1. International Agency for Research on Cancer Lyon, France Developing EU health quality standards and guidelines CANCER SCREENING GUIDELINES Lawrence von Karsa Quality Assurance Group Section of Early Detection and Prevention

2. EU Quality Standards and Guidelines in Cancer Screening Definition of Cancer Screening Council Recommendation on Cancer Screening European Guidelines for Quality Assurance in Cancer Screening and Diagnosis European Cancer (Screening) Network Implementation

3. Web links to relevant documents Segnan N, Patnick J & von Karsa L, (eds.) (2010). European Guidelines for Quality Assurance in Colorectal Cancer Screening and Diagnosis - First Edition. European Commission, Publications Office of the European Union, Luxembourg http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND3210390 http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND3210390 Arbyn M, Anttila A, Jordan J, Schenck U, Ronco G, Segnan N, Wiener H, Herbert A, Daniel J & von Karsa L (eds) (2008). European Guidelines for Quality Assurance in Cervical Cancer Screening - Second edition. European Commission, Office for Official Publications of the European Communities, Luxembourg. http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND7007117 http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND7007117 Perry N, Broeders M, de Wolf C, Törnberg S, Holland R, von Karsa L & Puthaar E (eds) (2006). European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis – Fourth edition. European Commission, Luxembourg:Office for Official Publications of the European Communities. http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND7306954 http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND7306954 Council of the European Union (2003), Council Recommendation of 2 December 2003 on cancer screening (2003/878/EC), Off J Eur Union no. L 327:34-38. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:327:0034:0038:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:327:0034:0038:EN:PDF von Karsa L, Anttila A, Ronco G, Ponti A, Malila N, Arbyn M, Segnan N, Castillo-Beltran M, Boniol M, Ferlay J, Hery C, Sauvaget C, Voti L & Autier P (2008). Cancer screening in the European Union, Report on the implementation of the Council Recommendation on cancer screening - First Report. European Communities (publ.), Luxembourg. http://ec.europa.eu/health/ph_determinants/genetics/documents/cancer_screening.pdf http://ec.europa.eu/health/ph_determinants/genetics/documents/cancer_screening.pdf Commission of the European Communities (2008), Report from the Commission to the Council, the European Parliament, the European Economic and Social committee and the Committee of the Regions - Implementation of the Council Recommendation of 2 December 2003 on cancer screening (2003/878/EC) Brussels, Report no.COM(2008) 882 final. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0882:FIN:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0882:FIN:EN:PDF Segnan N, Patnick J & von Karsa L, (eds.) (2010). European Guidelines for Quality Assurance in Colorectal Cancer Screening and Diagnosis - First Edition. European Commission, Publications Office of the European Union, Luxembourg http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND3210390 http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND3210390 Arbyn M, Anttila A, Jordan J, Schenck U, Ronco G, Segnan N, Wiener H, Herbert A, Daniel J & von Karsa L (eds) (2008). European Guidelines for Quality Assurance in Cervical Cancer Screening - Second edition. European Commission, Office for Official Publications of the European Communities, Luxembourg. http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND7007117 http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND7007117 Perry N, Broeders M, de Wolf C, Törnberg S, Holland R, von Karsa L & Puthaar E (eds) (2006). European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis – Fourth edition. European Commission, Luxembourg:Office for Official Publications of the European Communities. http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND7306954 http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=ND7306954 Council of the European Union (2003), Council Recommendation of 2 December 2003 on cancer screening (2003/878/EC), Off J Eur Union no. L 327:34-38. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:327:0034:0038:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:327:0034:0038:EN:PDF von Karsa L, Anttila A, Ronco G, Ponti A, Malila N, Arbyn M, Segnan N, Castillo-Beltran M, Boniol M, Ferlay J, Hery C, Sauvaget C, Voti L & Autier P (2008). Cancer screening in the European Union, Report on the implementation of the Council Recommendation on cancer screening - First Report. European Communities (publ.), Luxembourg. http://ec.europa.eu/health/ph_determinants/genetics/documents/cancer_screening.pdf http://ec.europa.eu/health/ph_determinants/genetics/documents/cancer_screening.pdf Commission of the European Communities (2008), Report from the Commission to the Council, the European Parliament, the European Economic and Social committee and the Committee of the Regions - Implementation of the Council Recommendation of 2 December 2003 on cancer screening (2003/878/EC) Brussels, Report no.COM(2008) 882 final. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0882:FIN:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0882:FIN:EN:PDF

4. Cancer Screening Screening aims to lower the burden of cancer in the population by: discovering latent disease in its early stages and treating it more effectively than if diagnosed later when symptoms have appeared

5. Need for Quality Assurance in Cancer Screening Screening is for predominantly healthy populations. The needs and concerns of healthy clients differ significantly from those of patients. The vast majority of clients are healthy - only a few will have a health benefit from screening. All clients are exposed to the risks of screening. The risks, even if only slight, may collectively shift the balance between harm and benefit into an inappropriate range.

