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National Clinical Guideline Centre (UK). Anaemia Management in Chronic Kidney Disease: Rapid Update 2011 [Internet]. London: Royal College of Physicians (UK); 2011 Feb. (NICE Clinical Guidelines, No. 114.)

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Anaemia Management in Chronic Kidney Disease: Rapid Update 2011 [Internet].

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Appendix BScope

Guideline title

Anaemia management in people with chronic kidney disease (CKD)

Short title

Anaemia in chronic kidney disease

Background

The National Institute for Clinical Excellence (‘NICE’ or ‘the Institute’) has commissioned the National Collaborating Centre for Chronic Conditions to develop a clinical guideline on the management of anaemia in chronic kidney disease (CKD) for use in the NHS in England and Wales. This follows referral of the topic by the Department of Health and Welsh Assembly Government (see below). The guideline will provide recommendations for good practice that are based on the best available evidence of clinical and cost effectiveness.

The Institute’s clinical guidelines will support the implementation of National Service Frameworks (NSFs) in those aspects of care where a Framework has been published. The statements in each NSF reflect the evidence that was used at the time the Framework was prepared. The clinical guidelines and technology appraisals published by the Institute after an NSF has been issued will have the effect of updating the Framework. The NSF for Renal Services (2004) is of particular relevance to this guideline.

Clinical need for the guideline

The NSF for Renal Services (2004) defines chronic kidney disease (CKD) as kidney (renal) disease that is irreversible and progressive. Established renal failure (also called end stage renal failure) is CKD that has progressed so far that renal replacement therapy (regular dialysis treatment or kidney transplantation) is needed to maintain life.

Established renal failure is an irreversible, long-term condition. A small number of people with established renal failure may choose conservative management only. Conventionally the total number of people receiving renal replacement therapy has been taken as a proxy measure for the prevalence of established renal failure. The NSF for Renal Services estimates that more than 27,000 people received renal replacement therapy in England in 2001. Approximately one-half of these had a functioning transplant and the remainder were on dialysis. It is predicted that numbers will rise to around 45,000 over the next 10 years. However, the most recent Renal Registry Report (2003) states that 32,500 patients received renal replacement therapy with 46% having a renal transplant.

The UK Renal Registry Report (2003) highlights that 43% of patients newly receiving dialysis had a haemoglobin level of <10 g/dl in 2002. This is despite the fact that patients receiving dialysis treatment during 2002 had haemoglobin concentrations that continued to improve. The Registry demonstrated that 82% of haemodialysis patients and 88% of peritoneal dialysis patients had a haemoglobin concentration >10 g/dl.

The clinical need for the guideline is supported by the wide variation in practice and lack of agreement on the optimal management of renal anaemia. The UK Renal Registry Report (2003) draws attention to the fact that it was not possible to provide accurate information about erythropoietin because of variations in the recording of erythropoietin data and also the provision of erythropoietin from primary care in some parts of the UK. An evidence-based guideline should improve the standards of care across renal units and aid appropriate commissioning of cost-effective treatments.

The guideline

The guideline development process is described in detail in two publications which are available from the NICE website (see further information below). Guideline development process – an overview for stakeholders, the public and the NHS describes how organisations can become involved in the development of a guideline. The Guideline development methods – information for national collaborating centres and guideline developers provides advice on the technical aspects of guideline development.

This document is the scope. It defines exactly what this guideline will (and will not) examine, and what the guideline developers will consider. The scope is based on the referral from the Department of Health and Welsh Assembly Government (see below).

The areas that will be addressed by the guideline are described in the following sections.

Population

  • Groups that will be covered
    1. The guideline will offer best practice advice on the care of people who have a clinical diagnosis of anaemia associated with CKD.
    2. The guideline will encompass the care of people with predialysis CKD, people with established renal failure receiving renal replacement therapy, people with established renal failure receiving conservative management, and people after renal transplant surgery.
    3. The guideline will cover children (aged <16 years).
  • Groups that will not be covered

Where CKD is not the principal cause of the anaemia it will be excluded, for example:

  • anaemia caused by haematological disease
  • anaemia caused by acute and chronic inflammatory disease states
  • anaemia caused by malignancy
  • anaemia caused by acquired immunodeficiency syndrome
  • anaemia caused by acute renal failure.

Healthcare setting

The guideline will cover the care provided by healthcare professionals in direct contact with patients with anaemia associated with CKD and make decisions about their care. This will include healthcare professionals in primary, secondary and tertiary NHS care settings.

Clinical management

The guideline will include recommendations in the following areas.

  1. Detection and diagnosis of anaemia in people with CKD:
    • exclusion of other causes of anaemia
    • diagnostic evaluation of anaemia in CKD
    • assessment of anaemia.
  2. Criteria for the threshold levels of haemoglobin concentration for initiating the treatment of anaemia.
  3. Factors which have an impact on anaemia in renal disease and their management including:
    • nutritional status including haematinics
    • dialysis adequacy (peritoneal and haemodialysis)
    • hyperparathyroidism
    • assessment and optimisation of erythropoiesis to include iron stores, iron supplements and erythropoiesis stimulating agents
    • monitoring of treatment of anaemia associated with people with CKD.

