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19/69 Clinical and cost-effectiveness of alternative urinary catheter design

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research Question: Among adults who require long-term urethral catheterisation, is an alternative catheter design to the traditional Foley catheter clinically and cost effective at preventing catheter-associated urinary tract infection?    

  1. Intervention: Novel urinary catheter design. Applicants should identify and justify their choice of design. The catheter of choice needs to be sufficiently developed to be suitable for evaluation within the HTA programme and for use in the NHS. Please note: Investigations focused on catheter coatings are not included in this research grant.  
  2. Patient group: Patients requiring long-term urethral catheterisation.
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Any appropriate setting, but should include primary care and community.
  4. Control: Foley catheter.
  5. Study design: A pragmatic and efficient randomised controlled trial with internal pilot phase with clear stop/go progression criteria. Applicants should describe how compliance with the 'Catheter-associated urinary tract infection (CAUTI) care bundle' would be considered. 
  6. Important outcomes: Urinary tract infection; antibiotic load. Applicants should define how urinary tract infection would be assessed. 
    Other outcomes: Patient and carer experience; mean number of catheter days in-situ (dwell time) and number of catheter changes; adverse events (including, but not limited to blockage, leakage, bladder spasms); cost-effectiveness; catheter related quality of life; ease of use and acceptability to healthcare professionals; health service utilisation.
  7. Minimum duration of follow-up: 6 months.
    Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale:

Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm for patients in hospital and incurs significant costs for health-care providers such as the NHS. Many preventative strategies and measures have been introduced to minimise CAUTI risk, including antibiotic prophylaxis and the use of antimicrobial catheters. However, there is considerable uncertainty over the usefulness and cost-effectiveness of these interventions for the reduction of symptomatic CAUTI.

Modified catheter designs have recently been developed in an attempt to reduce or eliminate the adverse events associated with the use of Foley catheters, including urinary tract infections, cystitis, blockage, damage to the urethra and bladder wall, haematuria and patient discomfort.

To date, there is a lack of research evidence to support the use of novel urinary catheters in routine practice. A study is needed to investigate the clinical and cost-effectiveness of these devices and to assess clinicians' and patients' experience.

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 htaresearchers@nihr.ac.uk.

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 22nd January 2020. Applications will be considered by the HTA Funding Committee at its meeting in March.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

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. 

Applications received after 1300 hours on the due date will not be considered.

Should you have any queries please contact us:

Email:   htacet@nihr.ac.uk

Telephone:  CET Funding Committee 02380 597484