Rationale and impact
- Indications for starting renal replacement therapy
- Preparing for renal replacement therapy or conservative management – when to assess
- Preparing for renal replacement therapy or conservative management – how to assess
- Choosing modalities of renal replacement therapy or conservative management
- Planning dialysis access formation
- Indications for switching or stopping renal replacement therapy
- Recognising symptoms
- Diet and fluids
- Frequency of review
- Information, education and support
- Decision support interventions
- Coordinating care
The committee agreed that when to start dialysis is a complex decision that should take into account a number of factors (symptoms, patient preference, biochemistry, fluid overload and estimated glomerular filtration rate [eGFR]). Most people start dialysis due to symptoms, but evidence suggested that there was no overall harm or benefit of starting dialysis at an eGFR of around 5 to 7 ml/min/1.73 m2 in the absence of symptoms. However, there was evidence that starting dialysis when there are symptoms or the eGFR reaches 5 to 7 ml/min per 1.73 m2 was cost saving compared with an earlier start. The committee noted that some people prefer to have an agreed starting point (eGFR), but may need dialysis before this because symptoms are affecting normal daily activities. Some people with slowly progressing chronic kidney disease may not recognise and report symptoms that indicate dialysis is needed. Taking all this information together, the committee acknowledged several indications for starting dialysis and agreed that these should be considered on an individual basis.
The committee agreed that it is important to establish whether symptoms (for example, fatigue and depression) are due to uraemia or not, and to discuss their impact on daily life.
Evidence on the timing of pre-emptive transplant was limited and contradictory, with one study showing a clinically important benefit of transplanting at an eGFR of less than 10 ml/min/1.73 m2 but another showing no difference. The committee agreed to make a research recommendation on this to guide future practice.
The recommendations reflect common practice for adults and children, and so are not likely to involve a change of practice for most NHS providers or have a substantial resource impact for the NHS in England. If providers need to change from an earlier to a later initiation strategy, this is likely to be cost saving due to a reduction in time on dialysis.
Full details of the evidence and the committee's discussion are in evidence review A: Initiating renal replacement therapy.
Some evidence indicated that earlier referral to nephrology services improved survival on RRT at 90 days. The committee were interested in the timing of referral for assessment for RRT and used their experience to recommend that this should be at least 1 year before RRT is likely to be needed. They agreed that this would provide time for clinical and psychological preparation for dialysis or pre-emptive transplantation, and give the person, family members and carers enough time to think about the options. The committee acknowledged that there might be possible harms and costs for people who were referred but did not go on to need RRT, but they agreed that these were outweighed by the benefits of early referral for most people.
The recommendation generally reflects current practice so there should be no significant change in practice or substantial resource impact to the NHS in England.
Full details of the evidence and the committee's discussion are in evidence review E: When to assess for renal replacement therapy.
The committee recognised that an assessment should involve preparing people for RRT, for example, by explaining the procedures to create vascular access and checking heart function and immunity. Psychosocial preparation is also important for reducing non-adherence and improving outcomes. They also highlighted the importance of discussing a person's preferences and understanding how decisions on RRT or conservative management are likely to affect a person's everyday life.
No evidence was identified on the psychological assessment of transplant recipients or donors. The committee agreed that there were likely benefits for identifying risk factors for non-adherence or morbidity after the operation. These could include substance misuse, current non-adherence or a previous or current mental health condition. Given the lack of evidence and potential resource impact, the committee agreed that assessment could be considered for specific high-risk groups.
There was no evidence on cardiac assessment before transplantation. The committee discussed current practice and agreed it is very variable. They therefore decided to make a research recommendation to inform future practice.
Psychological assessment in people at high risk of non-adherence or morbidity is current practice in many areas. The recommendation is likely to lead to better targeting of psychological assessment in other areas. The recommendation was not considered likely to have a substantial resource impact overall.
Full details of the evidence and the committee's discussion are in evidence review F: How to assess people for renal replacement therapy.
People who are likely to need RRT should be supported to make decisions about treatment options, including conservative management. There was no evidence of differential benefits or harms in any specific group of people and the committee agreed that the decision needs to be based on individual factors (such as frailty, cognitive impairment and multimorbidity) and patient preference.
