The Inflammatory Bowel Disease Working Group
Membership:
Sally Mitton (Chair), Consultant Paediatric Gastroenterologist, Dept of Child Health, St George's Hospital Medical School, Cranmer Terrace, London,SW17 0RE
e-mail smitton@sgul.ac.uk
John Fell, (Secretary) Consultant Paediatric Gastroenterologist, Paediatric Gastroenterology,Chelsea and Westminster Hospital, 369 Fulham Road, London, SW10 9NH
e-mail j.fell@imperial.ac.uk
Professor Simon Murch, Clinical Sciences Research Institute, Clifford Bridge Road, Coventry, CV2 2DX
e-mail: s.murch@warwick.ac.uk
David Wilson, Consultant Paediatric Gastroenterologist, Child Life and Health
University of Edinburgh, 20 Sylvan Place, Edinburgh,ED9 1UW
e-mail d.c.wilson@ed.ac.uk
Nick Croft – Consultant Paediatric Gastroenterologist, Wingate Institute, 26 Ashfield Street, London, E1
e-mail n.m.croft@qmul.ac.uk
Huw Jenkins – Consultant Paediatric Gastroenterologist, Dept of Child Health, University Hospital of Wales, Heath Park, Cardiff, CF4 4XN
e-mail huw.jenkins@cardiffandvale.wales.nhs.uk
Stephen Murphy, Consultant Paediatric Gastroenterologist, Birmingham Children's Hospital, Institute of Child Health, Whittall Street, Birmingham, B4 6NH e-mail m.s.murphy@bham.ac.uk
Professor Bhu, Royal Hospital for Children, Upper Maudlin Street, Bristol, BS2 8BJ
e-mail bhupinder.sandhu@ubht.swest.nhs.uk
Adrian Thomas, Consultant Paediatric Gastroenterologist, Booth Hall Children's Hospital, Charlestown Road, Blackley, Manchester, M9 7AA
e-mail adrian.thomas@cmmc.nhs.uk
Tony Akobeng, Consultant Paediatric Gastroenterologist, Dept of Paediatric Gastroenterology, Booth Hall Children's Hospital, Charlestown Road, Manchester
M9 7AA
e-mail: tony.akobeng@cmmc.nhs.uk
IBD WORKING GROUP – ANNUAL REPORT 2006
1. MEETINGS – The Group had one meeting in 2006, held during the BSPGHAN
Annual Winter Meeting on 19.01.06 in Newcastle.
2. RESEARCH UPDATE – (a) Stephen Murphy has continued developing the pilot trial of enteral nutrition versus corticosteroids in Crohn’s disease. He has obtained funding for three years from SHS, and Sally Mitton and Chris Taylor have local funding to join in also as pilot centres. The pilot study will require recruitment of 80 cases, and will provide data to inform a definitive study, estimated to need at least 300 cases and requiring national peer reviewed funding. Blood will be stored for genetic analysis and urine and blood for bone markers.
(b) Azathioprine trial – in the HTA submission by Dr Murphy, the reviewers suggested that the Azathioprine arm be removed from the planned large simple study of factorial design (so including both the enteral feeds - steroids trial and the Azathioprine or no Azathioprine at diagnosis trial). The revised application fell at the final hurdle. There is still much enthusiasm within the group for an appropriately designed Azathioprine at diagnosis trial, with consideration of separately applying for funding, for example, to the MRC Clinical Trials funding stream or to the HTA Pragmatic Randomized Control Trial funding stream.
3. IBD REGISTER – With the reconstitution of the IBD Registrar, seven centres are now actively involved. Constitutionally, the Register has always had to report to the IBD Working Group, but the decision was made between the Register and the IBD Working Group that the IBD Register define its own priorities, studies and so on, and report back in three years.
4. REVIEW OF EVIDENCE BASE – The review of the evidence base on management of Paediatric IBD had run up to the end of 2004 (5220 papers). There were concerns that any publication arising in 2006 would be criticised for not being completely up to date. The literature review has therefore been extended to the end of 2006, with the first draft of the review to be completed by 25.02.07, and an aim to submit to either Gut or Alimentary Pharmacology and Therapeutics in March 2007.
5. IBD WORKING GROUP GUIDELINES ON MANAGEMENT OF IBD – First draft guidelines are being drawn up by a subgroup (Bhu Sandhu, Sally Mitton) and will be presented to the Working Group meeting on 08.02.07 in Birmingham. The review will be completed and re-discussed at a second 2007 Working Group meeting held during the York RCPCH Meeting. Professor Sandhu has had preliminary discussions with the editor of Gut and the aim is to have these IBD Working Group Guidelines published as a supplement.
