Up to 250,000 deaths tied to incorrect E.R. diagnosis, study finds; critics say research is flawed

A federal report suggests as many as 250,000 deaths occur annually due to errors in diagnosis in emergency rooms, prompting calls to improve patient safety and criticism from emergency medicine groups who contend the study is flawed.

The Agency for Healthcare Research and Quality released the study Dec. 15, and it has received widespread media attention, including The New York Times and CNN.

Researchers from Johns Hopkins University conducted the study for the agency.

While the study said diagnostic accuracy in hospital emergency departments is “high,” researchers found about 5.7% of emergency department visits had an incorrect diagnosis.

“Although estimated ED error rates are low (and comparable to those found in other clinical settings), the number of patients potentially impacted is large,” the researchers wrote. “Not all diagnostic errors or harms are preventable, but wide variability in diagnostic error rates across diseases, symptoms, and hospitals suggests improvement is possible.”

Key findings of the study

With an estimated 130 million emergency department visits in the United States annually, the study projects about 7.4 million patients are misdiagnosed. About 2.6 million (2%) suffer an adverse event due to an incorrect diagnosis.

About 370,000 Americans (0.3%) suffer seriously harmful events due to a diagnostic error in the emergency department, including 250,000 deaths and more than 100,000 “permanent, high-severity disabilities,” the study found.

Stroke, the most commonly misdiagnosed condition, is missed an estimated 17% of the time, the study found.

After stroke, the rest of the top five incorrectly diagnosed conditions were, in order, myocardial infarction; aortic aneurysm/dissection; spinal cord compression/injury; and venous thromboembolism. Those five conditions account for 39% of all incorrect diagnoses, the study said.

Most of the harmful events (68%) were found in a relatively small number of conditions.

“Over two-thirds of serious harms are attributable to just 15 diseases and linked to cognitive errors, particularly in cases with ‘atypical’ manifestations,” the authors wrote.

Women and people of color were more likely to get diagnosed incorrectly, the researchers found. Female patients and members of minority groups (non-white patients) were 20% to 30% more likely to get an incorrect diagnosis.

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Criticism of the study

The American College of Emergency Physicians said the study contains serious flaws. The organization and seven other emergency medicine groups issued a letter outlining their problems with the study.

They also said they fear the report will deter some people from going to the hospital in an emergency.

"The repercussions of this faulty report cannot be overstated, as it will irresponsibly and falsely alarm the public and potentially lead them to delay or even forego treatment for time sensitive emergencies, while also undermining the relationship between patient and emergency physician,” the emergency medicine groups said in the letter. “The intended effect of improving patient care and increasing patient safety may, in fact, paradoxically result in greater harm."

The emergency medicine groups argued that the study is inaccurate because researchers made projections largely based on other studies of emergency medicine conducted outside the United States.

“While most medical specialties have similar training in all Western or advanced nations, EM (emergency medicine) does not,” the letter stated. “In fact, there was no residency training in EM in Spain until 2011, and there is still none in Switzerland. In contrast, training in EM has existed in the U.S. for decades.”

They also contend the projection of 250,000 preventable deaths improperly stems from a study performed nearly 20 years ago that examined one academic center in Canada.

“It is highly misleading, if not outright unconscionable, to misuse this scientific report to assert such widespread harm throughout the U.S.,” the emergency medicine groups said.

The study comes as emergency departments have been packed with patients with respiratory viruses, the flu, and COVID-19.

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‘Some solutions exist’

Advocates for patients said they hope the study can lead to meaningful reforms to protect patients.

The Society to Improve Diagnosis in Medicine issued a statement Monday urging the healthcare industry to come together to find ways to improve patient safety and care.

“SIDM invites everyone involved in the healthcare ecosystem to join us in pursuing education, novel technology solutions, standardized measurement, focused training, and better feedback systems,” the group said in its statement.

“In addition, we can improve workstreams for greater patient safety, reporting methods, and innovative performance monitoring. Increased teamwork and improved strategies that include patient engagement are essential.”

The study should spark renewed conversations and efforts to examine ways to ensure patients get diagnosed correctly, said Doug Salvador, president of the Society to Improve Diagnosis in Medicine board.

“When new data on diagnostic error emerges, industry leaders and policymakers should focus their energy on learning and funding opportunities to improve diagnosis,” Salvador said in a statement. “Some solutions exist, and others need to be discovered. We can reimagine the current diagnostic processes, interactions, and technologies and make a difference.”

Before the federal study on emergency medicine last week, federal officials have pointed to troubling declines in patient safety in the COVID-19 pandemic.

In an analysis published in the New England Journal of Medicine in February, they outlined sharp increases in infections. While federal officials acknowledge that hospitals encountered unprecedented challenges in the pandemic, they said they were troubled by the reversal of progress in patient safety occurring so quickly.

The emergency medicine report should serve as "as an urgent call to action for hospitals," said Leah Binder, president and chief executive officer of the Leapfrog Group, a watchdog group focused on improving safety. The organization issued a report in July offering steps hospitals can take to reduce diagnostic errors.

"Patient safety in hospitals begins with the correct diagnosis, communicated accurately and in a timely manner," Binder said in a statement issued Friday. "In practice, this process often fails. Health care workers are human and may make mistakes, but there are systems that should be in place to prevent human errors from harming patients. The issue of diagnostic errors is a systems issue."

Hospitals have made important strides in protecting patients over the past decade, Binder told Chief Healthcare Executive in November.

“We have some cautious optimism,” Binder said in November. “We think as a country we might be on the right track in addressing patient safety effectively. We haven’t gotten there. There’s a lot more work to do.”

“We still have a tremendous problem with patient safety.”