HEALTH TECHNOLOGY ASSESSMENT NEEDS INFORMATION TECHNOLOGY- THE EXPERIENCE FROM THE FIRST ITALIAN STUDY ON THE DA VINCI SURGICAL ROBOT
Author(s)
Manetti S1, Palla I1, Freschi C2, Cuschieri A3, Turchetti G1
1Scuola Superiore Sant'Anna, Pisa, Italy, 2University of Pisa, Pisa, Italy, 3University of Dundee, Dundee, UK
OBJECTIVES: Health Technology Assessment of innovative biomedical devices still requires the effort to introduce dedicated Information Technology tools able to support the implementation of the evaluation process. The aim of the study was to systematize the collection, the management and the analysis of large volumes of multidimensional data in order to optimally conduct an HTA study of emerging technologies. METHODS: We designed a relational database, subsequently we developed and implemented a centralized, web-based user-friendly data entry for Case Report Form (CRF) data collection. (i) The development of User Interface (UI), (ii) data anonymization, (iii) differentiate accesses, (iv) automated quality control checks for data entry, (v) appropriate system tables to make data entry uniform, and (vi) the possibility of creating final reports were addressed. In the data extraction phase, we used MySQL computer languages and combined PHP and HTML codes. Knowledge Discovery in Data process was implemented with different software and programming languages for automation of the data collection, extraction and analysis. RESULTS: The IT tools have been applied to the first multicenter prospective Italian study of HTA on the da Vinci surgical system, obtaining meaningful end points in terms of costs and clinical outcomes. The study involved the enrolment of 699 patients from the 8 Italian Teaching Hospitals in the period 2011-2014. Patients were enrolled and prospectively evaluated from the preoperative work-up till six months after the discharge. CONCLUSIONS: The IT tools developed allow researchers to more efficiently and effectively manage large volumes of various source of HTA data, enhancing data quality from storage to processing. The database design could be empowered and readjusted for other HTA studies in near future and the entire approach generalized. In the immature field of HTA of innovative biomedical devices, this example of application could promote the automation of the implementation process of HTA.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PRM63
Topic
Real World Data & Information Systems
Topic Subcategory
Reproducibility & Replicability
Disease
Multiple Diseases