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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. British Medical Journal, 363 . k3750. doi:10.1136/bmj.k3750 ISSN 0959-8146.
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Official URL: https://doi.org/10.1136/bmj.k3750
Abstract
• Central to the design of a randomised controlled trial is an a priori sample-size calculation, which ensures a high probability of the study achieving its pre-specified main objective
• An incorrect sample size can result in a study that is unable to inform clinical practice (hence directly or indirectly harming patients), or could expose excess patients to the uncertainty inherent in a clinical trial
• The target difference between treatments that is considered realistic or important by one or more key stakeholder groups plays a critical part in the s ample size calculation of a randomised controlled trial
• Guidance on how to choose the target difference and undertake a sample size calculation for funders and researchers is presented in this article
• 10 recommendations are made regarding choosing the target difference and undertaking a sample size calculation, along with recommended reporting it ems for trial proposal, protocols, and results papers
• This article on choosing the target difference for a randomised controlled trial and undertaking and reporting the sample size calculation has been dual published in The BMJ and BMC Trials journals
Item Type: | Journal Article | |||||||||
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Subjects: | R Medicine > R Medicine (General) | |||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Clinical trials -- Methodology | |||||||||
Journal or Publication Title: | British Medical Journal | |||||||||
Publisher: | BMJ Group | |||||||||
ISSN: | 0959-8146 | |||||||||
Official Date: | 5 November 2018 | |||||||||
Dates: |
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Volume: | 363 | |||||||||
Article Number: | k3750 | |||||||||
DOI: | 10.1136/bmj.k3750 | |||||||||
Status: | Peer Reviewed | |||||||||
Publication Status: | Published | |||||||||
Access rights to Published version: | Open Access (Creative Commons) | |||||||||
Date of first compliant deposit: | 6 November 2018 | |||||||||
Date of first compliant Open Access: | 6 November 2018 | |||||||||
RIOXX Funder/Project Grant: |
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