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Assessing reporting completeness and characteristics in decentralized randomized controlled trials: a scoping review
Juntao Wang1, Shuhui Li1, Chen Zhao2
1School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
This study evaluates reporting completeness in decentralized randomized controlled trials (RCTs) using a new checklist. Findings will inform improved CONSORT reporting guidelines for these evolving trial designs.
Area of Science:
- Clinical Trials Methodology
- Health Informatics
- Evidence-Based Medicine
Background:
- Decentralized clinical trials (DCTs) are rapidly increasing due to remote technology advancements.
- Existing CONSORT 2025 guidelines face challenges in addressing specific reporting needs of DCTs.
- This study addresses the need for enhanced reporting standards in decentralized randomized controlled trials.
Purpose of the Study:
- To evaluate the reporting characteristics and completeness of decentralized randomized controlled trials.
- To identify current reporting gaps in DCTs.
- To inform the development of a CONSORT extension guideline for DCTs.
Main Methods:
- A systematic search of six databases for DCTs published in 2023.
- Assessment of reporting completeness using a custom 26-item "CONSORT-DRCT" checklist, focusing on decentralized elements and intervention details.
- Independent review by two researchers with inter-rater agreement calculation, followed by descriptive and subgroup analyses.
Main Results:
- (Results will be populated upon study completion)
Conclusions:
- This protocol provides a framework for reviewing DCT reporting quality.
- The findings are expected to offer insights for refining CONSORT guidelines for decentralized randomized controlled trials.
- Improved reporting standards will enhance the transparency and reliability of DCTs.
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