RANDOMIZED CONTROLLED TRIALS IN SURGERY

Background. The objective was to determine the number of randomized co ntrolled trials (RCT) performed by surgeons, published in surgical jou rnals, or comprising a surgical arm and to assess their characteristic s and overall quality. Methods. RCT in general surgery (including gast rointestinal, breast, surgical oncology, vascular, critical care, and trauma) published in 1990 were retrieved by MEDLINE and analyzed to de termine the funding agency, type of therapy, area of surgery, journal published, country of origin, number of centers, and wheter a surgeon was the principal author. The completeness of MEDLINE search was compa red to a manual search of the literature. All RCT were assessed with C halmers' qualitative score. Results. MEDLlNE retrieved 202 surgical RC T (46% of those retrieved by a manual search) with a mean score of 0.4 0+/-0.13. However, surgical RCT were performed by surgeons in only one third of trials, compared surgical therapies in only one quarter of t rials, and were published in surgical journals in less than one third of trials. Only 22% of surgical RCT were funded by peer reviewed grant ing agencies. The strongest variables determining the quality of surgi cal RCT were the type of therapy tested (p = 0.0001), the type of jour nal published (p = 0.006), and the area of general surgery (p = 0.007) .