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WEDNESDAY, July 14 (HealthDay News) -- A review of nearly 150 recently published studies on children's health found that approximately half were at serious risk for bias and distorted results, researchers say.
The Johns Hopkins review of pediatric clinical trials found that 40 to 60 percent either had design flaws that could result in bias or that the researchers did not properly describe steps they had taken to minimize that risk.
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The finding, reported in the August issue of Pediatrics, stems from a review of 146 randomized controlled trials on children that appeared in one of eight prominent medical journals between 2007 and 2008, including Pediatrics, Pediatric Infectious Diseases, Journal of Pediatrics, Archives of Pediatrics and Adolescent Medicine, Journal of the American Academy of Child and Adolescent Psychiatry, the Journal of the American Medical Association, the New England Journal of Medicine and The Lancet.
Led by pediatrician Dr. Michael Crocetti of the Johns Hopkins Children's Center in Baltimore, the review authors noted that all the journals are well-regarded and that the latter three are the highest ranking general interest medical journals in the world.
"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," Crocetti said in a news release from the journal's publisher. "Our review is intended as a step in that direction."
To get a handle on potential bias problems in trials involving children, Crocetti and his colleagues looked at how well the studies handled the random assigning of patients to varying treatment options -- a key hallmark of "gold-standard" research.
In addition, they examined to what degree patients and doctors were unaware of whether or not any particular patient was receiving a trial medication or a sugar-pill substitute (called a placebo).
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-- Alan Mozes
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