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National Clinical Guideline Centre (UK). Infection: Prevention and Control of Healthcare-Associated Infections in Primary and Community Care: Partial Update of NICE Clinical Guideline 2. London: Royal College of Physicians (UK); 2012 Mar. (NICE Clinical Guidelines, No. 139.)

Cover of Infection: Prevention and Control of Healthcare-Associated Infections in Primary and Community Care

Infection: Prevention and Control of Healthcare-Associated Infections in Primary and Community Care: Partial Update of NICE Clinical Guideline 2.

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Appendix MHigh priority research recommendations

M.1. Standard Principles of infection prevention and control

M.1.1. What are the barriers to compliance with standard principles of infection prevention and control that patients and carers experience in their own homes?

Why is this important?

Recent changes to the delivery of healthcare mean that care is increasingly delivered within a patient’s home environment. Infection 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 required 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. The areas where there is low compliance in the home environment need identifying and could have far reaching implications for discharge planning and duty of care.

What are the barriers to compliance with standard principles of infection prevention and control that patients and carers experience in their own homes?
PICO/SPICE questionPopulation and setting: Patients and people who care for a family or friend in their own homes
Focus of Interest: Barriers or factors that promote the ability and/or likelihood of adherence to the standard principles of infection prevention and control. This includes knowledge or understanding of these principles.
Comparison: None
Evaluation: The following areas should be explored through qualitative studies (interviews, focus groups, observations) or surveys
Importance to patients or the populationIt is important to understand compliance with the standard principles of infection prevention and control which could potentially increase patient safety through decreasing healthcare associated infections. Given that much care is provided by lay people in the community it would be important to highlight the barriers to compliance with standard principles of infection prevention and control in order that these issues can be addressed.
Relevance to NICE guidanceThis research recommendation is relevant to all chapters within this guideline. It is also relevant to any other guidance where patient/carer information delivery and the risk of infection are particular concerns.
Relevance to the NHSThe prevention and control of infection within the patients’ own home (including care homes) will reduce hospital admissions/re- admissions, morbidity and mortality, reduce the amount of antibiotics prescribed and reduce the number of community staff visits, e.g. GP, District Nurses. It will also reduce carer and patient stress, and have a large impact on quality of life both for the patient and the carer.
National prioritiesReduce demand for emergency/urgent care (in National Operating Framework for the NHS).
Current evidence baseThe existing evidence base was systematically reviewed for literature related to barriers to hand decontamination. There was a lack of evidence of patient/carer education in a UK community setting.
Study designQualitative study of a range of carers regarding the education they received regarding infection control, their understanding of hand decontamination, supplies and use of protective equipment and disposal. The focus should be on barriers to compliance.
Economic considerationsWhen training is delivered in an ineffective or inappropriate manner it represents an inefficient use of NHS resources. By determining the factors with the greatest influence on the efficacy of training provided to patients and carers, more targeted and cost-effective training packages can be delivered. If more effective training packages lead to a reduction in healthcare associated infections, this will also have an impact the cost of treating infections, quality of life and mortality rates among patients. Outcomes with economic consequences (such as the cost and resource use associated with training interventions and associated infection rates) should be recorded.
FeasibilityThe GDG thought that it would be feasible to conduct a qualitative study in this area, so long as it was designed to be focused and specific. The time scale of such as study would ideally be designed to feed into the development and implementation of educational initiatives, but a three to six month impact study should be sufficient.
EqualitiesEducation needs to be tailored to the needs of patients and carers. This is particularly important for patients with specific cultural, religious, linguistic, or educational needs. Mental ability and physical capability should also be considered.
It should also be remembered that some people, particularly the elderly, have very little money to spare on purchasing items such as handrub.
Other commentsThis area is of potential interest to psychosocial and educational research institutes, in addition to health and social care researchers.
The GDG highlighted that education around the cleaning of reusable equipment was an important theme that could be incorporated in the study.

