The Register of Paediatric Inflammatory Bowel Disease

Introduction

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.

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

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

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