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. 2024 Jan 19;33(2):109-120.
doi: 10.1136/bmjqs-2021-014130.

Burden of serious harms from diagnostic error in the USA

David E Newman-Toker  1   2 , Najlla Nassery  3 , Adam C Schaffer  4   5 , Chihwen Winnie Yu-Moe  5 , Gwendolyn D Clemens  6 , Zheyu Wang  6   7 , Yuxin Zhu  8   6 , Ali S Saber Tehrani  8 , Mehdi Fanai  8 , Ahmed Hassoon  8   2 , Dana Siegal  9   10
Affiliations

Burden of serious harms from diagnostic error in the USA

David E Newman-Toker et al. BMJ Qual Saf. .

Abstract

Background: Diagnostic errors cause substantial preventable harms worldwide, but rigorous estimates for 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.

Objective: We sought to estimate the annual US burden of serious misdiagnosis-related harms (permanent morbidity, mortality) by combining prior results with rigorous estimates of disease incidence.

Methods: Cross-sectional analysis of US-based nationally representative observational data. We estimated annual incident vascular events and infections from 21.5 million (M) sampled US hospital discharges (2012-2014). Annual new cancers were taken from US-based registries (2014). Years were selected for coding consistency with prior 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 calculated uncertainty estimates using Monte Carlo simulations. Validity checks included sensitivity analyses and comparison with prior published estimates.

Results: Annual US incidence was 6.0 M vascular events, 6.2 M infections and 1.5 M cancers. Per 'Big Three' dangerous disease case, weighted mean 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 serious harms annually in the USA to be 795 000 (plausible range 598 000-1 023 000). Sensitivity analyses using more conservative assumptions estimated 549 000 serious harms. Results were compatible with setting-specific serious harm estimates from inpatient, emergency department and ambulatory care. The 15 dangerous diseases accounted for 50.7% of total serious harms and the top 5 (stroke, sepsis, pneumonia, venous thromboembolism and lung cancer) accounted for 38.7%.

Conclusion: An estimated 795 000 Americans become permanently disabled or die annually across care settings because dangerous diseases are misdiagnosed. Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined.

Keywords: adverse events, epidemiology and detection; diagnostic errors; medical error, measurement/epidemiology.

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Conflict of interest statement

Competing interests: DEN-T has a career focus and conducts research related to diagnostic errors, including in patients with dizziness and stroke. He serves as the principal investigator for multiple grants and contracts on these topics. DEN-T is a former volunteer President and member of the Board of Directors of the Society to Improve Diagnosis in Medicine. Johns Hopkins has been loaned research equipment (video-oculography (VOG) systems) by two companies for use in DEN-T’s research; one of these companies has also provided funding for DEN-T’s research on diagnostic algorithm development related to dizziness, inner ear diseases and stroke. DEN-T has no other financial interest in these or any other companies. DEN-T is an inventor on a provisional patent (US PCT/US2020/070304) for smartphone-based stroke diagnosis in patients with dizziness. He gives frequent academic lectures on these topics and occasionally serves as a medico-legal consultant for both plaintiff and defence in cases related to dizziness, stroke and diagnostic error. DS is also a former volunteer member of the Board of Directors of the Society to Improve Diagnosis in Medicine. There are no other conflicts of interest. None of the authors have any financial or personal relationships with other people or organisations that could inappropriately influence (bias) their work.

Figures

Figure 1.
Figure 1.. Annual population incidence of serious misdiagnosis-related harms from vascular events, infections, cancers, and all non-“Big Three” others.
The estimated grand total annual US incidence for serious harms (combining “Big Three” harms with other non-“Big Three” harms) is 795,000 (PPR 598,000-1,023,000). Whiskers denote probabilistic plausible ranges (PPRs) from the Monte Carlo analysis.
Figure 2.
Figure 2.. Fraction of serious misdiagnosis-related harms in the US attributed to the top diseases by category.
The treemap diagram proportionally represents hierarchical categories and specific diseases causing serious harms when the diagnosis is incorrect. As we reported previously, based solely on clinical studies, “Big Three” diseases account for 75.8% of all serious harms. The current analysis shows these are broken down as 34.0% infections, 28.6% vascular events, and 13.2% cancers. Taken together, the top 5 vascular events, infections, and cancers account for 50.7% of all serious harms; the five most frequently harmful conditions across “Big Three” categories account for 38.7% of all serious harms. Abbreviations: AA/AD – aortic aneurysm/aortic dissection; ATE – arterial thromboembolism; CRC – colorectal cancer; EC – endocarditis; ME – meningitis/encephalitis; MI – myocardial infarction; ML – melanoma; PC – prostate cancer; SA – spinal abscess; VTE – venous thromboembolism
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Comment in

  • How safe is the diagnostic process in healthcare?
    Marang-van de Mheen PJ, Thomas EJ, Graber ML. Marang-van de Mheen PJ, et al. BMJ Qual Saf. 2024 Jan 19;33(2):82-85. doi: 10.1136/bmjqs-2023-016496. BMJ Qual Saf. 2024. PMID: 37793802 No abstract available.

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