The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease

Lone Larsen, Michael Dam Jensen, Michael Due Larsen, Rasmus Gaardskjær Nielsen, Niels Thorsgaard, Ida Vind, Signe Wildt, Jens Kjeldsen

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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).

Original languageEnglish
JournalClinical Epidemiology
Volume8
Pages (from-to)607-612
ISSN1179-1349
DOIs
Publication statusPublished - 2016

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Inflammatory Bowel Diseases
Registries
Databases
Ulcerative Colitis
Research
Radiology
Crohn Disease
Guidelines
Confidence Intervals
Physicians
Weights and Measures
Population

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Larsen, Lone ; Jensen, Michael Dam ; Larsen, Michael Due ; Nielsen, Rasmus Gaardskjær ; Thorsgaard, Niels ; Vind, Ida ; Wildt, Signe ; Kjeldsen, Jens. / The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease. In: Clinical Epidemiology. 2016 ; Vol. 8. pp. 607-612.
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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).",
author = "Lone Larsen and Jensen, {Michael Dam} and Larsen, {Michael Due} and Nielsen, {Rasmus Gaardskj{\ae}r} and Niels Thorsgaard and Ida Vind and Signe Wildt and Jens Kjeldsen",
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The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease. / Larsen, Lone; Jensen, Michael Dam; Larsen, Michael Due; Nielsen, Rasmus Gaardskjær; Thorsgaard, Niels; Vind, Ida; Wildt, Signe; Kjeldsen, Jens.

In: Clinical Epidemiology, Vol. 8, 2016, p. 607-612.

Research output: Contribution to journalJournal articleResearchpeer-review

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AU - Larsen, Lone

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AB - 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).

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