Articles3 October 2006
    Author, Article, and Disclosure Information

    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.

    References

    • 1. Haas JSCook EFPuopolo ALBurstin HRBrennan TADifferences in the quality of care for women with an abnormal mammogram or breast complaint. J Gen Intern Med2000;15:321-8. [PMID: 10840267] CrossrefMedlineGoogle Scholar
    • 2. Marcus ACCrane LAKaplan CPReading AESavage EGunning Jet alImproving adherence to screening follow-up among women with abnormal Pap smears: results from a large clinic-based trial of three intervention strategies. Med Care1992;30:216-30. [PMID: 1538610] CrossrefMedlineGoogle Scholar
    • 3. Poon EGGandhi TKSequist TDMurff HJKarson ASBates DW“I wish I had seen this test result earlier!”: dissatisfaction with test result management systems in primary care. Arch Intern Med2004;164:2223-8. [PMID: 15534158] CrossrefMedlineGoogle Scholar
    • 4. Margo CEA pilot study in ophthalmology of inter-rater reliability in classifying diagnostic errors: an underinvestigated area of medical error. Qual Saf Health Care2003;12:416-20. [PMID: 14645756] CrossrefMedlineGoogle Scholar
    • 5. Bates DWCullen DJLaird NPetersen LASmall SDServi Det alIncidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA1995;274:29-34. [PMID: 7791255] CrossrefMedlineGoogle Scholar
    • 6. Leape LLBates DWCullen DJCooper JDemonaco HJGallivan Tet alSystems analysis of adverse drug events. ADE Prevention Study Group. JAMA1995;274:35-43. [PMID: 7791256] CrossrefMedlineGoogle Scholar
    • 7. Chandra ANundy SSeabury SAThe growth of physician medical malpractice payments: evidence from the national practitioner data bank. Health Aff (Millwood)2005;:W5240-9. [PMID: 15928255] CrossrefMedlineGoogle Scholar
    • 8. Phillips RLBartholomew LADovey SMFryer GEMiyoshi TJGreen LALearning from malpractice claims about negligent, adverse events in primary care in the United States. Qual Saf Health Care2004;13:121-6. [PMID: 15069219] CrossrefMedlineGoogle Scholar
    • 9. Kern KAMedicolegal analysis of bile duct injury during open cholecystectomy and abdominal surgery. Am J Surg1994;168:217-22. [PMID: 8080055] CrossrefMedlineGoogle Scholar
    • 10. Kern KAMalpractice litigation involving laparoscopic cholecystectomy. Cost, cause, and consequences. Arch Surg1997;132:392-8. [PMID: 9108760] CrossrefMedlineGoogle Scholar
    • 11. Kravitz RLRolph JEMcGuigan KMalpractice claims data as a quality improvement tool. I. Epidemiology of error in four specialties. JAMA1991;266:2087-92. [PMID: 1920696] CrossrefMedlineGoogle Scholar
    • 12. Weiler PCHiatt HHNewhouse JPJohnson WGBrennan TLeape LLA Measure of Malpractice: Medical Injury, Malpractice Litigation, and Patient Compensation. Cambridge, MA: Harvard Univ Pr; 1993. Google Scholar
    • 13. Studdert DMBrennan TAThomas EJBeyond dead reckoning: measures of medical injury burden, malpractice litigation, and alternative compensation models from Utah and Colorado. Indiana Law Rev2000;33:1643-86. Google Scholar
    • 14. Sowka MedsNational Association of Insurance Commissioners. Malpractice Claims: Final Compilation. Brookfield, WI: National Association of Insurance Commissioners; 1980. Google Scholar
    • 15. Thomas EJStuddert DMBurstin HROrav EJZeena TWilliams EJet alIncidence and types of adverse events and negligent care in Utah and Colorado. Med Care2000;38:261-71. [PMID: 10718351] CrossrefMedlineGoogle Scholar
