Patient Safety Alert-University study identifies problems with IOM report
The Institute of Medicine's (IOM) report on medical errors is faulty because it does not include a control group and all the patients studied on average were very sick, according to researchers at Indiana University School of Medicine in Indianapolis
"If you take their figures literally, you have to assume that patients never die if they do not suffer an adverse event," says Clement J. McDonald, MD, director of the Regenstrief Institute and Distinguished Professor of Medicine at Indiana University School of Medicine.
McDonald is referring to the study released by the IOM in November 1999 that stated "prevent-able adverse events are a leading cause of death" and "at least 44,000 and perhaps as many as 98,000 Americans die in hospitals each year as a result of medical errors."
Indiana University's report "Deaths Due to Medical Errors Are Exaggerated in Institute of Medicine Report"1 was published July 5 in The Journal of the American Medical Association (JAMA). Lucian L. Leape, MD, adjunct professor of health policy in the Harvard School of Public Health in Boston, published a rebuttal piece, which ran in the same issue.2
McDonald and his colleagues at Indiana University, Michael Weiner, MD, MPH, assistant professor of medicine, and Siu L. Hui, PhD, professor of medicine, said that it is wrong for the IOM to assert that all deaths in the study group were caused by adverse events without reporting any kind of comparison or control group.1
Leape's colleague, Thomas Nolan, PhD, a statistician at the Institute for Health Care Improvement in Boston, says there was no control group because the IOM study is an analysis of other literature.
The IOM report is based on a Colorado and Utah study that implies that at least 44,000 Americans die each year as a result of medical errors, and on a New York study that suggests the number may be as high as 98,000.
In its high-severity group of 1,278 patients for whom an adverse event was identified, the IOM's study reported that 173 patients (13.6%) died, at least in part because of an adverse event.2
"Indeed, an assertion that adverse events caused death in 13.6% of the patients who experienced adverse events is tantamount to the assertion that there would be no deaths in a group with similar baseline risks who avoided all adverse events. Clinical experience tells us that is not true," McDonald wrote in JAMA.
Nolan says Leape's study eliminated people who were at high risk of death. "The analysis that Dr. McDonald did was not appropriate because Dr. McDonald did not take that into account. The whole issue comes down to whether they excluded the very sick — they did," he says.
Leape wrote that the group screened included people who were not very sick. Patients who had major surgery, acute myocardial infarction, pneumonia, or stroke or were terminally ill, extremely ill, or with a do-not-resuscitate order were eliminated.2
According to Leape, three reasons suggest that the IOM report did not exaggerate the extent of medical injury and death. First, despite the limits of record reviews, it is unlikely the reviewers found adverse events that did not exist. Second, neither of the large studies examined the extent of injuries that occur outside of the hospital. Finally, when prospective detailed studies are performed, almost invariably, error and injury rates are much higher than indicated by the large record-review studies.
Louis H. Diamond, MB, ChB, FACP, vice president and medical director of MEDSTAT Group Inc. in Washington, DC, and member of the board of directors of the Chicago-based National Patient Safety Foundation, says, "Although this has raised some methodological questions, it doesn't detract from the fundamental fact that errors are occurring at a rate higher than they should, and patients are harmed by these errors."
Nolan agrees, saying there's no question that people are dying from medical errors, "despite whether it is 98,000 or 40,000 or 20,000. Come look at some of these cases; we need to work on this."
The research team's analysis will not change the message of the IOM report nor will it change future legislation or the way the private sector responds to the IOM report, Diamond says.
The IOM report concludes with a list of recommendations that includes creating a Center for Patient Safety within the Agency for Healthcare Research and Quality. Initial funding of $30 million to $35 million would permit the center to conduct activities in goal setting, tracking, research, and dissemination, according to the report.
Another component of the plan is mandatory reporting of errors. While 23 states (18 of which require hospital reporting) currently have mandatory reporting systems to track medical errors, President Clinton's plan will have a nationwide, state-based system in place within three years.
For more information, contact:
Clement J. McDonald, MD, director of Regenstrief Institute and Distinguished Professor of Medicine, Indiana University School of Medicine, Indianapolis. Telephone: (317) 630-7070.
Louis H. Diamond, MB, ChB, FACP, vice president and medical director of MEDSTAT Group Inc. in Washington, DC, and member of the board of directors, Chicago-based National Patient Safety Foundation. Telephone: (202) 719-9843.
Thomas Nolan, PhD, statistician, Institute for Health Care Improvement, Boston. Telephone: (301) 589-7981.
References
1. McDonald CJ, Weiner MJ, Hui SL. Deaths due to medical errors are exaggerated in Institute of Medicine report. JAMA 2000; 284:93. http://jama.ama-assn.org.
2. Leape L. Institute of Medicine medical error figures are not exaggerated. JAMA 2000; 284:95. http://jama.ama-assn.org.
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