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Johns Hopkins Researchers Determine 795,000 Americans Harmed from Diagnostic Errors Annually

Clinical laboratories can play a critical role in helping doctors to order correct tests and interpret the results

Nearly 800,000 Americans die or are permanently disabled each year due to diagnostic errors. That’s according to research conducted at Johns Hopkins School of Medicine that found most misdiagnoses are due to cognitive errors on the part of the treating physicians. Many diagnoses typically begin with–and are often achieved through—clinical laboratory testing. For that reason, the range of diagnostic errors identified in this study will interest pathologists and lab managers.

Of course, many types of diagnostic errors have nothing to do with lab tests. That said, the research team noted that some diagnostic errors take place when physicians do not pay attention to test results that indicate a patient is not doing well, or do not understand the significance of the test results. There are also examples where doctors order the wrong lab tests for patients’ symptoms.

The Johns Hopkins study findings were published in the journal BMJ Quality and Safety titled, “Burden of Serious Harms from Diagnostic Error in the USA.” The research team determined that only 15 diseases “accounted for 50.7% of total serious harms” and nearly 40% of those harms involved just five medical conditions:

These can be narrowed down even further to just three categories, the researchers noted in BMJ Quality and Safety. They are:

  • Major vascular events,
  • Infections, and
  • Cancers.

In an interview with CNN Health, lead author of the study David Newman-Toker, MD, PhD, a neurology professor at Johns Hopkins and Director of the Division of Neuro-Visual and Vestibular Disorders, said “These are relatively common diseases that are missed relatively commonly and are associated with significant amounts of harm.”

David Newman-Toker, MD, PhD

“We focused here on the serious harms, but the number of diagnostic errors that happen out there in the US each year is probably somewhere on the order of magnitude of 50 to 100 million,” neurologist David Newman-Toker, MD, PhD (above), professor and Director of the Division of Neuro-Visual and Vestibular Disorders at Johns Hopkins, who led the study, told STAT. “If you actually look, you see it’s happening all the time.” Clinical laboratories play a key role in ensuring correct understanding of the tests they perform. (Photo copyright: Johns Hopkins University.)

Changes to Healthcare Risk Management

According to Newman-Toker, the Johns Hopkins study is “the first population health estimate of the number of patients seriously harmed. It also provides more information about the distribution of the diseases that are involved,” Relias Media reported.

The sheer volume of this issue is not lost on the researchers. Newman-Toker likens it to measuring an iceberg.

“You dive below the surface, and you measure the circumference of the iceberg, and [you] will say, ‘Oh my gosh, it’s really big down here.’ And then you go five more feet, and you measure the circumference, and it keeps getting bigger. By the time you’re 20 feet below the surface, you realize this is huge,” he told Relias Media.  

Newman-Toker believes his team’s research offers an opportunity for physicians and healthcare risk managers to better understand how exactly to prioritize their resources and focus their efforts. “In terms of how it informs their day-to-day decision-making, it really is rebalancing some of the efforts a little bit in the direction of conditions that are more common and more commonly misdiagnosed than perhaps indicated by simply looking at claims data,” he noted.

Vascular events can present in symptoms typical of much less serious conditions. Strokes, for example, can present with vague symptoms such as a headache or dizziness. This is similar to heart attacks, which can just present as chest pains. However, heart attacks are far less misdiagnosed than strokes because of a decades-long effort to eradicate those diagnostic errors.

“Diagnostic errors are errors of omission,” Daniel Yang, MD, an internist and Program Director for the Diagnostic Excellence Initiative at the Gordon and Betty Moore Foundation, told CNN Health. “The question is: Could [the outcome] be prevented if we had done something differently earlier on? Oftentimes, that’s a judgment call that two doctors might disagree on.”

Physicians and risk managers can work together to determine the best course of action to identify vague symptoms and prevent the deaths and serious injuries that can come from diagnostic errors.

Economic Cost of Misdiagnosis

Misdiagnosis also comes with a huge economic burden. William Padula, PhD, Assistant Professor of Pharmaceutical and Health Economics at USC Mann School of Pharmacy and Pharmaceutical Sciences, laid out the cost burden for STAT News.

“A patient comes into the ED with a headache or dizziness, and they get told it’ll go away, and then they go home. And then a week later, you find out that they [had] a stroke,” he explained. “By then, the stroke has compounded so much that what could have been addressed in the moment … for $10,000 now becomes a $100,000 issue. … So, there’s a margin of $90,000 that has been added to the US health system burden because of the misdiagnosis.”

Padula estimates that the total cost for these misdiagnoses could come to as much as $100 billion on the healthcare system.

What’s the Solution?

How can physicians avoid misdiagnoses and keep their patients safe? Newman-Toker suggests that physicians consult with other doctors. “I believe that the quickest way to solve the diagnostic error problem in the real world would be to construct approaches that basically rely on the ‘phone a friend’ model,” he told STAT News.

“This doesn’t mean that the patient should have to seek a second opinion, but rather that providers should make it standard practice to consult with a colleague before providing a diagnosis or dismissing a patient,” STAT News added.

Clinical laboratory professionals should note that while these misdiagnoses do not take place in the lab, doctor may order incorrect tests for patients by misreading their symptoms. Thus, clinical pathologists and lab scientists can play a critical role in helping doctors to order the correct tests for their patients and accurately interpret the results.

