Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals

doi:10.1136/bmj.38413.576713.AE

BMJ 2005;330:1057-1058 (7 May), doi:10.1136/bmj.38413.576713.AE (published 10 March 2005)

Paper

Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals

Catherine Hewitt, PhD student¹, Seokyung Hahn, assistant professor², David J Torgerson, director¹, Judith Watson, research fellow¹, J Martin Bland, professor of health statistics¹

¹ York Trials Unit, Department of Health Sciences, University of York, York YO10 5DD, ² Medical Research Collaborating Center, Seoul National University Hospital/College of Medicine, Seoul 110-744, Korea

Correspondence to: C Hewitt ceh121@york.ac.uk

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

Introduction

In randomised controlled trials, allocation concealment (separatingthe process of randomisation from the recruitment of participants)is important for rigorously designed trials.^1-4 In 1996 manymajor medical journals adopted the CONSORT statement (wherebyresearchers have to include a short checklist of essential itemsand a flow diagram when reporting trials),⁵ and this move encouragedthe reporting of allocation concealment. We reviewed the prevalenceof adequate allocation concealment and its association withthe statistical significance of trial results.

Methods and results

We searched by hand four general medical journals (the BMJ,JAMA, the Lancet, and the New England Journal of Medicine) toidentify randomised controlled trials published from January2002 to December 2002. We included articles if the authors reportedthat participants were randomised and if the trial was publishedas a full report with the results of the main analyses. We categorisedarticles according to whether allocation concealment was adequate. . . [Full text of this article]

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