M.2. Hand decontamination

M.2.1. 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?

Why is this important?

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 other 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 (detergent and disinfectant), 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.

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?
PICO questionPopulation: Community based healthcare workers
Intervention: All types of hand wipes, hand rinses, gels and handrubs used on physically dirty hands without running water.
Comparison: Each other
Outcomes: Colony forming units (CFUs) based on the Adenosine triphosphate (ATP) surface test or swabbing on agar plates.
Compliance with different methods and acceptability to healthcare workers.
Importance to patients or the populationNeed to know which products are effective and what healthcare workers should be using when running water is not available.
Relevance to NICE guidanceParticularly relevant to community based healthcare workers, especially the ambulance service.
Relevance to the NHSAs more care is being provided in the community and at patient’s residence setting, the evidence behind maintaining hand decontamination with no running water will be of vital importance to inform healthcare workers, patients, carers and patients undertaking care treatments what to do in this situation.
National prioritiesNo relevant national priorities
Current evidence baseNo RCT evidence was identified in the clinical review for hand decontamination without running water for the removal of blood and /or body fluid.
Study designRCT. Power calculations should be conducted to establish the required sample size of the trial. It is important that the study is adequately powered to detect a clinically important effect size.
Economic considerationsYes, this study would affect a large number of the population, including patient groups and community based healthcare workers.
FeasibilityThis proposed research should be able to be carried out within a realistic timescale and cost. There may be technical issues around conducting this as an RCT as compared to in laboratory settings.
EqualitiesNone identified.
Other commentsNone.

M.3. Long term urinary catheters

M.3.1. 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?

Why is this important?

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 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?
PICO questionPopulation: People performing intermittent self catheterisation in the community.

This heterogeneous population should include:
People aged 16 and over, wheelchair users, people with spinal cord injuries, older people, males and females.

This population should not include:
People living in residential care

Interventions:
Multiple-use non-coated catheters, single use non-coated catheters, single use gel reservoir catheters and single use hydrophilic catheters.

Comparisons:
Multiple-use non-coated catheters, single use non-coated catheters, single use gel reservoir catheters and single use hydrophilic catheters.

Outcomes:
Symptomatic urinary tract infection, bacteraemia, mortality, patient comfort & preference, clinical symptoms of urethral damage quality of life and costs .

Trial duration: Follow-up should be a minimum of 1 year
Importance to patients or the populationCatheter-associated UTIs are the most common type of healthcare-acquired infection in the world. While most urinary tract infections (UTIs) are mild and easily resolved with appropriate antibiotic treatment, more severe infections can be devastating, resulting in bacteraemia, sepsis and death. ISC is an intimate procedure which is often associated with anxiety and discomfort; compliance and patient acceptability are key considerations informing the choice of catheter.

It is important that high quality clinical evidence is available to determine which type of intermittent catheter is the most effective for preventing catheter-associated infections and urethral damage and which represents the most acceptable option for patients.
Relevance to NICE guidanceCurrently, all non-coated intermittent catheters are considered as single use devices as they have a single use logo on them. This is in contrast to the Department of Health, who recommend that five non coated catheters represents one month’s supply and require that manufacturers provide instructions for cleaning these items. Due to the uncertain legal status of these devices, concerns raised by stakeholders, and the low to very low quality clinical evidence base, non coated catheters were not recommended for multiple-use in the current guideline.

