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3 Overview of Diagnostic Error in Health Care
Pages 81-144

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From page 81...
... Because diagnostic errors have been a very challenging area for measurement, the current focus of measurement efforts has been on understanding the incidence and nature of diagnostic error and determining the causes and risks of diagnostic error. The committee highlighted the way in which various measurement approaches could be applied to develop a more robust understanding of the epidemiology of diagnostic error and the reasons that these errors occur.
From page 82...
... . For instance, Graber and colleagues used a classification of error from the Australian Patient Safety Foundation to define diagnostic error as a "diagnosis that was unintentionally delayed (sufficient information was available earlier)
From page 83...
... will result in patient harm. Relating this model to Donabedian's structureprocess-outcome framework, Schiff and colleagues consider diagnosis to be an intermediate outcome of the diagnostic process, and any resulting adverse patient harm would be considered true patient outcomes (Schiff and Leape, 2012; Schiff et al., 2005, 2009)
From page 84...
... Newman-Toker also identifies unavoidable misdiagnosis, which is a diagnostic labeling failure that may occur in the absence of a diagnostic process failure and corresponds to the no-fault category described earlier. Furthermore, his model illustrates that harm may -- or may not -- result from diagnostic process failures and diagnostic labeling failures.
From page 85...
... , misdiagnosis-related harm n (Newman-Toker and ­ ronovost, 2009) , and preventable diagnostic errors P (Newman-Toker, 2014b)
From page 86...
... A fundamental conclusion from the committee's deliberations was that communication is a key responsibility in the diagnostic process. From a patient's perspective, an accurate and timely explanation of the health problem is meaningless unless this information reaches the patient so that a patient and health care professionals can act on the explanation.
From page 87...
... However, identifying failures in the diagnostic process is also critically important, which is reflected in the committee's dual focus on improving the diagnostic process and reducing diagnostic errors. The committee's discussion of measurement includes an emphasis on understanding where failures in the diagnostic
From page 88...
... Some failures in the diagnostic process will lead to diagnostic errors; however, other failures in the diagnostic process will not ultimately lead to a diagnostic error. In this report, the committee describes "failures in the diagnostic process that do not lead to diagnostic errors" as near misses.1 In other words, a near miss is a diagnosis that was almost erroneous.
From page 89...
... FIGURE 3-1  Outcomes from the diagnostic process. 89 Figures S-3 and 3-1
From page 90...
... Correct diagnoses, diagnostic errors, and near misses can be used as opportunities to learn how to improve the work system and the diagnostic process (Klein, 2011, 2014)
From page 91...
... . Because current diagnostic testing technologies often cannot distinguish the cancers that are likely to progress and lead to patient harm from those that will not, inevitably
From page 92...
... The committee makes a number of recommendations throughout the report that are targeted at preventing overutilization in the diagnostic process, including improved collaboration and communication among treating clinicians and pathologists, radiologists, and other diagnostic testing health care professionals, as well as increased emphasis on diagnostic testing in health care professional education (see Chapters 4 and 6)
From page 93...
... . The use of diagnostic testing to rule out conditions, clinicians' intolerance of uncertainty, an enthusiasm for the early detection of disease in the absence of symptoms, and concerns over medical liability can all contribute to overutilization (Grimes and Schulz, 2002; Newman-Toker et al., 2013; Plebani, 2014)
From page 94...
... . The Purposes of Measurement There are a variety of ways that measurement can be used in the context of the diagnostic process and in assessing the occurrence of diagnostic errors.
From page 95...
... T ­ oday this task is primarily the province of research and is likely to remain that way for the foreseeable future. Researchers have used a variety of methods to assess diagnostic errors.
From page 96...
... . Before reviewing each of these approaches, the committee sought to identify or construct a summary, population-based estimate of the frequency with which diagnostic errors occur.
From page 97...
... Although there are data available to examine diagnostic errors in some of these settings, there are wide gaps and much variability in the amount and quality of information available. In addition, a number of problems arise when aggregating data across the various research methods (such as postmortem examinations, medical record reviews, and malpractice claims)
From page 98...
... Alternatively, medical record charting practices could be improved to emphasize communication because of its importance in improving diagnosis and subsequent care. Measuring each arm of the definition is also consistent with the committee's approach to identifying failures in the diagnostic process; the committee specifies that each step in the diagnostic process can be evaluated for its susceptibility to failures (see section on determining the causes and risks of diagnostic error)
From page 99...
... Universe of claims Diagnostic Source data available Random sample Expert assessment testing for review Prespecified criteria compared to original Applies only to diagnoses for which diagnostic testing data are a key factor Focus on interpretation Medical Source data available Random sample Expert assessment imaging for review Prespecified criteria compared to original Applies only to diagnoses for which medical imaging data are a key factor Focus on interpretation Surveys of Subject to nonresponse Sample receiving Descriptive statistics clinicians bias survey on self-report May be difficult to validate Surveys of Subject to nonresponse Sample receiving Descriptive statistics patients bias survey on self-report May be difficult to validate
From page 100...
