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The Next Phase of Patient Safety Improvement: Tackling Misdiagnosis

Doctors issue recommendations in wake of Institute of Medicine report

The health care industry must adopt a system-wide approach to tackling medical misdiagnosis, a growing concern due to research that estimates 12 million U.S. people will experience a diagnostic error each year,  an opinion piece argues in the New England Journal of Medicine (NEJM).

The 1999 Institute of Medicine (IOM) report To Err Is Human transformed thinking about patient safety. On its 15th anniversary, a topic largely missing from that report is getting its due. In its new report, Improving Diagnosis in Health Care, the IOM called the need to address diagnostic error a “moral, professional, and public health imperative.” The report emphasizes that diagnostic errors may be one of the most common and harmful patient-safety problems.

Why has it taken so long to recognize the importance of diagnostic errors? Perhaps early safety advocates focused on more glaring problems, such as procedure-related and medication errors, because diagnostic errors are more difficult to detect and understand and less amenable to systems-based interventions. Diagnostic error may involve overlapping missed opportunities to make a correct and timely diagnosis; a diagnosis may be missed completely, the wrong one may be provided, or diagnosis may be delayed, all of which can lead to harm from delayed or inappropriate treatments and tests.

There are more than 8,000 diseases, and uncertainty is an inherent element at every step of the diagnostic process. Given these complexities, one might argue that getting the final diagnosis right in the great majority of cases is perfectly acceptable.

Much has been learned about diagnosis and diagnostic error in the past 15 years. As the IOM report notes, research findings suggest that diagnostic errors affect at least one in 20 U.S. adults in outpatient settings each year, or 12 million adults per year. This figure is in line with previous estimates that about one in 10 diagnoses is probably wrong, and it forms the basis for the report's conclusion that most of us will be affected by diagnostic errors in our lifetimes.

Many common diseases, such as common infections, cardiovascular conditions, and cancers — not just uncommon or rare conditions — are apt to be misdiagnosed. Progress has been stimulated by better understanding of clinical reasoning and the diagnostic process and by insights from cognitive psychology, human-factors engineering, informatics, and social sciences.

The NEJM argues that the new IOM report can contribute to a needed overhaul of the U.S. health care system. It proposes aspirational goals of improving the diagnostic process and gives concrete recommendations for major systems and process changes. It recognizes that a single clinician's knowledge and thinking are critical but not always sufficient to ensure an accurate diagnosis. It applies a broad 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” — that emphasizes the patient's vital role in the diagnostic process.

The recommendations address myriad system features and activities that affect diagnosis. These recommendations include strengthening teamwork, reforming the teaching of diagnosis, ensuring that health information technology supports the diagnostic process, measuring and learning from errors in real-world practice, promoting a culture of diagnostic safety, reforming the malpractice and reimbursement systems, and increasing research funding. Report recommendations involve all delivery-system stakeholders.

The NEJM called on researchers and other safety professionals to develop resources to help institutions and clinicians operationally define and identify diagnostic errors. In addition, novel solutions are needed to promote clinician-, patient-, and system-level learning. Providing clinicians feedback about their diagnostic performance could help them better calibrate their diagnostic skills. One recommendation calls for approaching diagnosis as a team process, leveraging the strengths of other team members and the benefits of having different eyes look at diagnostic dilemmas. Reforms should also facilitate creation of a blame-free environment, in which errors become opportunities for learning and quality improvement.

Now could be an opportune moment to create a national public–private partnership to propel progress. The NEJM is optimistic that the IOM report will spark a renaissance of interest in improving diagnosis and reducing patient harm from diagnostic error.

Source: New England Journal of Medicine, November 16, 2015.

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