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Review
. 2016 Oct 25:8:607-612.
doi: 10.2147/CLEP.S99478. eCollection 2016.

The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease

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 Kjeldsen  8
Affiliations
Review

The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease

Lone Larsen et al. Clin Epidemiol. .

Abstract

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: anti-TNF-α agents; biological therapy; database; inflammatory bowel disease; quality indicators.

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Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Patient flow in the database. Notes: Patients will be included at start or switch of biological therapy. A form for basic patient information, start of biological therapy, outpatient visit where biological therapy will be administered, switch of therapy, and discontinuation of biological therapy will be available at relevant time-point in course of therapy.
See this image and copyright information in PMC

References

    1. Vind I, Riis L, Jess T, et al. Increasing incidences of inflammatory bowel disease and decreasing surgery rates in Copenhagen City and county, 2003–2005: a population-based study from the Danish Crohn colitis database. Am J Gastroenterol. 2006;101(6):1274–1282. - PubMed
    1. Jacobsen BA, Fallingborg J, Rasmussen HH, et al. Increase in incidence and prevalence of inflammatory bowel disease in northern Denmark: a population-based study, 1978–2002. Eur J Gastroenterol Hepatol. 2006;18(6):601–606. - PubMed
    1. Jakobsen C, Paerregaard A, Munkholm P, et al. Pediatric inflammatory bowel disease: Increasing incidence, decreasing surgery rate, and compromised nutritional status: a prospective population-based cohort study 2007–2009. Inflamm Bowel Dis. 2011;17(12):2541–2550. - PubMed
    1. Norgard BM, Nielsen J, Fonager K, Kjeldsen J, Jacobsen BA, Qvist N. The incidence of ulcerative colitis (1995–2011) and Crohn’s disease (1995–2012) – based on nationwide Danish registry data. J Crohns Colitis. 2014;8(10):1274–1280. - PubMed
    1. Rungoe C, Langholz E, Andersson M, et al. Changes in medical treatment and surgery rates in inflammatory bowel disease: a nationwide cohort study 1979–2011. Gut. 2014;63(10):1607–1616. - PubMed

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