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Randomized Controlled Trials in Children’s Heart Surgery in the 21st Century: A Systematic Review

In this systematic review, Drury and colleagues evaluated 333 randomized trials in pediatric cardiac surgery that comprised approximately 24,000 children. Most of the trials were early phase trials and recruited relatively few patients. The authors found that less than one third of the trials met basic quality requirements. They emphasize the need for high-quality multicenter clinical trials to achieve reliable evidence for contemporary pediatric heart surgery.

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