title: A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Treatment guidelines recommend watchful waiting for children older than 2 years with acute otitis media (AOM) without perforation, unless they are at high risk of complications. The high prevalence of chronic suppurative otitis media (CSOM) in remote Aboriginal and Torres Strait Islander communities leads these children to be classified as high risk. Urban Aboriginal and Torres Strait Islander children are at lower risk of complications, but evidence to support the subsequent recommendation for watchful waiting in this population is lacking.
  
  
  METHODS
  This non-inferiority multi-centre randomised controlled trial will determine whether watchful waiting is non-inferior to immediate antibiotics for urban Aboriginal and Torres Strait Islander children with AOM without perforation. Children aged 2 - 16 years with AOM who are considered at low risk for complications will be recruited from six participating urban primary health care services across Australia. We will obtain informed consent from each participant or their guardian. The primary outcome is clinical resolution on day 7 (no pain, no fever of at least 38 °C, no bulging eardrum and no complications of AOM such as perforation or mastoiditis) as assessed by general practitioners or nurse practitioners. Participants and outcome assessors will not be blinded to treatment. With a sample size of 198 children in each arm, we have 80 % power to detect a non-inferiority margin of up to 10 % at a significance level of 5 %, assuming clinical improvement of at least 80 % in both groups. Allowing for a 20 % dropout rate, we aim to recruit 495 children. We will analyse both by intention-to-treat and per protocol. We will assess the cost- effectiveness of watchful waiting compared to immediate antibiotic prescription. We will also report on the implementation of the trial from the perspectives of parents/carers, health professionals and researchers.
  
  
  CONCLUSIONS
  The trial will provide evidence for the safety and effectiveness of watchful waiting for the management of AOM in Aboriginal and Torres Strait Islander children living in urban settings who are considered to be at low risk of complications.
  
