Early diagnosis of coeliac disease in the Preventive Youth Health Care Centres in the Netherlands: study protocol of a case-finding study (GLUTENSCREEN).

Meijer-Boekel, C.; van den Akker, M. E.; van Bodegom, L.; Escher, J. C.; van Geloven, N.; van Overveld, F.; Rings, E. H. H. M.; Smit, L.; de Vries, M. C.; Mearin, M. L.

Introduction: Coeliac disease (CD) occurs in 1% of the population, develops early in life and is severely underdiagnosed. Undiagnosed and untreated disease is associated with short- and long-term complications. Treatment with a gluten-free diet results in health improvement. The current health care approach is unable to solve the underdiagnosis of CD and timely diagnosis and treatment is only achieved by active case finding. Aim of this study is to perform a novel case-finding project to detect CD in 12 months-4 years old symptomatic children who visit the YHCCs in a well-described region in the Netherlands to show that it is feasible, cost-effective and well accepted by the population. Methods/analysis: Prospective intervention cohort study. Parents of all children aged 12 months-4 years attending the Youth Health Care Centres (YHCCs) for a regular visit are asked if their child has one or more CD-related symptoms from a standardized list. If so, they will be invited to participate in the case-finding study. After informed consent, a point of care test (POC) to assess CD-specific antibodies against tissue-transglutaminase (TG2A) from a droplet of blood, is performed onsite at the YHCCs. If the POC test is positive, CD is highly suspected and the child will be referred to hospital for definitive diagnosis according to the ESPGHAN guideline. Main outcomes: 1. incidence rate of new CD diagnoses in the study region Kennemerland in comparison to the rest of the Netherlands. 2. Feasibility and cost-effectiveness of active case-finding for CD in the YHCCs. All costs of active case finding, diagnostics and treatment of CD and the potential short and long term consequences of the disease will be calculated for the setting with and without case finding. 3. Ethical acceptability: by questionnaires on parental and health care professionals satisfaction. A statistical analysis plan (SAP) has been written and will be published on the GLUTENSCREEN website. Ethics and dissemination: The Medical Ethics Committee Leiden approved this study. If we prove that active case finding in the YHCC is feasible, efficient, cost-effective and well accepted by the population, implementation is recommended. Trial registration number: NL63291.058.17