UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

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

Cook, JA; Julious, SA; Sones, W; Hampson, LV; Hewitt, C; Berlin, JA; Ashby, D; ... Vale, LD; + view all (2018) DELTA(2) guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials , 19 , Article 606. 10.1186/s13063-018-2884-0. Green open access

[thumbnail of DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised.pdf]
Preview
Text
DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised.pdf - Published Version

Download (1MB) | Preview

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 (stage 3); a two-day consensus meeting bringing together researchers, funders and patient representatives (stage 4); and the preparation and dissemination of a guidance document (stage 5). Results and Discussion: The key messages from the DELTA2 guidance on determining the target difference and sample size calculation for a randomised caontrolled trial are presented. Recommendations for the subsequent reporting of the sample size calculation are also provided.

Type: Article
Title: DELTA(2) guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial
Open access status: An open access version is available from UCL Discovery
DOI: 10.1186/s13063-018-2884-0
Publisher version: https://doi.org/10.1186/s13063-018-2884-0
Language: English
Additional information: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10079176
Downloads since deposit
26Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item