Issue 4 - August 2010 - Pacini Editore

152
HPV test that, as it introduced by the protocol, could be used
for successive cytological tests of triage and for further elaborations
of studies with a particular attention for the markers
of the specificity of the infection caused by HPV and of the
progression of the neoplastic pathology.
The samples will be sent to the medical centres of Atri and
Sulmona, chosen to perform the test for the research of high
risk DNA HPV (Hybrid Capture 2, cut-off 1pg/ml), using
an automated system which will make it possible to process
a high number of samples a day, with very fast turnaround,
costs saving and quality improvement. Women with negative
results will receive a letter with the test results along with an
invitation to a new screening test after 3 years. At the moment,
the 3 years time lag is prudentially recommended, but
it is more likely that it will be extended to a 5-6 years, when
all the evidences on the duration of protective effects will
be proved and when the information will be updated by the
Ministry of Health.
The typing of positive results of high risk is centralized in
laboratories of molecular biology in Atri and Sulmona; in fact
we have forseen a triage with a specified type typing to value
better HPV positive women considering that also women
HPV 16 and 18 positive have a high risk to develop a Cin3+.
HPV HG test with positive results of high risk will be reported
to the Centre of Lanciano, entitled to cytological readings
of second level which will take care of slides preparation,
colouring and reading slides. Women with positive cytology
will be asked to take a colposcopy examination. Women with
negative cytology will receive an invitation letter for a further
examination in one year.
To guarantee the necessary sharing of results in order to create
conclusive data on the application of this strategy, we have
adopted a protocol analogous of other studies ongoing.
The software used for the screening is the only one in Abruzzo:
it’s based on Web servers and LAN networks connected
with the colon rectum screening. The software managed by
Winsap on Web, adopted by Abruzzo region for the screening
that uses the base of traced records of the regional vital
statistics and is continuously updated by our operators, has
been adjusted by the creation of a HPV module. A particular
element of quality has been presented by the traced record
produced individually, transmissible through the New Sanitary
Information Service (NSIS) to the national Data Ware
House that allows to equalize, to centralize and to simplify
statistical analysis.
A new screening methodology, which involves a first level
test different from the traditional one, and which detects a
viral infection sexually transmitted, needs of course a different
approach in terms of communication strategies. To
avoid useless over-treatments, it’s necessary to introduce a
new way of communication, which has to be scientific, but
at the same time easy to understand without creating anxiety
in women.
For these reasons the project introduces, for the new screening
type, the use of information material, scientifically correct
and easy to understand by population, people involved in the
medical centers and doctors of general medicine. Each invitation
letter for the test comes with a brochure, written with
simple and clear terms.
The given information illustrates the concept of the cervical
oncogenic risk underlining how the virus test results negative
for 90% of women over 30 and therefore allows to include
the tested subject among those of extremely reduced at risk
to develop a significant cervical pathology whereas the persistent
positivity in the virus test represents a simple indicator
5 th triennial congress of the italian society of anatomic Pathology and diagnostic cytoPathology
of a probable development of cervical pathology in years
analogously of any other test of screening usually made in the
medical prevention (weight, nutrition, etc.).
For all the levels of our regional project of screening there will
be settled a Quality Assurance programme. The creation of
a biological bank will allow to study molecular mechanisms
especially with regard to the determinants of progression and
regression of the infection itself and of the intraepithelial
cervical lesions.
We have already known that only persistent infections of HPV
are associated with a high risk of precancerous lesions. At this
moment persistent infections can only be valued by repeating
the test after 12 months whereas a clinical validation is necessary
for the study and the characterization of markers of the
integration HPV-DNA and DNA cells that could signal the
latency state, the persistence of the infection and the progression
to cancer.
At the moment there are not biomarkers of specificity in the
algorithms such as p16 and p16 Plus dual kit or mRNA, which
are extremely encouraging, but still under specific experimental
studies: it will be the person in charge of reading the
cytological triage to decide whether to use it or not.
In case of a CIN diagnosis, it is up to the pathologist, to guarantee
a more accurate diagnosis, to search for a confirmation
with the p16 histological test.
Results. The cost of the strategy of the screening with HPV
test as first level will be established regarding to the costs
met in the last decade with the use of a traditional strategy
of screening (Pap test I level) and with the adoption of new
technologies and computerized systems of cytological reading
(see attached: study ARINT of Abruzzo region and the project
of the research applied for programmes of screening by law
138 approved and financed by the CCM of the Health Ministry
for the year 2009) considering also the possible saving
derive from the eventuality of the expected extension of the
interval of the screening.
The heterogeneity of accounting systems and even more the
lacking criterions of analytic accounting stand in the way of
an activity based costing system that would be essential for
estimating the financial requirements.
On the other hand, the necessary overcoming of the criterion
obsoleted by the historic cost requires analysis and applications
of alternative systems. A recent decree Calderoli (known
as decree on ‘Federalism’ converted in law recently) has
moved in this direction establishing that costs having reference
according to the letter m) of the second paragraph of the
article 117 of the Constitution (that concerns Essential Levels
of Assistance including screenings) ‘should determine with
respect the standard costs associated on essential levels of
services established by the state law, to be distributed in terms
of efficiency and appropriateness in all the national territory’
(articles 6, paragraph 1, letter b).
It is about a sector of studies not having been yet explored and
not lacking of difficulties also because the decree does not
make clear what ‘standard costs’ means and therefore how it
should be calculated.
Moreover, for some economists it seems to be an unrealistic
idea that the efficient specific cost could be calculated for
every singular service of the National Health Service (SSN)
and then have by a simple summation the costs of services
of the Essential Level of Assistance (LEA) in the decision of
the total requirements. They think: ‘it appears substantially
out of reach for services of prevention and for those of territorial
medicine’ to prevent a tariff system analogous of that
of hospitals (for regional decree DRG), also because of the