Inappropriate use of randomised trials to evaluate complex phenomena: case study of vaginal breech delivery

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Abstract
Randomised controlled trials have greatly improved the quality of evidence guiding clinical practice, but when applied to complex phenomena, they have important limitations. Complex patient populations with poorly quantifiable variations between individuals present one area of difficulty; complex procedures requiring skill and clinical judgment present another. A large, well designed, and well executed randomised controlled trial of breech presentation at term, the “term breech trial,” by Hannah et al rapidly dictated a new standard of care for the management of breech deliveries around the world.1 Yet this trial failed to adequately appreciate both the complex nature of vaginal breech delivery and the complex mix of operator variables necessary for its safe conduct. Widespread acceptance of this trial's results has breached the limits of evidence based medicine.