EUROCHIP ROMANIA EUROCHIP ROMANIA REPORTREPORT

ononCervical Cancer Cervical Cancer

Screening Resources Screening Resources Evaluation in NW Evaluation in NW

RegionRegion

ISPRA, Italy, February 2012

Florian Nicula, Luciana Neamtiu, Bianca NiculaCervical Cancer Screening Management Unit“ Ion Chiricuta “ Institute of OncologyCluj-Napoca, Romania

PurpousePurpouse

► The purpouse of Romanian work within The purpouse of Romanian work within Eurochip Project was to evaluate cervical Eurochip Project was to evaluate cervical cancer screening resources in NW European cancer screening resources in NW European Development Region of Romania.Development Region of Romania.

► This study and report has been done with This study and report has been done with the approval of Romanian Ministry Cancer the approval of Romanian Ministry Cancer Comission and Working Group on Cervical Comission and Working Group on Cervical Cancer Screening leaded by Mr. Ladislau Cancer Screening leaded by Mr. Ladislau Ritli the Health Minister himself , on Ritli the Health Minister himself , on 11.11.11 at 11 o’clock.11.11.11 at 11 o’clock.

Methods and data sourcesMethods and data sources

► questionnaire ( under surveillance of Mr. Ahti Antilla ) for evaluation of laboratory resources, questionnaire ( under surveillance of Mr. Ahti Antilla ) for evaluation of laboratory resources, using European quidelines of quality assurance in organized cervical cancer screening using European quidelines of quality assurance in organized cervical cancer screening programmes - sended to all labs in NW region and all citopathologists -lists received from programmes - sended to all labs in NW region and all citopathologists -lists received from Counties Authorities in Public Health and Health Inssurance and Romanian Society of Counties Authorities in Public Health and Health Inssurance and Romanian Society of Citopathology.Citopathology.

► questionnaires to all Counties Authorities in Public Health and Health Inssurance in NW questionnaires to all Counties Authorities in Public Health and Health Inssurance in NW region regarding -total number of gynecologists and family doctors and the number of them region regarding -total number of gynecologists and family doctors and the number of them willing to take part to a cervical cancer screening programme.willing to take part to a cervical cancer screening programme.

► December 9th Regional Meeting - opportunity -Ministry of Health new strategy to implement December 9th Regional Meeting - opportunity -Ministry of Health new strategy to implement a National Cervical Cancer Screening Programme in 2012 - 8 Regional Management Units in a National Cervical Cancer Screening Programme in 2012 - 8 Regional Management Units in order to roll out NW Regional Pilot to national level- we were nominated as Management Unit order to roll out NW Regional Pilot to national level- we were nominated as Management Unit for NW Region and members of National Cervical Cancer Screening Coordination Committee for NW Region and members of National Cervical Cancer Screening Coordination Committee at the level of Ministry of Health.at the level of Ministry of Health.

► delegates from all six districts in NW Region, Cluj, Bihor, Bistrita-Nasaud, Maramures, Salaj, delegates from all six districts in NW Region, Cluj, Bihor, Bistrita-Nasaud, Maramures, Salaj, Satu-Mare were present, representing all Districtual Health Authorities and Districtual Satu-Mare were present, representing all Districtual Health Authorities and Districtual Health Inssurance Houses and 23 pathology labs - working groups on questionaires Health Inssurance Houses and 23 pathology labs - working groups on questionaires responses regarding regional overall screening resources.responses regarding regional overall screening resources.

► data from NW pilot regional programme coordinated by us between 2002-2008.data from NW pilot regional programme coordinated by us between 2002-2008.► NW Region Cancer Registry – 2012 First Report on Cancer Incidence and Mortality in NW NW Region Cancer Registry – 2012 First Report on Cancer Incidence and Mortality in NW

Region - data on burden of the disease and signs of former pilot impact on number of in situ Region - data on burden of the disease and signs of former pilot impact on number of in situ and preinvasive lesions found.and preinvasive lesions found.

► data from our Dysplasia Registry –citopathology cantitative and qualitative resources, taking data from our Dysplasia Registry –citopathology cantitative and qualitative resources, taking smears resources - sustaining conclusions after questionnaire evaluation.smears resources - sustaining conclusions after questionnaire evaluation.

► data from POSDRU Project on sreening human resources-partners data from POSDRU Project on sreening human resources-partners ► 2007 IARC Report on implementation of EC recommendations on cancer screening. 2007 IARC Report on implementation of EC recommendations on cancer screening.

