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Reprinted by permission of Pediatrics. 2015; 135(2):e477-e486.

Quality of Life and Obstructive Sleep Apnea Symptoms After Pediatric Adenotonsillectomy Susan L. Garetz, MD a , Ron B. Mitchell, MD b , Portia D. Parker, MS c , Reneé H. Moore, PhD d , Carol L. Rosen, MD e , Bruno Giordani, PhD f , Hiren Muzumdar, MD g , Shalini Paruthi, MD h , Lisa Elden, MD i , Paul Willging, MD j , Dean W. Beebe, PhD k , Carole L. Marcus, MBBCh l , Ronald D. Chervin, MD, MS m , Susan Redline, MD, MPH n

abstract

BACKGROUND AND OBJECTIVES: Data from a randomized, controlled study of adenotonsillectomy for obstructive sleep apnea syndrome (OSAS) were used to test the hypothesis that children undergoing surgery had greater quality of life (QoL) and symptom improvement than control subjects. The objectives were to compare changes in validated QoL and symptom measurements among children randomized to undergo adenotonsillectomy or watchful waiting; to determine whether race, weight, or baseline OSAS severity in fl uenced changes in QoL and symptoms; and to evaluate associations between changes in QoL or symptoms and OSAS severity. METHODS: Children aged 5 to 9.9 years with OSAS ( N = 453) were randomly assigned to undergo adenotonsillectomy or watchful waiting with supportive care. Polysomnography, the Pediatric Quality of Life inventory, the Sleep-Related Breathing Scale of the Pediatric Sleep Questionnaire, the 18-item Obstructive Sleep Apnea QoL instrument, and the modi fi ed Epworth Sleepiness Scale were completed at baseline and 7 months. Changes in the QoL and symptom surveys were compared between arms. Effect modi fi cation according to race and obesity and associations between changes in polysomnographic measures and QoL or symptoms were examined. RESULTS: Greater improvements in most QoL and symptom severity measurements were observed in children randomized to undergo adenotonsillectomy, including the parent-completed Pediatric Quality of Life inventory (effect size [ES]: 0.37), the 18-item Obstructive Sleep Apnea QoL instrument (ES: – 0.93), the modi fi ed Epworth Sleepiness Scale score (ES: – 0.42), and the Sleep-Related Breathing Scale of the Pediatric Sleep Questionnaire (ES: – 1.35). Effect modi fi cation was not observed by obesity or baseline severity but was noted for race in some symptom measures. Improvements in OSAS severity explained only a small portion of the observed changes. CONCLUSIONS: Adenotonsillectomy compared with watchful waiting resulted in signi fi cantly more improvements in parent-rated generic and OSAS-speci fi c QoL measures and OSAS symptoms.

WHAT ’ S KNOWN ON THIS SUBJECT: Pediatric obstructive sleep apnea syndrome (OSAS) has been associated with decreased health-related quality of life (QoL). Observational studies suggest that adenotonsillectomy for pediatric OSAS improves QoL, but these studies did not use a randomized study design or a control group of children with OSAS managed nonsurgically. WHAT THIS STUDY ADDS: A prospective, randomized controlled study of adenotonsillectomy for pediatric OSAS showed signi fi cantly greater QoL and symptom improvements in children undergoing adenotonsillectomy than in the nonsurgical control arm. The extent of improvement was not appreciably in fl uenced by baseline OSAS severity or obesity.

a Department of Otolaryngology – Head and Neck Surgery and Sleep Disorders Center, f Departments of Psychiatry and Psychology and Sleep Disorders Center, and m Department of Neurology and Sleep Disorders Center, University of Michigan Health Center, Ann Arbor, Michigan; b Departments of Otolaryngology and Pediatrics, Utah Southwestern and Children ’ s Medical Center, Dallas, Texas; c SAS Institute Inc, Cary, North Carolina; d Department of Statistics, North Carolina State University, Raleigh, North Carolina; e Department of Pediatrics, Rainbow Babies & Children ’ s Hospital, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio; g Division of Pulmonary Medicine, Allergy, & Immunology, Children ’ s Hospital of Pittsburgh of UPMC, University of Pittsburgh, Pittsburgh, Pennsylvania; h Department of Pediatrics, Cardinal Glennon Children ’ s Medical Center, Saint Louis University, St Louis, Missouri; Departments of i Otolaryngology and l Pediatrics, Sleep Center, Children ’ s Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania; j Department of Otolaryngology – Head and Neck Surgery, University of Cincinnati College of Medicine, and k Department of Pediatrics, Cincinnati Children ’ s Hospital Medical Center, Cincinnati, Ohio; and n Departments of Medicine and Neurology, Brigham and Women ’ s Hospital, and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts

This trial has been registered at www.clinicaltrials.gov (identi fi er NCT00560859). www.pediatrics.org/cgi/doi/10.1542/peds.2014-0620 DOI: 10.1542/peds.2014-0620 Accepted for publication Nov 4, 2014

PEDIATRICS Volume 135, number 2, February 2015

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