Transcript Proiectarea si implementarea unei aplicatii de date

EUROCHIP ROMANIA
REPORT
on
Cervical 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
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.
Methods and data sources
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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.
Romanian European Development Regions
Counties of NW Region
North-Western Region surface 34159 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.
REGISTRY
INDICATOR
Bistriţa
Năsăud
Bihor
Cluj-Napoca
Maramureş
Satu Mare
Sălaj
Regiunea NV
NW
Region
România
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
B
68.74
B
F
75.01
F
70.32
B
70.66
B
68.78
B
65.83
F
77.46
F
76.17
F
74.09
Life expectancy at birth
Birth rates/1000
76.41
B
B
68.34
F 75.67
68.95
F
75.9
B
69
F
77
11
11.3
9.7
10.7
11.3
11.1
10.7
10.32
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
Mortality rates/1000
Counties population distribution in NW Region
NW Region population – age distribution
NW COUNTIES POPULATION AT RISK –WOMEN 25-64 YEARS OLD
TOTAL TARGET POPULATION 754.000
2008 new cancer cases registered in NW Region
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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.
FEMALES
MALES
0,61%
0,61%
0,39%
0,52%
18,81%
8,95%
31,91%
39,11%
51,04%
48,07%
0-14years
15-24years
25-49years
50-69years
70+years
0-14years
15-24years
25-49years
50-69years
70+years
AGE –SPECIFIC RATES OF INCIDENCE AND
MORTALITY, BY CERVICAL CANCER, ROMANIA
2003
80
74.42
25-64 years
70
New cases: 77.88% (2545/3268)
60
Deaths:63.7% (12001884)
43.4
50
35.45
40
30
20
1.09
10
0.12
0
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
Source: National Cancer Registry. Sanitary Statistics and Medical
Research Center, from Ministry of Public Health, Bucharest
Trends of age-standardized incidence and mortality (world standard
population),by cervical cancer, Cluj County, 2000-2008 and Romania 2008
60
50
45.31
40
30
26.21
23.9
20
11.8
9.5
7.3
10
0
2000-2001 2002-2003 2004-2005
Incidence
2006-2007
2008
Romania
2008
Mortality
Source: North-Western Cancer Registry, Romania; WHO-IARC data for Romania 2008
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
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COVERAGE OF THE TARGET POPULATION BY SMEAR
TESTS (%), 1JUNE 2002-31 DEC. 2006, CLUJ COUNTY
30
25
24.96
25
24.19
22.13
24.38
22.97
GLOBAL COVERAGE = 18.42%
23.47
22.94
21.67
21.16
21.39
20
19.5
19.25
19.53
18.45
15.41
15.47
15
15.43
11.85
10.12 10.76
10
5.94 6.67
6.24
5
0
25-29
30-34
35-39
40-44
Urban
45-49
Rural
Source: Regional Cytology Register
Global coverage
50-54
55-59
60-65
Reviewers
► Rosemary Ancelle-Park
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Direction Générale de la Santé, Paris, France
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Instituto de Salud Publica, Pamplona, Spain
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Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands
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University Hospital, Nijmegen, The Netherlands
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Screening Group, International Agency for Research on Cancer, Lyon, France
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Public Association for Healthy People, Budapest, Hungary
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Screening Group, International Agency for Research on Cancer, Lyon, France
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Institutul Oncologic "I. Chiricuta", Cluj-Napoca, Romania
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Department of Epidemiology, Umea University, Umea, Sweden
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NHS Cancer Screening Programmes, University of Oxford, Oxford, United Kingdom
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Department of Cancer Screening, Oncologic Center, Karolinska Hospital, Stockholm, Sweden
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Infections and Cancer Epidemiology Group, International Agency for Research on Cancer, Lyon, France
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Agence pour le développement et évaluation des politiques de santé (ADSAN), Geneva, Switzerland
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Epidemiology and Cancer Registry Unit, Institute of Oncology, Ljubljana, Slovenia
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Center for Study and Prevention of Cancer (CSPO), Florence, Italy
Nieves Ascunce
Marjolein van Ballegooijen
Mireille Broeders Radboud
René Lambert
Szilvia Madai
Richard Muwonge
Florian Nicula
Lennarth Nyström
Julietta Patnick
Sven Törnberg
Hugo de Vuyst
Chris de Wolf
Maja Zakelj
Marco Zappa
EUROCHIP ROMANIA QUESTIONAIRE
Questionnaire 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.
