Stakeholder comments on draft scope - with developer's ...

656 views

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
656
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
2
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Stakeholder comments on draft scope - with developer's ...

  1. 1. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 National Institute for Clinical Excellence Page 1 of 52
  2. 2. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Addenbrooke's NHS Section The Scope indicates that ‘The guideline will offer best practice We are not seeking to cover the management of complicating Trust 4.1 advice on the care of people who have a clinical diagnosis of factors in any detail. The primary focus of the remit and anaemia associated with chronic kidney disease’, and specifies Scope is on anaemia management in CKD. which groups will and will not be covered. In several of the groups that the Scope does not intend to cover there will be patients where chronic kidney disease may be a contributory factor, but not the sole factor in causing anaemia. Examples would be patients with myeloma (haematological disease) or vascultiis (inflammatory disease), where there may be impaired renal function as a consequence of the primary disease. It would be helpful to clarify whether such patients would be included in the Scope. Addenbrooke's NHS Section It would be helpful to make this more explicit, so that guidelines Thank you. The remit we have been given is to develop a Trust 4.2 are prepared for the specific role of primary, secondary and single guideline and not individual sector delivery. tertiary care. Addenbrooke's NHS Section The provision of guidelines on the management of nutritional These issues will be covered but only as they relate to Trust 4.3.c status, dialysis adequacy and hyperparathyroidism is to be anaemia management in CKD. welcomed, but these are major tasks, each of which could warrant a NICE guideline in its own right. Aintree Hospitals NHS This organisation was approached but did not respond. Trust Aksys Healthcare Ltd 4.3 We consider the following two factors as important additions Thank you but this is a guideline and not a technology Clinical that must be included in this technology assessment. Whilst assessment. Managem neither of the two factors serve as first line approaches in ent anaemia management, they have important influences on its management and clinical outcomes: Aksys Healthcare Ltd 4.3.c DIALYSIS FREQUENCY Thank you, noted. Evidence will be submitted showing that more frequent dialysis leads to better removal of uraemic toxins, higher haematocrit and haemoglobin levels and a lowered need for Erythropoeitin Stimulating Agents (ESA). Aksys Healthcare Ltd 4.3.c ULTRAPURE DIALYSATE Thank you, noted. Evidence will be submitted showing that ultrapure dialysate leads to reduced endotoxin levels that are associated with the inflammatory response and ESA resistance. Amgen UK Ltd Amgen considers the draft Scope to be well considered, and Thank you. wishes to make no comment. National Institute for Clinical Excellence Page 2 of 52
  3. 3. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Anaemia Nurse 4.1.1 Population: There should be links with the Diabetes NSF with Specialist Association regard to the problem with Diabetes & anaemia. It would be We will use the stages 1–5 in the guideline (but not in the (ANSA) appropriate to develop guidelines that could overlap with these scope) as a more accurate method of defining CKD. two disease areas. A clear definition is needed for CKD related to level of kidney function. Anaemia Nurse 4.1.1 Transplantation should not be restricted to directly following Thank you. When the transplant is failing this is Specialist Association surgery. It should include all patients who have a transplant as encompassed under the category of pre dialysis. (ANSA) they can become anaemic and require treatment, which is We confirm that the Scope includes failing transplant. essential to prevent any cardiovascular complications. Clear Those who have well functioning transplants may not have parameters regarding transplantation need to be agreed. anaemia; hence we would not need to expand to encompass the whole of the transplant period. Anaemia Nurse 4.1.2 Groups’ not covered- haematological disease, Myeloma and The Scope of the guideline pertains to anaemia caused by Specialist Association CKD are closely linked. Whilst the primary cause of anaemia is CKD. Hence we are only seeking to exclude the treatment of (ANSA) myeloma, there are patients with ESRD & myeloma who are on malignancy where it is the primary cause of anaemia. dialysis. The guideline will only deal with the treatment of renal It is possible to carry out erythropoietin predication tests for contribution to anaemia in myeloma. patients who have haematological disorders to see if they would respond to treatment and to check erythropoietin levels. Perhaps it would be appropriate to have a more in depth screening process for this type of patient. Anaemia Nurse 4.1.2 Anaemia caused by acute/chronic inflammatory states requires Re infections/chronic inflammation – we agree that dialysis Specialist Association clarification. It needs to be disease specific as many Vasculitis patients are subject to infection. However, it is anaemia that (ANSA) patients have renal disease. is the focus of the guideline and hence it is the impact of infection on anaemia. This will be included in the Scope when considering management of, and factors, which have an impact on anaemia in renal disease under section 4.3c. Anaemia Nurse 4.1.2 Children should be included, as they will become the adults with We accept that this is a valid point and hence the Scope and Specialist Association renal failure. There is a great deal of evidence to prove the guideline will include children. (ANSA) benefits of treating anaemia early and preventing cardiovascular complications. Children should not be denied access to treatment, which may happen if they are not included in the guidelines. National Institute for Clinical Excellence Page 3 of 52
