November 30, 1999
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A study of more than 6,000 patients by Johns Hopkins researchers found that one or two out of every 100 people who come to larger medical centers for treatment following a biopsy arrive with a diagnosis that's "totally wrong." The results suggest that second opinion pathology exams not only prevent errors, but also save lives and money.
Patients who fail to receive a second pathologist's exam of their biopsied tissue at the incoming hospital or elsewhere "have a small but significant risk of getting the wrong treatment, including surgery or chemotherapy," says pathologist Jonathan L. Epstein, M.D., who led a Hopkins research team. "That's not to mention the psychological trauma of having the wrong prognosis for an illness," he adds, "or the financial burden of the wrong treatment."
The study appears in the December edition of the journal Cancer.
The team compared the original pathologists' reports that 6,171 patients brought to Hopkins prior to treatment, with additional Hopkins-required pathology reports on the incoming patients. Eighty-six of the patients or 1.4 percent were wrongly diagnosed, Epstein says. "That's not a huge number, percentage-wise," he adds, "but the fact that it's as high as it is remains significant, as does the actual number of patients affected across the country."
In reality, the number of patients misdiagnosed in their original pathology reports is probably closer to 2 percent, Epstein says, because the study didn't consider patients wrongly given a clean bill of health from cancer. Such patients don't typically come to a large medical center for treatment.
The researchers tallied only cases in which the difference in the second report would cause a real change in patients' therapy or in their prognosis. More subtle disparities, such as saying a particular type of cancer was somewhat more advanced, weren't part of the study.
In 23 percent of the suspect cases, patients' diagnoses changed from decidedly malignant to decidedly benign, Epstein says. "In 5 percent of the cases, we found the reverse: something would come in as benign condition and we'd find cancer," Epstein says. Other errors included patients diagnosed with the wrong type of cancer: "A patient's original diagnosis might be stomach cancer and we'd find it was a melanoma a case where the patient's future therapy would differ dramatically."
Some of the errors were "harrowing," Epstein says. He cites a patient referred to Hopkins with cancer of the ear canal. "The patient in this case would've had his middle ear removed, in an undeniably mutilating surgery. But with the second path report, the patient was found to have a fungal infection that responded well to treatment."
An earlier study at Hopkins that focused only on interpretation of prostate biopsies -- with a similar rate of faulty reports -- showed the second opinion canceled prostate surgery for six out of 535 cases, at a savings of almost $2 for every dollar spent on the second workup.
Both studies show that suspect or incorrect path reports come from a variety of sources. "We received them from community hospitals, commercial laboratories and large teaching institutions," says Epstein. Nor was Hopkins immune. In seven cases, an additional pathology review at Hopkins supported the patient's original report.
It's easy, Epstein says, to blame changes in the health care system for the problem. "In today's medicine, when HMOs and hospitals are looking to cut costs, doing a second look has come under attack. A second opinion is often viewed as an added administrative burden for overworked clinicians."
But the root of the misdiagnoses, he explains, may be advances in technology -- the needle biopsies, PSAs and improved radiology made to nip conditions in the bud. "With earlier diagnosis of suspect tissue, it's now much more difficult, for example, to separate out the mimics from the true cancers. Also, we used to get larger samples of tissue to evaluate; now we get needle biopsies of brain, breast, lymph nodes and prostate glands. That's good for patient recovery from the sampling procedure, but harder for the pathologist."
What the Hopkins pathologists recommend is that institutions set up policies requiring a review of the original biopsies before patients undergo surgery or other major therapy. "Patients, too, should recognize that a pathologist is a human capable of mistakes," says Epstein. "Evaluating tissue isn't a machine-like process where everything comes out 100 percent correct. So it's worth patients' while to get a second review of the pathology, just as they'd get a second surgeon's opinion."
Other researchers in the study are Joseph D. Kronz, M.D., and William H. Westra, M.D.
Related Web site: http://www.path.jhu.edu/
The Hopkins study appeared in Cancer, Dec. 1, 1999, vol. 86, no. 11 pp 2426-2435.