EUROCHIP ROMANIA REPORT on Cervical Cancer Screening Resources Evaluation in NW Region

1. EUROCHIP ROMANIA REPORTonCervical Cancer Screening Resources Evaluation in NW Region ISPRA, Italy, February 2012 Florian Nicula, Luciana Neamtiu, Bianca Nicula Cervical Cancer Screening Management Unit “ Ion Chiricuta “ Institute of Oncology Cluj-Napoca, Romania

2. Purpouse • The purpouse of Romanian work within Eurochip Project was to evaluate cervical cancer screening resources in NW European Development Region of Romania. • This study and report has been done with the approval of Romanian Ministry Cancer Comission and Working Group on Cervical Cancer Screening leaded by Mr. Ladislau Ritli the Health Minister himself , on 11.11.11 at 11 o’clock.

3. Methods and data sources • questionnaire ( under surveillance of Mr. Ahti Antilla ) for evaluation of laboratory resources, 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 Counties Authorities in Public Health and Health Inssurance and Romanian Society of Citopathology. • 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 willing to take part to a cervical cancer screening programme. • 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 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 at the level of Ministry of Health. • 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 Health Inssurance Houses and 23 pathology labs - working groups on questionaires responses regarding regional overall screening resources. • 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 Region - data on burden of the disease and signs of former pilot impact on number of in situ and preinvasive lesions found. • data from our Dysplasia Registry –citopathology cantitative and qualitative resources, taking smears resources - sustaining conclusions after questionnaire evaluation. • data from POSDRU Project on sreening human resources-partners • 2007 IARC Report on implementation of EC recommendations on cancer screening.

4. Romanian European Development Regions

5. Counties of NW RegionNorth-Western Regionsurface34159 km2, 14.32% of the total surface of our country includes 6 counties: Bihor, Bistriţa-Năsăud, Cluj, Maramureş, Satu-Mare, Sălaj. The capital is Cluj-Napoca.

7. Counties population distribution in NW Region

8. NW Region population – age distribution

9. NW COUNTIES POPULATION AT RISK –WOMEN 25-64 YEARS OLDTOTAL TARGET POPULATION 754.000

10. 2008 new cancer cases registered in NW Region • In 2008, 3209 new cancer cases were registered, of which 1632 were men and 1577 women. In women, breast cancer is the most frequent (303), followed by cervical cancer (216).Cervical cancer is on the first place for female patients of 15 – 49 years old.

11. AGE –SPECIFIC RATES OF INCIDENCE AND MORTALITY, BY CERVICAL CANCER, ROMANIA 2003 25-64 years New cases: 77.88% (2545/3268) Deaths:63.7% (12001884) Source: National Cancer Registry. Sanitary Statistics and Medical Research Center, from Ministry of Public Health, Bucharest

12. Trends of age-standardized incidence and mortality (world standard population),by cervical cancer, Cluj County, 2000-2008 and Romania 2008 Source: North-Western Cancer Registry, Romania; WHO-IARC data for Romania 2008

13. Cervical cancer prevention birth certificate • “Romania is the birth place of cervical screening. • It was in 1927 that Victor Babes presented the first evidence that cervical cancer could be diagnosed by cervical smears to the Gynaecology Society in Bucharest. • A year later, he published his findings in the prestigious medical journal Presse Médicale. • Another 15 years were to pass before these findings were sufficiently understood to use as the basis for a practical screening tool. The man responsible for this work was George Papanikolaou, who gave his name to the Pap test”. Cancer World Magazine

16. COVERAGE OF THE TARGET POPULATION BY SMEAR TESTS (%), 1JUNE 2002-31 DEC. 2006, CLUJ COUNTY GLOBAL COVERAGE = 18.42% Source: Regional Cytology Register

17. Reviewers • Rosemary Ancelle-Park • Direction Générale de la Santé, Paris, France • Nieves Ascunce • Instituto de Salud Publica, Pamplona, Spain • Marjolein van Ballegooijen • Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands • Mireille Broeders Radboud • University Hospital, Nijmegen, The Netherlands • René Lambert • Screening Group, International Agency for Research on Cancer, Lyon, France • Szilvia Madai • Public Association for Healthy People, Budapest, Hungary • Richard Muwonge • Screening Group, International Agency for Research on Cancer, Lyon, France • Florian Nicula • Institutul Oncologic "I. Chiricuta", Cluj-Napoca, Romania • Lennarth Nyström • Department of Epidemiology, Umea University, Umea, Sweden • Julietta Patnick • NHS Cancer Screening Programmes, University of Oxford, Oxford, United Kingdom • Sven Törnberg • Department of Cancer Screening, Oncologic Center, Karolinska Hospital, Stockholm, Sweden • Hugo de Vuyst • Infections and Cancer Epidemiology Group, International Agency for Research on Cancer, Lyon, France • Chris de Wolf • Agence pour le développement et évaluation des politiques de santé (ADSAN), Geneva, Switzerland • Maja Zakelj • Epidemiology and Cancer Registry Unit, Institute of Oncology, Ljubljana, Slovenia • Marco Zappa • Center for Study and Prevention of Cancer (CSPO), Florence, Italy

