ASSESSMENT STUDY OF CERVICAL CANCER CONTROL IN ROMANIA-

EUROCHIP PROJECT

Iuliana Apostol; Cornelia Nitipir

Dr. Victor Babes Foundation, Bucharest

OBJECTIVES

1 Analyzing the European guide for CC screening for countries with high specific mortality (Ed 4th Manual - Alliance

for Cervical Cancer Prevention).

2 Description of the opportunistic CC screening program existing in Romania

3 Identification of problems and barriers existing in implementing of an efficient CC screening program

4 Suggestions for competent health authorities to improve CC screening program

METHODOLOGY

National assessment study (all the 8 individual development regions and centralised) run by Dr Victor Babes Foundation, Nov 2006-Mars 2007

Method of collection data: medical statistics data / 2005, review documents, semi-structured interviews with key informants.

Method of analysing data: comparison with the European guidelines for CC control and lessons from experience of other European countries

Identification of the key stakeholders in the program for inviting them to participate in this study.

Collected data: Medical statistics about CC control in Romania/2005

Sources:

National Center for Organization & Assurance of Informatics System in Health Area, Bucharest

National Statistics Institute, Bucharest

0

500

1000

1500

2000

2500

3000

3500

200520042003200220012000

Cervical cancer incidence/years/regions

8 development regions: I North; II-North-East; III-South; IV-South-West; V-West; VI-North-West; VII-Bucharest

• Small variation of incidence by regions during years: 2000, 2001

• The incidence began to have differences between regions in 2002-2003

• The highest registered difference in incidence by regions in 2004, 2005.

• High incidence: lack of an efficient cervical cancer prevention program in Romania

0

500

1000

1500

2000

2500

I/N-E

II/S-E III

/S

IV/S

-W V/W

VI/N-W

VII/CE

VIII/B

u

200520042003200220012000

Cervical cancer mortality/ years/ regions

8 development regions: I North; II-North-East; III-South; IV-South-West; V-West; VI-North-West; VII-Bucharest

Homogeneous curves of mortality by regions in years: 2000, 2001

Slight variation in mortality by regions in years: 2003, 2004

A sharp increase of variation in mortality by regions in 2004, 2005; the highest mortality in regions I, III and VI

High mortality: poor treatment resources and facilities; bad compliance with guidelines.

572

16,24%

417

11,84

460

13,06%

392

11,13%

431

12,24%

365

10,36%

509

14,45%

376

10,68%

Cervical cancer incidence / Regions / 2005

• Highest incidence in regions I (16,24%) and III (14,45%).

• High incidence: lack of effective screening programs aimed at detecting precancerous conditions and treating them before they progress to invasive cancer.

•Exception: region North-West (including county Cluj; VI-13,06%). Incidence artificially higher comparative with the other regions, due to an organized screening program.

I

II

IIIIV

V

VI

VII

VIII

315

17,57%

216

12,05

232

12,94%

159

8,87% 215

11,99%

209

11,66%

302

16,84%

145

8,08%

Cervical cancer mortality / Regions / 2005

I

II

IIIIV

V

VI

VII

VIII

• The lowest mortality: regions VIII (8,08%) and VII (8,87%)

• Low mortality: better resources and facilities, compliance with the best guidelines.

Age-specific rates of the incidence of cervical cancer in females in Romania over the period 1999 - 2003

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

80.00

90.00

100.00

0-4

5 - 9

10 -

1415

-19

20-2

4

25-2

9

30-3

4

35-3

9

40-4

4

45-4

9

50-5

4

55-5

9

60-6

4

65-6

9

70-7

4

75-7

9

80-8

485

+

Age-group

Ag

e-s

pe

cif

ic r

ate

s

1999

2000

2001

2002

2003

Age-specific rates of the mortality of cervical cancer in females in Romania over the period 1999 -

2003

0.00

5.00

10.00

15.00

20.00

25.00

30.00

35.00

40.00

45.00

50.00

Age-group

Rate

s

1999

2000

2001

2002

2003

15,31%

4,61%

23,38%

13,14%

5,14%

8,57%

8,33%

15,38%

Cytology screening / Regions / 2005

The influence of pilot programs on screening activity:

1) 1999-2000 Cluj (The highest screening activity: VI-23,38%)

2) 2001-Bucharest & surroundings (VIII-15,38%)

3) 2002-2003-Bucharest, Iasi (I-15,31%)

I

IIIII

IV

V

VI

VII

VIII

2,58%

0,96%

5,12%

3,06%

1,54%

2,27%2,44%

3,72%

Coverage rates / Regions / 2005

• Coverage rates from the Health Reproductive Survey-2004: 20% per country; one factor-the reports are based only on public institutions although there are screening activities in private medical centres too.

