PathWin - Mass Population Screening Management

Necessary activities for starting of a mass cervical cancer screening plan are here listed in succession.

1. Pre-requirements
A lot of preliminary information is necessary before the beginning of processing with PathWin program. Some files should be transferred from other data bases: medical and town registers. In particular, medical & clinical data base systems has not always available all data about the resident population.
Collaboration of all people responsible should be guaranteed in order to obtain the fixed purpose, involving them in preliminary meetings where exchanges of information will be agreed.

1.1. Protocols and modalities of data transfer
In order to obtain a total autonomy and a quick re-examination of all parameters either on personal data or diagnostic ones, at first data should be transferred by links of terminal's emulation and file transfer network's functions with protocol in use. Record layouts for these transfers should be agreed and personalized procedure of data transfer and upgrade should be realized. PathWin isn't a client/server application and is able to process only data that are on Pathology's Department local area network. At the time an interrogation of other informative systems on individual data is possible, with the transfer of requests and answers with a format to agree with two systems. Real time update of all Pathology's individual data would be a great expense, besides onerous, both in terms of hardware resources and according to the point of view of specific software's realization in installation. During a meeting with people responsible of these information transfer modalities and times to effect the aforesaid operations should be agreed.

1.2. Individual data
Periodically individual data (ex. quarterly) should be updated to note births/ deceases/ emigrations/ immigrations on territory of relevance of screening's plan. Clinical systems has not always available all data about resident population. However all individual data should be obtained from the most reliable source. In Pathwin ambulatories' table should be inserted list of towns and respective districts which are attended by the some ambulatory and that are object of screening. Then nominatives of persons should be associated with town and fraction of residence. Through these codes should be possible to address reservation to ambulatory nearer to residence in order to improve percentage of answers.

1.3. Previous tests
Should be verified if is possible to transfer diagnoses of previous cases directly from other informative systems. If data will be transferred in a portable format, a procedure's for coding of transferred data could be needful. Updates couldn't be necessary if tests of screening's relevance will be managed only by PathWin procedures. As alternative to transfer data is that to manually fill significant tests in PathWin data base. Among other functions, PathWin provides the opportunity to entry tests that have been done before its management. Also histological testes are concerned as for example the of uterus' removal involves classification of the patient in the category "without uterus" that doesn't involve recalls by screening's management if it isn't positive case.

1.4. SNOMED codify tables
If SNOMED coding tables of version 2 are already in use, they should be compared through transfer files concerting layouts.

2. Preliminary activities
2.1. Transfer data
Some procedures of data transfer and update, from various sources in use, should be realized. Preliminary transfer data could concern a restricted sample of residents and tests in order to avoid errors during definitive transfer data.

2.2. Training
Soon after acquisition and installation of hardware & software components, a preliminary activity of training and test could be foreseen. A second phase of arrangement would allow to get refined and to consolidate procedures. In the last phase, with data's availability, it would be possible to start studies on stored series of cases. Although learning of PathWin's use is relatively simple, plurality of information, to discuss and to transfer, brings to a least of 10 hours of training and before these ones, other 4 hours at least in order to familiarize with Windows. Lessons should be effected with no more than 2 people for each personal computer and possibly separated according to activity of attendants: obstetrics, secretaries, technicals, biologists, doctors, and system's data base administrators.

3. Screening's management
Screening's management, which was added in PathWin, provides for use of some supplementary procedures and tables compared to simple clinical test writing. In particular, to the ending of diagnosis' data entry, if the test is concerning the screening, PathWin executes the update of screening's individual parameters.
The chart of the topographical SNOMED codes should be personalized pointing out the topographies that are restrain pertinent for cervical screening: uterine cervix, uterus, etc...

3.1. Protocol
Other parameters concerns the range of age to cover, the tolerance admitted for the expiration of the tests, the type of procedure standard for the PAP Test.

3.2. Ambulatory
Beyond to the data of the surgeries (denomination, address, telephone, place, etc.) that comes used for the composition of the letters of reservation, they must be compiled the schedule standard of admittance, the average time of visit and the towns and districts of coverage of each ambulatory should be filled in.

3.3. Ambulatory schedules
The schedules detailed for each day in each ambulatory must be inserted with sufficient advance respect the extraction of the nominatives to convoke. From these data besides the average time of visit, the possible reservations for each ambulatory are drawn monthly.

3.4. Categories
The mass of population comes divided in some categories that depends either on the personal data (sex, age, residence, etc.) and from the tests previously effected. They could be characterized any main principal categories from the individual data: minor, outside age, deceased, not resident, they refuse the screening.
From the diagnostic side the classification is much more complex and for example we could consider some groups of categories: outside checks, in entry, with tumor, protected, at risk. A percentage of places on all possible reservations could be associated to each category.

