- Overall diagnostic accuracy in the emergency department (ED) is high, but some patients receive an incorrect diagnosis (~5.7%). Some of these patients suffer an adverse event because of the incorrect diagnosis (~2.0%), and some of these adverse events are serious (~0.3%). This translates to about 1 in 18 ED patients receiving an incorrect diagnosis, 1 in 50 suffering an adverse event, and 1 in 350 suffering permanent disability or death. These rates are comparable to those seen in primary care and hospital inpatient care.
- We estimate that among 130 million emergency department (ED) visits per year in the United States that 7.4 million (5.7%) patients are misdiagnosed, 2.6 million (2.0%) suffer an adverse event as a result, and about 370,000 (0.3%) suffer serious harms from diagnostic error. Put in terms of an average ED with 25,000 visits annually and average diagnostic performance, each year this would be over 1,400 diagnostic errors, 500 diagnostic adverse events, and 75 serious harms, including 50 deaths per ED. Although overall error and harm rates are derived from three smaller studies conducted outside the United States (in Canada, Spain, and Switzerland, with combined n=1,758), study methods were prospective and rigorous. All three were conducted at university hospitals, and, for the two studies used to estimate harms, about 92 percent of clinicians under study at those institutions had full training or formal certification in emergency medicine.
- Five conditions (#1 stroke, #2 myocardial infarction, #3 aortic aneurysm/dissection, #4 spinal cord compression/injury, #5 venous thromboembolism) account for 39 percent of serious misdiagnosis-related harms, and the top 15 conditions account for 68 percent. Variation in diagnostic error rates by disease are striking (range 1.5% for myocardial infarction to 56% for spinal abscess, with the other thirteen falling between 10% and 36%). Stroke, the top serious harm-producing disease, is missed an estimated 17% of the time. Among these 15 diseases, myocardial infarction is the only one with false negative rates near zero (1.5%), well below the estimated average rate across all diseases (5.7%).
- For a given disease, nonspecific or atypical symptoms increase the likelihood of error. For stroke, dizziness or vertigo increases the odds of misdiagnosis 14-fold over motor symptoms (those with dizziness and vertigo are missed initially 40% of the time).
- Variation in diagnostic error rates across demographic groups is present and sometimes fairly large in magnitude. The effect of age is heterogeneous and disease-specific (e.g., younger age increases risk of missed stroke 6.7-fold, while older age increases risk of missed appendicitis). Female sex and non-White race were often associated with important (20–30%) increases in misdiagnosis risk; although these disparities were inconsistently demonstrated across studies, being a woman or a racial or ethnic minority was generally not found to be "protective" against misdiagnosis (i.e., was neutral at best).
- Variation in diagnostic error rates across specific hospital EDs is wide. Methods of measuring diagnostic errors in the ED are highly variable. However, even when similar methods are used, measured diagnostic error rates vary up to 100-fold across hospitals. In individual studies, missed cases varied by hospital for subarachnoid hemorrhage (0% to 100%), myocardial infarction (0% to 29%), and appendicitis (1% to 16%). Error rates are usually found to be lower in academic/teaching hospitals, but it is unknown if this is an effect of increased availability/intensive use of diagnostic technologies or other factors.
- Root causes of ED diagnostic errors were mostly cognitive errors linked to the process of bedside diagnosis. Malpractice claims associated with serious misdiagnosis-related harms involved failures of clinical assessment, reasoning, or decision making in about 90 percent of cases. Similar findings were seen in incident report data. These issues are not unique to the ED—they are seen across clinical settings, regardless of study method.
- The strongest, most consistent predictors of ED diagnostic error were individual case factors that increased the cognitive challenge of identifying the underlying disorder, with nonspecific, mild, transient, or "atypical" symptoms being the most frequent.
- Our findings are tempered by limitations in the underlying evidence base, including issues related to data sources, measurement methods, and causal relationships. Nevertheless, overall diagnostic error and misdiagnosis-related harm rates are consistent with what has been found in other clinical settings (e.g., primary care and inpatient).
Objectives. Diagnostic errors are a known patient safety concern across all clinical settings, including the emergency department (ED). We conducted a systematic review to determine the most frequent diseases and clinical presentations associated with diagnostic errors (and resulting harms) in the ED, measure error and harm frequency, as well as assess causal factors.
Methods. We searched PubMed®, Cumulative Index to Nursing and Allied Health Literature (CINAHL®), and Embase® from January 2000 through September 2021. We included research studies and targeted grey literature reporting diagnostic errors or misdiagnosis-related harms in EDs in the United States or other developed countries with ED care deemed comparable by a technical expert panel. We applied standard definitions for diagnostic errors, misdiagnosis-related harms (adverse events), and serious harms (permanent disability or death). Preventability was determined by original study authors or differences in harms across groups. Two reviewers independently screened search results for eligibility; serially extracted data regarding common diseases, error/harm rates, and causes/risk factors; and independently assessed risk of bias of included studies. We synthesized results for each question and extrapolated U.S. estimates. We present 95 percent confidence intervals (CIs) or plausible range (PR) bounds, as appropriate.
