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Data management system for diabetes clinical trials: a pre-post evaluation study
Aynaz Nourani1, Haleh Ayatollahi2,3, Masoud Solaymani-Dodaran4
1Department of Health Information Technology, Urmia University of Medical Sciences, Urmia, Iran.
BMC Medical Informatics and Decision Making
|January 20, 2023
Summary
A data management system for diabetes clinical trials largely met user expectations but requires improvements in system quality and user autonomy. Further evaluation in multicenter trials is recommended.
Area of Science:
- Clinical Informatics
- Health Data Management
- Diabetes Research
Background:
- Diabetes clinical trials rely on robust data management systems.
- Evaluating system quality and usability is crucial for effective clinical research.
- User perspectives are key to assessing data management tool performance.
Purpose of the Study:
- To evaluate the quality and usability of a diabetes clinical trial data management system.
- To assess user satisfaction and identify areas for system improvement.
- To compare user expectations with system performance.
Main Methods:
- A pre-post evaluation design was employed in 2020.
- Questionnaires assessed researcher expectations and post-use perspectives (n=30).
- The study focused on information quality, service quality, achievements, communication, system quality, and user autonomy.
Main Results:
- No significant differences in information quality, service quality, achievements, or communication.
- System quality (P=0.042) and user autonomy (P=0.026) fell short of user expectations.
- Overall system usability was rated as good by users.
Conclusions:
- The data management system generally met user expectations but needs enhancement in system quality and user autonomy.
- Recommendations include further development and re-evaluation in multicenter trials with a larger user base.
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