RAPID "Risk Assessment from Policy to Impact Dimension" survey

1. RAPID "Risk Assessment from Policy to Impact Dimension" survey Chaired by Gabriel Gulis and Odile Mekel onbehalf of the RAPID group

2. General objectives • Policies and strategies influence the wider determinants of health. These determinants have their impact on a range of different risk factors which then directly affect human health. The main aim of the project is to develop methodologies for conduct of "full chain" risk assessment and implement them on a case study application on selected EC policy and via a series of national workshops.

3. Strategic relevance and contribution to the public health programme • The proposal addresses the following areas of the health program and annual work plan: • Risk assessment thematic networks and training of risk assessors. The thematic network will address the "full-chain" approach on broad field of determinants of health including all elements of risk management cycle. • Moreover as secondary area our proposal contributes significantly to area 3.3.1 and specifically "Public health capacity building by having academic partners on board who will implement the knowledge developed to their routine public health curricula. • The strategic relevance is given by full-chain approach itself and by geographical coverage of partners.

4. Methods and means • Each partner will choose a policy and conduct assessment on impact on policy on determinants of health, impact of determinants of health on prevalence of risk factors and impact of risk factors on health effect (top-down approach). Similarly, each partner will choose a health effect and conduct the assessment process up to policies (the  bottom-up approach). Based upon them a merged assessment guidance document will be developed and tested on a case of a European Commission policy. National workshops will be conducted to train experts in participating countries on the developed method.Policy analysis, questionnaire survey (on risk perception), project meetings, focus group discussions, database searches, workshops will be the main methods to conduct the project.

5. Expected outcomes • Pilot tested model methodologies will be produced for bottom-up and top-down  risk assessment in range of the full chain between policy-health effects. Based upon them, a general assessment methodology will be presented for full-chain approach. In addition, via national workshops a set of national experts will be trained on the developed methods.

6. Aim of the Project • RAPID grew-out from a previous project “health impact assessment in new member states and accession countries” (HIA NMAC). HIA NMAC identified a lack of risk assessment methods for conducting policy health impact assessments across areas of broad determinants of health. • The main aim of the project is therefore to develop, pilot test and implement risk assessment methodology for full chain risk assessment (policy-determinants of health-risk factors-health effect).

7. Specific objectives • Establish a policy risk assessor database • Conduct risk assessment case studies from policy to health effect and from health effect to policy • Summarize the methodologies from national case studies and develop a “common methodology guidance” • Implement the new methodology guidance via conducting a case study of a selected EU policy and series of national workshops

8. General overview By Ph.D. student Stella R.J. Kræmer SDU Esbjerg, Denmark

9. As first step of the “Risk assessment from Policy to Impact Dimension – RAPID” project the project group aimed to establish a thematic network of risk assessors and develop a database where interested users can find information about those who do risk assessment in partner countries. • The project working group developed a survey tool which has been translated to each participant country language and used for data collection. • The collected data was then entered into a Access database.

10. 359 records • Policy oriented risk assessors – 25/359 • Public health – 169/359 • Policy and public health – 6/359 • Research on risk assessment, policy & law, – 71/359

11. Doing risk assessment within pre-defined disciplines by partner country, absolute numbers

12. Main area of work by partner country, absolute numbers

13. Elements of risk assessment by partner country, absolute numbers

14. Level of documentation by partner country, absolute numbers

15. Participation in RAPID Interest to participate in workshops in last phase of RAPID

16. Cross-tabulation of doing risk assessment within public health and policy & law area • 7.1% of respondents claimed doing RA on these two areas

17. Public health RA within different institutional settings, absolute numbers This table summarizes cases where a respondent answered “yes” both to doing public health risk assessment and within enlisted branches (settings). Most of public health related risk assessment is clearly done within governmental institutions, medicine and universities

18. The collected data has been made available to the executive agency • Throughout the project risk assessors will be added to this continued improved Database • At the conclusion of the project the Database will be made publically available and maintained

19. “Risk assessment form policy to impact dimension – RAPID”project funded by Executive Agency for Health and Consumers (EAHC) of DG SANCO

20. Risk assessor survey; country differences and similarities Authors: Joanna Kobza- Silesian Medical University, PublicHealth Department, Piekarska 18, 41-902 Bytom, Poland Razvan Chereches - Center for Health Policy and Public Health, Babes-Bolyai University, Cluj, Romania Piedad Martin-Olmedo & Inés García SánchezEscuela Andaluza de Salud Pública, Cuesta del Observatorio 4. 18080 Granada, Spain Presenting author: Joanna Kobza

21. Background Public health systems and practices do differ across Europe including differences among EU member states Summarizing our results we try to find the answer if these differences influence the way how we collect research data and are there differences in approaches to risk assessment We try to answer these questions by looking at methods used to collect data within risk assessor survey of RAPID project and results of the survey in three countries: Poland, Romania and Spain

22. Methods The RAPID risk assessor survey tool has been employed to collect data administered on electronic way (e-mail and direct online survey tool), translated and retranslated by each partner and collected among risk assessors The approaches to identify them were different in all partner-countries of the project Recrutation -Who is a risk assessment expert? Data were uploaded to a Microsoft Access database and analyzed with STATA statistical software

