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Treatment fidelity in clinical trials
Chad E Cook1,2,3, Bryan O'Halloran4, Steve Karas5
1Department of Orthopaedics, Duke University School of Medicine, Duke University, Durham, North Carolina - USA.
Archives of Physiotherapy
|September 23, 2024
Summary
Treatment fidelity ensures clinical trials are conducted as intended, encompassing protocol adherence, delivery quality, and patient compliance. Improving treatment fidelity is crucial for the overall accuracy and reliability of clinical trial results.
Area of Science:
- Clinical Trials
- Evidence-Based Medicine
- Healthcare Research
Background:
- Treatment fidelity (TF) traditionally assessed adherence to clinical trial protocols.
- Updated definitions incorporate therapeutic benefit and intervention design.
- Key components include protocol adherence, delivery quality, and participant adherence.
Purpose of the Study:
- To highlight the importance of treatment fidelity in clinical trials.
- To present cases where treatment fidelity was insufficient.
- To propose methods for enhancing treatment fidelity in research.
Main Methods:
- Review of clinical trial cases with identified treatment fidelity deficits.
- Discussion of updated treatment fidelity definitions and components.
- Exploration of opportunities for improving treatment fidelity.
Main Results:
- Identified instances where treatment fidelity was compromised in clinical trials.
- Highlighted the impact of deficits in protocol adherence, quality of delivery, and participant adherence.
- Provided actionable insights for addressing these deficits.
Conclusions:
- Treatment fidelity is a critical component of clinical trial integrity.
- Along with quality, risk of bias, and certainty of evidence, TF should be a key measure of clinical trial veracity.
- Enhancing TF is essential for reliable and therapeutically beneficial trial outcomes.
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