  4. 4. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Anaemia Nurse 4.2 Healthcare setting is unclear as to how, where and by whom the Thank -you. We need a firm evidence-base for healthcare Specialist Association care will given. In the UK the majority of renal units use the setting issues. Published evidence that these factors are (ANSA) expertise of nurses to run their anaemia management important can then be considered. It would be extremely programmes. This proves to be efficient and cost effective and helpful if you could please submit any references directly beneficial to the patient. This role has been promoted nationally pertaining to this that you would wish the developers to and internationally by the Anaemia Nurse Specialist Association consider during the stakeholder evidence submission stage. and has resulted in nurses in Europe adopting a similar role. Prior to such posts anaemia management was fragmented and uncontrolled. To manage anaemia across primary, secondary & tertiary care will require close monitoring, but it must be clear who will be responsible and accountable for the patient’s treatment. Renal Nurses play a key role in the management of anaemia in patients with CKD and EKD and this should not be overlooked when deciding where and who should manage these patients across health care settings. Anaemia Nurse 4.3 Diagnostic evaluation differs depending on which criteria are Thank you. We agree. Specialist Association used, often dependent on the tests that the pathology labs are (ANSA) capable of carrying out. A decision needs to be made as to which tests are most relevant, evidence based and available. Anaemia Nurse 4.3 Target levels – should not say target levels but criteria for point Thank you, we will delete ‘target’ and insert ‘threshold’. Specialist Association of referral, A target is an aim not a starting point. (ANSA) Anaemia Nurse 4.3 Management factors – should they be the same for CKD and Thank you, yes, they will be the same whether EKD means Specialist Association EKD. early or established KD by you in this context. (ANSA) Anaemia Nurse Nutritional status – an agreed marker is needed here such as We are referring to the use of conventional haematinics here Specialist Association albumin when considering haematinics. (for example ferritin and B12). The context of ‘haematinics’ as (ANSA) a term only is made reference to in Scope. Anaemia Nurse 4.3 Dialysis adequacy should have recommendations regarding Thank you but this is not a guideline about dialysis. It is Specialist Association water quality, dialysers, vascular access, time and frequency of anaemia that is the focus of the guideline and hence it is the (ANSA) treatment. impact of these on the anaemia. This will be included in the Scope when considering management of, and factors, which have an impact on anaemia in renal disease under section 4.3c. Anaemia Nurse 4.3 Transplantation should be included here as some of the immuno Thank you but this is not a guideline on transplantation. Specialist Association suppressant therapy can cause anaemia due to the effect of the (ANSA) bone marrow. National Institute for Clinical Excellence Page 4 of 52
  5. 5. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Anaemia Nurse 4.3 Assessment & Optimisation of Hb etc. should make Thank you, the evidence-base will be considered here. Specialist Association recommendations for targets and upper/lower parameters of (ANSA) Hb , iron status, Should discuss type of drug therapy recommended. There are current issues with use of iron dextran and is use has been questioned by the new European Best Practice Guidelines for anaemia management. Anaemia Nurse 4.3 Monitoring treatment should include management of non- Thank you, the evidence-base will be considered here. Specialist Association response to treatment. Also should address who manages this (ANSA) group of patients, how often and where. Anaemia Nurse 4.3 Funding has not been included but it is an area of concern as Funding generally lies outside of the remit. Specialist Association postcode prescribing does exist especially for patients not We need a firm evidence-base for healthcare setting issues.. (ANSA) receiving dialysis and inequity of funding results in poor service Published evidence that these factors are important can then provision and is detrimental to the patient. Patients who are be considered. It would be extremely helpful if you could denied treatment are compromised and should not be put at risk please submit any references directly pertaining to this that due to lack of resources and funding. you would wish the developers to consider during the stakeholder evidence submission stage. If there is indeed a published evidence-base relevant to these factors we will be able to consider this. Anaemia Nurse General Overall the document is very positive and addresses the key We will strive to include the evidence base as far as we can Specialist Association issues. Concerns regarding evidence are such that several of but there has to be an agreed date cut off point. The (ANSA) the studies being carried out in patients with CKD and anaemia published guideline will be reviewed at a 2-year period in will not have been completed when these guidelines are being order to decide whether an update of the evidence is devised. Evidence from these studies could well have an required. influence on future practice. Anaemia Nurse General The renal registry may not be a true picture of anaemia Thank you. Specialist Association management across the country as many units are not able to (ANSA) submit data due to software incompatibility. Most units undertake regional audits and it may be pertinent to collect data from units which cannot submit to the registry by other means. Anglesey Local Health This organisation was approached but did not respond. Board Association of Renal 4.1.1 a) The population should include patients with stages 1-V CKD as Thank you we agree and will use the stages 1–5 in the Industries & title defined in the KDOQI guidelines and adopted by the UK renal guideline (but not in the Scope). community. This a more accurate method of defining CKD. National Institute for Clinical Excellence Page 5 of 52
  6. 6. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Association of Renal 4.1.1b Transplant patients should be considered CKD patients and Thank you we agree and will use the stages 1–5 in the Industries staged and managed appropriately not just directly after guideline (but not in the Scope). transplant surgery. When the transplant is failing this is encompassed under the category of pre dialysis. We confirm that the Scope includes failing transplant. Those who have well functioning transplants may not have anaemia; hence we would not need to expand to encompass the whole of the transplant period. Association of Renal 4.1.2 Chronic inflammatory disease could be caused by non Re infections/chronic inflammation – we agree that dialysis Industries biocompatible dialysis solutions and membranes or the patients are subject to infection. However, it is anaemia that materials in which they are packed, catheters and infection. is the focus of the guideline and hence it is the impact of Water quality and protein-energy malnutrition can also be infection on anaemia. This will be included in the Scope when contributing factors inflammation. considering