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Missed and Delayed Diagnoses in the Ambulatory Setting: A Study of Closed Malpractice Claims
Abstract
BACKGROUND: Although missed and delayed diagnoses have become an important patient safety concern, they remain largely unstudied, especially in the outpatient setting. OBJECTIVE: To develop a framework for investigating missed and delayed diagnoses, advance understanding of their causes, and identify opportunities for prevention. DESIGN: Retrospective review of 307 closed malpractice claims in which patients alleged a missed or delayed diagnosis in the ambulatory setting. SETTING: 4 malpractice insurance companies. MEASUREMENTS: Diagnostic errors associated with adverse outcomes for patients, process breakdowns, and contributing factors. RESULTS: A total of 181 claims (59%) involved diagnostic errors that harmed patients. Fifty-nine percent (106 of 181) of these errors were associated with serious harm, and 30% (55 of 181) resulted in death. For 59% (106 of 181) of the errors, cancer was the diagnosis involved, chiefly breast (44 claims [24%]) and colorectal (13 claims [7%]) cancer. The most common breakdowns in the diagnostic process were failure to order an appropriate diagnostic test (100 of 181 [55%]), failure to create a proper follow-up plan (81 of 181 [45%]), failure to obtain an adequate history or perform an adequate physical examination (76 of 181 [42%]), and incorrect interpretation of diagnostic tests (67 of 181 [37%]). The leading factors that contributed to the errors were failures in judgment (143 of 181 [79%]), vigilance or memory (106 of 181 [59%]), knowledge (86 of 181 [48%]), patient-related factors (84 of 181 [46%]), and handoffs (36 of 181 [20%]). The median number of process breakdowns and contributing factors per error was 3 for both (interquartile range, 2 to 4). LIMITATIONS: Reviewers were not blinded to the litigation outcomes, and the reliability of the error determination was moderate. CONCLUSIONS: Diagnostic errors that harm patients are typically the result of multiple breakdowns and individual and system factors. Awareness of the most common types of breakdowns and factors could help efforts to identify and prioritize strategies to prevent diagnostic errors.
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“missed laboratory results or delayed recognition of results leads to a significant potential for outpatient diagnostic errors, adverse events and liability claims.”
From Notification of Abnormal Lab Test Results in an Electronic Medical Record: Do Any Safety Concerns Remain? (2010) · cites this paper as [13]
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“Although diagnostic errors may occur when signs of a disease are atypical or absent, diagnostic errors are often attributed to cognitive (e.g., faulty clinical reasoning) and/or systems-related factors (e.g., inefficient processes and poor communication7,9–21).”
From Reducing Diagnostic Errors through Effective Communication: Harnessing the Power of Information Technology (2008) · cites this paper as [9]
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Metadata
- Authors
- Gandhi, T. K., Kachalia, A., Thomas, E. J., Puopolo, A. L., Yoon, C., Brennan, T. A., & Studdert, D. M.
- Affiliations
- Brigham and Women's Hospital (US)
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2006-10-03
- Volume
- 145
- Issue
- 7
- Pages
- 488-496
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W2128347581
- Cited by
- 662
- References
- 36
- Citations by year
- 2026: 12 · 2025: 25 · 2024: 21 · 2023: 26 · 2022: 33 · 2021: 34 · 2020: 39 · 2019: 41 · 2018: 39 · 2017: 33 · 2016: 32 · 2015: 55 · 2014: 42 · 2013: 42 · 2012: 40
- FWCI
- 15.82
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- UCLA - Biblioteca de Ciencias de la Salud (submittedVersion)
- Funders
- Agency for Healthcare Research and Quality (HS011886-03, KO2HS11285)
- Topics
- Health Sciences › Medicine › Family Practice › Clinical Reasoning and Diagnostic Skills
- Social Sciences › Law › Medical Malpractice and Liability Issues
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Patient Safety and Medication Errors
- Keywords
- missed diagnosis, delayed diagnosis, diagnostic errors, malpractice claims, outpatient care, patient safety, cancer diagnosis, breast cancer, colorectal cancer, follow-up care, handover, error prevention
- MeSH terms
- Adolescent, Adult, Aged, Ambulatory Care, Child, Child, Preschool, Diagnostic Errors, Female, Humans, Infant, Male, Malpractice, Middle Aged, Quality of Health Care, Retrospective Studies, United States
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