Baltimore, MD—Nearly 10% of patients in the United States with symptoms caused by major vascular events, infections, or cancers actually are misdiagnosed, according to a new study.

The report in the journal Diagnosis also reveals that, of those with the most common misdiagnoses, 53.9% suffer a permanent disability or die because of the error. The Johns Hopkins School of Medicine–led study adds that nearly half of all serious misdiagnosis-related harms in malpractice claims stem from those three areas—major vascular events, infections or cancer—which also account for about 75% of serious harms.

As part of a larger project estimating total U.S. burden of serious misdiagnosis-related harms, the study team performed a focused literature review to measure diagnostic error and harm rates for 15 conditions falling into those categories. Those include:
• Five key vascular events—stroke, myocardial infarction, venous thromboembolism, aortic aneurysm and dissection, and arterial thromboembolism (primarily acute mesenteric ischemia)
• Five key infections—sepsis, meningitis and encephalitis, spinal abscess, pneumonia, and endocarditis; and
• Five key cancers—i.e. lung cancer, breast cancer, colorectal cancer, prostate cancer, and melanoma

Researchers aggregated rates for the 15 diseases from 28 published studies involving 91,755 patients. They determined that the rate of diagnostic error, defined as false negatives, ranged from 2.2% (myocardial infarction) to 62.1% (spinal abscess), with a median of 13.6% [interquartile range (IQR) 9.2-24.7] and an aggregate mean of 9.7% (probabilistic plausible range [PPR] 8.2-12.3). In addition, serious misdiagnosis-related harm rates per incident disease case ranged from 1.2% (myocardial infarction) to 35.6% (spinal abscess), with a median of 5.5% (IQR 4.6-13.6) and an aggregate mean of 5.2% (PPR 4.5-6.7).

“Diagnostic improvement initiatives should focus on dangerous conditions with higher diagnostic error and misdiagnosis-related harm rates,” the authors conclude.

“Finally, it is worth pointing out that diseases historically receiving the most sustained attention to diagnosis (i.e. research funding, clinical quality improvement, public awareness) are the ones with the lowest harm rates,” the researchers write. “Myocardial infarction is the prototype and the only acute illness approaching the target “standard” of <1% harmed often cited in the emergency department. This is, of course, after a half century of focused efforts to automate electrocardiogram interpretation, develop and refine biomarkers (e.g. troponin) and create routine diagnostic protocols for chest pain or suspected acute coronary syndromes. Similarly, basic research studies and clinical trials focused on prostate cancer biomarkers (e.g. prostate-specific antigen) date back to the 1960s. Achieving similar gains may be possible for other key diseases, but only if we make sustained investments in improving diagnosis (e.g., missed stroke in acute dizziness, where novel bedside tests and tele-medicine have shown early promise).”

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