The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.
Is it feasible to conduct a study to establish what is the optimal method of urine collection in infants, children and young people with a suspected urinary tract infection (UTI)?
- Intervention: Catheter or supra-pubic aspiration (SPA).
- Patient group: Infants, children and young people aged under 16 years with a suspected urinary tract infection, who are not yet toilet trained.
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
- Setting: Any appropriate setting.
- Comparator: Clean catch (mid-stream) urine, with or without bladder stimulation techniques (applicants to define and justify).
- Study design: A standalone study to assess the feasibility of whether a trial is possible and to establish key elements of the potential future trial design. This should include qualitative work with children, parents, and clinicians to understand the decisions and uncertainties of those involved.
- Important outcomes and outputs: Findings from qualitative work, including determination of equipoise, acceptability of randomisation to children, parents and clinicians; determination of important outcomes for use in a future trial to include potential benefits and harms; feasibility of trial delivery.
A randomised element is not expected as part of this commission. A decision whether to advertise for a full trial will be made at a later date once results of the feasibility report are known.
Urinary tract infections (UTIs) are very common in childhood, particularly in infancy, and can be potentially serious. Early diagnosis is important as missed episodes of UTIs can lead to more serious infections and potentially cause kidney scarring. A urine sample is required to diagnose a UTI but obtaining a sample from a child who is not continent can be very challenging. Non-invasive methods involve waiting for the child to urinate and collecting the urine using a nappy pad, bag, or a ‘clean catch’ of the urine stream. These collection methods can have high rates of contamination due to their proximity to skin in the perigenital area. Catheterisation and suprapubic aspiration (SPA) are both invasive methods of urine collection: catheterisation involves a small tube inserted through the urethra into the bladder, allowing urine to flow out, and SPA allows a sample of urine to be obtained via a needle inserted directly into the bladder. Invasive methods are much less likely to result in a urine sample being contaminated, but may cause the child pain and be less acceptable to parents/carers.
It is important that urine samples are obtained quickly and accurately: an unsuccessful collection increases the risk of a delayed diagnosis, and a contaminated sample could lead to increased inappropriate antibiotic prescribing and antibiotic resistance. Collection methods need to consider the time and resources required, rates of contamination, and the preferences of the parent/carer, child and clinician. Internationally, guidelines for the collection of urine samples from children vary. There is uncertainty about which is the optimal method of urine collection: in the UK, clean catch collection is recommended, whereas North America recommends SPA. Optimising urine collection methods in children who are not yet continent will enable UTIs to be diagnosed quickly and accurately, improving patient outcomes and parent/carer satisfaction.
Therefore, the HTA programme is interested in commissioning research to investigate the feasibility of conducting a trial in this are to establish the optimal method of urine collection in infants, children and young people with suspected UTI. As well as establishing the key parameters of a potential future trial, it is anticipated that the feasibility study will also identify the acceptability of the different methods to parents/carers, and patients where appropriate.
Additional commissioning brief background information
A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email email@example.com.
Making an application
If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.
Your application must be submitted on-line no later than 1pm on the 25 January 2023. Applications will be considered by the HTA Funding Committee at its meeting in March 2023.
Guidance notes and supporting information for HTA Programme applications are available.
Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in July 2023.
Applications received electronically after 1300 hours on the due date will not be considered.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.
For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.
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