Put to the test

February 1, 2018

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.

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.

 

Seems logical, right?

A few years later, a study was performed to see the effects of the new rules. Guess what? A JAMA Internal Medicine paper reported that the 2,300 residents questioned did not sleep more hours and did not have reduced risk of depression. In a confidential survey, they self-reported that they had committed more medical errors that harmed patients after the new rules went into effect.3

How can this be? One possibility is that the more-frequent handing off of patients from one resident to another results in the risk of some important information falling through the cracks, and more patients being harmed by an error. The authors conclude that “further study is needed to assess what’s happening.”

Now, I am certain no one proposes new rules with the goal of increasing the numbers of injured and dead patients. It seems only logical that we should require-before allowing the widespread implementation of well-intentioned dramatic changes to our healthcare system-the performance of well-designed controlled trials comparing the proposed change with current practice.

For example, if some group wants to mandate a change, such as instituting a new single-payer system (along the lines of Canada or the United Kingdom), wouldn’t it make sense to test this prospectively in a region of the country and carefully document the pluses and minuses? Then there are no surprises and before seriously enforcing the new rules, we know the consequences.

Vermont spent 4 years planning implementation of a single-payer system before pulling the plug when Gov. Peter Shumlin (D-VT) decided “the risk of economic shock is too high.”4

Too bad. I say let’s have one or more states, Vermont or others, conduct the controlled clinical trials before we seriously consider going nationwide with new policies.

 

References

http://www.medindia.net/news/program-to-reduce-hospital-readmission-increases-risk-of-death-174581-1.htm

http://www.onlinepcd.com/article/S0033-0620(15)30016-5/pdf

http://www.uofmhealth.org/news/archive/201303/paradox-young-docs-new-work-hour-restrictions-may-increase

http://www.nejm.org/doi/full/10.1056/NEJMp1501050