Burden of Illness in Atrial Fibrillation in Denmark
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 107,532
- Primary Endpoint
- Mortality among AF patients compared with that of the general population/the 'controls', if possible by gender and age group
Study Overview
Brief Summary
The overall goal of this retrospective registry study is to investigate the burden-of.illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect information on the diseases epidemiology including incidence and prevalence of AF and stroke as well as a stroke risk stratification of the Danish AF-population, the clinical and economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients, healthcare providers / healthcare system and society as well as describing treatment patterns with anticoagulant agents and their consequences in terms of stroke, bleeds, death and according cost in a real-life setting.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primary and secondary diagnosis with AF;
- •The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code (ICD10-code: DI480, DI481, DI482, DI483, DI484, DI489) will be included.
Exclusion Criteria
- •Patients younger than 18 and older than 90 years of age.
Arms & Interventions
AF patients in Denmark / Cohort 1
The base population of AF patients for diagnosis and health care utilization / resource use will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code will be identified.
Further Data sources used:
Registry of Medicinal Product Statistics: for determining the individuals' use of prescription medicine DREAM database: for investigation of sickness benefit and productivity loss Statistics Denmark's databases: on social services from municipalities Cause of Death Registry: AF-patients or controls who died during the study period (2000-2013) Danish Civil Registry: used for identification of controls, holds information about age, gender
Intervention: Standard of care in AF in Denmark (Drug)
Outcomes
Primary Outcomes
Mortality among AF patients compared with that of the general population/the 'controls', if possible by gender and age group
Time Frame: up to 4 weeks
Mortality among stroke patients (in AF) compared with that of the population/the 'controls' and the total AF-population, if possible by gender and age group
Time Frame: up to 4 weeks
Number of patients with (non-valvular) AF in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+
Time Frame: up to 4 weeks
Number of patients with (non-valvular) AF per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+
Time Frame: up to 4 weeks
Number of newly diagnosed patients with (non-valvular) AF per year and per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+
Time Frame: up to 4 weeks
Direct cost in AF (in total and per patient)
Time Frame: up to 4 weeks
Costs due to: Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
Indirect cost in AF (in total and per patient)
Time Frame: up to 4 weeks
Costs due to: Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
Number of patients with stroke in (non-valvular) AF-patients in Denmark by gender and age groups 18-65, 66-75, 75+, 80+
Time Frame: up to 4 weeks
Number of newly diagnosed patients with (non-valvular) AF per year in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+
Time Frame: up to 4 weeks
Number of newly diagnosed patients with stroke in (non-valvular) AF-patients per year in Denmark by gender and age groups 18-65, 66-75, 75+, 80+
Time Frame: up to 4 weeks
Direct cost in AF-related stroke (in total and per patient)
Time Frame: up to 4 weeks
Costs due to: Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
Indirect cost in AF-related stroke (in total and per patient)
Time Frame: up to 4 weeks
Costs due to: Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
Secondary Outcomes
- Number of patients per HAS-BLED-score (0 to 9) in Danish AF-population(up to 4 weeks)
- Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-population(up to 4 weeks)
- Number of patients per average HAS-BLED-score in Danish AF-population(up to 4 weeks)
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatment(up to 4 weeks)
- Number of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population(up to 4 weeks)
- Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA](up to 4 weeks)
- Number of patients in total and per CH2ADS2-VASc-score receiving no treatment(up to 4 weeks)
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA](up to 4 weeks)
- Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total(up to 4 weeks)
- Vitamin K antagonist (VKA) treated AF-patients in AC-clinics versus GP-setting(up to 4 weeks)
- Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population(up to 4 weeks)
- Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population(up to 4 weeks)
- Percentage (%) of patients per average HAS-BLED-score in Danish AF-population(up to 4 weeks)
- Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total(up to 4 weeks)
- Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score(up to 4 weeks)
- Percentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish populationPercentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish population(up to 4 weeks)
- Number of patients in total and per CH2ADS2-VASc-score receiving warfarin(up to 4 weeks)
- Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs](up to 4 weeks)
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarin(up to 4 weeks)
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs](up to 4 weeks)
- Direct and indirect cost of AC medication treatment patterns(up to 4 weeks)
- Percentage (%) of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population(up to 4 weeks)
- Number of patients with AF-related stroke rated per average CHADS-score in Danish population(up to 4 weeks)
- Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score(up to 4 weeks)