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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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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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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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