Crohn s disease: scope consultation 19 May June Scope Consultation Table

Transcription

1 National Institute for Health and Clinical Excellence Crohn s disease: scope consultation 19 May June 2010 Scope Consultation Table Type Stakeholder Order No Section No Abbott Laboratories Epidemiol ogy a) Abbott Laboratories Epidemiol ogy c) and 4.3 Clinical manage ment Abbott Laboratories Epidemiol Comments Please insert each new comment in a new row. The scope estimates that approximately 5% of Crohn s patients have severe disease. Evidence discussed in TA187 suggests that around 20% of all Crohn s patients have severe disease. In order to effectively manage Crohn s patients with varying disease severity, it would be very useful if the guidelines clearly delineated different states of disease severity with examples/caveats. For example, there are some patients that would be considered 'moderate' but would have high CRP, low albumin, and be anaemic; and these people could be failing immunomodulators agents. Conversely, patients with CDAI > 300 (definition of severe Crohn s disease in TA187) will have severe disease but not present with all the systemic symptoms listed in 3.1 c). There is also no mention of number of bowel movements, pain, and fatigue, which are all important considerations in severe Crohn s disease. It might be worth adding a paragraph on the prognosis factors at diagnosis, although diagnosis per se will not be covered in the guideline. For Developer s Response Please respond to each comment Thank you. We have investigated this and can find no reference to 20% within TA187. Thank you. This is epidemiology. The developers have focused the scope on aspects of management. The guideline cannot cover everything, and the GDG will consider relevant factors on the basis of the evidence. Thank you. This section of the scope is not meant to be exhaustive we are happy with it as it currently reads. 1

2 ogy Abbott Laboratories Current practice Abbott Laboratories Clinical manage ment Abbott Laboratories b) example perianal disease, young age, previous course of steroids etc. The first studies showing that anti-tnfs are effective in inducing remission were back in 1997, which can probably no longer be termed recent studies. In addition, the studies of the anti-tnfs have shown that TNF alpha inhibitors are effective in inducing and also maintaining remission. It would be very useful if the guidelines included an integrated care pathway with recommendations for therapy/management at different stages of the disease beginning at diagnosis. For example the introduction of routine screening for nutritional deficiencies or the routine collection of severity and response to treatment using validated tools like the Harvey Bradshaw etc. It may also be of benefit to healthcare professionals if a section on how to manage patients post surgical operation to prevent recurrence/relapse. Will enteral nutrition refer to oral nutritional substitution (ONS), food fortification or tube feeding? To what types of medical management will enteral feeding be compared? Will this be an assessment of different treatment algorithms. It might be worth adding this as an additional point to the guideline. Furthermore, if enteral nutrition vs. medical management is to be explored, then the clinical management section of this guideline should include recommendations for the routine screening of patients for nutritional deficiencies and some wording to ensure that those with deficiencies are Thank you. We will delete recent. Thank you for your comment. Different stages of the disease may be taken into account depending upon the evidence found. Regarding your second point, this document is the scope which sets out the areas to be addressed by the guideline. Not every detail can be predicted at this stage and many details, such as this, have to wait for the multidisciplinary GDG to be convened so that they can be prioritised. Thank you. This document is the scope which sets out the areas to be addressed by the guideline. Not every detail can be predicted at this stage and many details, such as this, have to wait for the multidisciplinary GDG to be convened so that they can be prioritised. 2

3 Abbott Laboratories f) treated appropriately. The monitoring section in the clinical management part of the draft scope currently only includes osteopenia and early relapse. It should probably also include monitoring for kidney stones and vitamin B12 deficiency. Thank you. We are unable to cover all associated comorbidities within the time available. Furthermore, the monitoring section should certainly include some recommendations about the use of bio-markers such as faecal calprotectin to monitor inflammatory disease. Particularly as biomarkers maybe the best determinants of early relapse. Abbott Laboratories Will exclusion diets and parenteral nutrition also be excluded in the clinical management of Crohn s disease, or do these topics need to be added to Abbott Laboratories Main outcomes a) Abbott Laboratories Main outcomes b) Abbott Laboratories Main outcomes e) section Will the focus be on remission with or without steroids? i.e. steroid free remission is a better treatment outcome for patients than remission whilst continuing steroids. It would be logical if the guideline was to look at both hospitalisation and surgery events as outcomes before moving on to mortality as an outcome. Particularly as some evidence indicates that there isn t a large mortality risk associated specifically with Crohn s disease over and above the standard age-related general population mortality risk. It would be interesting as well as looking at IBDQ as an indicator of HRQoL that depression and work productivity were also examined. For example data to show how many days of work a patient with severe Crohn s disease missed as a result of symptom flare. Thank you. The GDG may review specific questions once it has convened. Thank you. The GDG will consider these issues in detail when convened. Thank you for your comment. This is detail for GDG debate and inappropriate detail for the scope. Thank you for your comments. We will include hospitalisations if these data are available, however operational definitions of surgery events are too non-specific. Thank you for your comment. NICE takes an NHS and personal social services perspective and therefore productivity losses to the economy are not explicitly included in considerations of efficiency. The benefits of returning to usual activities including work are implicitly included 3

