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  1. Surgery on trial : An account of clinical trials evaluating operations.

    Article - En anglais

    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.

    Mots-clés Pascal : Chirurgie, Technique, Intervention, Complaisance, Modification, Relation incertitude, Résultat, Etude comparative, Revue bibliographique, Homme

    Mots-clés Pascal anglais : Surgery, Technique, Operation, Compliance, Modification, Uncertainty relation, Result, Comparative study, Bibliographic review, Human

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 98-0353748

    Code Inist : 002B25N. Création : 27/11/1998.