European Multicenter Study about Spinal Cord Injury
Design and purpose of the project > The Database

The Database

In the clinical environment the problem arises that the acquisition of hundreds of parameters and the examination dates have to be coordinated in each participating center, which is a time and cost demanding challenge.

Therefore an electronic tool was developed within the EMSCI project. The main design criteria for the implementation of the EMSCI assessment scheme into an electronic tool for supporting the centers in data acquisition and data transfer were the following:

  1. Maximum data security = no third party access to personal patient records
  2. Maximum accessibility = distributed storage
  3. Easy to install in a clinical computational infrastructure
  4. Widespread and inexpensive runtime environment
  5. Maximum flexibility for integration of additional tests forms or deletion of parameters

To fulfil the demands listed above especially the concerns about data security, accessibility and flexibility we have decided not to implement a web-based concept, but to follow the standards of the “National Spinal Cord Injury Database”, which suggest a decentralized, stand-alone solution. Microsoft Access (Microsoft Inc.) as part of the widespread Office package and Visual Basic for Applications (VBA, Microsoft Inc.) were used either as the development and the runtime environment. The database is accessible via a network and is designed for simultaneous multi-user access. In regular intervals an update database, which makes necessary modifications to the backends (Fig. 1), based on VBA procedures, is distributed together with an updated version of the frontend. For performing the update no additional software tools are necessary. The unified implementation of the update database guarantees the flexibility needed within research projects.

The frontend contains all the definitions of the acquisition forms for the neurological, functional and electrophysiological documentation of SCI patients with a consistent appearance. Additional functions for automated time scheduling and a “missing tests”-function help to comply with the dedicated time frames for each patient. Either text-based or graphical reports may be generated. Beside rules for online data validation also additional calculation algorithms are included like an automated determination of the ASIA (American Spinal Injury Association) Impairment Scale. Especially the latter is an effective method for minimization of a likely source of errors in the formation of patient subgroups.

The EMSCI-database has been originally used in 5 spinal cord injury centers as a valuable tool for data collection within the framework of the “European Multi-Center Study about Spinal Cord”. Since its first distribution in 2001 the tests data of over 800 patients (March 2006) with more than 1000 parameters each have been collected and statistically analysed.

In the meantime the presented tool has been distributed to 18 (february 2006) spinal cord injury centers all over Europe. This will form the basis for documentation of novel therapies for spinal neuroregeneration within a European-wide network as a serious counterpart to the American “Model Spinal Cord Injury System”.

(from: Rupp R, et. al. An electronic tool for multicenter administration, assessment and analysis of clinical trials in spinal cord injury
Biomedizinische Technik, 2005)