Susan L Garetz1, Ron B Mitchell2, Portia D Parker3, Reneé H Moore4, Carol L Rosen5, Bruno Giordani6, Hiren Muzumdar7, Shalini Paruthi8, Lisa Elden9, Paul Willging10, Dean W Beebe11, Carole L Marcus12, Ronald D Chervin13, Susan Redline14. 1. Department of Otolaryngology-Head and Neck Surgery and Sleep Disorders Center, garetz@umich.edu. 2. Departments of Otolaryngology and Pediatrics, Utah Southwestern and Children's Medical Center, Dallas, Texas; 3. SAS Institute Inc, Cary, North Carolina; 4. Department of Statistics, North Carolina State University, Raleigh, North Carolina; 5. Department of Pediatrics, Rainbow Babies & Children's Hospital, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio; 6. Departments of Psychiatry and Psychology and Sleep Disorders Center, and. 7. Division of Pulmonary Medicine, Allergy, & Immunology, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh, Pittsburgh, Pennsylvania; 8. Department of Pediatrics, Cardinal Glennon Children's Medical Center, Saint Louis University, St Louis, Missouri; 9. Departments of Otolaryngology and. 10. Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati College of Medicine, and. 11. Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; and. 12. Pediatrics, Sleep Center, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania; 13. Department of Neurology and Sleep Disorders Center, University of Michigan Health Center, Ann Arbor, Michigan; 14. Departments of Medicine and Neurology, Brigham and Women's Hospital, and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
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 influenced 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 modified Epworth Sleepiness Scale were completed at baseline and 7 months. Changes in the QoL and symptom surveys were compared between arms. Effect modification 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 modified Epworth Sleepiness Scale score (ES: -0.42), and the Sleep-Related Breathing Scale of the Pediatric Sleep Questionnaire (ES: -1.35). Effect modification 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 significantly more improvements in parent-rated generic and OSAS-specific QoL measures and OSAS symptoms.
RCT Entities:
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 influenced 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 modified Epworth Sleepiness Scale were completed at baseline and 7 months. Changes in the QoL and symptom surveys were compared between arms. Effect modification 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 modified Epworth Sleepiness Scale score (ES: -0.42), and the Sleep-Related Breathing Scale of the Pediatric Sleep Questionnaire (ES: -1.35). Effect modification 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 significantly more improvements in parent-rated generic and OSAS-specific QoL measures and OSAS symptoms.
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