    • 16. Kohn LTCorrigan JMDonaldson MSTo Err Is Human. Building a Safer Health System. Institute of Medicine. Washington, DC: National Academy Pr; 1999. Google Scholar
    • 17. Brennan TALeape LLLaird NMHebert LLocalio ARLawthers AGet alIncidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med1991;324:370-6. [PMID: 1987460] CrossrefMedlineGoogle Scholar
    • 18. Landis JRKoch GGThe measurement of observer agreement for categorical data. Biometrics1977;33:159-74. [PMID: 843571] CrossrefMedlineGoogle Scholar
    • 19. Reason JManaging the Risks of Organizational Accidents. Brookfield, VT: Ashgate; 1997. Google Scholar
    • 20. Harvard Risk Management Foundation. Breast care management algorithm: improving breast patient safety. Accessed at www.rmf.harvard.edu/files/flash/breast-care-algorithm/index.htm on 9 August 2006. Google Scholar
    • 21. Croskerry PThe importance of cognitive errors in diagnosis and strategies to minimize them. Acad Med2003;78:775-80. [PMID: 12915363] CrossrefMedlineGoogle Scholar
    • 22. Graber MGordon RFranklin NReducing diagnostic errors in medicine: what's the goal? Acad Med2002;77:981-92. [PMID: 12377672] CrossrefMedlineGoogle Scholar
    • 23. Elstein ASSchwarz AClinical problem solving and diagnostic decision making: selective review of the cognitive literature. BMJ2002;324:729-32. [PMID: 11909793] CrossrefMedlineGoogle Scholar
    • 24. Schoen COsborn RHuynh PTDoty MDavis KZapert Ket alPrimary care and health system performance: adults' experiences in five countries. Health Aff (Millwood)2004; suppl W4-487-503. [PMID: 15513956] MedlineGoogle Scholar
    • 25. Kawamoto KHoulihan CABalas EALobach DFImproving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ2005;330:765. [PMID: 15767266] CrossrefMedlineGoogle Scholar
    • 26. Friedman CPGatti GGFranz TMMurphy GCWolf FMHeckerling PSet alDo physicians know when their diagnoses are correct? Implications for decision support and error reduction. J Gen Intern Med2005;20:334-9. [PMID: 15857490] CrossrefMedlineGoogle Scholar
    • 27. Joint Commission on Accreditation of Healthcare Organizations. National Patient Safety Goals. Accessed at www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/07_amb_obs_npsgs.htm on 9 August 2006. Google Scholar
    • 28. Gandhi TKFumbled handoffs: one dropped ball after another. Ann Intern Med2005;142:352-8. [PMID: 15738454] LinkGoogle Scholar
    • 29. Guthrie CRachlinski JJWistrich AJInside the judicial mind. Cornell Law Rev2001;86:777-830. Google Scholar
    • 30. LaBine SJLaBine GDeterminations of negligence and the hindsight bias. Law Hum Behav1996;20:501-16. CrossrefGoogle Scholar
    • 31. Studdert DMMello MMGawande AAGandhi TKKachalia AYoon Cet alClaims, errors, and compensation payments in medical malpractice litigation. N Engl J Med2006;354:2024-33. [PMID: 16687715] CrossrefMedlineGoogle Scholar
    • 32. Burstin HRJohnson WGLipsitz SRBrennan TADo the poor sue more? A case–control study of malpractice claims and socioeconomic status. JAMA1993;270:1697-701. [PMID: 8411499] CrossrefMedlineGoogle Scholar
    • 33. Studdert DMThomas EJBurstin HRZbar BIOrav EJBrennan TANegligent care and malpractice claiming behavior in Utah and Colorado. Med Care2000;38:250-60. [PMID: 10718350] CrossrefMedlineGoogle Scholar
    • 34. Brennan TAGawande AThomas EStuddert DAccidental deaths, saved lives, and improved quality. N Engl J Med2005;353:1405-9. [PMID: 16192489] CrossrefMedlineGoogle Scholar