21. EUROCHIP ROMANIA QUESTIONAIRE

22. Citopathologists questioned • Cluj-County : 16 citopathologists • Bihor County : 5 citopathologists • Bistrita-Nasaud County : 5 citopathologists • Maramures County : 3 citopathologists • Salaj County : 2 citopathologists • Satu-Mare : 3 citopathologists

23. Number of cytopathologists35 people with 91 contracts in 23 labs

24. Cluj County labs and number of contracts: • “ Prof . Dr. Ion Chiricuta” Institute of Oncology – 5 citopathologists • Cluj County Hospital with 3 laboratories – 3 citopathologists • Cluj Infectios Deseases with 1 laboratory – 2 citopathologists • Cluj Adult Clinical Hospital – 2 citopathologists • Romanian Railway Hospital – 2 citopathologists • Cluj Military Hospital – 1 citopathologist • Dej Municipal Hospital – 1 citopathologist • Private laboratories - Radusan – 9 citopathologists, Medstar – 3 citopathologists, Santomar – 2 citopathologists

25. Labs questioned Bihor County : • Bihor County Hospital with 2 laboratories – 5 citopathologists • 7 private laboratories Bistrita-Nasaud County : • Bistrita County Hospital – 2 citopathologists • Nasaud hospital – 2 citopathologists • Private laboratories – Sanovil – 3 citopathologists, Optimus - 1 citopathologist,

26. Labs questioned Maramures County : • Baia Mare County Hospital – 3 citopathologists • 2 private laboratories – 3 citopathologists Salaj County : • Zalau County hospital – 2 citopathologists • 5 private laboratories – 15 citopathologists Satu-Mare : • Satu- Mare County hospital - 2 citopathologists

27. Type of staining equipment

28. Analysis regarding the analytical quality management measures

29. Internal quality control based on correlation with clinical/ histological outcome

30. Smears distribution on labs and citopathologists • 6 labs finally did almost all smears examination, and 6 citopathologists have done more than 60% of the job. • The fact that inittially we had to distribute smears equally to all authorized labs according to romanian rules, and different citopathologists were working in more than one lab allowed initially some problems in cantitative and qualitative diagnosis of smears with respect to European Quality Assurance Guinelines .

31. Total number of smears examined by several cytopathologists - smears were distributed equal to each lab

33. Citopathologists differences in smears evaluation – source Pilot Screening Registry

34. Labs quality control • differences between citopathologists both in finding invasive lesions as in lesions precursory to cancer. • we had to be prudent in considering labs declarations regarding quality control, because despite good work attended in coloration, fixation, archivation and proper classification used, internal and external quality control in smears examination and results must still remain the most important issue: we failed at the beginning in our pilot in ensuring quality control in citopathology as Romanian rules allow citopathologists to work in any lab with almost no internal and external surveillance compulsory by law, so we had in the beginning to enroll all labs, and only after proving problems in diagnosis of smears we coud renounce to some of labs and citopathologists, remaining finally with only 6 labs. • It took some time in adopting European guidelines of quality assurance for citopathology ( when we started in 2002, almost no lab was using even recommended staining and classification procedure ) and we needed to check labs performances in the in the field of duty.

35. Reasons to extend Eurochip work • Ministry of Health is planning a national cervical cancer screening programme starting from early 2012, based on a regional strategy. • Ministry of Health also lead a POSDRU Project on screening human resources started since 2010 that will end in 2012 by training 6000 family doctors and 1.200 specialists, including citopathologists and gynecologists- we are partners in this project too; an evaluation of national screening resources in the framework of this project confirmed some data from our present report at regional level, but no questions on labs quality control and number of citopathologists were asked. • This national situation and our positionas Regional Screening Management Unit gaved us one more reason to complete evaluation within Eurochip Project, to do it inside our work in the national system as an example for other regional units and as an important tool for us in designing our future screening implementation network. • We also considered that this opportunity is also a reason te extend evaluation on regional resources on taking smears and screening management resources.

36. Smear taking resources Cluj-County : • family doctors – 348, 232 urban, 116 rural • gynecologists - 68 Bihor County : • family doctors - 333 • gynecologists - 41 Bistrita-Nasaud County : • family doctors - 143 • gynecologists - 12 Maramures County : • family doctors - 382 • gynecologists - 24 Salaj County : • family doctors - 82 • gynecologists - 12 Satu-Mare : • family doctors - 178 • gynecologists – 11

37. Smear taking difficulties in rural • rural area represent the main problem from the point of wiew of taking smears. • gynecologists does not exist in Romania in rural areas. • family doctors are resistant to such activities in our experience, even intensively stimulated: initially we gaved to a lot of them gynecologic tables, lamps, sterilization resources, we payed them for taking smears, we trained them twice in our institute and in a programme with american assistance, and still they covered only 14% from smears taken in the pilot, mainly in cities: in rural almost no family doctor took smears despite all our efforts. • the most and only effective resource of taking smears in rural areas was the mobile unit.

