title: Cost-effectiveness of treatment of acute otorrhea in children with tympanostomy tubes.
abstract: BACKGROUND
  Acute otorrhea is a common problem in children with tympanostomy tubes. We recently demonstrated that treatment with antibiotic-glucocorticoid eardrops is clinically superior to oral antibiotics and initial observation. The aim of this study was to assess the cost-effectiveness of these three common treatment strategies for this condition.
  
  
  METHODS
  We performed an open-label pragmatic trial in which 230 children with acute uncomplicated tympanostomy-tube otorrhea were randomly allocated to receive 1 of 3 treatments: hydrocortisone-bacitracin-colistin eardrops, oral amoxicillin-clavulanate suspension, and initial observation (no assigned medication prescription to fill). Parents kept a daily diary capturing ear-related symptoms, health care resource use, and non-health care costs for 6 months. At 2 weeks and 6 months, the study doctor visited the children at home performing otoscopy. Using a societal perspective, treatment failure (otoscopic presence of otorrhea at 2 weeks) and number of days with otorrhea as reported in the daily diary were balanced against the costs.
  
  
  RESULTS
  Antibiotic-glucocorticoid eardrops were clinically superior to oral antibiotics and initial observation both at 2 weeks and 6 months. At 2 weeks, mean total cost per patient was US$42.43 for antibiotic-glucocorticoid eardrops, US$70.60 for oral antibiotics, and US$82.03 for initial observation. At 6 months, mean total cost per patient was US$368.20, US$420.73, and US$640.44, respectively. Because of the dominance of eardrops, calculating incremental cost-effectiveness ratios was redundant.
  
  
  CONCLUSIONS
  Antibiotic-glucocorticoid eardrops are clinically superior and cost less than oral antibiotics and initial observation in children with tympanostomy tubes who develop otorrhea.
authors.affiliation: Departments of Epidemiology, t.m.a.vandongen@umcutrecht.nl.
authors.forename: Thijs M A
authors.initials: TM
authors.lastname: van Dongen
authors.affiliation: Departments of Epidemiology, Otorhinolaryngology, Division of Surgical Specialties, University Medical Center Utrecht, Utrecht, Netherlands; UCL ENT Clinical Trials Programme, Ear Institute, Faculty of Brain Sciences, University College London, London, United Kingdom;
authors.forename: Anne G M
authors.initials: AG
authors.lastname: Schilder
authors.affiliation: Departments of Epidemiology, Otorhinolaryngology, Division of Surgical Specialties, University Medical Center Utrecht, Utrecht, Netherlands;
authors.forename: Roderick P
authors.initials: RP
authors.lastname: Venekamp
authors.affiliation: Public Health, Health Technology Assessment and Medical Humanities, Julius Center for Health Sciences and Primary Care, and Department of Nutrition, Prevention and Care, National Institute of Public Health and the Environment, Bilthoven, Netherlands; and.
authors.forename: G Ardine
authors.initials: GA
authors.lastname: de Wit
authors.affiliation: Departments of Epidemiology, Otorhinolaryngology, Division of Surgical Specialties, University Medical Center Utrecht, Utrecht, Netherlands; Department of Social Dentistry, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands.
authors.forename: Geert J M G
authors.initials: GJ
authors.lastname: van der Heijden
mesh_terms: D000208:Acute Disease; D000900:Anti-Bacterial Agents / Q000191:economics* / Q000627:therapeutic use*; D001826:Body Fluids; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D004427:Ear Diseases / Q000188:drug therapy* / Q000191:economics*; D005938:Glucocorticoids / Q000191:economics* / Q000627:therapeutic use*; D006801:Humans; D008876:Middle Ear Ventilation / Q000295:instrumentation*; D011183:Postoperative Complications / Q000188:drug therapy* / Q000191:economics*
chemical_list: D000900:Anti-Bacterial Agents; D005938:Glucocorticoids
keywords: epidemiology; otitis media