TY - JOUR T1 - Randomised trials of new surgical procedures are necessary JF - Heart JO - Heart SP - 100 LP - 101 DO - 10.1136/hrt.81.1.100 VL - 81 IS - 1 AU - L D SHARPLES AU - N CAINE AU - P M SCHOFIELD AU - L M SHAPIRO AU - J DUNNING AU - J WALLWORK Y1 - 1999/01/01 UR - http://heart.bmj.com/content/81/1/100.abstract N2 - Sir,—It was with some dismay that we read the editorials on the problems and pitfalls of randomised controlled trials (RCTs) for evaluating new procedures in general1 and minimally invasive direct coronary artery bypass (MIDCAB) in particular.2 Many of the opinions offered in the articles arise from problems encountered as a result of poor design, planning, and execution of RCTs rather than as a result of the methodology itself.The timing of trials of new technologies is problematic. The ideal moment is between standardisation of the new technique and its wide dissemination, but this is often a very brief moment given the understandable enthusiasm for the newest methods. The “tidal wave” of new technology and the tendency to follow the “evaluation bypass” route in its introduction to the health service were two of the problems the National Health Service research and development strategy was set up to tackle. It is doing so by providing funding for scientific evaluation in RCTs, and minimally invasive cardiac surgery is one of the current priorities for research under the health technology assessment programme.Many technologies have been widely adopted and then later shown to be ineffective or harmful—for example, prophylactic antiarrhythmic drugs in acute myocardial infarction. Nor can we assume that less invasive or apparently more convenient techniques will be more acceptable to patients. The much praised trial comparing laparoscopic and open surgery for cholecystectomy has shown no difference between the two in terms of hospital stay, patient discomfort, return to work, and complications.3 Bonchek1 suggests that meta-analysis of large clinical series … ER -