Article type
Year
Abstract
Introduction: Otitis media in Aboriginal children with high rates of chronic disease is poorly managed.
Objective: To describe the process of obtaining evidence for a benefit or otherwise of treatment for OME in Aboriginal infants living in a remote, disadvantaged and cross-cultural setting.
Methods: Natural history and pilot antibiotic treatment studies were required to provide scientific evidence and a rationale for an RCT of OME treatment.
Results: The natural history and aetiology of OME in populations of low socio-economic status had previously been poorly understood. Metaanalyses show limited benefits of treatment in low-risk populations with higher natural cure rates. Our prospective studies showed that onset of OME occurred within weeks of birth and persisted throughout early childhood. Nasopharyngeal colonisation with respiratory bacteria was predictive of OM onset. Uncontrolled studies showed that early treatment led to less perforation but facilitated the spread of an antibiotic resistant strain of Streptococcus pneumoniae. Challenges in implementing an RCT include issues related to the cross-cultural and disadvantaged setting, ethical approval, obtaining clinical trial expertise and procurement of placebo.
Discussion: A strong rationale for an RCT was established during 3 years of preliminary research. Successful conduct of this RCT will have implications for management of otitis media with effusion and will provide incentives for further RCTs that address the many health problems of Aboriginal Australians.
Objective: To describe the process of obtaining evidence for a benefit or otherwise of treatment for OME in Aboriginal infants living in a remote, disadvantaged and cross-cultural setting.
Methods: Natural history and pilot antibiotic treatment studies were required to provide scientific evidence and a rationale for an RCT of OME treatment.
Results: The natural history and aetiology of OME in populations of low socio-economic status had previously been poorly understood. Metaanalyses show limited benefits of treatment in low-risk populations with higher natural cure rates. Our prospective studies showed that onset of OME occurred within weeks of birth and persisted throughout early childhood. Nasopharyngeal colonisation with respiratory bacteria was predictive of OM onset. Uncontrolled studies showed that early treatment led to less perforation but facilitated the spread of an antibiotic resistant strain of Streptococcus pneumoniae. Challenges in implementing an RCT include issues related to the cross-cultural and disadvantaged setting, ethical approval, obtaining clinical trial expertise and procurement of placebo.
Discussion: A strong rationale for an RCT was established during 3 years of preliminary research. Successful conduct of this RCT will have implications for management of otitis media with effusion and will provide incentives for further RCTs that address the many health problems of Aboriginal Australians.