6. Minimum population recommended for cancer screening in EU 27 500 million population (2006) 136 million men and women 50-74 yrs. (min. for CRC screening) 109 million women 30-60 yrs. (min. for cervical screening) 59 million women 50-69 yrs. (min. for breast screening) 27 current Member States 15 acceded before 2004 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 12 acceded in 2004 and 2007 Bulgaria, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovak Republic, Slovenia,

7. Comprehensive Screening Process To achieve and maintain an appropriate balance between benefit and harm… Quality must be optimal at every step in the screening process: information and invitation of the target population performance of the screening test diagnostic work-up of persons with suspicious test results treatment of screen-detected lesions

8. THE COUNCIL OF THE EUROPEAN UNION Recommendation on Cancer Screening of 2 December 2003 Over 30 specific recommendations Based on: WHO principles of cancer screening (Wilson and Jungner) Scientific evidence and experience in implementing cancer screening programmes in EU member states Covering how to: implement cancer screening programmes maintain appropriate quality of screening programmes reach appropriate decisions on new or modified programmes

9. THE COUNCIL OF THE EUROPEAN UNION Recommendation on Cancer Screening of 2 December 2003 1. Implementation of cancer screening programmes (a)Offer evidence-based cancer screening through a systematic population-based approach with quality assurance at all appropriate levels. The tests which should be considered in this context are listed in the Annex; (b) Implement screening programmes in accordance with European guidelines on best practice where they exist and facilitate the further development of best practice for high quality cancer screening programmes on a national and, where appropriate, regional level;

10. Key elements of cancer screening policies and programmes Evidence-based screening policy Appropriate QA, monitoring and evaluation at all levels when running a programme, Linkage studies with the screening, cancer, cause-of- death registers and other registers in health-care for effective monitoring and evaluation Proper information among population and health-care professionals Randomised controled trials (RCTs) on the balance of benefits/harms before deciding on a new programme Council of the European Union 2003

11. THE COUNCIL OF THE EUROPEAN UNION Recommendation on Cancer Screening of 2 December 2003 HEREBY INVITES THE COMMISSION: 7. To report on the implementation of cancer screening programmes, on the basis of the information provided by Member States, not later than the end of the fourth year after the date of adoption of this Recommendation, to consider the extent to which the proposed measures are working effectively, and to consider the need for further action. ANNEX: pap smear screening for cervical cancer precursors starting not before the age of 20 and not later than the age of 30; mammography screening for breast cancer in women aged 50 to 69 in accordance with European guidelines on quality assurance in mammography; faecal occult blood screening for colorectal cancer in men and women aged 50 to 74.

12. Approach to Guideline Development Comprehensive and multidisciplinary, covering entire process: information and invitation of target population performance of screening test diagnostic work-up of test positives treatment of screen-detected lesions Programmatic issues – documentation, monitoring, evaluation, training, implementation, communication Experience-based – expert consensus (breast/cervical) Evidence-based – systematic review (CRC)

13. EU Guidelines for Breast, Cervical and Colorectal Cancer Screening coming soon Financial support through: a) EU Health Programme, b) UEGF, ACS, CDC 4 th Edition2 nd Edition1 st Edition 2006 a) 2008 a) 2010 b)

14. Evidence base for European recommendations on cancer screening – relevant reviews WHO (1968), Wilson JMG & Jungner G. Principles and practice of mass screening for disease Advisory Committee on Cancer Prevention. (2000) Recommendations on cancer screening in the European union. Eur J Cancer 44(10 36(12):1473-8. IARC Handbooks of Cancer Prevention vol. 7 (2002) Breast Cancer Screening. Boyle et al. (2003) Ann Oncol;14(7):973-1005. IARC Handbooks of Cancer Prevention vol. 10 (2005) Cervix Cancer Screening. World Cancer Report. Cancer site by site – colorectal cancer. In: Boyle P, Levin B, editors. World cancer report 2008. Lyon: Hakama et al (2008) Eur J Cancer 2008; 44(10):1404-13. Lansdorp-Vogelaar I & von Karsa L (2010) in: EU CRC Screening Guidelines

15. Colorectal cancer screening Recent overview 1 Commonly implemented approaches Good evidence for guaiac faecal occult blood test (gFOBT), reasonable evidence for immunochemical FOBT (iFOBT) (tests fulfil criteria of EU for screening) 1,2 Reasonable evidence for flexible sigmoidoscopy Limited evidence for total colonoscopy (and recent concerns about effectiveness of CS screening in the right colon) Other technologies such as CT colonography, stool DNA testing and capsule endoscopy are not implemented in Europe in population-based screening programmes due to insufficient evidence of efficacy 1 Landsdorp-Vogelaar and von Karsa in: Segnan, Patnick and von Karsa, EU Guidelines for Quality Assurance in CRC Screening and Diagnosis,in press

