Although missed and delayed diagnoses have become an important patient safety concern, they remain largely unstudied, especially in the outpatient setting.
To develop a framework for investigating missed and delayed diagnoses, advance understanding of their causes, and identify opportunities for prevention.
Retrospective review of 307 closed malpractice claims in which patients alleged a missed or delayed diagnosis in the ambulatory setting.
4 malpractice insurance companies.
Diagnostic errors associated with adverse outcomes for patients, process breakdowns, and contributing factors.
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).
Reviewers were not blinded to the litigation outcomes, and the reliability of the error determination was moderate.
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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Author, Article, and Disclosure Information
Tejal K. Gandhi,
From Brigham and Women's Hospital and Harvard School of Public Health, Boston, Massachusetts; University of Texas Health Science Center, Houston, Texas; and the Harvard Risk Management Foundation, Cambridge, Massachusetts.
Note: Drs. Gandhi, Kachalia, and Studdert had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Grant Support: This study was supported by grants from the Agency for Healthcare Research and Quality (HS011886-03) and the Harvard Risk Management Foundation. Dr. Studdert was also supported by the Agency for Healthcare Research and Quality (KO2HS11285).
Disclosures:Employment: T.A. Brennan (Aetna); Stock ownership or options (other than mutual funds): T.A. Brennan (Aetna); Expert testimony: T.A. Brennan.
Corresponding Author: David M. Studdert, LLB, ScD, Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115; e-mail, studdert@hsph.
Current Author Addresses: Drs. Gandhi and Kachalia and Ms. Yoon: Division of General Internal Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02114.
Dr. Thomas: University of Texas Medical School at Houston, 6431 Fannin, MSB 1.122, Houston, TX 77030.
Ms. Puopolo: CRICO/RMF, 101 Main Street, Cambridge, MA 02142.
Dr. Brennan: 151 Farmington Avenue, RC5A, Hartford, CT 06156.
Dr. Studdert: Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115.
Author Contributions: Conception and design: T.K. Gandhi, E.J. Thomas, T.A. Brennan, D.M. Studdert.
Analysis and interpretation of the data: T.K. Gandhi, A. Kachalia, C. Yoon, D.M. Studdert.
Drafting of the article: T.K. Gandhi, A. Kachalia, T.A. Brennan D.M. Studdert.
Critical revision of the article for important intellectual content: T.K. Gandhi, A. Kachalia, E.J. Thomas, T.A. Brennan D.M. Studdert.
Final approval of the article: T.K. Gandhi, A. Kachalia, E.J. Thomas, D.M. Studdert.
Provision of study materials or patients: A.L. Puopolo.
Statistical expertise: D.M. Studdert.
Obtaining of funding: D.M. Studdert.
Administrative, technical, or logistic support: A. Kachalia, A.L. Puopolo, D.M. Studdert.
Collection and assembly of data: A. Kachalia, A.L. Puopolo, D.M. Studdert.