It seems that every time researchers
estimate how often a medical mistake contributes to a hospital patient’s death,
the numbers come out worse.
In 1999, the Institute of Medicine published
the famous “To Err Is Human” report, which dropped a bombshell on the medical
community by reporting that up to 98,000 people a year die because of mistakes
in hospitals. The number was initially disputed, but is now widely accepted by
doctors and hospital officials — and quoted ubiquitously in the media.
In 2010, the Office of Inspector General for
Health and Human Services said that bad hospital care contributed to the deaths
of 180,000 patients in Medicare alone in a given year.
Now comes a study in the current issue of the Journal of Patient
Safety that says the numbers may be much higher — between 210,000 and 440,000 patients each
year who go to the hospital for care suffer some type of preventable harm that contributes
to their death, the study says.
That
would make medical errors the third-leading cause of death in America, behind heart disease, which is
the first, and cancer, which is second.
The new estimates were
developed by John T. James, a toxicologist at NASA’s
space center in Houston who runs an advocacy organization called Patient Safety America. James
has also written a book about the death of his
19-year-old son after what James maintains was negligent hospital care.
Asked about the higher estimates, a
spokesman for the American Hospital Association said the group has more confidence
in the IOM’s estimate of 98,000 deaths. ProPublica asked three prominent
patient safety researchers to review James’ study, however, and all said his methods
and findings were credible.
What’s the right number? Nobody knows for
sure. There’s never been an actual count of how many patients experience
preventable harm. So we’re left with approximations, which are imperfect in
part because of inaccuracies in medical records and the reluctance of some
providers to report mistakes.
Patient safety experts say measuring the
problem is nonetheless important because estimates bring awareness and research
dollars to a major public health problem that persists despite decades of
improvement efforts.
“We need to get a sense of the magnitude of
this,” James said in an interview.
James based his estimates on the findings of
four recent studies that identified preventable harm suffered by patients –
known as “adverse events” in the medical vernacular – using use a
screening method called the Global Trigger Tool, which guides
reviewers through medical records, searching for signs of infection, injury or
error. Medical records flagged
during the initial screening are reviewed by a doctor, who determines the
extent of the harm.
In the four studies, which examined records
of more than 4,200 patients hospitalized between 2002 and 2008, researchers
found serious adverse events in as many as 21 percent of cases reviewed and
rates of lethal adverse events as high as 1.4 percent of cases.
By
combining the findings and extrapolating across 34 million hospitalizations in
2007, James concluded that preventable errors contribute to the deaths of 210,000 hospital
patients annually.
That is the baseline. The actual number more
than doubles, James reasoned, because the trigger tool doesn’t catch errors in
which treatment should have been provided but wasn’t, because it’s known that medical
records are missing some evidence of harm, and because diagnostic errors aren’t
captured.
An estimate of 440,000 deaths from care in
hospitals “is roughly one-sixth of all deaths that occur in the United States
each year,” James wrote in his study. He also cited other research that’s shown
hospital reporting systems and peer-review capture only a fraction of patient
harm or negligent care.
“Perhaps it is time for a national patient bill of rights for
hospitalized patients,” James wrote. “All evidence points to the need for much
more patient involvement in identifying harmful events and participating in
rigorous follow-up investigations to identify root causes.”
Dr. Lucian Leape,
a Harvard pediatrician who is referred to the “father of patient safety,” was on the committee that wrote
the “To Err Is Human” report. He told ProPublica that he has confidence in the
four studies and the estimate by James.
Members of the Institute of Medicine
committee knew at the time that their estimate of medical errors was low, he
said. “It was based on a rather crude method compared to what we do now,” Leape said. Plus, medicine has become much more complex in
recent decades, which leads to more mistakes, he said.
Dr.
David Classen, one of the leading developers of the Global Trigger Tool, said
the James study is a sound use of the tool and a “great contribution.” He said
it’s important to update the numbers from the “To Err Is Human” report because
in addition to the obvious suffering, preventable harm leads to enormous
financial costs.
Dr.
Marty Makary, a surgeon at The Johns Hopkins Hospital
whose book “Unaccountable” calls for greater transparency in health care, said
the James estimate shows that eliminating medical errors must become a national
priority. He said it’s also important to increase the awareness of the
potential of unintended consequences when doctors perform procedure and tests.
The risk of harm needs to be factored into conversations with patients, he
said.
Leape, Classen and Makary all said it’s
time to stop citing the 98,000 number.
Still, hospital association spokesman Akin Demehin said the group is sticking with the Institute of
Medicine’s estimate. Demehin said the IOM figure is
based on a larger sampling of medical charts and that there’s no consensus the
Global Trigger Tool can be used to make a nationwide estimate. He said the tool
is better suited for use in individual hospitals.
The
AHA is not attempting to come up with its own estimate, Demehin
said.
Dr. David Mayer, the vice president of
quality and safety at Maryland-based MedStar Health, said people can make arguments about how many
patient deaths are hastened by poor hospital care, but that’s not really the
point. All the estimates, even on the low end, expose a crisis, he said.
“Way too many people are being harmed by
unintentional medical error,” Mayer said, “and it needs to be corrected.”
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