DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial

Cook, J.A. and Julious, S.A. and Sones, W. and Hampson, L.V. and Hewitt, C. and Berlin, J.A. and Ashby, D. and Emsley, R. and Fergusson, D.A. and Walters, S.J. and Wilson, E.C.F. and MacLennan, G. and Stallard, N. and Rothwell, J.C. and Bland, M. and Brown, L. and Ramsay, C.R. and Cook, A. and Armstrong, D. and Altman, D. and Vale, L.D. (2018) DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. BMJ, 363. ISSN 0959-8138

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Abstract

Randomised controlled trials are considered to be the best method to assess comparative clinical efficacy and effectiveness, and can be a key source of data for estimating cost effectiveness. Central to the design of a randomised controlled trial is an a priori sample size calculation, which ensures that the study has a high probability of achieving its prespecified main objective. Beyond pure statistical or scientific concerns, it is ethically imperative that an appropriate number of study participants be recruited, to avoid imposing the burdens of a clinical trial on more patients than necessary. The scientific concern is satisfied and the ethical imperative is further addressed by the specification of a target difference between treatments that is considered realistic or important by one or more key stakeholder groups. The sample size calculation ensures that the trial will have the required statistical power to identify whether a difference of a particular magnitude exists. In this article, the key messages from the DELTA 2 guidance on determining the target difference and sample size calculation for a randomised controlled trial are presented. Recommendations for the subsequent reporting of the sample size calculation are also provided. © 2018 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to.

Item Type:
Journal Article
Journal or Publication Title:
BMJ
Uncontrolled Keywords:
/dk/atira/pure/subjectarea/asjc/2700
Subjects:
ID Code:
129468
Deposited By:
Deposited On:
13 Dec 2018 11:16
Refereed?:
Yes
Published?:
Published
Last Modified:
16 Sep 2020 05:04