4 Abbott Laboratories Main outcomes The guideline ought to also include both mucosal healing and fistulae closure as outcomes because these are very relevant and important to Crohn s disease patients. Although the management of extra-intestinal manifestations (EIMs) associated with Crohn s disease is not part of the guideline remit, some treatments (e.g., anti-tnfs) may have benefits in resolving the symptoms of EIMs, beyond the symptoms of Crohn s disease. Therefore, the GDG may want to consider adding EIMs might as one of the outcomes. Abbott Laboratories 13 General It would be very useful if the guideline had a section investigating the burden of Crohn s disease in terms of the cost to the NHS for mild, moderate and severe patients. This would add additional weight to the clinical need for this guideline and be a useful tool in helping to bring Crohn s disease in to the spot light, as well as helping different stakeholders understand the financial impact of not treating the disease appropriately. Alder Hey Children s NHS Foundation Trust Alder Hey Children s NHS Foundation Trust 1 General There is no recommendation for screening of eyes for uveitis? A comment should be made whether this is necessary 2 General Despite 3 paediatric gastroenterologists strongly arguing for inclusion of children in the guideline i see we have been left out. within both generic and disease-specific measures of quality of life. We do not feel that this needs to be prioritised as a separate outcome. Thank you. This is an interesting point, but difficult to measure practically at this stage in terms of the informing evidence base. The outcomes listed in the scope are following debate and consultation at the workshop and review of the existing literature. Thank you. We will not be conducting a cost of illness studies per se, as these do not directly inform the development of recommendations. However, such an analysis might be conducted as part of a cost-effectiveness analysis, if required. The GDG will consider the best methods of staging/classifying Crohn s disease. Thank you. Screening is outside the remit of this guideline. The term management does not usually include screening. Given the time limitations, unfortunately it is not possible to address everything relevant to Crohn s disease in the guideline. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. 4

5 British Dietetic Association 1 general We do not have any specific comments Thank you. 1 2 The remit from the Department of Health was to prepare a guideline for all ages and did not exclude children. Our understanding is that children should only be excluded from NICE guidelines under exceptional circumstances but this seems to have been ignored in the drafting of this guideline. Although there is a paediatric route for guideline development, Crohn's disease in children is only a tiny part of the speciality of paediatrics, and would compete with much larger disease areas, whereas it is a very significant part of and fits much better in the Crohn's/gastroenterology portfolio. An absence of participation of paediatrics in this guideline risks among other things uneven prescription of immunomodulators and variable access to biological treatment for this vulnerable group of patients. The guideline as it stands would also fail to address the long-term morbidity issues for adult Crohn s patients who were diagnosed in childhood or adolescent period. Equality of care and access to specialists is a fundamental standard for paediatric and adult Crohn s disease patients. This issue is not addressed within the current scope of the guideline a The incidence of disease in children has been rising steadily in the UK (Sawczenko A et al. Lancet 2001; 357(9262): ) and recent studies suggest it continues to rise (Henderson P et al Gut 2010). Upto 25% of patients with CD will present under the age of 18 (Loftus EV 2004; 126(6): ).The management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. 5

6 3 3.1 c e proportion of extensive disease and more severe disease is higher than the 5% quoted in children when directly compared to adults from the same population (Van Limbergen J, et al. 2008; 135(4): and Goodhand J, et al. Inflammatory Bowel Diseases 2010; 16(6): ). The need for immunosuppressants is high in children with >85% of children needing treatment with immunosuppressants at least by 5 years post diagnosis (Van Limbergen J, et al. 2008; 135(4): ). The use of biological therapy is higher in children compared to adults (Goodhand J, et al. Inflammatory Bowel Diseases 2010; 16(6): ). Growth failure is a specific complication not mentioned with upto 20% of childhood onset patients not achieving their final adult height (Sawczenko A, et al. Pediatrics 2006; 118(1): ). Specific types of fatal cancer are a feature of younger patients i.e. Hepatosplenic T cell lymphoma and are a concern to gastroenterologists treating all ages of patients (Shale M et al Gut 2008; 57(12): ) The recent NICE appraisal on anti-tnf therapy included patients of all ages and did not exclude children. 6 4 As previously stated the referral to NICE from the Department of Health did not say to exclude children. Thank you. This guideline will not cover the use of biologics. We will cross refer to TA 187. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. management of Crohn s disease in children. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. 6

