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

Abbott, Penelope, Gunasekera, Hasantha, Leach, Amanda Jane, Askew, Deborah, Walsh, Robyn, Kong, Kelvin, Girosi, Federico, Bond, Chelsea, Morris, Peter, Lujic, Sanja, Hu, Wendy, Usherwood, Tim, Tyson, Sissy, Spurling, Geoffrey, Douglas, Markeeta, Schubert, Kira, Chapman, Shavaun, Siddiqui, Nadeem, Murray, Reeion, Rabbitt, Keitha, Porykali, Bobby, Woodall, Cheryl, Newman, Tina and Reath, Jennifer (2016) 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. Trials, 17 119: 119.1-119.10. doi:10.1186/s13063-016-1247-y


Author Abbott, Penelope
Gunasekera, Hasantha
Leach, Amanda Jane
Askew, Deborah
Walsh, Robyn
Kong, Kelvin
Girosi, Federico
Bond, Chelsea
Morris, Peter
Lujic, Sanja
Hu, Wendy
Usherwood, Tim
Tyson, Sissy
Spurling, Geoffrey
Douglas, Markeeta
Schubert, Kira
Chapman, Shavaun
Siddiqui, Nadeem
Murray, Reeion
Rabbitt, Keitha
Porykali, Bobby
Woodall, Cheryl
Newman, Tina
Reath, Jennifer
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
Journal name Trials   Check publisher's open access policy
ISSN 1745-6215
Publication date 2016-03-03
Year available 2016
Sub-type Article (original research)
DOI 10.1186/s13063-016-1247-y
Open Access Status DOI
Volume 17
Issue 119
Start page 119.1
End page 119.10
Total pages 10
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2017
Language eng
Formatted 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/Design
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.

Discussion
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.

Trial registration
The trial is registered with Australia New Zealand Clinical Trials Registry (ACTRN12613001068752). Date of registration: 24 September 2013.
Keyword Otitis media
Acute otitis media
Aboriginal and Torres Strait Islander peoples
Indigenous population
Children
Antimicrobial agents
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Discipline of General Practice Publications
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