management of, and factors, which have an It may not be appropriate to exclude all patients with impact on anaemia in renal disease under section 4.3c. haematological disease or malignancy if their primary cause of The Scope of the guideline pertains to anaemia caused by anaemia is renal failure. CKD. Hence we are only seeking to exclude the treatment of malignancy where it is the primary cause of anaemia. Association of Renal 4.1.2b Is the exclusion of children appropriate as this is a small but We accept that this is a valid point and hence the Scope and Industries important treatment group who would benefit from good guideline will include children. anaemia management. Association of Renal 4.3 a In vitro diagnostics should include test which monitor nutritional Thank you for your suggestion. We will consider the evidence Industries status prealbumin, Vit B12, and folate. Markers of infection and base. inflammation, CRP, cytokines such as TNFα, interleukin-6. Differential tests diagnosis of anaemia, ESR, & fibrinogen. Iron status, total iron binding capacity (TIBC) transferring and ferritin. Association of Renal 4.3 b Account should be taken of normal ranges for different patient Thank you. Industries groups, male/female, young/old. A “one size fits all may not be appropriate. It may be more relevant to have targets which state that Hb levels should not fall below a certain level for a patient group which should help to minimise the consequences of chronic anaemia such as LVH etc. Preventing chronic anaemia in the CKD population is probably more effective than trying to build patients back up to a certain HB level. National Institute for Clinical Excellence Page 6 of 52
  7. 7. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Association of Renal 4.3 c Nutritional status should take account of both protein/energy Thank you. This is not specific to anaemia management. This Industries malnutrition and the use of phosphate binders. The type of is considered to be part of the general management of CKD binder needs to be considered and the affect each has on the not anaemia. patient. Particular note of the use of aluminium based binders and the potential effect on bone marrow and the development of microcytic anaemia needs to be taken and its use limited to the absolute minimum and carefully monitored. Association of Renal 4.3 c hPTH the importance of the early intervention of dietary Thank you. This is not specific to anaemia management. This Industries management and the use of phosphate binders, vitamin D is considered to be part of the general management of CKD analogues and other interventions as they become available, to not anaemia. reduce the risk of parathyroid hyperplasia at an early stage. Association of Renal 4.3 c As well as dialysis adequacy the quality of dialysis should be It is anaemia that is the focus of the guideline and hence it is Industries considered, biocompatible membranes and solutions, strategies the impact of infection on anaemia. This will be included in for minimising infection from access sites and water quality. the Scope when considering management of, and factors, which have an impact on anaemia in renal disease under section 4.3c. Association of Renal 3b RRT patient numbers. Need to use data from the 2003 registry When the Scope was written, recently published update Industries data giving figures for 2002. Estimate for England and Wales figures were not available. 2003 figures will have now been 32,500 patients with 46% transplanted patients. used to update the Scope. Association of Renal 3d Update information from the 2003 renal registry document. Thank you – noted. Industries Effective use of IV iron and EPO should be considered in stages 1-1V. Association of Renal Overall The Scope is quite wide ranging and does go beyond the Thank you. Industries comment narrow remit of EPO therapy which is to be commended. However note does need to be taken of the confounding factors which may work against efficient and effective anaemia management. Association of the This organisation was approached but did not respond. British Pharmaceuticals Industry,(ABPI) Barking, Havering & This organisation was approached but did not respond. Redbridge NHS Trust National Institute for Clinical Excellence Page 7 of 52
  8. 8. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Barts and The London This is a very important topic in renal medicine. Proper The question about the selection of the topic lies outside the NHS Trust management of anaemia and the introduction of erythropoeisis consultation on the development of the Scope. stimulating agents (ESA) and intravenous iron therapy has NICE are referred topics from the Department of Health via a revolutionised the quality of life of these patients. topic selection process. Details of the process can be found at However, I am interested as the why this topic has been http://www.dh.gov.uk/Consultations/ClosedConsultations/Clos commissioned as there are already several generally accepted edConsultationsArticle/fs/en? detailed guidelines published on this subject. For the NICE CONTENT_ID=4016963&chk=7lPThG guidelines to be helpful the Scope needs to be reviewed. It needs to consider the practicalities of administration and funding of such programs. The European and K/DOQI guidelines are Service delivery models and funding are generally outside the clear in the targets that we should be aiming for, how best we Scope of a NICE clinical guideline. achieve them, but do not look at the UK specific issues of delivery. For the perspective of a renal physician, the biggest issue is the funding and prescribing of ESA. Many units are faced with extremely complicated arrangements in order to ensure that patients are receiving the appropriate products at the right doses in a timely fashion. This is because we are having to negotiate with primary care continuously. This leads to both clinical and staff inefficiencies. The end result is patients suffering. This Scope should therefore also examine the most efficient way to run and fund a anaemia program. Bedfordshire & This organisation was approached but did not respond. Hertfordshire NHS Strategic Health Authority Birmingham Heartlands General The term established renal failure (used interchangably with end Thank you. This will be reflected within the staging terms that & Solihull NHS Trust stage renal failure) is confusing. The term established renal we will use. failure doesn't define the degree of renal failure and there is considerable potential for readers to confuse this with the term We will use the stages 1–5 in the guideline (but not in the chronic kidney disease (CKD). End stage renal failure does Scope). define the degree of renal failure clearly and should be the preferred term. Birmingham Heartlands 4.1.1 Patients with a failing renal transplant are a particular sub group We confirm that we include patients with poorly functioning & Solihull NHS Trust of CKD (pre-dialysis) who may have significant anaemia. For transplants within 4.1.1. of the Scope and that they will be completeness it would be helpful in the Scope to acknowledge included in the guideline. this sub group which represents an overlap between CKD, pre- dialysis and renal replacement therapy (transplant). National Institute for Clinical Excellence Page 8 of 52
