Summary Background Diagnostic errors cause substantial preventable harm worldwide, but rigorous estimates of the total burden are lacking. We previously estimated diagnostic error and serious harm rates for key dangerous diseases in major disease categories and validated plausible ranges using clinical experts. Aim We sought to estimate the annual US burden of serious harms related to misdiagnosis (permanent morbidity, mortality) by combining previous results with rigorous estimates of disease incidence. Methods Cross-sectional analysis of US-based nationally representative observational data. We estimated annual vascular incidents and infections from 21.5 million (M) US hospital discharges (2012-2014). Annual new cancers were taken from US registries (2014). Years were selected for consistency of coding with previous literature. Disease-specific incidences for 15 major vascular events, infections and cancers ( ’Big Three’ categories ) were multiplied by literature-based rates to derive diagnostic errors and serious harms. We compute uncertainty estimates using Monte Carlo simulations. Validity checks included sensitivity analyzes and comparison with previously published estimates. Results The annual incidence in the US was 6.0 million vascular events, 6.2 million infections, and 1.5 million cancers. For each ’Big Three’ dangerous disease case , the weighted average error and serious harm rates were 11.1% and 4.4%, respectively. Extrapolating to all diseases (including non-’Big Three’ dangerous disease categories ), we estimated total annual serious harms in the US. Sensitivity analyzes using more conservative assumptions estimated 549,000 serious harms . The results were consistent with serious harm estimates specific to the inpatient, emergency, and outpatient care settings. The 15 dangerous diseases represented 50.7% of the total serious damages and the top 5 (stroke, sepsis, pneumonia, venous thromboembolism and lung cancer) accounted for 38.7%. Conclusion An estimated 795,000 Americans are permanently disabled or die annually in care settings due to misdiagnosed dangerous illnesses. Just 15 diseases account for about half of all serious damage, so the problem may be more treatable than previously imagined. |
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Johns Hopkins Medicine experts emphasize the path toward greater diagnostic excellence through improved diagnosis of high-impact, dangerous diseases.
Improving diagnosis in health care is a moral, professional and public health imperative, according to the US National Academy of Medicine . However, little is known about the full extent of harms related to medical misdiagnosis ; Current estimates vary widely. Using novel methods, a team from the Johns Hopkins Armstrong Institute Center for Diagnostic Excellence and partners from the Harvard Medical Institutions Risk Management Foundation sought to derive what is believed to be the first rigorous national estimate of disability. permanent and death due to diagnostic error.
The original research article was published in BMJ Quality & Safety . Results from the new analysis of national data found that across all clinical settings, including hospital and clinical care, approximately 795,000 Americans die or are permanently disabled from diagnostic error each year , confirming the pressing nature of the public health problem.
“Previous work has typically focused on errors that occur in a specific clinical setting, such as primary care, emergency department, or inpatient care,” says David Newman-Toker, MD, Ph.D. , principal investigator and director of the Center for Diagnostic Excellence. “These studies failed to address total serious harms across multiple care settings, for which previous estimates ranged widely from 40,000 to 4 million per year. "The methods used in our study are notable because they leverage disease-specific damage and error rates to estimate an overall total."
To identify their findings, the researchers multiplied national measures of disease incidence by the disease-specific proportion of patients with that disease who experience errors or harms. The researchers repeated this method for the 15 diseases that cause the most damage and then extrapolated it to the grand total of all dangerous diseases. To assess the accuracy of the final estimates, the study authors conducted the analyzes under different sets of assumptions to measure the impact of the methodological choices and then tested the validity of the findings by comparing them to independent data sources and expert review.
The resulting national estimate of 371,000 deaths and 424,000 permanent disabilities reflects serious harms broadly in care settings.
Vascular events , infections and cancers , called the Big Three , account for 75% of serious harm. The study found that 15 diseases represent 50.7% of the total serious damages. Five conditions that cause the most frequent serious damage represent 38.7% of total serious damage:
- stroke
- Sepsis
- Pneumonia
- venous thromboembolism
- Lung cancer
The overall average error rate across all diseases was estimated at 11.1%, but the rate varies widely from 1.5% for heart attack to 62% for spinal abscess. The leading cause of serious harm from misdiagnosis was stroke, which was missed in 17.5% of cases.
