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. GROUP OF SPECIALISTS on TREATMENT AND CLINICAL ASPECTS Edinburgh, 21st-22nd November 2002 EUROCHIP 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. Comprehensive range of health indicators for cancer: LISTOFCANCER INDICATORS INDICATORS RISK FACTORS PRE-CLINICAL ACTIVITY/ SCREENING CLINICAL FOLLOW-UP DIAGNOSTIC AND THERAPEUTIC PROCEDURES CANCER RECURRENCE AND MORTALITY CANCER CARE/ PREVALENCE SURVIVAL OCCURENCE Standardised methods for collecting, checking and validating the data will be proposed for each indicator EUROCHIP CAMON EUROCARE/EUROPREVAL Www.istitutotumori.mi.it/project/eurochip/homepage.htm

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

11. Www.istitutotumori.mi.it/project/eurochip/homepage.htm 130 130 CANCER SPECIALISTS ARE INVOLVED IN EUROCHIP 16 16 INTERNATIONAL MEETINGS HELD ALL ALL COUNTRIES OF THE EUROPEAN UNION ARE PARTICIPATING IN THE PROJECT FIRST AND FUTURE STEPS 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

12. Www.istitutotumori.mi.it/project/eurochip/homepage.htm RESULTS 158 PRELIMINARY LIST OF 158 INDICATORS 39 39 INDICATORS AT HIGH PRIORITY FORM For each indicator we compile a FORM subdivided in three sections: DESIRED INDICATOR  DESIRED INDICATOR: all indicator characteristics we wish to have METHODOLOGY  METHODOLOGY: operational definition, possible sources and methodological issues AVAILABILITY  AVAILABILITY in different countries EUROCHIP MEETINGS LIST OF INDICATORS

13. EUROCHIP FINAL RESULTS (AT THE END OF STEP 3) For each indicator at high priority EUROCHIP will produce: DESCRIPTIVE FORM 1.A DESCRIPTIVE FORM including: Desired indicators characteristics (definition, use, caveat …) Operational definition and indications on sources Indications on availability in all EU member countries METHODOLOGICAL FORM 2.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 1.Tobacco consumption 2.Exposure to asbestos PREVENTION 5.Breast cancer screening coverage 6.Cervical cancer screening coverage 7.Performance indicators of organized screening programmes organized screening programmes SCREENING 8.Interval between first 8.Interval between first symptoms and diagnosis symptoms and diagnosis 9.Interval between diagnosis 9.Interval between diagnosis and first treatment and first treatment 10.Radiation equipment 11.% of centres with at least 2 radiation equipments 2 radiation equipments 12.Doctors by specialization 13.Compliance with guidelines 14.Pain units and hospices 15.Use of morphine TREATMENT AND CLINICAL ASP. 3.Coverage of cancer registration 4.Stage at diagnosis Person-years life lost due to cancer Completeness of the registration EPIDEMIOLOGY AND CANCER REG. 16.Total National Expenditure on Health for cancer on Health for cancer 17.Total Public Expenditure on Health for cancer on Health for cancer MACRO SOCIAL- ECONOMIC VARIABLES

18. Www.istitutotumori.mi.it/project/eurochip/homepage.htm PREVENTION Tobacco consumption 1)Tobacco consumption 2)Consumption of fruit and vegetable * 3)Consumption of alcohol * 4)Body Mass Index * Exposure to asbestos 5)Exposure to asbestos 6)AIDS incidence * 7)Prevalence of hepatitis B/C * EPIDEMIOLOGY AND CANCER REGISTRATION Coverage of cancer registration 8)Coverage of cancer registration 9)Incidence rates * 10)Survival rates * 11)Prevalence proportion * 12)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 * INDICATORS AT HIGH PRIORITY (1) * Connected with other HMP projects

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

20. Www.istitutotumori.mi.it/project/eurochip/homepage.htm 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 * Total National Expenditure on Health for cancer 35)Total National Expenditure on Health for cancer 36)Total Public Expenditure on Health * Total Public Expenditure on Health for cancer 37)Total Public Expenditure on Health for cancer 38)% elderly in 2010-2020-2030 39)Age distribution of population * Connected with other HMP projects

21. PRIORITYLEVELS Dr. Ian Kunkler

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

23. 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 DO YOU WANT SOMETHING ELSE AT HIGH PRIORITY?

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

25. STAGE AT DIAGNOSIS Dr. Carmen Martinez

26. 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 sex and by age STAGE AT DIAGNOSIS Descriptive Form

27. 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 STAGE AT DIAGNOSIS Methodological Form

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 STANDARDIZATION VARIABILITY VALIDITY Cancer Registries The dates have to be in the form DD/MM/YY We need exact definitions of the phases of the disease history Relevant 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 STANDARDIZATION VARIABILITY VALIDITY Cancer registries Studies should be conducted using a common protocol and criteria Relevant To use studies as “High resolution studies”

39. First Methodological Group Results deviance to best practice guidelines comply with guidelines rather best practice collapse the guidelines themselves into a few simple items should refer to patients potentially eligible for treatment 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. “deviation” Defining the non- adherence is easier and more robust 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 STANDARDIZATION VARIABILITY VALIDITY Survey on all health structures The Lin Acs have to be working on 31st Dec of the year before the survey Relevant 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 STANDARDIZATION VARIABILITY VALIDITY Survey on all health structures The Lin Acs have to be working on 31st Dec of the year before the survey No problems

47. Indicator characteristics delete 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 STANDARDIZATION VARIABILITY VALIDITY National Medical Associations We need the classification of various specializations in the 3 classes 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

51. PAIN UNITS AND HOSPICES Diffusion of the pain units and hospices CONTEXT SOURCE STANDARDIZATION VARIABILITY VALIDITY International Association of Palliative Care Definition of “pain units” No problems

