Children and young people
Mae'r cynnwys hwn ar gael yn Saesneg yn unig.
We help support improvements in the health of children through studies to promote more accurate diagnosis of illness, and trialling novel interventions.
- Biological, social and environmental determinants of child health and social outcomes and inequalities
- Developing and testing interventions, services and programmes to improve health and social outcomes
- Design, evaluation and implementation of high quality health and care services for children
A follow up to the Building Blocks study published in the Lancet in 2015, this important data linkage project will not involve any further data collection from individual participants, but, instead, uniquely link pre-existing data to track potential longer term benefits of the initial intervention.
The Building Blocks trial assessed the short-term impact of the Family Nurse Partnership (FNP) programme - an intensive programme of antenatal and postnatal visiting by specially trained nurses to support young pregnant women in England.
The FNP programme has been shown to reduce child maltreatment in US studies, however this has largely been evidenced in the longer term (beyond the first two years).
Routinely collected data
The Building Blocks: 2-6 study will assess the long term impacts of the programme for mothers and children (n=1562), through the linkage of routinely collected data to the trial data, with a particular emphasis on the programme’s impact upon child maltreatment.
We have contacted the trial participants to notify them of this follow-on study and they have had the opportunity to opt-out. To date, less than 10 participants have opted out.
This is a data linkage project and will not involve any further data collection from individual participants. Data instead will be accessed from routine data sources held by information centres – NHS Digital (previously HSCIC), Department of Health and Department for Education. Data currently available includes hospital admissions & attendance, social care data and education data.
Upon approval for access to these data sources, the information centres will:
- Match the study participants to their data sources;
- Link hospital, education and social care data for these participants;
- Send this data to SAIL (Swansea University) - our trusted third party;
- The Secure Anonymised Information Linkage (SAIL) Databank will anonymise the data and then make it available to the BB:2-6 study team for cleaning and analysis.
This model of data-linkage offers potential benefits:
- the possibility for long term evaluation of interventions
- lower costs to conduct the study
- reduced participant burden
- reduced bias associated with differential elective participation and
- potential to extend to other sources of routine data.
Involving the public and patients
A group of care-experienced young people (CASCADE voices) advised on the layout, wording and tone of the letter that was sent to participants. A key consideration was to communicate the focus of this follow-on study in a sensitive manner. Their input helped to shape the letter considerably.
Communicating data linkage and the use of routine data for research is a challenge. It is a complicated method to explain but it is important that participants understand what is happening to their data and are reassured with regards to data security.
The first wave of data collection from routine records will incorporate a formal pilot to develop cleaning and analysis scripts. This first wave will be carried out mid-2016. The second wave will be carried out once all children have reached key stage one – in 2017.
A benefit of this project is the understanding and learning of the governance challenges involved with accessing data from information centres. There is potential to use this method for future trials looking at longer term follow-up. Therefore this study has the potential to contribute greatly to the knowledge of using routine data and data linkage methods in a clinical trial setting in the future.
Funder: National Institute for Health Research Public Health Research Programme (NIHR PHR)
Chief Investigator: Dr Mike Robling
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