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Medscape article by Leigh Page

The Ticklish Problem of Diagnostic Errors

The quality improvement (QI) community is becoming more active in working toward reducing diagnostic errors, but misdiagnoses remains an uncertain field, and some say they might well be nearly impervious to significant improvement.

Every physician knows that diagnostic errors are a problem—for the patient, who may needlessly suffer a bad outcome, and for a physician, who is concerned about his or her patient and may also end up with a malpractice lawsuit. But physicians also understand that getting the right diagnosis may take a while, and even with their best efforts, a diagnosis may not be right.

This was the IOM’s first report aimed at tackling diagnostic errors. Its 1999 report,To Err Is Human—credited with launching the QI movement—mentioned diagnostic errors only twice, according to Robert M. Wachter, MD, an authority on patient safety and health information technology at the University of California, San Francisco (UCSF).In September 2015, a report[1] by the Institute of Medicine (IOM) declared that doctors and the healthcare system have a “moral, professional and public health imperative” to reduce diagnostic errors. To do so, the diagnostic process must be “re-envisioned,” the IOM said.

When To Err Is Human was released, diagnostic errors were still widely seen as a problem that would be extremely difficult to address. Diagnoses were thought to be too nuanced, too difficult to measure, and inappropriate for QI. In 2010, Dr Wachter wrote a commentary[2] titled, “Why Diagnostic Errors Don’t Get Any Respect—and What Can Be Done About Them.”

Even now, with the IOM on board, key metrics used to evaluate healthcare quality still don’t include diagnostic error, says Mark Graber, MD, founder of the Society to Improve Diagnosis in Medicine and a member of the committee that wrote the new IOM report. “Not a single healthcare organization is measuring the incidence of diagnostic error in its own practices,” he says.

Misdiagnosis is too big a problem to be ignored, Dr Wachter says. After all, diagnosis is the first step in the medical process. If you get it wrong, then everything that follows—prescriptions, surgeries and other therapies—will be wrong, too.

However, all of the factors that are involved in leading to misdiagnosis still exist. The IOM report doesn’t call for elimination of diagnostic error. Its title—Improving Diagnosis in Health Care—focuses on a more modest goal.

Mark Graber, MD, says that although misdiagnoses can be markedly reduced, they never will be eliminated. He points to an article[3] he cowrote, stating that there will always be “no-fault errors,” which occur “when the disease is silent, presents atypically or mimics something more common.”

Moreover, identifying diagnoses in real time is often complicated. It can sometimes take weeks or months of follow-up tests for doctors to identify the right diagnosis. And then, if a misdiagnosis is made, it may take years for it to become noticeable. Autopsies show that some patients die of diseases they were never diagnosed with.[4]

The QI movement has already taken on medication errors, wrong-site surgery, and healthcare-associated infections, but Dr Wachter says improving diagnosis involves considerably greater challenges.

“In the absence of ways to measure diagnostic accuracy, we limited ourselves to process measures because they were easy to measure,” he says. “But process measures show only part of the picture. You can score very well on process measures, but if your underlying diagnosis is wrong, there is still harm to the patient.”

Can Misdiagnoses Be Prevented?

Experts are still debating the actual number of misdiagnoses, and how many of them can actually be prevented. The IOM report cites a 2014 observational study[5] estimating that 5% of US adults, or 12 million patients a year, are misdiagnosed. Many of these errors are thought to be relatively harmless, but some of them lead to serious complications and death.

One study[6] estimates that 80,000-160,000 patients a year are affected by serious misdiagnoses, such as failing to diagnose a heart attack, stroke, or cancer, whereas another study[7] estimated that about 40,000-80,000 patients a year die of misdiagnoses.

Physicians tend to estimate lower misdiagnosis rates. A 2011 survey[8] on diagnostic errors by QuantiaMD, collaborating with Dr Wachter, polled more than 6400 clinicians—almost three quarters of whom were physicians. Only about one half said that they came across a misdiagnoses at least once a month in their healthcare setting – a much lower rate than 5% of all diagnoses, and more in line with estimates of serious misdiagnoses.

Furthermore, the clinicians were skeptical that many misdiagnoses could be prevented. Whereas almost 90% agreed that errors were “sometimes” preventable, only 8% said they were “always” preventable. They were also skeptical that a protracted campaign could lower misdiagnoses: Sixteen percent were very confident that errors would fall, 67% were only somewhat confident, and 17% were not confident.

This skepticism may have to do with how these clinicians saw misdiagnoses coming about. Three quarters cited “atypical patient presentation,” which cannot be addressed by improving’ one’s diagnostic reasoning.

