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Reporting randomized, controlled trials: where quality of reporting may be improved
Clifford Y Ko1, Jonathan Sack, John T Chang
1Department of Medicine, UCLA School of Medicine and Public Health, Los Angeles, California 90095-6904, USA.
Diseases of the Colon and Rectum
|May 15, 2002
Summary
Reporting quality in colorectal surgery journals is improving, but statistical power calculations remain underreported. Enhancing reporting of this key element could significantly improve the quality of clinical studies.
Area of Science:
- Clinical research methodology
- Surgical reporting standards
- Evidence-based medicine
Background:
- High-quality reporting is crucial for evidence-based medicine.
- Previous studies show room for improvement in clinical trial reporting.
- This study assesses reporting quality in colorectal surgery journals.
Purpose of the Study:
- Evaluate reporting quality of randomized controlled trials (RCTs) in Diseases of the Colon and Rectum.
- Identify specific areas for improvement in RCT reporting.
- Compare reporting quality with other major surgical and medical journals.
Main Methods:
- Two independent evaluators assessed RCTs published in Diseases of the Colon and Rectum in 1990, 1995, and 2000.
- RCTs from Annals of Surgery, Archives of Surgery, and Gastroenterology were also assessed for 2000.
- Reporting frequency of 11 key design and analysis elements was determined.
Main Results:
- Reporting quality in Diseases of the Colon and Rectum improved from 60% in 1990 to 77% in 2000.
- Eligibility criteria, statistical tests, and loss to follow-up were well-reported.
- Statistical power calculations were reported in only 11% of 2000 RCTs, a significantly underreported item.
Conclusions:
- While reporting quality in Diseases of the Colon and Rectum is improving, specific elements require attention.
- Underreporting of statistical power calculations hinders the interpretation of RCT results.
- Adherence to reporting guidelines for key elements, especially power calculations, can enhance overall study quality in colorectal surgery.