EUROCHIP

1. EUROCHIP Health Indicators for Monitoring Cancer in Europe Health Monitoring Program (HMP) EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Www.istitutotumori.mi.it/project/eurochip/homepage.htm

2. EUROCHIP INTRODUCTION AIM:To produce a list of health indicators which describe cancer in Europe, to help the development of the future European Health Information System STEP 1(Jan 2002 – Jul 2002) : To discuss a preliminary list at national level, in all members of the European Union. The result was a list of more than 100 indicators subdivided by priority level STEP 2(Sep 2002 – Dec 2002) : To discuss the indicators (of the list produced at STEP 1) by different domain (prevention, epidemiology and cancer registration, screening, treatment and clinical aspects, and macro social-economic variables). To discuss methodological problems for the indicators at high priority. STEP 3(Jan 2003 – May 2003) : Definition of the final list of indicators subdivided by domain and by priority level. Www.istitutotumori.mi.it/project/eurochip/homepage.htm

3. EUROCHIP Comprehensive range of health indicators for cancer: OCCURENCE RISK FACTORS LIST OF CANCER INDICATORS PRE-CLINICAL ACTIVITY/ SCREENING SURVIVAL CAMON EUROCARE/EUROPREVAL DIAGNOSTIC AND THERAPEUTIC PROCEDURES CANCER CARE/ PREVALENCE CANCER RECURRENCE AND MORTALITY CLINICAL FOLLOW-UP Standardised methods for collecting, checking and validating the data will be proposed for each indicator Www.istitutotumori.mi.it/project/eurochip/homepage.htm

4. STEPS 130CANCER SPECIALISTS ARE INVOLVED IN EUROCHIP 23 INTERNATIONAL MEETINGS HELD ALL COUNTRIES OF THE EUROPEAN UNION ARE PARTICIPATING IN THE PROJECT This step: • Final meeting at which the final selection of indicators will be drawn up Www.istitutotumori.mi.it/project/eurochip/homepage.htm

5. RESULTS For each indicator we compile a FORM subdivided in three sections: • DESIRED INDICATOR: all indicator characteristics we wish to have • METHODOLOGY: operational definition, possible sources and methodological issues • AVAILABILITY in different countries LIST OF INDICATORS PRELIMINARY LIST OF 158 INDICATORS EUROCHIP MEETINGS 60 INDICATORS SUBDIVIDED BY DOMAIN Www.istitutotumori.mi.it/project/eurochip/homepage.htm

6. EUROCHIP FINAL RESULTS(AT THE END OF STEP 3) • For each indicator EUROCHIP will produce: • A DESCRIPTIVE FORM including: • Desired indicators characteristics (definition, use, caveat …) • Operational definition and indications on sources • Indications on availability in all EU member countries • A METHODOLOGICAL FORM including: • Methodological aspects (standardisation, validity, variability) • Bibliography on the indicator • Suggestions to the European Commission Www.istitutotumori.mi.it/project/eurochip/homepage.htm

9. FUTURE • EUROCHIP 2 • National EUROCHIP groups • Publications

10. PUBLICATIONS • European Journal of Public Health: special number with the abstracts of the EUPHA meeting (Dresden, Nov 2002) • Cultural spanish review “Las Claras” : an article on the EUROCHIP Murcia meeting will be published • European Journal of Public Health: an article on EUROCHIP is under review NATIONAL OR INTERNATIONAL MEETINGS • Abstracts of various presentations or posters are under review for: • NAACCR annual meeting: Honolulu (Jun 03) • AIRT (Italian association CR) meeting: Biella (Apr 03) • Reunion du groupe pour l'epidemiologie et l'enregistrement du cancer dans le pays de langue latine: Cuba (May 03) • “Sociedad Española de Epidemiología” meeting: Toledo (Oct 03)