NICE consider the reuse of these items to be ‘off-licence’. In order to make an ‘off-licence’ recommendation, NICE requires sound clinical and cost-effectiveness evidence. The current clinical evidence base is of low to very low quality and better quality evidence is needed. If the results of the proposed research are found to contradict the current recommendation, the recommendation may be put forward for rapid update.
Relevance to the NHSThe uncertainty inherent in the current recommendation represents a large opportunity cost for patients within the NHS. The results of this trial have the potential to change this recommendation. A change in this recommendation would represent a significant cost savings and would result in a more efficient use of resources across the NHS.
National prioritiesThis research is relevant to two key national priority areas: reducing healthcare-associated infections and identifying efficiency savings as set out in the Operating Framework for the NHS in England in 2010/11.
Current evidence baseThe current clinical evidence base consists of five randomised controlled trials: one comparing single use gel reservoir to single use non-coated catheters; two comparing single use hydrophilic to single use non-coated catheters; and two comparing re-used single use catheters to single use non-coated catheters. These studies varied in length of follow up between patients and had unclear randomisation, allocation concealment, and blinding. All were assigned a GRADE rating of low to very low quality.
The cost-effectiveness model developed for this guideline combined evidence of clinical effectiveness, costs, and quality of life of symptomatic UTI and its associated complications. The results of this analysis showed that in 100% of model simulations, non-coated catheters used multiple times are the most cost-effective option for ISC. This conclusion was robust to a wide range of sensitivity analyses, including exploratory analysis of the impact of urethral strictures to cost and quality of life and varying levels of use of non-coated catheters.
Study designThis research should be a randomised controlled trial with a minimum follow-up of one year. Although blinding will not be possible, the trial should have good randomisation and allocation concealment. Sample size should be calculated using appropriate statistical methods. It is important that the study is adequately powered to detect a clinically important effect size. ISC technique (including the use of lubricant for non coated catheters) and patient characteristics should be clearly reported. The trial should include a diverse community-based population who regularly self catheterise. The primary outcome measures should be symptomatic urinary tract infections, UTI-associated bacteraemia, mortality, patient comfort & preference, quality of life, clinical symptoms of urethral damage, and costs. Clinical results should be fully reported and uncertainty surrounding cost-effectiveness should be explored using appropriate bootstrap analyses.

The criteria for symptomatic UTI, UTI-associated bacteraemia and mortality should be clearly defined, consistently applied and clearly reported. Clinical symptoms of urethral damage could include stricture, epididymitis and urethritis; these outcomes should be confirmed in a clinically appropriate manner and be clearly described. Patient comfort and preference should be measured using a validated score or scale.
At a minimum, quality of life should be captured using the EQ-5D. If other measures of quality of life are also thought to be appropriate these could also be included. Costs should be measured from the NHS and personal social services perspective and should include both the cost associated with each type of catheter (and lubricant for non-coated catheters) and costs associated with treating UTI, urethral damage and any other catheter-associated complications. In order to ‘future proof’ this research, cost data could also be collected from a societal perspective; however these costs should be reported and analysed separately.
Economic considerationsSee “current evidence base” above. There is a proportion of the community that require long-term intermittent catheterisation. The net gain of finding the most cost effective catheter that minimises the risks of catheter associated urinary tract infection and bacteraemia would be of ongoing benefit.
FeasibilityIt should be possible to undertake this trial within a realistic timescale and at reasonable cost.
EqualitiesEquality considerations apply regarding patients’ physical abilities, such as problems with manual dexterity or mobility, including wheelchair users. Other equality issues such as cognitive and visual impairment would be taken into consideration prior to selecting an intermittent catheter.
Other commentsThe research is of high priority. The results of this research have the potential to alter future guidance on the use of intermittent urinary catheters. If the results of this research are found to contradict the current recommendation, the recommendation may be put forward for rapid update.

M.3.2. In patients using long-term indwelling urinary catheters what is the clinical and cost effectiveness of impregnated versus hydrophilic versus silicone catheters in reducing symptomatic urinary tract infections, encrustations and/or blockages?

Why is this important?

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 revealed an absence of evidence for the effectiveness of indwelling catheters over the long term. A comparison of impregnated (for example with silver) catheters, hydrophilic catheters 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 mean number of days the catheter remains in situ (mean dwell time) and patient comfort.