Romanian European Development Romanian European Development Regions Regions

Counties of NW RegionCounties of NW Region

North-Western RegionNorth-Western Region surfacesurface 34159 km234159 km2, ,

14.32% of the total surface of our country14.32% of the total surface of our country includes includes 6 counties: Bihor, Bistriţa-Năsăud, Cluj, Maramureş, Satu-Mare, 6 counties: Bihor, Bistriţa-Năsăud, Cluj, Maramureş, Satu-Mare,

Sălaj.Sălaj. The capital is Cluj-Napoca. The capital is Cluj-Napoca.

INDICATOR

REGISTRY

BihorBistriţa

NăsăudCluj-Napoca Maramureş Satu Mare Sălaj

Regiunea NV NW

RegionRomânia

Area (km2) 7544 5355 6674 6304 4418 3864 34159 238391

Inhabitans 592564 318508 676476 514409 367199 244962 2714118 21504442

Females (%) 51.36 50.43 51.64 50.84 51.45 50.09 51.21 51.3

Population density (inhabitans/km2)

78.55 59.48 101.36 81.60 83.11 63.40 79.46 90.21

Life expectancy at birth B 68.74 B 70.32 B 70.66 B 68.78 B 65.83

B 68.34

B 68.95

B 69

F 75.01 F 76.41 F 77.46 F 76.17 F 74.09 F 75.67 F 75.9 F 77

Birth rates/1000 11 11.3 9.7 10.7 11.3 11.1 10.7 10.32

Mortality rates/1000 12.7 10.3 11.4 10.3 12.2 12.7 11.6 11.8

Cities 10 4 6 13 6 4 43 320

Villages 91 58 75 63 58 57 402 12951

Unemployment rate (2007) 2.4 2.4 3 3.4 2.6 4.4 2.9 6.4

Counties population distribution in NW RegionCounties population distribution in NW Region

NW Region population – age distributionNW Region population – age distribution

NW COUNTIES POPULATION AT RISK –WOMEN 25-64 YEARS NW COUNTIES POPULATION AT RISK –WOMEN 25-64 YEARS OLDOLD

TOTAL TARGET POPULATION 754.000TOTAL TARGET POPULATION 754.000

2008 new cancer cases registered in NW 2008 new cancer cases registered in NW RegionRegion

► In 2008, 3209 new cancer cases were registered, of which 1632 were men and 1577 In 2008, 3209 new cancer cases were registered, of which 1632 were men and 1577 women. women. In women, breast cancer is the most frequent (303), followed by In women, breast cancer is the most frequent (303), followed by cervical cancer (216)cervical cancer (216)..Cervical cancer is on the first place for female patients of 15 – 49 years old.Cervical cancer is on the first place for female patients of 15 – 49 years old.

MALES

8,95%

51,04%

39,11%

0,39%0,52%

0-14years 15-24years 25-49years 50-69years 70+years

FEMALES

18,81%

48,07%

31,91%

0,61%0,61%

0-14years 15-24years 25-49years 50-69years 70+years

MALES

8,95%

51,04%

39,11%

0,39%0,52%

0-14years 15-24years 25-49years 50-69years 70+years

FEMALES

18,81%

48,07%

31,91%

0,61%0,61%

0-14years 15-24years 25-49years 50-69years 70+years

AGE –SPECIFIC RATES OF INCIDENCE AND AGE –SPECIFIC RATES OF INCIDENCE AND MORTALITY, BY CERVICAL CANCER, MORTALITY, BY CERVICAL CANCER,

ROMANIA 2003ROMANIA 2003

Source: National Cancer Registry. Sanitary Statistics and Medical Research Center, from Ministry of Public Health, Bucharest

25-64 years

New cases: 77.88% (2545/3268)

Deaths:63.7% (12001884)

1.09

74.42

43.435.45

0.12

0

10

20

30

40

50

60

70

80

15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 >85

Incidence Mortality

Trends of age-standardized incidence and mortality (world Trends of age-standardized incidence and mortality (world standard population),by cervical cancer, Cluj County, 2000-2008 standard population),by cervical cancer, Cluj County, 2000-2008

and Romania 2008and Romania 2008

Source: North-Western Cancer Registry, Romania; WHO-IARC data for Romania 2008

23.926.21

45.31

9.5 7.311.8

0

10

20

30

40

50

60

2000-2001 2002-2003 2004-2005 2006-2007 2008 Romania2008

Incidence Mortality

Cervical cancer prevention birth Cervical cancer prevention birth certificatecertificate

► ““Romania is the birth place of cervical screening.Romania is the birth place of cervical screening.► It was in 1927 that Victor Babes presented the first It was in 1927 that Victor Babes presented the first

evidence that cervical cancer could be diagnosed evidence that cervical cancer could be diagnosed by cervical smears to the Gynaecology Society in by cervical smears to the Gynaecology Society in Bucharest.Bucharest.