11. PLAN OF THE PUBLICATIONS • The Steering Committee decided this plan of publications: • 1 article with EUROCHIP introduction: EUROPEAN JOURNAL OF CANCER or EUROPEAN JOURNAL OF PUBLIC HEALTH • 1 article on methodological aspects: ? • 1 article on treatment aspects: EUROPEAN JOURNAL OF CANCER • 1 article on prevention: EUROPEAN JOURNAL OF CANCER ON PREVENTION • 1 article on screening: EUROPEAN JOURNAL OF CANCER ON PREVENTION • 1 article on cancer registration and epidemiology: EUROPEAN JOURNAL OF CANCER • Preparation: before summer In press: October-November

12. AIMS OF THE MEETING • Approval of the entire list with relevant material • Give a priority to the indicators: to find 15-20 most important indicators • A look of the future

13. EUROCHIP PROJECT: LIST OF INDICATORS GOAL: PRIORITIES

14. AXES OF CLASSIFICATION • The natural history of cancer • Prevention • Screening • Diagnosis • Treatment • End results • ECHI classification • Demographic and social-economic factors • Health status • Determinants of health • Health system • Tumour sites

15. CANCER SITES (1) • All cancers combined without non melanoma skin cancersfor cancer burden and cancer trends. For total cost of cancer care. For Incidence and mortality • Major cancers(in terms of incidence or prevalence) • Lung for prevention, tobacco smoking (very limited for asbestos). For mortality (in countries without data). For preventable estimation of deaths • Breast for monitoring screening programmes (mortality and incidence) and to evaluate the care (tamoxifen) • Colorectal to evaluate the care, evaluation of early diagnosis (and screening programmes ). For delay of diagnosis • Prostatefor future trends and future resources

16. CANCER SITES (2) • Other major cancers • Stomach for monitoring the decreasing trends (ethnic differences) • Head and neck-larynx, oropharynx (specifying ICD-9 code) for prevention and care. Treatment for organ preservation. Melanoma for prevention (early diagnosis-stage migration) • Bladder: for mortality • Other cancers • Kaposi for sentinel • Mesothelioma for sentinel • Testis for rare cancer • Lymphomas (H for health services and NH for trends) and Leukaemia (for treatment) • All (or just Leukaemia?) childhood (0-14) cancers (for survival) rare cancer • Cervix (for screening) We need information on incidence and mortality (note: corpus uteri vs cervix misclassification)

17. BACKGROUND OF THE LIST • The final list is the result of various • discussions on the priorities of each indicator. • These priorities considered together: • added value of the indicator, • problems on the collection of the data, • problems on the comparability among European countries, and • costs of the collection

18. INDICATORS: UNRESOLVED PROBLEMS (1) • Awareness of risk associated to exposure to UV radiations: which question for the survey? • PM10 emissions: cut-off • Screening coverage indicators: only on organized screening or also on opportunistic screening? Which source? PAGE 23 PAGE 25 PAGES 63-68

19. INDICATORS: UNRESOLVED PROBLEMS (2) • Number of units with at least 2 Linear Accelerators or with a single Lin Acc. • Patients treated by surgery, chemotherapy…: which is the utility of this indicator after the collection of the indicator “deviance from best oncology practice”? • Palliative care: which indicator? PAGE 97 PAGES 113-116 PAGE 117

20. PREVENTION: 14 (4) Lifestyle: 7 (0) Environment & Occupational risk: 6 (4) Medicaments: 1 (0) EPIDEMIOLOGY AND CANCER REGISTRATION: 10 (5) Cancer registration coverage: 1 (1) Epidemiological measure: 7 (3) Cancer registration quality: 2 (1) SCREENING: 13 (13) Screening coverage: 3 (3) National evaluation of org. scr. process indicators: 10 (10) TREATMENT AND CLINICAL ASPECTS: 10 (10) Health system delay: 1 (1) Resources: 3 (3) Treatment: 5 (5) Palliative care: 1 (1) SOCIAL AND MACRO-ECONOMIC VARIABLES: 18 (8) Social indicators: 3 (0) Macro economic indicators: 13 (8) Demographic indicators: 2 (0) L I S T

