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 GROUP OF SPECIALISTS on TREATMENT AND CLINICAL ASPECTS Edinburgh, 21st-22nd November 2002 Chairperson: Dr Ian Kunkler

3. INTRODUCTION TO THE MEETING Dr. Ian Kunkler

4. AIMS OF THE MEETING • An updated list of indicators for “treatment and • clinical aspects” domain • A consensual classification of these indicators by priority • An updated DESCRIPTIVE FORM for each indicator • Indications on the methodological problems • Indications on the availability of these indicators

5. SUBJECTS OF THE MEETING • Verification of the completeness of the list of indicators • Discussion about priorities of the indicators • Discussion on cancer sites to include in EUROCHIP • Discussion/modification of the forms of the indicators of • this domain • Indications on methodological aspects

6. CONSIDERATIONS • Participants have to consider that: • indicators at high priority should be in a limited • number; • indicators should be able to suggest actions to • reduce inequalities and to promote health; • indicators should refer to the “treatment and clinical aspects” domain • indicators have been developed considering 3 axes: 1) the natural disease’s history (prevention, screening, • diagnosis, treatment, surveillance, end results) • 2) indicator groups as suggested by the ECHI • HMP project (demographic and social-economic factors, health status, determinant of health, health system) • 3) cancer sites

7. EUROCHIP PROJECT: PRESENTATION Dr. Andrea Micheli

8. 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

9. 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

10. FRAMEWORK OF THE PROJECT Steering Committee GS: Groups of specialists Discussion of indicators at national and domain level Working Team Operational work Panel of Experts Discussion & organization at national level Methodological Group Methodological aspects of the indicators GS GS GS GS GS GS GS Www.istitutotumori.mi.it/project/eurochip/homepage.htm

11. FIRST AND FUTURE STEPS 130CANCER SPECIALISTS ARE INVOLVED IN EUROCHIP 16 INTERNATIONAL MEETINGS HELD ALL COUNTRIES OF THE EUROPEAN UNION ARE PARTICIPATING IN THE PROJECT Next steps: • Groups of Specialists in each of five domains (prevention, screening, data registration and epidemiology, macro-health variables, and clinical aspects and treatment) discuss the indicators at the European level. • Final meeting at which the final selection of indicators will be drawn up Www.istitutotumori.mi.it/project/eurochip/homepage.htm

12. 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 39 INDICATORS AT HIGH PRIORITY Www.istitutotumori.mi.it/project/eurochip/homepage.htm

13. EUROCHIP FINAL RESULTS(AT THE END OF STEP 3) • For each indicator at high priority 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

16. THOROUGHNESS OF THE INDICATOR LIST Dr. Franco Berrino

17. LIST OF EUROCHIP HIGH PRIORITY INDICATORS EPIDEMIOLOGY AND CANCER REG. PREVENTION 3.Coverage of cancer registration 4.Stage at diagnosis Person-years life lost due to cancer Completeness of the registration 1.Tobacco consumption 2.Exposure to asbestos SCREENING TREATMENT AND CLINICAL ASP. 5.Breast cancer screening coverage 6.Cervical cancer screening coverage 7.Performance indicators of organized screening programmes 8.Interval between first symptoms and diagnosis 9.Interval between diagnosis and first treatment 10.Radiation equipment 11.% of centres with at least 2 radiation equipments 12.Doctors by specialization 13.Compliance with guidelines 14.Pain units and hospices 15.Use of morphine MACRO SOCIAL-ECONOMIC VARIABLES 16.Total National Expenditure on Health for cancer 17.Total Public Expenditure on Health for cancer

18. INDICATORS AT HIGH PRIORITY (1) PREVENTION 1) Tobacco consumption 2) Consumption of fruit and vegetable * 3) Consumption of alcohol * 4) Body Mass Index * 5) Exposure to asbestos 6) AIDS incidence * 7) Prevalence of hepatitis B/C * EPIDEMIOLOGY AND CANCER REGISTRATION 8) Coverage of cancer registration 9) Incidence rates * 10) Survival rates * 11) Prevalence proportion * Mortality rates * 13) Stage at diagnosis 14) Person-years life lost due to cancer 15) Completeness of the registration (DCO and Incidence / mortality) 16) % of microscopically cases * * Connected with other HMP projects Www.istitutotumori.mi.it/project/eurochip/homepage.htm

19. INDICATORS AT HIGH PRIORITY (2) SCREENING 17) Breast cancer screening coverage 18) Cervical cancer screening coverage 19) Performance indicators of organized screening programmes TREATMENT AND CLINICAL ASPECTS 20) Interval between first symptoms and diagnosis 21) Interval between diagnosis and first treatment 22) Radiation equipment 23) % of centres with at least 2 radiation equipments 24) Doctors by specialization 25) Compliance with guidelines 26) Patients treated by surgery * 27) Pain units and hospices 28) Use of morphine * Connected with other HMP projects Www.istitutotumori.mi.it/project/eurochip/homepage.htm