Results. We identified 19,127 citations and included 279 studies. The top 15 clinical conditions associated with serious misdiagnosis-related harms (accounting for 68% [95% CI 66 to 71] of serious harms) were (1) stroke, (2) myocardial infarction, (3) aortic aneurysm and dissection, (4) spinal cord compression and injury, (5) venous thromboembolism, (6/7 – tie) meningitis and encephalitis, (6/7 – tie) sepsis, (8) lung cancer, (9) traumatic brain injury and traumatic intracranial hemorrhage, (10) arterial thromboembolism, (11) spinal and intracranial abscess, (12) cardiac arrhythmia, (13) pneumonia, (14) gastrointestinal perforation and rupture, and (15) intestinal obstruction. Average disease-specific error rates ranged from 1.5 percent (myocardial infarction) to 56 percent (spinal abscess), with additional variation by clinical presentation (e.g., missed stroke average 17%, but 4% for weakness and 40% for dizziness/vertigo). There was also wide, superimposed variation by hospital (e.g., missed myocardial infarction 0% to 29% across hospitals within a single study). An estimated 5.7 percent (95% CI 4.4 to 7.1) of all ED visits had at least one diagnostic error. Estimated preventable adverse event rates were as follows: any harm severity (2.0%, 95% CI 1.0 to 3.6), any serious harms (0.3%, PR 0.1 to 0.7), and deaths (0.2%, PR 0.1 to 0.4). While most disease-specific error rates derived from mainly U.S.-based studies, overall error and harm rates were derived from three prospective studies conducted outside the United States (in Canada, Spain, and Switzerland, with combined n=1,758). If overall rates are generalizable to all U.S. ED visits (130 million, 95% CI 116 to 144), this would translate to 7.4 million (PR 5.1 to 10.2) ED diagnostic errors annually; 2.6 million (PR 1.1 to 5.2) diagnostic adverse events with preventable harms; and 371,000 (PR 142,000 to 909,000) serious misdiagnosis-related harms, including more than 100,000 permanent, high-severity disabilities and 250,000 deaths. Although errors were often multifactorial, 89 percent (95% CI 88 to 90) of diagnostic error malpractice claims involved failures of clinical decision-making or judgment, regardless of the underlying disease present. Key process failures were errors in diagnostic assessment, test ordering, and test interpretation. Most often these were attributed to inadequate knowledge, skills, or reasoning, particularly in “atypical” or otherwise subtle case presentations. Limitations included use of malpractice claims and incident reports for distribution of diseases leading to serious harms, reliance on a small number of non-U.S. studies for overall (disease-agnostic) diagnostic error and harm rates, and methodologic variability across studies in measuring disease-specific rates, determining preventability, and assessing causal factors.
Conclusions. Although estimated ED error rates are low (and comparable to those found in other clinical settings), the number of patients potentially impacted is large. Not all diagnostic errors or harms are preventable, but wide variability in diagnostic error rates across diseases, symptoms, and hospitals suggests improvement is possible. With 130 million U.S. ED visits, estimated rates for diagnostic error (5.7%), misdiagnosis-related harms (2.0%), and serious misdiagnosis-related harms (0.3%) could translate to more than 7 million errors, 2.5 million harms, and 350,000 patients suffering potentially preventable permanent disability or death. Over two-thirds of serious harms are attributable to just 15 diseases and linked to cognitive errors, particularly in cases with "atypical" manifestations. Scalable solutions to enhance bedside diagnostic processes are needed, and these should target the most commonly misdiagnosed clinical presentations of key diseases causing serious harms. New studies should confirm overall rates are representative of current U.S.-based ED practice and focus on identified evidence gaps (errors among common diseases with lower-severity harms, pediatric ED errors and harms, dynamic systems factors such as overcrowding, and false positives). Policy changes to consider based on this review include: (1) standardizing measurement and research results reporting to maximize comparability of measures of diagnostic error and misdiagnosis-related harms; (2) creating a National Diagnostic Performance Dashboard to track performance; and (3) using multiple policy levers (e.g., research funding, public accountability, payment reforms) to facilitate the rapid development and deployment of solutions to address this critically important patient safety concern.
Newman-Toker DE, Peterson SM, Badihian S, Hassoon A, Nassery N, Parizadeh D, Wilson LM, Jia Y, Omron R, Tharmarajah S, Guerin L, Bastani PB, Fracica EA, Kotwal S, Robinson KA. Diagnostic Errors in the Emergency Department: A Systematic Review. Comparative Effectiveness Review No. 258. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 75Q80120D00003.) AHRQ Publication No. 22(23)-EHC043. Rockville, MD: Agency for Healthcare Research and Quality; December 2022. DOI: 10.23970/AHRQEPCCER258. Posted final reports are located on the Effective Health Care Program search page.