The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease

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:

• inflammatory bowel disease
• biological therapy
• anti-TNF-α agents
• quality indicators
• database

Acknowledgments

The authors would like to thank all members of the steering committee for their contribution in the development the BIO-IBD database. The members of the steering committee are Data Manager, Pia Andersen, MSc, Katrine Abildtrup Nielsen, MSc in Health Science, Esra Öztoprak, MSc in Health Science, all from The Danish Clinical Registries – a National quality improvement program, Statistician Jan Nielsen, MSc, PhD, and Bente Nørgaard, MD, PhD, DMSc. This paper was funded by the Program for Clinical Research Infrastructure (PROCRIN) established by the Lundbeck Foundation and the Novo Nordisk Foundation and administered by the Danish Regions.

Disclosure

The authors report no conflicts of interest in this work.