Hostname: page-component-78c5997874-ndw9j Total loading time: 0 Render date: 2024-11-02T19:49:06.201Z Has data issue: false hasContentIssue false
  • English
  • Français

Generalisability of results from randomised drug trials

A trial on antimanic treatment

Published online by Cambridge University Press:  03 January 2018

Rasmus Wentzer Licht ,
Georg Gouliaev ,
Per Vestergaard  and
Morten Frydenberg
Rasmus Wentzer Licht*
Affiliation:
Institute for Basic Psychiatric Research, Department of Psychiatric Demography, Psychiatric Hospital in Aarhus
Georg Gouliaev
Affiliation:
Clinical Department, Psychiatric Hcospitail in Aarhus, University of Aarhus, Risskov, Denmark
Per Vestergaard
Affiliation:
Clinical Department, Psychiatric Hcospitail in Aarhus, University of Aarhus, Risskov, Denmark
Morten Frydenberg
Affiliation:
Department of Biostatistics, University of Aarhus, Aarhus, Denmark
*
Dr Rasmus Wentzer Licht, Department A, Psychiatric Hospital in Aarhus, Skovagervej 2, DK-8240 Risskov, Denmark. Fax: +45 86-179124
Get access Rights & Permissions [Opens in a new window]

Abstract

Background

Exemplified by a randomised trial on antimanic treatment, this paper addresses the question of whether selection of patients for drug trials may limit the applicability of study results from the randomised patients to a wider population.

Method

During two-year period, all consecutively admitted patients from a defined catchment area were screened for inclusion criteria concerning age, diagnosis and severity of illness. The subsequently excluded subgroups of patients were compared with the randomised patients by multivariate data analysis.

Results

One hundred and sixty-four patients met the inclusion criteria. However, after exclusion for various reasons, only 27 (17%) patients remained for randomisation. The randomised patients and the excluded patients differed substantially.

Conclusions

The generalisability of trial results is limited. Reports of randomised drug trials should carefully describe the screening procedure for inclusion and, when possible, present relevant comparisons-between the randomised patients and the various subgroups of excluded patients.

Type
Papers
Information
The British Journal of Psychiatry , Volume 170 , Issue 3 , March 1997 , pp. 264 - 267
Copyright
Copyright © 1997 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.)

References

American Psychiatric Association (1987) Diagnostic and Statistical Manual of Mental Disorders (3rd edn. revised) (DSM-III-R). Washington, DC: APA.Google Scholar
Bech, P., Bolwig, T. G., Kramp, P., et al (1979) The Bech-Rafaelsen Mania Scale and the Hamilton Depression Scale. Acta Psychiatrica Scandinavica. 59, 420–430.CrossRefGoogle ScholarPubMed
Bowden, C. L., Calabrese, J. R., Wallin, B. A., et al (1995) Who enters therapeutic trials? Illness characteristics of patients in clinical drug studies of mania. Psychophcymocology Bultetin. 31, 103–109.Google Scholar
Bowen, J. & Hirsch, S. (1992) Recruitment rates and factors affecting recruitment for a clinical trial of a putative antipsychotic agent in the treatment of acute schizophrenia. Human Psychopharmacology. 7, 337–441.Google Scholar
Bowen, J. T. & Barnes, T. R. E. (1994) The clinical characteristics of schizophrenic patients consenting or not consenting to a placebo controlled trial of antipsychotic medication. Human Psychopharmacology, 9, 423–433.CrossRefGoogle Scholar
Elwood, J. M. (1988) Selection of subjects for study. In Causal Relationships in Medicine (ed. Elwood, J. M.). pp. 38–57 Oxford: Oxford University Press.Google Scholar
Endicott, J. & Spitzer, R. L. (1978) A diagnostic interview; The Schedule for Affective Disorders and Schizophrenia. Archives of General Psychiatr, 35, 837–844.CrossRefGoogle ScholarPubMed
Goullaev, G., Licht, R. W., Vestargaard, P., et al (1998) Treatment of manic episodes: Zuclopenthixol and clonazepam versus lithium and clonazepam. Acto Psychiatrica Scandinavica, 93 119–124.Google Scholar
Grell, W., Ludwig-Mayerhofer, W., Steller, B., et al (1993) The recruitment process for a multicenter study on the longterm prophylactic treatment of affective disorders. Journal of Affeaive Disorders. 28, 257–265.Google Scholar
Johnstone, E. C., Crow, T. J., Frith, C. D., et al (1988) The Northwick park ‘functional’ psychosis study: Dagnosis and treatment response. lancet, ii. 119 125.CrossRefGoogle Scholar
Leff, J. P. & Wing, J. K. (1971) Trial of maintenance therapy in schizophrenia. British Medical Journal. 3, 559–604.CrossRefGoogle ScholarPubMed
Licht, R. W., Goullaev, G., Vestergarrrd, P., et al (1994) Treatment of manic episodes in Scandinavia: The use of neuroleptic drugs in a clinical routine setting. Journal of Affective Disorders. 32, 179–185.CrossRefGoogle ScholarPubMed
Norusis, M. J. (1993) SPSS for Windows: Release 6.0. Chicago. IL: SPSS Inc.Google Scholar
Submit a response

eLetters

No eLetters have been published for this article.