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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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(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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WRAP-guidance-choosing-target-difference-undertaking-sample-trial-Stallard-2018.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1176Kb) | Preview |
Official URL: http://dx.doi.org/10.1186/s13063-018-2884-0
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 | ||||||||||||
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| Subjects: | R Medicine > R Medicine (General) | ||||||||||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology Faculty of Medicine > Warwick Medical School |
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| 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: |
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| 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: |
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