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Pediatric clinical studies appear prone to bias, Hopkins review shows
Date:7/11/2010

A Johns Hopkins review of nearly 150 randomized controlled trials on children all published in well-regarded medical journals reveals that 40 to 60 percent of the studies either failed to take steps to minimize risk for bias or to at least properly describe those measures.

A report of the team's findings in the August issue of Pediatrics shows that experimental trials sponsored by pharmaceutical or medical-device makers, along with studies that are not registered in a public-access database, had higher risk for bias. So were trials that evaluate the effects of behavioral therapies rather than medication, the report states.

"There are thousands of pediatric trials going on in the world right now and given the risk that comes from distorted findings, we must ensure vigilance in how these studies are designed, conducted and judged," says lead investigator Michael Crocetti, M.D., M.P.H., a pediatrician at Johns Hopkins Children's Center. "Our review is intended as a step in that direction."

Considered the gold standard of medical research, the hallmark of double-blind randomized controlled trials (RTC) is a design that rules out or accounts for actual or potential bias. Results of such studies, when peer-reviewed and published in reputable medical journals, can influence the practice of medicine and patient care. A poorly designed or executed trial can therefore lead researchers to erroneous conclusions about the effectiveness of a drug or a procedure.

Citing the degree of bias risk in the studies they reviewed, the researchers caution pediatricians to be critical readers of studies, even in highly respected journals.

The investigators advise that when reading a report on a trial, pediatricians should not merely look at the bottom line but ask two essential questions: How did the researchers reach the conclusion? and Was their analysis unbiased?

Doctors should apply "smell tests," common sense and s
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Contact: Ekaterina Pesheva
epeshev1@jhmi.edu
410-516-4996
Johns Hopkins Medical Institutions
Source:Eurekalert

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