  9. 9. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Birmingham Heartlands 4.3 c) The guideline should include recommendations about the type Thank you. & Solihull NHS Trust of vascular access to be used in haemodialysis patients. This should be a native AV fistula whenever possible. Temporary vascular access use (i.e. catheters) is associated with a lower haemoglobin concentration, probably due to the fact that dialysis adequacy is worse and infection rates, and hence erythropoetin resistance, are greater with catheters. [References: Patient characteristics associated with hemoglobin concentrations: the DOPPS. Pisoni RL, Prutz KG, Canaud B et al. J Am Soc Nephrol 2003; 14: 265A. Erythropoietin therapy and associated haemodialysis patient characteristics: DOPPS results. Pisoni RL, Young EW Gillespe BW et al. J Am Soc Nephrol 2003; 14: 267A.] Birmingham Heartlands 4.3 c) The optimal management of anaemia in CKD should minimise Thank you. This is already covered by the Scope. & Solihull NHS Trust the use of blood transfusion. The importance of this cannot be over emphasised given the restricted supply of blood products, their expense and the amount of blood products administered in renal units. It would be helpful to include in the Scope - guidelines on best practice in relation to blood transfusion in this patient group. National Institute for Clinical Excellence Page 9 of 52
  10. 10. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response British Association for 4.1.2 b Following on from the Stakeholder meeting held on Monday 28th We accept that this is a valid point and hence the Scope and Paediatric Nephrology June, we wish to reiterate our view that under 16 year olds guideline will include children. And should be included within the Scope of this guideline. Royal College of 1. The remit from the Department of Health was to Paediatrics & Child “develop a guideline ………… for ………. people with Health poor renal function.” It is therefore discriminatory against children to exclude them simply on account of their age. 2. The underlying causes and the underlying principles for the treatment of renal anaemia in children are essentially the same as they are in adults. It is therefore logical to include children within the remit of the guidelines. 3. We understand that there is a concern that there would be inadequate resources to cope with the additional work required to include children within the guidelines. In comparison to the adult literature on erythropoietin there is only a very small body of evidence specifically relating to children. It is therefore unlikely that this will make a material difference to the amount of evidence that needs reviewing. There would however be a need for considering the children separately because of the differences in target haemoglobin levels and drug dosing. 4. There are in the United Kingdom some 800 children with end stage renal failure and a considerably greater number of children with chronic renal failure (pre- dialysis). These guidelines will therefore potentially benefit a large number of children and young people. We are concerned for the plight of children with chronic, uncommon diseases. These children tend to be excluded from chronic disease initiatives (e.g. National Service Frameworks, Clinical Guidelines) but also excluded from Paediatric initiatives because they are a small group of children in comparison to those with common childhood disorders. The anaemia guidelines are a great opportunity to ensure that children and young people receive the same high quality management as their adult counterparts. National Institute for Clinical Excellence Page 10 of 52
  11. 11. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response British Association for 4.1.2 b) The BAPN wishes the guideline to include children & young We accept that this is a valid point and hence the Scope and Paediatric Nephrology people under 16 yrs. Reasons for inclusion: guideline will include children. 1. Under 16’s with CKD fulfil the inclusion criteria in section 4.1.1 2. The anaemia in under 16s due to CKD has essentially the same causation and impact as in adults 3. Under 16s are included in the renal NSF. 4. Under 16s with CKD will be disadvantaged in comparison to adults if not included. 5. Whilst the evidence base for management is not as well documented for children, this is in itself a strong reason for developing a guideline. British Dietetic General When does a patient become predialysis. As there is a shift of Thank you we agree and will use the stages 1–5 in the Association emphasis from hospital Nephrology (in centre) to community / guideline (but not in the Scope). primary care Nephrology (out of centre) what about the many patients that are classed as General Nephrology being managed in the primary care that are anaemic and may benefit from therapy. British Dietetic People directly after transplant – suggest this may need to be Thank you. When the transplant is failing this is Association expanded to encompass the whole of the transplant period encompassed under the category of pre dialysis. particularly failing transplant. We confirm that the Scope includes failing transplant. Those who have well functioning transplants may not have anaemia; hence we would not need to expand to encompass the whole of the transplant period. British Dietetic More consideration needed about whether to include paediatrics We accept that this is a valid point and hence the Scope and Association or not. As far as I am aware paediatrics tend to remain in guideline will include children. This has been changed in the paediatrics up until 18yrs or full time secondary education. Scope. British Dietetic Address the aspect of patient education. It won’t matter what Patient education is a generic issue across all guidelines. We Association gold standard of therapy you come up with if patients are not will look specifically for literature pertaining to anaemia in educated appropriately then the effectiveness of the treatment is CKD for example self-management / management plans. lost. British Dietetic ? Address compliance issues. This is a generic issue across all guidelines. It has been Association recognised that this needs to be addressed in a separate guideline dedicated to concordance issues. British Dietetic ? Look at measurements of improved therapy on QOL issues for QoL outcome measures will be addressed in the evidence Association patients. base. National Institute for Clinical Excellence Page 11 of 52