21. PR 7 hp (2) 4 mp (2) EP 6 hp (2) SC 4 hp (4) 7 mp (7) TR 5 hp (5) 3 mp (3) MV 5 hp (2) 11 mp (2) 27 hp (15) 25 mp (14)

22. LEGENDA OF NEXT SLIDES • In “red”: indicators proposed by EUROCHIP • In “black”: indicators proposed by other projects or networks • In “CAPITAL”: indicators at high priority • In “small”: indicators at medium priority

23. INDICATORS ALREADY AVAILABLE - LOW COSTS or NO NEW COSTS • EXPOSURE TO ASBESTOS:MESOTHELIOMA INCIDENCE • AND MORTALITY TRENDS • CANCER INCIDENCE RATE AND TREND • CANCER SURVIVAL RATE AND TREND • CANCER PREVALENCE PROPORTION AND TREND • CANCER MORTALITY RATE AND TREND • PERSON-YEARS LIFE LOST DUE TO CANCER • POPULATION COVERED BY CRs IN EUROCIM DATABASE • Percentage of cases confirmed microscopically • Education level attained • Average income and Gini’s index • GROSS DOMESTIC PRODUCT • TOTAL SOCIAL EXPENDITURE • TOTAL NATIONAL EXPENDITURE ON HEALTH • TOTAL PUBLIC EXPENDITURE ON HEALTH • Age distribution in 2010-20-30 • Life table quantities

24. SOURCES ALREADY AVAILABLE - LOW COSTS or NO NEW COSTS • ANTI-TOBACCO REGULATIONS • NATIONAL EVALUATION IN HMP OF THE ORGANIZED SCREENING PROCESS INDICATORS • SCREENING VOLUME • SCREENING RECALL RATE • SCREENING DETECTION RATE • SCREENING LOCALIZED CANCERS • SCREENING BENIGN/MALIGNANT BIOPSY RATIO • SCREENING INTERVAL CANCERS • SCREENING SENSITIVITY • SCREENING SPECIFICITY

25. SOURCE: UPDATE OF DATABASES - MEDIUM COSTS • PREVALENCE OF OCCUPATIONAL EXPOSURE TO CARCINOGENS • PM10 EMISSIONS SOURCE: HEALTH SURVEYS - MEDIUM COSTS • Consumption of fruit and vegetables • Consumption of alcohol • Body Mass Index distribution in the population • Physical activity • PREVAL. OF CURRENT TOBACCO SMOKERS AMONG • ADULTS • PREVALENCE OF TOBACCO SMOKERS AMONG 10-14 • PREVALENCE OF EX-SMOKERS • Prevalence population exposed to environmental tobacco smoke (ETS) • Awareness of risk associated to exposure to Ultra-Violet radiations • Breast cancer screening coverage • Cervical cancer screening coverage • Colo-rectal cancer screening coverage

26. SOURCE: OTHER SURVEYS - MEDIUM COSTS • % OF RADIATION EQUIPMENTS ON POPULATION • % OF UNITS WITH AT LEAST 2 LINACS • % OF CT (COMPUTED AXIAL TOMOGRAPHY) ON POP. • PUBLIC EXPENDITURE FOR CANCER DRUGS • Public expenditure for cancer prevention on anti-tobacco activity • Public expenditure for organized mass screening programmes • Private/Non profit expenditure on cancer screening • Public expenditure for cancer research • Private non profit expenditure for cancer research • Public expenditure for population-based Cancer Registries • Private/Non profit expenditure for cancer registration • Prevalence of use of hormonal replacement treatment drugs • Palliative care indicator

27. SOURCE: CANCER REGISTRIES - HIGH COSTS • STAGE AT DIAGNOSIS: CASES RECORDED IN CRS AND • MEDICAL RECORDS • Completeness of cancer registration • DELAY OF CANCER TREATMENT • DEVIANCE FROM BEST ONCOLOGY PRACTICE • Patients treated by • - Surgery • - Chemotherapy • - Radiotherapy • - Endocrine therapy SOURCE: OTHER - HIGH COSTS • Indoor radon exposure