6. FORMAL CONSENSUS BASED GUIDELINES – There are strict methodological
issues involved in the drawing up of formal clinical guidelines. The result
is that the IBD Working Group Guidelines (item 5) would not be accepted as
clinical guidelines by groups such as NICE, or the Royal College of Paediatrics
and Child Health Quality of Practice Committee, failing to meet their criteria
on issues such as formal construct, patient involvement, and broad based
consensus with modification using a Delphi type process, and finally open
presentation at a consensus conference. Once the evidence based review and
the IBD Working Group Guidelines are submitted for publication, the Group
will consider whether it is worth pursuing the construction of formal consensus
based clinical guidelines on paediatric IBD management.
7. REVIEW OF IBD WORKING GROUP – The current structure of the Group include a Chair (three years duration), Secretary and Members, including IBD Nurse Specialist and Paediatric Specialist Dieticians. The aims of the Group have been to promote audit in IBD, produce guidelines, promote good practice, and promote collaborative research.
Dr Nigel Meadows, representing BSPGHAN Council, will chair the 08.02.07
meeting of the Group in Birmingham to fully review the structure of this
Working Group. Dr Wilson has been Chair of the Group since June 2004, and
the meeting in Birmingham is therefore an appropriate time to nominate and
select a new Chair of the Group.
The Register of Paediatric Inflammatory Bowel Disease
Introduction
| Consent and Registration Process... |
| Important Developments... |
| Flow Chart... |
Overview
This register is based at the Institute of Child Health within the University of Liverpool. It aims to record all patients who are newly diagnosed with an inflammatory bowel disease whilst under the age of 16 years from any of 47 selected centres throughout England, Scotland and Wales.
Basic diagnostic and clinical data is collected once the consent of the patient and their guardian has been obtained. If consent is not given only annonymised data- diagnosis and gender- are recorded in order to allow estimation of incidence.
This process has been approved by South Thames MREC (need to include reference and document). This MREC approval incorporates the understanding that consent allows the register to review the notes of registered patients without re-approaching the patient or their guardian. It also allows for patients to be re-approached to be asked to participate in any further study but does not oblige participation in such a study for which a separate ethical approval will have been obtained.
Aims
In many ways inflammatory bowel diseases in the paediatric age group represents a group of diseases whose characteristics are distinct from the nominally similar diseases in adults. Thus there appears to be a bimodal incidence peak according to age which suggests some distinction between children and adolescents when compared with adults. Certain genetic linkage studies for paediatric Crohn’s disease are distinct from those of the same disease in adults. A lower age at diagnosis is associated with an increased likelihood of having affected relatives, an increased incidence of small bowel involvement, an increased frequency of structuring disease and an increased likelihood of the need for surgical intervention
Accurate epidemiological data pertinent to inflammatory bowel diseases in the paediatric age group is vital to understand the impact it has on patients, their families and associates and society as a whole. This data is also vital if we are to understand the underlying disease mechanisms and have the facility to test whether or not therapeutic interventions are beneficial.
- To establish incidence figures and trends
The initial impetus to the establishment of this register was ignorance over the incidence of inflammatory bowel diseases in the paediatric population. - To designate cohorts of patients
Effective clinical research requires large numbers of patients who have a given diagnosis or feature in common. Without this results are inconclusive. The register will facilitate this process. - To enable longitudinal study of patients diagnosed in childhood.
This could comprise such aspects as progression to employment, psychological impact, growth, development of long-term complications such as cancer...It will also facilitate the coordination of interventional studies.
Historical progression
The register was initially established in 1997 and was based at the Royal Free Hospital with funding via a charitable donation from GlaxoWellcome. In 1999, in order to strengthen its standing it was placed under the auspices of the British Society of Paediatric Gastroenterology, Hepatology and Nutrition.
Since 2000 it has been generously funded by the charity Crohn’s and Colitis in Childhood research Association (CICRA). A lumps sum contribution from Nestle allowed the purchase of computer equipment and consumables. These items were subsidised through the University of Liverpool. Also since this time it has been housed at the Institute of Child Health of the University of Liverpool. The contribution from the university has offset the costs due to office space, maintenance and upgrading of computer equipment, courses in statistics and software, management of resources and advertising for posts.
