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Reporting clinical trials in general surgical journals
Surgery
|May 1, 1984
Summary
Reporting of clinical trial design and analysis in surgical journals is often inadequate. Key aspects like random allocation were well-reported, but methods for treatment assignment and statistical power were frequently missing.
Area of Science:
- Medical Research Methodology
- Clinical Trial Design
- Scientific Publication Standards
Background:
- Effective evaluation of therapeutic clinical trials requires clear reporting of design and analysis.
- Previous studies have highlighted deficiencies in reporting across medical journals.
Purpose of the Study:
- To assess the quality of reporting for key design and analysis elements in therapeutic clinical trials published in general surgical journals.
- To identify specific areas of strength and weakness in trial reporting within surgical literature.
Main Methods:
- A systematic review of 84 therapeutic clinical trials published in six general surgical journals between July 1981 and June 1982.
- Assessment of the reporting of 11 predefined critical aspects of clinical trial design and analysis.
Main Results:
- Overall, only 59% of the assessed design and analysis items were clearly reported.
- Reporting was strongest for random allocation (89%), loss to follow-up (86%), and statistical analyses (85%).
- Significant deficiencies were noted in reporting the method of treatment assignment (27%) and statistical power (5%).
Conclusions:
- Reporting standards for clinical trial design and analysis in surgical journals are suboptimal, mirroring issues in general medical journals.
- Recommendations include encouraging journals to provide explicit guidelines for reporting essential clinical trial components to improve transparency and interpretability.