title: Effect of day-case unilateral cochlear implantation in adults on general and disease-specific quality of life, postoperative complications and hearing results, tinnitus, vertigo and cost-effectiveness: protocol for a randomised controlled trial.
abstract: Cochlear implantation is an increasingly common procedure in the treatment of severe to profound sensorineural hearing loss (SNHL) in children and adults. It is often performed as a day-case procedure. The major drive towards day-case surgery has been from a logistical, economical and societal perspective, but we also speculate that the patient's quality of life (QoL) is at least equal to inpatient surgery if not increased as a result of rapid discharge and rehabilitation. Even though cochlear implantation seems well suited to a day-case approach and this even seems to be common practice in some countries, evidence is scarce and of low quality to guide us towards the preferred treatment option.
  
  
  
  A single-centre, non-blinded, randomised, controlled trial was designed to (primarily) investigate the effect on general QoL of day-case cochlear implantation compared to inpatient cochlear implantation and (secondarily) the effect of both methods on (subjective) hearing improvement, disease-specific QoL, tinnitus, vertigo and cost-effectiveness. 30 adult patients with severe to profound bilateral postlingual SNHL who are eligible for unilateral cochlear implantation will be randomly assigned to either the day-case or inpatient treatment group. The outcome measures will be assessed using auditory evaluations, questionnaires (preoperatively, at 1-week, 3-week, 3-month and 1-year follow-up) and costs diaries (weekly during the first month postoperatively, after which once in a month until 1-year follow-up). Preoperative and postoperative outcomes will be compared. The difference in costs and benefit will be represented using the incremental cost utility/effectiveness ratio. The analyses will be carried out on an intention-to-treat basis.
  
  
  
  This research protocol was approved by the Institutional Review Board of the UMC Utrecht (NL45590.041.13; V.5, November 2015). The trial results will be disseminated through peer-reviewed medical journals and presented at scientific conferences.
  
  
  
  NTR4464; Pre-results.
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Laura S M
authors.initials: LS
authors.lastname: Derks
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Inge
authors.initials: I
authors.lastname: Wegner
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Adriana L
authors.initials: AL
authors.lastname: Smit
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Hans G X M
authors.initials: HG
authors.lastname: Thomeer
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Vedat
authors.initials: V
authors.lastname: Topsakal
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Wilko
authors.initials: W
authors.lastname: Grolman
mesh_terms: D000293:Adolescent; D000328:Adult; D019929:Cochlear Implantation / Q000009:adverse effects; D003362:Cost-Benefit Analysis; D006309:Hearing; D006319:Hearing Loss, Sensorineural / Q000150:complications / Q000601:surgery*; D006760:Hospitalization; D006801:Humans; D011183:Postoperative Complications; D011788:Quality of Life; D011795:Surveys and Questionnaires; D014012:Tinnitus / Q000209:etiology*; D016896:Treatment Outcome; D014717:Vertigo / Q000209:etiology*
keywords: cochlear implantation; day-case; hearing results; inpatient; quality of life; sensorineural hearing loss