7 b a and b This is contradictory with the later section a as women of child bearing potential start from age 12 years. BSPGHAN is extremely disappointed that despite the overwhelming opinion at the stakeholders meeting the GDG has excluded children less than 16 years from this guideline. We believe this is seriously disadvantaging one of the most important groups of patients who have Crohn's disease. Children under 16 are still managed in a range of settings, not all of whom are managed by specialist paediatric gastroenterologists, including adult gastroenterologists. In the 2nd round of the UK IBD audit, 135 cases of IBD under 16 years of age were looked after by adult services, representing 18% of total of under 16s entered into audit (UK IBD Audit 2008 [Executive Summary] 2009, Royal College of Physicians of London). In the UK the IBD community in recent years has appreciated that separating paediatric from adult Crohn's disease is an arbitrary and unnecessary split. Recent National initiatives which have included all ages include the National IBD Standards, ( Dstandards.pdf) the National IBD Audit and the ongoing National IBD biologics audit and register. Of note the first round of the IBD audit in 2006 excluded children and after acknowledging this was a mistake children have been included successfully in subsequent audits. BSPGHAN believes that for a small amount of extra work this guideline will be made applicable to Thank you. We will edit 4.1.1b) to pregnancy and females of childbearing age. management of Crohn s disease in children. 7

8 a b patients of all ages ensuring seamless and equitable care for all ages of Crohn's disease patients and believe the scope must be changed to include them. BSPGHAN has recently completed a systematic review of medical treatments of Crohn's in children using SIGN methodology (Wilson DC et al JPGN 2010; 50:S14-S34) which can provide part of the evidence base for the proposed guideline with regard specifically to children which has already been made available to NICE. Where there are differences in paediatric and adult practice (for example growth and puberty), it is well recognised that these are very poorly understood and managed outwith specialist departments (Barton JR et al, BMJ 1989; 298(6677): ). These are clinical problems that will carry on into adult services and must be improved via this guideline. By excluding <16 year olds from this guideline will remove the opportunity to ensure that the equity and appropriateness of their care will be evened out nationally. As previously mentioned the recent NICE appraisal now published (" 54/47754.pdf") on anti-tnf therapy included patients of all ages and did not exclude children and therefore there seems no logic in the decision to not include them in the current NICE guideline. The majority of studies in and clinical experience of using enteral nutrition have been carried out in children (Day AS et al APT 2008; 27(4): ). This is another reason children should be included in the current guideline. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG Surgical treatment is needed in 50-80%, as the Thank you for your comment. It is not possible to 8

9 c e f document states. To restrict surgical treatment to the 2 indications is inappropriate, when the majority of patients with the condition need surgery. This will lead to a medical management guideline, which is manifestly inappropriate when the goal is combined medical and surgical management. The national IBD standards recommend joint medical and surgical management for the support of Crohn s patients. ( Dstandards.pdf) The NICE guideline is an opportunity to bring the disciplines together in the interest of the patient, not to divide them in the interest of convenience. The current proposed age group starts at 16 when the adolescent/young adult is in transition from paediatric to adult services. A significant percentage of these patients are still under a paediatric gastroenterologist and in secondary education. It is recognised that a formal multidisciplinary transition process is the most effective way to support these patients (and their families) through the adjustment to care delivery. The guidelines in formally commenting on support will need to include transition. It is therefore most appropriate that the patients (children and adolescents) who will enter this transition process are included. Osteopenia is a recognised as a long-term complication of Crohn s disease. It is associated with significant morbidity and has a detrimental effective on QALY. The onset of osteopenia is partially related to the management of bone health in childhood and adolescent when bone mineralisation occurs. Monitoring and treatment of cover the evidence base in all aspects of surgery, in all areas of the bowel in which Crohn s disease occurs, within the time available. Following discussion at the scoping workshop, these were the two main areas that were suggested as being most useful, and having the largest evidence base, for the guideline to investigate. Final decisions about what surgery to include will be taken by the fully convened GDG. Thank you. The GDG will consider this when prioritising questions for review and this will be done once the GDG is convened. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. The health economists will consider the QALY implications with the GDG once convened. 9

10 British Specialist Association patients at risk of osteopenia before adulthood would therefore be a more cost effective strategy Please see point 8. Additionally, previous NICE b guidelines that had initially only included adults at the scoping stage were successfully completed to include children and young people too (Richey R et al Recognition and assessment of coeliac disease in children and adults: summary of NICE guidance. BMJ 2009; 338: ) It is difficult to understand why some treatments e are not be considered within the guideline. Some of these treatments represent newer therapies that should be critically examined within the context of a guideline rather than excluded before the evidence is appraised Young people under the age of 18 would need to a be assessed using similarly validated disease activity scores (Hyams JS, et al. Journal of Pediatric & 1991; 12(4): ) As children and young people are diagnosed at the youngest age they will have the disease together with its consequences and complications for longest. This does have an impact on educational achievement and personal social functioning which have implications for their earning capacity and social status as adults. Therefore QALY analysis within this group of patients is likely to provide a lower cost per QALY potentially than other age groups Epidemiol ogy a) The scope estimates that approximately 5% of Crohn s patients have severe disease. Evidence discussed in TA187 suggests that around 20% of all Crohn s patients have severe disease. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. Thank you. We are unable to cover all aspects of Crohn s disease within the time frame and seek to be transparent in the exclusions at the start of the process. None of the other stakeholders have asked us to reverse these exclusions. management of Crohn s disease in children (and appropriate disease activity scores) and shall recruit a paediatric gastroenterologist to the GDG. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. The health economists will consider the QALY implications with the GDG once convened. Thank you. We have investigated this and can find no reference to 20% within TA187. British Specialist In order to effectively manage Crohn s patients Thank you. This is epidemiology. The developers 10

