Department of Neurology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Director, Armstrong Institute Center for Diagnostic Excellence, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Diagnosis (Berl). 2020 May 14;8(1):67-84. doi: 10.1515/dx-2019-0104. Print 2021 Feb 23.
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.
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.
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.
Diagnostic improvement initiatives should focus on dangerous conditions with higher diagnostic error and misdiagnosis-related harm rates.
漏诊的血管事件、感染和癌症约占诊断错误导致的严重伤害的 75%。仅这“三大类”中的 15 种疾病就导致了近一半的医疗事故索赔中与误诊相关的严重伤害。作为估计美国严重误诊相关伤害总负担的更大项目的一部分，我们进行了一项重点文献综述，以衡量这 15 种疾病的诊断错误和伤害率。
我们在 PubMed、Google 和参考文献中进行了搜索。对于错误，我们选择了高质量的、现代的、基于美国的研究，如果有可用的研究，否则则选择最佳的现有证据。对于伤害，我们使用基于文献的严重伤害（发病率/死亡率）的通用（无疾病）率估计值，然后应用索赔基础上的严重程度权重来构建特定疾病的比率。结果通过专家审查和与使用不同方法的先前文献进行比较进行验证。我们使用蒙特卡罗分析来构建概率可信区间（PPR）。
15 种疾病的比率来自 28 项发表的研究，涉及 91755 名患者。诊断错误（假阴性）率范围从 2.2%（心肌梗死）到 62.1%（脊柱脓肿），中位数为 13.6%（四分位距[IQR]9.2-24.7），总平均值为 9.7%（PPR 8.2-12.3）。每例疾病的严重误诊相关伤害率范围从 1.2%（心肌梗死）到 35.6%（脊柱脓肿），中位数为 5.5%（IQR 4.6-13.6），总平均值为 5.2%（PPR 4.5-6.7）。这些比率得到了领域专家的认可，与之前的文献报告一致。
诊断改进计划应侧重于诊断错误和误诊相关伤害率较高的危险情况。