... While this chapter focuses on full-body postmortem exams, Chapter 6 describes the potential future state of postmortem examinations, which may include more minimally invasive approaches, such as medical imaging, laparoscopy, biopsy, histology, and cytology. Notes about the data source  Postmortem exams are considered a very strong method for identifying diagnostic errors because of the extensiveness of the examination that is possible (Graber, 2013; Shojania, 2002)
From page 101...
... . On average, 10 percent of postmortem exams were associated with diagnostic errors that might have affected patient outcomes (i.e., Class I errors)
From page 102...
... The committee concluded that it would be more efficient to have a limited number of systems who are highly qualified in conducting postmortem exams participate to produce research-quality information about the incidence and nature of diagnostic errors among a representative sample of patient deaths. This approach reflects both financial realities and workforce challenges (i.e., a limited number of pathologists being available and willing to conduct a large number of such exams)
From page 103...
... Estimates of the incidence of diagnostic errors based on medical records need to account for the probability that an individual is included in the study sample and the likelihood that a visit (or set of visits) requires that a diagnosis be made.
From page 104...
... . What is known  Two studies based on medical record reviews reported in the literature in the 1990s and early 2000s estimated that diagnostic errors account for 7 and 17 percent of adverse events in hospitalized patients, respectively.
From page 105...
... Medical Malpractice Claims Description of the data source  Medical malpractice claims are defined as the electronic and paper databases maintained by professional liability insurers on claims that have been filed by patients or their families seeking compensation for alleged medical errors, including diagnostic errors;
From page 106...
... The probability that a claim would be paid was 91 percent for negligent injury claims and 21 percent for nonnegligent injury claims. Thus, malpractice claims data provide a small window into the problem of diagnostic errors and are biased toward more serious diagnostic errors.
From page 107...
... (2013) analyzed 25 years of closed medical malpractice claims from the National Practitioner Data Bank in order to characterize the frequency, patient outcomes, and economic consequences of diagnostic errors.
From page 108...
... This will require significant research activity, and such research would have to explore variations by geography, specialty, type of error, and other factors. Databases from malpractice insurers contain much more clinical detail than the NPDB and are likely to be more useful in describing patterns of diagnostic errors, such as the steps in the diagnostic process that present the highest risk for different diagnoses.
From page 109...
... . Health insurance claims data may be linked to other data sources (e.g., National Death Index, diagnostic testing results, medical records)
From page 110...
... Opportunities for improvement Health insurance claims databases maintained by the Centers for Medicare & Medicaid Services (CMS) and by commercial insurers offer the possibility of measuring certain types of diagnostic errors, identifying their downstream clinical consequences and costs, and understanding the system-level, health care professional–level, and patient-level factors that are associated with these errors.
From page 111...
...   Because testing involves multiple steps, there are many different methods for identifying errors, including an examination of other data sources such as medical records, malpractice claims, or pharmacy databases (Callen et al., 2011)
From page 112...
... A review published in 2002 (that only classified the diagnostic testing process in three phases) found that 32 to 75 percent of errors occurred in the pre-analytic phase, 13 to 32 percent in the analytic phase, and 9 to 31 percent in the post-analytic phase (Bonini et al., 2002)
From page 113...
... In this context, the medical imaging data are reviewed by at least one other clinician, and the findings of all health care professionals are recorded. Notes about the data source  As with anatomic pathology, a unique feature of this data type is the availability of the original images for review by a second radiologist.
From page 114...
... Surveys of Clinicians Description of the data source  The data come from questionnaires (written, telephone, interview, Web-based) that obtain clinicians' self-reports about diagnostic errors they have made or what they know about diagnostic errors made by other clinicians.
From page 115...
... 70) surveyed pediatricians about diagnostic errors and found that "more than half of respondents reported that they made a diagnostic error at least once or twice per month." In another survey of physicians, 35 percent reported that they had experienced medical errors either in their own or a family member's care (Blendon et al., 2002)
From page 116...
... . More recently, 23 percent of people surveyed in Massachusetts indicated that they or someone close to them had experienced a medical error, and approximately half of these errors were diagnostic errors (Betsy Lehman Center for Patient Safety and Medical Error Reduction, 2014)
From page 117...
... Patient actors are asked to portray typical presentations of disease, and clinicians are assessed on their diagnostic performance. In one study in internal medicine, physicians made diagnostic errors in 13 percent of interactions with patient actors portraying four common conditions (Peabody et al., 2004)
From page 118...
... . This likely applies to the measurement of diagnostic errors; with the complexity of the diagnostic process, multiple approaches will be necessary to provide a more ­ horough t understanding of the occurrence of these errors.
From page 119...
... The committee used its conceptual model and input from other frameworks to provide a context for the measurement of the causes and the risks of diag­ ostic error. Measurement can focus on diagnostic process steps, the n work system components, or both in order to identify causes and risks of diagnostic error.
From page 120...
