Ms. Goodwin is manager of clinical risk and patient safety at Cambridge Health Alliance, Cambridge, MA.
"Where other indicators of medical malpractice claims have decreased over the years, the prevalence of diagnostic error has not changed, calling for more innovating thinking, introspection, and systematic approaches to prevention and shared learning," writes Brianne Goodwin, JD, RN.
Diagnostic error continues to be a common and troubling factor in malpractice claims. Consider this case: A 66-year-old female patient with a history of Parkinson’s disease presented to her primary care physician with a complaint of the recent onset of urinary symptoms including frequency and urgency. The primary care physician obtained a urinalysis, which was negative, and referred the patient to a urologist for further follow-up.
The patient presented to the urologist about 5 weeks later, still with the same symptoms. Another urinalysis was done, along with a urine culture, both with a negative result. The urologist attributed the symptoms to the patient’s Parkinson’s disease and continued to see her periodically in follow-up over the next few years.
Over the course of 3 years, the patient’s urinary symptoms continued to deteriorate. She experienced urinary retention proven with bladder ultrasound, and had an episode of hematuria, for which the urologist performed a cystoscopy with no findings. The patient had tried a number of different pharmacologic products over the years for her troubling urinary symptoms. During this 3-year period, the patient’s Parkinson’s disease remained quite stable, though she had reported complaints of fatigue and unintended weight loss.
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One summer evening, the patient presented to a local emergency department with a complaint of dysuria and blood in her urine for 3 days. A urinalysis confirmed this and she was discharged home with a prescription for antibiotics and phenazopyridine (Pyridium) for a presumed urinary tract infection with instructions to follow-up with her urologist.
Stage III cancer diagnosed
The patient returned to the urologist within the week and was scheduled for a computed tomography scan in 4 weeks. The CT demonstrated a large (7-cm) right renal mass, which was ultimately diagnosed as Stage III with involvement of the adrenal gland. Despite efforts at surgical and medical management, the patient died less than 2 years later.
A battle of expert witnesses ensued in pre-trial motions for summary judgment. The expert for the defendant urologist affirmed that the urologist did not depart from good and accepted medical practice in failing to order imaging earlier on the patient or further work up the patient for her complaints of fatigue and weight loss, in the setting of both hematuria and Parkinson’s disease.
The expert for the plaintiff affirmed that there was a departure from the standard of care in failing to order a CT scan at the time of hematuria and cystoscopy years earlier, and to continue serial imaging given the facts. In addition, the plaintiff’s expert opined that the defendant urologist was negligent in developing a differential diagnosis that included renal tumor, and for failing to further work up the patient given her contemporaneous symptoms of fatigue and weight loss.
Questions of fact remained at the conclusion of pre-trial motions, both motions were denied, and the case went to trial. The jury found for the plaintiff.
At the heart of this case was the appropriate workup and diagnosis of renal cell carcinoma. When to image, when not to image, what other studies to obtain, and what other disciplines to involve in the setting of a progressive neurologic disease were also argued by both plaintiff and defendant. This is just one of many cases across all disciplines of medicine that question diagnostic error.
Next: ~30% of claims involve diagnostic error~30% of claims involve diagnostic error
According to Coverys, a large medical liability insurer, approximately 30% of all malpractice claims involve diagnostic error(bit.ly/diagnosticaccuracy). Of these, claims involving cancer diagnosis were the most prevalent at 27%. The cited Coverys report identified four key steps of the diagnostic process, all of which were implicated in the aforementioned case: history and physical, lab/diagnostic testing, management of referral, and patient follow-up.
A recent report authored by a group of clinicians, educators, and health policy and communication experts sets forth several suggestions for what the authors call a more “Care-Full” attempt at diagnosis (Ann Intern Med 2018; 169:643-5). While diagnostic error may appear to be linked to a single clinician or perhaps two, there are organizational systems and processes that can aid in preventing similar future occurrences.
Visibility level of a diagnostic error varies depending on the culture of an organization. Those where a diagnostic error is associated with shame or impaired clinical judgment are unlikely to benefit from having robust quality assurance and improvement systems where other clinicians can learn about the root causes of the error. Another recommendation is to implement clinical decision support tools available in electronic medical records and automating second reads for critical diagnostic tests. Yet another suggestion for reduction of error, requiring some introspection, is looking at clinician overconfidence in diagnosis and its contribution to error (Am J Med 2008; 121:S2-23).
Where other indicators of medical malpractice claims have decreased over the years, the prevalence of diagnostic error has not changed, calling for more innovating thinking, introspection, and systematic approaches to prevention and shared learning.