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Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A
Zet Wei Tan1, Aidan Christopher Tan2, Tom Li1
1Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
BMJ Open
|August 28, 2020
Summary
Reporting quality of randomized controlled trial (RCT) protocols improved after the SPIRIT statement. However, many checklist items remain poorly reported, necessitating continued efforts for completeness and transparency in clinical trial research.
Area of Science:
- Clinical Trials Methodology
- Research Integrity
- Scientific Publishing Standards
Background:
- The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement was published in 2013 to enhance the quality of clinical trial protocols.
- Assessing the impact of the SPIRIT statement on the reporting quality of published randomized controlled trial (RCT) protocols is crucial for improving research transparency.
Purpose of the Study:
- To evaluate the reporting quality of RCT protocols published before and after the implementation of the SPIRIT statement.
- To identify factors associated with the reporting quality of RCT protocols.
Main Methods:
- A methodological study involving the electronic search of MEDLINE, Embase, and CENTRAL databases.
- Analysis of 300 RCT protocols (150 pre-SPIRIT and 150 post-SPIRIT) to determine the proportion of adequately reported checklist items.
Main Results:
- Adequate reporting of checklist items in RCT protocols increased from 47.9% before SPIRIT to 56.7% after SPIRIT, representing a significant mean improvement of 8.8%.
- While 40% of items showed improvement, 11.3% deteriorated in reporting quality; no protocols were fully complete.
- Factors associated with higher reporting quality included author expertise, multicenter trials, longer protocol length, and journals with explicit SPIRIT compliance policies.
Conclusions:
- The SPIRIT statement has led to a significant improvement in the overall reporting quality of RCT protocols.
- Despite improvements, substantial deficiencies in reporting individual checklist items persist, highlighting the need for ongoing efforts.
- Enhanced transparency and completeness in RCT protocols require concerted action from journals, editors, reviewers, and investigators.
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