16. Recent Publications Updating Evidence on Effectiveness of Breast Screening Programmes Brief overview in Chapter on Breast Cancer Screening in IARC 2008 World Cancer Report Cancer Epidemiol Biomarkers Prev 2006; 15(1):45-51 Swedish Organized Service Screening Evaluation Group (>0.5 million women each in pre-screening and screening epochs) 40-69-year-old women - 40-45% breast cancer mortality reduction (27% in screened population) Hellquist et al. 2010 (Cancer) Swedish Mammography Screening in Young Women (SCRY) Cohort (control group > 8 mil. per.-yrs, screening group > 7 mil. per.-yrs) 40-49-year-old women - 29% breast cancer mortality reduction (26% in screened population). Effect higher 45-49-yrs

17. Cancer Screening in the European Union L v Karsa, A Anttila, G Ronco, A Ponti, N Malila, M Arbyn, N Segnan, M Castillo-Beltran, M Boniol, J Ferlay, C Hery, C Sauvaget, L Voti, P Autier http://ec.europa.eu/health/ph_determinants/genet ics/documents/cancer_screening.pdf Financial support of EU Health Programme (ECN/EUNICE/ECCG) Report on the implementation of the Council Recommendation on cancer screening First Report

18. Number of Countries with Breast, Cervical or CRC Screening Programmes in the EU by Programme Type and estimated % of Minimum Recommended Target Population in the EU in 2007* Table 1. Number of Countries with Breast, Cervical or CRC Screening Programmes in the EU by Programme Type and estimated % of Minimum Recommended Target Population in the EU in 2007 A) Type Breast CancerCervical CancerColorectal cancer Number of countries Women 50-69 yrs. (59 x 10 6 ) Number of countries Women 30-60 yrs. (109 x 10 6 ) Number of countries Women / Men 50-74 yrs. (136 x 10 6 ) Population- based 2291.5 %1550.5 %1242.6 % Non- population- based 56.2 %1247.4 %727.4 % No programme 11.8 %20.2 %88.3 % * Nos. do not add up to 27 due to dual status of breast and cervical cancer screening in 1 and 2 countries, respectively. Percents do not add up to 100% due to excluded regions or age groups in some countries

19. COLORECTAL Cancer Screening Programmes in the EU in 2007 FOBT-based programmes Sources: Karsa, Anttila, Ronco et al. 2008, European Commission, IARC, ECN and EUNICE Financial support of EU Public Health Programme

20. Colorectal Cancer Screening Programmes in the EU 1/2011 Population-based FOBT/FS-based FOBT/CS-based CS-based Italy Poland Austria Belgium Cyprus Czech Rep. Denmark Germany Greece Slovak Rep. Bulgaria France Finland Hungary Ireland Latvia Lithuania Malta Portugal Romania Slovenia Spain Sweden UK No programme FOBT-based Non population- based Estonia Luxembourg Netherlands Belgium * Cyprus Denmark* Finland France Hungary Ireland* Italy Lithuania Malta* Portugal Romania Slovenia Spain Sweden UK Austria Bulgaria Czech Rep. Germany Greece Latvia Poland Slovak Rep. No programme Estonia Luxembourg Netherlands

21. Sequence of Steps in Quality-controlled Implementation of Screening Programmes* 1. Comprehensive planning of screening process: feasibility of screening models, professional performance, organisation and financing, quality assurance (QA) 2. Preparation of all components of screening process to perform at requisite high level (including feasibility testing) 3. Expert verification of adequacy of preparations 4. Piloting and modification, if necessary, of all screening systems and components, including QA, in routine settings 5. Expert verification of adequacy of pilot performance 6. Transition of pilot to service screening and geographically phased programme rollout in other regions of the country 7. Intensive monitoring of programme rollout for early detection and correction of quality problems *Source: L. von Karsa, Quality Assurance Group, Prevention and Early Detection Section, International Agency for Research on Cancer

22. Programme implementation - Key requirements Involvement of civil society Engagement in discussion of benefits and harm of screening Cancer registration Accurate assessment of cancer burden for effective monitoring and evaluation Good governance Long-term political commitment Adequate, sustainable resources Competent oversight (standards) Autonomous programme management Coordination of numerous stakeholders and activities Organisational development Control of resources (dedicated budget and staff) International collaboration (EU network)

23. Council Recommendation on Cancer Screening Model for stimulating sustainable development in the EU Evidence-based approach defuses potential conflicts in implementation Mandate provided for continuous improvement (guidelines and catalog of recommended interventions require regular updating) Efforts of stakeholders channelled to continuous improvement in the way a problem is dealt with Updates do not require changes in the body of the Council Recommendation (no political watering down) Quality loop in the Recommendation focuses the political debate on the pace of progress

24. Thank you for your attention

25. Organized, Population-based Screening Preferred Infrastructure of organized programmes facilitates QA. Individual data for monitoring / auditing Linkage with cancer registries for evaluation Nationwide implementation of population-based programmes makes services performing to the high multidisciplinary standards accessible to the entire eligible target population. Large numbers of professionals undertake further specialisation in order to meet the screening standards. These nationwide efforts also lead to widespread improvement in diagnosis and management of cancers detected outside of screening programmes.

26. Action plan for establishing population-based screening programmes* v. Karsa et al., QAS/IARC

27. Action plan for establishing population-based screening programmes* v. Karsa et al., QAS/IARC