@article{13614,
  author = {David E. Newman-Toker and Zheyu Wang and Yuxin Zhu and Najlla Nassery and Ali S Saber Tehrani and Adam C Schaffer and Chihwen Winnie Yu-Moe and Gwendolyn D Clemens and Mehdi Fanai and Dana Siegal},
  title = {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”},
  abstract = {<jats:title>Abstract</jats:title><jats:sec id="j_dx-2019-0104_s_999_w2aab3b7b1b1b6b1aab1c14b1Aa"><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="j_dx-2019-0104_s_998_w2aab3b7b1b1b6b1aab1c14b2Aa"><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="j_dx-2019-0104_s_997_w2aab3b7b1b1b6b1aab1c14b3Aa"><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="j_dx-2019-0104_s_996_w2aab3b7b1b1b6b1aab1c14b4Aa"><jats:title>Conclusions</jats:title><jats:p>Diagnostic improvement initiatives should focus on dangerous conditions with higher diagnostic error and misdiagnosis-related harm rates.</jats:p></jats:sec>},
  year = {2021},
  journal = {Diagnosis (Berl)},
  volume = {8},
  pages = {67-84},
  month = {05/2020},
  issn = {2194-802X},
  doi = {10.1515/dx-2019-0104},
}