The principal source of cases will be the regional network of pathologists. Three expert leaders for second opinion on sarcoma in Veneto agreed to support the study.
BARRIERS
In order to achieve the study objective, all the regional Pathology Departments were identified and the following barriers were overcome:
lack of cooperation;
obstacles due to confidentiality and internal rules;
type of data storage and data processing;
type of morphological classification and codes for case classification;
procedures for case identification and sorting.
Lack of cooperation
All the data needed were located in the pathology records. In an automated environment, reporting could be as simple as a few keystrokes. Unfortunately, in Veneto an automated reporting of pathological diagnoses to a single archive does not exist, thus rendering our study heavily dependent on the actions of very busy pathologists. Therefore, the pathologists of Veneto were personally invited to team up with the expert leaders to whom they apply for the second opinion for sarcoma. A person was assigned to clinical monitoring in order to help the collection of cases from the Pathology departments every three months.
Obstacles by confidentiality legislation and internal rules
The clearance from the Ethical Committee was obtained along with the support of the managing tams of all the Local Health Units (LHUs) in Veneto. An informed consent will be requested from all patients for data storage and follow-up.
Type of morphological classification and codes for cases classification
All pathologists agreed to use the morphological classification of WHO in 2002 [
19] and the SNOMED codes for sarcoma in their daily practice. Classification and codes are reported in Additional File
2.
Procedures for cases identification and sorting
In the pathology departments of Veneto, computerized data are processed by using different software packages: Armonia, WindoPath, APSIS, and others. All departments in Veneto have to be scrutinized.
Second opinion diagnosis
The Section of Pathology (Department of Oncology and Surgery, University of Padua) and the Department of Pathology (Treviso Regional Hospital), perform both primary cancer diagnosis and second opinion diagnosis. The primary diagnoses of Padua will be reviewed by Treviso experts and vice versa.
Scrutinising other archives
As already known, the incident cases of sarcoma will be searched through parallel scrutiny of multiple independent sources: network of pathologists and archives of hospital discharges.
Tracing clinical records
All medical records regarding the above patients will be traced and photocopied from the relevant hospital offices.
Statistical analysis
The incidence will be calculated by age, gender, main nosological group (STS and VS), primary site and the histological type of the tumor. The incidence rates will be age-standardised with the direct method, using the World and European populations as standard. Survival rates will be calculated by the Kaplan-Meier method [
20]. A capture-recapture approach will be used to determine and improve accuracy in estimating frequency of STS and VS [
21].