► A year later, he published his findings in the A year later, he published his findings in the prestigious medical journal prestigious medical journal Presse MédicalePresse Médicale..

► Another 15 years were to pass before these findings Another 15 years were to pass before these findings were sufficiently understood to use as the basis for were sufficiently understood to use as the basis for a practical screening tool. The man responsible for a practical screening tool. The man responsible for this work was this work was George George Papanikolaou, who gave his Papanikolaou, who gave his name to the Pap test”.name to the Pap test”.

Cancer World MagazineCancer World Magazine

25 24.96

23.47

21.67

19.5

10.12

11.85

6.675.94

15.4115.4718.45

19.53

21.39

22.9722.13

19.25

6.24

10.76

15.43

21.16

22.94

24.3824.19

0

5

10

15

20

25

30

25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-65

Urban Rural Global coverage

COVERAGE COVERAGE OF THE TARGET POPULATIONOF THE TARGET POPULATION BY BY SMEAR SMEAR TESTSTESTS (%) (%), , 1J1JUNUNE E 2002-2002-31 DEC.31 DEC. 2006, CLUJ COUNTY 2006, CLUJ COUNTY

GLOBAL COVERAGE = 18.42%

Source: Regional Cytology Register

ReviewersReviewers ► Rosemary Ancelle-Park Rosemary Ancelle-Park

Direction Générale de la Santé, Paris, France Direction Générale de la Santé, Paris, France ► Nieves Ascunce Nieves Ascunce

Instituto de Salud Publica, Pamplona, Spain Instituto de Salud Publica, Pamplona, Spain ► Marjolein van Ballegooijen Marjolein van Ballegooijen

Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands ► Mireille Broeders Radboud Mireille Broeders Radboud

University Hospital, Nijmegen, The Netherlands University Hospital, Nijmegen, The Netherlands ► René Lambert René Lambert

Screening Group, International Agency for Research on Cancer, Lyon, France Screening Group, International Agency for Research on Cancer, Lyon, France ► Szilvia Madai Szilvia Madai

Public Association for Healthy People, Budapest, Hungary Public Association for Healthy People, Budapest, Hungary ► Richard Muwonge Richard Muwonge

Screening Group, International Agency for Research on Cancer, Lyon, France Screening Group, International Agency for Research on Cancer, Lyon, France ► Florian Nicula Florian Nicula

Institutul Oncologic "I. Chiricuta", Cluj-Napoca, Romania Institutul Oncologic "I. Chiricuta", Cluj-Napoca, Romania ► Lennarth Nyström Lennarth Nyström

Department of Epidemiology, Umea University, Umea, Sweden Department of Epidemiology, Umea University, Umea, Sweden ► Julietta Patnick Julietta Patnick

NHS Cancer Screening Programmes, University of Oxford, Oxford, United Kingdom NHS Cancer Screening Programmes, University of Oxford, Oxford, United Kingdom ► Sven Törnberg Sven Törnberg

Department of Cancer Screening, Oncologic Center, Karolinska Hospital, Stockholm, Sweden Department of Cancer Screening, Oncologic Center, Karolinska Hospital, Stockholm, Sweden ► Hugo de Vuyst Hugo de Vuyst

Infections and Cancer Epidemiology Group, International Agency for Research on Cancer, Lyon, Infections and Cancer Epidemiology Group, International Agency for Research on Cancer, Lyon, France France

► Chris de Wolf Chris de Wolf Agence pour le développement et évaluation des politiques de santé (ADSAN), Geneva, Agence pour le développement et évaluation des politiques de santé (ADSAN), Geneva,

Switzerland Switzerland ► Maja Zakelj Maja Zakelj

Epidemiology and Cancer Registry Unit, Institute of Oncology, Ljubljana, Slovenia Epidemiology and Cancer Registry Unit, Institute of Oncology, Ljubljana, Slovenia ► Marco ZappaMarco Zappa

Center for Study and Prevention of Cancer (CSPO), Florence, Italy Center for Study and Prevention of Cancer (CSPO), Florence, Italy

EUROCHIP ROMANIA QUESTIONAIREEUROCHIP ROMANIA QUESTIONAIREQuestionnaire for

Evaluation of Cytological Laboratories

Within Romania EUROCHIP Project

Please, mark the correct answer

Questions about personnel and organisation

1. General

1. How many cervical citology Pap tests per year are processed in your laboratory ?:

2. and 3. Cytotehnologists and other technical laboratory personnel

In Romania citotehnologists does not exist for the moment, enabled to perform primary

screening. Technicians with at least 3 years training in laboratory are allowed only to handle

relevant laboratory techniques according to guidelines and procedure descriptions and to take part

in quality control programs, but with no samples examination and any kind of consecutive

reports. So, no questions on this issue should be asked in questionaire. Any way, I think an

evaluation of number of technical personnel may be interesting for a future prescreening attitude

and strategy.

