NATALI--a model for National Computer Databases in the investigation of new therapeutic techniques

Area of Science:

• Vascular Surgery
• Medical Informatics
• Clinical Trial Monitoring

Background:

• New medical treatments, such as peripheral arterial thrombolysis, are frequently implemented without rigorous randomized trials.
• Effective monitoring systems are crucial for assessing the safety and efficacy of novel therapeutic interventions.
• Existing methods for outcome analysis in thrombolysis may lack standardization and comprehensive data capture.

Purpose of the Study:

• To describe the development of a national computerized database for monitoring peripheral arterial thrombolysis.
• To introduce a novel method for analyzing angiograms using computer-generated arterial maps.
• To establish a framework for multi-center audit and the evaluation of new treatments.

Main Methods:

• Creation of a national computerized database (Auditbase for Windows) by the Thrombolysis Study Group.
• Prospective data collection from 14 hospitals across the UK.
• Development of a technique to transfer angiograms to computer-generated arterial maps for outcome classification and analysis.

Main Results:

• The database successfully integrated prospective data from multiple institutions.
• The novel arterial mapping method aids in the classification and analysis of thrombolysis outcomes.
• Contributing hospitals receive continuous audits of their results and complications, benchmarked against the group average.

Conclusions:

• The developed computerized database and arterial mapping system provide a robust method for monitoring peripheral arterial thrombolysis.
• This model is suitable for multi-center audits of new treatments, especially those lacking randomized trial data.
• The system enhances continuous quality improvement by enabling comparison of individual and group performance.