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Published on: February 19, 2021
Implementation science in hybrid randomized controlled trials: a state-of-the-art systematic review
Mark G Liu1, Elouise Comber2,3, Andrew Martin1
1ULTRA, The University of Queensland Clinical Trials Capability, Centre for Clinical Research, Brisbane, Qld, Australia.
JBI Evidence Implementation
|July 16, 2026
Summary
Hybrid randomized controlled trials (RCTs) are increasing but need improvement. Implementation science theories, models, and frameworks (TMFs) are used, but reporting quality requires attention for better evidence translation.
Area of Science:
- Implementation Science
- Clinical Trials
- Evidence Translation
Background:
- Hybrid randomized controlled trials (RCTs) integrate effectiveness and implementation research to expedite evidence translation.
- This methodology is evolving, necessitating a review of current practices and reporting standards.
Purpose of the Study:
- To characterize hybrid RCTs and assess their reporting quality.
- To examine the utilization of implementation science theories, models, and frameworks (TMFs) within hybrid RCTs.
Main Methods:
- A systematic search of citation-indexed databases (Web of Science, Scopus) was conducted from 2012 to 2025.
- Included studies were identified as 'hybrid' RCTs and cited/applied a TMF.
- Data on RCT design, implementation characteristics, and reporting quality (using StaRI standards) were extracted and analyzed.
Main Results:
- 111 papers were included, with most published recently (79%) and conducted in North America (62%) and primary care settings (50%).
- The Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework was most common (44%).
- Reporting quality was higher for clinical components (60%) than for implementation strategies (27%).
Conclusions:
- Hybrid RCTs applying TMFs are growing, but require further development.
- Most hybrid RCTs prioritize clinical effectiveness over implementation aspects.
- Enhanced application and reporting of TMFs can improve future hybrid RCT quality.
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