The opportunities for RWE studies in Norway
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1 Dept of Pharmacoepidemiology Division of Mental and Physical Health WHO Collaborating Centre for Drug Statistics Methodology The opportunities for RWE studies in Norway Senior research scientist Kari Furu Nordic conference on Real World Data by NTA, Helsinki 29 November 2016
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4 Aims Public health Increase life expectancy Improve health and well-being Reduce inequity Health system Patient and user oriented Effective and efficient High quality Research Knowledge and discovery Innovation Economic and social development
5 What kind of data do we need?
6 Infrastructure for research: e-health Registries Biobank Cohorts Clinical data Include self-reported information
7 Norway today Nationwide central health registers: Births and deaths Cancer Infectious diseases & Childhood vaccinations Pharmaceuticals (based on dispensed drugs, NorPD) Diagnoses in the health care system Specialist health Care (hospitals and ambulatory specialist care both mental and somatic) Cardiovascular incl details from quality registers Medical quality registries: Information on specific conditions Populationbased cohorts (HUNT, Tromsø, CoNor, MoBa) Biobanks
8 Norwegian Prescription Database linked to other Norwegian registers/data sources Medical birth register of Norway (MBRN) Causes of death register Diagnosis from primary health care Quality registers System for Immunization Surveillance and Control Central Tuberculosis surveillance Register System of Surveillance of Infectious Diseases Cardiovascular register incl. Details from quality registers NorPD 2004 Health surveys Medical journals Biobanks Statistics Norway (income, education, marital status etc) Norwegian Patient Register (NPR) Hospital discharges + specialist outpatient contacts 2008 Cancer registry of Norway
9 What kind of knowledge do we need?
10 Distribution What is the incidence, prevalence and distribution of risk factors, utilization of drugs, health promoting factors, diseases and death in the population? Cause What are the causes of health, disease and early death? Effect What works? What prevents and cures disease? What reduces suffering? What does it cost? Does it harm? What side effects and long term effects does it have?
11 Distribution
12 Type of ADHD drugs used when starting treatment in adults, years
13 Annual Incidence of ADHD drug use in adult MEN in Nordic countries
14 Effect Wanted: Evidence based policies and practices
15 Vaccine: Pandemic vaccination did not increase the risk of fetal death Pregnant women who were vaccinated did not have an increased risk of fetal death Pregnant women who were vaccinated had lower risk of pandemic infuenza More than 117,000 births before, during and after the pandemic Ca 26,000 pregnant women were vaccinated Pregnant women who received an influenza diagnosis during the pandemic nearly doubled the risk of fetal death
16 Prescription registry Antivirale medication Other medication Infectious disease registry Positive H1N1 tests Date of symptom onset Primary care reimbursment database (GPs) Influenza Other diagnoses Patient registry Diagnoses and date Central Population Registry Study population Statistics Norway Income Education Medical Birth Registry Birth outcome Maternal diseases/conditions Perinatal diagnoses Vaccination registry Type of vaccine Date of vaccination 16
17 Need for more Nordic Collaboration Nordic collaboration Collaboration with data-pooling is increasing Legal problems with sharing of some types of data (socio-demographic data) Common systems for secure data management should be developed Institutions and groups need to look for opportunities for collaboration Develop Nordic research infrastructure and networks
18 Nordic countries as a cohort Exposed to at least 1 drug 18 mill people 2/3 of the population/year Nordic Prescription registers Entire population: 26 mill Population registers Non-exposed 8 mill people 1/3 of the population Linked to different outcome data Furu K et al: The Nordic Countries as a cohort in pharmacoepidemiological research. Basic & Clin. Pharmacol.&Toxicology 2010;106:86-94 Wettermark B, Zoega H, Furu K, et al. The Nordic prescription databases as a resource for pharmacoepidemiological research a literature review. Pharmacoepidemiol Drug Saf. 2013;22:691-9
19 NORDIC RWE studies Effect of SSRI exposure in utero and different outcomes BMJ Januar 2012 JAMA Januar 2013 Conclusion: Mothers who take SSRIs in late pregnancy are more likely to give birth to children with persistent pulmonary hypertension Conclusion: No association between use of SSRI in utero and risk of stillbirth or perinatal death
20 BMJ 2015;350:h1798, 17 APRIL 2015 BMJ 2015: Birth defects 2.3 mill births Any SSRI : (1.6%) births exposed during Specific SSRIs: from 255 (fluvoksamine) to (citalopram) exposed Cohort design and sibling design to adjust for family and lifestyle factors Conclusions No substantial increase in prevalence of overall cardiac birth defects among infants exposed to SSRIs or venlafaxine in utero. Lack of an association in the sibling controlled analyses points against a teratogenic effect of these drugs. Still, one should follow the recommendations that only those with moderate to severe depression should be treated with SSRIs
21 Need «transnational research partnerships» Crump et al, Editorial i JECH 12 March 2015: International data to enhance US health: For example, Nordic prescription databases have enabled numerous landmark studies of the health effects, safety and cost-effectiveness of medications that are commonly used in the USA
22 Opportunities 1. Reality-based when RCTs are not possible 2. New methodological approaches based on registries can combine advantages from RCTs with those from registry-based observational epidemiology ( quasiexperimental methods ) 3. Longterm follow-up 4. Big numbers and powerful results 5. Unselected or possible to assess selection 6. Many exposures and outcomes can be evaluated simultaneously 7. Safe and gentle for participants 8. Protection of privacy - Can secure individual rights 9. Cost effective 10.Basis for many kinds of research
23 Challenges 1. Trust is limited and sometimes threatened 2. Data are not used 3. Results are not fed back Implementing the new knowledge 4. Data capture is separate from clinical recording 5. Regulations are complicated time-consuming 6. Statistics Norway: Transfer of personal data outside the country s borders is not allowed according to the statistics act 2-2
24 Questions? Photo by Kari Furu
25 Access to data Norwegian Institute of Public Health (10 health registers, biobank and cohorts) Norwegian Patient Registry Cancer Registry of Norway Statistics Norway
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