New Research Can Be Too Much Too Soon
Research - Too much too soon?
Dec. 12, 2000 -- From designer drugs to robots that guide heart surgery, we're regularly bombarded with reports on exciting new medical advances and cutting-edge technologies. But before you run to your doctor for that promising new treatment, bear in mind that when it comes to medical research, preliminary results are just that -- preliminary, and even the most carefully conducted experiments need to be repeated over and over before the data can really be trusted.
In fact, a new study by Cary P. Gross, MD, and colleagues shows that when particularly promising research results are released ahead of schedule, even doctors can inadvertently misinterpret or misuse the information in their rush to help patients.
The research in question came from two studies of carotid endarterectomy -- a once experimental but now fairly common surgery to remove plaque from arteries in the neck and hopefully prevent a stroke. When it became obvious to investigators that the procedure was even more helpful than anticipated, the National Institutes of Health decided to send a "clinical alert" out to the medical community, informing them of the results before complete reports were published.
Despite the fact that both studies included only patients younger than 80, operated on at high-capacity hospitals, and that the investigators explicitly warned against applying their findings to other situations, the number of carotid endarterectomies shot up quickly and dramatically -- even in elderly patients and at less-experienced centers.
In the Dec. 13 issue of the Journal of the American Medical Association, Gross' team writes that the early dissemination of the findings did indeed change medical practice as intended, but that "the observed changes suggest that the results were extrapolated to patients and settings not directly supported by the trials."
Part of the explanation may be that "at the time, [plaque in the carotid arteries] was a condition for which there wasn't really convincing evidence that there was much you could do. And here was a promise of something that might help," says the journal'sexecutive deputy editor Phil B. Fontanarosa, MD, who co-authored an editorial accompanying the report. So, he tells WebMD, although the decision to release the findings early was made "very, very judiciously," in a mostly successful attempt to help these patients, in a minority of cases, the findings were misapplied.
The warning for laymen, then, is to be very, very skeptical. "We really all want the same thing," Fontanarosa says. Researchers, doctors, patients, and journalists all want to get potentially lifesaving information out to those who need it as quickly as possible, he tells WebMD. But "no single study is ever definitive, and early and preliminary reports are just that -- early and preliminary."
Gross's team concludes that "policy-makers should consider that the [early release] of clinical trial results may have unintended consequences." They suggest that in the future, "publication of the full article," rather than a shortened summary, "may help promote optimal use of the new information."