission rates would be financially penalized. Heart failure, it turns out, is the leading cause of readmissions of Medicare recipients.

    Recently, results of this initiative were examined. The good news is the rate of readmissions did decrease. The bad news, however, is that the mortality of these patients increased.1 The authors conclude: “Whether the 30-day re-admission rate is an appropriate quality metric is debatable.”2

    Here’s a second example. In 2011, to keep interns and residents from getting too tired on the job and making mistakes in caring for patients, new rules were put in place to limit the number of consecutive hours they can work to 16 hours.

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