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Clinical trials in general surgical journals: are methods better reported?
L P Schumm1, J S Fisher, R A Thisted
1University of Chicago Hospitals, Ill., USA.
Surgery
|January 16, 1999
Summary
Reporting of clinical trial design and analysis in surgical journals has improved but remains inadequate in key areas like randomization and blinding. Further improvements are needed for readers to properly assess study findings.
Area of Science:
- Medical Research Methodology
- Surgical Clinical Trials
Background:
- Clinical trial reports frequently lack sufficient design and analysis details, hindering reader assessment of findings.
- A 1984 review found only 59% reporting of 11 essential clinical trial elements in surgical journals.
- This study aimed to identify persistent areas needing improvement in reporting standards.
Purpose of the Study:
- To assess the current reporting standards of clinical trial design and analysis in general surgery journals.
- To compare reporting frequencies with a previous study from 1984.
- To identify specific elements of clinical trial reporting that require further enhancement.
Main Methods:
- A review of 68 comparative clinical trials published in 6 general surgery journals between July 1995 and June 1996.
- Evaluation of the reporting frequency of 11 previously identified basic elements of clinical trial design and analysis.
- Prospective studies with at least two treatment arms were included.
Main Results:
- Reporting accuracy increased by 15% to 74%, with improvements across all journals.
- Eligibility criteria and statistical power reporting showed the most significant gains.
- Reporting remained inadequate for statistical power (32%), randomization methods (40%), and blinding of outcome assessors (49%).
Conclusions:
- While reporting of surgical clinical trials has improved since the 1980s, critical methodological elements continue to be poorly reported.
- Key areas such as randomization and blinding require substantial improvement to ensure trial transparency and validity.
- Surgical journal editors should implement guidelines for authors on reporting clinical trial design and analysis effectively.
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