Evidence showed that if RRT is chosen, transplantation offers a clear advantage over dialysis in terms of extending life. This benefit was observed in each age group. In the committee's experience, quality of life and hospitalisation are also likely to be improved by transplantation. However, the individual factors that affect the risks and benefits of transplantation, for example, comorbidities, should be discussed. There was no evidence on cost effectiveness but the committee considered transplantation likely to have a lower cost over the long term due to the cost of avoiding dialysis. The committee agreed to recommend pre-emptive transplantation with a living donor or, if this is not an option, a transplant from a deceased donor.
The committee noted that the only available evidence suggested that people with a BMI greater than 30 benefited from transplant (as opposed to dialysis) to a similar degree as people with a BMI of 30 or under, in terms of mortality. The committee agreed to recommend that healthcare professionals do not exclude people from transplantation based on BMI alone.
Limited evidence showed that if a transplant is not possible, peritoneal dialysis and haemodialysis (HD) offered similar benefits and equivalent harms. There was uncertainty about the differences in costs between peritoneal dialysis and HD due to uncertainty in current UK dialysis costs and transport costs. There was no evidence comparing haemodiafiltration (HDF) and peritoneal dialysis. The committee agreed that peritoneal dialysis and HD/HDF may have quite different effects on a person's life (for example, affecting their ability to travel and the need for self-care) so they agreed that a person should be able to choose the type of dialysis most suitable for them. Peritoneal dialysis should be considered for children under 2 years due to difficulties with vascular access and extracorporeal blood volume.
There was no evidence to suggest clear differences between home and in-centre (hospital or satellite unit) HD/HDF. There is uncertainty in current UK dialysis costs but they may be lower at home. The committee acknowledged that these treatments can have very different effects on lifestyle and recommended patient choice.
Evidence suggested that in-centre HDF was more effective than in-centre HD and was cost effective, so the committee agreed that HDF rather than HD should be recommended when dialysis was in centre. However, they were aware of an ongoing trial H4RT comparing high-volume HDF with high-flux HD and, following stakeholder consultation, changed the recommendation to consider HDF rather than HD for in-centre dialysis. The committee noted that HD may be done more frequently at home than in centre. The benefits of HDF are unknown in people who dialyse more frequently. There was no evidence on the efficacy of HDF at home. The committee was aware that some centres offer home HDF, although some people opt for transportable dialysis machines (which cannot do HDF currently) and these centres also provide home HD. Taking all of this information together the committee could not recommend one option over another for HD/HDF at home. They decided that either HD or HDF could be considered.
There was no evidence comparing HD/HDF and peritoneal dialysis as initial therapy for people who start dialysis in an unplanned way. The committee agreed to make a research recommendation on this to inform future guidance.
There was no evidence to suggest clear differences between automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD). Again the committee acknowledged that these treatments can have very different effects on lifestyle and recommended patient choice.
The committee agreed that people should have regular opportunities to review treatment options.
Currently there is a mix of HDF and HD provision in the NHS in England. The recommendation to consider HDF over HD for in-centre dialysis may affect resource use in areas where this is a change in practice. There are likely to be additional costs relating to consumables and water consumption with HDF compared with HD, but these may be partly offset by reduced use of erythropoietin-stimulating agent (ESA). There may be additional costs for machines where HDF-capable machines are not currently used. However, most centres already have some HDF-capable machines. This will enable them to accommodate any initial increased demand for HDF. Provision can be expanded if demand increases within the usual replacement cycles. These additional costs may result in a substantial resource impact to the NHS in England overall. However, this is uncertain as it is not possible to accurately predict how widely additional use of HDF will be considered.
Although use of different RRT modalities and conservative management varies between areas, other recommendations reinforce current good practice to offer people a choice of modalities and settings, and conservative management, and so are not expected to have a substantial resource impact.
The committee agreed that people are often not offered regular opportunities to discuss the option of switching treatment modality or stopping RRT and so this may be a change in practice in many areas. However, these discussions could form part of current patient reviews and so would not mean a difference in resource use. More regular discussions may lead to more people switching or stopping RRT but this is not expected to result in a substantial resource impact overall.
