For decades, the delivery of health care has proceeded with a blind spot: Diagnostic errors—inaccurate or delayed diagnoses—persist throughout all care settings and harm an unacceptable number of patients. Getting the right diagnosis is a key aspect of health care, as it provides an explanation of a patient’s health problem and informs subsequent health care decisions (Holmboe and Durning, 2014). Diagnostic errors can lead to negative health outcomes, psychological distress, and financial costs. If a diagnostic error occurs, inappropriate or unnecessary treatment may be given to a patient, or appropriate—and potentially lifesaving—treatment may be withheld or delayed. However, efforts to identify and mitigate diagnostic errors have so far been quite limited. Absent a spotlight to illuminate this critical challenge, diagnostic errors have been largely unappreciated within the quality and patient safety movements. The result of this inattention is significant: It is likely that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences.
The topic of diagnosis raises a number of clinical, personal, cultural, ethical, and even political issues that commonly capture public interest. Members of the public are concerned about diagnosis and many have reported experiencing diagnostic errors. For example, a survey by Isabel Healthcare found that 55 percent of adults indicated that their main concern when visiting a family practitioner was being correctly diagnosed (Isabel Healthcare, 2006). A poll commissioned by the National Patient Safety Foundation found that approximately one in six of those surveyed had experience with diagnostic error, either personally or through a close
friend or relative (Golodner, 1997). More recently, 23 percent of people surveyed in Massachusetts stated 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). In the United Kingdom, the country’s National Health Service concluded that diagnosis—including diagnostic error—was the most common reason individuals complained about their health care, accounting for approximately 35 percent of complaints (Parliamentary and Health Service Ombudsman, 2014).
In addition to diagnostic errors, the public is concerned about other aspects of diagnosis, such as the value of making and communicating diagnoses at early stages in conditions such as Alzheimer’s disease and amyotrophic lateral sclerosis (Lou Gehrig’s disease) for which there is currently no known cure (Hamilton, 2015). There is also a growing concern about overdiagnosis, such as the assignment of diagnostic labels to conditions that are unlikely to affect the individual’s health and well-being (Welch et al., 2011); the focus of clinical attention on making new diagnoses in older patients while ignoring limitations to their daily living that need immediate attention (Gawande, 2014; Mechanic, 2014); and the elevation of common behavioral traits to the level of formal diagnoses, with the attendant treatment and confidentiality implications (Hazen et al., 2013; Kavan and Barone, 2014; NHS, 2013). The Institute of Medicine (IOM) report Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness brought attention to the problem that individuals with debilitating but previously non-recognized symptom complexes may be given inadequate attention by clinicians or ignored altogether because a diagnosis is lacking (IOM, 2015; Rehmeyer, 2015). Diagnoses also affect the health care that patients receive, eligibility for social security and veterans disability benefits, as well as health care research and education priorities.
The widespread challenge of diagnostic errors frequently rises to broad public attention, whether the widely reported diagnostic error of Ebola virus infection in a Dallas hospital emergency department or in the occasional report of an extraordinarily high malpractice award for failure to make a timely diagnosis of cancer or some other life threatening disease (Pfeifer, 2015; Upadhyay et al., 2014; Wachter, 2014). The subjects of diagnosis and diagnostic error have captured media interest, as indicated by television shows and columns about perplexing diagnoses and coverage of patient experiences with diagnosis (Dwyer, 2012; Genzlinger, 2012; Gubar, 2014; New York Times, 2014; Washington Post, 2014). For example, Harper’s Magazine featured an essay that chronicled one patient’s diagnostic journey and experience with diagnostic error through multiple clinicians, Internet searches, conversations with friends and family, and
decision support tools (Julavits, 2014). Books featuring patients’ experiences with diagnosis and the health care system have also been published (Cahalan, 2012; Groopman, 2007; Sanders, 2010).
