title: Patient perception of a randomised, controlled trial of laryngeal reinnervation versus thyroplasty for unilateral vocal fold paralysis.
abstract: OBJECTIVE
  To explore unilateral vocal fold paralysis patients' perception of a proposed randomised, controlled trial of laryngeal reinnervation versus thyroplasty, and to identify patients' concerns regarding their voice.
  
  
  METHODS
  Seventeen patients from five voice clinics in London were identified as being eligible for the randomised, controlled trial. Eleven of these patients (9 females and 2 males; age range, 18-65 years) were interviewed using a semi-structured topic guide (they were given a minimum of 2 weeks to read through the study information sheet). The interviews were recorded, transcribed and analysed using thematic analysis.
  
  
  RESULTS
  The patients were satisfied with the clarity of the information sheet. Most of them perceived that reinnervation was a more 'attractive' option than thyroplasty. This may have been the result of certain phraseology used in the information sheet and by recruiters. Patients' main concern was reduced voice strength and the effects of this on work and social life.
  
  
  CONCLUSIONS
  Phraseology that needed changing was identified; these changes may optimise the recruitment process for a trial. We propose using the voice handicap index 10 as the primary measure of outcome in the proposed randomised, controlled trial.
authors.affiliation: Ear Institute,University College London,UK.
authors.forename: M
authors.initials: M
authors.lastname: Mat Baki
authors.affiliation: Joint Research Office,University College London,UK.
authors.forename: R
authors.initials: R
authors.lastname: Yu
authors.affiliation: Royal National Throat,Nose and Ear Hospital,University College London Hospital NHS Trust,UK.
authors.forename: J S
authors.initials: JS
authors.lastname: Rubin
authors.affiliation: Guy's and St Thomas' NHS Trust,London,UK.
authors.forename: E
authors.initials: E
authors.lastname: Chevretton
authors.affiliation: Charing Cross Hospital,Imperial College Healthcare NHS Trust,London,UK.
authors.forename: G
authors.initials: G
authors.lastname: Sandhu
authors.affiliation: Ear Institute,University College London,UK.
authors.forename: M A
authors.initials: MA
authors.lastname: Birchall
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D061224:Laryngeal Nerve Injuries / Q000601:surgery*; D007823:Laryngeal Nerves / Q000601:surgery*; D058753:Laryngoplasty; D008297:Male; D008875:Middle Aged; D010361:Patients / Q000523:psychology*; D014826:Vocal Cord Paralysis / Q000601:surgery*; D014831:Voice
keywords: Laryngeal Nerve Injuries; Laryngeal Reinnervation; Randomized Controlled Trial; Thyroplasty; Vocal Cord Paralysis