Randomised trials in surgery: problems and possible solutions

doi:10.1136/bmj.324.7351.1448

BMJ 2002;324:1448-1451 ( 15 June )

Education and debate

Randomised trials in surgery: problems and possible solutions

Peter McCulloch, senior lecturer in surgery ^a, Irving Taylor, professor of surgery ^b, Mitsuru Sasako, professor of surgery ^c, Bryony Lovett, lecturer in surgery ^d, Damian Griffin, clinical reader ^e.

^a Academic Unit of Surgery, University of Liverpool, Clinical Sciences Centre, University Hospital Aintree, Liverpool L9 7AL, ^b Department of Surgery, Royal Free and University College Medical School, Charles Bell House, London W1W 7EJ, ^c Gastric Surgery Division, National Cancer Centre Hospital, Tsukiji, 5-1-1 Chuo-Ku, Tokyo, Japan, ^d Basildon Hospital, Nethermayne, Basildon SS16 5NL, ^e Nuffield Department of Orthopaedic Surgery, Orthopaedic Centre, Oxford OX3 7LD

Correspondence to: P McCulloch, Academic Unit of Surgery, University of Liverpool, Clinical Sciences Centre, University Hospital Aintree, Long Lane, Liverpool L9 7AL petermcculloch@cs.com

The first 150 words of the full text of this article appear below.

The quality and quantity of randomised trials of surgical techniques is acknowledged to be limited. According to Peter McCullochand colleagues, however, some aspects of surgery present specialdifficulties for randomised trials. In this article they analysewhat these difficulties are and propose some solutions for improvingthe standards of clinical research in surgery

The improvement in the quality of clinical research in the past decade is to be welcomed, but it carries its own dangers.Some have extrapolated the advantages of the randomised controlledtrial (RCT) into the dogma that it is the only valid method forcomparing treatments,¹ ignoring the difficulties that havehampered the use of RCTs in some disciplines. The RCT has theoreticaladvantages over other study designs, but experimental studiescomparing treatment effect estimates in randomised and non-randomisedstudies have not consistently confirmed this, ² ³ ^w1-w3 and the superiority of RCTs should not therefore be acceptedas. . . [Full text of this article]

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