Given the importance of diagnosis to patients and to health care decision making, as well as the pervasiveness of diagnostic errors in practice, it is surprising that this issue has been neglected within the quality improvement and patient safety movement (Gandhi et al., 2006; Graber et al., 2012; Newman-Toker and Pronovost, 2009; Singh, 2014). There are a number of reasons for the lack of attention to diagnostic errors. Major contributors are the lack of effective measurement of diagnostic error and the difficulty in detecting these errors in clinical practice (Graber et al., 2012; Singh, 2013). Even if they can be measured or identified, diagnostic errors may not be recognized, for example, when the error is identified by a second clinician and feedback about the error is not provided to the original clinician. There may also be debate about what constitutes a diagnostic error; even after an extensive review of a patient’s chart, expert reviewers often disagree about whether or not an error has occurred (Wachter, 2010; Zwaan and Singh, 2015). Diagnostic errors may also be perceived as too difficult to address because the reasons for their occurrence are often complex and multifaceted (Berenson et al., 2014; Croskerry, 2003; Graber et al., 2005; Schiff et al., 2005; Zwaan et al., 2009). This difficulty in identifying the etiology of errors, combined with a lack of feedback on diagnostic performance in many health care settings, limits understanding and makes it more difficult to prioritize improving diagnosis and reducing diagnostic errors. Other factors that contribute to the limited focus on diagnostic error include a lack of awareness of the problem, attitudes and culture that encourage inaction and tolerance of errors, poorly understood characteristics of the diagnostic and clinical reasoning processes, and the need for financial and other resources to address the problem (Berenson et al., 2014; Croskerry, 2012).
Although diagnostic error has been largely underappreciated in efforts to improve the quality and safety of health care, this issue has garnered national attention, and there is growing momentum for change (Graber et al., 2012; Schiff and Leape, 2012; Wachter, 2010). Emerging research has found new opportunities for the identification of diagnostic errors and has led to a better understanding of the epidemiology and etiology of these errors and of potential interventions to improve diagnosis (Singh et al., 2014; Tehrani et al., 2013; Trowbridge et al., 2013; Zwaan and Singh, 2015; Zwaan et al., 2010). Patients and families who have experienced diagnostic error have become increasingly vocal about their desire to share their unique insights to help identify patterns and improve the diagnostic process for future patients (Haskell, 2014; McDonald et al., 2013).
Efforts to accelerate progress toward improving diagnosis can leverage four important movements in health care: the movements to improve patient safety, to increase patient engagement, to foster professionalism, and to encourage collaboration. Diagnostic error has been called the next frontier in patient safety, even though the challenge of diagnostic error will have benefits beyond the realm of patient safety, as such errors are a major challenge to the quality of patient care (Newman-Toker and Pronovost, 2009). Patient engagement and the importance of shared decision making are recognized as critical aspects of improving health care quality (IOM, 2001). The current focus on professionalism emphasizes health care professionals’ intrinsic motivation and commitment to provide patients with high-quality, patient-centered care (Berwick, 2015; Chassin and Baker, 2015; Madara and Burkhart, 2015). The growing recognition of health care as a team-based activity has led to greater collaboration among health care professionals, both intra- and interprofessionally (IOM, 2001; Josiah Macy Jr. Foundation and Carnegie Foundation for the Advancement of Teaching, 2010). These four movements have collectively transformed the way that health care is provided in the United States, and progress toward improving diagnosis and reducing diagnostic errors is a natural outgrowth of these movements. This report by the Committee on Diagnostic Error in Health Care synthesizes current knowledge about diagnostic error and makes recommendations on how to reduce diagnostic errors and improve diagnosis.
