Wednesday, September 7, 2011

Medical Errors: Much Ado About Numbers


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The now-famous Institute of Medicine (IOM) Report, To Err is Human which was released in 1999 created a huge furor and led to a large number of quality improvement initiatives with increased funding for quality improvement initiatives designed to reduce medical errors. Arguably, the major reason for such a drastic response from the US Congress and other Governmental and Non-Governmental Organizations is that the report stated that, " At least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented, according to estimates from two major studies". Surely, these numbers are indeed headliners and you can imagine the headlines from the major news agencies when the report was released!
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It is worth noting that the report emphasizes that the major problem is not a human problem, but a systemic problem. This means that most problems are not caused by problems with humans but that somehow, the systems are not quite structured correctly.

Two groups of scholars debated the issues related to the findings of the two studies cited by the report: the Harvard Medical Practice Study and a 1992 Study done in Colorado and Utah. In the first argument as published in JAMA in September 2000, Clement McDonald, Jonathan Weiner and others argued that the IOM's numbers are false. They argued that the rate of medical errors are not statistically accurate because among other things, there was no comparison group to enable us calculate the "excess mortality" and the data did not take into consideration, the baseline risks of death, the study design was not able to imply causality and other interesting observations. Bottom-line, the numbers are not that high.

In a rebuttal published in the same journal, Lucian Leape argued that the numbers are actually an under-estimation for many reasons including the fact that the selection criteria made it difficult to detect as many errors as there are in the real world and other interesting arguments. Barbara Starfield in her own study which was also published by JAMA estimated a much higher number, stating that as much as 225,000 deaths occur every year from iatrogenic causes in the United States in essence, agreeing with Leape.

My conclusion, which was also alluded to by Leape is that the focus should not be on the numbers but on the fact that this is a serious issue which needs to be tackled for the good of everyone. By my own estimates, almost one in 5 people know someone who has been a victim of a medical error in one way or another. Whether these errors lead to harm is another matter altogether. Let us focus on reducing the probability of errors been committed rather than on spending time on epidemiological and statistical arguments to argue how "statistically significant" the differences in our estimates are. Granted, this is an old question, but I wanted to put my voice out there. I am curious to know if the numbers have reduced over the years due to the measures instituted by Congress. I will explore this and post my thoughts at a later date.