RATIONALE AND DESIGN OF CHILDHOOD ADENOTONSILLECTOMY TRIAL
The Childhood Adenotonsillectomy Trial (CHAT): Rationale, Design, and Challenges of a Randomized Controlled Trial Evaluating a Standard Surgical Procedure in a Pediatric Population
Susan Redline, MD, MPH1; Raouf Amin, MD2; Dean Beebe, PhD2; Ronald D. Chervin, MD, MS3; Susan L. Garetz, MD4; Bruno Giordani, PhD5; Carole L. Marcus, MBBCh6; Renee H. Moore, PhD7; Carol L. Rosen, MD8; Raanan Arens, MD9; David Gozal, MD10; Eliot S. Katz, MD11; Ronald B. Mitchell, MD, PhD12; Hiren Muzumdar, MD9; H.G. Taylor, PhD8; Nina Thomas, PhD13; Susan Ellenberg, PhD7
1Division of Sleep Medicine, Harvard Medical School, Brigham and Women's Hospital and Beth Israel Medical Center, Boston, MA; 2Children's Hospital Medical Center, Cincinnati, OH; 3Sleep Disorders Center and Department of Neurology, University of Michigan, Ann Arbor, MI; 4Department of Otolaryngology/Head and Neck Surgery, University of Michigan Health System, Ann Arbor, MI; 5Neuropsychology Section, Departments of Psychiatry, Neurology, and Psychology, University of Michigan, Ann Arbor, MI; 6Sleep Center, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA; 7Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, PA; 8Department of Pediatrics, Case Western Reserve University School of Medicine, University Hospitals-Case Medical Center, Rainbow Babies and Children' Hospital, Cleveland, OH; 9Children's Hospital at Montefiore, Albert Einstein College of Medicine, Bronx, NY; 10Department of Pediatrics, Comer Children's Hospital, Pritzker School of Medicine, The University of Chicago, Chicago, IL; 11Division of Respiratory Diseases, Harvard Medical School, Children's Hospital, Boston, Boston, MA; 12Pediatric Otolaryngology, Saint Louis University School of Medicine, Cardinal Glennon Children's Medical Center, St Louis, MO; 13Neuropsychology & Assessment, Department of Child and Adolescent Psychiatry and Behavioral Science, Children's Hospital of Philadelphia, Philadelphia, PA
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.
Redline S; Amin R; Beebe D; Chervin RD; Garetz SL; Giordani B; Marcus CL; Moore RH; Rosen CL; Arens R; Gozal D; Katz ES; Mitchell RB; Muzumdar H; Taylor HG; Thomas N; Ellenberg S. The Childhood Adenotonsillectomy Trial (CHAT): rationale, design, and challenges of a randomized controlled trial evaluating a standard surgical procedure in a pediatric population. SLEEP 2011;34(11):1509-1517.