This study is a continuation of the IOM Quality Chasm Series, which focuses on assessing and improving the quality and safety of health care. It includes the IOM reports To Err Is Human: Building a Safer Health System and Crossing the Quality Chasm: A New Health System for the 21st Century. The first report was a call to action: The committee concluded that the care patients receive is not as safe as it should be (IOM, 2000). Estimating that tens of thousands of lives are lost each year because of medical errors, the report catalyzed a movement to improve the safety of health care in America. The second report defined high-quality care broadly and set out a vision to close the chasm between what was known to be high-quality care and what patients received in practice (IOM, 2001). Together these reports stimulated widespread scrutiny of the health care system and brought about large-scale efforts to improve the quality and safety of care.
However, these reports focused primarily on the quality and safety of medical treatment rather than on the diagnostic process. The majority of quality improvement and patient safety efforts that have since followed have been focused on improving the delivery of evidence-based care and
preventing the adverse outcomes of treatment, such as medication and surgical errors, and health care–associated infections.
In the summer of 2013, the Society to Improve Diagnosis in Medicine requested that the IOM Board on Health Care Services undertake a study on diagnostic error as a continuation of the IOM’s Quality Chasm Series. With support from a broad coalition of sponsors—the Agency for Healthcare Research and Quality, the American College of Radiology, the American Society for Clinical Pathology, the Cautious Patient Foundation, the Centers for Disease Control and Prevention, the College of American Pathologists, The Doctors Company Foundation, Janet and Barry Lang, Kaiser Permanente National Community Benefit Fund at the East Bay Community Foundation, and the Robert Wood Johnson Foundation—the study began in January 2014.
An independent committee was appointed with a broad range of expertise, including diagnostic error, patient safety, health care quality and measurement, patient engagement, health policy, health care professional education, cognitive psychology, health disparities, human factors and ergonomics, health information technology (health IT), decision analysis, nursing, radiology, pathology, law, and health economics. Brief biographies of the 21 members of this Committee on Diagnostic Error in Health Care are presented in Appendix B. The charge to the committee was to synthesize what is known about diagnostic error as a quality of care challenge and to propose recommendations for improving diagnosis (see Box 1-1).
The committee deliberated during five in-person meetings and numerous conference calls between April 2014 and April 2015. At three of the meetings, the committee invited a number of speakers to inform its deliberations. These speakers provided invaluable input to the committee on a broad range of topics, including patient experiences with diagnostic error; the measurement, reporting, and feedback of diagnostic error; health IT design and decision support; diagnostic errors in pathology and radiology; patient safety culture; teams in diagnosis; psychiatry and diagnostic error; legal issues in diagnosis; and the prioritization of diagnostic error. The committee also held a webinar with experts in cognition and health care professional education. A number of experts and organizations provided written input to the committee on a broad array of topics. In addition to receiving this expert input, the committee reviewed an extensive body of literature to inform its deliberations.
An ad hoc committee of the Institute of Medicine will evaluate the existing knowledge about diagnostic error as a quality of care challenge; current definitions of diagnostic error and illustrative examples; and areas where additional research is needed. The committee will examine topics such as the epidemiology of diagnostic error, the burden of harm and economic costs associated with diagnostic error, and current efforts to address the problem.
The committee will propose solutions to the problem of diagnostic error, which may include: clarifying definitions and boundaries; integrating educational approaches; addressing behavioral/cognitive processes and cultural change; teamwork and systems engineering; measures and measurement approaches; research; changes in payment; approaches to medical liability; and health information technology and other technology changes.
The committee will devise conclusions and recommendations that will propose action items for key stakeholders, such as patients/advocates, health care providers, health care organizations, federal and state policy makers, purchasers and payers, credentialing organizations, educators, researchers, and the diagnostic testing and health information technology industries to achieve desired goals.
To help frame and organize its work, the committee developed a conceptual model that defined diagnostic error and also illustrated the diagnostic process, the work system in which the diagnostic process occurs, and the outcomes that result from this process (see Chapters 2 and 3 for detailed information on the conceptual model). The committee developed a patient-centered definition of diagnostic error: the failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) or (b) communicate that explanation to the patient.
