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The Importance of Randomized Controlled Trials in Pediatric Cardiology
Samuel S. Gidding, MD
JAMA. 2007;298:1214-1216.
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Experience with randomized controlled clinical trials in pediatric cardiology is limited. Perhaps the most cited article in the field had a sample size of 1, a baby with transposition of the great arteries who successfully underwent balloon dilation of a patent foramen ovale.1 When this procedure was found to improve survival from a median of less than a week to several years, the immediate challenge to clinicians was not to replicate the finding by a randomized trial but to determine how best to manage a living child with an oxygen saturation of 60% to 70% and persistent complex anatomical defects.
Within 25 years and incorporating many technical innovations into diagnosis and management, more than 95% of children born with this defect survived an arterial switch procedure with little morbidity until adulthood.2-3 Along the path to these results, many treatment centers simply converted from performing the conventional . . . [Full Text of this Article]
Author Affiliations: Nemours Cardiac Center, A. I. duPont Hospital for Children, Wilmington, Delaware; Jefferson Medical College, Philadelphia, Pennsylvania.
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Robert E. Shaddy, Mark M. Boucek, Daphne T. Hsu, Robert J. Boucek, Charles E. Canter, Lynn Mahony, Robert D. Ross, Elfriede Pahl, Elizabeth D. Blume, Debra A. Dodd, David N. Rosenthal, Jeri Burr, Bernie LaSalle, Richard Holubkov, Mary Ann Lukas, Lloyd Y. Tani, and For the Pediatric Carvedilol Study Group
JAMA. 2007;298(10):1171-1179.
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