The Importance of Integration of Stakeholder Views in Core Outcome Set Development: Otitis Media with Effusion in Children with Cleft Palate

被引：98

作者：

Harman, Nicola L. ^{[1
]}

Bruce, Iain A. ^{[2
]}

Kirkham, Jamie J. ^{[1
]}

Tierney, Stephanie ^{[3
]}

Callery, Peter ^{[4
]}

O'Brien, Kevin ^{[5
]}

Bennett, Alex M. D. ^{[6
]}

Chorbachi, Raouf ^{[7
,8
]}

Hall, Per N. ^{[9
]}

Harding-Bell, Anne ^{[9
]}

Parfect, Victoria H. ^{[9
]}

Rumsey, Nichola ^{[10
]}

Sell, Debbie ^{[11
]}

Sharma, Ravi ^{[12
]}

Williamson, Paula R. ^{[1
]}

机构：

[1] Univ Liverpool, Dept Biostat, MRC North West Hub Trials Methodol Res, Liverpool L69 3BX, Merseyside, England

[2] Cent Manchester Univ Hosp NHS Fdn Trust, Royal Manchester Childrens Hosp, Manchester, Lancs, England

[3] Univ Warwick, Warwick Med Sch, Royal Coll, Nursing Res Inst, Warwick, England

[4] Univ Manchester, Sch Nursing Midwifery & Social Work, Manchester, Lancs, England

[5] Univ Manchester, Sch Dent, Healing Fdn, Cleft & Craniofacial Clin Res Ctr, Manchester, Lancs, England

[6] NHS Lothian, ENT Dept, Edinburgh, Midlothian, Scotland

[7] Great Ormond St Hosp Sick Children, North Thames Cleft Serv, London WC1N 3JH, England

[8] Great Ormond St Hosp Sick Children, Dept Audiol Med Audiol Cochlear Implants, London WC1N 3JH, England

[9] Cambridge Univ Hosp NHS Trust, Cleft Net East, Cambridge, England

[10] Univ W England, Dept Hlth & Social Sci, Ctr Appearance Res, Bristol BS16 1QY, Avon, England

[11] Great Ormond St Hosp Sick Children, North Thames Cleft Serv, Speech & Language Therapy, London, England

[12] Alder Hey Childrens NHS Fdn Trust, North West Isle Man & North Wales Cleft Lip & Pal, Liverpool, Merseyside, England

来源：

PLOS ONE | 2015年 / 10卷 / 06期

关键词：

RANDOMIZED CONTROLLED-TRIAL; MIDDLE-EAR DISEASE; TYMPANOSTOMY TUBE INSERTION; 1ST; YEARS; CLINICAL-TRIALS; LANGUAGE-DEVELOPMENT; VENTILATION TUBES; PRESCHOOL-CHILDREN; GLUE EAR; HEARING IMPAIRMENT;

D O I：

10.1371/journal.pone.0129514

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

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. Methods and Findings 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.

引用

页数：22

共 79 条

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