2. How many citotechnologists work in your laboratory ?:

And maybe

3. Do you think that your citopathologists shoud perform prescreening in cervical cancer

screening programs and if yes how many will be willing to participate in specific

training programs ?:

4. Cytopathologists

In Romania examination of Pap smears and either normal and patological reports are made

legally only by three categories of trained personnel: doctors trained in pathology or laboratory

and biologists with highschool of at least 4 years, all with postgraduate training in citology and at

least one year of experience with at least 2000 supervised reports in the last year.

Regarding Quidelines requirement for cytopathologysts questions regardind comunication with

gynecologists, intra-laboratory discussions of hystological and cytological discrepancies and

wiilingness of participations to future quality assurance programs should be asked:

4. How many cytopathologists are working in your laboratory ?:

5. What is their training profile and how many of each category ?:

Citopathologists questionedCitopathologists questioned

► Cluj-County :Cluj-County :16 citopathologists 16 citopathologists ► Bihor County :Bihor County : 5 citopathologists5 citopathologists► Bistrita-Nasaud County :Bistrita-Nasaud County : 5 citopathologists5 citopathologists► Maramures County :Maramures County : 3 citopathologists3 citopathologists► Salaj County :Salaj County : 2 citopathologists2 citopathologists► Satu-Mare :Satu-Mare : 3 citopathologists 3 citopathologists

Number of cytopathologistsNumber of cytopathologists 35 people with 91 contracts35 people with 91 contracts in 23 labs in 23 labs

68%

19%

13%

Pathologists

Laboratory phisicians

Biologist

Cluj Cluj County labs and number of County labs and number of contracts:contracts:

► “ “ Prof . Dr. Ion Chiricuta” Institute of Oncology – 5 Prof . Dr. Ion Chiricuta” Institute of Oncology – 5 citopathologistscitopathologists

► Cluj County Hospital with 3 laboratories – 3 Cluj County Hospital with 3 laboratories – 3 citopathologists citopathologists

► Cluj Infectios Deseases with 1 laboratory – 2 Cluj Infectios Deseases with 1 laboratory – 2 citopathologistscitopathologists

► Cluj Adult Clinical Hospital – 2 citopathologistsCluj Adult Clinical Hospital – 2 citopathologists► Romanian Railway Hospital – 2 citopathologistsRomanian Railway Hospital – 2 citopathologists► Cluj Military Hospital – 1 citopathologistCluj Military Hospital – 1 citopathologist► Dej Municipal Hospital – 1 citopathologistDej Municipal Hospital – 1 citopathologist► Private laboratories - Radusan – 9 citopathologists, Private laboratories - Radusan – 9 citopathologists,

Medstar – 3 citopathologists, Santomar – 2 Medstar – 3 citopathologists, Santomar – 2 citopathologistscitopathologists

Labs questionedLabs questioned

Bihor County :Bihor County :► Bihor County Hospital with 2 laboratories – 5 Bihor County Hospital with 2 laboratories – 5

citopathologistscitopathologists► 7 private laboratories7 private laboratoriesBistrita-Nasaud County :Bistrita-Nasaud County :► Bistrita County Hospital – 2 citopathologistsBistrita County Hospital – 2 citopathologists► Nasaud hospital – 2 citopathologistsNasaud hospital – 2 citopathologists► Private laboratories – Sanovil – 3 Private laboratories – Sanovil – 3

citopathologists, Optimus - 1 citopathologist,citopathologists, Optimus - 1 citopathologist,

Labs questionedLabs questioned

Maramures County :Maramures County :► Baia Mare County Hospital – 3 citopathologistsBaia Mare County Hospital – 3 citopathologists► 2 private laboratories – 3 citopathologists2 private laboratories – 3 citopathologists

Salaj County :Salaj County :► Zalau County hospital – 2 citopathologistsZalau County hospital – 2 citopathologists► 5 private laboratories – 15 citopathologists5 private laboratories – 15 citopathologists