The researchers suggest that diseases that account for the greatest amount of serious misdiagnosis-related harm and with high rates of diagnostic error should become priority targets for developing, implementing, and scaling systematic solutions.
“A disease-focused approach to the prevention and mitigation of diagnostic errors has the potential to significantly reduce these harms,” says Newman-Toker. “Reducing diagnostic errors by 50% for stroke, sepsis, pneumonia, pulmonary embolism and lung cancer could reduce permanent disabilities and deaths by 150,000 per year.”
Newman-Toker adds that disease-based solutions have already been developed and implemented at Johns Hopkins to address undetected stroke, the leading identified cause of serious harm. These solutions include virtual patient simulators to improve the skills of frontline doctors in stroke diagnosis, portable recordings of eye movements through video glasses and mobile phones to allow specialists to remotely assist doctors. front-line in stroke diagnosis, computer algorithms to automate aspects of the diagnostic process to facilitate escalation, and diagnostic excellence dashboards to measure performance and provide feedback on quality improvement.
“Funding for these efforts remains a barrier,” Newman-Toker says. “Diagnostic errors are by far the most under-resourced public health crisis we face, yet research funding recently hit the $20 million per year mark. “If we want to achieve diagnostic excellence and the goal of zero preventable harm from diagnostic errors, we must continue to invest in efforts to achieve success.”
A growing body of evidence shows that diagnostic errors are the most common, catastrophic and costly of all medical errors. They are difficult to identify and often go unnoticed until it is too late. The science of diagnostic safety and quality remains underdeveloped and underfunded. The center, which is the first of its kind in the world, provides a unique, collaborative and transdisciplinary environment for clinicians, researchers, engineers and data experts to work together to address the challenges of medical misdiagnosis. The Armstrong Institute’s Center for Diagnostic Excellence was born out of the need to address this dangerous and costly problem. Located at the Armstrong Institute and led by Dr. David Newman-Toker, a world leader in diagnostic error research, the center plans to eliminate preventable patient harm caused by diagnostic errors. The impact of diagnostic errors Diagnostic errors are likely to affect all of us throughout our lives.
Although appropriate use of diagnostic testing can help combat diagnostic errors and add value to patient-centered care, more testing alone will not provide diagnostic value. The costs of advanced diagnostic tests are spiraling faster than any sector of the healthcare industry, and inappropriate overuse of diagnostic tests will only multiply costs. Diagnostic error and overuse of diagnostic tests are global problems that require bold and innovative solutions. Center Initiatives The center’s first signature initiative will be to address stroke misdiagnoses in Johns Hopkins Hospital emergency departments. Future initiatives will address sepsis and cancer diagnosis. Together, the initiatives will address the "big three" that account for at least a third of all diagnostic errors and likely more than half of the harms caused by diagnostic errors. Why a misdiagnosis of stroke? More than 1 million people in the United States suffer a stroke or transient ischemic attack (TIA, or pre-stroke) each year, and about three in four are first-time strokes. Stroke is the fifth leading cause of death in the United States, killing nearly 130,000 people a year, or one every 4 minutes. That’s one in every 20 deaths. Stroke is one of the leading causes of long-term disability and one of the most preventable. Rapid access to treatment reduces brain injuries, prevents complications, prevents serious strokes after minor strokes, and improves patient outcomes. Minor early strokes are currently missed 30 to 50 percent of the time, often when patients have common symptoms (dizziness, vertigo, headaches) that are diagnosed as a less serious problem. Timely diagnosis leading to prompt and correct treatments can prevent death and disability. Currently, lack of timely treatment leads to preventable harm because patients suffer major strokes after undiagnosed minor strokes. Our goal is to halve lost stroke harms within five years. |
Other members of the multidisciplinary research team involved in the report are Najlla Nassery, Adam Schaffer, Chihwen Winnie Yu-Moe, Gwendolyn Clemens, Zheyu Wang, Yuxin Zhu, Ali Saber Tehrani, Mehdi Fanai, Ahmed Hassoon and Dana Siegal.
These studies were funded by the Society for Improving Diagnosis in Medicine, the Agency for Healthcare Research and Quality (EPC VI [TOPIC ID 503-4262], R01 HS 27614, R18 HS 029350) and the Center of Excellence Diagnostics from the Armstrong Institute at Johns Hopkins Medicine.
