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Abstract
Introduction Children with chronic gastrointestinal symptoms are frequently seen in primary care, yet general practitioners (GPs) often experience challenges distinguishing functional gastrointestinal disorders (FGID) from organic disorders. We, therefore, aim to evaluate whether a test strategy that includes point-of-care testing (POCT) for faecal calprotectin (FCal) can reduce the referral rate to paediatric specialist care among children with chronic gastrointestinal symptoms. The study findings will contribute to improving the recommendations on FCal use among children in primary care.
Methods and analysis In this pragmatic cluster randomised controlled trial, we will randomise general practices into intervention and control groups. The intervention group will use FCal-POCT when indicated, after completing online training about its indication, interpretation and follow-up as well as communicating an FGID diagnosis. The control group will test and treat according to Dutch GP guidelines, which advise against FCal testing in children. GPs will include children aged 4–18 years presenting to primary care with chronic diarrhoea and/or recurrent abdominal pain. The primary outcome will be the referral rate for children with chronic gastrointestinal symptoms within 6 months after the initial assessment. Secondary outcomes will be evaluated by questionnaires completed at baseline and at 3- and 6-month follow-up. These outcomes will include parental satisfaction and concerns, gastrointestinal symptoms, impact of symptoms on daily function, quality of life, proportion of children with paediatrician-diagnosed FGID referred to secondary care, health service use and healthcare costs. A sample size calculation indicates that we need to recruit 158 GP practices to recruit 406 children.
Ethics and dissemination The Medical Research Ethics Committee (MREC) of the University Medical Center Groningen (The Netherlands) approved this study (MREC number: 201900309). The study results will be made available to patients, GPs, paediatricians and laboratories via peer-reviewed publications and in presentations at (inter)national conferences.
Trial registration number The Netherlands Trial Register: NL7690 (Pre-results)
- primary care
- paediatric gastroenterology
- functional bowel disorders
- inflammatory bowel disease
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This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Twitter @PFvRheenen
Correction notice This article has been corrected since it was published. Author name 'Patrick Ferry van Rheenen' has been updated.
Contributors GAH, PvR, KV and MYB conceived the original research concept. All authors contributed to the study design. SMA, MC and GB will collect and manage data during the trial. SMA has written and revised this protocol. All authors have contributed important intellectual content to the manuscript and have approved the final version for publication in this journal.
Funding This trial was supported by ZonMW, The Dutch Organization for Health Research and Development (project number 852001930). The BÜHLMANN Group funded testing. However, the funders had no role in the protocol development and will have no role in data collection, analysis, decision to publish or manuscript preparation. All authors will have full access to all data.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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