Abstract
Diagnostic errors in hospitalized patients are a leading cause of preventable morbidity and mortality. Significant challenges in defining and measuring diagnostic errors and underlying process failure points have led to considerable variability in reported rates of diagnostic errors and adverse outcomes. In this article, we explore the diagnostic process and its discrete components, emphasizing the centrality of the patient in decision-making as well as the continuous nature of the process. We review the incidence of diagnostic errors in hospitalized patients and different methodological approaches that have been used to arrive at these estimates. We discuss different but interdependent provider- and system-related process-failure points that lead to diagnostic errors. We examine specific challenges related to measurement of diagnostic errors and describe traditional and novel approaches that are being used to obtain the most precise estimates. Finally, we examine various patient-, provider-, and organizational-level interventions that have been proposed to improve diagnostic safety in hospitalized patients.
Keywords: diagnostic error, hospital medicine, patient safety.
Diagnosis is defined as a “pre-existing set of categories agreed upon by the medical profession to designate a specific condition.”1 The diagnostic process involves obtaining a clinical history, performing a physical examination, conducting diagnostic testing, and consulting with other clinical providers to gather data that are relevant to understanding the underlying disease processes. This exercise involves generating hypotheses and updating prior probabilities as more information and evidence become available. Throughout this process of information gathering, integration, and interpretation, there is an ongoing assessment of whether sufficient and necessary knowledge has been obtained to make an accurate diagnosis and provide appropriate treatment.2
Diagnostic error is defined as a missed opportunity to make a timely diagnosis as part of this iterative process, including the failure of communicating the diagnosis to the patient in a timely manner.3 It can be categorized as a missed, delayed, or incorrect diagnosis based on available evidence at the time. Establishing the correct diagnosis has important implications. A timely and precise diagnosis ensures the patient the highest probability of having a positive health outcome that reflects an appropriate understanding of underlying disease processes and is consistent with their overall goals of care.3 When diagnostic errors occur, they can cause patient harm. Adverse events due to medical errors, including diagnostic errors, are estimated to be the third leading cause of death in the United States.4 Most people will experience at least 1 diagnostic error in their lifetime. In the 2015 National Academy of Medicine report Improving Diagnosis in Healthcare, diagnostic errors were identified as a major hazard as well as an opportunity to improve patient outcomes.2
Diagnostic errors during hospitalizations are especially concerning, as they are more likely to be implicated in a wider spectrum of harm, including permanent disability and death. This has become even more relevant for hospital medicine physicians and other clinical providers as they encounter increasing cognitive and administrative workloads, rising dissatisfaction and burnout, and unique obstacles such as night-time scheduling.5
Incidence of Diagnostic Errors in Hospitalized Patients
Several methodological approaches have been used to estimate the incidence of diagnostic errors in hospitalized patients. These include retrospective reviews of a sample of all hospital admissions, evaluations of selected adverse outcomes including autopsy studies, patient and provider surveys, and malpractice claims. Laboratory testing audits and secondary reviews in other diagnostic subspecialities (eg, radiology, pathology, and microbiology) are also essential to improving diagnostic performance in these specialized fields, which in turn affects overall hospital diagnostic error rates.6-8 These diverse approaches provide unique insights regarding our ability to assess the degree to which potential harms, ranging from temporary impairment to permanent disability, to death, are attributable to different failure points in the diagnostic process.
Large retrospective chart reviews of random hospital admissions remain the most accurate way to determine the overall incidence of diagnostic errors in hospitalized patients.9 The Harvard Medical Practice Study, published in 1991, laid the groundwork for measuring the incidence of adverse events in hospitalized patients and assessing their relation to medical error, negligence, and disability. Reviewing 30,121 randomly selected records from 51 randomly selected acute care hospitals in New York State, the study found that adverse events occurred in 3.7% of hospitalizations, diagnostic errors accounted for 13.8% of these events, and these errors were likely attributable to negligence in 74.7% of cases. The study not only outlined individual-level process failures, but also focused attention on some of the systemic causes, setting the agenda for quality improvement research in hospital-based care for years to come.10-12 A recent systematic review and meta-analysis of 22 hospital admission studies found a pooled rate of 0.7% (95% CI, 0.5%-1.1%) for harmful diagnostic errors.9 It found significant variations in the rates of adverse events, diagnostic errors, and range of diagnoses that were missed. This was primarily because of variabilities in pre-test probabilities in detecting diagnostic errors in these specific cohorts, as well as due to heterogeneity in study definitions and methodologies, especially regarding how they defined and measured “diagnostic error.” The analysis, however, did not account for diagnostic errors that were not related to patient harm (missed opportunities); therefore, it likely significantly underestimated the true incidence of diagnostic errors in these study populations. Table 1 summarizes some of key studies that have examined the incidence of harmful diagnostic errors in hospitalized patients.9-21
The chief limitation of reviewing random hospital admissions is that, since overall rates of diagnostic errors are still relatively low, a large number of case reviews are required to identify a sufficient sample of adverse outcomes to gain a meaningful understanding of the underlying process failure points and develop tools for remediation. Patient and provider surveys or data from malpractice claims can be high-yield starting points for research on process errors.22,23 Reviews of enriched cohorts of adverse outcomes, such as rapid-response events, intensive care unit (ICU) transfers, deaths, and hospital readmissions, can be an efficient way to identify process failures that lead to greatest harm. Depending on the research approach and the types of underlying patient populations sampled, rates of diagnostic errors in these high-risk groups have been estimated to be approximately 5% to 20%, or even higher.6,24-31 For example, a retrospective study of 391 cases of unplanned 7-day readmissions found that 5.6% of cases contained at least 1 diagnostic error during the index admission.32 In a study conducted at 6 Belgian acute-care hospitals, 56% of patients requiring an unplanned transfer to a higher level of care were determined to have had an adverse event, and of these adverse events, 12.4% of cases were associated with errors in diagnosis.29 A systematic review of 16 hospital-based studies estimated that 3.1% of all inpatient deaths were likely preventable, which corresponded to 22,165 deaths annually in the United States.30 Another such review of 31 autopsy studies reported that 28% of autopsied ICU patients had at least 1 misdiagnosis; of these diagnostic errors, 8% were classified as potentially lethal, and 15% were considered major but not lethal.31 Significant drawbacks of such enriched cohort studies, however, are their poor generalizability and inability to detect failure points that do not lead to patient harm (near-miss events).33