In patients using long-term indwelling urinary catheters what is the clinical and cost effectiveness of impregnated versus hydrophilic versus silicone catheters on reducing symptomatic urinary tract infections, encrustations and/or blockages?
PICO questionPopulation: Patients with indwelling LTUC in the community
Intervention: Impregnated silver or antimicrobial catheters, hydrophilic catheters (both urethral and suprapubic)
Comparison: Silicone catheters
Outcomes: Symptomatic urinary tract infections, encrustations, blockages, mean no of days catheter in situ/mean dwell time and patient comfort.
Importance to patients or the populationThe impact would be that future guidance could recommend the most appropriate long-term urinary catheter type to minimise catheter associated urinary tract infection, bacteraemia and unnecessary urinary catheter changes due to blockage and encrustations. Patients will benefit from preventive measures that are appropriate.
Relevance to NICE guidanceThe results would ensure that long-term catheter choice is informed by evidence to ensure the best patient outcome.
Relevance to the NHSThe study results would ensure the minimisation of catheter associated urinary tract infection and bacteraemia in patients with long-term urinary catheterisation with inherent cost savings on treatment and additional service delivery due to morbidity. The minimisation of additional professional resources involved in unscheduled urinary catheter changes, due to encrustations and blockage. Minimisation of patient discomfort would also lead to reduced costs generated by catheter changes.
Patients will benefit from preventive measures that are appropriate and reduce variation in clinical practice and patient care.
National prioritiesThis study is in line with national antibiotic prescribing, reducing the variation in practice thereby supporting the patient safety agenda.
Current evidence baseNo evidence was identified in the clinical review for any impregnated catheters (silicone vs. hydrogel only).
Study designRCT. Power calculations should be conducted to establish the required sample size of the trial. It is important that the study is adequately powered to detect a clinically important effect size.
The study should be in non-hospitalised patients but could include residential/nursing homes.
Economic considerationsThere is a proportion of the community that require long-term catheterisation. The net gain of finding the most cost effective catheter that minimises the risks of catheter associated urinary tract infection and bacteraemia would be of ongoing benefit.
FeasibilityThis research could be completed within a reasonable timescale. There are technical issues over trial design but it is unlikely there would be ethical problems as both types of catheter are already in widespread clinical use and there is no denial of treatment or placebo involved.
EqualitiesNo specific equality issues identified
Other commentsNone.

M.3.3. 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?

Why is this important?

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 to compare single-dose antibiotic prophylaxis with selected major antibiotic groups isneeded. 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.

When recatheterising patients who have long term indwelling urinary catheters 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?
PICO questionPopulation: Patients with long term indwelling urinary catheters
Intervention: single dose antibiotic prophylaxis
Comparison: no antibiotic prophylaxis
Outcomes: symptomatic urinary tract infections.
Importance to patients or the populationThe importance would be:
to avoid the use of unnecessary antibiotic prescribing
to minimise the development of antibiotic resistance organisms
to minimise the risk of infective antibiotic diarrhoea e.g. clostridium difficile
to minimise symptomatic urinary tract infections.
Relevance to NICE guidanceA recommendation on using antibiotic prophylaxis has been made in the current guideline but the quality of evidence was low and the decision largely made on consensus. RCT/cohort evidence would be important to inform update of this guideline.
Relevance to the NHSThis has the potential to produce cost savings either through reduced prescribing or, if the research concludes that antibiotics are effective, by reducing the associated costs from catheter associated urinary tract infection.
National prioritiesThis research would have impacts in the reduction of catheter associated urinary tract infection, reduction in antibiotic resistant bacteria and the risk of infective antibiotic diarrhoea e.g. clostridium difficile.
Current evidence baseLow quality evidence that supports the current recommendation. One small RCT was identified in the clinical review that had serious limitations.
Study designThe most feasible design would be a cohort study, however an RCT study design would be preferable in terms of study quality.
Economic considerationsEconomic considerations include appropriate use of antibiotics, reducing the risk of infective antibiotic diarrhoea e.g. clostridium difficile, reducing the risk of antibiotic resistant bacteria.
FeasibilityAlthough an RCT is preferable there are likely to be ethical issues over withholding antibiotics from high risk groups, therefore a cohort study is more feasible.
EqualitiesNone identified.
Other commentsNone.

