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Published on: June 21, 2010
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A framework for best practices in clinical outcome assessment (COA) concept mapping: a case study
Meaghan O'Connor1, Lynne Broderick2, Miranda Lauher-Charest2
1Quality Metric, Johnston, RI, USA. moconnor@qualitymetric.com.
Summary
This study developed a framework for best practices in clinical outcome assessment (COA) concept mapping. Applying it to knee osteoarthritis (KO) showed 75% of SF-36v2 items mapped to KO concepts, demonstrating framework utility.
Area of Science:
- Health Outcomes Research
- Clinical Trial Methodology
- Patient-Reported Outcomes
Background:
- Evaluating concept coverage of clinical outcome assessments (COAs) often involves mapping items to condition-defining concepts.
- A lack of formal guidance exists for conducting COA concept mapping effectively.
Purpose of the Study:
- To develop a framework outlining best practices for COA concept mapping.
- To apply this framework in a case study evaluating the SF-36v2 Health Survey for knee osteoarthritis (KO).
Main Methods:
- Literature review and expert focus groups were used to develop the best practices framework.
- Data from a systematic review of KO symptoms and impacts were extracted.
- The developed framework was applied to map concepts to items in the SF-36v2.
Main Results:
- The framework provides guidance on mapping purpose, data sources, principles, and decision thresholds.
- The case study successfully mapped 27 out of 36 (75%) SF-36v2 items to concepts defining KO.
- This demonstrates the framework's utility in assessing COA concept coverage.
Conclusions:
- The developed framework facilitates consistent, reliable, and reproducible COA concept mapping.
- Clear concept definitions, guiding principles, and a structured process are crucial.
- This approach provides evidence for COA suitability for specific patient populations.
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