Recommendations for research
The GDG has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.
Recent changes to the delivery of healthcare mean that care is increasingly delivered within a patient's home environment. Infection prevention in this setting is just as important as in hospital. There are currently approximately 6 million unpaid carers in the UK, a number that is likely to increase with an aging population. The association between carer training and infection rates is unknown. No evidence of surveillance of healthcare-associated infections in the community is currently available in the UK.
A qualitative study is needed to investigate the themes surrounding the barriers to patient and carer compliance with the standard principles of infection prevention in their own homes. It would be important to assess whether lack of awareness or knowledge is a barrier. If patients and carers have received education, this should be assessed to see if this was applicable to the patient's home setting. Areas of low compliance in the home environment need to be identified. The findings could have far-reaching implications for discharge planning and duty of care.
When clean running water is not available, what is the clinical and cost effectiveness of using wipes, gels, handrubs or other products to remove visible contamination?
Community healthcare workers often encounter challenges in carrying out hand decontamination when there is no access to running water. This particularly affects ambulance service staff, who often provide emergency care at locations where running water is not available. No evidence from randomised controlled trials is available on the most effective way for community-based healthcare workers to remove physical contamination, such as blood, from their hands in the absence of running water. In recent years, hand decontamination products that can be used without running water, such as gels, handrubs and wipes, have become available. However, their efficacy and suitability in actual clinical practice for use with visibly dirty hands has not been determined. A randomised controlled trial is required to compare hand wipes (alcohol and antiseptic), hand gels and other hand decontamination products that can be used without running water, to determine the most effective way to remove physical dirt in the absence of running water, in order to make a recommendation for their use in real situations. The primary outcome measure should be colony-forming units on the basis of the adenosine triphosphate (ATP) surface test.
For patients performing intermittent self-catheterisation over the long term, what is the clinical and cost effectiveness of single-use non-coated versus single-use hydrophilic versus single-use gel reservoir versus reusable non-coated catheters with regard to the following outcomes: symptomatic urinary tract infections, urinary tract infection-associated bacteraemia, mortality, patient comfort and preference, quality of life, and clinical symptoms of urethral damage?
Long-term (more than 28 days) intermittent self-catheterisation is performed by many people living in the community. It is important that the choice between intermittent catheters is informed by robust evidence on clinical and cost effectiveness.
The cost-effectiveness model developed for this guideline combined evidence of clinical effectiveness, costs and quality of life with respect to symptomatic urinary tract infection and associated complications. The results of the analysis showed that reusable non-coated catheters were the most cost-effective option for intermittent self-catheterisation. However, the clinical evidence informing this model was of low to very low quality. Currently, non-coated catheters are considered to be single-use devices. In order to make an 'off-licence' recommendation for the use of these catheters, better quality evidence is needed.
A four-arm randomised controlled trial is required. The trial population should be diverse, including wheelchair users, people with spinal cord injuries and people over 16 who regularly self-catheterise. The primary outcome measures should be incidence of symptomatic urinary tract infections, urinary tract infection-associated bacteraemia, mortality, patient comfort and preference, quality of life, clinical symptoms of urethral damage, and costs.
For patients using a long-term indwelling urinary catheter, what is the clinical and cost effectiveness of impregnated versus hydrophilic versus silicone catheters in reducing symptomatic urinary tract infections, encrustations and/or blockages?
Long-term indwelling catheters (both urethral and suprapubic) are commonly used in both hospital and community care settings. Long-term catheterisation carries a significant risk of symptomatic urinary tract infection, which can lead to more serious complications. Several different types of impregnated and hydrophilic long-term indwelling catheters on the market claim to be more effective than non-coated catheters, but are also more expensive.
The clinical evidence review for the guideline revealed an absence of evidence for the effectiveness of indwelling catheters over the long term. A comparison of impregnated (for example, with silver), hydrophilic and silicone catheters is needed. The primary outcome measures should be symptomatic urinary tract infections, encrustations, blockages, cost/resource use and quality of life. Secondary outcome measures should include the mean number of days the catheter remains in situ (mean dwell time) and patient comfort.
When recatheterising patients who have a long-term indwelling urinary catheter, what is the clinical and cost effectiveness of single-dose antibiotic prophylaxis in reducing symptomatic urinary tract infections in patients with a history of urinary tract infections associated with catheter change?
The immediate clinical and economic impact of urinary tract infection is so great that patients at risk of infection are sometimes offered the option to receive prophylactic antibiotics. However, the widespread use of antibiotics, including their prophylactic use, has been identified as a major factor in the increasing levels of antibiotic resistance observed across England and Wales. There is currently an absence of evidence about the short-term and long-term effects of prophylactic antibiotic use during catheter change. The GDG identified this as an important area for research to establish the benefits and harms of this practice in order to develop future guidance (the recommendation on this topic in the current guideline was based on GDG consensus).
A randomised controlled trial or cohort trial comparing single-dose antibiotic prophylaxis with selected major antibiotic groups is needed. The primary outcome measures should be symptomatic urinary tract infection, cost and quality of life. This is an important area for patients as it could minimise the inappropriate use of antibiotics
What is the clinical and cost effectiveness of 2% chlorhexidine in alcohol versus 0.5% chlorhexidine in alcohol versus 2% chlorhexidine aqueous solution versus 0.5% chlorhexidine aqueous solution for cleansing skin (before insertion of peripheral vascular access devices [VADs] and during dressing changes of all VADs) in reducing VAD-related bacteraemia and VAD site infections?
The effective management of VADs is important for reducing phlebitis and bacteraemia. In the community, compliance is improved when a single solution is used for all aspects of VAD-related skin care. There is no direct evidence comparing different percentages of chlorhexidine in aqueous and alcohol solutions, and little evidence on the use of such solutions in the community. A randomised controlled trial is required to compare the clinical and cost effectiveness of the different solutions available. The trial should enrol patients in the community with a VAD. The protocol would need to use the same skin preparation technique regardless of solution, and could also investigate the effects of decontamination technique and drying time. The primary outcome measures should be rate of VAD-related bacteraemia, rate of VAD site infections, mortality, cost and quality of life. Secondary outcome measures should include visual infusion phlebitis (VIP) score, insertion times and skin irritation.