Registry Design and Technology Planning

Abstract

The specific aim is to develop a scheme for a pediatric trauma information system to collect standardized, representative pediatric trauma data into a centralized national trauma registry for children (NTRC). The following objectives will be implemented to develop a model for future implementation:

1. We will evaluate whether existing trauma databases have software mechanisms for exporting data into a usable format. If exporting capabilities do not exist, software conversion programs will be evaluated for potential use.
2. Design a data transfer method to encrypt the file using a public key encryption (PGP), transfer file electronically to a central site by using File Transfer Protocol (FTP), Secure Shell (SSH) or via a web interface. A web interface will be designed which enables sites without data exporting capabilities to enter data into the national registry. The server software will also incorporate data validation. For security purposes, a secure web server will be used so that any data transmitted to/from it will be encrypted and therefore secure.
3. A sampling frame will be determined that includes hospitals by region. Existing trauma registries will be excluded from the sampling frame because it is anticipated that they will join the national program at some level. Information on type of hospital and volume of trauma patients seen, will be included. A two-stage probability proportional to size (PPS) cluster sampling design will be applied to this sampling frame.
4. Packets containing educational materials, automated free of charge report templates and descriptions of the benefits of joining the registry will be distributed to enhance site participation.
5. A database structure will be developed to utilize the intuitive format of Internet/Web technologies providing an easy to use interface on the client-side (clinical centers, other data collection sites), while providing the performance and reliability of MySQL on the server-side.
6. design a prospective chart review methodology with concurrent IRR aimed at: determining the extent of agreement between data submitted and data recorded on the patient chart; identifying areas for improvement of the data collection procedure; and improving data reliability.

A Gantt chart has been designed to track each objective and monitor the progress of each task within these objectives.

1. A documentation manual will be developed containing information on each existing registry with respect to data file types, exporting capabilities, export templates, entrance criteria, unique aspects of the registry, narrative identifying potential strengths and weaknesses, potential concerns and contact information.
2. The electronic data transfer design and creation of a user-friendly database will be monitored through regular progress reports from the data manager and systems analyst consultant outlining completion status of each task, potential obstacles and successful pilot testing.
3. Selection of a sample of hospitals for inclusion in the registry will be tracked through progress reports describing the completeness of the sampling scheme.
4. Major milestones include completion and distribution of the educational and benefit packets. Progress will also be monitored by the percent of hospitals contacted that agree to participate.
5. Data quality assurance activities will be monitored through regular progress reports of percent of sites with complete scheme designed, percent with data collected and percent analyzed. Analyzed results of the pilot IRR studies will be considered as milestones for this task, but will be conducted on anonymous patient data.