The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease.
OBJECTIVE
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.


METHODS
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.


METHODS
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.
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.


CONCLUSIONS
The database will be available for research during 2016. Data will be made available by The Danish Clinical Registries (www.rkkp.dk).
Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg.
Lone
L
Larsen
Department of Internal Medicine, Section of Gastroenterology, Lillebaelt Hospital Vejle, Vejle.
Michael Dam
MD
Jensen
Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark.
Michael Due
MD
Larsen
Department of Paediatrics, Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense C.
Rasmus Gaardskær
RG
Nielsen
Department of Internal Medicine, Section of Gastroenterology, Hospital Unit West, Herning.
Niels
N
Thorsgaard
Department of Gastroenterology, Copenhagen University Hospital, Hvidovre.
Ida
I
Vind
Department of Medicine, Section of Gastroenterology, Køge Hospital, Køge.
Signe
S
Wildt
Department of Medical Gastroenterology, Odense University Hospital, Odense C, Denmark.
Jens
J
Kjeldsen
anti-TNF-α agents; biological therapy; database; inflammatory bowel disease; quality indicators