Full details of the evidence and the committee's discussion are in evidence review B: Modalities of renal replacement therapy and in evidence review C: Sequencing modalities of renal replacement therapy.
The committee highlighted the importance of discussing with the person the different types of dialysis and their access and the impacts of these on everyday life.
Evidence suggested that the best time for creating access for peritoneal dialysis by open surgery is around 2 weeks before starting dialysis. There was no evidence on the best time for creating other types of peritoneal access so the committee decided to make a research recommendation to inform future guidance.
Evidence suggested that the best time for creating an arteriovenous fistula (AVF) for vascular access was 3 to 6 months before starting HD or HDF. It suggested that earlier AVF creation may increase the rate of AVF success. The committee agreed that doing this early (around 6 months) reduced the need for additional access procedures. However, when a fistula is created early, some people may never need it, for example, because they have a pre-emptive transplant. The committee agreed that the benefits of establishing a fistula around 6 months before starting dialysis, including the cost savings associated with avoiding additional access procedures, were likely to outweigh the potential disadvantages and increased costs associated with unused fistulae. The committee noted that the precise timing will vary from person to person, depending on the likely success of fistula creation.
Evidence showed a benefit of routine ultrasound scanning in terms of reduced failure of AVF. Cost calculations based on the clinical evidence suggested that routine scanning is likely to reduce overall costs because of fewer repeat interventions. The committee agreed to recommend routine ultrasound scanning to determine vascular access sites.
The committee noted that there was no evidence to guide the optimum timing of transplant listing and therefore made a research recommendation in this area.
Current practice for creating vascular access is variable. A minimum timing from creation to use of 6 weeks has been suggested – however, the committee agreed that creation around 6 months reflected common practice. The recommendation is not expected to have a significant impact on practice, but should standardise some current variability. It is not expected to have a substantial resource impact to the NHS in England.
Current practice for creating peritoneal dialysis access via open surgery is broadly in line with the recommendation (that is, 2 weeks before use) and so this recommendation is not expected to have a substantial resource impact to the NHS in England.
Current practice regarding ultrasound scanning to determine access sites is variable; some centres use routine ultrasound scanning but others offer a more selective approach. The recommendation would not involve a large change in practice and is likely to be cost saving because of the reduced need for repeat intervention. It is not expected to have a substantial resource impact to the NHS in England.
Full details of the evidence and the committee's discussion are in evidence review D: When to create access formation and/or list for transplantation and evidence review F: How to assess people for renal replacement therapy.
There was no evidence on indications for switching treatment and the committee agreed to make research recommendations on possible indicators to inform future guidance. There was no evidence that people on peritoneal dialysis should switch modality in anticipation of future complications such as encapsulating peritoneal sclerosis and the committee agreed this should not be routine. They highlighted that healthcare professionals should monitor for risk factors predicting complications (for example, loss of ultrafiltration).
There was also no evidence to support a switch from peritoneal dialysis to HD/HDF for women who become or wish to become pregnant. The committee agreed that the need for a switch would depend on the adequacy of dialysis, the health of the fetus and the control of urea. They recommended that specialist advice should be sought before any decisions were made.
The recommendations broadly reflect current good practice and are not expected to have a resource impact to the NHS in England.
Full details of the evidence and the committee's discussion are in evidence review G: Indicators for transferring or discontinuing renal replacement therapy.
Evidence identified symptoms that people approaching the need for RRT or receiving RRT or conservative management frequently report as affecting their lives. The committee also identified others (for example, change in urinary habits). People may feel uncomfortable talking about some symptoms (for example, sexual dysfunction) and may not associate them with their condition or its treatment. The committee agreed that healthcare professionals should ask people about symptoms and determine the likely cause. It is important that people understand which symptoms they may experience, which may need further management and if treatment will control them.
Currently, not all healthcare professionals ask people about all of the symptoms they are experiencing. They may only ask about specific symptoms and not explore all of them. Healthcare professionals should ascertain whether symptoms are due to the person's renal condition or not and explain this to them. This may be a change in practice for some, but is not expected to have a substantial resource impact to the NHS in England.