... 120 FIGURE 3-2  Places in the diagnostic process where failures can occur that contribute to diagnostic errors. Figure 3-2 raster image, not editable
From page 121...
... (e.g., signs and symptoms that Postmortem examinations have not been recognized as a specific disease) Failure to • P  atient not notified Video recording and debriefing communicate the • D  elay in notification Survey patients explanation to • I  ncomplete explanation Medical record review the patient • P  atient does not understand Shared decision making result explanation a Adapted from Schiff et al., 2009.
From page 122...
... reported that an erroneous laboratory or radiology reading of a test contributed to 11 percent of the diagnostic errors that they examined. Studies have shown that an incorrect interpretation of diagnostic tests occurs in internal medicine (38 percent reported in Gandhi et al., 2006)
From page 123...
... Potential measurement methods for this step include video recording and debriefing, patient surveys, medical record reviews, and shared decision-making results. Other researchers have employed different classification schemes to illustrate where in the diagnostic process failures occur.
From page 124...
... Targeted measurement has shown that the phases of the process that are most prone to errors occur outside of the analytical phase and include test ordering (part of the diagnostic process information-gathering step) and subsequent decision making on the basis of the test results (part of the interpretation step)
From page 125...
... Factors contributing to diagnostic errors can be mapped along the components of the work system, including diagnostic team members and their tasks, technologies and tools, organizational characteristics, the physical environment, and the external environment. Some of the more familiar approaches for assessing the system causes of medical errors are M&M conferences that apply a modern patient safety framework (a focus on understanding contributing factors rather than a focus on individual errors and blame)
From page 126...
... The focus here is on the specific measurement tools that are available to help health care organizations better identify aspects of the work system that present vulnerabilities for diagnostic errors. A distinctive feature of some of these methods is TABLE 3-3  Methods for Assessing the Effect of the Work System on Diagnostic Errors Contribution to Diagnostic Examples of Methods for Work System Dimension Errors Assessing Effects Tasks and workflow •  roblems with P Information gathering Cognitive task and work information Information integration analysis methods (e.g., o Amount Information interpretation decision ladder model)
From page 127...
... Tasks and workflow The diagnostic process involves a series of tasks and an implicit or explicit workflow that contains and connects those tasks. A variety of challenges can occur with the tasks and workflow that are required to make a diagnosis, including problems with the information (amount, accuracy, completeness, appropriateness)
From page 128...
... . Because cognitive errors are an important contributing factor to diagnostic errors (Croskerry, 2003)
From page 129...
... These methods have great potential for helping to understand the dynamic sequences of tasks performed by various team members in the diagnostic process.
From page 130...
... National Center for Patient Safety and provide concrete examples of its application. Technology  A variety of technologies are used in the diagnostic process, and these can contribute to diagnostic errors for a variety of reasons, including inappropriate technology selection, poor design, poor implementation, use error, technology breakdown or failure, and misuse of automation.
From page 131...
... Some of the culture-related issues that can contribute to diagnostic error are a lack of organizational support for improvements, conflicting messages about regulations, confusion about task responsibilities, and the perception by people that they should not speak up even when they know a problem is occurring. These issues have been identified in the broader context of patient safety but are likely to affect diagnostic processes as well.
From page 132...
... For both purposes it would be helpful to develop assessment tools that can be implemented within routine clinical practice to rapidly identify potential failures in the diagnostic process, to alert clinicians and health care organizations to diagnostic errors, and to ascertain trend changes over time. For quality improvement approaches, establishing a baseline (knowing the current rate of failure in a particular step in the diagnostic process using some of the measurement methods in Table 3-2)
From page 133...
... The researchers identified 14 randomized trials (rated as having mostly a low to moderate risk of bias) , 11 of which reported interventions that reduced diagnostic errors.
From page 134...
... or cognitive problems (e.g., debriefing to determine what biases are at play and at what frequency) will continue to provide useful information for under­ tanding the influence of an intervention at its point of expected s action (as part of the diagnostic process or other component of the work system, or at the sharp or blunt end of care)
From page 135...
... . Such a resource could build on the domains and measures shown in Tables 3-2 and 3-3, as well as other sources from quality improvement and patient safety research applicable to diagnostic error.
From page 136...
... :S2–S23. Betsy Lehman Center for Patient Safety and Medical Error Reduction.
From page 137...
... 2015. Diagnostic errors in a PICU: Insights from the Morbidity and Mortality Conference.
From page 138...
... Newsletter of the National Patient Safety Foundation 1(1)
From page 139...
... 2014. Diagnostic errors -- Patient safety.
From page 140...
... 2013. Patient safety strategies targeted at diagnostic errors: A systematic review.
From page 141...
... 2009. Diagnostic errors: The next frontier for patient safety.
From page 142...
... 2012a. Electronic health record-based surveillance of diagnostic errors in primary care.
From page 143...
... 2014. Diagnostic errors: Central to patient safety, yet still in the periphery of safety's radar screen.
From page 144...
... 2012. Relating faults in diagnostic reasoning with diagnostic errors and patient harm.


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