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Created on : 16 Jul 2006
Modified on : 02 Dec 2007

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Bibliographical entry (without author) :

Inappropriate use of randomised trials to evaluate complex phenomena: case study of vaginal breech delivery. BMJ 2004;329:1039-1042 (30 October)

Author(s) :

Kotaska, Andrew

Year of publication :

2004

URL(s) :

http://bmj.bmjjournals.com/cgi/content/full/329/74…

Résumé (français)  :

Abstract (English)  :

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.

Hannah et al’s trial showed a significant increase in perinatal mortality and morbidity in women randomised to a trial of labour compared with elective caesarean section.1 The trial’s methodological flaws have been examined,2-4 but the intrinsic limitations of applying large scale randomisation to complex phenomena have received little attention. These limitations are the focus of this paper.

Sumário (português)  :

Resumen (español)  :

Comments :

Argument (français) :

As randomised trials continue to ascend in the evolution of evidence based medicine, we must recognise
and respect their limitations when examining complex phenomena in heterogeneous populations

Argument (English):

Argumento (português):

Argumento (español):

Keywords :

➡ evidence-based medicine/midwifery ; dystocy ; breech presentation

Author of this record :

Bernard Bel — 16 Jul 2006