A new study by researchers at the U.S. Agency for Healthcare Research and Quality (AHRQ) and Yale and Johns Hopkins universities suggests that when medical trial results are released prior to journal publication, doctors can change their practice dramatically. However, the changes may not be in line with the detailed research results later published in a peer-reviewed journal and may be harmful to some patients.
Yale University's Cary Gross, M.D., who led the study in today's Journal
of the American Medical Association, said, "A real balance must be struck
between the public's demand for rapid information and publication in medical
journals -- an inherently slower process." Dr. Gross said that health
policymakers, medical journal editors, scientists and the press have long
debated whether it is in the public's best interest to release the results of
clinical trials prior to publication in medical journals.
AHRQ researcher Claudia Steiner, M.D., a coauthor of the study, said,
"Physicians may be able to judge how to use a new medical treatment better
after they have read all the details in the full report published in the
medical literature. Future research could focus on how clinical alerts -- the
means used for alerting clinicians early to trial findings -- might be
structured to preserve their advantage while avoiding any potential downside."
The authors tracked the use of carotid endarterectomy (CEA) -- a surgical
procedure for clearing a diseased carotid artery in stroke-threatened patients
-- after the National Institutes of Health (NIH) disseminated the results of
two clinical trials prior to journal publication. Each of the trials had been
halted early, as potentially life-saving benefits of CEA were found. Rather
than waiting for the studies to be published in the medical literature, the
NIH expedited dissemination of the results to physicians by means of clinical
alerts. These alerts explained the findings of the studies, but also
cautioned doctors that the trials included only patients under 80 years of age
and they were conducted at medical centers with documented expertise in CEA, a
highly complex procedure.
Immediately after the alerts were released, there was a substantial
increase in CEA use in the states studied. The adjusted CEA use rate
increased roughly 18 percent over the six-month period following the issuance
of the first alert in 1991, but then diminished to only 0.5 percent after the
clinical trial's findings were published later that year.
Following release in late 1994 of the clinical alert on the second CEA
trial, the procedure's rate of use increased an overall 42 percent over the
next seven months, but after the findings were published in May, 1995, there
was a decrease of 0.3 percent in use.
The study also found that the use of CEA following each clinical alert was
greater among patients over 80 years of age, despite the fact that these
patients would not have been eligible for either trial because of their higher
risk of complications and death. In contrast, following the publication of
the results in a medical journal, there was a greater decrease among those 80
and older, compared with patients under 80 years of age. The researchers also
found that many patients were referred to hospitals with less experience in
the use of CEA, despite the warnings of the clinical alerts.
The study used data from the State Inpatient Databases (SID) of
California, Colorado, Florida, Illinois, New York, Pennsylvania and Wisconsin.
SID is part of the Healthcare Cost and Utilization Project, a family of
powerful state and national hospital databases built in partnership with 22
states and AHRQ.
Details of the study are in "The Impact of Prepublication Release of
Clinical Trial Results on the Practice of Carotid Endarterectomy in the United
States," by Drs. Gross and Steiner, and by Eric Bass, M.D. and Neil Powe, M.D.
of Johns Hopkins University, in the December 13, 2000 issue of the Journal of
the American Medical Association.