29. INTRODUCTION

30. AXES OF CLASSIFICATION • The natural history of cancer • Prevention • Screening • Diagnosis • Treatment • End results • ECHI classification • Demographic and social-economic factors • Health status • Determinants of health • Health system • Tumour sites

31. CANCER SITES (1) • All cancers combined without non melanoma skin cancersfor cancer burden and cancer trends. For total cost of cancer care. For Incidence and mortality • Major cancers(in terms of incidence or prevalence) • Lung for prevention, tobacco smoking (very limited for asbestos). For mortality (in countries without data). For preventable estimation of deaths • Breast for monitoring screening programmes (mortality and incidence) and to evaluate the care (tamoxifen) • Colorectal to evaluate the care, evaluation of early diagnosis (and screening programmes ). For delay of diagnosis • Prostatefor future trends and future resources

32. CANCER SITES (2) • Other major cancers • Stomach for monitoring the decreasing trends (ethnic differences) • Head and neck-larynx, oropharynx (specifying ICD-9 code) for prevention and care. Treatment for organ preservation. For quality of life • Melanoma for prevention (early diagnosis-stage migration) • Other cancers • Kaposi for sentinel • Mesothelioma for sentinel • Testis for rare cancer • Lymphomas (H for health services and NH for trends) and Leukaemia (for treatment) • All (or just Leukaemia?) childhood (0-14) cancers (for survival) rare cancer • Cervix (for screening) We need information on incidence and mortality (note: corpus uteri vs cervix misclassification)

33. INDICATORS (at high priority)

34. EXPOSURE TO ASBESTOS: MESOTHELIOMA INCIDENCE AND MORTALITY TRENDS Incidence/Mortality variations for Pleureal cancer and/or Perithoneal cancer and/or Mesothelioma by period and by administrative unit DEFINITION The recent trends of mesothelioma or pleural and perithoneal cancers mortality and incidence (last 3-5 years) can be real proxies of the exposure to asbestos in the past. They indicate either increasing, decreasing or even stable rates, thus indicating a different phase of the asbestos epidemic. INDICATORS ALREADY AVAILABLE NO NEW COSTS HIGH PRIORITY

35. PERSON-YEARS OF LIFE LOST DUE TO CANCER Years lost due to cancer using general life expectancy as reference DEFINITION FORMULA where a=age, l=age limit, dat=number of deaths at age a, pat=number of persons aged a in country i at time t, Pa=number of persons aged a in the reference population, Pn=total number of persons aged 0 to l-1 in the reference population SOURCES ALREADY AVAILABLE LOW COSTS HIGH PRIORITY

36. POPULATION COVERED BY CANCER REGISTRIES PRESENT IN EUROCIM DATABASE Proportion of the national population that is covered by general population-based Cancer Registries present in the EUROCIM database in a given period (year) DEFINITION By registration span. For a given calendar year, the indicator shows the percentage of cancer registration coverage of 5, 10 and 20 years at least CLASSIFICATION INDICATORS ALREADY AVAILABLE NO NEW COSTS HIGH PRIORITY

37. NATIONAL EVALUATION IN HMP OF THE ORGANIZED SCREENING PROCESS INDICATORS The “screening group” underlined the importance to realise in HMP a national evaluations of the process indicators of the organised screening programmes activity. The group individuated the information necessary for this national evaluation: Breast and colo-rectal cancer Extension => Availability of the programmes in the pop. and coverage Acceptance => Participation Specificity => Recalled, benign operations (open surgical procedures) Sensitivity => Detected by stage Cervical cancer Extension => Availability of the programmes in the pop. and coverage Acceptance => Participation Specificity => Recalled (anything no negative) Sensitivity => Detected by CIN (histology) and invasive by stage SOURCES ALREADY AVAILABLE HIGH PRIORITY LOW COSTS