In the QuantiaMD survey, one half of respondents said that one of the top causes of misdiagnoses was “failure to consider other diagnoses,” which might be addressed by improving one’s diagnostic reasoning, but three quarters cited “atypical patient presentation.”

Errors Due to Atypical Presentation and Rare Diseases

Diagnoses can be sidetracked by atypical disease presentation and by rare diseases that the doctor has never seen before.

Studies show that most errors involve common diseases. In a 2013 study,[9] the most common misses were pneumonia (6.7%), decompensated congestive heart failure (5.7%), acute renal failure (5.3%), cancer (5.3%), and urinary tract infection (4.8%).

Many misdiagnoses of common diseases involve an atypical presentation. In a 2005 study,[10] Dr Graber and fellow researchers found that of 44 cases of diagnosis errors that were considered “no-fault”—that is, the physician could not be blamed for missing the diagnosis—33 had to do with an atypical or masked disease presentation.

Philip C. Cory, MD, an anesthesiologist in Bozeman, Montana, says both he and his wife had atypical presentations that were misdiagnosed. “Doctors tend to miss the unusual diagnosis,” he says.

For about 15 years, Dr Cory says, doctors missed his wife’s hypothyroidism because it wasn’t picked up by the usual method of a thyroid-stimulating hormone test. In his own case, he went to the emergency department after a spell of dizziness and was diagnosed with benign positional vertigo, but it turned out to be atypical migraine, he says.

Rare diseases can be even more difficult to detect, because the doctor has often never seen the disease before. According to the Shire Disease Impact Report,[11] it takes an average of 7.6 years for a US patient with a rare disease to receive the proper diagnosis. Such patients typically visit up to eight physicians before they get the right diagnosis, the report said.

According to the National Institutes of Health (NIH),[12] a rare disease is one that affects fewer than 200,000 Americans at any given time, but the total impact of rare diseases is significant. There are almost 7000 rare diseases affecting 25 million Americans, the NIH says. Medscape maintains a Rare Diseases site,[13] which provides reports on journal articles and other sources involving rare diseases.

Both atypical presentations and rare diseases require extra spadework, Dr Cory says. “As patients, we want a doctor who has a lot of curiosity—someone who will dig into the case, like Doc Martin or Dr House on TV,” he says. “But you don’t get that, in many cases.” Instead, he says, many doctors agree with the obvious diagnosis. “They don’t like ambiguity,” or they may be too burned out to care, he says. On the other hand, if they believe they have a correct diagnosis, there’s no need to test further.

Last year, Dr Cory and his wife, who holds a PhD in microbiology and immunology, launched a consultancy that works with patients with hard-to-solve cases, in collaboration with their usual physicians. “We like puzzles, and we think we’re doing something worthwhile,” he says. “Nothing is more distressing than having a significant medical issue and not getting answers.”

Although Dr Cory has only had a few patients so far, other physicians have already found a niche in working on challenging diagnoses. Outside New York City, Thomas J. Bolte, MD, bills himself as a “medical mystery investigator” and has been lauded in the media as “the real Dr House.” And at the University of Alabama at Birmingham, the Undiagnosed Diseases Program bills itself as “the last hope” for people with mystery diseases.

The Need for Feedback

Researchers think physicians are often not fully aware of diagnostic errors because they don’t get enough feedback about them. “We don’t have routine autopsies anymore, and nothing has replaced the autopsy in providing feedback,” Dr Graber says.

Emergency physicians, hospitalists, laboratory pathologists, and diagnostic radiologists don’t follow their patients. Even the primary care physicians who do follow them are often in the dark. “When patients discover your diagnosis was wrong, they may not tell you,” Dr Graber says. “They may just go elsewhere, and you won’t hear from them again.”

One way to provide feedback to physicians is to create a voluntary error reporting system, which is what the Maine Medical Center in Portland has done. Robert Trowbridge, MD, a hospitalist at the medical center who helped create the program, says the program gets about two reports a week. Clinicians can anonymously report errors, and most of the reports come from someone other than the person who made the error, he says. The report is confirmed by a review of the patient’s medical records.

Dr Trowbridge says setting up the program took a lot of work—”we had to convince clinicians that this was an important thing to do”—but once it was up and running, doctors accepted it. Errors are dealt with in “a nonpunitive manner,” he says. “I haven’t really found that doctors are defensive about this. They want to know if they’ve made an error.”