• Very low coverage /regions/2005: in the whole country (5,12-0,96%)

• Estimation was based on smears counted rather then individuals entered the program; not counted the women who repeat smear (Ministry of Health and National Statistic Institute) .

Total Stage 0 14,87

Total Stage I 43,30

Total Stage II 10,47

Total Stage III/IV 31,70

Total (0-IV) 100,00

Histological confirmed CC cases / Romania / 2005

• In Romania, a significant percent of cases were detected in invasive stages (II-10,47; III/IV-31,70 %);

• Delayed detection may lead to lack of benefit from a curative treatment existing in CC for incipient stages.

Collected data: Review documents about CC control in Romania

Legal frame: Ordinance No 86/06.02.2006 from Official Monitor, Part I no 174/23 Feb 2006 and no 174 bis (Annex I, II, III) budget financed health programs and subprograms for 2006. Annex II Subprogram 2.2. – Prevention and Control in Oncology

National assessment studies

• “Psychosocial and Health System Dimensions of Cervical Screening in Romania” 2005 authors: Adriana Baban, Robert Balazsi, Janet Bradley, Camelia Rusu, Aurora Szentagotai, Raluca Tataru

• “Reproductive Health Survey Romania 2004”, UNFPA, UNICEF, USAID/JSI R& T, SDC, OMS, IOMC

• “Description of the National Health Information System in Romania: Results of a participative evaluation conducted in June 2003 “; World Health Organisation 2004.

• “Improving of NCD Monitoring and Evaluation Capacity in Romania” 2005, RO 2002/000-586.04.11.03, Phare, EU.

• “Assessment of Cervical Cancer Screening in Romania” 2004, Cristian Vladescu, Centre for Health Policies

• “Electronic system for Monitoring of the National Cervical Cancer Screening Program in county Cluj” 2005, Luciana Nemtiu, Ofelia Suteu, Florian Nicula, Daniela Coza

Collected data: semi-structured interviews with key informants about CC control in Romania

1 Ministry of Health-National Center for Organization and Assurance of Informatics System in Health Area, Bucharest-Director Ioana Pertache

2 Ministry of Health-Agency for National Health Programs-Director Luminita Varlan

3 National Statistics Institute, Bucharest-President Prof Univ. Dr. Vergil Voineagu

4 National Oncology Commission-Director Prof. Dr Rodica Anghel

5 National Society of General Medicine & Family Medicine

6 Romanian Society of Obstetrics & Gynecology-President Prof. Dr Florin Stamatian

7 National Society of Histopathologists

8 National House of Health Insurance

Analyzing data using categories outlines in ACCP Manual, ed 2004

1. Program policies, guidelines and norms

2. Program management issues

3. Health services

4. Laboratories

5. Training professionals

5. Community perspectives

6. Information systems

THE CATEGORIES ASSESSED

Policies & Management problems/barriers

Program policies, guidelines and norms Ordinance No 86/06.02.2006 do not define clearly fundamental elements for the cervical cancer screening program: target age group; frequency of screening; the desired coverage; method for screening and treatment; integrate/vertical programs; regulation for mid-level professional to perform clinical procedures. The focus are on the most frequent locations of cancer (cervical, breast, prostate, colon-rectal), where screening activities can have an impact.

Program management Frequent changes of the person charged with the program No clear monitoring and evaluation indicators in use for each component of the program.

Total women target group (18-69 years)/2005: 7.252.550 GPs: 6094 GPs in urban (1 GPs for 2097 patients) and 4501 in rural (1 GPs for 1740 patients)/country. Drawbacks: insufficient primary assistance in urban/rural also; insufficient practical skills and theoretical training for smear-takers; insufficient time for preventive activities; inadequate infrastructure for smear-taking; insufficiently paid. Nurses: 6625 in urban and 5376 in rural; community nurses: 97 in urban and 371 in rural

Gynaecologists: 2009 gynaecologists/country . Drawbacks: unequal covering of the developing regions; insufficient time because of multi-competent tasks (obstetricians, colposcopists, ultrasonographyst etc). Histopathologists: 461/ country. Drawbacks: insufficient number; qualification as cytotechnicians doesn’t exist in Romania. Colposcopists : 87 physicians/2005

Oncologists: 303/country. Radiotherapists: 81/country. Surgeons/oncology surgeons: 1750/country. Palliative medicine specialists: 5 physicians/2005. In 2003 this speciality was recognised as an individual specialty and the activities in this field are incipient.

