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DATA PRESENTATION

Database for Biological Therapy of Inflammatory Bowel Disease

DATABASE

Primary variables


Age

Biological treatment

Diagnosis

Gender

Global Assessment of Functioning (GAF) score

HBI score

Height

Medicine

Paediatric Ulcerative Colitis Activity Index (PUCAI) score

Patient Simple Clinical Colitis Activity Index (P-SCCAI) score

Pediatric Crohn's Disease Activity Index (PCDAI) score

Severity of symptoms

Side-effects/ADRs

Weight

Introduction

The Database for Biological Therapy of Inflammatory Bowel Disease (BIOIBD) is a clinical quality database that contains information about patients with inflammatory bowel disease (IBD), Crohn's disease (chronic bowel inflammation) and ulcerative colitis (bleeding inflamed colon). Thus, patients without prior biological treatment (bio-naive), patients who have previously received biological therapy (bio-experienced) and patients switching from one biological drug to another (bio-shift) are included in the database.

BIOIBD is aimed at improving the quality of treatment by ensuring that biological treatments are undertaken in accordance with applicable national guidelines. BIOIBD has been operating nationwide since 2016 and is based on direct entry and data extracts from the National Patient Register (LPR).

More details

Abbreviation
BIOBD
Type
Nationwide clinical quality database
Purpose
Clinical quality

Collection Period

Collection Period
Coverage
Nationwide
Population
The population consists of all patients with Crohn's disease CD) and ulcerative colitis (UC) and unclassified IBD who start on biological treatment of their disease. Accordingly, patients are included without previous biological treatment (bio-naive), patients who have previously received biological therapy (bio-experienced) and patients switching from a biological drug to another (bio-switch)
Database Categories

Application requirements

The Regional Clinical Quality Databases

Data about clinical quality are collected with the purpose of monitoring and raising the quality of patient treatment in the Danish health-care system. These data can, as well as all other public registers, be made accessible for research projects based on systematic protocols and approved according to the relevant legislations.

Applying for access to data from a regional clinical database requires a list of demands to be obtained. A project description should be attached containing a description of the project explaining the rationale, purpose, methods, budget, publication plan etc.

Furthermore, The Danish Data Protection Agency must approve the project.

Application process

  • Apply via research access (Danish: forskeradgang), an online application system
  • Submit the protocol to The Danish Clinical Registries (RKKP)
  • RKKP registers the application
  • The application is forwarded to the relevant clinical database
  • Potential dialog about adjustment to the protocol
  • Approval and extradition of data (expected 6 months after application)

 

Legislation

The Regional clinical quality databases subject to rules for treatment of personal data, that should secure high quality of patient treatment in Denmark. These legislations include The Act on Processing of Personal Data (Danish: Persondataloven) and The Danish Act of Health (Danish: Sundhedloven). These legislations ensure that data access is limited to relevant purposes.

Contact information

Data owner
Central Denmark Region
Contact data owner
Regionshuset Viborg
Skottenborg 26
8800 Viborg 
Website - data owner
www.rm.dk/om-os/english
Data administrator
The Danish Clinical Registries (RKKP)
Contact data administrator
Esra Öztoprak
T: 21 68 69 88
E: ESROEZ@rkkp.dk
Website - data administrator
www.rkkp.dk/om-rkkp/de-kliniske-kvalitetsdatabaser/database-for-biologisk-behandling-af-inflammatoriske-tarmsygdomme