38. Management unit – Dept of Prevention and Cancer Control – Cancer Institute Working group : panel of experts in epidemiology and public health, GP-ies, gynecological oncology and colposcopy, citology-pathology, psihology, data manager plus ONG-ies: members in EUNICE-ECN Cervical Cancer Working Group since 2006, members in ECCA since 2007 Population Based Cancer Registry connected to IACR since 1974, to ENCR since 2003 : target population and screening database ( dysplasia, colposcopy, treatment and follow-up registry ) Quality Control Resources of Management Unit and Implementation Units Network (111 GP-ies , 60 gynecologists, 6 cytology labs, mobile unit, 3 centers of colposcopy, treatment and follow up) ORGANIZATION OF SCREENING NETWORK

39. FEMALE TARGET POPULATION FOR CERVICAL CANCER SCREENING CLUJ COUNTY- 195000 women 25-64years old in 2004 6cities: Cluj Napoca Turda Câmpia Turzii Dej Gherla Huedin 420 villages URBAN: 70.5% RURAL: 29.5%

40. TESTS PERFORMED BY THE MOBILE UNIT2003-2007 Source:Regional Cytology Register

41. Use of sanitary mediators – mandatory in special communities • population information, both of women at risk and husbands, difficult and very important in relogious and ethnical groups. • sanitary mediators in isolated areas were used with huge success, in roma communities or in the willages in the mountains, in Maramures ethnical communities, in hungarian population of some willages. • the response was very good, especially in Maramures were we had two willages with over 90% population at risk covered, in Hungarian willages with more than 80% women at risk tested ( here mobile unit finally competed with family doctors ) • roma non traditional communities - hundreds of women were tested with the help of roma sanitary mediators - few dysplasia were found and treated and only one invasive case.

42. Disparities and approaches • in Romania acces to population and acces of population to screening resources are marked by important disparities: disparities due to rural and urban, disparities in religion and ethnical cultural disparities in habitual and sexual behaviour; socio-economical disparities are day by day more semnificative. • this situation need two main approaches: first of all, screening must be free and offered to all women population at risk, at same quality with no discrimination; second, efforts must be made to get to the most hard to reach woman in the most isolated and resistant area, to convince her, her husband, her family, friends and neighbours and finally her community that this action is mandatory to her health and to everyone welfare. • this is not an easy task in Romania. • invitations as in other countries may be sometimes usefull, but are in vain in a lot of particular situations described above.

43. Some final remarks on screening implementation evaluation of resources • We started this evaluation effort wondering if citopathology is capable to support a populationbased programme. We found that citopatology is enough in number of labs and people, but not enough cheked in quality. • We also found that populationbased means finding and reaching population. Population profile is important to know. • Covering women with tests in all conditions and quality of tests we think will be the most important two challenges of our future organized cervical cancer screening programme

44. MANAGEMENT RESOURCES • National Public Health Institute Report on National Health System Evaluation In the Perspective of Screening Implementation, management resources - our unit has the only regional human “ tactical “resources. • This is true if we consider experience in organizing screening programmes. • 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 other actors exist everywhere. More that that, special training for each category will be provided next months in POSDRU Project. • It is only a matter of time and proper oranising that management units will be in place in each region. • We provided Through Cancer Comission guidelines in organizing Management Units, adopted by Ministry of Health as Methodological Normatives this year. • A National Working Group on Cervical Cancer Screening National Programme will be leaded by Health Ministry himself ( he is medical oncologist anyway ). Leaders of Regional Management Units and representatives of all professional groups involved will be members. • Regional Management Units will be assisted by a commission of specialists in epidemiology and public health, gynecology, citopathology, family doctor, data manager, leaded by any of those specialists involved. • We delivered data from our Pilot regarding management. • 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 not parts in same comprehensive cancer and control units like in our situation.

45. CONCLUSIONSNW Regional resources in place Resources of management • Management Screening Unit and Cancer Registry in place since 2002. Resources of implementation • Enough citopathologists, but many not enough trained, quality control of labs must be improved and legislation must be changed in domain. • Family doctors must be trained and convinced to participate at taking smears, especially in rural. • Mobile units must be authorized and sanitary mediators trained to reach and convince women in isolated areas in mountains, roma , ucrainean, hungarian and other minorities living in willages. • Gynecologists must be trained in follow-up and treatment of lesions, feed back to Fail Safe System Screening Registry as ultimate quality resource. • Finally, epidemiologists at Cancer Registry at the bottom of the cake with hope of decreasing mortality and incidence.