38. ANTI-TOBACCO REGULATIONS • The indicator refers to the description of the anti-tobacco regulation. • It is a multiple-indicator indicating presence or absence (Y/N) of a set of specific laws on anti-tobacco regulation. These laws should refer to: • restrictions in public places • prohibition in hospitals • prohibition at school (or universities) • prohibition in public transport vehicles • on-pack warnings • indications on nicotine on pack • limits on tar content • employeees protection law (ETS) • prohibition of Tv and radio advertising • flight smoke prohibition in national airline • sales to children/teenagers • tobacco smoke labeled as a carcinogen HIGH PRIORITY SOURCES ALREADY AVAILABLE LOW COSTS SOURCE: Corrao MA et al. Tobacco Control Country Profiles. American Cancer Society, Atlanta, GA (2000)

39. PREVALENCE OF OCCUPATIONAL EXPOSURE TO CARCINOGENS Current prevalence of occupational exposure to a given carcinogen (recognized by the “International Agency for Research on Cancer” in the classifications 1, 2A and 2B) DEFINITION EUROCHIP suggest to update and expand the present CAREX database. This database, subsidized by the “Europe Against Cancer” Programme, estimated the occupational exposure in all European countries by agent and by industries for the period 1990-93. Updating the already available database with the same methodology we could also study if in the country the occupational exposure to carcinogens is changed in this 10 years UPDATE OF AVAILABLE DATABANKS MEDIUM COSTS HIGH PRIORITY

40. PM10 (PARTICULATE MATTER <= 10µ3) EMISSIONS* Percentage of population living in areas with a PM10 daily average concentration above ? microgrammes per air cubic metre DEFINITION MEDIUM COSTS “Percentage of population living in urban areas with a PM10 daily average above 50 microgrammes per air cubic metre” is an indicator proposed in Europe by the group “Environmental health indicators for the WHO Europe”. This group already provided a methodological definition of the indicator and also considers it as a realistic goal in the next future. This indicator is the same proposed by EUROCHIP (we had not proposed any limit value, as yet) so we recommends the EC to include in the European Database also this indicator of the WHO group. The only doubt is the value of 50 microgrammes per air cubic metre because the EU directive indicates a lower value

41. INDICATORS ON TOBACCO * • Prevalence of current tobacco smokers among adults • Prevalence of tobacco smokers among 10-14 • Prevalence of ex-smokers • Prevalence of exposure to environmental tobacco • smoke (ETS) The project EHRM (European Health Risk Monitoring) proposed the same indicators of EUROCHIP. HEALTH SURVEY MEDIUM COSTS HIGH PRIORITY

42. INDICATORS ON RESOURCES Number of linear accelerators per 1 000 000 population RADIATION EQ. Number of CT (Computed Axial Tomography or computed tomography scanners) equipments per 1 000 000 population CT Number of units with at least 2 Linear Accelerator radiation equipments per 1 000 000 population ORNumber of units with a single Linear Accelerator OTHER Survey on health structures and services. The resource have to be working on 31st December of the year prior to the survey SOURCE OTHER SURVEYS MEDIUM COSTS HIGH PRIORITY

43. STAGE AT DIAGNOSIS: CLARIFICATIONS We need to have this information: CANCER REGISTRIES HIGH COSTS HIGH PRIORITY

44. STAGE AT DIAGNOSIS: PERCENT OF CASES RECORDED IN CANCER REGISTRIES Proportion of cases classified with the TNM value or, in absence, with condensed-TNM DEFINITION The expected value of this percentage is site dependent. For some sites (like lung) the expected value of the indicator is lower than 100%, but comparisons among countries are still informative. CONTEXT The sources are the Cancer Registries and exactly their routinary activity of registration SOURCE