5.
How many cytopathologists are working in your laboratory ?:
What is their training profile and how many of each category ?:
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
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Number of cytopathologists
35 people with 91 contracts
in 23 labs
13%
19%
Pathologists
Laboratory phisicians
Biologist
68%
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
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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,
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
Type of staining equipment
31%
manual
automat
69%
Analysis
regarding the analytical quality management measures
% of laboratories
targeted screening
31%
automated
rescreening
0%
rescreening of
slides
23%
rescreening of slides
rapid rewiew
random rescreening
random rescreening
23%
rapid rewiew
23%
targeted screening
automated rescreening
Internal quality control
based on correlation with clinical/ histological outcome
% of laboratories
audit of interval
cancers
16%
cyto-clinical correlation
cyto-virological
correlation
26%
cyto-clinical
correlation
58%
cyto-virological correlation
audit of interval cancers
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 .
Total number of smears examined by several cytopathologists
- smears were distributed equal to each lab
Pais
40%
43%
Apostol
Bungardean
Galatir
Duma
Bologa Mircea
1%
2%
Alti
4%
4%
6%
CITOLOG
Apostol Silvana
ASCUS
LSIL
HSIL
Invaziv
AGUS
Total
1.33
0.63
0.61
0.01
0.05
7655
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
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
Botezan Andreea
Encica Svetlana
Citopathologists differences in smears evaluation –
source Pilot Screening Registry
Todea Daniela
Spanu Ileana
Pascal Alexandrina
Pais Rodica
Irene Paris
Ilie Bologa Mircea
Galatar Mihaela
AGUS
Invaziv
HSIL
LSIL
ASCUS
Floristeanu Delia
Encica Svetlana
Duma Milena
Duca Atanasie
Simon Laura
Coroiu Georgiana
Bungardean Catalina
Buiga Rares
Botezan Andreea
Apostol Silvana
0
1
2
3
4
%
5
6
7
8
Labs quality control
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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.
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.
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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
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.
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ORGANIZATION OF SCREENING
NETWORK
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)
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FEMALE TARGET POPULATION FOR CERVICAL
CANCER SCREENING CLUJ COUNTY195000 women 25-64 years old in 2004
6 cities:
Cluj Napoca
Turda
Câmpia Turzii
Dej
Gherla
Huedin
420 villages
45%
55%
Women 25-65 years old
URBAN: 70.5%
RURAL: 29.5%
Women other ages
TESTS PERFORMED BY THE MOBILE UNIT
2003-2007
9000
8000
7000
6000
5000
4000
8209
5972
3000
2000
2127
1000
1516
0
CLUJ
BISTRITA
NASAUD
SATU MARE
SALAJ
Source: Regional Cytology Register
758
MARAMURES
Use of sanitary mediators – mandatory in special communities
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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.
Disparities and approaches
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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.
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
MANAGEMENT RESOURCES
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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.
CONCLUSIONS
NW Regional resources in place
Resources of management
► Management Screening Unit and Cancer Registry in place since 2002.
Resources of implementation
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Enough citopathologists, but many not enough trained, quality control of labs
must be improved and legislation must be changed in domain.
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Family doctors must be trained and convinced to participate at taking smears,
especially in rural.
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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.
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Gynecologists must be trained in follow-up and treatment of lesions, feed
back to Fail Safe System Screening Registry as ultimate quality resource.
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Finally, epidemiologists at Cancer Registry at the bottom of the cake with
hope of decreasing mortality and incidence.