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The View from Europe

The View from Europe. Professor Helen Dolk EUROCAT Project Leader EUROCAT Central Registry, University of Ulster Annual BINOCAR Meeting, Swansea Cotober 2014. NORWAY. DENMARK Odense. SWEDEN. FINLAND. Map of EUROCAT Full and Associate Member Registries. NETHERLANDS

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The View from Europe

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  1. The View from Europe Professor Helen Dolk EUROCAT Project Leader EUROCAT Central Registry, University of Ulster Annual BINOCAR Meeting, Swansea Cotober 2014

  2. NORWAY DENMARK Odense SWEDEN FINLAND Map of EUROCAT Full and Associate Member Registries NETHERLANDS Northern Netherlands UNITED KINGDOM WessexThames Valley E Mid & S York Northern England South West England Wales GERMANY Saxony-Anhalt Mainz Central Registry Belfast POLAND Wielkopolska IRELAND Dublin South East Ireland Cork & Kerry UKRAINE BELGIUM Antwerp Hainaut-Namur CZECH REPUBLIC FRANCE Paris Strasbourg Rhone-Alps Ile de la Reunion French West Indies Full Member HUNGARY Associate Member AUSTRIA Styria Size of Circle CROATIA Zagreb PORTUGAL South Portugal < 10,000 births per year SWITZERLAND Vaud 10,000 - 40,000 births per year SPAIN Basque Country Valencia Region Spain Hospital Network ITALY Emilia Romagna Tuscany >40,000 births per year MALTA

  3. Why European Collaboration? • Pooling of data • Comparison of data between registries/countries • Sharing of expertise • Joint approach to European public health questions • Sharing of resources (e.g. website, software)

  4. History of EUROCAT • Conceived in 1974, at a Workshop convened by the European Economic Community's Committee on Medicinal and Public Health Research to improve "the methodology of population studies throughout the Community". Congenital anomalies chosen as first topic for concerted action. • EUROCAT established in 1979 as a prototype for European health surveillance aiming to assess the feasibility of pooling data across national boundaries, in terms of standardization of definitions, diagnosis and terminology and confidentiality. Central Registry in Department of Epidemiology, Catholic University of Louvain, Brussels. • Michel Lechat 1927-2014 Co-founder of EUROCAT with Josephine Weatherall

  5. Timeline 1979-2014 and beyond Continued: • 1991 transfers from “Research” to “Health Information”. Central Registry at Scientific Institute for Public Health, Brussels. Central Registry moved briefly to LSHTM, UK in 1999. • 2000-2014 - Funded by EU DSanco as Rare Diseases activity, Central Registry at University of Ulster • 2015 Central Registry will move to Joint Research Centre at ISPRA, Italy, under the EU Rare Diseases Platform.

  6. What is a disease registry and is there an ideal size? The bringing together of sources of expertise (people) and sources of data to shed light on a disease in relation to its prevalence, causes/prevention and care/services in a specified population • expertise: different clinical areas, epidemiology, statistics, public health, specific exposure assessment fields ……….. and the expertise of those personally affected • data sources • Electronic data sources present increasing opportunities, but also challenges, across Europe • Registry = validated data Regional (up to 40,000 births), national networking, European networking

  7. Types of surveillance based on CA registries • Statistical Monitoring (without prior hypothesis) • Recent Clusters in time • Trends in time, geographical differences • Response to exposure incidents/health threats/disasters • Chernobyl • Swine Flu/H1NI • Surveillance oriented to identifying environmental causes (with different levels of prior hypothesis) • Pharmacovigilance • Envirovigilance • Surveillance oriented to evaluating primary prevention • NTD prevalence and prevention by periconceptional folic acid • Surveillance oriented to health service needs and evaluation • Prenatal screening and diagnosis, TOPFA, mortality rates • Children needing services

  8. Antiepileptic studies . Literature review for signals Test signals in Case-malformed control design for specificity 3.9 million births, 1995-2005 19 registries: pooling Including TOPFA Exposure data collected mainly prospectively in pregnancy Epilepsy: 3 per 1,000 women, now AEDs used for other indications

  9. To develop a European reproductive pharmacovigilance system  • To develop and test an efficient and cost-effective system for safety evaluation of drugs during pregnancy, based on EUROCAT registries combined with existing healthcare databases • Signal detection and signal evaluation • Registry Linkage to prescription databases, exposed cohorts, population databases • Designs: case-malformed control, cohort • To quantify the risk of congenital anomalies related to four drug classes: • new antiepileptics, • insulin analogues, • anti-asthmatics, • Antidepressants (SSRIs) • To develop a framework for evaluation of the efficacy of pregnancy-related drug safety measures including • drug utilisation studies • monitoring the effectiveness of pregnancy prevention programmes (e.g. isotretinoin) • a scoping study of the role of internet access todrugs and related safety information by pregnant women

