Evolution of Methodological Standards in Surgical Trials

Background: The Consolidated Standards of Reporting Trials (CONSORT) Statement outlines acceptable ways of performing and reporting clinical trials. The objective of the present study was to identify evolving patterns in the methodological standards of surgical trials.

Methods: Compliance with 12 key standards from the CONSORT statement were evaluated in 490 trials published in either the ANZ Journal of Surgery or the British Journal of Surgery between January 1969 and December 2003.

Results: There has been an irregular but progressive improvement in the methodological standards of published trials. The criteria with the greatest improvement related to estimation of sample size, randomization, concealment of the allocated intervention, baseline comparisons, and the method of expressing outcomes. Compliance rates were <50% for three criteria during the last decade of the review, that is, concealment of the allocated intervention, blindness of assessment, and the method of expressing outcomes.

Conclusion: The results of surgical trials need to be interpreted with care.