—Ashley Croce

Related Information:

Burden of Serious Harms from Diagnostic Error in the USA

Burden of Harm from Diagnostic Error Still High

Diagnostic Errors Linked to Nearly 800,000 Deaths or Cases of Permanent Disability in US Each Year, Study Estimates

Misdiagnoses Cost the US 800,000 Deaths and Serious Disabilities Every Year, Study Finds

Cognitive Errors in Clinical Decision Making

What is Diagnostic Error?

Study of Cross-Contamination of Biopsy Specimens in 69 Anatomic Pathology Laboratories Raises Concerns about Test Quality and Patient Safety

Extraneous tissue cross-contamination found in all participating pathology laboratories Cross-tissue contamination, regardless of specimen volume or how frequently reagents were changed

Pathologists and histotechnologists have long known that traditional methods of processing tissue for diagnosis have the potential to cross-contaminate human biopsy specimens. This risk to patient safety and diagnostic accuracy was accepted over the decades because of the limitations of technology and inability to more precisely measure the performance of individual work processes in the histology laboratory.

In recent years, two things have begun to change this long-standing status quo in medical laboratories. These developments now make it possible to more accurately measure the performance of histology work processes. In turn, this allows an understanding of the true rate of errors that happen from the time a human biopsy specimen arrives in the anatomic pathology laboratory until the completed slides are ready to be diagnosed by a pathologist. (more…)

Could Patient-Error Reports Cause Pathologists To Be Responsible for Other Providers’ Mistakes?

Who is responsible when a patient is misdiagnosed because the patient’s physician read a clinical laboratory test report incorrectly?

Could clinical pathologists be held responsible for medical errors caused by other providers? That’s a possibility under a proposal from the federal Agency for Healthcare Research and Quality (AHRQ).

AHRQ is seeking approval for a prototype of a new reporting system for medical errors, AHRQ Director Carolyn M. Clancy, M.D., told The New York Times in a story published on September 22, 2012. “Currently there is no mechanism for consumers to report information about patient safety events,” she said.

New York Times Writes about Pathologists’ Misdiagnoses of Breast Cancer Cases

Variability in the accuracy provided by pathologists at different hospital laboratories is highlighted…

Pathology misdiagnoses for selected types of breast cancer was the subject of a New York Times story this week. In recent days, Newsweek and several other newspapers across the nation picked up the theme and published their own stories centered on misdiagnoses of breast cancer.

Such extensive media coverage elevates public awareness of the role of pathologists in diagnosing disease—but, in this case, not in a positive way. However, media attention on these types of issues should not surprise pathologists and clinical laboratory managers. It is consistent with the trend of consumers becoming ever more educated and sophisticated in their knowledge of healthcare.


Doctors Get Electronic Help with Their Diagnoses Via Decision Support Software

Misdiagnosis by doctors leads to many of the cases that we hear about in the news (or on the TV show “House.”). We live in an age where doctors are under pressure to see as many patients in as little time as possible. Not surprising, then, that many physicians often diagnose the most obvious medical condition they deem appropriate without full and detailed consideration of what alternative medical conditions may also be present.

Kaiser Permanente and the Veterans Health Administration are bringing the issue of misdiagnosis to the forefront with their adoption of a Web-based “decision support” software program called “Isabel.” Isabel and similar systems help doctors by offering an array of possible diagnoses they might not have considered or prompting them to perform appropriate tests on patients with certain symptoms. In a study at the VA Medical Center in Northport, NY, Isabel suggested the correct diagnosis in 98% of cases in which the system was used. Doctors have recognized that this system is an excellent training tool for residents and an invaluable reminder that the simplest explanation is not always the right one when it comes to medical conditions.

I spoke to a friend of mine who is a general practice doctor at the Scott & White Clinic in Georgetown, TX. The facility was on the verge of adopting a decision support program that involved PDAs programmed to suggest an appropriate diagnosis based on symptoms in each general practice exam room. “At what point,” she asked, “am I even necessary anymore? I’m starting to question why I even needed to go to medical school – Anyone could use this thing and come up with the right diagnosis!” Unfortunately, my friend’s attitude will likely be mirrored by many doctors who are set in their ways and unfamiliar with this technology. It’s true that, in a large portion of medical cases, the right answer is a simple one, but decision support programs assist doctors who use them correctly to consider alternative conditions, which may save a patient’s life.

Dark Daily predicts that use of clinical decision support systems like Isabel will increase in coming years. It is a logical consequence of the patient safety movement as well as the motivations provided by pay-for-performance programs. Another reason why health care facilities are likely to embrace these systems is that they can electronically document that the physician did the right thing for the patient, based on the fact that the clinical decision support system agreed with the physicians’ evaluation of symptoms and likely medical conditions.

What remains to be seen is how such clinical decision support systems impact laboratory test ordering patterns and how clinicians follow up on laboratory test results. Clinical laboratory managers and pathologists in health systems and hospitals already using such systems report that overall test utilization declines in the weeks following implementation. Going forward, they say that physicians begin to increase their consultations with pathologists and technical lab staff. So the early evidence is that clinical decision support systems can encourage physicians to make better use of the clinical laboratory’s expertise.

Related Articles:

Preventing the tragedy of misdiagnosis

Why Doctors So Often Get It Wrong

More on Clinical decision support systems (CDSSs)