Available clinical information for clinical decision-making within inflammatory bowel disease: A Danish nationwide registry study (R-IBD)
Personalised medicine is considered to enable large improvements of treatment of patients. Using nationwide Danish registries as a source, this project will describe the clinical information available for clinical decision-making within inflammatory bowel diseases (IBD). Thereby, the project will investigate the potentials of using registry information for personalized medicine within IBD. We will define the current population of patients with IBD in Denmark and investigate which and to which extent clinical information is available before decisions about diagnosis and treatment. The overall aim is to improve IBD care.
Personalised Medicine (PM) is considered to enable large improvements of treatment of patients. This has been made possible by the fast development within high-throughput omics technology and the concomitantly falling prices. Until now, the improvements have mostly been seen within cancer, but it is expected that this will spread to, i.e., chronic inflammatory bowel diseases (IBDs). The IBDs are life-long, disabling diseases of the immune system with some genetic and environmental predisposing factors. They are prevalent diseases with an estimated incidence rate of 6-7 per 10,000 person-years and affecting approximately 75,000 people in the Danish population in 2019. The diseases represent a public health problem because of their large impact on the patients and their families' quality of life, and on the health care system and society due to costly treatments.
In the end, the aim of the healthcare system is to normalise or at least improve the quality of life of the patients. PM holds promises for a better care of patients. Within IBD, there is a lack of tools for PM. First of all, tools for a faster and more precise disease diagnosis is needed to avoid the unavoidable organ damage associated with the delayed diagnosis seen today which in many cases is more than a year. Next, tools for prognostication are needed in order to identify the patients that are in need of early intervention. Moreover, tools for deciding when to start which treatment in the individual patient are needed. Eventually, tools for identifying those in need of preventative strategies. Hence, despite the appearance of a number of new treatments targeted specific pathways, the number of patients that have to be operated due to uncontrollable disease manifestation is fairly constant.
Using the registries as a source, this PhD proposal will describe the clinical information available for clinical decision-making. We will combine information from various Danish registries such as the Danish National Patient Registry (DNPR), the Danish National Prescription Registry (NPR), the Danish Cancer Registry (DCR), the Danish National Registry for Biological Therapy in Inflammatory Bowel Disease (BIO-IBD), the Danish Pathology Registry (DPR) and the Registry of Laboratory Results for Research (LAB_F), and investigate the present information. In addition, we will analyse the availability of biobank material for research. In many cases, the diagnosis of IBD relies on an endoscopy and, often, biopsies are taken for pathological investigation. Some biopsies are taken before the diagnosis and before any treatment have been initiated. Other biopsies are taken before a switch in treatment or an operation. Such biopsies therefore represent unique material for research. We will use the Danish Pathology Registry (DPR) to investigate the presence of biological material for research within IBD PM.
Using the registries as a source, this PhD project will describe the clinical information available for clinical decision-making. Thereby, this PhD project will investigate the potentials of using registry information for PM within IBD. The overall aim is to improve IBD care. The project will be organized in two sub-studies:
Study 1: Literature review
A literature review of previous studies investigating the potential of using available central registry and biobank data for research within PM.
Study 2: Registry-based study using Danish registries
Based on data from the Danish nationwide registries we will:
1) define the current population of patients with IBD in Denmark and provide a description and distribution of types of disease course (based on treatment history, complications and comorbidities).
2) Use Danish registries to investigate which and to which extent clinical information (e.g. imaging, laboratory, and endoscopic information) is available for personalized clinical decision-making.
3) set up a basic predictive model based on available data.
Description of the cohort
The study population includes all individuals living in Denmark with a diagnosis of IBD including Crohn's disease (CD) and ulcerative colitis (UC) registered in the Danish National Patient Registry with the following International Classification of Diseases (ICD) 8 and 10 codes for CD (563.00–563.09, 563.91 and K50) and UC (563.19, 563.99, 569.04, and K51).
Data and biological material
Data used in this project is registry data. We will extract information on the study participants from the following registries:
- the Danish National Patient Registry (DNPR)
- the Danish National Prescription Registry (NPR)
- the Danish Cancer Registry (DCR)
- the Danish National Registry for Biological Therapy in Inflammatory Bowel Disease (BIO-IBD)
- the Danish Pathology Registry (DPR)
- the Registry of Laboratory Results for Research (LAB_F),
The following information will be extracted:
- ICD8- and 10 codes
- Contact patterns to hospital (i.e. type of visit (outpatient or inpatient), time of hospitalization, hospital department)
- Information on diagnostic procedures (imaging, endoscopies, results from blood samples, biopsies, other biological samples)
- Information on treatment (medicine (ATC codes), operations)
- Demographic information (i.e. age, gender, civil status, death, immigration)
- Socioeconomic factors (income, education, family size)
Collaborating researchers and departments
Focused Research Unit for Molecular Diagnostic and Clinical Research (MOK), IRS-Center Sonderjylland, Hospital of Southern Jutland :
Nathalie Fogh Rasmussen, cand.scient.san.publ.
Vibeke Andersen, MD, PhD, DrMedSci, Professor, Internal Medicine and Gastroenterology
Odense Patient data Explorative Network (OPEN), Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark:
Anders Green, MD, PhD, DrMedSci, Professor in Clinical Epidemiology
Department of Clinical Pathology, Odense University Hospital
Gunvor Iben Madsen, DrMedSci