Missed and delayed diagnoses in the ambulatory setting: a study of closed malpractice claims. Ann Intern Med

Brigham and Women's Hospital and Harvard School of Public Health, Boston, Massachusetts 02115, USA.
Annals of internal medicine (Impact Factor: 17.81). 11/2006; 145(7):488-96.
Source: PubMed


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.

Full-text preview

Available from:
    • "In a large retrospective study of diagnostic adverse events in Dutch hospitals, cognitive factors were found to have played a significant part in 96% of the events and system failures in only 25% (Zwaan et al., 2010). A U.S. study of closed malpractice claims (patients alleging missed or delayed diagnosis) in the ambulatory setting estimated that cognitive factors (e.g., judgment errors, vigilance and memory lapses, lack of knowledge) were implicated in virtually all diagnostic errors, either alone (in 55% of errors) or in association with patient-and/or systemrelated factors (Gandhi et al., 2006). The most frequent breakdowns in the diagnostic process were failure to order appropriate diagnostic tests (55%), failure to follow up appropriately (45%), inadequate history taking and physical examination (42%), and incorrect interpretation of diagnostic tests (37%), mostly imaging. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Despite its 40-year history, computerized diagnostic support is not used in routine clinical practice. As part of a European project to develop computerized diagnostic support for family physicians, we identified user decision requirements and made design recommendations. To this end, we employed multiple data types and sources. All data were elicited from UK family physicians and pertained to consultations with patients, either real or simulated. To elicit user requirements, we conducted in situ observations and interviews with 8 physicians, and performed a hierarchical task analysis of the diagnostic task. We also analysed 34 think-aloud transcripts of 17 family physicians diagnosing detailed patient scenarios on a computer, and 24 interview transcripts of 18 family physicians describing past cases of intuitive diagnoses from their experience. All transcripts were coded using the Situation Assessment Record (SAR) method. We report our methods and results using the Decision-Centered Design framework. Studies employing multiple human factors techniques and data types in order to elicit user requirements are rare. Our approach enabled us to propose interface design recommendations that go beyond existing “differential diagnosis generators”, aiming to improve physicians’ performance and acceptance of the resulting tool.
    Journal of Cognitive Engineering and Decision Making 08/2015; DOI:10.1177/1555343415608973
  • Source
    • "Discontinuity in patient care is associated with increased in-hospital complications (Laine et al. 1993), diagnostic test delays (Laine et al. 1993), preventable adverse events (Petersen et al. 1994), and likely increased cost due to unnecessary tests being ordered by residents not familiar with the patient (Lofgren et al. 1990). There is also evidence of negative consequences due to poor communication and information loss associated with inadequate handoffs (Sutcliffe et al. 2004; Greenberg et al. 2007; Gandhi et al. 2006; Kachalia et al. 2007). "
    [Show abstract] [Hide abstract]
    ABSTRACT: Continuity is critical for safe patient care and its absence is associated with adverse outcomes. Continuity requires handoffs between physicians, but most published studies of educational interventions to improve handoffs have focused primarily on residents, despite interns expected to being proficient. The AAMC core entrustable activities for graduating medical students includes handoffs as a milestone, but no controlled studies with students have assessed the impact of training in handoff skills. The purpose of this study was to assess the impact of an educational intervention to improve third-year medical student handoff skills, the durability of learned skills into the fourth year, and the transfer of skills from the simulated setting to the clinical environment. Trained evaluators used standardized patient cases and an observation tool to assess verbal handoff skills immediately post intervention and during the student's fourth-year acting internship. Students were also observed doing real time sign-outs during their acting internship. Evaluators assessed untrained control students using a standardized case and performing a real-time sign-out. Intervention students mean score demonstrated improvement in handoff skills immediately after the workshop (2.6-3.8; p < 0.0001) that persisted into their fourth year acting internship when compared to baseline performance (3.9-3.5; p = 0.06) and to untrained control students (3.5 vs. 2.5; p < 0.001, d = 1.2). Intervention students evaluated in the clinical setting also scored higher than control students when assessed doing real-time handoffs (3.8 vs. 3.3; p = 0.032, d = 0.71). These findings should be useful to others considering introducing handoff teaching in the undergraduate medical curriculum in preparation for post-graduate medical training. Trial Registration Number NCT02217241.
    Advances in Health Sciences Education 07/2015; DOI:10.1007/s10459-015-9621-1 · 2.12 Impact Factor
  • Source
    • "Delays in primary care can contribute to later cancer diagnosis (Neal, 2009) with potential effects on prognosis, intensity of treatment and negative impacts on the quality of life (Singh et al, 2007). Delayed cancer diagnosis is one of the most common, harmful and costly types of diagnostic error in ambulatory care settings (Gandhi et al, 2006; Singh et al, 2009, 2010). A recent systematic review of patient safety strategies targeted at reducing diagnostic errors by primary care clinicians found the strongest evidence for technology-based interventions such as computer-assisted diagnostic aids, decision support algorithms, text messages and pager alerts and adaptations to testing equipment (McDonald et al, 2013). "
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: Reducing diagnostic delays in primary care by improving the assessment of symptoms associated with cancer could have significant impacts on cancer outcomes. Symptom risk assessment tools could improve the diagnostic assessment of patients with symptoms suggestive of cancer in primary care. We aimed to explore the use of a cancer risk tool, which implements the QCancer model, in consultations and its potential impact on clinical decision making. Methods: We implemented an exploratory 'action design' method with 15 general practitioners (GPs) from Victoria, Australia. General practitioners applied the risk tool in simulated consultations, conducted semi-structured interviews based on the normalisation process theory and explored issues relating to implementation of the tool. Results: The risk tool was perceived as being potentially useful for patients with complex histories. More experienced GPs were distrustful of the risk output, especially when it conflicted with their clinical judgement. Variable interpretation of symptoms meant that there was significant variation in risk assessment. When a risk output was high, GPs were confronted with numerical risk outputs creating challenges in consultation. Conclusions: Significant barriers to implementing electronic cancer risk assessment tools in consultation could limit their uptake. These relate not only to the design and integration of the tool but also to variation in interpretation of clinical histories, and therefore variable risk outputs and strong beliefs in personal clinical intuition.
    British Journal of Cancer 03/2015; 112. DOI:10.1038/bjc.2015.46 · 4.84 Impact Factor
Show more