John R. Ball

Safety, Efficacy, and Effectiveness of Clinical Practices: A New Initiative

Excerpt A new vaccine is developed to prevent a form of pneumonia. How does a physician determine whether to vaccinate a particular patient? How does an insurer decide whether to reimburse for such...

Improving Diagnosis in Health Care: Highlights of a Report From the National Academies of Sciences, Engineering, and Medicine

Fifteen years ago, in its landmark report, To Err Is Human: Building a Safer Health System (1), the Institute of Medicine (IOM) dramatically exposed the issue of patient safety in health care. Stating the obviousthat human beings make errorsbut highlighting the theretofore rarely discussed fact that those of us in health care make errors, the report began a quiet revolution in the way health care organizations address safety and quality. To Err Is Human was followed shortly by a second report, Crossing the Quality Chasm: A New Health System for the 21st Century (2), which set a course to close the gulf between high-quality health care and the care many people receive in practice. Although To Err Is Human mentioned diagnostic error as an issue, neither report devoted substantial analysis to it nor made recommendations related to it. Also surprising is that there has been little attention paid to the issue in the interim. This lack of attention motivated an eclectic group of 10 organizations and individuals (see the Financial Support section at the end of the text) to ask the IOM, the health arm of the National Academies of Sciences, Engineering, and Medicine, to evaluate the existing knowledge on diagnostic error and to propose solutions in a broad array of areas and with a diverse group of stakeholders. The resulting report, Improving Diagnosis in Health Care (3), was released in September 2015. Following are the 3 major themes: First, it exposes a critical areadiagnostic errorthat has received insufficient attention. There are several reasons why diagnostic error has been underappreciated, even though the correct diagnosis is a critical aspect of health care. The data on diagnostic error are sparse, few reliable measures exist, and the error is often identified only in retrospect. Yet the best estimates indicate that all of us will probably experience a meaningful diagnostic error in our lifetime. Perhaps the most important contribution of this report is to highlight that issue and to direct discussion among patients, health care professionals, organizations, researchers, and policymakers on what should be done. Second, patients are central to the solution. The report defines diagnostic error from the patients viewpoint as the failure to (a) establish an accurate and timely explanation of the patients health problem(s) or (b) communicate that explanation to the patient [emphasis added]. The reports first goal centers on the need to establish partnerships with patients and their families to improve diagnosis, and several recommendations address this goal. Third, diagnosis is a collaborative effort. A single physician contemplating a patients presentation and discerning a diagnosis is often a stereotype; the diagnostic process often involves intra- and interprofessional teamwork. Further, diagnostic error is not always due to human error; it often occurs because of errors in the health care system. The complexity of health and disease and the increasing complexity of health care demands collaboration among and between health care professionals, as well as with patients and their families. The committees visualization of the diagnostic process illustrates its collaborative, iterative, and complex nature (Figure). Figure. The committees visualization of the diagnostic process illustrates its complexity and the need for collaboration among clinicians, patients, and their families to achieve accurate, timely diagnosis. The committee identifies 4 types of information-gathering activities in the diagnostic process: clinical history and interview, physical examination, diagnostic testing, and referral and consultation. Throughout the process, there is an iterative cycle of information gathering, information integration and interpretation, and developing a working diagnosis. A key responsibility is communicationthroughout the diagnostic process, patients need an explanation of their health problem, along with an understanding of the degree of uncertainty involved, communicated each time the working diagnosis is revised. Treatment can often inform the diagnostic process and refine the diagnosis; in addition, clinicians need to identify treatment-related health problems. Outcomes from the diagnostic process can inform efforts to strengthen the diagnostic process and improve outcomes for patients and their families. In addition to these major themes, the report highlights the following key issues that must be addressed to reduce diagnostic errors: Health care professional education and training does not take fully into account advances in the learning sciences. The report emphasizes training in clinical reasoning, teamwork, and communication. Health information technology, while potentially a boon to health care quality, is often a barrier to effective clinical care in its current form. The report makes several recommendations to improve the utility of health information technology in the diagnostic process specifically and the clinical process generally. Data on diagnostic error are sparse. The report recommends, in addition to specified research, the development of processes to monitor the diagnostic process and to identify, learn from, and reduce diagnostic error. The health care work system and culture do not sufficiently support the diagnostic process. Echoing previous IOM work, the current report also recommends development of an organizational culture that values open discussion and feedback on diagnostic performance. The report highlights the increasingly important role of radiologists and pathologists as members of the diagnostic team. There were also areas where the committee wished the report could go further, but found that data are currently insufficient to support strong recommendations. One of those areas is the payment system, which is now evolving from fee-for-service to more value- and population-based methods. Research on the effects of payment on diagnosis is needed. Another area of interest is medical liability: The report recommends the adoption of communication and resolution programs as a key lever to improve disclosure of diagnostic errors to patients and to facilitate improved organizational learning from these events. Other approaches to resolution of medical injuries, such as safe harbors for adherence to clinical practice guidelines and administrative health courts, hold promise. However, we need more data on their effect on the diagnostic process, and the report recommends demonstration projects to expand the knowledge base in these areas. A final area of potential controversy is the measurement of diagnostic errors for public reporting and accountability purposes. The committee believed that, given the lack of agreement on what constitutes a diagnostic error, the paucity of hard data, and the lack of valid measurement approaches, the time was simply not ripe to call for mandatory reporting. Instead, it was considered appropriate at this time to leverage the intrinsic motivation of health care professionals to improve diagnostic performance and to treat diagnostic error in the same way as quality improvement efforts by health care organizations. Better identification, analysis, and implementation of approaches to improve diagnosis and to reduce diagnostic error are needed throughout all settings of health care.

Standards Setting and the Joint Commission on Accreditation of Hospitals: The Right and the Responsibility of Medicine

Excerpt The hallmark of any profession is the right—and the consequent responsibility—to establish and to enforce its own standards. Both the right and the responsibility of medicine are now at iss...

Law, Medicine, and the Gag Rule

The Supreme Court of the United States, in Rust v. Sullivan (1), decided late this spring that regulations prohibiting counseling concerning abortion in federally funded family planning clinics (th...

A Tribute to Edward Huth, Editor

Excerpt This symposium is intended as a tribute to Ed Huth, a tribute combining three elements of high importance to Ed: words, the medical journal, and his friends and colleagues. A symposium in w...