Guideline recommendations will normally fall within licensed indications; exceptionally, and only where clearly supported by evidence, use outside a licensed indication may be recommended. The guideline will assume that prescribers will use the Summary of product characteristics to inform their decisions for individual patients.

Status

  • Scope

This is the final version of the scope.

  • Guideline

The development of the guideline recommendations will begin in October 2004.

Further information

Information on the guideline development process is provided in:

  • Guideline development process – an overview for stakeholders, the public and the NHS
  • Guideline development methods – information for national collaborating centres and guideline developers

These booklets are available as PDF files from the NICE website (www.nice.org.uk). Information on the progress of the guideline will also be available from the website.

Referral from the Department of Health and Welsh Assembly Government

The Department of Health and Welsh Assembly Government asked the Institute:

‘To develop a guideline for the NHS in England and Wales for the management of anaemia in people with poor renal function, including chronic kidney disease and established renal failure, based on evidence of clinical and cost effectiveness of interventions available for treating anaemia in such people. The interventions should be all those factors that have an impact on anaemia including nutritional status, dialysis effectiveness, iron stores and the use of recombinant human erythropoietin. The purpose of the guideline will be to take renal staff and patients through the most cost-effective set of investigations and procedures which will optimise haemoglobin and if possible keep it above the accepted international standard, for example European and K-DOQI of 11 g/dl.’

Scope [2011]

The Scope is now a retrospective document and sets the scene for what the guidelines amendment covered.

B.1. Guideline title

Anaemia management in people with chronic kidney disease (rapid partial update of NICE clinical guideline 39)

B.2. Short title

Anaemia in chronic kidney disease (rapid partial update)

B.3. The remit

This is a partial update of ‘Anaemia management in people with chronic kidney disease’, NICE clinical guideline 39 (2006), available from www.nice.org.uk/guidance/CG39. This update is being undertaken because new evidence has emerged on haemoglobin target levels and the published recommendations in this area will be considered for amendment. See “Key clinical issues that will be covered” for details of which sections will be updated.

This partial update does not alter the scheduled review date for the guideline and all other areas of the original scope will be considered for review then.

B.4. Clinical need for the guideline

B.4.1. Epidemiology

  1. The National Service Framework for Renal Services (2004) defines chronic kidney disease (CKD) as kidney (renal) disease that is irreversible and progressive. Epidemiological studies suggest that between 10.2 and 11.7% of the adult population have CKD, roughly half of whom have stage 3–5 CKD (defined by a glomerular filtration rate of less than 60 ml/minute/1.73m2). Established renal failure, also called end stage renal failure, is CKD that has progressed so far that renal replacement therapy (regular dialysis treatment or kidney transplantation) is needed to maintain life.
  2. Established renal failure is defined in the Renal National Service Framework as a glomerular filtration rate (GFR) below 15 ml/minute (CKD stage 5) and is an irreversible, long-term condition. A small number of people with established renal failure may choose conservative management only, but the total number of people receiving renal replacement therapy has generally been taken as a proxy measure for the prevalence of established renal failure. The UK Renal Registry records that at the end of 2008 there were 47,525 adults receiving renal replacement therapy for established renal failure (774 per million population). Of these, 47% had a functioning kidney transplant, 43% were receiving centre-based haemodialysis, 1% home haemodialysis and 9% peritoneal dialysis. Significant trends include a plateauing of incident end stage renal disease rates but a continued annual increase in prevalence of approximately 4.4%.
  3. Many people with CKD or established renal failure also develop associated anaemia. The prevalence of anaemia associated with CKD increases progressively with stage of CKD.
  4. UK population data show the prevalence of haemoglobin levels below 11 g/dl is 2.7% in those with a glomerular filtration rate (GFR) above 60 ml/minute. This increases to 2.9% in those with a GFR between 45 and 59 ml/minute (CKD stage 3A), 4.1% in those with a GFR between 30 and 44 ml/minute (CKD stage 3B) and 10% in those with a GFR below 30 ml/minute (CKD stages 4 and 5).