M.4. Vascular access devices

M.4.1. What is the clinical and cost effectiveness of 2% chlorhexidine in alcohol versus 0.5% chlorhexidine in alcohol versus 2% chlorhexidine in aqueous solution versus 0.5% chlorhexidine in aqueous solution for cleansing skin (beforeinsertion of peripheral vascular access devices [VADs] and during dressing changes of all VADs) in reducing VAD-related bacteraemia and VAD site infections?

Why is this important?

The effective management of vascular access devices (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 looking at 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 follow the same skin preparation technique regardless of solution, and could also investigate the effects of decontamination technique and drying time. The primary outcome measure should be rates of VAD-related bacteraemia, rate of VAD site infections, mortality, cost and quality of life. Secondary outcomes measures should include Visual Infusion Phlebitis (VIP) score, insertion times and skin irritation.

It was recognised that decontamination of VAD hubs would be another important alternative to skin. The GDG wanted to design the study to include these but concluded that this would probably require another research study.

What is the clinical and cost effectiveness of 2%chlorhexidine in alcohol versus 0.5% chlorhexidine in alcohol versus 2% chlorhexidine in aqueous solution versus 0.5% chlorhexidine in aqueous solution for cleansing skin (beforeinsertion of peripheral vascular access devices [VADs] and during dressing changes of all VADs) in reducing VAD-related bacteraemia and VAD site infections?
PICO questionPopulation: Patients in the community with a VAD.
Interventions: 2% chlorhexidine in alcohol vs. 0.5% chlorhexidine in alcohol vs. 2% chlorhexidine aqueous solution vs. 0.5% chlorhexidine aqueous solution. The method and technique used for cleaning need to be clearly defined and reported in the protocol.
Comparison: Each other
Outcomes: VAD related bacteraemia and VAD site infection.
Importance to patients or the populationIt is clinically easier to have one solution for everything. It is currently unknown which solution is best to use – knowing could help reduce VAD related bacteraemia and VAD site infections.
Relevance to NICE guidanceThis study would provide evidence with regard to the specificity of the recommendation of correct skin cleansing agent.
There would be potential to recommend a standard across skin cleansing for insertion and site care.
Relevance to the NHSIt would be more cost effective buying a standard solution across the NHS (both secondary and primary care).
There would be greater compliance by staff where there is certainty in practice, inherent cost savings on treatment and additional service delivery due to morbidity.
The minimisation of additional professional resources involved in unscheduled VAD changes, delayed treatment or treatment of acquired infection, hospitalisation.
The minimisation of patient discomfort associated with VAD infections.
National prioritiesThis study has a direct bearing on the prevention of infection agenda.
Saving Lives: reducing infection, delivering clean and safe care (Department of Health, 2007)99.
Current evidence baseThere is no direct evidence looking at percentages of chlorhexidine in randomised controlled trials and little evidence looking at the use of solutions for cleansing skin prior to insertion of peripheral VADs and during dressing changes of all VADs in the community.
Study designRCT. Power calculations should be conducted to establish the required sample size of the trial. It is important that the study is adequately powered to detect a clinically important effect size.
Economic considerationsThe specific evidence base to inform practice would ensure that patients are properly protected against HCAI in relation to VAD insertion thereby reducing both the risks and costs of acquiring an infection.
FeasibilityCurrently, all the proposed solutions are available and in use in practice, therefore it should be feasible to carry out the research in a realistic timescale at a reasonable cost.
EqualitiesThere are no specific equality issues.
Other commentsAn ongoing concern is the possibility of chlorhexidine resistant microorganisms.
It was recognised that decontamination of VAD hubs would be another important alternative to skin decontamination. The GDG wanted to design the study to include these but concluded that this would probably require a separate research study.
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