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.

16 Reads
  • 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
  • Source
    • "As noted by Graber, many methods to study diagnostic errors have limited use in calculating the frequency of the problem. For example, autopsy rates have declined,22 the number of self-reports remains low and malpractice claims data are prone to bias and are non-representative.11 20 23–25 On the other hand, population-based studies have relied on medical record reviews, which are generally a gold standard for determining diagnostic error.26 "
    [Show abstract] [Hide abstract]
    ABSTRACT: The frequency of outpatient diagnostic errors is challenging to determine due to varying error definitions and the need to review data across multiple providers and care settings over time. We estimated the frequency of diagnostic errors in the US adult population by synthesising data from three previous studies of clinic-based populations that used conceptually similar definitions of diagnostic error. Data sources included two previous studies that used electronic triggers, or algorithms, to detect unusual patterns of return visits after an initial primary care visit or lack of follow-up of abnormal clinical findings related to colorectal cancer, both suggestive of diagnostic errors. A third study examined consecutive cases of lung cancer. In all three studies, diagnostic errors were confirmed through chart review and defined as missed opportunities to make a timely or correct diagnosis based on available evidence. We extrapolated the frequency of diagnostic error obtained from our studies to the US adult population, using the primary care study to estimate rates of diagnostic error for acute conditions (and exacerbations of existing conditions) and the two cancer studies to conservatively estimate rates of missed diagnosis of colorectal and lung cancer (as proxies for other serious chronic conditions). Combining estimates from the three studies yielded a rate of outpatient diagnostic errors of 5.08%, or approximately 12 million US adults every year. Based upon previous work, we estimate that about half of these errors could potentially be harmful. Our population-based estimate suggests that diagnostic errors affect at least 1 in 20 US adults. This foundational evidence should encourage policymakers, healthcare organisations and researchers to start measuring and reducing diagnostic errors.
    BMJ quality & safety 04/2014; 23(9). DOI:10.1136/bmjqs-2013-002627 · 3.99 Impact Factor
  • Source
    • "Recent research shows that diagnostic errors can often lead to severe consequences and preventable morbidity and mortality.2 6 7 Despite an urgency to study and reduce diagnostic errors, for various reasons discussed in other articles in the supplement, they have remained an underemphasised and understudied area of patient safety research.8 9 "
    [Show abstract] [Hide abstract]
    ABSTRACT: Diagnostic errors remain an underemphasised and understudied area of patient safety research. We briefly summarise the methods that have been used to conduct research on epidemiology, contributing factors and interventions related to diagnostic error and outline directions for future research. Research methods that have studied epidemiology of diagnostic error provide some estimate on diagnostic error rates. However, there appears to be a large variability in the reported rates due to the heterogeneity of definitions and study methods used. Thus, future methods should focus on obtaining more precise estimates in different settings of care. This would lay the foundation for measuring error rates over time to evaluate improvements. Research methods have studied contributing factors for diagnostic error in both naturalistic and experimental settings. Both approaches have revealed important and complementary information. Newer conceptual models from outside healthcare are needed to advance the depth and rigour of analysis of systems and cognitive insights of causes of error. While the literature has suggested many potentially fruitful interventions for reducing diagnostic errors, most have not been systematically evaluated and/or widely implemented in practice. Research is needed to study promising intervention areas such as enhanced patient involvement in diagnosis, improving diagnosis through the use of electronic tools and identification and reduction of specific diagnostic process 'pitfalls' (eg, failure to conduct appropriate diagnostic evaluation of a breast lump after a 'normal' mammogram). The last decade of research on diagnostic error has made promising steps and laid a foundation for more rigorous methods to advance the field.
    BMJ quality & safety 08/2013; 22(Suppl 2). DOI:10.1136/bmjqs-2012-001624 · 3.99 Impact Factor
Show more


16 Reads
Available from