To illustrate the complexity of the diagnostic process and the range of diagnostic errors that can occur, the committee has included a variety of examples of experiences with diagnosis and diagnostic error. The committee was honored to hear patients’ and family members’ experiences with diagnosis, both positive and negative; three of these experiences are described in Box 1-2. During the committee’s deliberations, the United States experienced its first case of Ebola virus infection; because the diagnosis was initially missed in the emergency department, it illustrated a
Jeff was driving home from work when he started experiencing sharp chest pains. Because he was close to the local hospital, he decided to drive directly to the emergency department (ED). Jeff entered the ED stating that he believed he was having a heart attack. He was immediately provided aspirin and nitroglycerin. An electrocardiogram (EKG) was performed, with normal results. Jeff continued to have chest pain. Because of his ongoing symptoms, the clinicians told Jeff that they would ready the hospital’s helicopter in case he needed to be quickly transported to another hospital for heart surgery. Jeff then started complaining of pain in his leg to his wife, who had by then arrived at the hospital, and she told the nurse that something must really be wrong because Jeff rarely complained of pain. Upon further examination, clinicians found that Jeff’s left foot and leg were swollen, and a computed tomography (CT) scan of Jeff’s chest was performed. The CT scan showed that Jeff had an aortic dissection, “a serious condition in which there is a tear in the wall of the major artery carrying blood out of the heart” (MedlinePlus, 2015). His clinicians immediately put him in a helicopter and flew him to another hospital, where he underwent an extensive surgery to repair the aortic dissection and repair damage to his leg.
Jeff cited the willingness of his clinicians to listen to him and his wife and to continue investigating his symptoms despite his normal EKG results as major contributors to his rapid diagnosis. Because aortic dissections are lifethreatening events that require urgent treatment, the quick action of the ED to get Jeff to surgery also contributed to the successful outcome.
Before his aortic dissection, Jeff was in good health. He now has several ongoing medical conditions as well as continued surveillance and treatment related to the dissection. He sees a number of health care professionals on a regular basis. Jeff’s experience has taught him the importance of communicating with one’s health care professionals. He now proactively educates himself on his health conditions, speaks up when he has a concern, prepares questions in advance when he has an appointment, and continues to seek answers to questions that he feels are not adequately addressed.
Carolyn came to the ED with chest pain, nausea, sweating, and radiating pain through her left arm, which are often considered classic symptoms of a heart attack. The ED clinicians ordered an EKG, blood tests, a chest X-ray, and a treadmill stress test; all of these tests came back normal. Her ED clinician diagnosed her as having acid reflux, noting she was in the right demographic for this condition. When she asked the ED doctor about the pain in her arm, he was dismissive of the symptom. Privately, a nurse in the ED asked Carolyn to stop asking questions of the doctor, noting that he was a very good doctor and didn’t like to be questioned. Carolyn was released from the hospital less than 5 hours after the onset of her symptoms, feeling embarrassed about making a “big fuss”
over a relatively common condition. Over the next 2 weeks, she developed increasingly debilitating symptoms, which prompted her return to the ED where she received a diagnosis of significant heart disease. Carolyn had a myocardial infarction caused by 99 percent blocked artery—what clinicians still call the “widow maker” heart attack.
