[Experience in data management of the clinical retrospective project in Czech and Slovak oncology centres (IKARUS...

The retrospective part of the IKARUS Project (Incidence of Skeletal Related Events in Breast Cancer) was focused on monitoring the incidence of skeletal related events in patients with metastatic breast cancer treated in the Czech and Slovak Republics.The aim was to describe the experience with data collection management in the conditions of the Czech and Slovak Republics.

Retrospective collection of data in multi-centre, non-interventional, epidemiological and explorative studies. Female patients diagnosed since 2000 were involved in the project in order to respect the five-year period of monitoring and to describe the treatment of the period.

During the initiation phase of the retrospective study each of the 18 Complex Cancer Centres in the Czech Republic (see www.linkos.cz) and 18 chosen oncology centres in the Slovak Republic were addressed. In the end, data were collected from 13 oncology centres in the Czech Republic and 12 oncology centres in the Slovak Republic. The initial plan to enrol 650 patients was not completed; data on 254 patients from the Czech Republic and 125 patients from the Slovak Republic were finally analysed.The effectiveness of retrospective data collection in the conditions of Czech and Slovak oncology corresponded with the possibilities of access to data of formerly diagnosed and treated patients. In searching for retrospective data the present hospital information systems could not be used in most oncology centres.Therefore, the cost of retrospective data collection was estimated and was shown to be relatively high.

The binding methodical conclusion is that unless a systemic change is made in the functionality of hospital information systems and standardised electronic documentation is introduced, the retrospective collection of clinical data in our conditions will be associated with high costs and a relatively low recovery factor.