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BMC Public Health

Title:		The ADEM2 project: early pathogenic mechanisms of preschool wheeze and a randomised controlled trial assessing the gain in health and cost-effectiveness by application of the breath test for the diagnosis of asthma in wheezing preschool children
Author(s):		Kienhorst S; van Aarle MHD; Jobsis Q; Bannier M; Kersten ETG; Damoiseaux J; van Schayck OCP; Merkus P; Koppelman GH; van Schooten FJ; Consortium A; Smolinska A; Dompeling E;
Address:		"Department of Paediatric Pulmonology, Maastricht University Medical Centre, Maastricht, The Netherlands. sophie.kienhorst@mumc.nl. Department of Paediatric Pulmonology, Maastricht University Medical Centre, Maastricht, The Netherlands. Department of Paediatric Pulmonology and Pediatric Allergology, Beatrix Children's Hospital, and GRIAC Research Institute, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands. Central Diagnostic Laboratory, Maastricht University Medical Centre, Maastricht, The Netherlands. Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands. Department of Paediatric Pulmonology, Radboud University Medical Centre, Nijmegen, The Netherlands. Department Pharmacology and Toxicology, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands"
Journal Title:		BMC Public Health
Year:		2023
Volume:		20230403
Issue:		1
Page Number:		629 -
DOI:		10.1186/s12889-023-15465-6
ISSN/ISBN:		1471-2458 (Electronic) 1471-2458 (Linking)
Abstract:		"BACKGROUND: The prevalence of asthma-like symptoms in preschool children is high. Despite numerous efforts, there still is no clinically available diagnostic tool to discriminate asthmatic children from children with transient wheeze at preschool age. This leads to potential overtreatment of children outgrowing their symptoms, and to potential undertreatment of children who turn out to have asthma. Our research group developed a breath test (using GC-tof-MS for VOC-analysis in exhaled breath) that is able to predict a diagnosis of asthma at preschool age. The ADEM2 study assesses the improvement in health gain and costs of care with the application of this breath test in wheezing preschool children. METHODS: This study is a combination of a multi-centre, parallel group, two arm, randomised controlled trial and a multi-centre longitudinal observational cohort study. The preschool children randomised into the treatment arm of the RCT receive a probability diagnosis (and corresponding treatment recommendations) of either asthma or transient wheeze based on the exhaled breath test. Children in the usual care arm do not receive a probability diagnosis. Participants are longitudinally followed up until the age of 6 years. The primary outcome is disease control after 1 and 2 years of follow-up. Participants of the RCT, together with a group of healthy preschool children, also contribute to the parallel observational cohort study developed to assess the validity of alternative VOC-sensing techniques and to explore numerous other potential discriminating biological parameters (such as allergic sensitisation, immunological markers, epigenetics, transcriptomics, microbiomics) and the subsequent identification of underlying disease pathways and relation to the discriminative VOCs in exhaled breath. DISCUSSION: The potential societal and clinical impact of the diagnostic tool for wheezing preschool children is substantial. By means of the breath test, it will become possible to deliver customized and high qualitative care to the large group of vulnerable preschool children with asthma-like symptoms. By applying a multi-omics approach to an extensive set of biological parameters we aim to explore (new) pathogenic mechanisms in the early development of asthma, creating potentially interesting targets for the development of new therapies. TRIAL REGISTRATION: Netherlands Trial Register, NL7336, Date registered 11-10-2018"
Keywords:		"Humans Child, Preschool Child *Volatile Organic Compounds Respiratory Sounds/diagnosis Cost-Benefit Analysis *Asthma/diagnosis/drug therapy Breath Tests/methods Asthma Biomarkers Breath test Diagnosis Exhaled VOC Pathogenesis Preschool Wheeze;"
Notes:		"MedlineKienhorst, Sophie van Aarle, Moniek H D Jobsis, Quirijn Bannier, Michiel A G E Kersten, Elin T G Damoiseaux, Jan van Schayck, Onno C P Merkus, Peter J F M Koppelman, Gerard H van Schooten, Frederik-Jan Smolinska, Agnieszka Dompeling, Edward eng Multicenter Study Observational Study Randomized Controlled Trial Research Support, Non-U.S. Gov't England 2023/04/05 BMC Public Health. 2023 Apr 3; 23(1):629. doi: 10.1186/s12889-023-15465-6"