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Randomisation in clinical trials

Published online by Cambridge University Press:  03 January 2018

Loafe Ogundipe ,
Anthony P. Boardman  and
Amy Masterson
Loafe Ogundipe
Affiliation:
Department of Psychiatry, School of Postgraduate Medicine, Keele University, Staffordshire
Anthony P. Boardman*
Affiliation:
Academic Department of Psychiatry, The Guy's, King's College and St Thomas' Hospitals' Medical and Dental School, London
Amy Masterson
Affiliation:
Academic Department of Psychiatry, The Guy's, King's College and St Thomas' Hospitals' Medical and Dental School, London
*
Dr A. P. Boardman, Academic Department of Psychiatry, The Guy's, King's College and St Thomas' Hospitals' Medical and Dental School, Guy's Campus, 5th Floor, Thomas Guy House, Guy's Hospital, London SE1 9RT
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Abstract

Background

Several studies of papers published in non-psychiatric medical journals that report on randomised controlled trials (RCTs) indicate that there is inadequate reporting of the process by which randomisation is carried out.

Aims

To examine the adequacy of the reporting of the procedure of randomisation in clinical trials of parallel design published in the British Journal of Psychiatry (BJP) and the American Journal of Psychiatry (AJP).

Method

All issues of the BJP and the AJP published between January 1990 and December 1998 were surveyed, and papers that reported on RCTs were examined to judge the adequacy of the reporting of the process of randomisation.

Results

We found 183 papers which claimed to report on RCTs (73 in the BJP and 110 in the AJP). Nine (8.2%) of those in the AJP and six (8.2%) in the BJP described the technique of creating the randomisation sequence. Two (1.8%) of those in the AJP and 11 (15.1%) of those in the BJP described the mechanism of allocating treatment. One paper in the AJP and five papers in the BJP described both the generation of random numbers and allocation.

Conclusions

Adequate reporting of the method of randomisation was uncommon. The RCT status of some of the papers must therefore be in doubt.

Type
Papers
Information
The British Journal of Psychiatry , Volume 175 , Issue 6 , December 1999 , pp. 581 - 584
Copyright
Copyright © 1999 The Royal College of Psychiatrists 

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Footnotes

Declaration of interest

None.

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