B.4.2. Current practice

  1. The UK Renal Registry Report (2009) highlights that the median haemoglobin level (Hb) of patients in the UK in 2008 was 10.2 g/dl at the time of starting dialysis, with 57% of patients having Hb levels above 10.0 g/dl (compared with 58% in the 2008 report). The variation between centres remained high (29–84%).
  2. The median Hb of patients on haemodialysis in the UK was 11.6 g/dl with an interquartile range (IQR) of 10.6–12.5 g/dl, 85% of haemodialysis patients had Hb levels of at least 10.0 g/dl and 54% were within the current target range of 10.5–12.5 g/dL.
  3. The median Hb of peritoneal dialysis patients in the UK was 11.7 g/dl (IQR 10.8–12.6 g/dl), 89% of peritoneal dialysis patients had Hb levels of at least 10.0 g/dl, and 55% were within the recommended range of 10.5–12.5 g/dL.
  4. In haemodialysis patients receiving erythropoiesis stimulating agents, the median dose was 8000 iu/week. In peritoneal dialysis patients receiving erythropoiesis stimulating agents the median dose was 4000 iu/week.
  5. At the time of publication of the 2006 NICE guideline, guidance on limiting the upper level of haemoglobin was primarily driven by health economics and a lack of evidence of additional benefit in patients treated to achieved Hb levels above 12.5 g/dL. Studies published since the guidance was released highlight a lack of benefit and possible harm related to higher Hb levels; we are therefore reviewing the published recommendations.

B.5. The guideline

The guideline development process is described in detail on the NICE website (see section 6, ‘Further information’).

This scope defines what the guideline will (and will not) examine, and what the guideline developers will consider.

The areas that will be addressed by the guideline are described in the following sections.

B.6. Population

B.6.1. Groups that will be covered

  1. Adults and children with a clinical diagnosis of anaemia associated with CKD, including:
    1. those with pre-dialysis CKD
    2. those with established renal failure receiving renal replacement therapy
    3. those with established renal failure receiving conservative management, and
    4. after renal transplant surgery.
  2. No patient subgroups have been identified as needing specific consideration.

B.6.2. Groups that will not be covered

  1. People with anaemia not principally caused by CKD, for example anaemia caused by:
    1. haematological disease
    2. acute and chronic inflammatory disease states
    3. malignancy
    4. acquired immunodeficiency syndrome
    5. acute kidney injury.

B.7. Healthcare setting

Care provided by healthcare professionals who are in direct contact with patients with anaemia associated with CKD and who make decisions about their care. This will include healthcare professionals in primary, secondary and tertiary NHS settings.

B.8. Clinical management

B.8.1. Key clinical issues that will be covered

  1. The level of haemoglobin at which treatment should commence, and the optimal haemoglobin target range.
  2. Update of recommendations 1.1.1.1 (diagnostic role of Hb levels) and 1.3.8.1 (optimal Hb levels) from NICE clinical guideline 39:
    1. 1.1.1.1 Management of anaemia should be considered in people with anaemia of chronic kidney disease (CKD) when their haemoglobin (Hb) level is less than or equal to 11 g/dl (or 10 g/dl if younger than 2 years of age).
    2. 1.3.8.1 In people with anaemia of CKD, treatment should maintain stable Hb levels between 10.5 and 12.5 g/dl for adults and children older than 2 years of age, and between 10 and 12 g/dl in children younger than 2 years of age, reflecting the lower normal range in that age group. This should be achieved by:
      • adjusting treatment, typically when Hb rises above 12.0 or falls below 11.0 g/dl.
      • taking patient preferences, symptoms and comorbidities into account and revising the aspirational range and action thresholds accordingly.

B.8.2. Clinical issues that will not be covered

All other issues considered in NICE clinical guideline 39.

B.9. Main outcomes

B.9.1. Diagnostic role of Hb levels review

  • All-cause mortality.
  • Cardiovascular mortality.
  • Increased hospitalisation.
  • Stroke.
  • Myocardial infarction.
  • Left ventricular hypertrophy/left ventricular mass index.
  • Progression of CKD in non-dialysis patients.

B.9.2. Optimal Hb level review

  • All-cause mortality.
  • Cardiovascular mortality.
  • CKD progression (studies with non-dialysis patients).
  • Access thrombosis (for studies with haemodialysis patients).
  • Stroke.
  • Myocardial infarction.
  • Left ventricular hypertrophy/left ventricular mass index.
  • Reduction in transfusion requirements.
  • Haemoglobin variability.
  • Hypertension/blood pressure control.

B.10. Economic aspects

Developers will take into account both clinical and cost effectiveness when considering the update of the two recommendations. A review of the economic evidence will be conducted and analyses will be carried out as appropriate. The preferred unit of effectiveness is the quality-adjusted life year (QALY), and the costs considered will usually be only from an NHS and personal social services (PSS) perspective. Further detail on the methods can be found in ‘The guidelines manual’ (see ‘Further information’).

B.11. Status

B.11.1. Scope

This is the final scope.

B.12. Timing

The development of the guideline recommendations will begin in June 2010.

B.13. Related NICE guidance (Published guidance)

B.13.1. NICE guidance to be updated

This guideline will partially update and replace the following NICE guidance.

B.13.2. Other related NICE guidance

B.13.3. Further information

Information on the guideline development process is provided in:

  • ‘How NICE clinical guidelines are developed: an overview for stakeholders the public and the NHS
  • ‘The guidelines manual’.

These are available from the NICE website (www.nice.org.uk/GuidelinesManual). Information on the progress of the guideline will also be available from the NICE website (www.nice.org.uk).

Copyright © 2011, National Clinical Guideline Centre.

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