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Development of best practice principles for simplifying eligibility criteria
Justin Doods1, Kirstin Holzapfel, Martin Dugas
1Institute of Medical Informatics, University of Münster, Germany.
Studies in Health Technology and Informatics
|August 8, 2013
Summary
Real-world data from electronic health records (EHR) can improve clinical research. This study simplified complex eligibility criteria and created a guideline to bridge the gap between EHR data and study protocols.
Area of Science:
- Clinical research informatics
- Health data science
- Medical informatics
Background:
- Real-world data (RWD) is essential for advancing clinical research.
- Electronic health records (EHR) are increasingly storing valuable RWD within healthcare systems.
- Challenges exist in utilizing EHR data for clinical trial feasibility and patient recruitment due to complex study criteria.
Purpose of the Study:
- To simplify complex eligibility criteria found in clinical study protocols.
- To develop a guideline with best practice principles for formulating understandable and electronically usable criteria.
- To bridge the gap between available EHR data and the requirements of clinical trial eligibility criteria.
Main Methods:
- Simplification of existing eligibility criteria from study protocols.
- Development of a guideline based on best practice principles.
- Inclusion of illustrative examples of 'good' and 'bad' criteria formulation.
Main Results:
- A simplified set of eligibility criteria was developed.
- A guideline detailing best practices for criterion formulation was created.
- Examples were provided to differentiate between effective and ineffective criteria.
Conclusions:
- Simplified eligibility criteria enhance the usability of EHR data for clinical research.
- The developed guideline provides a framework for creating understandable and electronically accessible criteria.
- Implementing these principles can improve clinical trial feasibility and patient recruitment by leveraging RWD.
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