Newman-Toker DE, Nassery N, Schaffer AC, Yu-Moe CW, Clemens GD, Wang Z, Zhu Y, Saber Tehrani AS, Fanai M, Hassoon A, Siegal D, et al.
BMJ quality & safety. Date of publication 2024 Jan 19;volume 33(2):109-120.
1. BMJ Qual Saf. 2024 Jan 19;33(2):109-120. doi: 10.1136/bmjqs-2021-014130.
Burden of serious harms from diagnostic error in the USA.
Newman-Toker DE(1)(2), Nassery N(3), Schaffer AC(4)(5), Yu-Moe CW(5), Clemens
GD(6), Wang Z(6)(7), Zhu Y(8)(6), Saber Tehrani AS(8), Fanai M(8), Hassoon
A(8)(2), Siegal D(9)(10).
Author information:
(1)Department of Neurology, Johns Hopkins School of Medicine, Baltimore,
Maryland, USA toker@jhu.edu.
(2)Department of Epidemiology, Johns Hopkins University Bloomberg School of
Public Health, Baltimore, Maryland, USA.
(3)Department of Medicine, Johns Hopkins School of Medicine, Baltimore,
Maryland, USA.
(4)Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.
(5)Department of Patient Safety, The Risk Management Foundation of the Harvard
Medical Institutions Inc, Boston, Massachusetts, USA.
(6)Department of Biostatistics, Johns Hopkins University Bloomberg School of
Public Health, Baltimore, Maryland, USA.
(7)Department of Oncology, Johns Hopkins School of Medicine, Baltimore,
Maryland, USA.
(8)Department of Neurology, Johns Hopkins School of Medicine, Baltimore,
Maryland, USA.
(9)Candello, The Risk Management Foundation of the Harvard Medical Institutions
Inc, Boston, Massachusetts, USA.
(10)Department of Risk Management & Analytics, Coverys, Boston, Massachusetts,
USA.
Comment in
BMJ Qual Saf. 2024 Jan 19;33(2):82-85. doi: 10.1136/bmjqs-2023-016496.
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.
© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and
permissions. Published by BMJ.
DOI: 10.1136/bmjqs-2021-014130
PMCID: PMC10792094
PMID: 37460118 [Indexed for MEDLINE]
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.