52. USE OF MORPHINE Indicator of the attitude to treat pain of the cancer patients CONTEXT SOURCE STANDARDIZATION VARIABILITY VALIDITY WHO No problems Overestimate the use of morphine for cancer DELETED

53. EUROPEAN COMMISSION PUBLIC HEALTH PROGRAMS Dr. Andrea Micheli

54. PUBLIC HEALTH IN EUROPE the European past and next strategy FOCUS ON CANCER past/present in HMP: EUROCHIP and CAMON next: Working Party

55. Priority areas of the public health programme General health policy Health determinants Health threats Health information By Dr. Tapani Piha

56. Health information Bringing programmes together Cancer Injury Health monitoring Pollution Aids Rare diseases -2002 2003- By Dr. Tapani Piha

57. Health information Bringing programmes together Cancer Injury Health monitoring Pollution Aids Rare diseases -2002 2003- By Dr. Tapani Piha

58. Public health programme Implementation focus European added value Large scale (in content and geographical coverage) multi-annual and multidisciplinary Lead to sustainable results and outputs Relevant and contribute to policy development Attention to the evaluation of the process and results By Dr. Tapani Piha

59. Stages in data processing Stage 1 Data definition and quality development Stage 2 Support to data collection at national level Stage 3 Data collection, processing and storage at EU level Stage 4 Analysis, advice, reporting, informing and consulting Stage 5 Mechanisms for exchanging, promoting and disseminating results By Dr. Tapani Piha

60. SUMMARY OF THE FIRST DAY

61. Indicators to be deleted “Interval between first symptoms and first diagnosis” “Use of morphine” Add at high priority indicators “% patients treated by …” For the indicator “Stage at diagnosis” the group suggests to collect TNM data also for cervix, prostate and lung and not only for breast and colo-rectal cancers. The group defines also the metastasis detection tests for the different sites considered For palliative care the indicator should be “Number of specialised palliative care teams” DECISIONS

62. The group recommends that Cancer Registries (for breast, prostate, colon, rectum, lung cancers) have to collect the dates of 1 st diagnosis (or 1 st medical attendance for colon and rectum cancer), 1 st surgery, 1 st radiotherapy, 1 st chemotherapy and 1 st endocrine therapy (for breast and prostate)PROPOSAL These dates are necessary for the indicator “Delay of care” so defined “Difference between 1 st diagnosis (or 1 st medical attendance for colon and rectum cancers) and 1 st treatment (among surgery, chemotherapy, radiotherapy or other therapy) These dates indicate if a patient has had a particular treatment so we can use them for the indicators “% of patients treated by surgery, chemotherapy, radiotherapy and endocrine therapy”

63. MEETINGDECISIONS

64. What are the detection tests we have to do to decide if there is a metastasis? - Cervix: chest x-ray and pelvic imagine - Colon: liver ultrasound or CT and chest x-ray - Rectum: liver ultrasound or CT and chest x-ray - Prostate: bone-scan - Lung: CT thorax - Breast: T1-T2 chest x-ray T3-T4 or N+: bone-scan and liver ultrasound STAGE AT DIAGNOSIS

65. BREAST CANCER From First FNA (First fine-needle aspirate) or histological confirmation To First surgical resection or neo-adjuvant treatment (date of start of adjuvant radiotherapy, date of start of adjuvant chemotherapy, Date of start of adjuvant endocrine therapy) INTERVAL BETWEEN DIAGNOSIS AND 1ST TREATMENT

66. COLON CANCER From First medical referral to a specialist To Surgical resection INTERVAL BETWEEN DIAGNOSIS AND 1ST TREATMENT

67. RECTUM CANCER From First medical referral to a specialist To Date of first adjuvant radiotherapy treatment Date of surgical resection INTERVAL BETWEEN DIAGNOSIS AND 1ST TREATMENT

68. LUNG CANCER From date of first histological/cytological confirmation To surgical resection / date of first curative radiotherapy treatment / date of first chemotherapy treatment INTERVAL BETWEEN DIAGNOSIS AND 1ST TREATMENT

69. PROSTATE CANCER From date of first histological confirmation To date of radical prostatectomy or Date of other surgery date of radical radiotherapy (external beam and/or brachytherapy) date of first endocrine therapy INTERVAL BETWEEN DIAGNOSIS AND 1ST TREATMENT

70. BREAST CANCER 1) Proportion of patients receiving post- operative breast radiotherapy after breast conserving surgery By age 2) Proportion of patients with pathological or clinical tumour site 3cm or less receiving conserving surgery By age COMPLIANCE WITH GUIDELINES

71. COLON CANCER 1) Proportion of patients with Dukes C receiving adjuvant chemotherapy By age COMPLIANCE WITH GUIDELINES

72. RECTUM CANCER 1)Proportion of patients receiving pre- operative radiotherapy By age COMPLIANCE WITH GUIDELINES

73. PROSTATE CANCER 1)Proportion of patients receiving radical prostatectomy By age 2) Proportion of patients receiving radical radiotherapy by external beam or brachytherapy By age COMPLIANCE WITH GUIDELINES

74. LUNG CANCER 1)Proportion of patients with non small cell undergoing radical surgery By age 2) Proportion of patients undergoing staging with thoracic CT scanning By age COMPLIANCE WITH GUIDELINES

75. CERVIX CANCER 1)Proportion of patients with FIGO-stage III/IV in cervix cancer receiving chemoradiotherapy By age 2) Proportion of patients undergoing WERTHEIM-MEIGS hystorectomy by FIGO-stage (including insitu) By age COMPLIANCE WITH GUIDELINES