title: Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 5. Speech outcomes in 5-year-olds - consonant proficiency and errors.
abstract: OBJECTIVE
  Normal articulation before school start is a main objective in cleft palate treatment. The aim was to investigate if differences exist in consonant proficiency at age 5 years between children with unilateral cleft lip and palate (UCLP) randomised to different surgical protocols for primary palatal repair. A secondary aim was to estimate burden of care in terms of received additional secondary surgeries and speech therapy.
  
  
  METHODS
  Three parallel group, randomised clinical trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark, Finland, Norway, Sweden, and the UK.
  
  
  METHODS
  Three different surgical protocols for primary palatal repair were tested against a common procedure in the total cohort of 448 children born with non-syndromic UCLP. Speech audio- and video-recordings of 391 children (136 girls and 255 boys) were available and transcribed phonetically. The main outcome measure was Percent Consonants Correct (PCC) from blinded assessments.
  
  
  RESULTS
  In Trial 1, arm A showed statistically significant higher PCC scores (82%) than arm B (78%) (p = .045). No significant differences were found between prevalences in Trial 2, A: 79%, C: 82%; or Trial 3, A: 80%, D: 85%. Across all trials, girls achieved better PCC scores, excluding s-errors, than boys (91.0% and 87.5%, respectively) (p = .01).
  
  
  CONCLUSIONS
  PCC scores were higher in arm A than B in Trial 1, whereas no differences were found between arms in Trials 2 or 3. The burden of care in terms of secondary pharyngeal surgeries, number of fistulae, and speech therapy visits differed.
  
  
  BACKGROUND
  ISRCTN29932826.
authors.affiliation: a Department of Nordic Studies and Linguistics , University of Copenhagen , Denmark.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Willadsen
authors.affiliation: b Division of Speech and Language Pathology , Karolinska Institutet, Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Anette
authors.initials: A
authors.lastname: Lohmander
authors.affiliation: c Division of Speech and Language Pathology , Sahlgrenska University Hospital , Gothenburg , Sweden.|d Institute of Neuroscience and Physiology, Speech and Language Pathology Unit , Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden.
authors.forename: Christina
authors.initials: C
authors.lastname: Persson
authors.affiliation: e Division of Speech and Language Pathology , Linköping University , Linköping , Sweden.
authors.forename: Inger
authors.initials: I
authors.lastname: Lundeborg
authors.affiliation: f Cleft Palate and Craniofacial Center , Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Suvi
authors.initials: S
authors.lastname: Alaluusua
authors.affiliation: g Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Ragnhild
authors.initials: R
authors.lastname: Aukner
authors.affiliation: h Copenhagen Cleft Palate Centre , University Hospital of Copenhagen , Denmark.
authors.forename: Anja
authors.initials: A
authors.lastname: Bau
authors.affiliation: h Copenhagen Cleft Palate Centre , University Hospital of Copenhagen , Denmark.
authors.forename: Maria
authors.initials: M
authors.lastname: Boers
authors.affiliation: i Greater Manchester Cleft Unit , Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Bowden
authors.affiliation: i Greater Manchester Cleft Unit , Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Davies
authors.affiliation: j Cleft Palate Centre , Aarhus , Denmark.
authors.forename: Berit
authors.initials: B
authors.lastname: Emborg
authors.affiliation: k Cleft Palate Team , Sahlgrenska University Hospital , Gothenburg , Sweden.
authors.forename: Christina
authors.initials: C
authors.lastname: Havstam
authors.affiliation: l The Royal Hospital for Sick Children , Belfast , Northern Ireland.
authors.forename: Christine
authors.initials: C
authors.lastname: Hayden
authors.affiliation: m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Gunilla
authors.initials: G
authors.lastname: Henningsson
authors.affiliation: n Statped Vest , Bergen , Norway.
authors.forename: Anders
authors.initials: A
authors.lastname: Holmefjord
authors.affiliation: e Division of Speech and Language Pathology , Linköping University , Linköping , Sweden.
authors.forename: Elina
authors.initials: E
authors.lastname: Hölttä
authors.affiliation: j Cleft Palate Centre , Aarhus , Denmark.
authors.forename: Mia
authors.initials: M
authors.lastname: Kisling-Møller
authors.affiliation: g Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Lillian
authors.initials: L
authors.lastname: Kjøll
authors.affiliation: m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Maria
authors.initials: M
authors.lastname: Lundberg
authors.affiliation: l The Royal Hospital for Sick Children , Belfast , Northern Ireland.
authors.forename: Eilish
authors.initials: E
authors.lastname: McAleer
authors.affiliation: m Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Jill
authors.initials: J
authors.lastname: Nyberg
authors.affiliation: f Cleft Palate and Craniofacial Center , Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Marjukka
authors.initials: M
authors.lastname: Paaso
authors.affiliation: n Statped Vest , Bergen , Norway.
authors.forename: Nina Helen
authors.initials: NH
authors.lastname: Pedersen
authors.affiliation: n Statped Vest , Bergen , Norway.
authors.forename: Therese
authors.initials: T
authors.lastname: Rasmussen
authors.affiliation: n Statped Vest , Bergen , Norway.
authors.forename: Sigvor
authors.initials: S
authors.lastname: Reisæter
authors.affiliation: h Copenhagen Cleft Palate Centre , University Hospital of Copenhagen , Denmark.
authors.forename: Helene Søgaard
authors.initials: HS
authors.lastname: Andersen
authors.affiliation: h Copenhagen Cleft Palate Centre , University Hospital of Copenhagen , Denmark.
authors.forename: Antje
authors.initials: A
authors.lastname: Schöps
authors.affiliation: g Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Inger-Beate
authors.initials: IB
authors.lastname: Tørdal
authors.affiliation: g Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.|o Dental School , University of Manchester , Manchester , UK.|p Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
authors.forename: Gunvor
authors.initials: G
authors.lastname: Semb
mesh_terms: D001184:Articulation Disorders / Q000209:etiology / Q000628:therapy; D002675:Child, Preschool; D002971:Cleft Lip / Q000175:diagnosis / Q000601:surgery*; D002972:Cleft Palate / Q000175:diagnosis / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D038622:Internationality; D008297:Male; D016032:Randomized Controlled Trials as Topic; D019651:Plastic Surgery Procedures / Q000009:adverse effects / Q000379:methods*; D020127:Recovery of Function; D013064:Speech Disorders / Q000209:etiology / Q000628:therapy*; D013068:Speech Production Measurement; D013070:Speech Therapy / Q000379:methods*; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome
keywords: Primary palatal repair; cleft speech characteristics; consonant proficiency; randomised clinical trial; unilateral cleft lip and palate