Sue and Her Family
Sue’s son, Cal, was born healthy in a large hospital, but jaundice appeared soon afterward. Jaundice, or yellowing of the skin, occurs when many red blood cells break down and release a chemical called bilirubin into the bloodstream. Cal’s father, Pat, and Sue were informed that treatment for such newborn jaundice isn’t usually necessary. Unfortunately, because of an incorrect entry of the family blood types into Cal’s medical record, the hospital’s clinicians had not recognized that a common blood incompatibility existed and could lead to serious elevations in Cal’s bilirubin levels. Within 36 hours, Cal’s jaundice had deepened and spread from head to toe. Nevertheless, without measuring his bilirubin level, the hospital discharged Cal to home and provided Pat and Sue with reassuring information about jaundice, never mentioning that high levels of bilirubin in the blood can cause damage to the brain (Mayo Clinic, 2015). Four days later, Cal was more yellow, lethargic, and feeding poorly. His parents took him to a pediatrician, who noted the jaundice, still did not do a bilirubin test, and advised them to wait 24 more hours to see if Cal improved. The next day, at the request of his parents, Cal was admitted to the hospital, and a blood test showed that the bilirubin level in Cal’s blood was dangerously high. Over the next few days while Cal was in the hospital, Pat and Sue reported to staff that he was exhibiting worrisome new behaviors, such as a highpitched cry, respiratory distress, increased muscle tone, and arching of the neck and back. They were told not to worry. Later it became clear that Cal was experiencing kernicterus, a preventable form of brain damage caused by high bilirubin levels in the blood of newborns. As a result, at age 20, Cal now has significant cerebral palsy, with spasticity of his trunk and limbs, marked impairment of his speech, difficulty aligning his eyes, and other difficulties.
high-profile example of diagnostic error with important public health implications (Upadhyay et al., 2014) (see Chapter 5). Appendix D includes additional examples of diagnostic error in order to convey a broader sense of the types of diagnostic errors that can occur.
Several years after Cal’s birth, Pat experienced progressively severe neck pain, and a scan showed a mass on his cervical spine. While removing the mass, the neurosurgeon sent a tissue sample to a hospital pathologist, who examined the sample and called back to the operating room to report that it was an atypical spindle cell neoplasm. Assuming that this meant a benign mass, the surgical team completed the operation and declared Pat cured. Following the operation, however, the hospital pathologist performed additional stains and examinations of Pat’s tissue, eventually determining that the tumor was actually a malignant synovial cell sarcoma. Twenty-one days after the surgery, the pathologist’s final report of a malignant tumor was sent to the neurosurgeon’s office, but it was somehow lost, misplaced, or filed without the neurosurgeon seeing it. The revised diagnosis of malignancy was not communicated to Pat or to his referring clinician. Six months later, when his neck pain recurred, Pat returned to his neurosurgeon. A scan revealed a recurrent mass that had invaded his spinal column. This mass was removed and diagnosed to be a recurrent invasive malignant synovial cell sarcoma. Despite seven additional operations and numerous rounds of chemotherapy and radiation, Pat died 2 years later, at 45 years old, with a 4-year-old daughter and a 6-year-old son.
Cal’s and Pat’s (and Sue’s) experiences are examples of diagnostic errors that led to inadequate treatment with major adverse consequences—all enabled by poor communication and uncoordinated care by multiple health care providers. Based on her family’s experiences, Sue believes that health care systems, providers, patient advocates, payers, and regulators have a responsibility to collaborate to reduce diagnostic errors by:
- Improving the processes of—and the accountability for—secure intra- and interprofessional communication of patients’ clinical information.
- Engaging patients more actively as true partners with their health care providers—with improved information sharing, joint decision making, and self-monitoring and reporting of health conditions and symptoms.
SOURCE: Personal communications with Jeff, Carolyn, and Sue (last names are not provided for anonymity).
and diagnostic error in health care. Section II, or Chapters 4 through 8, describes the challenges of diagnosis and is organized by the elements of the work system: Chapter 4 discusses the diagnostic team members and the tasks they perform in the diagnostic process; Chapter 5 discusses the technologies and tools (specifically health IT) used in the diagnostic process; Chapter 6 focuses on health care organizations and their impact on the diagnostic process and diagnostic error; Chapter 7 describes the external elements that influence diagnosis, including payment and care delivery, reporting, and medical liability; and Chapter 8 highlights the
research needs concerning the diagnostic process and diagnostic errors, as drawn from the previous Chapters. Section III (Chapter 9) synthesizes the committee’s main conclusions and recommendations for improving diagnosis and reducing diagnostic error.
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