Health services –A. Health providers

problems/barriers

An opportunistic screening program

Unavailable often in rural areas

Offered primarily to young women through maternal/child health or family planning clinics where the population being screened is not at high risk. A lot of women low-risk are screened and some are screened more frequent then necessary ; resources are used inadequate.

 There counted the number of smears performed not the persons screened; a part of the smears are controls.

  No follow-up system for women screened positive; even if women are screened they are sometimes not adequately treated and monitored.

These approaches have had little effect on morbidity and mortality and are not as cost-effective as centrally organized screening programs implemented by the public sector (Fahs et al-1996)

Health services - B. Cytology screening

problems/barriers

Health services – C. Diagnostic and treatment services

problems/barriers

No statistics information about diagnostic & treatment facilities / Regions.

No linking system between screening services and accessible treatment facilities for precancerous lesion/ Regions

No functional referral network for continuity of care ( linking between screening, diagnostic and treatment precancer and cancer) and no follow-up system in use.

It is known the number of public histopatology labs, including cytology and histology labs (161 labs/country). No separate registration for cytology labs, no registration for private labs.

No internal quality controls systems to detect poor experienced smear-takers and poor performers inside smear-readers. No map of the cytology and histology laboratories /region Results are not standardised in accordance with EU recommendation in all cytology labs (Papanicolau staining, the Bethesda classification system; time for providing results, double reports-to GPs and to the woman) Lack of enough statistics about qualifications and number of technical staff available to process tests/laboratory Lack of information about maximum processing capacity /labs and about the storing capacity/labs

Cytology & histology laboratories

problems/barriers

Community perspective assessment

“Psychosocial and Health System Dimensions of Cervical Screening in Romania” authors: Adriana Baban, Robert Balazsi, Janet Bradley, Camelia Rusu, Aurora Szentagotai, Raluca Tataru

Very low rate of screening participation: 20,2% women screened; 73,3% never received a Pap smear; 6,5% did not know if they received or not.

“Reproductive Health Survey Romania 2004”, UNFPA, UNICEF, USAID/JSI R& T, SDC, OMS, IOMC

Only regional campaigns of I & E regarding CCP in Romania, limited in time and most focusing on urban areas; there is only one regional project with rural focus, regarding the importance of CCP. The studies indicated a low impact of I & E campaigns.

Attitudes regarding own health: 80% of sexually active women have never been tested with PAP smear and 37% never heard of it.

Women that never heard about PAP smear: low educational level (62%), low socio-economic status (60%), women with three or more children (56%), younger women (53% between 15-24 years), rural women.

Information system assessment

“Description of the National Health Information System in Romania: Results of a participative evaluation conducted in June 2003 “-World Health Organisation 2004, it is the most comprehensive study of our health information system.

Reports of indicators related to the National Health Programs (like subprogram 2.2) are mandatory for all public health providers, first to the Public Health County Directions (42 Directions) and then to Health Ministry. The information system is an essential component for monitoring and evaluation of an organized screening program but in Romania there is no staff trained in data collection, data entry and report preparation for CC prevention program.

The best model is offered by county Cluj (25-65 years; three years interval): collection of data with a standardised questionnaire/women tested, electronic entry data and administration of data with a application like as FileMaker Pro 4.1 The first County Cytology Registry in Romania-2002; the first County Dysplasia Registry in Romania 2004. The application is a good instrument for financial assessment of the costs/women.

Recommendations for competent medical authorities

Policy recommendations

Redefine the target group based on age-related incidence & low-level resources in Romania. First priority is 30-55 (Cervical cancer prevention Conference for developing countries, Dures, Albania 2004); second, extension to 25-64 (like is currently in most European countries).

The frequency of screening : three years, based on experience and studies processed in European countries. It is stated as the optimum interval in “Comprehensive Cervical Cancer Control”- June 2006. Women screened positive must repeat the test after three months period.

Plan for an organised screening program (the target population is actively asked to make the screening test, with expenses covered by state) versus an opportunistic (any medical examination may be accompanied by recommendation for test, with expenses covered by state).

Program management recommendations

Defining objectives in accordance with CC prevention national policy and international organizations.

Collecting and analysing data related to these goals

Monitoring and evaluation should cover all services provided (screening, diagnostic and/or treatment, community information)

Estimation of costs/ each program level (level of recruitment; level of screening; level of diagnostic (colposcopy & biopsy); level of treatment; level of follow-up)

Integrating services of CC prevention with the other medical services but with developing reference prevention units/each developing region, with specific roles: educational campaigns, smear-taking offices or mobile units for screening, reference cytology labs, CC Screening Regional Registries.

Organize a training plan for all professionals involved in program

Improve the efficiency of I & E campaigns

 

THANK YOU FOR YOUR ATTENTION