Hostname: page-component-cd9895bd7-gxg78 Total loading time: 0 Render date: 2024-12-29T14:17:56.208Z Has data issue: false hasContentIssue false
  • English
  • Français

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
Get access Rights & Permissions [Opens in a new window]

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 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

Declaration of interest

None.

References

Altman, D. G. (1996) Better reporting of randomised controlled trials: the CONSORT statement. British Medical Journal, 313, 570–571.CrossRefGoogle ScholarPubMed
Altman, D. G., Gore, S. M., Gardner, M. J., et al (1998) Statistical guidelines for contributors to medical journals. In Statistics with Confidence (eds Gardner, M. J. & Altman, D. G.), pp 83–100. London: BMJ Press.Google ScholarPubMed
Altman, D. G., & Dore, C. J. (1990) Randomisation and baseline comparisons in clinical trials. Lancet, 335, 149 153.CrossRefGoogle ScholarPubMed
Bailar, J. C. & Hosteller, F. (1988) Guidelines for statistical reporting in articles for medical journals. Annals of Internal Medicine, 108, 266–273.CrossRefGoogle ScholarPubMed
British Medical Journal (1991) Uniform requirements for manuscripts submitted to biomedical journals. British Medical Journal, 302, 338–341.CrossRefGoogle Scholar
Chalmers, I. (1998) Unbiased, relevant and reliable assessments in healthcare. British Medical Journal, 317, 1167–1168.CrossRefGoogle Scholar
Chalmers, T. C., Celano, P., Sacks, H. S., et al (1983) Biases in treatment assignment in controlled clinical trials. New England Journal of Medicine, 309, 1358–1361.CrossRefGoogle ScholarPubMed
Der Simonian, R., Charette, L. J., McPeer, B., et al (1982) Reporting on methods in clinical trials. New England Journal of Medicine, 306, 1332–1337.CrossRefGoogle ScholarPubMed
Liberati, A., Himel, H. N. & Chalmers, T. C. (1986) A quality assessment of randomised controlled trials of primary treatment of breast cancer. Journal of Clinical Oncology, 4, 942–951.CrossRefGoogle Scholar
Pocock, S. J. (1983) Clinical Trials. A Practical Approach. Chichester: John Wiley & Sons.Google Scholar
Sachet, D. L., Haynes, R. B., Guyatt, G. H., et al (1991) Clinical Epidemiology. A Basic Science for Clinical Medicine (2nd edn). Boston, MA: Little Brown.Google Scholar
Schulz, K. F., Chalmers, L., Grimas, A., et al (1994) Assessing the quality of randomisation from reports of controlled clinical trials published in obstetrics and gynaecology journals. Journal of the American Medical Association, 272, 125–128.CrossRefGoogle Scholar
Schulz, K. F., Chalmers, L., Hayes, R. J., et al (1995) Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Journal of the American Medical Association, 273, 408–412.CrossRefGoogle ScholarPubMed
Simon, R. & Wittes, R. E. (1985) Methodological guidelines for reports of clinical trials. Cancer Treatment Reports, 69, 1–3.Google ScholarPubMed
Sonis, J. & Joines, J. (1994) The quality of clinical trials published in the Journal of Family Practice. Journal of Family Practice, 39, 226–235.Google ScholarPubMed
van der Sande, R., van Rooijan, L., Buskens, E., et al (1997) Intensive in-patient and community intervention versus routine care after attempted suicide. A randomised controlled intervention study. British Journal of Psychiatry, 171, 35–41.CrossRefGoogle ScholarPubMed
Williams, H. & Davies, C. (1994) Reporting of assignment methods in clinical trials. Controlled Clinical Trials, 15, 294–298.CrossRefGoogle ScholarPubMed
Submit a response

eLetters

No eLetters have been published for this article.