Using steroids to treat Otitis Media with Effusion or glue ear in children.
The Oral Steroids for the resolution of Otitis Media with effusion in children study (OSTRICH) is funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme.
Otitis media with effusion (OME), also known as glue ear, is a common condition, especially in young children. Whilst 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 3 months, children are often offered hearing aids or a grommet operation.
Professor Chris Butler at the University of Oxford, who co-led the study with Professor Nick Francis at Cardiff University, said:
"Glue ear is an important cause of deafness and the most common reason for children to have an operation in the UK. If oral steroids, which are commonly used as a treatment for asthma in children, prove to be effective, we will be able to offer parents a new treatment choice to improve their child's quality of life and that may avert the need for an operation. Such an approach is also likely to result in significant savings for the NHS."
Some studies have found that taking a prescribed steroid medication 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 have not measured how long any effects last. This provides the rationale for a randomised controlled trial to determine if a short course of oral steroids improves the hearing of children with OME in the short and longer term.
The study team planned to recruit 380 participants (children aged 2-8 years) from seven main hospitals in Wales. However, recruitment was slower than anticipated and the study was extended into England, opening an additional 16 sites. Challenges to recruitment have included the fluctuating and seasonal nature of glue ear. It is most prevalent in the colder, winter period so the number of eligible children varies and decreases in the summer months.
Since opening more sites and making slight amendments to the protocol to make it easier for sites to recruit (such as extending the time window for follow up appointments), the study reached its recruitment target.
Participants take a course of oral steroid, or a matched placebo, for one week. Measurements, including hearing, persistence of glue ear, functional health status and quality of life, will be made just before the start of treatment and at 5 weeks, 3, 6 and 12 months.
The main outcome will be satisfactory hearing 4 weeks after steroid treatment. Other outcomes include:
- satisfactory hearing in the long term
- clearing of OME
- quality of life
- cost effectiveness.
Bringing services together
The trial uniquely requires bringing together two distinct clinical services (Ear, Nose and Throat and Audiology). We had extensive discussions with every site to work out the logistics of running the trial between the separate services, including booking hearing tests when audiology clinics run on separate days or are in separate locations to the recruiting ENT clinics, and scheduling follow up appointments when capacity is limited.
Involving the public and patients
Public and patient representatives on the steering and management committees have provided the OSTRICH team with valuable input throughout the duration of the trial from the design stage, questionnaire development and recruitment. One representative appeared on the BBC Wales news and was interviewed on BBC Wales breakfast radio to help provide exposure to the trial and give her experiences of having a child with glue ear. This generated interest from parents who wanted their children to take part in the trial.
Recruitment has just completed, with some participants undergoing follow ups until March 2017. The potential impact of this study - if treatment with an oral steroid does improve hearing – is that some children may avoid needing an operation or having to wear a hearing aid.
Funder: The National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme
Chief Investigators: Professor Chris Butler and Dr Nick Francis