Satu-Mare :Satu-Mare :► Satu- Mare County hospital - 2 citopathologistsSatu- Mare County hospital - 2 citopathologists

Type of staining equipmentType of staining equipment

69%

31%

manual

automat

Analysis Analysis regarding the analytical quality management regarding the analytical quality management

measures measures % of laboratories

rescreening of slides23%

rapid rewiew23%random rescreening

23%

targeted screening31%

automated rescreening

0% rescreening of slides

rapid rewiew

random rescreening

targeted screening

automated rescreening

Internal quality control Internal quality control based on correlation with clinical/ histological based on correlation with clinical/ histological

outcomeoutcome

% of laboratories

cyto-clinical correlation

58%

cyto-virological correlation

26%

audit of interval cancers

16%

cyto-clinical correlation

cyto-virological correlation

audit of interval cancers

Smears distribution on labs and Smears distribution on labs and citopathologistscitopathologists

► 6 labs finally did almost all smears 6 labs finally did almost all smears examination, and 6 citopathologists have examination, and 6 citopathologists have done more than 60% of the job.done more than 60% of the job.

► The fact that inittially we had to distribute The fact that inittially we had to distribute smears equally to all authorized labs smears equally to all authorized labs according to romanian rules, and different according to romanian rules, and different citopathologists were working in more than citopathologists were working in more than one lab allowed initially some problems in one lab allowed initially some problems in cantitative and qualitative diagnosis of smears cantitative and qualitative diagnosis of smears with respect to European Quality Assurance with respect to European Quality Assurance Guinelines . Guinelines .

Total number of smears examined by several Total number of smears examined by several

cytopathologists - cytopathologists - smears were distributed equal to each labsmears were distributed equal to each lab

40%

6%4%4%2%

1%

43%

Pais

Apostol

Bungardean

Galatir

Duma

Bologa Mircea

Alti

CITOLOG ASCUS LSIL HSIL Invaziv AGUS Total

Apostol Silvana 1.33 0.63 0.61 0.01 0.05 7655

Botezan Andreea 0 0 0 0 0 11

Buiga Rares 1.74 0.43 0.43 0 0.22 461

Bungardean Catalina 1.66 1.27 0.7 0.23 0.16 4402

Coroiu Georgiana 2.17 3.8 0.54 0 0.54 184

Simon Laura 1.59 1.59 1.59 0 1.59 126

Duca Atanasie 1.13 0 0 0 0 707

Duma Milena 6.89 6.44 3.3 0.95 1.75 2002

Encica Svetlana 0 0 0 0 1.52 66

Floristeanu Delia 1.79 0 0.26 0 0 391

Galatar Mihaela 1.77 3.01 1.07 0.18 1.39 8909

Ilie Bologa Mircea 0.11 0.11 0.22 0.11 0 894

Irene Paris 1.7 0 0 0 0.85 235

Pais Rodica 1.8 1.82 0.94 0.11 0.57 50303

Pascal Alexandrina 5.97 0.62 0.21 0 0.62 486

Spanu Ileana 0.34 1.01 1.34 0 0 298

Todea Daniela 1.94 0.39 0 0 0.39 258

Citopathologists differences in smears Citopathologists differences in smears evaluation – source Pilot Screening Registryevaluation – source Pilot Screening Registry

0 1 2 3 4 5 6 7 8

Apostol Silvana

Botezan Andreea

Buiga Rares

Bungardean Catalina

Coroiu Georgiana

Simon Laura

Duca Atanasie

Duma Milena

Encica Svetlana

Floristeanu Delia

Galatar Mihaela

Ilie Bologa Mircea

Irene Paris

Pais Rodica

Pascal Alexandrina

Spanu Ileana

Todea Daniela

%

AGUS

Invaziv

HSIL

LSIL

ASCUS

Labs quality controlLabs quality control► differences between citopathologists both in finding invasive differences between citopathologists both in finding invasive

lesions as in lesions precursory to cancer.lesions as in lesions precursory to cancer.► we had to be prudent in considering labs declarations regarding we had to be prudent in considering labs declarations regarding

quality control, because despite good work attended in quality control, because despite good work attended in coloration, fixation, archivation and proper classification used, coloration, fixation, archivation and proper classification used, internal and external quality control in smears examination and internal and external quality control in smears examination and results must still remain the most important issue: we failed at results must still remain the most important issue: we failed at the beginning in our pilot in ensuring quality control in the beginning in our pilot in ensuring quality control in citopathology as Romanian rules allow citopathologists to work citopathology as Romanian rules allow citopathologists to work in any lab with almost no internal and external surveillance in any lab with almost no internal and external surveillance compulsory by law, so we had in the beginning to enroll all labs, compulsory by law, so we had in the beginning to enroll all labs, and only after proving problems in diagnosis of smears we coud and only after proving problems in diagnosis of smears we coud renounce to some of labs and citopathologists, remaining finally renounce to some of labs and citopathologists, remaining finally with only 6 labs. with only 6 labs.

