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Understanding implementability in clinical trials: a pragmatic review and concept map
Miranda S Cumpston1, Steven A Webb2, Philippa Middleton3
1School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Rd, Melbourne, VIC, 3004, Australia. miranda.cumpston@monash.edu.
This study developed a concept map to improve the implementation of clinical trial evidence into practice. The map helps researchers enhance trial design, conduct, and reporting for better real-world application.
Area of Science:
- Clinical Trials
- Implementation Science
Background:
- Translating clinical trial evidence into practice is challenging.
- Trial implementability, encompassing design, execution, and reporting, influences evidence adoption.
- The Australian Clinical Trials Alliance (ACTA) initiated this review to address implementability.
Purpose of the Study:
- To develop a concept map of implementability for late-phase clinical trials.
- To identify factors influencing the capacity for trial evidence to be implemented.
Main Methods:
- A pragmatic literature review was conducted.
- Included documents published after 2009, focusing on trial design, conduct, reporting, and implementability factors.
- Snowballing searches and expert input were utilized to develop the concept map.
Main Results:
- Sixty-five resources were included in the review.
- A concept map with 38 concepts was developed, covering validity, relevance, and usability across trial phases.
- Concepts integrated knowledge from implementation science, consumer engagement, and reporting guidelines.
Conclusions:
- The concept map serves as a tool for trialists to enhance implementability.
- Future research should validate concept associations and intervention effectiveness.
- ACTA plans to use the map to create guidance for Australian trialists.
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