11 Association - Epidemiol ogy c) and 4.3 Clinical manage ment British Specialist Association British Specialist Association Clinical manage ment b) with varying disease severity, it would be very useful if the guidelines clearly delineated different states of disease severity with examples/caveats. For example, there are some patients that would be considered 'moderate' but would have high CRP, low albumin, and be anaemic; and these people could be failing immunomodulators agents. Conversely, patients with CDAI > 300 (definition of severe Crohn s disease in TA187) will have severe disease but not present with all the systemic symptoms listed in 3.1 c). There is also no mention of number of bowel movements, pain, and fatigue, which are all important considerations in severe Crohn s disease. It would be very useful if the guidelines included an integrated care pathway with recommendations for therapy/management at different stages of the disease beginning at diagnosis. For example the introduction of routine screening for nutritional deficiencies or the routine collection of severity and response to treatment using validated tools like the Harvey Bradshaw etc. Will enteral nutrition refer to oral nutritional substitution (ONS), food fortification or tube feeding? To what types of medical management will enteral feeding be compared? Will this be an assessment of different treatment algorithms. It might be worth adding this as an additional point to the guideline. have focused the scope on aspects of management. The guideline cannot cover everything, and the GDG will consider relevant factors on the basis of the evidence. Thank you for your comment. Different stages of the disease may be taken into account depending upon the evidence found. Thank you. This document is the scope which sets out the areas to be addressed by the guideline. Not every detail can be predicted at this stage and many details, such as this, have to wait for the multidisciplinary GDG to be convened so that they can be prioritised. Furthermore, if enteral nutrition vs. medical management is to be explored, then the clinical management section of this guideline should include recommendations for the routine screening of patients for nutritional deficiencies and some 11

12 British Specialist Association f) wording to ensure that those with deficiencies are treated appropriately. The monitoring section in the clinical management part of the draft scope currently only includes osteopenia and early relapse. It should probably also include monitoring for kidney stones and vitamin B12 deficiency. Thank you. We are unable to cover all associated comorbidities and extraintestinal manifestations within the time available. British Specialist Association British Specialist Association British Specialist Association Furthermore, the monitoring section should certainly include some recommendations about the use of bio-markers such as faecal calprotectin to monitor inflammatory disease. Particularly as biomarkers maybe the best determinants of early relapse Will exclusion diets and parenteral nutrition also be excluded in the clinical management of Crohn s disease, or do these topics need to be added to Main outcomes b) Main outcomes e) section It would be logical if the guideline was to look at both hospitalisation and surgery events as outcomes before moving on to mortality as an outcome. Particularly as some evidence indicates that there isn t a large mortality risk associated specifically with Crohn s disease over and above the standard age-related general population mortality risk. It would be interesting as well as looking at IBDQ as an indicator of HRQoL that depression and work productivity were also examined. For example data to show how many days of work a patient with severe Crohn s disease missed as a result of symptom flare. The GDG may consider these issues and prioritise questions once it has convened. Thank you. The GDG will consider these issues in detail when convened. Thank you for your comments. We will include hospitalisations if these data are available, however operational definitions of surgery events are too non-specific. Thank you for your comment. NICE takes an NHS and personal social services perspective and therefore productivity losses to the economy are not explicitly included in considerations of efficiency. The benefits of returning to usual activities including work are implicitly included within both generic and disease-specific measures of quality of life. We do not feel that this needs to be prioritised as a separate outcome. 12