  12. 12. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response British Dietetic Comment Whole heartedly agree that nutritional status of an individual will Thank you. Association s on have an impact on anaemia but evidence will be limited. Nutrition British Dietetic Nutritional status affects anaemia but this is also true if reversed Thank you, noted. Association i.e. anaemia will affect nutritional status. British Dietetic Limited evidence about the micronutrient nutritional status of our Thank you. There is limited evidence on micronutrient Association patients most evidence concentrates on macro nutrients – nutritional status (e.g. carnatine). We will be led by the protein / calorie. evidence base. British Dietetic Limited evidence generally. Thank you. Association British Dietetic Not sure whether by increasing the iron, B12 and folate content Thank you, noted. Association of the diet will improve serum levels and ultimately anaemia management. British Dietetic Also not sure whether by improving general nutritional status Thank you, noted. Association this will impact on anaemia management, similarly whether improving anaemia management results in an improvement in anaemia. British Geriatrics 4.1 Whilst there has been no specific exclusion of older people with Thank you. We are not excluding the elderly. Society Population chronic kidney disease (CKD) it should be noted and possibly mentioned in the Scope that older people should be included. 4.11 CKD is a disease of older people increasing from 1,900 people Groups per million age 50-59 years to 17,000 people per million age that will be 70-79 years. Most of these older patients are at stages 3 and 4 covered CKD and are not on dialysis. British Geriatrics 4.2 It is worth noting that many patients with CKD are under the Thank you. This is already covered by the Scope in section Society Healthcare care of secondary care physicians who are not renal physicians. 4.2. setting The care of patients with anaemia caused by CKD under other hospital teams should not be included. British Geriatrics 4.3 4.3a Detection and diagnosis of anaemia in CKD- CKD in older We agree. Society Clinical people has been missed on many occasions due to the use of managem serum creatinine as a marker of glomerular filtration rate (GFR). ent This will be improved with the use of calculated clearances such as the MDRD and the Cockcroft and Gault equation. The Scope should take this into account. British National This organisation was approached but did not respond. Formulary (BNF) British Psychological This organisation was approached but did not respond. Society, The National Institute for Clinical Excellence Page 12 of 52
  13. 13. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response British Renal This organisation was approached but did not respond. Association, The British Renal Society General Excellent document : focussed , deliverable, clear and hopefully Thank you. will complement Renal NSF. British Renal Society Section 3 There is clear agreement by clinicians on “optimal management Thank you. d renal anaemia. The variations in different regions is rather due to differences in funding and commissioning arrangements. British Renal Society We welcome an evidence based guideline, however we hope Thank you. that UK experience will be looked at even if the publications of single centres are not from large RCTs provided such experience is multidisciplinary. We hope to supply a list of some of the abstracts on anaemia management presented in the past at our symposia. British Renal Society Section Predialysis CKD hopefully does not only refer to advanced CKD We will use the stages 1–5 in the guideline (but not in the 4.1.1 (GFR <20), one particular group of patients of concern are Scope). diabetics who may develop anaemia requiring treatment at earlier stages of CKD. British Renal Society Section I would concur with the exclusion criteria .The evidence for Thank you. 4.1.2 most of the conditions excluded is patchy , otherwise the guideline will be full of Class C evidence, however we would hope that at the time of guideline review in the future consideration would be given to these groups depending on evidence available. British Renal Society Section The guideline should include when treatment will be withdrawn Thank you the evidence base will be considered 4.3 c in refractory/resistant anaemia when there is lack of response to erythropoiesis stimulating agents. CHI This organisation was approached but did not respond. Cochrane Renal Group, This organisation was approached but did not respond. NHMRC Centre for Clinical Research Excellence, University of Sydney, Australia and Dept of Emergency & Organ Transplantation, University of Bari, Italy Conwy and This organisation was approached but did not respond. Denbighshire NHS Trust National Institute for Clinical Excellence Page 13 of 52
  14. 14. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Countess of Chester This organisation was approached but did not respond. Hospital NHS Foundation Trust Department of Health The Department of Health has no comments on the draft Scope Thank you. of the anaemia management in chronic kidney disease appraisal. Department of Health - This organisation was approached but did not respond. Publication of the National Service Framework for Renal Services, Part One: Dialysis and Transplantation (Gateway reference 1611) Diabetes UK General Diabetes is the most common cause of kidney failure in the People with diabetes are included within the evidence base and westernised world affecting as many as 40% of patients on (and hence this is not excluded when searching the 4.1.1 dialysis. In the UK this figure is estimated at 15% of dialysis literature). However, people with diabetes will not be patients also having diabetes. However, it is also accepted that considered as a separate subgroup as this is outside of the the prevalence of diabetes is notably undiagnosed in patients Scope. with kidney failure. Because of this, we strongly feel that people with diabetes should be considered as a separate subgroup within this guidance. Diabetes UK 4.3.c Erythropoietin deficiency is probably more common in patients People with diabetes are included within the evidence base with diabetes, although the precise reason for this is unclear. (and hence this is not excluded when searching the This again raises the need for a separate subgroup within this literature). However, people with diabetes will not be guidance for people with diabetes. considered as a separate subgroup as this is outside of the Scope. East Kent Hospitals This organisation was approached but did not respond. NHS Trust Genzyme Products Ltd 4.1.1 a) The population should specify that the guidelines will include Thank you we agree and will use the stages 1–5 in the patients with Chronic Kidney Failure Stages 1-5 and specific guideline (but not in the Scope). criteria for determining these stages 1-5 CKD (according to UK practice guidelines, European Best Practice Guidelines, and Kidney Disease Outcomes Quality Initiative/KDOQI). National Institute for Clinical Excellence Page 14 of 52
