Case study: OSTRICH study
Oral STeroids for Resolution of otitis media with effusion (OME) In CHildren
• Funded by the NIHR Health Technology Assessment (HTA) programme.
• Managed by NIHR Clinical Research Network Children Specialty, delivered by Ear, Nose and Throat Specialty.
• Recruitment open March 2014 to May 2016.
• 389 children were recruited through 21 sites (in England and Wales) across 10 Local Clinical Research Networks.
• Chief Investigators: Professor Chris Butler, Nuffield Department of Primary Care Health Sciences, University of Oxford; and Professor Nick Francis, Division of Population Medicine, School of Medicine, Cardiff University.
Otitis media with effusion, also known as glue ear, is a very common condition, especially in young children. Whilst we know that glue ear usually gets better by itself, in thousands of children each year it can cause hearing loss, which can lead to further problems such as difficulty with learning and speech development. If hearing loss lasts longer than three months children are often offered a grommet operation and sometimes a hearing aid. Some research studies have found that taking a prescribed steroid medication (these steroids are commonly used to treat asthma and other conditions, and are not the same as steroids that are used to build muscles) for a short period seems to result in glue ear getting better in some children. However, the studies that have been done so far have been small, have mostly not measured the effect on hearing and learning, and have not measured how long any effects last. If treatment with an oral steroid does improve hearing then it is likely that some children can avoid having an operation or needing to wear a hearing aid. The OSTRICH study aims to provide more definite measurements, recruiting 380 children aged between two to eight years who have glue ear for at least three months.
Outcomes and findings
Over 380 children aged between two to eight years and their families took part in the study. One third of the children could hear well after five weeks, slightly more children could hear well in the group that took the steroid tablets but the difference between the groups was small and might have been a chance finding. More than half the children could hear well after six months and slightly more at twelve months. There was no difference between the two groups in hearing or response to questionnaires that covered things like school work, mood and concentration. This means that most children with glue ear will find that their hearing gets better within a few months, even in children with longer lasting glue ear that causes hearing loss in both ears. Treatment with steroid tablets for a week does not make a big difference to how quickly hearing improves in two to eight year old children.
“Our study shows that glue ear often gets better by itself – one in three of these children with prolonged glue ear, and who took placebo tablets, had satisfactory hearing by five weeks. “One third of the children could hear well after five weeks, slightly more children could hear well in the group that took the steroid tablets but the difference between the groups was small and might have been a chance finding.”
Professor Nick Francis, Cardiff University Co-led the study with Professor Chris Butler, University of Oxford
Value to the NHS
There is currently considerable variation in practice regarding the management of otitis media with effusion. Evidence does not support a one-week course of oral steroids as a clinical or cost effective intervention for children aged two to eight years. This study should lead to a reduction in the number of children being exposed to oral steroids, thereby reducing the risk of adverse effects and saving the NHS money. Evidence also suggests that by waiting, the need for a grommet operation or hearing aid may also be avoided. It is too early to evidence whether study findings have influenced practice. The results were recently published in the Lancet and summarised in the New England Journal of Medicine, BMJ and Journal of Paediatrics and Child Health, they are yet to make their way into published guidelines.