Surgery on trial: an account of clinical trials evaluating operations.

Abstract

BACKGROUND: The objective of this study was to review published clinical trials to determine the level of compliance with issues relevant to operations. METHODS: We evaluated 10 methodologic criteria in 186 trials that were published in 10 prestigious journals between January 1986 and December 1995. RESULTS: One quarter of the trials failed to provide a clear account of the operative technique, 34% of the trials did not adequately detail the adverse events that occurred after operation, and 40% of the trials neglected to declare the nature and success of the follow-up of patients after the operation. Only 35% of the trials indicated that there was an attempt to standardize either the surgical procedure or perioperative care. In addition, less than 20% of the trials declared a method for assessing compliance with the surgical protocol or commented on the use of resources during the perioperative period. CONCLUSIONS: Greater attention needs to be paid to the specific issues that arise when operations are evaluated in clinical trials.

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