► It took some time in adopting European guidelines of quality It took some time in adopting European guidelines of quality assurance for citopathology ( when we started in 2002, almost assurance for citopathology ( when we started in 2002, almost no lab was using even recommended staining and classification no lab was using even recommended staining and classification procedure ) and we needed to check labs performances in the in procedure ) and we needed to check labs performances in the in the field of duty.the field of duty.

Reasons to extend Eurochip Reasons to extend Eurochip workwork

► Ministry of Health is planning a national cervical cancer screening Ministry of Health is planning a national cervical cancer screening programme starting from early 2012, based on a regional strategy.programme starting from early 2012, based on a regional strategy.

► Ministry of Health also lead a POSDRU Project on screening human Ministry of Health also lead a POSDRU Project on screening human resources started since 2010 that will end in 2012 by training 6000 resources started since 2010 that will end in 2012 by training 6000 family doctors and 1.200 specialists, including citopathologists and family doctors and 1.200 specialists, including citopathologists and gynecologists- we are partners in this project too; an evaluation of gynecologists- we are partners in this project too; an evaluation of national screening resources in the framework of this project national screening resources in the framework of this project confirmed some data from our present report at regional level, but confirmed some data from our present report at regional level, but no questions on labs quality control and number of citopathologists no questions on labs quality control and number of citopathologists were asked. were asked.

► This national situation and our positionas Regional Screening This national situation and our positionas Regional Screening Management Unit gaved us one more reason to complete evaluation Management Unit gaved us one more reason to complete evaluation within Eurochip Project, to do it inside our work in the national within Eurochip Project, to do it inside our work in the national system as an example for other regional units and as an important system as an example for other regional units and as an important tool for us in designing our future screening implementation network.tool for us in designing our future screening implementation network.

► We also considered that this opportunity is also a reason te extend We also considered that this opportunity is also a reason te extend evaluation on regional resources on taking smears and screening evaluation on regional resources on taking smears and screening management resources. management resources.

Smear taking resourcesSmear taking resources

Cluj-County :Cluj-County :► family doctors – 348, 232 urban, 116 ruralfamily doctors – 348, 232 urban, 116 rural► gynecologists - 68 gynecologists - 68 Bihor County :Bihor County :► family doctors - 333family doctors - 333► gynecologists - 41gynecologists - 41Bistrita-Nasaud County :Bistrita-Nasaud County :► family doctors - 143family doctors - 143► gynecologists - 12 gynecologists - 12 Maramures County :Maramures County :► family doctors - 382family doctors - 382► gynecologists - 24gynecologists - 24Salaj County :Salaj County :► family doctors - 82family doctors - 82► gynecologists - 12 gynecologists - 12 Satu-Mare :Satu-Mare :► family doctors - 178family doctors - 178► gynecologists – 11gynecologists – 11

Smear taking difficulties in ruralSmear taking difficulties in rural

► rural area represent the main problem from the rural area represent the main problem from the point of wiew of taking smears. point of wiew of taking smears.

► gynecologists does not exist in Romania in rural gynecologists does not exist in Romania in rural areas. areas.

► family doctors are resistant to such activities in our family doctors are resistant to such activities in our experience, even intensively stimulated: initially we experience, even intensively stimulated: initially we gaved to a lot of them gynecologic tables, lamps, gaved to a lot of them gynecologic tables, lamps, sterilization resources, we payed them for taking sterilization resources, we payed them for taking smears, we trained them twice in our institute and in smears, we trained them twice in our institute and in a programme with american assistance, and still a programme with american assistance, and still they covered only 14% from smears taken in the they covered only 14% from smears taken in the pilot, mainly in cities: in rural almost no family pilot, mainly in cities: in rural almost no family doctor took smears despite all our efforts.doctor took smears despite all our efforts.

► the most and only effective resource of taking the most and only effective resource of taking smears in rural areas was the mobile unit. smears in rural areas was the mobile unit.

