BackgroundMissed 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.MethodsWe 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.ResultsRates 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.ConclusionsDiagnostic improvement initiatives should focus on dangerous conditions with higher diagnostic error and misdiagnosis-related harm rates.

Background Diagnostic errors cause substantial preventable harm, but national estimates vary widely from 40,000 to 4 million annually. This cross-sectional analysis of a large medical malpractice claims database was the first phase of a three-phase project to estimate the US burden of serious misdiagnosis-related harms. Methods We sought to identify diseases accounting for the majority of serious misdiagnosis-related harms (morbidity/mortality). Diagnostic error cases were identified from Controlled Risk Insurance Company (CRICO)’s Comparative Benchmarking System (CBS) database (2006–2015), representing 28.7% of all US malpractice claims. Diseases were grouped according to the Agency for Healthcare Research and Quality (AHRQ) Clinical Classifications Software (CCS) that aggregates the International Classification of Diseases diagnostic codes into clinically sensible groupings. We analyzed vascular events, infections, and cancers (the “Big Three”), including frequency, severity, and settings. High-severity (serious) harms were defined by scores of 6–9 (serious, permanent disability, or death) on the National Association of Insurance Commissioners (NAIC) Severity of Injury Scale. Results From 55,377 closed claims, we analyzed 11,592 diagnostic error cases [median age 49, interquartile range (IQR) 36–60; 51.7% female]. These included 7379 with high-severity harms (53.0% death). The Big Three diseases accounted for 74.1% of high-severity cases (vascular events 22.8%, infections 13.5%, and cancers 37.8%). In aggregate, the top five from each category (n = 15 diseases) accounted for 47.1% of high-severity cases. The most frequent disease in each category, respectively, was stroke, sepsis, and lung cancer. Causes were disproportionately clinical judgment factors (85.7%) across categories (range 82.0–88.8%). Conclusions The Big Three diseases account for about three-fourths of serious misdiagnosis-related harms. Initial efforts to improve diagnosis should focus on vascular events, infections, and cancers.

Adverse events associated with health IT vulnerabilities can cause extensive harm and are encountered across the continuum of health care settings and sociotechnical factors. The recurring patterns provide valuable lessons that both practicing clinicians and health IT developers could use to reduce the risk of harm in the future. The likelihood of harm seems to relate more to a patient's particular situation than to any one class of error.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share thework provided it is properly cited. The work cannot be changed in any way or used commercially.

Abstract:Just as radiologic studies allow us to see past the surface to the vulnerable and broken parts of the human body, medical malpractice claims help us see past the surface of medical errors to the deeper vulnerabilities and potentially broken aspects of our healthcare delivery system. And just as the insights we gain through radiologic studies provide focus for a treatment plan for healing, so too can the analysis of malpractice claims provide insights to improve the delivery of safe patient care. We review 1325 coded claims where Radiology was the primary service provider to better understand the problems leading to patient harm, and the opportunities most likely to improve diagnostic care in the future.Keywords: diagnostic error; malpractice claims; radiology. OverviewThe medical diagnostic process involves a complex network of interactions between the patient and the healthcare system. This process is also dynamic, requiring one or more cycles of patient interaction, informationgathering and data synthesis in order to understand the intricacies of each patient's clinical picture and pathology. Failures can occur at any point along the continuum of care, each of which has the potential to result in inaccurate or delayed diagnosis as well as inappropriate treatment. While radiology typically does not play the initial role in the diagnostic process, misinterpretation or delayed communication of imaging findings can certainly lead to a breakdown in the progression towards clarity of diagnosis and appropriate patient care.Analysis of the CRICO Comparative Benchmarking System (CBS) determined that 29,777 medical malpractice cases, asserted between 2010 and 2014, had completed an in-depth review by CRICO's team of Clinical Taxonomy Specialists. Reviewing the medical and legal files of each of these cases, an experienced clinician used CRICO's propriety coding taxonomy to capture and code multiple case attributes including allegation, patient demographics, diagnosis and injury, location, tests and services, and the key causation factors contributing to the clinical error or failure.Of the 29,777 medical malpractice cases available for analysis, 1325 cases named Radiology as the Primary Responsible Service -42% resulted in high severity (based on National Associationn of Insurance Commissioners clinical injury severity score) clinical injuries including 235 deaths (Figure 1). Diagnostic related events represent nearly 60% of the 1325 radiology claims, followed by procedural issues (22%), equipment issues, (7%) and falls and safety issues (6%). In those cases involving diagnostic radiology, nearly 50% of the cases involved one of these four modalities: computed tomography (CT) scans (20%), mammography (11%), magnetic resonance imaging (MRI) (10%) and diagnostic ultrasound (4%). Cases occurred in a variety of settings though ambulatory cases were the most common at 63% followed by inpatient (26%) and emergency department (11%).In many cases, Radiology is not the only clinical service identified as "responsible" o...

BackgroundMisdiagnosis of dangerous cerebrovascular disease is a substantial public health problem. We sought to identify and describe breakdowns in the diagnostic process among patients with ischemic stroke to facilitate future improvements in diagnostic accuracy.MethodsWe performed a retrospective, descriptive study of medical malpractice claims housed in the Controlled Risk Insurance Company (CRICO) Strategies Comparative Benchmarking System (CBS) database from 1/1/2006 to 1/1/2016 involving ischemic stroke patients. Baseline claimant demographics, clinical setting, primary allegation category, and outcomes were abstracted. Among cases with a primary diagnosis-related allegation, we detail presenting symptoms and diagnostic breakdowns using CRICO’s proprietary taxonomy.ResultsA total of 478 claims met inclusion criteria; 235 (49.2%) with diagnostic error. Diagnostic errors originated in the emergency department (ED) in 46.4% (n = 109) of cases, outpatient clinic in 27.7% (n = 65), and inpatient setting in 25.1% (n = 59). Across care-settings, the most frequent process breakdown was in the initial patient-provider encounter [76.2% (n = 179 cases)]. Failure to assess, communicate, and respond to ongoing symptoms was the component of the patient-provider encounter most frequently identified as a source of misdiagnosis in the ED. Exclusively non-traditional presenting symptoms occurred in 35.7% (n = 84), mixed traditional and non-traditional symptoms in 30.6% (n = 72), and exclusively traditional in 23.8% (n = 56) of diagnostic error cases.ConclusionsAmong ischemic stroke patients, breakdowns in the initial patient-provider encounter were the most frequent source of diagnostic error. Targeted interventions should focus on the initial diagnostic encounter, particularly for ischemic stroke patients with atypical symptoms.