Title: The PINPOINT study -The Prospective Incidence of Paediatric-Onset Inflammatory bowel disease in the United Kingdom
Funder: Guts UK

Abstract: Background: Identifying a true rise in disease incidence is invaluable for organising current health care provision and for planning future service design, both of which are vital for patients and families. The only prospective UK-wide paediatric inflammatory bowel disease (PIBD) incidence data is the 13-month British Paediatric Surveillance Unit survey of 1998-1999. There is therefore a pressing need to update this data to ensure that current healthcare provision is based on accurate epidemiology and to assess, for the first time, incidence trends covering the entire UK over a period of 20 years. We aim to prospectively collect demographic and basic clinical information on every child under 16 years of age newly diagnosed with inflammatory bowel disease (IBD) in the United Kingdom (UK) over a 15-month period. Hypothesis and objectives: We hypothesise that the incidence of PIBD (i.e. diagnosed less than 16 years of age) in the UK has risen significantly since 1999. Our objectives are to (1) determine the accurate incidence of paediatric IBD (PIBD) to help inform future epidemiological studies and NHS service design; (2) create the first traceable UK-wide prospective PIBD cohort; and (3) give every paediatric IBD centre access to the IBD Registry. Design and methods: An exhaustive list of 31 study sites where diagnostic paediatric endoscopy is performed in the UK has already been generated and local investigators identified and contacted. Over a 15-month period each site, after gaining written patient consent, will enter a mandatory minimum dataset for each new patient (e.g. age, IBD sub-type, sex) through the IBD Registry Web Tool or the IBD Registry Patient Management System if already in use. Following study completion data will be collated and analysed (using publicity available population data) to generate UK-wide incidence rates for IBD, Crohn’s disease, ulcerative colitis and IBD-unclassified. Robust identification of these patients will generate the first traceable UK-wide PIBD cohort allowing future prospective analyses of health data. Incidence figures from historical cohorts will be also standardised to the 2011 Census data to allow trend analysis. Age-sex standardised rates will be calculated using the direct method(1) and 95% confidence intervals (CIs) determined using a method based on gamma distribution(2). P values for comparisons between time periods/UK regions will be obtained from Poisson regression models. Clinical and scientific impact: Based on currently available data we estimate that we would record a minimum of 1,600 new cases of paediatric IBD using the above methods. With the incidence trends generated, coupled with other environmental factors, these data will help provide useful insights into disease aetiology, as to date there is a paucity of data on disease rates within countries which may uncover clues to disease causation. Moreover, the creation of the first paediatric, UK-wide, prospective IBD cohort provides a vital resource which will allow serial evaluation of outcomes and therapies to improve the efficacy of current therapies and to improve the lives of people living with IBD. Providing access to the IBD Registry for each paediatric IBD centre is also seen as a major infrastructure improvement.

Lay abstract: The number of children with a new diagnosis of inflammatory bowel disease (IBD) each year (known as incident cases) has been increasing across the world. However, the last study collecting this information in UK was done in 1999. This study involves 38 centres UK-wide to determine how many children are diagnosed with IBD each year. This will help informing future IBD research investigations and NHS service design.

Research activity codes: 2.1 BIOLOGICAL AND ENDOGENOUS FACTORS;2.4 SURVEILLANCE AND DISTRIBUTION
Health categories: ORAL AND GASTROINTESTINAL