  
  BACKGROUND
  The trial is registered with Australia New Zealand Clinical Trials Registry ( ACTRN12613001068752 ). Date of registration: 24 September 2013.
authors.affiliation: School of Medicine, Western Sydney University, Sydney, NSW, Australia. p.abbott@westernsydney.edu.au.
authors.forename: Penelope
authors.initials: P
authors.lastname: Abbott
authors.affiliation: University of Sydney, Sydney, NSW, Australia. hasantha.gunasekera@sydney.edu.au.
authors.forename: Hasantha
authors.initials: H
authors.lastname: Gunasekera
authors.affiliation: Menzies School of Health Research, Darwin, NT, Australia. Amanda.Leach@menzies.edu.au.
authors.forename: Amanda Jane
authors.initials: AJ
authors.lastname: Leach
authors.affiliation: Discipline of General Practice, University of Queensland, Brisbane, QLD, Australia. Deborah.askew@health.qld.gov.au.|Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care (Inala Indigenous Health Service), Queensland Health, Brisbane, QLD, Australia. Deborah.askew@health.qld.gov.au.
authors.forename: Deborah
authors.initials: D
authors.lastname: Askew
authors.affiliation: School of Medicine, Western Sydney University, Sydney, NSW, Australia. r.walsh@westernsydney.edu.au.
authors.forename: Robyn
authors.initials: R
authors.lastname: Walsh
authors.affiliation: University of Newcastle, Newcastle, NSW, Australia. a.profkkong@hunterent.com.au.
authors.forename: Kelvin
authors.initials: K
authors.lastname: Kong
authors.affiliation: School of Medicine, Western Sydney University, Sydney, NSW, Australia. f.girosi@westernsydney.edu.au.
authors.forename: Federico
authors.initials: F
authors.lastname: Girosi
authors.affiliation: Indigenous Studies Research Network, Queensland University of Technology, Brisbane, QLD, Australia. chelsea.bond@qut.edu.au.
authors.forename: Chelsea
authors.initials: C
authors.lastname: Bond
authors.affiliation: Menzies School of Health Research, Darwin, NT, Australia. Peter.Morris@menzies.edu.au.
authors.forename: Peter
authors.initials: P
authors.lastname: Morris
authors.affiliation: School of Medicine, Western Sydney University, Sydney, NSW, Australia. s.lujic@unsw.edu.au.|Centre for Big Data Research in Health, University of NSW, Sydney, NSW, Australia. s.lujic@unsw.edu.au.
authors.forename: Sanja
authors.initials: S
authors.lastname: Lujic
authors.affiliation: School of Medicine, Western Sydney University, Sydney, NSW, Australia. w.hu@westernsydney.edu.au.
authors.forename: Wendy
authors.initials: W
authors.lastname: Hu
authors.affiliation: Sydney Medical School Westmead, University of Sydney, Sydney, NSW, Australia. tim.usherwood@sydney.edu.au.
authors.forename: Tim
authors.initials: T
authors.lastname: Usherwood
authors.affiliation: Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care (Inala Indigenous Health Service), Queensland Health, Brisbane, QLD, Australia. Claudette.Tyson@health.qld.gov.au.
authors.forename: Sissy
authors.initials: S
authors.lastname: Tyson
authors.affiliation: Discipline of General Practice, University of Queensland, Brisbane, QLD, Australia. g.spurling@uq.edu.au.|Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care (Inala Indigenous Health Service), Queensland Health, Brisbane, QLD, Australia. g.spurling@uq.edu.au.
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Spurling
authors.affiliation: Awabakal Aboriginal Primary Health Care Centre, Newcastle, NSW, Australia. mdouglas@awabakal.org.
authors.forename: Markeeta
authors.initials: M
authors.lastname: Douglas
authors.affiliation: Awabakal Aboriginal Primary Health Care Centre, Newcastle, NSW, Australia. KSchubert@awabakal.org.
authors.forename: Kira
authors.initials: K
authors.lastname: Schubert
authors.affiliation: Winnunga Nimmityjah Aboriginal Health Service, Canberra, ACT, Australia. Shavaun.Chapman@winnunga.org.au.
authors.forename: Shavaun
authors.initials: S
authors.lastname: Chapman
authors.affiliation: Winnunga Nimmityjah Aboriginal Health Service, Canberra, ACT, Australia. Nadeem.Siddiqui@winnunga.org.au.
authors.forename: Nadeem
authors.initials: N
authors.lastname: Siddiqui
authors.affiliation: Winnunga Nimmityjah Aboriginal Health Service, Canberra, ACT, Australia. Reeion.Murray@winnunga.org.au.
authors.forename: Reeion
authors.initials: R
authors.lastname: Murray
authors.affiliation: Aboriginal and Torres Strait Islander Community Health Services, Brisbane, QLD, Australia. Keitha.Rabbitt@atsichsbrisbane.org.au.
authors.forename: Keitha
authors.initials: K
authors.lastname: Rabbitt
authors.affiliation: Aboriginal and Torres Strait Islander Community Health Services, Brisbane, QLD, Australia. Bobby.Porykali@atsichsbrisbane.org.au.
authors.forename: Bobby
authors.initials: B
authors.lastname: Porykali
authors.affiliation: Tharawal Aboriginal Corporation, Sydney, NSW, Australia. Cheryl.Woodall@tacams.com.au.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Woodall
authors.affiliation: Tharawal Aboriginal Corporation, Sydney, NSW, Australia. tina.newman@tacams.com.au.
authors.forename: Tina
authors.initials: T
authors.lastname: Newman
authors.affiliation: School of Medicine, Western Sydney University, Sydney, NSW, Australia. j.reath@westernsydney.edu.au.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Reath
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D000208:Acute Disease; D000367:Age Factors; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D000095283:Australian Aboriginal and Torres Strait Islander Peoples; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D057194:Intention to Treat Analysis; D010033:Otitis Media / Q000175:diagnosis / Q000191:economics / Q000208:ethnology / Q000628:therapy; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014504:Urban Health; D057832:Watchful Waiting / Q000191:economics; D000074099:Equivalence Trials as Topic
chemical_list: D000900:Anti-Bacterial Agents