3.5. Diagnostic
The lookup table, for a correct evaluation of individual diagnosis, contains all combinations of diagnostics SNOMED codes that should provoke an expressive action or during general evaluation of screening individual parameters or in the moment in which you finish the diagnosis data entry of a screening pertinent test. Through this table are drawn the changes of category, the corrections of the risk's index and the period to wait for the next recall are collected. A second table contains all diagnoses that have not influence on the data evaluation. Besides there are indications for no diagnostic tests: insufficient or inadequate material.

4. Screening procedures
While all standard procedures of diagnosis data entry are applied to individual test and/or to the individual patient, screening's management involves data processing concerning global information from the individual data of the residents and from the test. Some activity requires then processing that could end in some minute and in other cases also few hours.

4.1. Global tests evaluation
Categories assigned to patients are not a stable datum. It's sufficient think that in the case of emigration out of the district, the category of patient doesn't take on automatically indication of "not resident". Also PAP-tests should be done with a due regularity and then, in case of lateness, patient should be disposed among those with "expired test" category. But from the point of view of management of diagnosis data entry doesn't exist a direct "event" that could be considered cause of such changes.
It's necessary to periodically evaluate all individual data and diagnostics. This evaluation would be preferably effected after the update of global individual data after transfer file from the towns registery and before extraction of reservations.
Right management of individual data and diagnostics requires a great engagement in all activity of screening. Approximately we could consider 2-3 days per month necessary for these elaborations (for 50,000 women). Either printing and preparation of the letters or material times, necessary to Mails to deliver the reservations, should be added to previous times.
Considering 10-15 days early between extraction of reservations and receipt of letter at the patient is reasonable.

4.2. Reservation preview
The number of daily and total reservations can be calculate according to personalized schedules of each ambulatory, getting a printed comparable list with the monthly consulting rooms' calendars.
Total reservations can be divided, for each category of convoked women, according to the percentage established in the respective table.

4.3. Reservation's extraction
Individual data are ordered by town's and district's code of residence, category, due date, index of risk and street's code.
At the end of the extraction, printings of the real reservations for each category and the list of the reservations are ready.
Now these data should be compared each other by the screening's manager in order to confirm or correct the reservations. After confirmation, the reservations become operative and both browses, with nominatives, and reservation's letters could be printed for each ambulatory.

4.4. Tests' data entry
If PathWin tests' data entry is already extremely rapid, the screening's PAP-tests is more facilitated by reservation letters quotes protocol number. Patients identification, record's creation and deflection of reservation are possible through this code. Browses' print of patients, who have not answered to reservation is available.

4.5. Diagnosis' data entry
Also PAP-Tests diagnoses' data entry have become better and two versions are available:
the first one is linked to a scheme of mnemonic coding that groups all diagnoses for tests of vaginal cytology;
the second one proposes a windows based data entry system with check box and locks among different selections, reducing to essential schematization (check-list) suggested from the Italian National Research Committee (CNR).
In both cases, SNOMED codes stored for diagnoses is the same.

5. Reports
In the previous sections of this document, different reports, that are here summarized, have been recalled:
screening protocol, ambulatories' data, ambulatories' schedules, categories, diagnostic look-up table; summary cases/categories, theorical / real reservations by ambulatory and by category; reservations' browse; personalized letters of reservation.

In particular, it's necessary to notice that if patients data base is subject to frequent changes for immigration and emigration in the territory, while updates, put at disposal by town registries and by patients' registry of Sanitary Department, are transferred after a lot of time (2-3 months); letters, send to patients, could be delivered to wrong address. These errors, caused by updating times, calculation and transfer, bring to a decrease of reservations' efficiency lowering, therefore, the percentage of patients' answer. Convocations' browses could be created on file so then the hospital CED or other town's departments could print letters whose personal data's precision could be examined by the aforesaid departments.

6. Statistics
The great quantity of data, filed in order to proceed among different phases of screening's progress, can be summarized in some statistics: summary of cases/category summary of convocations, answers, spontaneous and total withdrawal per period summary of diagnostic cases divided among ambulatories, average time between two negative tests, adhesions, spontaneous adhesions times at cytology tests, answer recalls to the second level tests, cervical biopsies, identification rate, interval cancers, cases appeared in women who haven't answered or not invited.

7. Conclusions
Organization, suggested by PathWin, doesn't want to be an example of method's to follow strictly. It's however the result of different years of experimentation and application in a territory like that of Imola where about 90.000 women are followed with diagnostic files for a total of about 400.000 histological and cytological tests.