At present Dr David Casson chairs a committee which oversees the progression of the register. This in turn is under the mandate of the Paediatric Inflammatory Bowel Disease Steering Group and all is under the umbrella of the British Society of Paediatric Gastroenterology, Hepatology and Nutrition.
This hierarchy has been established in order for the society to clearly establish its priorities from which the steering group can formulate research questions which it can then direct to the register in order to facilitate an appropriate project.
This structure has evolved in parallel to the evolution of the register structure itself. This has incorporated the need for consent from patients and their parents prior to data being recorded- this was not an initial stipulation of the register. It has incorporated the development of a sophisticated ’referential’ data-base whereas the original data-base was severely restricted by its longitudinal structure. It has streamlined the registration and consent procedure which was initially seen as too cumbersome (Registration pack enclosed).
The population covered by the register has been rigorously confirmed as being representative of the national population. This was done by an in-house analysis of comparison of data collected by the register and that collected by a national incidence study undertaken by the British Paediatric Surveillance Unit in 1999 (see enclosed paper).
The register employs a full-time research assistant Lucy Taylor, presently on maternity leave, who will return on a part-time basis in October 2003. In her absence the funding has been diverted to allow employment of a part-time clerical support post presently occupied by Carla Roberts. As the register evolves it is envisaged that these personnel will both be maintained on a part-time basis. The day-to-day running and communication will be undertaken by Carla Roberts allowing Lucy Taylor to utilise the register to undertake her PhD on the incidence pattern s of inflammatory bowel diseases in the paediatric age group.
Outgoing information
Regular newsletters are produced to inform those who contribute information about patients
Research output
Valuable output from disease registers generally requires a considerable period of time to allow sufficient data to be appropriately collated. Nevertheless, despite being early in the early stages of it’s development, the Register of paediatric Inflammatory Bowel Diseases has begun to contribute to the body of knowledge about these diseases:
The register was commissioned to write an editorial article for Archives of Diseases of Childhood regarding the structure and utilization of disease registers. This has been accepted and is awaiting publication.
Issues relating to the establishment and development of a
paediatric research register
L.B. Taylor
The register has contributed to the debate about whether there is a birth date associated seasonal effect in the onset of inflammatory bowel diseases:
No Evidence of Month of Birth or Seasonality as a Risk Factor for Crohn’s Disease in Children
Lucy B Taylor
bmj.com/cgi/eletters/323/7318/907#18167 , 20 Dec 2001
Presentation to the 2002 winter meeting of the British Society of Paediatric Gastroenterology, Hepatology and Nutrition
Is indeterminate colitis a distinct entity in the paediatric population?
E. Newby
The numbers
| Consented | Non Consented | |
| Crohn’s | 205 | 767 |
| Ulcerative Colitis | 96 | 351 |
| Indeterminate Colitis | 41 | 145 |
| Orofacial Granulomatosis | 1 | 22 |
| Crohn’s Disease & Orofacial Granulomatosis | 5 | 3 |
| Total | 348 | 1288 |
| Overall Total at end of June 2003 | 1636 | |
The present
The register is an extremely valuable tool for future research. However it faces the dilemma of all registers in that it must be well established before it can become an important resource. The register has been generously supported to allow it to get to this point and is now preparing to undertake its first longitudinal review of those patients for whom consent has been obtained (see enclosed protocol).
This project will undertake a notes review of all these patients. Those aspects which will be documented have been arrived at by consensus between the members of the IBD Steering Group and patient representative organisations- Crohn’s and Colitis in Childhood (CICRA) and the National Association of Crohn’s and Colitis (NACC).
The future
The register must be able to maintain its structure in order to facilitate its role for the future. Funding needs to contribute to the day-to-day running costs as well as to any given projects. These two are intimately related and for practical purposes such funding will need to be raised in concert.
The majority of the support for infrastructure, space and maintenance will continue to be provided by the University of Liverpool.
A business case has been submitted to the NHS numbers Commission. This will allow the register to obtain and confirm the NHS number for all consented patients. This is a unique identifier which will allow patients to be accurately traced with regard to geographical location for improved follow-up and for medical progression such as the development of cancers or death.
Conclusion:
Having been through many stages in its development the register has now achieved equilibrium and has defined clearly stated aims. The need for such a resource is becoming ever more apparent and we look forward to productive period in which the register will be at the forefront in defining and influencing progress in understanding inflammatory bowel diseases.
David Casson July 2003
Chairman of the Register of Paediatric Inflammatory Bowel Diseases
Copyright © 2006 British Society of Paediatric Gastroenterology Hepatology and Nutrition