Methodologic standards in surgical trials

Surgery. 1996 Apr;119(4):466-72. doi: 10.1016/s0039-6060(96)80149-8.


Background: Concerns have been raised that flaws in the design and analysis of trials will hinder the interpretation of their relevance to clinical practice. The objective of this study was to review the nature and methodologic standards of surgical trails published in 10 prestigious journals between January 1988 and December 1994.

Methods: We evaluated the demography and methodologic standards of 364 trials. Each article was independently scrutinized by two assessors with documentation of the interassessor variation.

Results: Less than 50% of the trials made comment about an unbiased assessment of outcome, gave an adequate description of the randomization technique, or provided a prospective estimate of the sample size. Economic factors were declared in 6.5% of the trials. Only 2% of the trials attempted to measure the effect of an intervention on the quality of life patients.

Conclusions: Readers should be cautious when interpreting the results of surgical trials.

MeSH terms

  • Clinical Trials as Topic / methods*
  • Humans
  • Surgical Procedures, Operative*