Management unit – Management unit –

Dept of Prevention and Cancer Control – Dept of Prevention and Cancer Control – Cancer InstituteCancer Institute

► Working group : panel of experts in Working group : panel of experts in

epidemiology and public health, GP-ies, epidemiology and public health, GP-ies, gynecological oncology and colposcopy, gynecological oncology and colposcopy, citology-pathology, psihology, data citology-pathology, psihology, data manager plus ONG-ies: members in manager plus ONG-ies: members in EUNICE-ECN Cervical Cancer Working EUNICE-ECN Cervical Cancer Working Group since 2006, members in ECCA since Group since 2006, members in ECCA since 2007 2007

► Population Based Cancer Registry Population Based Cancer Registry connected to IACR since 1974, to ENCR connected to IACR since 1974, to ENCR since 2003 : target population and since 2003 : target population and screening database ( dysplasia, screening database ( dysplasia, colposcopy, treatment and follow-up colposcopy, treatment and follow-up registry )registry )

► Quality Control Resources of Management Quality Control Resources of Management Unit and Unit and Implementation Units NetworkImplementation Units Network (111 GP-ies , 60 gynecologists, 6 cytology (111 GP-ies , 60 gynecologists, 6 cytology labs, mobile unit, 3 centers of colposcopy, labs, mobile unit, 3 centers of colposcopy, treatment and follow up)treatment and follow up)

ORGANIZATION OF SCREENING ORGANIZATION OF SCREENING NETWORKNETWORK

FEMALE TARGET POPULATION FOR FEMALE TARGET POPULATION FOR CERVICAL CANCER SCREENING CERVICAL CANCER SCREENING CLUJ CLUJ

COUNTYCOUNTY- - 191955000 000 women women 25-625-644 years old inyears old in 2004 2004

6 cities:Cluj NapocaTurdaCâmpia TurziiDejGherlaHuedin420 villages

URBAN: 70.5% RURAL: 29.5%

55%

45%

Women 25-65 years old Women other ages

TESTS PERFORMED BY TESTS PERFORMED BY THE MOBILE THE MOBILE UNITUNIT2003-2002003-20077

Source: Regional Cytology Register

8209

5972

2127 1516758

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

CLUJ BISTRITANASAUD

SATU MARE SALAJ MARAMURES

Use of sanitary mediators – mandatory in special communitiesUse of sanitary mediators – mandatory in special communities

► population information, both of women at risk and husbands, population information, both of women at risk and husbands, difficult and very important in relogious and ethnical groups.difficult and very important in relogious and ethnical groups.

► sanitary mediators in isolated areas were used with huge sanitary mediators in isolated areas were used with huge success, in roma communities or in the willages in the success, in roma communities or in the willages in the mountains, in Maramures ethnical communities, in hungarian mountains, in Maramures ethnical communities, in hungarian population of some willages.population of some willages.

► the response was very good, especially in Maramures were we the response was very good, especially in Maramures were we had two willages with over 90% population at risk covered, in had two willages with over 90% population at risk covered, in Hungarian willages with more than 80% women at risk tested Hungarian willages with more than 80% women at risk tested ( here mobile unit finally competed with family doctors )( here mobile unit finally competed with family doctors )

► roma non traditional communities - hundreds of women were roma non traditional communities - hundreds of women were tested with the help of roma sanitary mediators - few tested with the help of roma sanitary mediators - few dysplasia were found and treated and only one invasive case. dysplasia were found and treated and only one invasive case.

Disparities and approachesDisparities and approaches

► in Romania acces to population and acces of population to in Romania acces to population and acces of population to screening resources are marked by important disparities: screening resources are marked by important disparities: disparities due to rural and urban, disparities in religion and disparities due to rural and urban, disparities in religion and ethnical cultural disparities in habitual and sexual behaviour; ethnical cultural disparities in habitual and sexual behaviour; socio-economical disparities are day by day more socio-economical disparities are day by day more semnificative.semnificative.

► this situation need two main approaches: first of all, screening this situation need two main approaches: first of all, screening must be free and offered to all women population at risk, at must be free and offered to all women population at risk, at same quality with no discrimination; second, efforts must be same quality with no discrimination; second, efforts must be made to get to the most hard to reach woman in the most made to get to the most hard to reach woman in the most isolated and resistant area, to convince her, her husband, her isolated and resistant area, to convince her, her husband, her family, friends and neighbours and finally her community that family, friends and neighbours and finally her community that this action is mandatory to her health and to everyone this action is mandatory to her health and to everyone welfare.welfare.

► this is not an easy task in Romania.this is not an easy task in Romania.► invitations as in other countries may be sometimes usefull, invitations as in other countries may be sometimes usefull,

but are in vain in a lot of particular situations described but are in vain in a lot of particular situations described above.above.