By reviewing the cases, he says, physicians can better understand diagnostic pitfalls, and hospital officials can make system changes, such as making sure that hospitalists have access to the patient’s ambulatory medical record.

Dr Trowbridge says the program takes steps to keep the information from plaintiff’s attorneys in malpractice cases. After the cases are analyzed, patient and physician identifiers are removed and medical record numbers are discarded, he says.

However, on the basis of national estimates, the program captures only a small percentage of diagnostic errors. Many reformers want to create a more robust database. One method is to survey patients, but Dr Trowbridge says that sending out and collecting survey forms would be too expensive. Furthermore, patient reports can be misleading, researchers say. Some patients might be unaware that an error took place, whereas others might wrongly assume that an error was made.

Another problem is voluntary and patient-based reporting may uncover errors weeks or even years after the fact. That may be too late to avert fast-moving conditions, such as heart attack, stroke, and many cancer cases.

Instead, researchers would like to use electronic health records (EHRs) to create a robust, real-time misdiagnosis database, using electronic searches of patient records. A search algorithm, called a “trigger,” identifies patients who had been treated and then had the same symptoms later—suggesting that the diagnosis had been inaccurate. Then physicians perform detailed chart reviews on these patients to confirm a misdiagnosis.

David E. Newman-Toker, MD, associate professor of neurology at Johns Hopkins University, has been using this technique to study patients with dizziness who were treated and released by emergency departments and then had a major stroke requiring hospitalization. He says he is getting closer to having a reliable measurement that can be used to monitor misdiagnoses. “These approaches are hard to build,” he says, “but then are easy to maintain and use.”

When the trigger identifies a case, researchers follow up with chart reviews to confirm a diagnostic error. However, physicians reviewing the same chart may disagree on what constitutes an error, so such instruments as the Safer Dx framework are being developed to standardize these reviews.

Researchers say that using triggers and chart reviews is still very much a work in progress. “Triggers will need to be developed further, because the accuracy is still quite low,” says Dr Wachter at UCSF. He thinks the process could take 5-10 years, if not longer.

Diagnostic Shortcuts Can Get in the Way

Dr Graber says one common way that doctors make misdiagnoses is by not undertaking a step-by-step differential diagnosis. Instead, doctors often apply heuristics, which are mental shortcuts based on experience. Dr Graber says doctors use heuristics a lot, and he doesn’t expect them to stop—they are very efficient and are accurate in many situations—but he does think heuristics should be used more sparingly.[14]

Going with your gut and not overthinking a problem was popularized by Blink, the 2007 bestseller by Malcolm Gladwell. However, Dr Graber and other researchers say that instincts don’t help when the diagnostic problem doesn’t match past experience, such as when symptoms present atypically. They say doctors need to know when to stop thinking heuristically and switch to the slower process of thinking analytically.

Most doctors already see the need for combining heuristics with an analytical approach. The QuantiaMD survey asked clinicians to state their preferences between medical as an “art,” which involves heuristics, and medicine as a “science,” which involves an analytical approach. Whereas 14% said medicine is a science and 12% said it’s an art, fully 74% said that it’s both.

Gurpreet Dhaliwal, MD, a professor of clinical medicine at UCSF, has been a proponent of examining and improving one’s own cognitive processes in making diagnoses, called “metacognition.” For example, he reviews case reports in medical journals to get an idea of how the diagnostic process needs to be adjusted. “Once you know your brain is capable of making errors, you’re going to be more careful about the diagnoses you make,” he says.

Dr Wachter, who teaches residents at UCSF, says younger physicians are taking metacognition more seriously. When reviewing cases at morbidity and mortality conferences, “I hear my residents refer to things like an ‘anchoring error’ [when the doctor clings to an initial impression, despite contradictory information coming later],” he says. “You didn’t hear that term 10 years ago.”

System-Based Barriers Cause Misdiagnoses

Besides the reasoning process, there are many issues having to do with the system of care that can cause diagnostic errors. Basically, these involve issues with patients and diagnostic tests.

It’s clear that patients play a key role in misdiagnoses. A 2013 study[9] found that the biggest source of process breakdowns that cause diagnostic errors had to do with a faulty patient/practitioner encounter. For example, patients might fail to come in for a follow-up visit with their regular physician or with a specialist that would help narrow the diagnosis.

Dr Graber thinks physicians should make a greater effort to make patients “partners” in the diagnostic process, and this is a recommendation of the IOM report. Even before doctors have formulated a final diagnosis, Dr Graber says, they should work with patients to sort through possible diagnoses. Many doctors don’t want to let on to patients that they are unsure of the diagnosis, but “if you admit you’re not sure yet and give them some possibilities, the patient can help you narrow them down,” he says.

