Two Decades of Evidenced-based Outcomes Research: The Erlangen Stroke Registry

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Two Decades of Evidenced-based Outcomes Research: The Erlangen Stroke Registry 06.06.2017 Prof. Dr. Peter Kolominsky-Rabas, MD, PhD, MBA Interdisciplinary Center for Health Technology Assessment (HTA) and Public Health Friedrich-Alexander-University Erlangen-Nürnberg, Bavaria, Germany National Cluster of Excellence Medical Technologies - Medical Valley EMN

Erlangen Stroke Registry Study Design Location in south of Germany, northern Bavaria longitudinal study (started in 1994) prospective population of 108.000 inhabitans well-defined geographic area Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 2

Erlangen Stroke Registry - Geographical Area Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 3

Erlangen Stroke Registry - Study Criteria Source population all residents of Erlangen (Community Registration Office) Age no restriction of age Case ascertainment hospitalized non-hospitalized stroke-patients Follow-up 3 months 12 months yearly follow-up (according to Helsingborg Declaration) home visits with f2f interviews Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 4

Gold Standards for an Ideal Stroke Study 1. Complete case ascertainment Concept of overlapping sources of information to ensure complete case ascertainment Regular checks of: hospital wards residential and nursing homes records of ambulance and emergency services general practitioners death certificates Reference: Malmgren at al., Lancet 1987; Sudlow & Warlow, Stroke 1996; Feigin et al., Lancet 2004 Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 5

Gold Standards for an Ideal Stroke Study (Cont.) 2. Specification of diagnosis/ exclusion of stroke-like events Diagnosis of stroke Diagnostic criteria WHO stroke definition Classification of stroke subtypes Brain CT-scan at admission CT scan rate of 98% Etiology of ischemic stroke TOAST-classification Reference: Malmgren at al., Lancet 1987; Sudlow & Warlow, Stroke 1996; Feigin et al., Lancet 2004 Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 6

Erlangen Stroke Registry - Outcome variables Cinical assessment (acute) Risk factors assessment Clinical assessment (long-term) Cognitive assessment Quality of Life NIHSS modified Rankin Scale ABDC2 score (TIA) CHA2DS2-VASc Score TOAST- classification (Adams et al. 1998) Barthel Index Functional Independence Measure Frenchay Activity Index Social Support Scale MMST Depression Status Inventory SF-36 SF-36 Care Giver Burden Scale Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 7

Resource Use of Stroke Servivors Stroke Unit Aid tools Physiotherapy Medication Occupational therapy Long-term Care Cognitive training General Practitioners Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 8

Direct cost of ischemic stroke by time horizon Statutory Health Insurance in Germany (Euros, discounted) Horizon Men Women All 1 y 15,566 14,799 15,140 5 y 30,159 29,582 29,837 10 y 37,711 36,176 36,873 35% of the lifetime cost Lifetime 45,549 41,304 43,129 Reference: Kolominsky-Rabas at al., Stroke 2006 Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 9

National Direct Ischemic Stroke Cost Projections Statutory Health Insurance in Germany Men Women All Horizon Strokes Cost (Billion) Strokes Cost (Billion) Strokes Cost (Billion) 2006-2010 331,000 13.8 425,000 16.1 756,000 29.9 2006-2015 701,000 27.1 880,000 30.9 1,581,000 58.0 2006-2020 1,108,000 39.7 1,367,000 44.6 2,475,000 84.3 2006-2025 1,547,000 51.5 1,883,000 57.1 3,430,000 108.6 Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 10

Erlangen Stroke Registry - Cost-of-Illness of Stroke Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 11

Erlangen Stroke Registry - Long Term Outcome of Stroke Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 12

Erlangen Stroke Registry - Epidemiology Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 13

Contact: Prof. Dr. Peter Kolominsky-Rabas, MD, PhD, MBA Interdisciplinary Center for Health Technology Assessment (HTA) and Public Health Friedrich-Alexander-University Erlangen-Nürnberg, Bavaria, Germany National Cluster of Excellence Medical Technologies - Medical Valley EMN peter.kolominsky@uk-erlangen.de Prof. Dr. Kolominsky-Rabas, MD, PhD, MBA I Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health I Friedrich-Alexander-University of Erlangen-Nürnberg, Germany I 01.06..2017 14

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