13 British Specialist Association British Specialist Association Crohn s in Childhood Research Association Main outcomes The guideline ought to also include both mucosal healing and fistulae closure as outcomes because these are very relevant and important to Crohn s disease patients. 10 General It would be very useful if the guideline had a section investigating the burden of Crohn s disease in terms of the cost to the NHS for mild, moderate and severe patients. This would add additional weight to the clinical need for this guideline and be a useful tool in helping to bring Crohn s disease in to the spot light as well as helping different stakeholders understand the financial impact of not treating the disease appropriately. 1 General CICRA was represented at the NICE Scoping exercise about the future Crohn s disease guidelines and we are therefore extremely disappointed to find that although the Scoping Workshop discussions had highlighted a wide range of paediatric associated issues, as listed in the notes published following the workshop, your revised Scoping Proposal of 19 May 2010, relating to the proposed clinical practice guidelines, indicates you have only extended the lower age from 18 to 16 years. Thank you. This is an interesting point, but mucosal healing is difficult to measure practically at this stage in terms of the informing evidence base. The outcomes listed in the scope are following debate and consultation at the workshop and review of the existing literature. Thank you. We will not be conducting a cost of illness studies per se, as these do not directly inform the development of recommendations. However, such an analysis might be conducted as part of a cost-effectiveness analysis, if required. The GDG will consider the best methods of staging/classifying Crohn s disease. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. During our workshop discussions we took into account the complexity of this life-long debilitating condition in children and adolescents who have many of the same issues as adults, and currently often receive adult medication with dosage tailored to their needs. In some instances children under 16 are treated by adult gastroenterologists and 13

14 therefore it would appear that children are being disadvantaged. We strongly recommend that paediatrics should be included in the upcoming work of the NICE Crohn's guidelines group. Within this group NICE should ensure sufficient paediatric experts and lay representatives who understand this chronic condition in childhood. Whilst we acknowledge that there will always be time pressures on guideline preparation, Crohn s, with unknown cause, is a life-long, debilitating condition, with a need for improved treatments. With the possibility of poor growth, delayed puberty and emotional problems at a crucial stage of their development, children and young people need careful, consistent and well managed treatment and an ensured smooth transition when transferring into adult care. Those of us working in the field of Crohn s collaborate and this guideline initiative now presents an opportunity for joined up thinking by the authorities in their approach to the often difficult management of this chronic disease. For over 30 years CICRA has been supporting parents and children afflicted by Crohn s and has funded 5million on research (including the 3 year training of 20 paediatric gastroenterologists). Children should not be disadvantaged just because a lifelong illness, once thought of as only appearing in adults, is now affecting children at an earlier age than had been thought possible 30 years ago. We would remind you that both the British Society 14

15 of, and the have issued Crohn's guidelines, as have the European counterparts, where there has been open dialogue among the stakeholders including the patient and lay representatives in producing these documents and we hope that these will be taken into account when undertaking the work associated with the preparation of the Crohn's Guidelines. Department of Health 1 General The Department of Health has no substantive comments to make, regarding this consultation NHS Direct 1 General NHS Direct have no comments on the content and welcome the guideline. NICE NICE IP Programme We note that photophoresis will not be considered in the guideline and agree with this decision. e) Extracorporeal photophoresis has been assessed by the NICE IP Programme and has been issued only in research guidance in April NICE NICE NICE NICE NICE Technical Advisors NICE Technical Advisors NICE Technical Advisors NICE Technical Advisors (second paragrap h) Perhaps delete and others are in development? My worry is that by noting these in this way, we may give the impression/set the expectation that new, as yet unlicensed medications may also be covered by the guideline A minor comment, the term approach to management is used here. Does this add meaning over and above management, surgery or treatment? b) A minor comment, could we delete or young women? ie consideration of all women of childbearing potential, regardless of age Perhaps also include outcomes with cost implications such as length of hospital stay etc? Thank you. Thank you. Thank you. Please see section of the scope. Thank you, we agree and will delete. Thank you. We will delete approaches to. Thank you. We will edit 4.1.1b) to pregnancy and females of childbearing age. Thank you, we routinely extract these outcomes for the consideration of economic implications. We have added generic HRQoL to the list of outcomes 15

16 NICE NICE Technical Advisors Norgine Pharmaceuticals Ltd Would it be useful to include HRQoL as an outcome separately to explicitly cover other scales than the IBDQ in the scope? a We would suggest that antibiotics should be added to the specific drug categories listed in this section. As section 3.2 of the scope says: Corticosteroids, aminosalicylates, antibiotics and immunosuppressive drugs form the basis of drug treatment. in the scope. Thank you, we routinely extract these outcomes for the consideration of economic implications. We have added generic HRQoL to the list of outcomes in the scope. Thank you. There was conflicting stakeholder feedback regarding the merit of including antibiotics in the guideline. As time is limited, we are unfortunately unable to include everything within the guideline, and we have decided to exclude this analysis. Pharmacosmos c It is therefore logical for the sake of consistency to specifically add antibiotics to section Anaemia is mentioned as a clinically significant haematological disturbance in this section, but nowhere in the scope is it mentioned that there will be any treatment considerations or recommendations for anaemia. The reported prevalence of anaemia varies between 6.2% and 73.7%, with higher reported frequencies in older studies and in in-patients. Iron deficiency is the most common underlying condition. (1) Based of the high frequency of this complicating disturbance in Crohn s disease and considering its implication on morbidity and QoL I suggest that the scope includes recommendations on the handling of anaemia in section 4.3 despite the comment in section that treatment of extraintestinal manifestations of Crohn s disease will not be covered. Thank you. Anaemia is a manifestation of many chronic conditions and it is not possible to address everything relevant to Crohn s disease within this guideline. 16

