Improvement in Reporting Quality of Clinical Trials in Gastroenterology Journals
Author Information
Author(s): Wang Ji-Lin, Sun Tian-Tian, Lin Yan-Wei, Lu Rong, Fang Jing-Yuan
Primary Institution: Department of Gastroenterology, Shanghai Jiao-Tong University School of Medicine Ren-Ji Hospital
Hypothesis
The methodological reporting quality of randomized controlled trials in major hepato-gastroenterology journals improved after the CONSORT Statement was revised in 2001.
Conclusion
The reporting of several important methodological aspects improved in 2008 compared to 1998, indicating increased awareness of the CONSORT statement, but there is still much room for improvement.
Supporting Evidence
- The proportion of RCTs reporting sequence generation increased from 10% in 1998 to 22% in 2008.
- Allocation concealment reporting improved from 25% in 1998 to 62% in 2008.
- Sample size calculation reporting rose from 47% in 1998 to 78% in 2008.
- Intention-to-treat analyses improved from 42% in 1998 to 69% in 2008.
- Incomplete outcome data addressed increased from 34% in 1998 to 49% in 2008.
Takeaway
This study looked at how well clinical trials in gastroenterology reported their methods. It found that reporting got better over ten years, but there's still a lot of work to do.
Methodology
RCTs from five major journals published in 1998 or 2008 were evaluated based on the CONSORT Statement and Cochrane Handbook.
Potential Biases
Potential bias due to inadequate reporting of methodological details.
Limitations
The study only included five major journals and assessed RCTs for two years, which may not represent the entire field.
Participant Demographics
RCTs published in 2008 had a median of 167 participants, while those in 1998 had a median of 94 participants.
Statistical Information
P-Value
<0.05
Confidence Interval
95%CI 3.11-10.42
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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