Global Physicians and Healthcare Congress

Objective: Despite the lack of supportive evidence, the claim that randomized trials (RCT’s) is the Gold Standard is unfortunately too popular to be questioned. This is a presentation of original research exposing the fallacies of RCT’s in surgery. Material & Method: A prospective study of enrolment patterns in the largest completed Australian RCT for laparoscopic surgery for colon cancer (ALCCaS) was conducted for a six-month period and the results compared with those from other published studies. This was followed by a systematic review of the reasons for non-entry of eligible patients in surgical RCT’s. The results of an RCT and of a case control study performed under the same conditions were statistically compared. Two contemporaneous meta-analyses of RCT’s and of non-randomized comparative studies (NRCS’S) of the same procedure were then conducted and their results statistically compared. Result: At best, 45% of eligible patients are enrolled in RCT’s of surgical procedures. The most commonly recorded reason for failure to enroll is a preference for one form of surgery. In the ALCCaS, about 1 in 5 accredited surgeons never recruited any patients and a further 29% ceased to be involved very early in the trial. There is a strong suggestion that systematic differences between enrolled and eligible but not enrolled patients do exist. There is a suggestion that a NRCS of surgical procedure may exaggerate the effect estimate compared with and a RCT but the evidence for this is weak. The results of the meta-analysis of 12 RCT’s (2512 resections) and those of the meta-analysis of 49 NRCS’s (6438 resections) for 13 variables common between the two meta-analyses, were more than 95% similar. Conclusion: There may be no need for us to bother with RCT’s for surgical procedures as the results of their meta-analyses are probably just as accurate or just as inaccurate as those of NRCS’s.