He also thinks physicians should have the right amount of time to evaluate patients. “Diagnosis takes time,” Dr Graber says. “It takes time to get a complete history, to do a meaningful physical examination, and to get to know the patient.”

According to a 2015 Medscape survey,[15] doctors typically spend about 13-16 minutes with a patient. But that may not be enough for a challenging diagnosis. The IOM report says payments should be adequate for “performing a thorough clinical history, interview, and physical exam,” but it notes that the payment system discourages this. Under Medicare, the report says, doctors who have to spend 20 minutes instead of 15 minutes for a level 3 visit receive 25% less revenue per hour.

To deal with these problems, the IOM report says payers should improve payments for cognitive activities, such as “a thorough clinical history, interview, and physical exam, or decision-making in the diagnostic process.”

In the realm of diagnostic testing, misdiagnoses can occur when the tests are not performed, the interpretation of tests is faulty, or abnormal results are missed, the IOM report says.

Physicians may fail to order a test because they’re confident that they already have the diagnosis. A 2013 study[16] found that internists who indicated that they were highly confident of their diagnosis but were wrong did not order more tests.

Physicians may be discouraged from ordering more tests by insurance company policies, such as requiring precertification for an imaging exam. For example, a pilot program run by UnitedHealthcare in Florida requires doctors to submit a “prenotification” electronically and get a confirmation back before ordering any of nearly 80 different lab tests. According to a news report,[17]several medical societies in Florida have objected to this program, saying that it requires extensive data entry.

The movement to cut down on possibly unnecessary testing may also discourage physicians from ordering the tests they need. In the Choosing Wisely campaign, for example, some specialty societies have identified imaging tests as subject to overuse. The campaign has been criticized for attempting to replace a physician’s judgment with a rigid set of rules, when in fact there are many exceptions.

Even when tests are ordered, some physicians may fail to follow up on abnormal results. In a 2014 study[18] detected 1048 cases of delayed or missed follow-up of abnormal findings of diagnostic tests, including 47 high-grade cancers.

Failure to follow up on test results may be caused by poor communication between the treating physician and the physician interpreting the results. The IOM report advises that Medicare should reimburse physicians for the “time spent by pathologists and radiologists in advising treating physicians on testing for specific patients.”

Using EHRs to Reduce Errors

EHRs have been touted as a key tool to help physicians reduce diagnostic errors. They can provide prompts, collate information from far-flung sources and display it in easily comprehensible graphics, and follow changes in the patient’s condition. “When all the records are in the system, you can digitally follow patients’ progress and see whether the diagnosis was correct,” Dr Wachter says.

However, most of these capabilities are not yet part of basic EHR packages. Users have had to create helpful programs on their own. For example, Dr Dhaliwal has created a “do-it-yourself” program to review patient records and track his own diagnostic decision-making. He says this has become a central feature in his own efforts to improve his cognitive processes.

At Maine Medical Center, Dr Trowbridge says the EHR used by hospitalists displays admission and discharge summaries side by side to instantly show whether their initial diagnosis matches the discharge diagnosis.

Dr Wachter thinks that someday, EHRs may have prompts that question the physician’s diagnosis. “If someone comes up with a different diagnosis than what the computer suggests, you might look into the case,” he says.

This would involve packing EHRs with clinical decision support (CDS) software, which is already being used as stand-alone systems. CDS systems, such as DXplain and Isabel, download the latest clinical findings and use reasoning processes to provide physicians with a hierarchical list of possible diagnoses.

However, CDS systems have been “tremendously underutilized,” Dr Graber says. “Physicians think they’re labor-intensive and won’t help much, but in fact, they take just a few seconds to use, and clinicians who regularly use them really like them.” In a 2015 report,[19] for example, Isabel provided the right diagnosis for a child with a high fever. Emergency physicians had struggled for 2 days to come up with a diagnosis, and the CDS provided it in just seconds.

Conclusion

The movement to reduce misdiagnoses is gathering momentum, but it’s still not clear yet how successful it can be. Few healthcare organizations are addressing the problem, and many physicians are still skeptical that diagnostic errors can be identified and averted. In addition, payment systems have to be changed to allow physicians to spend more time on diagnoses.

These changes will be challenging but will be worth the effort, Dr Wachter thinks. “Diagnosis represents a big hole in quality measurement,” he says. “Patients need a way to evaluate doctors’ diagnostic skills.”

References

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