What is DUTY all about?
What is the purpose of this study?
The study is called DUTY: The Diagnosis of Urinary Tract Infection in Young Children.
We want to improve the way doctors and nurses find out if a child has a urine infection (UTI). Doctors could then start the right treatment earlier for those who need it, and avoid unnecessary treatment for those who don’t.
Bladder or urinary infections in children are common. In rare cases, these infections may lead to future medical problems which could be prevented by early treatment. This is a particular problem in children under the age of five because their kidneys are more prone to damage from infections. It can be difficult to diagnose if a child has a urine infection as the symptoms are often the same as those for other illnesses, also young children cannot tell us what is wrong.
We do know that urine infection is more common in children who are already unwell but we don’t know how common or which children are at greatest risk.
For this study we will…
· Check the urine of nearly all children under the age of five who are seeing the doctor because they are not well, even if there seems to be another reason for the illness.
· See whether using a simple test on the urine, completed in the doctor’s surgery, can detect infection.
If we take part, what will happen to my child today?
· We will check that your child is OK to take part.
· There will be a form to fill in with the Researcher about your child and his/her illness.
· We will collect a urine sample from your child.
· We will then perform a quick test on the sample and send if off for further tests.
How long will this take
Taking part in the study may mean spending between 15 and 30 minutes longer in the surgery for the research nurse/officer to ask about symptoms and to collect the urine sample. In some cases the research nurse/officer will see you while you are waiting to see the doctor so you won’t be delayed at all. If you are delayed and it is more convenient for you, the research nurse/ officer may be able to visit you at home later in the day.
Would there be any follow-up?
A member of the research team may phone you about 2 weeks from the time you joined the study to ask how your child is and what treatment (if any) s/he has received. With your permission we will also look at your child’s medical records in 3 months.
What are the possible disadvantages and risks of taking part?
Taking part will mean that we take up a little of your time asking certain questions about your child’s illness, and in taking a urine sample. The way in which we are taking urine samples is safe and does not cause discomfort. We will not take any blood as part of this study.
What are the possible benefits of taking part?
There may be no direct benefit to your child taking part, but if your child is found to have an infection, treatment can be given. Improving the understanding, diagnosis and management of urinary infections may benefit your own child or other children in the future.
DUTY – improving the efficiency of diagnosing UTI in young children
Do we have to take part?
No. It is up to you whether or not you want your child to take part. Deciding not to take part will not affect the standard of care you or your child receives now or in the future.
What will happen if we don’t want to carry on with the study?
You and your child can leave the study at any time, without giving a reason. This will not affect the standard of care your family receives now or in the future.
What will happen to the results of the research study?
A report of the research results will be written and sent to the National Institute of
Health Research (NIHR), part of the Department of Health, who is funding the study. Results will also be published in scientific journals and presented at scientific conferences. Once the research study is completed, we will send a summary to your doctor to display in the waiting room.
If you would like any more information about the DUTY Study or have any questions, please ask to speak to a member of the DUTY team.
Principal Investigator:
Professor Brendan Delaney
Division of Health and Social Care Research
Kings College London
5th Floor Capital House
42 Weston Street
London SE1 3QD
Tel: 020 7848 6615
Email: Brendan.delaney@kcl.ac.uk
Pat Taylor – Study Administrator, London
Tel: 0208 848 8700
email: patricia.taylor@kcl.ac.uk
Introducing
The DUTY Study
Diagnosis of Urinary Tract infection in Young children
For more information please ask to speak to a member of the DUTY team!