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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
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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 

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