17 1) kulnigg S, Gasche C Systematic review: Managing anemia in Crogn s disease. Aliment Pharmacol Ther 2006 Dec; 24 (11-12): RCGP Wales 1 General We welcome a review of Crohn s Disease management and are cognisant of new medications currently available and in development. Clarification of treatment options and guidance would be valuable. RCGP Wales 2 General Recognition of the difficulties for pregnant women is welcomed RCGP Wales 3 General Recognition of the need for smoking cessation and Royal College of Nursing Royal College of Nursing linkage to established guidance is welcomed 1 General The Royal College of Nursing welcomes proposals to develop this guideline. The draft scope seems comprehensive We consider it is inappropriate to exclude young people who are presented with many of the same issues as adults with IBD just because of their age. Also, why stipulate under 16 rather than under 18, as transition usually occurs after the 16th birthday and a young person is still a child in the law till age of 18. Covering the issues from age 16 mean paediatric aspects such as growth delay will need to be addressed, therefore why not cover all children as well. Thank you. Thank you. Thank you. Thank you. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. Royal College of Nursing F This seems a missed opportunity in the approach to effective management of IBD. This scope is potentially disadvantaging patients purely on the basis of an arbitrary age cut off. Will the issue of expected waiting time between referral from gastroenterology to colorectal surgeon be addressed as well as the issue of time Thank you. This and other issues of timing will be considered by the multidisciplinary GDG once it is convened. It is up to the GDG to prioritise topics 17

18 to surgery in case of elective surgery? for review. Royal College of Nursing Royal College of s and Child Health Many of these patients wait the maximum period allowed by current RTT guidelines after being listed for surgery due to current cancer targets taking precedence, as this can mean repeated courses of steroid, liquid diet, time lost from work or a combination of any of these, this would seem like a good opportunity to address some of these issues if possible. 4 General Are alternative sources of information going to be used to inform this guideline other than NICE guidelines, such as the guidance for Sexual and Reproductive Health for Individuals with Inflammatory Bowel Disease nceibd09.pdf BSG and ECCO guidelines and IBD standards. 1 General The RCPCH is very disappointed that the scope excludes those under 16 years. National level evidence-based guidelines for the secondary and tertiary care of children and young people with Crohn s disease would be very desirable. Many of the questions are just as relevant in children if not more so. We note that other populations included in the scope, such as women of childbearing age, have specific needs that may affect management. Why discriminate against children? Thank you. We will consider relevant evidencebased information (as per the NICE Guidelines Manual) during development of the guideline. management of Crohn s disease in children and shall recruit a paediatric gastroenterologist to the GDG. Up to 50% of children with Crohn s disease present before the age of 11 years (Personal communication Dr Stephen Murphy, Consultant Gastroenterologist, Birmingham). It is illogical to have an arbitrary cutoff of 16 years, which we believe will result in discrimination 18

19 against many children with the condition. It risks perpetuating the problems faced in securing funding for medications, and misses an opportunity to highlight deficiencies in the evidence upon which decisions are based. A recent systematic review of treatments for paediatric IBD has highlighted the lack of high quality paediatric studies. Wilson DC et al. J Pediatr Gastroenterol Nutr 2010;50:S There is considerable variation in practice between adult and paediatric centres in the UK and also between paediatric centres internationally the use of enteral nutrition and steroids are important examples of this. Royal College of s and Child Health Royal College of Physicians (RCP) & (BSG) Children with Crohn s disease will become adults with Crohn s disease and poor management in childhood may have lifelong consequences, e.g. permanent short stature, mental health problems, educational effects, long term employment consequences and osteoporosis. The economic consequences may be enormous and should be evaluated. 2 General We recommend the guideline development group consider standards for transition arrangements (the movement of adolescents from paediatric to adult services) within its remit, as there is evidence of widespread variation in practice with many centres having very limited arrangements. 1 General The BSG and RCP are grateful for the opportunity to comment on this draft scope consultation. We would like to make the following comments. Thank you. The GDG will consider this when prioritising questions for review and this will be done once the GDG is convened. Thank you. 19