  15. 15. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Genzyme Products Ltd 4.3. a) The Scope recommends that anaemia due to haematological Thank you. Regarding the last sentence – this will be covered malignancy, acute and chronic inflammatory disorders and HIV in guideline but it is premature to include detail here. should not be covered. The problem is that the cause of anaemia in ESRD due to these conditions will be difficult to distinguish from anaemia due to the anaemia caused by these conditions themselves. The clinical question raised is the process of distinguishing between the causes of anaemia in ESRD – how will the guideline propose to diagnose causes of anaemia in ESRD? Genzyme Products Ltd 4.3. A separate section on factors related to resistance to anaemia Thank you, this is addressed in maintaining threshold levels General therapy should be added as this can be quite complex. under section 4.3.b of the Scope. Genzyme Products Ltd 4.3. Clarification on measuring certain outcomes in anaemia, i.e., The evidence base will be considered. General evidence on mortality, morbidity and quality of life (also likely included). Genzyme Products Ltd 4.3. c) The guideline should address the clinical question raised Thank you, noted. regarding management of factors which have an impact on anaemia in renal disease as relates to bone and mineral metabolism. These include treatment of factors such as hyperparathyroidism and hyperphosphatemia in which the choice of treatment can impact the severity of anaemia and the resistance or success of anaemia treatment such as erythropoietin and Vitamin D efficacy. Phosphate binders such as aluminium-based binders and related toxicity have been shown to have an impact on bone marrow health, erythropoietin efficacy, and progression of anaemia. Control of hyperparathyroidism with different binders is likely to have different impacts on anaemia levels. Genzyme Products Ltd 4.3. c) The terminology on ‘optimization of hemoglobin’ and ‘targets’ Thank you. Please see Scope for amended text 4.3.c. The should be clarified as a more accurate description would be word ‘target’ will be deleted and amended to ‘threshold’. ‘improvement and maintenance of haemoglobin within a defined range’. Genzyme Products Ltd 4.3. c) Inflammation as a factor related to the management of anaemia Thank you, noted. should be addressed, as relates to levels of C-reactive protein (CRP), a marker of inflammation. The presence of inflammation has been associated with increased resistance to erythropoietin treatment; therefore reducing the levels of inflammation would be favourable for the management of anaemia. Management of hyperohosphatemia with different binders is likely to have different impacts on inflammation and anaemia. National Institute for Clinical Excellence Page 15 of 52
  16. 16. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Gloucestershire This organisation was approached but did not respond. Hospitals NHS Trust Guys & St Thomas 4.1.1 The use of the term pre-dialysis CKD should not restrict the Yes, we agree with your comment. We will consider them if NHS Trust guideline to those patients known to renal services and being the anaemia is due to CKD. considered/prepared for dialysis. The guideline should cover all patients with CKD irrespective of the stage of CKD, and whether or not they are under renal or other services (diabetic clinic, primary care). Guys & St Thomas 4.1.1 Patients soon after transplant and those with longer standing Thank you. When the transplant is failing this is NHS Trust patients with impaired graft function and anaemia should be encompassed under the category of pre dialysis. considered separately. We confirm that the Scope includes failing transplant. Those who have well functioning transplants may not have anaemia; hence we would not need to expand to encompass the whole of the transplant period. Guys & St Thomas 4.1.2 a) This should be worded as to avoid interpretation that pts with Thank you, noted. NHS Trust CKD causing anaemia who have one of these co-morbid states The guideline specifically deals with anaemia caused by should be treated in a different fashion. chronic kidney disease. Patients with these co-morbidies Patients with co-morbid conditions contributing to both anaemia have other causes of anaemia and are therefore being and renal failure should not be covered by these exclusions. excluded. Guys & St Thomas 4.3 b) This might be more accurately an Hb range in which treatment Thank you – noted. NHS Trust for anaemia should be commenced, and a level below which Hb should not be allowed to fall. Careful consideration needs to be given as to whether minimal acceptable levels or desirable targets are stated, and whether these targets apply to individual patients or to cohorts. Guys & St Thomas 4.3 b) It should be considered whether an overall target range for Hb Thank you. NHS Trust level should be given, or whether different target ranges are desirable in different conditions (heart disease, diabetes, young patients). Guys & St Thomas 4.3.c) Recommendations on iron use should include recommendations Thank you – we will consider the evidence base. NHS Trust that the best measures of iron stores and iron availability be readily available. Guys & St Thomas 4.3 c) An indication as to the use of blood transfusions should be Thank you. This is already covered by the Scope. NHS Trust considered, as there is likely to be greater restrictions on blood stocks in the next few years and tighter controls on blood transfusions generally. It should be made clear that blood transfusions are not to be used to maintain Hb in target range. National Institute for Clinical Excellence Page 16 of 52