Some final remarks on Some final remarks on screening implementation screening implementation

evaluation of resourcesevaluation of resources

► We started this evaluation effort wondering if We started this evaluation effort wondering if citopathology is capable to support a citopathology is capable to support a populationbased programme. We found that populationbased programme. We found that citopatology is enough in number of labs and citopatology is enough in number of labs and people, but not enough cheked in quality.people, but not enough cheked in quality.

► We also found that populationbased means We also found that populationbased means finding and reaching population. Population finding and reaching population. Population profile is important to know.profile is important to know.

► Covering women with tests in all conditions Covering women with tests in all conditions and quality of tests we think will be the most and quality of tests we think will be the most important two challenges of our future important two challenges of our future organized cervical cancer screening organized cervical cancer screening programme programme

MANAGEMENT RESOURCESMANAGEMENT RESOURCES

► National Public Health Institute Report on National Health System Evaluation In the National Public Health Institute Report on National Health System Evaluation In the Perspective of Screening Implementation, management resources - our unit has the Perspective of Screening Implementation, management resources - our unit has the only regional human “ tactical “resources.only regional human “ tactical “resources.

► This is true if we consider experience in organizing screening programmes.This is true if we consider experience in organizing screening programmes.► in 2002, when we started the Pilot, none of us had any experiencey.in 2002, when we started the Pilot, none of us had any experiencey.► Epidemiologists exist, even if not specialy trained in particular screening aspects. All Epidemiologists exist, even if not specialy trained in particular screening aspects. All

other actors exist everywhere. More that that, special training for each category will be other actors exist everywhere. More that that, special training for each category will be provided next months in POSDRU Project.provided next months in POSDRU Project.

► It is only a matter of time and proper oranising that management units will be in place It is only a matter of time and proper oranising that management units will be in place in each region.in each region.

► We provided Through Cancer Comission guidelines in organizing Management Units, We provided Through Cancer Comission guidelines in organizing Management Units, adopted by Ministry of Health as Methodological Normatives this year.adopted by Ministry of Health as Methodological Normatives this year.

► A National Working Group on Cervical Cancer Screening National Programme will be A National Working Group on Cervical Cancer Screening National Programme will be leaded by Health Ministry himself ( he is medical oncologist anyway ). Leaders of leaded by Health Ministry himself ( he is medical oncologist anyway ). Leaders of Regional Management Units and representatives of all professional groups involved will Regional Management Units and representatives of all professional groups involved will be members.be members.

► Regional Management Units will be assisted by a commission of specialists in Regional Management Units will be assisted by a commission of specialists in epidemiology and public health, gynecology, citopathology, family doctor, data epidemiology and public health, gynecology, citopathology, family doctor, data manager, leaded by any of those specialists involved.manager, leaded by any of those specialists involved.

► We delivered data from our Pilot regarding management. We delivered data from our Pilot regarding management. ► A mandatory resource of programme quality control is Regional Cancer Registry. A mandatory resource of programme quality control is Regional Cancer Registry.

Screening Management Units must be at least in contact with Cancer Registry Units, if Screening Management Units must be at least in contact with Cancer Registry Units, if not parts in same comprehensive cancer and control units like in our situation. not parts in same comprehensive cancer and control units like in our situation.

CONCLUSIONSCONCLUSIONSNW Regional resources in NW Regional resources in

placeplaceResources of management Resources of management ► Management Screening Unit and Cancer Registry in place since 2002.Management Screening Unit and Cancer Registry in place since 2002.Resources of implementationResources of implementation► Enough citopathologists, but many not enough trained, quality control Enough citopathologists, but many not enough trained, quality control

of labs must be improved and legislation must be changed in domain.of labs must be improved and legislation must be changed in domain.► Family doctors must be trained and convinced to participate at taking Family doctors must be trained and convinced to participate at taking

smears, especially in rural.smears, especially in rural.► Mobile units must be authorized and sanitary mediators trained to Mobile units must be authorized and sanitary mediators trained to

reach and convince women in isolated areas in mountains, roma , reach and convince women in isolated areas in mountains, roma , ucrainean, hungarian and other minorities living in willages. ucrainean, hungarian and other minorities living in willages.

► Gynecologists must be trained in follow-up and treatment of lesions, Gynecologists must be trained in follow-up and treatment of lesions, feed back to Fail Safe System Screening Registry as ultimate quality feed back to Fail Safe System Screening Registry as ultimate quality resource.resource.

► Finally, epidemiologists at Cancer Registry at the bottom of the cake Finally, epidemiologists at Cancer Registry at the bottom of the cake with hope of decreasing mortality and incidence. with hope of decreasing mortality and incidence.