20. INDICATORS AT HIGH PRIORITY (3) MACRO SOCIAL-ECONOMIC VARIABLES 29) Education level attained * 30) Deprivation index * 31) Income * 32) Gross Domestic Product * 33) Total Social Expenditure 34) Total National Expenditure on Health * 35) Total National Expenditure on Health for cancer 36) Total Public Expenditure on Health * 37) Total Public Expenditure on Health for cancer 38) % elderly in 2010-2020-2030 39) Age distribution of population * Connected with other HMP projects Www.istitutotumori.mi.it/project/eurochip/homepage.htm

21. PRIORITY LEVELS Dr. Ian Kunkler

22. PRIORITY LEVELS ADirect indicator – Important – With or without any problem BIndirect indicator – Important – With or without any problem C Potentially useful but with presenting a great deal of problems D Very low priority – Irrelevant

23. DO YOU WANT SOMETHING ELSE AT HIGH PRIORITY? • TREATMENT AND CLINICAL ASPECTS • Interval between symptoms and diagnosis (DELETED) • Interval between diagnosis and first treatment (3) • Radiation equipment (2) • % of centres with at least 2 radiation equipments • Number of CT scan per …. (NEW) • Medical cancer work force (DELETED) • Compliance with guidelines (3) • Patients treated by surgery / chemotherapy /… (NEW) • Palliative care (3) • Pain units and hospices

24. ARE THESE PRIORITIES OK? • A • Interval between first symptoms and diagnosis • Interval between diagnosis and first treatment • Radiation equipment • % of centres with at least 2 LinAcs • Doctors by specialization • Compliance with guidelines • Patients treated by surgery, chemotherapy, … • Pain units and hospices • Use of morphine • CAT • B • CAT • C • Nr of bad-days attributable to cancer care • Patients treated with conservative surgery / • radiotherapy / chemotherapy / hormonal treatment • Quality of cancer patients indicators

25. STAGE AT DIAGNOSIS Dr. Carmen Martinez

26. STAGE AT DIAGNOSIS Descriptive Form • Cancer type: Breast, colorectal cancer, cervix, lung, prostate (NEW SITES) • Generic definition: proportion of incidence cases classified with the TNM value or, in absence, with condensed-TNM. The non-metastatic cases will be classified by presence or absence of a specific test for the detection of the metastasis • Rationale: Early/late diagnosis • Utility: Determinant of treatment and prognosis • Modalities of classification: TNM or cond. TNM (+ non-metastatic cases with/without detection test) • By sexandby age

27. STAGE AT DIAGNOSIS Methodological Form • Suggestions to the EC: to subsidize CR. In the first years we will have to recommend clinicians and pathologists to indicate the stage in the clinical reports • Source: Cancer Registries with High resolution studies

28. INDICATORS ON DELAY OF CARE Dr. Ian Kunkler

29. DELAY OF CARE: PHASES OF THE DISEASE HISTORY SYMPTHOM: there is not an event and it is not strictly defined on time FIRST MEDICAL ATTENDANCE: date in which patient reports his sympthoms to the Health System DIAGNOSIS: date defined using the conventional date index of Cancer Registries FIRST TREATMENT: Date of the beginning of primary treatment DEFINITIVE TREATMENT: ?

30. INDICATORS ON DELAY OF CARE:INTERVAL BETWEEN FIRST SYMPTOMS AND DIAGNOSIS and INTERVAL BETWEEN DIAGNOSIS AND TREATMENT We suggest to use the distance between first medical attendance and diagnosis and between diagnosis and first treatment CONTEXT SOURCE Cancer Registries The dates have to be in the form DD/MM/YY We need exact definitions of the phases of the disease history STANDARDIZATION VARIABILITY Relevant VALIDITY A lot of problems (see methodological form)

31. FIRST MG RESULTS • study colon, cervix and breast cancers • distinguish between screening clinical diagnosis • use the date of pathological confirmation as the date of • diagnosis • use the date of first medical attendance as the first stage • of the disease • A1.4Tr.2 interval is from date of pathological • confirmation and start of first treatment • The two indicators should be condensed in only one • The sources are the Cancer Registries. For frequent cancer sites as breast, cervix and colorectal a sample of cases could be studied.

