Journal article
The Childhood Adenotonsillectomy Trial (CHAT): Rationale, Design, and Challenges of a Randomized Controlled Trial Evaluating a Standard Surgical Procedure in a Pediatric Population
Sleep (New York, N.Y.), v 34(11), pp 1509-1517
01 Nov 2011
PMID: 22043122
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Each year, over 500,000 adenotonsillectomies (AT), mostly for the treatment of pediatric obstructive sleep apnea (OSA) are performed in the US in children under 15 years of age. No definitive study, however, has been yet conducted that has rigorously evaluated the effectiveness of AT for not only improving sleep disordered breathing, but also for improving clinically relevant outcomes, such as neurocognitive function, behavior, and quality of life. The Childhood Adenotonsillectomy Trial (CHAT) was designed to assess neuropsychological and health outcomes in children randomized to receive early AT (eAT) as compared to Watchful Waiting with Supportive Care (WWSC). Important secondary goals of the study are to evaluate outcomes in subgroups defined by obesity and race. This paper addresses key elements in the design and implementation of a controlled trial for a widely used "standard practice" surgical intervention in a pediatric population, that include establishment of standardized data collection procedures across sites for a wide variety of data types, establishment of equipoise, and approaches for minimizing unblinding of selected key personnel. The study framework that was established should provide a useful template for other pediatric controlled studies or other studies that evaluate surgical interventions.
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Details
- Title
- The Childhood Adenotonsillectomy Trial (CHAT): Rationale, Design, and Challenges of a Randomized Controlled Trial Evaluating a Standard Surgical Procedure in a Pediatric Population
- Creators
- Susan Redline - Harvard University PressRaouf Amin - Cincinnati Children's Hospital Medical CenterDean Beebe - Cincinnati Children's Hospital Medical CenterRonald D. Chervin - University of MichiganSusan L. Garetz - University of MichiganBruno Giordani - University of MichiganCarole L. Marcus - University of PennsylvaniaRenee H. Moore - University of PennsylvaniaCarol L. Rosen - Case Western Reserve UniversityRaanan Arens - Yeshiva UniversityDavid Gozal - University of ChicagoEliot S. Katz - Harvard University PressRonald B. Mitchell - UCLouvain Saint-Louis BrusselsHiren Muzumdar - Yeshiva UniversityH. G. Taylor - Case Western Reserve UniversityNina Thomas - Childrens Hosp Philadelphia, Dept Child & Adolescent Psychiat & Behav Sci, Philadelphia, PA 19104 USASusan Ellenberg - University of Pennsylvania
- Publication Details
- Sleep (New York, N.Y.), v 34(11), pp 1509-1517
- Publisher
- Oxford Univ Press
- Number of pages
- 9
- Grant note
- NIH; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA Proctor Gamble; Procter & Gamble Ethicon Endo-Surgery, Inc. Dymedix Inc. Elan Corporation Wyeth Eli Lilly UL1RR024989 / NATIONAL CENTER FOR RESEARCH RESOURCES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Research Resources (NCRR) U01HL083075 / NATIONAL HEART, LUNG, AND BLOOD INSTITUTE; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Heart Lung & Blood Institute (NHLBI) ASMF Philips Respironics
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Epidemiology and Biostatistics
- Web of Science ID
- WOS:000296727200012
- Scopus ID
- 2-s2.0-80655149478
- Other Identifier
- 991021448022604721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Clinical Neurology
- Neurosciences