23. Poland identified the risk assessors through the institutions, key for risk assessment, especially inenvironmental health area and then by individual, personal contact with experts sending e-mails Spain used a combined approach of personal contacts and mailing sent around throughout the executive boards of main national scientific societies Romania developed a national health and environmental system structure and used it to distribute the survey tool

24. Poland - chosen institutions National Institute of Public Health 2 Institutes of Occupational Medicine Institute for Ecology of Industrial Areas Central Institute for Labour Protection-National Research Institute Institute of Environmental Protection Central Mining Institute Institute of Agriculture Medicine Universities Associations – for ex.: Polrisk (Polish Association of Risk Assessors)

25. Romania- chosen institutions • Environment Ministry • Environment Guard headquarters • non-governmental organisation • Environmental protection agency • Environmental Direction in the Local County of the Municipality of Cluj-Napoca • Ministry of the Economy • Ministry of Transport, Construction and Tourism • A private company from the top 10 quoted at the Romanian Stock Exchange • Agency for Development North-West • 3 private companies • Ministry of Education and Research • The Institute for the Research of the Quality of Life • The Institute of Sociology of the Romanian Academy • The Faculty of Sociology and Social Work of the University of Bucharest • 1 regional portal based in the Municipality of Cluj-Napoca • Direction of Communication and Public Relations of the Local Council of the Municipality • Ministry of Health • National School for Public Health and Health Services Management, Bucharest • 4 Institute of Public Health • 3 Public Health Directions based in the residences of the Regional Development Agencies • 4 hospitals • Presidential Administration • National Agency for Governmental Strategies • 7 County Councils based in the residences of Regional Development Agencies

26. Spain- chosen institutions • Spanish Society of Environmental Health • Spanish Society of Food Safety • Spanish Society of Toxicology • Spanish Society of Epidemiology • Ministry of Health • Regional Health Authorities • Group of experts

27. ResultsThe highest percentage of risk assessors who reported to be involved in public health risk assessment at certain extent was identified in: Spain - 73,75% Poland - 27,78% Romania - 19,3%The extension of risk assessment methodology into policy was more often applied in:Poland - 24,1%Romania - 23,7%Spain – 10%

28. Results

29. Why differencesThe differences could be explained partially by the data collection process used in each country but also by important differences on how risk assessment is being understood across Europe, for instance the tradition of education, research in risk assessment domain in each country.Different approaches existing to refer to Risk Assessment  confusion among professionals to identify their role in the process (Spain)

30. Why differences Examples: Poland- risk assessment, risk management in environmental health high developed during decades public health relatively new sciences/specialization Poland and Romania –new Member States (perhaps local politicians more open for new strategies) Romania- Spain-Risk assessment is being introduced in different policy actions for several years but there is no an official procedure to tackle quantification of health impacts a part from those done by research institutions

31. ConclusionsThe experience gathered via risk assessor survey confirms existing differences in public health systems and approaches across EU member states. This implies a need for careful planning of methodology development and training content and method selection expected in last phase of the RAPID project

32. Thank you for your attention

33. HIA framework to investigate additional cancer risk from Ionizing Radiation in Medical Imaging Top-Down case study – Italian partner Nunzia Linzalone, Elisa Bustaffa, Liliana Cori, Fabrizio Bianchi and IFC cardio-staff Prepared for the projectRisk Assessment from Policy to Impact Dimension (RAPID) 2009-2012 EU (DG-SANCO) Grant agreement No 20081105

34. HIA framework • To develop effective precautionary policies, policy-makers and stakeholders need evidences based on an integrated risk assessment • To match this need RAPID project have included a case study to develop and test a framework and methodology for “full chain” impact assessment • The aim of this work is to incorporate existing models of risk management and quantitative risk assessment, into a framework of health impact assessment

35. POLICY SELECTIONPatient Safety from Ionizing Radiation (IR) • European directive 97/43 (D. Lgs. 187/00) • Legislative Decree 187/00 • Regional Health Plan 2008-2010 • Tuscan Region funded projects on medical use of IR • “Communication of patient dose” • “Stop Useless Ionizing Testing in Heart Disease” (SUITheart) • Guidelines • EU, 2001 • Italy, 2006 last update • American College of Radiology 2007, • International Atomic Energy Agency 2008 Reducing Environmental Cancer Risk, What We Can Do Now : 2008-2009 Annual Report, President’s Cancer Panel

36. FOCUS ON CARDIOVACULAR IMAGINGAn emerging concern at local and international level Computed tomography (CT) was introduced into medical imaging in the 1970s and has grown exponentially particularly in cardiovascular clinical test for a wide variety of cardiovascular conditions. Cardiovascular CT use has recently been tempered by a string of high-impact publications raising concern about the increase inradiation exposure to the population from medical procedures and the potential cancer risk. The current cardiological practice is based on a deregulated, radiation-insensitive, and imaging prescription policy. (Brenner, 2007)

