WATCH Trial
| Watchful waiting for Aboriginal and Torres Strait Islander Children with Acute Otitis Media |
What is Otitis Media and what is the WATCH trial about?
Acute otitis media (AOM, or middle ear infection) is very common in childhood. The infection can be painful and may cause significant hearing loss during the critical period of a child’s development, particularly auditory processing. Persistent hearing loss causes problems with learning at school and difficulties getting a job later in life.
Antibiotics are recommended for high risk children such as those under 2 years of age, or Aboriginal and Torres Strait Islander children living in remote areas, where AOM is more likely to progress to eardrum perforation.
On the other hand, antibiotics are not recommended for older children who live in low risk areas, because these children tend to get better without antibiotics, and there are concerns that bacteria may become resistant to antibiotics.
Recent research has shown that Aboriginal children who live in low-risk urban areas have more episodes of AOM than their non-Aboriginal peers. Whether these children should or should not have antibiotics is not clear.
The goal of this WATCH trial is to find the best treatment for AOM in urban Aboriginal communities.
Watching closely without giving antibiotics straight away is called ‘watchful waiting’. Watchful waiting is a good option for children older than 2 years who are at low risk of complications. “Watchful waiting” is the recommended approach for non-Aboriginal children.
Aboriginal and Torres Strait Islander children from the city get less AOM than those from remote and rural areas, but they still get it more than non- Aboriginal and Torres Strait Islander children. The latest treatment guidelines now advise GPs to use a ‘watchful waiting’ approach with Aboriginal and Torres Strait Islander children from cities. Our study will make sure this is a safe and effective approach.
What will happen in the WATCH study?
Urban Indigenous health services were invited to review the research proposal.
Local Research Officers will recruit 500 children who have AOM diagnosed by their General Practitioner (GP). A computer program is used to randomly allocate children to one of two groups;
- Immediate antibiotics.
- “Watchful waiting” - no antibiotics.
All children will be offered pain relief.
After 3 days: A Research Officer from the health service will phone or visit the parent or carer.
After one week: The GP will check the child.
After 2 and 7 weeks: The Research Officer will check the child again at the health service.
At any time: The GP can change treatment or give antibiotics at any time if necessary.
After 3 months: The GP will also look at the child’s health service record after 3 months to check if there have been any problems.
VALUE FOR MONEY
As part of the study, we will also check to see which treatment is the best value for money. This will take into account things like how sick the child is with the infection, how much time parents and carers spend looking after the child and how much money they spend.
PEOPLE’s OPINIONS
Another part of the study will look at how carers, Aboriginal Health Workers, GPs, researchers and others feel about treatment of AOM and how the study worked. We will ask questions like ‘what was it like being in the study?’, ‘how do you feel about antibiotics?’, ‘what worked well in the study?’ and ‘what could we have done differently?’.
This study will provide good evidence for treatment of AOM in Aboriginal and Torres Strait Islander children in cities.
This research process will provide opportunities to improve the quality of future research with Aboriginal and Torres Strait Islander people.
How is the study working with local Aboriginal and Torres Strait Islander communities?
The project will take place in partnership with 5 Aboriginal Community Controlled Health Services (ACCHSs) and one Indigenous health service that have formally approved the study taking place in their communities. At all times the university researchers will work respectfully with these services.
Aboriginal researchers: Four members of the research team are Aboriginal researchers and six of the research team have worked for a long time in Aboriginal Medical Services (AMSs). All are strong supporters of Aboriginal and Torres Strait Islander community control of health and health research.
Associate Investigators: Each service will nominate one of their staff as an Associate Investigator to advise the research team about how best to work with their health service.
Local Reference Group: Each health service will establish a ‘Reference Group’ to link the researchers and the community.
Research officers (ROs): Each health service will employ ROs to receive research and clinical training from the WATCH team and to implement the trial at the site.
Funding: The study was funded by the National Health and Medical Research Council (NHMRC). Funding includes payment to health services, Reference Group members, gifts for parental time, and specialist diagnostic equipment which will remain with the health services to ensure ongoing “best-practice” approaches to diagnosing and treating AOM.
Ethical approvals: the study has been approved by AH&MRC, Menzies School of Health research, Metro South Health, University of Queensland and Western Sydney University Human Research Ethics committees.
If you would like any further information about this research, please contact
Robyn Walsh
Clinical Trial Coordinator
R.Walsh@westernsydney.edu.au
T: 02 4620 3486 or 0427 313 531
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