Burden of serious harms from diagnostic error in the USA.

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.

Rates and Characteristics of Medical Malpractice Claims Against Hospitalists.

BACKGROUND: Hospitalists practice in high-stakes and litigious settings. However, little data exist about the malpractice claims risk faced by hospitalists. OBJECTIVE: To characterize the rates and characteristics of malpractice claims against hospitalists. DESIGN, SETTING, AND PARTICIPANTS: An analysis was performed of malpractice claims against hospitalists, as well as against select other specialties, using data from a malpractice claims database that includes approximately 31% of US malpractice claims. MAIN OUTCOMES AND MEASURES: For malpractice claims against hospitalists (n = 1,216) and comparator specialties (n = 18,644): claims rates (using a data subset), percentage of claims paid, median indemnity payment amounts, allegation types, and injury severity. RESULTS: Hospitalists had an annual malpractice claims rate of 1.95 claims per 100 physician-years, similar to that of nonhospitalist general internal medicine physicians (1.92 claims per 100 physician-years), and significantly greater than that of internal medicine subspecialists (1.30 claims per 100 physician-years) (P < .001). Claims rates for hospitalists nonsignificantly increased during the study period (2009-2018), whereas claims rates for four of the five other specialties examined significantly decreased over this period. The median indemnity payment for hospitalist claims was $231,454 (interquartile range, $100,000-$503,015), significantly higher than the amounts for all the other specialties except neurosurgery. The greatest predictor of a hospitalist case closing with payment (compared with no payment) was an error in clinical judgment as a contributing factor, with an adjusted odds ratio of 5.01 (95% CI, 3.37-7.45). CONCLUSION: During the study period, hospitalist claims rates did not drop, whereas they fell for other specialties. Hospitalists' claims had relatively high injury severity and median indemnity payment amounts. The malpractice environment for hospitalists is becoming less favorable.

Rate of diagnostic errors and serious misdiagnosis-related harms for major vascular events, infections, and cancers: toward a national incidence estimate using the "Big Three".

BACKGROUND: Missed vascular events, infections, and cancers account for ~75% of serious harms from diagnostic errors. Just 15 diseases from these "Big Three" categories account for nearly half of all serious misdiagnosis-related harms in malpractice claims. As part of a larger project estimating total US burden of serious misdiagnosis-related harms, we performed a focused literature review to measure diagnostic error and harm rates for these 15 conditions. METHODS: We searched PubMed, Google, and cited references. For errors, we selected high-quality, modern, US-based studies, if available, and best available evidence otherwise. For harms, we used literature-based estimates of the generic (disease-agnostic) rate of serious harms (morbidity/mortality) per diagnostic error and applied claims-based severity weights to construct disease-specific rates. Results were validated via expert review and comparison to prior literature that used different methods. We used Monte Carlo analysis to construct probabilistic plausible ranges (PPRs) around estimates. RESULTS: Rates for the 15 diseases were drawn from 28 published studies representing 91,755 patients. Diagnostic error (false negative) rates ranged from 2.2% (myocardial infarction) to 62.1% (spinal abscess), with a median of 13.6% [interquartile range (IQR) 9.2-24.7] and an aggregate mean of 9.7% (PPR 8.2-12.3). Serious misdiagnosis-related harm rates per incident disease case ranged from 1.2% (myocardial infarction) to 35.6% (spinal abscess), with a median of 5.5% (IQR 4.6-13.6) and an aggregate mean of 5.2% (PPR 4.5-6.7). Rates were considered face valid by domain experts and consistent with prior literature reports. CONCLUSIONS: Diagnostic improvement initiatives should focus on dangerous conditions with higher diagnostic error and misdiagnosis-related harm rates.

The Effect of Clinical Volume on Annual and Per-Patient Encounter Medical Malpractice Claims Risk.

OBJECTIVES: The relationship between medical malpractice risk and one of the fundamental characteristics of physician practice, clinical volume, remains undefined. This study examined how the annual and per-patient encounter medical malpractice claims risk varies with clinical volume. METHODS: Clinical volume was determined using health insurance charges and was linked at the physician level to malpractice claims data from a malpractice insurer. The annual medical malpractice claims risk was expressed as the percent of physicians with a malpractice claim, and the per-encounter medical malpractice claims risk was expressed as malpractice claims per 1000 patient encounters. Both of these malpractice claims risk metrics were analyzed as a function of clinical volume, using linear and spline regression. RESULTS: As clinical volume increased, the percent of physicians with a malpractice claim increased linearly. Among all physicians studied, for each decile increase in clinical volume, there was a 0.373% increase in physicians with a malpractice claim (95% confidence interval, 0.301%-0.446%; P < 0.0001). As clinical volume increased, the rate of malpractice claims per 1000 patient encounters decreased. This relationship between clinical volume and per-encounter claims risk was nonlinear. There was a clinical volume threshold, below which decreasing clinical volume was associated with increasing per-encounter claims risk, and above which claims risk no longer significantly varied with increases in clinical volume. CONCLUSIONS: Clinical volume is a crucial determinant of physician malpractice risk, with higher-volume physicians having higher annual risk but lower per-encounter risk. Clinical volume data should be incorporated into analyses of malpractice risk.