37. Policy Determinants of health Greatest social benefit at lowest cost Medical practice Environmental, , Biological, Clinical, Economic determinants Communication and consultation Risk factors Pediatric and adult population Gender, age, diagnosis Health outcomes RAPIDTop-down risk assessment model • Core determinants of health influenced by the policy • Risk factors linked to determinants of health • Health effects linked to selected risk factor • Risk perceptionand communication on each level

38. Ionizing radiation in medical practice: exposure and health • Medical imaging is the largest controllable source of radiation exposure in the population of industrialized countries • One out of two examinations is completely or partially inappropriate (i.e. risk outweighs benefit) and cardiologists are often unaware of the radiological dose of the examination they prescribe or practice • This avoidable exposure is associated with increased, significant cancer risk at both the individual and population levels • Exposure can be minimized through a knowledge-based intervention targeted to increasing radiological awareness of prescribers and practitioners.

39. Individual risk Population risk Risk-benefit balance • Exposures for medical purposes account for a variable percentage of cases of cancer between 1 and 3 per cent of all those observed in developed countries (underestimated risk) • 30% of tests involving ionizing radiation are inappropriate—that is, patients take a long term risk without a commensurate acute benefit. • Need to know the risk for each test and balance it with the benefits of diagnosis • Better knowledge of risks will help to avoid small individual risks translating into substantial population risks.

40. Tuscany Policy on Radiprotection 2008-2010 Proximal health determinants (physical environment) Greatest social benefit at lowest cost Current guideline, technological updating, continuing training, patient and operator awareness, etc……. Workplace environment and community environment Communication and consultation Pediatric and adult population Gender, age, diagnosis Cumulative individual dose, working tasks, technologies availability, co-morbidity,… Fatal and non fatal cancer, other non cancer outcomes RAPID Model: the full chain assessment • How do different policies, focused to the issue of awareness in diagnostic use of ionizing radiation, correspond to changes in individual exposure to cumulative dose? • How do they account for the associated attributable long term cancer risk. • Is estimated individual risk comprehensive of cumulative exposures?

41. Stop Useless Imaging Testing in Heart Disease SUIT Heart Levels of investigation • Main factors in the causation chain. • Percent of cancers avoided depending on the different medical practice used in the context of heart disease (IFC – SUIT Heart Project).

42. The inquiry methodology • Main factors in the causation chain To make an overall assessment of the policy effects on health, most important determinants and risk factors are identified by: • Review of literature • Experts consultation

43. 1.1. Review of literature • What? • Higher Impact Factor Scientific Journal focused to MI and/or CT use • Scientific Association Guidelines and Recommandations • How many? • Selected references are primary study or most updated reviews, published from 2004 to 2010. They totally sum to #69

44. 1.2. Experts consultation • Who are they? • Inner resources from IFC-CNR and collaborative consultants from University and Helth care Dept.s • What they are requested to do? • Identify and rank the most important determinants and risk factors. A scoring system helps to prioritize them from “high relevant” to “not relevant”. • Cardiologist (Senior Researcher, ICP-NRC Pisa-Italy) • Radiologist (Technical Consultant, ICP-NRC Pisa-Italy) • Hemodynamist (Research Director, ICP-NRC Pisa-Italy) • Pulmonologist (Researcher, ICP-NRC Pisa-Italy) • Nuclear physicist (Principal Investigator, ICP-NRC Pisa-Italy) • Geneticist (Researcher, ICP-NRC Pisa-Italy) • GP (Generic Physician) • Manager and Scientific Coordinator, Physical co-worker (USL Lucca, Livorno – Italy

45. Informing policy actions Are determinants of health as relevant as already known risk factors? very relevant relevant moderate Main cathegories slight effect not relevant

46. The inquiry methodology • Percent of cancers avoided • The risk of cancer associated with diagnostic imaging is quantified by: • A developed software based on three main sub-components of exposure: natural,diagnostic, professional. The result is the amount of cumulative risk. • The simulated risk is associated with current indications of appropriateness.

47. 2.1. RADIORISK Software – IFC Tool Awareness of radiological risk is low among cardiologists, who prescribe the majority (60-80%) of ionizing test examinations (totaling today the dose equivalent of about 150 chest x-rays per head per year) and are the most exposed among health professionals (250-300 chest x-rays per head per year for most active interventional cardiologists)

48. Reference European guideline (2001) • Guidelines of Italian Minister of Health • Peer reviewed journal • Government Agency • From each exam data file (if available) Dose reference and Cancer Risk estimates BEIR VII, 2006 • The estimation is base on 100000 studies, including 87000 Hiroshima and 407000 nuclear workers • 2 to 3 confidence intervals of attributable risks estimate • X-rays and gamma-rays are a proven carcinogen (WHO’s International Agency of Research of Cancer) • Epidemiological evidence up to now above 50 mSv • Re-affirm Linear No-Threshold hypothesis

49. Risk report: cancer incidence and mortality Individual informations Exposure, charts, risk estimation Table of risk and extra cancer risk from medical exposure History of exposure to ionizing radiation

50. Communication of risk Comparison to other risks: all data are transferred into images