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DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial

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Cook, Jonathan A., Julious, Steven A., Sones, William, Hampson, Lisa V., Hewitt, Catherine, Berlin, Jesse A., Ashby, Deborah, Emsley, Richard, Fergusson, Dean A., Walters, Stephen J. et al.
(2018) DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials, 19 (1). 606. doi:10.1186/s13063-018-2884-0

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Official URL: http://dx.doi.org/10.1186/s13063-018-2884-0

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Abstract

Background

A key step in the design of a RCT is the estimation of the number of participants needed in the study. The most common approach is to specify a target difference between the treatments for the primary outcome and then calculate the required sample size. The sample size is chosen to ensure that the trial will have a high probability (adequate statistical power) of detecting a target difference between the treatments should one exist.

The sample size has many implications for the conduct and interpretation of the study. Despite the critical role that the target difference has in the design of a RCT, the way in which it is determined has received little attention. In this article, we summarise the key considerations and messages from new guidance for researchers and funders on specifying the target difference, and undertaking and reporting a RCT sample size calculation. This article on choosing the target difference for a randomised controlled trial (RCT) and undertaking and reporting the sample size calculation has been dual published in the BMJ and BMC Trials journals

Methods

The DELTA2 (Difference ELicitation in TriAls) project comprised five major components: systematic literature reviews of recent methodological developments (stage 1) and existing funder guidance (stage 2); a Delphi study

Item Type: Journal Article
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Clinical trials -- Methodology, Clinical trials -- Standards
Journal or Publication Title: Trials
Publisher: Biomed Central
ISSN: 1745-6215
Official Date: 5 November 2018
Dates:
DateEvent
5 November 2018Published
UNSPECIFIEDAvailable
29 August 2018Accepted
Volume: 19
Number: 1
Article Number: 606
DOI: 10.1186/s13063-018-2884-0
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
UNSPECIFIED[MRC] Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
UNSPECIFIED[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
UNSPECIFIEDScotland. Chief Scientist Officehttp://viaf.org/viaf/130615999

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