  10. Antidepressant (SSRI) exposure in early pregnancy • Aims: To examine the specificity of association between specific SSRIs and specific congenital anomalies • Case-malformed control study • Population: 12 EUROCAT registries , 1995-2009, 3.3 million births • SSRI exposure among registrations 0.8% • Cases: CHD, CHD subtypes, and other CA “signals” from the literature • Controls: other CA (excl genetic syndromes) • EUROCAT study Results: • Severe CHD OR 1.56 (1.03-2.38) • OR>2 for anorectalatresia&stenosis, gastroschisis, renal dysplasia, clubfoot • Risks similar for all types of SSRI • Interpretation: non-specific SSRI teratogenic effect? depression? Susceptibility to depression? Lifestyle confounders? Or more than one of these. • EUROmediCAT: updating data to 2012, prescription data linkage where available, population cohort in 3 countries, drug utilisation study

  11. Types of surveillance based on CA registries • Statistical Monitoring (without prior hypothesis) • Recent Clusters in time/ clusters in space • Trends in time, geographical differences • Response to exposure incidents/health threats/disasters • Chernobyl • Swine Flu/H1NI • Surveillance oriented to identifying environmental causes (with different levels of hypothesis) • Pharmacovigilance • Envirovigilance • Surveillance oriented to evaluating primary prevention • NTD prevalence and prevention by periconceptional folic acid • Surveillance oriented to health service needs and evaluation • Prenatal screening and diagnosis, TOPFA, mortality rates • Children needing services

  12. Has periconceptional folic acid supplementation in Europe prevented neural tube defects? Prevalence per 10,000 births of Neural Tube Defects, for All Full Member Registries, from 1991 – 2010 *Still births and Fetal Deaths from 20 weeks gestation *

  13. Primary Prevention of Congenital Anomalies • EUROCAT in collaboration with EUROPLAN have developed recommendations on policies to be considered for the primary prevention of congenital anomalies in National Plans (and Strategies) on Rare Diseases • EUCERD approval • J Public Health Genomics 2014, Taruscio et al. • In the field of: • Medicinal drugs • Food/nutrition and lifestyle (e.g. folic acid, obesity, smoking, alcohol) • Health Services (e.g. vaccination, women with chronic diseases, genetic counselling) • Environmental pollution incl. the workplace • Mechanisms: • Preconceptional care – high vs low risk parents • Health promotion to future parents and awareness raising: major health determinants + pregnancy specific issues • Public health approaches: vaccination, food fortification • Regulatory policies (pharmaceutical, food, environmental, tobacco, alcohol) • Research and surveillance (CA and exposure), and expert review

  14. Key Public Health Indicators for CA 2008-2012: where is the UK?

  15. Perinatal Mortality due to CABy Country 2008-2012

  16. Prevalence of Prenatally Diagnosed CABy Country 2008-2012

  17. Termination of Pregnancy for Fetal Anomaly By Country 2008-2012

  18. Down Syndrome By Country 2008-2012(9% of all CA)

  19. Proportion of all births to mothers 35 years and older, 1990-99,2000-9. See Loane et al European Journal of Human Genetics 2013: Twenty-year trends in the prevalence of Down syndrome and other trisomies in Europe: impact of maternal age and prenatal screening.

  20. Neural Tube Defects By Country 2008-2012(3.6% of all CA)

  21. Conclusions - 1 • Why European? • To pool, compare, and share people & resources • Why CA Surveillance? • For prevention and care • Why registers? • To bring the people (expertise of many kinds) together with the data • TOPFA coverage essential

  22. Conclusions - 2 • Why are not having more success preventing CA? • TOPFA are preventable too • Expectations • Preconceptional and interconceptional interventions • Emerging issues: • Obesity and diabetes • Asthmatics/asthma and antidepressants/depression • Internet availability of teratogenic drugs

