By David Meyers, MD, FACEP, Sinai Hospital, Baltimore

Diagnostic errors and the need to improve diagnosis have been largely in the background since the early reports of the significance of medical error first came into the national consciousness in 1999 with the publication of the report, To Err is Human: Building a Safer Health System,1 by the Institute of Medicine (IOM, now known as the National Academy of Medicine [NAM]). That report was the first under the auspices of the Committee on the Quality of Health Care in America. It burst onto the scene with its headline-grabbing assertion, derived from the Harvard Medical Practice Study2 and a separate study of medical errors in Utah and Colorado,3 that between 44,000 and 98,000 deaths occurred annually due to medical errors in the United States, including as many as 7,000 deaths due to medication errors alone. Total costs were estimated at between $17 billion and $29 billion, including “lost income, lost household production, disability, and healthcare costs.” The report further noted that these numbers were very likely significant underestimates, as both studies were of hospitalized patients and did not include outpatient or ambulatory settings. The report decried the silence on an issue of such magnitude and severity of outcomes and proceeded to lay out the detail of the problem, describing a series of recommendations to address it. Interestingly, diagnostic errors were mentioned twice in the entire 312 pages.

One year later, a second report in the series, “Crossing the Quality Chasm: A New Health System for the 21st Century,” was issued.4 Its opening words were “The American healthcare delivery system is in need of fundamental change,” and went on to state its goal of “providing a strategic direction for redesigning the healthcare delivery system of the 21st century. Fundamental reform of healthcare is necessary to ensure that all Americans receive care that is safe, effective, patient-centered, timely, efficient, and equitable.”

Detailed analyses of the problems with our healthcare system were carried out, and a series of recommendations were made to achieve these goals. The term “diagnostic error” was not used at all in the document, though it was alluded to once.

Over the succeeding 16 years, at least 10 more reports were issued as part of the “Quality Chasm series”5 on a broad range of topics relevant to the understanding and resolution of factors that contribute to the quality of healthcare and which must be addressed to achieve the goals set for our healthcare system kin to meeting the needs of our patients.

It is known now that, in most professional liability insurers claims databases, the most frequently identified causes of such claims are related to diagnostic errors, accounting for more claims than all other causes combined. Similarly, the most costly category of claims is related to diagnostic errors, again accounting for at least half or more of all payouts. And, of course, malpractice claims reflect just a portion of total injuries, though arguably those with, on average, the most harmful outcomes. Estimates of the frequency of diagnostic errors across all sites of care, including the ED, range from ~10-30%, depending on the source of data.

In 2013, thanks to a growing body of research, recognition of the significant mortality, morbidity, and cost burdens of diagnostic errors, through the efforts of interested parties, including payers, patients, and the Society to Improve Diagnosis in Medicine (SIDM), NAM convened a panel of experts to study the diagnostic process, diagnostic errors, and how to reduce harm to patients from them. The panel’s report, “Improving Diagnosis in Health Care,” was published in September 2015.6 It, like To Err Is Human, generated headlines, particularly for its statement, “It is likely that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences.”

The report, which proposed a new definition of diagnostic error, contains three major themes: 1) a focus specifically on diagnosis and diagnostic errors; 2) recognition that the patient perspective is critical and diagnostic error must be defined from the patient’s viewpoint, and 3) teamwork is essential to the diagnostic effort, requiring collaboration among professionals, patients, and their families. The report also noted that diagnosis takes place within our systems of care, and those systems and culture do not adequately support the diagnostic process, contributing significantly to diagnostic errors. The report lays out eight goals for improving diagnosis:

  • Facilitate more effective teamwork in the diagnostic process among healthcare professionals, patients, and their families;
  • Enhance healthcare professional education and training in the diagnostic process;
  • Ensure that health information technologies support patients and healthcare professionals in the diagnostic process;
  • Develop and deploy approaches to identify, learn from, and reduce diagnostic errors and near misses in clinical practice;
  • Establish a work system and culture that supports the diagnostic process and improvements in diagnostic performance;
  • Develop a reporting environment and medical liability system that facilitates improved diagnosis by learning from diagnostic errors and near misses;
  • Design a payment and care delivery environment that supports the diagnostic process;
  • Provide dedicated funding for research on the diagnostic process and diagnostic errors.

In response to this report, SIDM chose as its theme for the 2016 9th Annual International Diagnostic Errors in Medicine Conference (DEM9) “From IOM to Action.”7 Held over five days in early November in Hollywood, CA, the conference and related events included special programs for patients and researchers, short courses for those seeking in-depth material on subjects critical to addressing diagnostic errors, numerous expert presentations, and breakout sessions with practical exercises and tools to take home.

Like the IOM report, the conference provided material useful for many different sites of care, virtually all clinical specialties, nurses, insurers and risk managers, educators, researchers, institutional administrators, and quality and safety professionals.

Patient Engagement Summit

The purpose of this event was to convene patients interested in improving diagnosis and provide a forum for sharing their experiences, ideas, and suggestions with professionals about how they can contribute. The role of patients in helping solve some of our biggest healthcare quality problems is under scrutiny from CMS and other bodies like the Patient-Centered Outcomes Research Institute (PCORI), which is charged with assuring that research on quality and safety contains measures that are meaningful to patients.

Many of those who attended experienced delayed or wrong diagnoses with devastating and life-changing consequences for themselves or family members, and they were eager to share thoughts about what went wrong and what could have prevented or avoided those outcomes. In almost every case, communication, or lack thereof, among clinicians, patients, and providers played an important role in the harms the patients suffered. Their ideas related not just to the immediate physician-patient encounter, but also how education of clinicians and research on the diagnostic process could benefit with their input. In addition, tools for patient use, such as those produced by the Kaiser organization, SIDM, and others were discussed and shared.8

Research Summit

This event provided an opportunity for clinicians and research scientists to discuss strategic issues in understanding, quantifying, and solving the problem of harm from diagnostic errors.