20 Royal College of Physicians (RCP) & (BSG) Royal College of Physicians (RCP) & (BSG) Royal College of Physicians (RCP) & (BSG) Royal College of Physicians (RCP) & We believe that the scope should cover current and new therapies not just new therapies. Since aminosalicylates, steroids and other conventional therapies are included, this would be consistent with the goal of the document We strongly believe that young people must be included. This topic was much discussed at the scoping workshop and to exclude a group of people who are at highest risk of complications and a severe course without timely management of disease is inappropriate. Many people under adult care had disease develop in childhood. Treatment, including conventional immunomodulator and biological therapy, is more effective when started at an early stage, soon after diagnosis Surgical treatment is needed in 50-80%, as the c document states. To restrict surgical treatment to the two indications is inappropriate, when the majority of patients with the condition need surgery. This will lead to a medical management guideline, which is manifestly inappropriate when the goal is combined medical and surgical management. The guideline is an opportunity to bring the disciplines together in the interest of the patient, not to divide them in the interest of convenience. Colonic defunctioning, management of fistulae (examination under anaesthetic and seton insertion, with biological therapy), timing of surgery and post-operative therapy are crucial aspects of management. We believe that to leave d this out will lack credibility as a guideline Smoking cessation, while important, is generic to conditions other than CD and could be dispensed with. Thank you. We will edit accordingly. management of Crohn s disease in children. Thank you. It is not possible to cover all aspects of surgery, in all areas of the bowel in which Crohn s occurs, within the time available. Following discussion at the scoping workshop, these were the two main areas that were identified as being most useful, and having the largest evidence base, for the guideline to investigate. Final decisions about what surgery to include will be taken by the fully convened GDG. Thank you. We will cross refer to other guidelines. 20

21 (BSG) Royal College of Physicians (RCP) & (BSG) Royal College of Physicians (RCP) & (BSG) b f Enteral vs medical management. The data are largely from children. It would therefore only be appropriate to include this if children are included (see above recommendation) within the work. Osteopenia is a lesser concern than is cancer. Cancer risks and monitoring (if any necessary) could usefully appraise the value of colonoscopy and save money from unnecessary surveillance. This would be instructive, change practice and achieve savings in other parts of the health budget, in the same way that management of osteopenia can potentially save health costs through reducing fractures RPSGB 1 General The RPSGB welcomes the opportunity to contribute to the scope of this guideline. RPSGB Could key clinical issues to be covered include lifestyle issues such as diet, hydration, exercise, weight management and alcohol consumption? The Society and College of Radiographers 1 General The only comment from the Society and College of Radiographers would be that appropriate imaging can influence management and surveillance. Currently there issues around the provision and availability of small bowel imaging in MRI. The lack of MRI capacity is hampering progression of this side of GI imaging in some hospitals. Perhaps NICE guidance on imaging in Crohn's disease (especially in the small bowel) should be considered, especially in light of MRI developments, capsule endoscopy and the radiation burden of CT and fluoroscopy. Vifor Pharma UK 1 General In March 2009 the UK IBD Standards document Service standards for the healthcare of people management of Crohn s disease in children. Thank you. We anticipate that the NICE Short Guideline on colonoscopic surveillance will be published soon. We will cross reference to this guidance as appropriate. Thank you. Thank you. The developers have focused the scope on key clinical issues as it is not possible to cover all areas relevant to Crohn s disease. Thank you, but service provision is outside the remit of a clinical guideline. We are not able to cover all aspects of Crohn s disease within the limited time available. Thank you. Anaemia is a manifestation of many chronic conditions and it is not possible to address 21

22 who have Inflammatory Bowel Disease (IBD) was published and the following statement is prominent on page 8 IBD can produce symptoms of urgency, diarrhoea, pain, profound fatigue and anaemia. This merits guidance on anaemia and its management in this patient group. Anaemia in this group is currently not managed well overall in most UK gastroenterology units. An audit in Chase Farm Hospital presented at UEGW November 2009 showed that out of 212 IBD patients 48% were anaemic. They conclude that Vigilance in investigating and treating patients with anaemia should be one of our prime goals in the optimising IBD patient's management and normalisation of haemoglobin level should be paramount. (Gut 2009; 58 (Suppl II) A316 Aljabiri) everything relevant to Crohn s disease within this guideline. In a poster from ECCO 2010, 22.6% of 106 Crohn s Disease (CD) patients were identified as anaemic in an audit in a tertiary referral centre at St Mark s Hospital, London. (ECCO Prague 2010 Abstract, Tee CT) Another group at ECCO 2010 looked at co morbidities of over 23,000 patients with CD and noted that over a 4 year period the healthcare resource utilisation due to anaemia increased from 1.5% in year one to 4.5% by year four when comparing existing patients against newly diagnosed patients. (ECCO Prague 2010 Abstract PO39, Yu A) Vifor Pharma UK 2 General Increasingly IV iron is being administered in a community setting. ANSA (Anaemia Nurse Specialist Association) have guidelines on how this can be managed. This fits in well with the trend to Thank you. Anaemia is a manifestation of many chronic conditions and it is not possible to address everything relevant to Crohn s disease within this guideline. 22