45. STAGE AT DIAGNOSIS: PERCENT OF CASES RECORDED IN MEDICAL RECORDS Percentage of cancer cases registered by the clinician with the information of the presence or absence of a detection tests for metastasis DEFINITION - Cervix: chest x-ray and pelvic imagine - Colon and rectum: liver ultrasound or CT and chest x-ray - Prostate: bone-scan - Lung: CT thorax - Breast: different per stage - T1-T2: chest x-ray - T3-T4 or N+: bone-scan and liver ultrasound DETECTION TESTS The sources are the Cancer Registries performing specific studies for major cancer sites SOURCE

46. DELAY OF CANCER TREATMENT: CONTEXT Phases of the disease history: · Symptoms: there is not an event and for this it is not strictly defined on time · First medical attendance: date on which patient reports his symptoms to the Health System (general practitioner, hospital ...) · Diagnosis: date defined specifically site per site · First treatment: date of the beginning of primary treatment. The date of first symptoms is not intrinsically defined as an event and for this reason we suggest to use the date of the first diagnosis (or first medical attendance for some sites) as a reference. The treatment group suggests specifically definitions for the dates of first diagnosis (or first medical attendance) and of first treatment for 5 cancer sites: breast, colon, rectum, lung and prostate. The Methodological Group suggests to study only breast, colon and rectum for the high percentage of patients non-treated. To define these indicators, the Cancer Registries have to collect the dates of first treatment (and exactly on surgery, chemotherapy, radiotherapy or endocrine therapy)

47. DELAY OF CANCER TREATMENT: DEFINITION OF THE DATES CANCER REGISTRIES HIGH COSTS

48. DELAY OF CANCER TREATMENT : COMMENTS Isabel Izarzugaza (Basque Country Cancer Registry) The data for the delay of cancer treatment indicator could be collected periodically for breast and colorectum. In a different period for prostate, in a different period for some other tumour. For example during 1 year every 3 years breast and colorectum, the following year (everey 3 years) for prostate and so on. Risto Sankila (Cancer Registry of Finland Why do we collect data, e.g. on delay of care, when in some parts of the expanding EU there are no resources for proper diagnostics!Who will utilise the information on 'Interval between first diagnosis and first treatment' on the EU level, if the data are only collected from a (biased?) sample of cancer clinics? (To be continued…)

49. DELAY OF CANCER TREATMENT : COMMENTS Torgil Moller (Swedish Cancer registry) I think this is a very difficult item if you wish to study the time from symptom to diagnosis and diagnosis to treatment. The date of start of symptom is often very vague and undefined, maybe preceeded by irrelevant symptoms and thus a matter of great subjectivity. I would like to suggest date of first contact with health care system leading to the diagnosis in question as the starting point. This is of course also a difficult item to collect, and necessitates maybe visits to primary health care centres and GPs, but in any case it is a date that could be defined. The next problem relates to date of diagnosis. If we are studying delay in the system, the date of histological confirmation based on surgical specimen would in many cases result in a negative delay between date of diagnosis and date of start of treatment. Thus, it is important to accept for example a positive mammography plus cytology as the date of diagnosis, or clinical investigation where no histological confirmation can be obtained, for example melanoma of the eye or tumour of the brain stem. If this problem can be solved, then this indicator might be of value. However, it could never be based on a routine data collection but must be collected now and then within well defined projects.

50. DEVIANCE FROM BEST ONCOLOGY PRACTICE: CONTEXT The indicator is aimed to reflect the deviance to best practice in oncology. It implies the existence of specific professional guidelines and express something related to the attitude to comply with guidelines rather best practice. To give an indication on the patients treated according to the guidelines, we need to collapse the guidelines themselves into a few simple items. As guidelines usually refer to cases that can be potentially cured, the indicator should refer to patients potentially eligible for treatment according to guidelines. An examination of the “deviation” from guidelines is usually more robust than a look at their “adherence”. The medical attitude in following guidelines may vary considerably and thus, is very difficult to classify. Defining the non-adherence is easier and more robust.