  17. 17. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Guys & St Thomas 4.3 c) It may be desirable to give guidance on those patients who Thank you – the evidence base will be considered. NHS Trust exhibit resistance to treatment, in terms of their identification, investigation and management. Hammersmith Hospitals 4.3 The guideline should be as explicit as possible about the actions Yes, we agree and acknowledge this. NHS Trust that needs to be undertaken to optimise anaemia, prior to instituting EPO therapy. (Not just Ix required). Hammersmith Hospitals 4.3 What maintenance targets of Hb should be aimed at and how Thank you – noted. NHS Trust specific co-morbidities may influence that target. Hammersmith Hospitals 4.3 Defining which conditions/patients should be excluded from Thank you, the evidence-base will be considered here. NHS Trust requirement to reach anaemia targets (ie those in whom this would result in significant iron overload). Hammersmith Hospitals 4.3 Comments on type and route of therapy. Thank you – noted. NHS Trust Hammersmith Hospitals 4.3 Guidelines on the assessment of complications of EPO therapy Thank you – noted. NHS Trust – recommendations for BP monitoring. Hammersmith Hospitals 4.3 Management of poor responders. Thank you – the evidence base will be considered. NHS Trust Hammersmith Hospitals 4.3 Actions to be taken if Hb overshoots desired target range Hb. Thank you. This will be considered. NHS Trust International Myeloma This organisation was approached but did not respond. Foundation (UK) Kidney Alliance, The This organisation was approached but did not respond. King's College Hospital This organisation was approached but did not respond. NHS Trust Long Term Medical This organisation was approached but did not respond. Conditions Alliance National Institute for Clinical Excellence Page 17 of 52
  18. 18. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Media Innovations General 1. Existing Guidelines for Renal Anaemia: Thank you – noted. Limited comments National and international guidelines (Renal Association, : European Renal Association, Dialysis Outcomes Quality Initiative (DOQI), and other national bodies) are available for the management of renal anaemia covering much of the population suggested in the NICE scoping document. 1.1 These have typically been through several versions already. 1.2 They concentrate in particular on the ‘targets’ for haemoglobin (and iron) to be achieved in individual patients. 1.3 They have reviewed the extensive literature on the use of Epoetins and Iron therapy, as well as contingent clinical factors as outlined in the NICE scoping document. 1.4 They too attempt to provide ‘recommendations for good practice that are based on the best available evidence of clinical (but not cost) effectiveness’ [2a]. 1.5 Despite these efforts, clinical studies (ESAM, DOPPS) and Registry data show systematic underachievement in managed renal anaemia in Europe and there is ‘wide variation in practice’. National Institute for Clinical Excellence Page 18 of 52
  19. 19. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Media Innovations 2. Aspirations for Guidelines: Thank you, noted. Limited Whether or not there is ‘lack of agreement on the optimal management’ rather depends on the definition of ‘optimal’, but certainly processes are varied and depend on a range of principles of staffing and clinical methods [2d]. 2.1 Whether ‘an evidence based guideline would improve the standards of care across renal units’ remains to be seen, since that has not occurred necessarily as a consequence of the existing work. 2.2 There has been an annual improvement in both pre-dialysis and dialysis related Haemoglobin outcomes as documented by the UK Renal Registry (UKRR) that probably represents an intuitive effect of improving clinical practice on the part of renal units generally. 2.3 Unfortunately, great and sophisticated effort, however transparent, is no guarantee that any subsequent guideline will be effective in improving clinical outcomes and costs. 2.4a By contrast, a guideline statement is likely to beneficially influence ‘appropriate commissioning of cost-effective treatments’ in this area, in part because it is apparent that lack of investment in Epoetin has occurred regionally in England, with consequences for Haemoglobin outcomes. The extent and specificity of the relation between funding and performance have not been clearly described, the UKRR finding it hard to compile Epoetin doses, in particular, from clinical databases. 2.4b It is worth emphasising that the cost-effectiveness of Epoetin is especially dependent on the pricing of the agents, with recent competition creating discounts of up to 50% in some areas. Improvements in clinical practice are unlikely to challenge that scale of cost reduction. National Institute for Clinical Excellence Page 19 of 52
  20. 20. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Media Innovations 3. Characteristics of current guidelines: Thank you, noted. Limited Existing guidelines are imperfect. They often incorporate an element of yardstick or clinical performance measure, without acknowledging that is the case (for example, in the past, 85% compliance with a guideline statement as a criterion of performance). 3.1 Alternatively, in recent versions, they appear to abrogate the responsibility for any yardstick whatsoever. 3.2 Even more mischievously, they tend to create ‘pseudo- algorithms’ for management from the literature of clinical efficacy, typically untested in general populations for practical effect. This is demonstrably misleading in the case of European guidelines for the control of high Se Ferritin levels, for example. 3.4 Lastly, despite the fact that unit performance must be represented by summary statistics, the guideline documents rehearse individual patient management exhaustively but give little or no guidance on how to manage a patient population to achieve desirable outcomes overall. 3.5 Little work has been done in this area, general distributions being simply compiled from the sum of individual clinical encounters. National Institute for Clinical Excellence Page 20 of 52
