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Cancer, Vascular Events, Infections Account for Vast Majority of Misdiagnosis-Related Harm, Study Says

NEW YORK – Three disease categories — cancer, vascular events, and infections — accounted for almost three-quarters of all serious patient harm that resulted from diagnostic errors, according to a study published today.

Looking at more than 11,000 diagnostic error cases between 2006 and 2015, researchers found that the so called "Big Three" conditions accounted for 74.1 percent of high-severity diagnostic error cases, or cases that led to permanent, serious injury (such as blindness, loss of limb, or severe brain damage) or death, they said in the study published in Diagnosis.

The diagnostic error cases were identified from Controlled Risk Insurance Company's (CRICO) Comparative Benchmarking System database, which contains information from 400 hospitals and is used for many patient safety research programs.

Disease categories were grouped based on disease categories categorized by the Agency for Healthcare Research and Quality Clinical Classifications Software.

Individually, vascular events accounted for 22.8 percent of high-severity diagnostic error cases, infections 13.5 percent, and cancers 37.8 percent. Within vascular events, stroke was the most frequent condition that accounted for high-severity cases; sepsis had the most high-severity cases in infections; and lung cancer had the most high-severity cases in cancer.

In the study, the researchers said that while diagnostic errors are recognized as a major source of preventable harm to patients in the US, figures on the number of deaths and/or serious harm to patients due to such errors vary wildly.

"Given the wide range in current estimates for serious misdiagnosis-related harms (40,000 to 4 million individuals per year in the US), a new approach is warranted," the researchers wrote in Diagnosis. The main goal of their effort, they added, was to identify a list of top diseases that, when missed, cause serious harm to patients.

After stroke, the vascular events that accounted for the most misdiagnosis-related harm were myocardial infarction; venous thromboembolism; aortic aneurysm and dissection; and arterial thromboembolism.

The four leading infectious diseases associated with diagnostic error-related harm, aside from sepsis, were meningitis and encephalitis; spinal abscess; pneumonia; and endocarditis.

After lung cancer, breast cancer; colorectal cancer; prostate cancer; and melanoma were the leading cancers associated with misdiagnosis-related errors.

The researchers said that another key finding of their work was that clinical judgement was the leading identified cause for serious misdiagnosis-based harm to patients — 85 percent of misdiagnosed cases — pointing "to a need for solutions that support better bedside clinical decision-making." They include computer-based tools, automated image interpretation, better education about diagnostic methods, diagnostic performance feedback, and clinical teamwork in diagnosis, as well as better engagement of patients, nurses, and allied health professionals.  

"We know that diagnostic errors happen across all areas of medicine," David Newman-Toker, director of the Johns Hopkins Armstrong Institute Center for Diagnostic Excellence, said in a statement. With more than 10,000 diseases, each manifesting a variety of symptoms, tackling diagnostic problems is daunting. "Our findings suggest that the most serious harms can be attributed to a surprisingly small number of conditions. It still won't be an easy or quick fix, but that gives us both a place to start and real hope that the problem is fixable," he added.

The Diagnosis results are the first of a planned three-part study by Newman-Toker and his colleagues. In the next phase, they will estimate the frequency of misdiagnosis within the 15 most commonly misdiagnosed conditions. In the last phase, they will use "nationally representative data sets to derive a population-level" estimate of the total number of people in the US who are harmed by diagnostic errors annually.