Miriam E. Tucker

WASHINGTON — Misdiagnosis-related harms are concentrated in the “big three” areas of vascular events, infections, and cancers, new research suggests.

The findings, from an analysis of nearly 12,000 malpractice claims, were presented here on Thursday at a Capitol Hill briefing sponsored by the Society to Improve Diagnosis in Medicine (SIDM), which funded the research through a grant from the Gordon and Betty Moore Foundation.

The study, by David E. Newman-Toker, MD, PhD, professor of neurology at the Johns Hopkins University, Baltimore, Maryland, and colleagues, was simultaneously published online in Diagnosis.

“Diagnostic errors are the most common, most catastrophic, and most costly medical errors both for society and for individual patients. A place to start is with the ‘big three’ — cancers, infections, and vascular events. Together these account for about 75% of the serious harms from diagnostic error,” said Newman-Toker, who is also director of the Center for Diagnostic Excellence, Johns Hopkins Armstrong Institute for Patient Safety and Quality, and president of the SIDM board.

Diagnostic errors account for 34% of all medical errors that cause serious harm; 64% of such errors lead to death or permanent disability. They account for 28% of all payouts for medical malpractice claims. The median payout is $766,000 per highly severe case, Newman-Toker noted.

Moreover, he pointed out, it is estimated that malpractice claims represent just 1.5% of medically negligent care events, so the results of the study barely scratch the surface. He and his colleagues previously estimated that the overall total societal cost is more than $100 billion annually.

With these new findings, “We’ve started to gain insights into how to move the ball forward to fix this problem, but only if we work together and commit seriously to making a difference in this area,” Newman-Toker said.

In an interview with Medscape Medical News, Newman-Toker advised that individual clinicians “demand from the healthcare systems that they work to make [patient safety initiatives] a priority focus.” He also advised that in the clinical setting, “really stay attuned to focus on what the patient is saying. The patient is giving them the diagnosis. It’s really easy in this time-pressured world to forget that piece.”

Helen Burstin, MD, executive vice president and chief executive officer of the Council of Medical Specialty Societies, also spoke at the briefing, noting, “We have to acknowledge the complexity of this issue. This is not the time for clinician-blaming. This is a complex process, and we need to put the right resources into making this better…. This is a systems issue.”

She told Medscape Medical News, “We now have increasing research that should target where we know patients are most at risk.” She advised that physicians reach out to specialist colleagues when they’re not sure of a diagnosis. “Take a chance and phone a friend. If you don’t know, it’s okay to seek help,” she said.

Burstin also emphasized the importance of using tools that help in the diagnostic process, such as electronic health record–based decision support that provides easy-to-access information. “It’s hard to put anything else on the plate of physicians with the degree of burnout…. How do we offer this in a way that works for them?,” she asked.

“The Big Three”
Newman-Toker and colleagues identified 11,592 cases of diagnostic error from the Controlled Risk Insurance Company’s Comparative Benchmarking System database for 2006–2015. The cases represent 28.7% of all US malpractice claims. Of those, 7379 resulted in permanent disability or death.

The 11,592 cases of diagnostic error represent 21% of all claims cases, 28% of surgical cases, and 23% of medical treatment cases. The “big three” disease categories accounted for 61.7% of all diagnostic error claims and 67.3% of all diagnostic error payouts.

Within each of the “big three” categories, the authors identified five specific diseases or conditions that together accounted for about 50% of serious harms — equally distributed between death and permanent disability — in the claims data. In the vascular category, these were stroke, venous and arterial thromboembolism, myocardial infarction, and aortic aneurysm and dissection.

Among infections, the top five were sepsis, pneumonia, meningitis/encephalitis, and spinal abscess. Types of cancer most associated with misdiagnosis were lung cancer, colorectal cancer, breast cancer, melanoma, and prostate cancer.

“What this suggests to us, although diagnostic errors happen everywhere across medicine, is we might be able to take a big chunk out of this problem and save a lot of lives and prevent a lot of disability if we focus energy on tackling these problems. At least it gives us a roadmap and a starting place to move the ball forward…. It really wasn’t known prior to this study,” Newman-Toker said.

The study also revealed the distribution of diagnostic errors by practice setting. Cancer diagnostic errors were more likely to occur in the clinic, whereas vascular event- and infection-related diagnostic errors were more likely to occur in inpatient and emergency department settings. Infection-related misdiagnoses were also common in pediatric clinic settings. These findings suggest potential areas for targeting improvement efforts, he noted.

Tackling the Misdiagnosis Problem
In 2016, US federal healthcare spending on research that specifically focused on diagnostic error totaled just $7 million, Newman-Toker said. He noted, “That’s less than we spend each year on smallpox, which was eradicated half a century ago.”

That could change with recent initiatives. According to an SIDM handout that was distributed at the briefing, the House Appropriations Labor/Health and Human Services funding bill for fiscal 2020 includes “no less than $4 million to support improving diagnosis in medicine, including a multiyear competitive grant program to address diagnostic errors, which may include the establishment of Research Centers of Excellence to develop systems, measures, and new technology solutions to improve diagnostic safety and quality. This is an increase of $2 million above the fiscal year 2019 enacted level.”

The SIDM supports congressional funding for the establishment of four to eight centers of diagnostic excellence across the country, at a minimum of $2 million each per year for 5 years. These would foster research on improving diagnosis, forge partnerships among institutions to speed translation of solutions into clinical practice, and create a diagnostic research workforce.

In 2015, the SIDM launched the Coalition to Improve Diagnosis, a collaboration involving professional societies, healthcare management organizations, hospital/health systems, patient organizations, medical education and training programs, insurers, quality and safety groups, measurement/assessment boards, laboratory organizations, and federal liaisons.

Medical specialty organizations involved in the coalition include the American Board of Internal Medicine, the American Academy of Family Physicians, the American Academy of Pediatrics, the American Association of Nurse Practitioners, the American College of Emergency Physicians, the American Association of Medical Colleges, and the Society of Hospital Medicine.

In 2018, the coalition launched ACT for Better Diagnosis, an effort aimed at “identifying and spreading practical steps that everyone throughout the healthcare system — patients, physicians, nurses, health system leaders, laboratory scientists, and others — can take to improve diagnosis,” according to the statement.

The new “big three” data are the first set of findings from a three-part study examining the total annual burden of harms from diagnostic errors in the United States. A subsequent publication will address rates of diagnostic errors in the highlighted diseases, and the third will report on the total population impact of these misdiagnoses. Those two will be published in the coming months, Newman-Toker told Medscape Medical News.

The study was funded by the Society to Improve Diagnosis in Medicine through a grant from the Gordon and Betty Moore Foundation and was partly supported by the Armstrong Institute Center for Diagnostic Excellence at the Johns Hopkins University School of Medicine. Newman-Toker and Burstein have disclosed no relevant financial relationships.

Diagnosis. Published online July 11, 2019. Full text