International Agency for Research on Cancer

Lyon, France

Developing EU health quality standards and guidelines

CANCER SCREENING GUIDELINES

Lawrence von KarsaQuality Assurance Group

Section of Early Detection and Prevention

EU Quality Standards andGuidelines 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

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, Luxembourghttp://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

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

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

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

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

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, Luxembourghttp://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

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

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

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

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

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

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.

Minimum population recommendedfor 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 2007Bulgaria, Cyprus, Czech Republic, Estonia, Hungary, Latvia,

Lithuania, Malta, Poland, Romania, Slovak Republic, Slovenia,

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

THE COUNCIL OF THE EUROPEAN UNIONRecommendation 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

THE COUNCIL OF THE EUROPEAN UNIONRecommendation 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;

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

THE COUNCIL OF THE EUROPEAN UNIONRecommendation 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.

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)

EU Guidelines for Breast, Cervical and Colorectal

Cancer Screening

coming soon

Financial support through: a)EU Health Programme,b)UEGF, ACS, CDC

4th Edition 2nd Edition 1st Edition

2006a) 2008a) 2010b)

Evidence base for European recommendationson 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

Colorectal cancer screeningRecent overview1

• 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

1Landsdorp-Vogelaar and von Karsa in: Segnan, Patnick and von Karsa,EU Guidelines for Quality Assurance in CRC Screening and Diagnosis,in press

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

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 Autierhttp://ec.europa.eu/health/ph_determinants/genetics/documents/cancer_screening.pdf

Financial support of EU Health Programme (ECN/EUNICE/ECCG)

Report on theimplementation of the

Council Recommendation on cancer screening

First Report

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*

Type

Breast Cancer Cervical Cancer Colorectal cancer

Numberof

countries

Women50-69 yrs.(59 x 106)

Numberof

countries

Women30-60 yrs. (109 x 106)

Numberof

countries

Women / Men

50-74 yrs.(136 x 106)

Population- based

22 91.5 % 15 50.5 % 12 42.6 %

Non- population- based

5 6.2 % 12 47.4 % 7 27.4 %

No programme

1 1.8 % 2 0.2 % 8 8.3 %* 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

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

Colorectal Cancer Screening Programmes in the EU 1/2011

Population-based

FOBT/FS-based

FOBT/CS-based

CS-basedItaly

Poland

AustriaBelgiumCyprusCzech Rep.DenmarkGermanyGreeceSlovak Rep.

BulgariaFranceFinlandHungaryIrelandLatviaLithuania MaltaPortugalRomaniaSloveniaSpainSwedenUK

No programme

FOBT-based

Non population-based

EstoniaLuxembourgNetherlands

Belgium *CyprusDenmark*FinlandFranceHungaryIreland*ItalyLithuaniaMalta*PortugalRomaniaSloveniaSpainSwedenUK

AustriaBulgariaCzech Rep.GermanyGreeceLatviaPolandSlovak Rep.

No programmeEstoniaLuxembourgNetherlands

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 geographicallyphased programme rollout in other regions of the country

7. Intensive monitoring of programme rollout for early detectionand correction of quality problems *Source: L. von Karsa, Quality Assurance

Group, Prevention and Early Detection Section, International Agency for Research on Cancer

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)

Council Recommendation on Cancer ScreeningModel 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

Thank you for your attention

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.

Action plan for establishing population-based screening programmes*

v. Karsa et al., QAS/IARC

Action plan for establishing population-based screening programmes*

v. Karsa et al., QAS/IARC