Full details of the evidence and the committee's discussion are in evidence review H: Symptom recognition.
Limited evidence, including in people with a transplant, indicated that people receiving RRT or conservative management may benefit from dietary and/or fluid management. The committee agreed that current practice is for people receiving dialysis or conservative management to have an assessment by a specialist dietitian. NICE's guideline on managing hyperphosphataemia in chronic kidney disease recommends assessment by a specialist renal dietitian for those at risk of hyperphosphataemia, which would include these groups of people. They also considered it current practice for dietary advice to be given after transplantation, although this advice is not always given by a specialist renal dietitian. The committee noted that there is some variation in how long people have to wait for this assessment, and variation in ongoing management. The committee agreed that dietary advice is important for people with a transplant, particularly straight after the surgery. This was supported by the evidence. The committee noted the importance of the person giving dietary advice having specialist knowledge of dietary requirements in transplant patients. However, the evidence was too limited to recommend that dietary advice should routinely be from a specialist renal dietitian for this group given it would be a change in practice in many areas and could result in a substantial resource impact.
The committee agreed that following initial assessment further dietary assessment would be determined by specific circumstances or indicators and made a recommendation summarising what these would be. They highlighted that there is variation in the level of dietitian input available in renal centres, which may affect how quickly people can access services or the level of input following initial assessment. However, the evidence was not considered sufficient to make specific recommendations to address this.
The committee agreed that involving family members and carers in discussions was important for improving adherence to dietary management and fluid allowance. There was no evidence on the benefits or harms of a low protein diet so the committee was not able to make a recommendation on this. The committee agreed that dietary management and fluid assessment should not be a 'one-step' process and that people's needs should be reviewed when circumstances change (for example, when switching RRT modalities) or when biochemical measures indicate.
The recommendations made reflect current practice and are not expected to result in a substantial resource impact to the NHS in England.
Full details of the evidence and the committee's discussion are in evidence review I: Dietary management and fluid restriction.
No evidence was identified to support any particular strategy for timing of review for people on RRT or conservative management. Because of the lack of evidence, considerable variation in current practice and the likely resource implications of a practice recommendation, the committee made a research recommendation to inform future guidance.
Full details of the evidence and the committee's discussion are in evidence review J: Frequency of review.
The committee used the evidence and their own experience to update the recommendations on information and support from NICE's 2011 guideline on peritoneal dialysis (CG125) and to extend these to cover other forms of RRT and conservative management. Key findings related to information being provided well in advance of decisions being needed, multiple formats of information being available, and full information on all modalities being provided. Information should also be provided on the psychological impact of starting RRT and the decision-making process.
The recommendations broadly reflect current practice and therefore are unlikely to have a resource impact. They focus mainly on the principles of information and support rather than on specific interventions.
Full details of the evidence and the committee's discussion are in evidence review K: Information, education and support.
Limited evidence suggested a benefit of structured education programmes although results were inconsistent. The committee noted that decision aids are used in clinical practice but do not replace discussions between the patient, families and carers, and healthcare professionals when making decisions about RRT or conservative management. Education classes and peer support are also important to support decision-making. In the absence of evidence showing clinically important benefits, the committee were unable to recommend that decision aids should be used. They decided to make a research recommendation to inform future practice.
Full details of the evidence and the committee's discussion are in evidence review L: Decision support interventions.
There was limited evidence on the coordination of care but the committee agreed that people should know who to contact with questions about their condition or treatment. This is particularly important when they start or change RRT modalities. The committee noted that people on RRT experience considerable treatment burden and that strategies should be adopted to reduce this. There was no evidence on care coordination by a keyworker so the committee recommended the healthcare professional responsible for renal care as a first point of contact. They made a research recommendation on care coordination by a keyworker to inform future guidance.
Current practice is variable in terms of when a person is given the details of the person responsible for care. This recommendation will ensure that this is done before starting treatment or when switching modalities or to conservative management. Similarly the recommendation on reducing treatment burden standardises and reinforces good practice. Some healthcare professionals may need to change their practice but this would not result in a substantial resource impact.
Full details of the evidence and the committee's discussion are in evidence review M: Coordinating care.