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Quantitative evaluation of clinical software, exemplified by decision support systems
1ICRF Centre for Statistics in Medicine, Institute for Health Sciences, Headington, Oxford, UK. jeremy.wyatt@ucl.ac.uk
International Journal of Medical Informatics
|March 26, 1998
Summary
Evaluating clinical computer systems requires rigorous testing to ensure accurate information for regulatory agencies. This paper focuses on the complex challenge of evaluating clinical decision support systems.
Area of Science:
- Health Informatics
- Computer Science
- Medical Software Evaluation
Background:
- Regulatory agencies need reliable data on clinical computer systems for "truth in labelling" and licensing.
- Evaluating system structure, performance, and user impact is crucial for informed decisions.
- Clinical decision support systems (CDSS) present unique evaluation challenges due to their complexity.
Purpose of the Study:
- To highlight the necessity of structured, rigorous evaluation programs for clinical computer systems.
- To identify clinical decision support systems as a key focus area for evaluators.
- To outline the information required by regulatory bodies for system certification.
Main Methods:
- The paper emphasizes the need for a structured and rigorous evaluation program.
- It identifies the types of information required: structure, performance, and impact.
- The focus is on the challenges posed by complex software like CDSS.
Main Results:
- A structured evaluation program is essential for reliable data collection.
- Clinical decision support systems are identified as posing the greatest challenge to evaluators.
- The paper underscores the importance of comprehensive system assessment.
Conclusions:
- Rigorous evaluation is paramount for ensuring the safety and efficacy of clinical computer systems.
- Specialized approaches are needed for evaluating complex systems like CDSS.
- Standardized evaluation protocols are vital for regulatory oversight and user trust.