[Evaluation of standardized routine documentation with implementation of the requirements of multicenter studies....

In 1988 we did develop an EDP-System for data collection of daily routine documentation, which allows on the one hand a complete registration and on the other hand only offers entire and plausible data because of the logical program structure. The registered data are saved in a data bank structure as well as in report form for routine documentation. The substitution of routine documentation by such a system essentially depends on the content of interrogation which has to reflect the user's individual indication and operative technique. First doubts about reflection of the high variation of the individual operative technique could be disproved with help of the evaluation of this system of documentation. None of the 200 registered cases had to be documented without the help of the standardized system. The use in a prospective multicenter study for endoprosthesis of the knee was the starting point of the evaluation for the system's efficiency and acceptance. It had been analyzed the expressiveness of the study's documentation. As there was no standard in free dictated operation records the information content seemed to be reduced and with regard to scientific aspects unqualified. The analysis of the EDP-system especially checked three aspects: the general suitability to represent medical facts by standardized evaluation as well as the user's and patient's acceptance. All in all this system is an instrument for standardized daily routine documentation in a clinic which seems able to establish a quality management because of the high data quality, the differentiated registrations of multiple parameters and timeneutral application.