title: The Importance of Integration of Stakeholder Views in Core Outcome Set Development: Otitis Media with Effusion in Children with Cleft Palate.
abstract: BACKGROUND
  Approximately 75% of children with cleft palate (CP) have Otitis Media with Effusion (OME) histories. Evidence for the effective management of OME in these children is lacking. The inconsistency in outcome measurement in previous studies has led to a call for the development of a Core Outcome Set (COS). Despite the increase in the number of published COS, involvement of patients in the COS development process, and methods to integrate the views of patients and health professionals, to date have been limited.
  
  
  RESULTS
  A list of outcomes measured in previous research was identified through reviewing the literature. Opinion on the importance of each of these outcomes was then sought from key stakeholders: Ear, Nose and Throat (ENT) surgeons, audiologists, cleft surgeons, speech and language therapists, specialist cleft nurses, psychologists, parents and children. The opinion of health professionals was sought in a three round Delphi survey where participants were asked to score each outcome using a bespoke online system. Parents and children were also asked to score outcomes in a survey and provided an in-depth insight into having OME through semi-structured interviews. The results of the Delphi survey, interviews and parent/patient survey were brought together in a final consensus meeting with representation from all stakeholders. A final set of eleven outcomes reached the definition of "consensus in" to form the recommended COS: hearing; chronic otitis media (COM); OME; receptive language skills; speech development; psycho social development; acute otitis media (AOM); cholesteatoma; side effects of treatment; listening skills; otalgia.
  
  
  CONCLUSIONS
  We have produced a recommendation about the outcomes that should be measured, as a minimum, in studies of the management of OME in children with CP. The development process included input from key stakeholders and used novel methodology to integrate the opinion of healthcare professionals, parents and children.
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
authors.forename: Nicola L
authors.initials: NL
authors.lastname: Harman
authors.affiliation: Central Manchester University Hospitals NHS Foundation Trust, Royal Manchester Children's Hospital, Manchester, United Kingdom.
authors.forename: Iain A
authors.initials: IA
authors.lastname: Bruce
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
authors.forename: Jamie J
authors.initials: JJ
authors.lastname: Kirkham
authors.affiliation: Royal College of Nursing Research Institute, Warwick Medical School, University of Warwick, Warwick, United Kingdom.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Tierney
authors.affiliation: School of Nursing, Midwifery and Social Work, Jean McFarlane Building, University of Manchester, Manchester, United Kingdom.
authors.forename: Peter
authors.initials: P
authors.lastname: Callery
authors.affiliation: The Healing Foundation Cleft and Craniofacial Clinical Research Centre, School of Dentistry, University of Manchester, Manchester, United Kingdom.
authors.forename: Kevin
authors.initials: K
authors.lastname: O'Brien
authors.affiliation: NHS Lothian, ENT Department, Lauriston Place, Edinburgh, United Kingdom.
authors.forename: Alex M D
authors.initials: AM
authors.lastname: Bennett
authors.affiliation: North Thames Cleft Service and the Department of Audiological Medicine/ Audiology/Cochlear implants. Great Ormond Street Hospital for Children, London, United Kingdom.
authors.forename: Raouf
authors.initials: R
authors.lastname: Chorbachi
authors.affiliation: Cleft Net East, Cambridge University Hospital NHS Trust, Hills Road, Cambridge, United Kingdom.
authors.forename: Per N
authors.initials: PN
authors.lastname: Hall
authors.affiliation: Cleft Net East, Cambridge University Hospital NHS Trust, Hills Road, Cambridge, United Kingdom.
authors.forename: Anne
authors.initials: A
authors.lastname: Harding-Bell
authors.affiliation: Cleft Net East, Cambridge University Hospital NHS Trust, Hills Road, Cambridge, United Kingdom.
authors.forename: Victoria H
authors.initials: VH
authors.lastname: Parfect
authors.affiliation: Centre for Appearance Research, Department of Health & Social Sciences, University of the West of England, Bristol, United Kingdom.
authors.forename: Nichola
authors.initials: N
authors.lastname: Rumsey
authors.affiliation: North Thames Cleft Service, Speech and Language Therapy, Great Ormond Street Hospital for Children, London, United Kingdom.
authors.forename: Debbie
authors.initials: D
authors.lastname: Sell
authors.affiliation: North West, Isle of Man and North Wales Cleft Lip and Palate Network, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom.
authors.forename: Ravi
authors.initials: R
authors.lastname: Sharma
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
authors.forename: Paula R
authors.initials: PR
authors.lastname: Williamson
mesh_terms: D002648:Child; D002675:Child, Preschool; D002972:Cleft Palate / Q000150:complications / Q000453:epidemiology* / Q000628:therapy; D032921:Consensus; D019468:Disease Management; D006281:Health Occupations; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010034:Otitis Media with Effusion / Q000453:epidemiology* / Q000209:etiology / Q000628:therapy; D017063:Outcome Assessment, Health Care; D010290:Parents; D011795:Surveys and Questionnaires