32. MG Results: FIRST MEDICAL ATTENDANCE The group defines this event as the first medical attendance reporting symptoms for the cancerous disease. For cases discovered by screening procedures, either organized or spontaneous (breast, cervix, colorectum), we consider positive mammography, PAP smear, and colonscopy as first medical attendance. People at high risk or presenting suspicious symptoms who are under observation with repeated examinations are assimilated to spontaneous screening with respect to first medical attendance definition

33. MG Results: PATHOLOGICAL CONFIRMATION Pathological confirmation (histology) is assumed as the major clinically significant event associate to diagnosis. Patients following their first medical attendance are addressed to perform a diagnostic procedure including biopsy. Pathological confirmation following biopsy defines diagnosis and is a basic information for treatment. Cases discovered by screening follow the same diagnostic procedure and the pathological confirmation defines the diagnosis. This is valid for breast, colorectal, and cervical cancers either screening or symptomatic patients

34. MG Results: FIRST TREATMENT First treatment represents the start of a defined treatment for a patient. This would include any treatment that that is defined as a starting point in a protocol, not always the principal treatment. As an example, radiotherapy is sometimes the first treatment before surgery for cervical cancers, and treatment with tamoxifen before surgery for breast cancer. We will consider as first treatment radiotherapy and tamoxifen, instead of surgery that is the principal treatment, in these cases

35. Results from Cancer Registration group • The indicator could be collected by CR • The registration cannot be routinely • It is reasonable that a sample of population for a number of Cancer Registries will be included in periodical activities • This periodical activity will cost a large quantity of money • The treatment group will have to indicate a few sites and will have to provide very clear definitions of the phases of the disease

36. Indicator characteristics • The Methodological Group suggests • to define exactly the 3 dates (first medical attendance, diagnosis and first treatment) for 3 cancer sites: colon, breast and cervix • to put together the two indicators. The 2 intervals would become the modalities of classification of the new indicator on delay of cancer care • The indicator is completely new. For its realization the cancer registration will have to improve: infact the Cancer Registries will have to found also these dates for each case

37. COMPLIANCE WITH GUIDELINES Dr. Carmen Martinez

38. COMPLIANCE WITH GUIDELINES We need to collapse the guidelines in a few items CONTEXT SOURCE Cancer registries Studies should be conducted using a common protocol and criteria STANDARDIZATION VARIABILITY Relevant VALIDITY To use studies as “High resolution studies”

39. First Methodological Group Results 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.

40. Example As an example, Sant (2001) showed that in Southern Italy a very low proportion of breast cancer patients T1N0M0 were treated with conservative surgery while many received Hastled mastectomy. This a clear deviation to guidelines, although motivated by lack of radiotherapy centres in the area. Source: Sant M, and the EUROCARE Working Group: Differences in stage and therapy for breast cancer across Europe. International Journal of Cancer 93: 894-901 (2001)

41. SOURCE The indicator is a new indicator The sources should be the Cancer Registries. The Methodological group suggests specific studies on sample of cases in order to collect information on therapy and stage, such as the EUROCARE High Resolution Studies

42. Results from Cancer Registration group • The indicator could be collected by Cancer Registries • It is reasonable that a sample of population for a few number of sites and items will be included in periodical activities • It is important studying the “non-adherence”. • The treatment group has to define a few items with treatments that have not be done

43. Indicator characteristics • The Methodological Group suggests • to study the “deviation” from guidelines. • to define the indicator “Deviation from the best practice” or “Frequency of inappropriate treatment”. • the Treatment Group of Specialists to define 3 or 4 cancer sites to study and 2 or 3 treatments universally considered inappropriate for these cancer sites (also considering different stages) • The indicator should change in the future following the diffusion of new treatments

44. INDICATORS ON RESOURCES Dr. Jan Willem Coebergh

45. RADIO-THERAPY EQUIPMENT Number of linear accelerators installed max since 10 years CONTEXT SOURCE Survey on all health structures The Lin Acs have to be working on 31st Dec of the year before the survey STANDARDIZATION VARIABILITY Relevant VALIDITY No problems

46. UNITS WITH AT LEAST 2 LINEAR ACCELERATORS Number of cancer units with at least 2 linear accelerators installed max since 10 yrs CONTEXT SOURCE Survey on all health structures The Lin Acs have to be working on 31st Dec of the year before the survey STANDARDIZATION VARIABILITY No problems VALIDITY No problems

47. Indicator characteristics • The Methodological group suggests to delete this indicator as before studying the indicator we should reply to this question: • If a country has 10 Lin Acs is it better to have all 10 Lin Acs in only a cancer unit or 1 Lin Acs in 10 different units?

48. Medical cancer work-force The medical specializations are not standardized. We suggest to classify the specialization in 3 classes (e.g. medical oncology, radiology and haematology areas) CONTEXT SOURCE National Medical Associations We need the classification of various specializations in the 3 classes STANDARDIZATION VARIABILITY No problems VALIDITY No problems DELETED

49. Indicator characteristics • The group has to discuss on • the possibility to classify the specializations in some broad classes • definition of the broad classes • classification of the various specializations in the broad classes

50. INDICATOR ON PALLIATIVE CARE Dr. Kaija Holli