23 moving care of chronic diseases into the community environment. The international IBD anaemia guidelines state that Blood transfusion is no substitute for the treatment of iron deficiency anaemia with intravenous iron, possibly in combination with erythropoietic agents. Should transfusion be judged necessary, iron replacement therapy is still required. (Inflamm Bowel Dis (2007) 13: Gasche C.) Vifor Pharma UK QOL Anaemia is a well known common complication of Crohn s disease. Many studies have looked at the prevalence of anaemia and it varies from 6% to 74% (Kulnigg 2006) depending on the definition of anaemia used and the patients studied (E.g. hospitalised or not). The Guidelines on the Diagnosis and Management of iron Deficiency Anaemia in IBD 2007 suggest that treatment should be considered for all patients with a haemoglobin below normal. They also comment that anaemia impairs quality of life even in the absence of specific symptoms and that treatment leads to improvement in QOL. (Aliment Pharmacol Ther (2006) 24, Kulnigg S) (Inflamm Bowel Dis (2007) 13: Gasche C.) Thank you. Anaemia is a manifestation of many chronic conditions and it is not possible to address everything relevant to Crohn s disease within this guideline. A recent RCT of ferric carboxymaltose versus placebo in Chronic Heart Failure patients (FAIR- HF) demonstrated that in anaemic and nonanaemic patient s correction of iron deficiency improved symptoms, functional capacity, and QOL. (FAIR-HF study, NEJM 2009; 361 Anker S.) The Crohn s population is a relatively young 23

24 Vifor Pharma UK c Vifor Pharma UK a population compared to patients with other chronic diseases such as heart failure and chronic kidney disease and may have young families. We know the impact that anaemia treatment may have on the improvement of QOL of Inflammatory Bowel Disease (IBD) patients as defined by Wells in (Inflamm Bowel Dis 2006;12: Wells CW.) In regard to anaemia as a symptom, an international IBD guideline includes suggestions for assessing anaemia and iron deficiency in table 3. (Inflamm Bowel Dis (2007) 13: Gasche C.) There is increasing use of biological therapies to treat Crohn s patients and treatment of the inflammation will help start to resolve any anaemia present. However, in some circumstances the use of infliximab can initiate a functional iron deficiency as outlined by Katsanos. Katsanos points out that this could be overcome by administering iv iron at the same treatment session as the infliximab. This could prove to be very cost effective. (Journal of Crohn s and Colitis (2007) 1, Katsanos K.) Vifor Pharma UK Any QOL assessment tool should consider recording the anaemic status of patients as well as their haematological markers. Fatigue and anaemia are often interlinked and correction of iron deficiency irrespective of anaemia may improve functional and physical well being as recently described in a heart failure and heavy uterine bleeding populations. (FAIR-HF study, NEJM 2009; 361 Anker S.) Van Wyck (Transfusion Dec;49(12): ) Thank you. Thank you your comment is noted, but the use of infliximab has been covered in TA187. Thank you. Anaemia is a manifestation of many chronic conditions and it is not possible to address everything relevant to Crohn s disease within this guideline. 24

25 Vitaline Pharmaceuticals UK Ltd Vitaline Pharmaceuticals UK Ltd Vitaline Pharmaceuticals UK Ltd Warner Chilcott UK Ltd (formerly Procter & Gamble Pharmaceuticals) c A recent analysis of more than 12,000 patients carried out in Europe by the EFCCA and published in the Journal of Crohn s & Colitis in December 2007 showed that fatigue was the second most reported symptom affecting their QOL. (Journal of Crohn's and Colitis (2007) 1, Ghosh S). This section acknowledges patients can have extensive intestinal inflammation, with associated biochemical and haematological evidence of clinically significant systemic disturbance (eg. Anaemia). No mention of management. 2 General Include the assessment of iron status and treatment if iron deficiency The use of oral vs intravenous iron No mention of managing the concomitant anaemia, and impact on HRQoL. (using the IBDQ) Our comments are as follows and relate to the use of Aminosaliclates in the management of Crohn s disease. Aminosalicylates are not all the same, indeed of the wide group of aminosalicylates available only few are licensed in Crohn s disease namely: Sulfasalazine Mesalazines o Asacol 400mg MR tablets o Asacol 800mg MR tablets o Mesren 400mg MR tablets Thank you. Anaemia is a manifestation of many chronic conditions and it is not possible to address everything relevant to Crohn s disease within this guideline. Thank you. Anaemia is a manifestation of many chronic conditions and it is not possible to address everything relevant to Crohn s disease within this guideline. Thank you. Anaemia is a manifestation of many chronic conditions and it is not possible to address everything relevant to Crohn s disease within this guideline. Thank you. This document is the scope which sets out the areas to be addressed by the guideline. Not every detail can be predicted at this stage and many details, such as this, have to wait for the multidisciplinary GDG to be convened so that they can be prioritised. We will comply with the Guidelines Manual. The scope should only cover these licensed 25