The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease
Authors Larsen L, Jensen MD, Larsen MD, Nielsen RG, Thorsgaard N, Vind I, Wildt S, Kjeldsen J
Received 16 November 2015
Accepted for publication 29 January 2016
Published 25 October 2016 Volume 2016:8 Pages 607—612
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 3
Editor who approved publication: Professor Henrik Toft Sørensen
Lone Larsen,1 Michael Dam Jensen,2 Michael Due Larsen,3 Rasmus Gaardskær Nielsen,4 Niels Thorsgaard,5 Ida Vind,6 Signe Wildt,7 Jens Kjeldsen8
1Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg,2Department of Internal Medicine, Section of Gastroenterology, Lillebaelt Hospital Vejle, Vejle, 3Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, 4Department of Paediatrics, Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense C, 5Department of Internal Medicine, Section of Gastroenterology, Hospital Unit West, Herning, 6Department of Gastroenterology, Copenhagen University Hospital, Hvidovre, 7Department of Medicine, Section of Gastroenterology, Køge Hospital, Køge, 8Department of Medical Gastroenterology, Odense University Hospital, Odense C, Denmark
Aim: The aims of The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease are to ensure that biological therapy and the clinical management of patients with inflammatory bowel disease (IBD) receiving biological treatment are in accordance with the national clinical guidelines and, second, the database allows register-based clinical epidemiological research.
Study population: The study population comprises all Danish patients with IBD (both children and adults) with ulcerative colitis, Crohn's disease, and IBD unclassified who receive biological therapy. Patients will be enrolled consecutively when biological treatment is initiated.
Main variables: The variables in the database are: diagnosis, time of diagnosis, disease manifestation, indication for biological therapy, previous biological and nonbiological therapy, date of visit, clinical indices, physician's global assessment, pregnancy and breastfeeding (women), height (children), weight, dosage (current biological agent), adverse events, surgery, endoscopic procedures, and radiology.
Descriptive data: Eleven clinical indicators have been selected to monitor the quality of biological treatment. For each indicator, a standard has been defined based on the available evidence. National results will be published in an annual report and local results on a quarterly basis. The indicators will be reported as department-specific proportions with 95% confidence intervals, and the national average will be provided for comparison. An estimated 1,200–1,300 new biological therapies are initiated each year in Danish patients with IBD.
Conclusion: The database will be available for research during 2016. Data will be made available by The Danish Clinical Registries (www.rkkp.dk).
Keywords: inflammatory bowel disease, biological therapy, anti-TNF-α agents, quality indicators, database
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