• Dtsch Arztebl Int · Sep 2024

    Randomized Controlled Trial Multicenter Study

    The Care of Children and Adolescents With Chronic Inflammatory Bowel Disease: A Cluster-Randomized Trial on Improving the Guideline Conformity of Treatment by the Use of the CEDATA-GPGE Patient Registry.

    • Luisa Tischler, Aletta Boerkoel, Heiko Krause, Neeltje van den Berg, and Jan de Laffolie.
    • Greifswald University Hospital, Institute for Community Medicine and German Center for Pediatric and Adolescent Medicine (DZKJ), Greifswald/Rostock site; Justus Liebig University Giessen, Center for Pediatrics and Adolescent Medicine, Department of General Pediatrics and Neonatology.
    • Dtsch Arztebl Int. 2024 Sep 20; 121 (19): 627633627-633.

    BackgroundFor children and adolescents with chronic inflammatory bowel disease (IBD), treatment that is not in adequate conformity with the guidelines can adversely affect both the course of disease and the patients' development. The targeted use of digital patient registries may improve real-life adherence to the recommendations of evidence-based guidelines.MethodsIn a cluster-randomized, controlled trial (DRKS00015505), treatment providers for the intervention group (IG) documented the treatment of children and adolescents with IBD in the CEDATA-GPGE patient registry; they received automated feedback on the data they entered and on potential deviations of the documented treatment from recommendations contained in the guidelines (care deficits). Treatments providers for the control group (CG) documented treatments as previously, i.e., only in the patients' charts. At the end of a twelve-month observation period, the data from both groups at baseline and on follow-up were analyzed in an intergroup comparison. The primary endpoint was the number of care deficits at twelve months.Results319 patients were recruited from 47 pediatric gas troen tero logical centers in Germany (IG: 21 centers and 160 subjects; CG: 26 centers and 159 subjects). Among the 146 subjects in the IG who were followed up at 12 months, there were an average (mean) of 0.17 care deficits per patient (95% confidence interval [0.10; 0.24]). Among the 134 subjects in the CG who were followed up at 12 months, there were an average (mean) of 0.55 [0.43; 0.66] identified care deficits per patient (p < 0.0001).ConclusionRegistry-based feedback can help bring treatment and its documentation into better con for - mity with the relevant guidelines and thereby reduce or prevent care deficits in children and adolescents with IBD.

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