  23. EUROCAT Registry Leaders Prof. Martin Haeusler (Styria, Austria) Dr. Vera Nelen (Antwerp, Belgium) Prof. Christine Verellin-Dumoulin (Hainut, Belgium) Prof.IngeborgBarisic (Zagreb, Croatia) Dr. Antonin Sipek (Czech Republic) Dr. Ester Garne (Odense, Denmark) Dr.AnnukkaRitvanen (Finland) Dr. Babak Khoshood (Paris, France) Dr Bruno Schaub (French West Indies, France) Dr HanitraRandrianaivo (Reunion, France) Dr. Annette Queisser-Luft (Mainz, Germany) Dr.AnkeRissmann (Saxony Anhalt, Germany) Dr. Judit Beres (Hungary) Dr. Robert McDonnell (Dublin, Ireland) Dr. Carmel Mullaney (SE Ireland) Dr. Mary O’Mahoney (Cork and Kerry, Ireland) Dr.GioacchinoScarano (Campania, Italy) Prof. Elisa Calzolari (Emilia Romagna, Italy) Dr.Fabrizio Bianchi (Tuscany, Italy) Dr. Miriam Gatt (Malta) Dr.Ieve Grinfelde and Dr.IveaCirule (Latvia) Dr. Marian Bakker (N Netherlands) Prof.Marta Ebbing (Norway) Prof. Anna Latos-Bielenska (Wielkopolska, Poland) Dr. Carlos Matias Dias (S Portugal) Dr Gorazd Rudolf (Slovenia) Dr.LarraitzArriola (Basque Country, Spain) Prof. Maria-Luisa Martinez Frias (Spain Hospital Network) Dr. Oscar Zurriaga (Valencia, Spain) Dr Karin Kallen (Sweden) Dr.Marie-Claude Addor (Switzerland) Prof. Liz Draper (EMYSCAR, UK) Prof. Judith Rankin (N England, UK) Dr. Rosie Thompson (SW England, UK) Dr. Catherine Rounding (Thames Valley, UK) Mr David Tucker (Wales) Dr. Diana Wellesley (Wessex, UK) Prof Joan Morris (UK) Dr WladimirWertelecki (Ukraine) EUROCAT Central Registry (University of Ulster, UK) Prof. Helen Dolk Ms Maria Loane Mrs Ruth Greenlees Mrs Barbara Norton Dr. Nichola McCullough Dr.Breidge Boyle Mrs Barbra Webber Dr. Rhonda Curran

  24. Percentage of births in population covered by EUROCAT registries 2011(should it be 100%? – quality vs quantity) Austria (1F) 13% Belgium (2F) 27% Croatia (1F) 20% Czech Republic (1A) 100% Denmark (1F) 8% Germany (2F) 3% Ireland (3F) 62% Spain (2F, 1A) 34% Finland (1A) 100% France (3F, 1A) 14% Hungary (1F) 100% Italy (2F) 14% Malta (1F) 100% Netherlands (1F) 10% Norway (1F) 100% Poland (1F, 1A) 100% Portugal (1F) 19% Sweden (1A) 100% Switzerland (1F) 10% United Kingdom (6F) 32% Affilliates and applicants Bulgaria Cyprus Greenland Latvia Moldova Slovenia EU countries not covered Estonia, Greece, Lithuania, Luxembourg, Romania, Slovakia

  25. Perinatal Mortality By Registry 2008-2012

  26. Termination of Pregnancy for Fetal Anomaly By Registry 2008-2012

  27. Prenatal Diagnosis By Registry 2008-2012

  28. Down Syndrome By Registry 2008-2012

  29. Anomalies Typically Requiring Surgery By Registry 2008-2012 (Excluding Chromosomal Cases)

  30. Neural Tube Defects By Registry 2008-2012

  31. Types of surveillance based on CA registries • Statistical Monitoring (without prior hypothesis) • Recent Clusters in time • Trends in time, geographical differences

  32. Cluster output: Scan method

  33. Cluster detection for the period 2007-2013 by year: no. EUROCAT registries included in monitoring and their population coverage, number of tests conducted and clusters detected, and results of cluster investigations.

  34. Anomalies Typically Requiring Surgery By Country 2008-2012 (Excl Chrom)20% of all CA, half of all cases needing surgery

  35. Overview:2008-2012

  36. Types of surveillance based on CA registries • Statistical Monitoring (without prior hypothesis) • Recent Clusters in time • Trends in time, geographical differences • Response to exposure incidents/health threats/disasters • Chernobyl • Swine Flu/H1NI

  37. Pandemic influenza studies • Time series study • January 2007 – March 2011 conceptions • 26,976 non-chromosomal congenital anomaly registrations from 10 European countries • Exposure based on country-specific influenza season data from WHO-EuroFlu influenza season tables Conception LMP EUROCAT CA case delivery Corresponding CA-specific Critical Period Timeline Gestational age is subtracted A fortnight Is added

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