There was general agreement that the amount of research support is extremely low compared to the magnitude of the problem and its impact.

Getting widespread recognition of the need for research funding, establishing research priorities, patient involvement in the design, and carrying out of research as well as practical matters were identified as important priorities.

Short Courses

An Introduction to Diagnostic Error contained a broad overview of the topic, including the System 1/System 2 model of decision-making based on the work of Daniel Kahneman and Amos Tversky,9 as well as the many human and system factors, including unconscious biases, which are at work in diagnostic decision-making.

Reducing Diagnostic Errors in Clinical Settings focused on translating our knowledge into action plans, while two other workshops addressed cognitive psychology in depth and educational strategies to use in developing diagnostic capabilities in trainees. This latter subject attracted a lot of interest as medical schools are working hard to create more effective pedagogical approaches to teaching diagnosis.

Addressing Institutional Culture

The opening keynote speaker, Brian Goldman, MD, from Mount Sinai Hospital in Toronto, addressed the role of institutional culture in diagnostic error, particularly the “blame and shame” model, which creates an atmosphere of defensiveness, denial, and antipathy toward transparency of disclosure. He also addressed the second victim, i.e., the clinician who made the error and suffers in a different way, with implications for quality of care, empathy, burnout, mental health, suicide, early departure from practice, and other consequences, as well as production pressures, the legal climate, and other factors that impede efforts to improve and correct contributory elements. A panel comprised of representatives of patient interests, insurers and risk managers, and healthcare institutions discussed available tools and resources offered by various government and private agencies.10

Catherine Lucey, MD, the vice dean for education at the University of California, San Francisco Medical School, was the keynote speaker on the second day. An acknowledged thought leader in clinical education, Dr. Lucey’s personal anecdotes at the outset revealed personal and family experiences with harmful diagnostic errors, affirming the statement in Improving Diagnosis. She went on to elucidate what must happen in undergraduate medical education to produce better diagnosticians, including changes in pedagogical techniques, use of illness scripts, and coaching to expertise. She also exploded some myths about clinical reasoning.

Future Expectations

Two sessions on the expectations of purchasers, payers, and consumers presented the audience with ideas about how quality and cost will drive developments in the evolution of our healthcare system and how incentives will affect how care is provided. Allusions to “choosing wisely” as a model for improving care were recognized. The future effect of CMS’s Quality Clinical Data Registries, MACRA, MIPS, and other initiatives on the reporting of errors, including diagnostics and reimbursement, also were addressed. The recently formed Coalition to Improve Diagnosis, a consortium of professional societies, patient advocacy organizations, quality- and safety-promoting groups, and government agencies, was described along with its goals of 1) raising awareness about diagnostic errors and the need to improve diagnosis, 2) developing an advocacy platform for securing research funding, and 3) identifying and disseminating effective tools for improving diagnosis. ACEP is involved actively with this organization.

Breakout Sessions

A breakout session, led by Doug Salvador, MD, MPH, and Harry Hoar, MD, physicians at Baystate Medical Center, demonstrated a tool called “How To Engage Your Administration” to create an approach to generate support for a diagnostic error program, which was used successfully at their institution.

In another interesting breakout session on embracing uncertainty in the diagnostic process, Drs. Gordon Schiff and Alexa Miller spoke about how acknowledging uncertainty can facilitate more openness of thinking and avoiding pitfalls of early closure and other biases while also reducing risk of lawsuits when patients are aware of the clinician’s thinking.

Speaking on the role of certification in improving and maintaining clinicians’ diagnostic skills, Dr. Lucey moderated a panel of representatives from the American Boards of Emergency Medicine, Internal Medicine, and Medical Specialties during which the lively discussion and debate focused on the role of Maintenance of Certification, new approaches to assessing clinical reasoning, and testing of clinicians’ diagnostic and patient management abilities.

The 9th Annual Diagnostic Errors in Medicine Conference covered a broad range of material of interest to anyone who deals with diagnosis — as a practitioner, educator, researcher, risk manager, or patient. And reminders were constant that we will all be patients at some time or another, so these efforts will help us all receive better diagnostic care when we need it.

REFERENCES

  1. Institute of Medicine. To Err is Human: Building a Safer Health System. 1999. Available at: http://bit.ly/2h8u5ev.
  2. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370-376.
  3. Thomas EJ, et al. Costs of medical injuries in Utah and Colorado. Inquiry 1999;36:255-264.
  4. Institute of Medicine. Preface from Crossing the Quality Chasm: A New Health System for the 21st Century. 2001. Available at: http://bit.ly/2hazuon.
  5. Quality Chasm Series: Health Care Quality Reports. Available at: http://bit.ly/2gpuxGN.
  6. The National Academies of Science, Engineering, and Medicine. Improving Diagnosis in Health Care. Available at: http://bit.ly/2gfYPsx.
  7. 9th Annual Diagnostics Errors in Medicine Conference. Program Schedule. Available at: http://bit.ly/2gfNM2u.
  8. Society to Improve Diagnosis in Medicine. Resources for patients and families. Available at: http://bit.ly/2gGPx9T.
  9. Kahneman D. Thinking Fast and Slow. 2013. Farrar, Straus and Giroux.
  10. Agency for Healthcare Research and Quality. Patient Safety Primer. Available at: http://bit.ly/2gGW0BB.