  21. 21. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Media Innovations 4. Necessary features of anaemia outcomes: Limited As indicated in UKRR Reports (www.renalreg.com), the currently achievable haemoglobin and iron outcomes to give any desired unit profile can be precisely known (Rose-Day plots). 4.1 The clinical technology to allow their definition on a predictable and consistent basis is not practised except in a few northern UK renal units. 4.2 The evidence that this is feasible has been ignored by recent European guideline authors. 4.3 This may have been in part because literature search techniques are incomplete for the supporting experimental papers. This is reflected in their absence in the Cochrane renal database and will be repeated unless especial care is taken in the NICE searches for supporting evidence. 4.4 There is also a strong undercurrent of cultural antipathy for the management of patient sets or groups for optimal management, rather than individuals, even though this may be beneficial overall. Part of this in Europe and the US can be related to the financing of medical care in different Health Care Systems. Media Innovations 5. The necessary Guideline: Thank you, noted. Limited The issue then resolves into the need for a guideline that does not simply repeat the aspirational ‘target’ values for individuals that are unachievable, except systematically, at unit level, but goes some way to explain how predictable, consistent and cost effective results may be brought about through appropriate clinical processes. 5.1 The ‘optimal’ clinical outcomes from any given spend on Epoetin and Iron are unlikely to be achieved from unsystematic, piecemeal clinical management. 5.2 An effective system also has clinical benefit, since any anaemic patients stand out from the adequately managed population as ‘non-responders’ and are revealed as in need of clinical attention. 5.3 In addition, the facilitation of recurrent audit of anaemia management is an important part of clinical and cost- effectiveness. National Institute for Clinical Excellence Page 21 of 52
  22. 22. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Media Innovations 6. The advantage of the NICE: Thank you, noted. Limited It is easier to frame an ideal guideline than produce it, of course, but there are possibilities that have not been considered by previous authors in this area that fit well with the NICE remit. 6.1 The focus of the NICE on the clinical technologies required to manage patient sets coincides with available, mature work in renal anaemia on the benefit of managing renal unit cohorts to achieve predictable haemoglobin and iron outcomes at the individual level. 6.2 By these means a platform of unit achievement can be reliably achieved, with individual modulation if believed necessary. 6.3 Further evidence will be presented to demonstrate these assertions in the later part of this exercise by the Media Innovations Group of the University of Leeds. Media Innovations Specific Comments by section: PRCA – This will be considered when addressing EPO and Limited 4.1 Population route of administration. 4.1.2 These categories presumably exclude Primary Red Cell Aplasia (PRCA-EPO), the consequence of developing neutralising Re infections/chronic inflammation – we agree that dialysis antibodies to epoetins. patients are subject to infection. However, it is anaemia that Dialysis patients are subject to frequent infections and any is the focus of the guideline and hence it is the impact of management system will need to address/make provision for infection on anaemia. This will be included in the Scope when the response to acute infection/inflammation in that setting. considering management of, and factors, which have an Haemodialysis patients, in particular, are considered by many to impact on anaemia in renal disease under section 4.3c. express a chronic inflammation as a background to their illness, modified perhaps by the conditions of dialysis, so that some inflammatory component will need to be addressed, if not Primary inflammatory diseases. Media Innovations 4.2 Healthcare setting Thank you. We need a firm evidence-base for healthcare Limited The NHS care of chronic illness is in a state of flux and is likely setting issues. Published evidence that these factors are to change over the next few years. It will be important to keep important can then be considered. It would be extremely open the potential for commentary on management in all three helpful if you could please submit any references directly settings, including by nurses and nurse practitioners/’anaemia pertaining to this that you would wish the developers to co-ordinators’. consider during the stakeholder evidence submission stage. The home delivery of epoetin by the companies or their If there is indeed a published evidence-base relevant to these associates and the effect on VAT charges of different factors we will be able to consider this. Health Economic cost prescribing mechanisms will also need to be considered. effective evidence will also be taken into account. National Institute for Clinical Excellence Page 22 of 52
  23. 23. Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses 7 June – 5 July 2004 Organisation Section Comments Response Media Innovations 4.3 Clinical management Thank you Limited [a] Guidance on the investigation of potential blood loss would a. This is outside of the remit and Scope. be of interest since haemodialysis patients often show evidence of persistent minor bowel losses that can be misconstrued as requiring expensive imaging for diagnosis. [b] The use of ‘target’ here appears to be an error, since b. Yes we agree, this has been amended. threshold would be more apposite. There has been much confusion in clinical intervention in the terminology of aims, goals and targets that have been clarified in the field of renal anaemia, at least. This has been shown to have an important bearing on the principles of management. [c] Mention should be made of the dialytic features that c. It is anaemia that is the focus of the guideline and influence renal anaemia as well as dialysis adequacy, which hence it is the impact of these on the anaemia. This would include water treatment, chloramines, dialysis frequency will be included in the Scope when considering and, possibly, dialyser type. management of, and factors, which have an impact on anaemia in renal disease under section 4.3c. The meaning of the ‘optimisation of haemoglobin (and iron stores)’ will need to be considered precisely; for individuals or unit cohorts, over time, variability etc.? What exactly would be ‘optimised’? d. Opportunity costs – we need a firm evidence-base for The opportunity costs of clinical time and effort should also be this to be considered. Published evidence that these considered since this is demonstrable, sometimes expressed in factors are important can then be considered. It the employment of a separate nurse/pharmacist co-ordinator. would be extremely helpful if you could please submit This has also been prompted by the need to undertake any references directly pertaining to this that you administrative functions in order to run the epoetin contract or would wish the developers to consider during the undertake the multiple liaisons required to make ‘shared care’ stakeholder evidence submission stage. A health effective in a locality. economist will guide us. Medicines and This organisation was approached but did not respond. Healthcare Products Regulatory Agency (MHRA) National Institute for Clinical Excellence Page 23 of 52

×