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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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DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. / Cook, Jonathan A; Julious, Steven A; Sones, William; Hampson, Lisa V; Hewitt, Catherine Elizabeth; Berlin, Jesse A; Ashby, Deborah; Elmsley, Richard; Fergusson, Dean A; Walters, Stephen J; Wilson, Edward CF; MacLennan, Graeme S; Stallard, Nigel; Rothwell, Joanne C; Bland, John Martin; Brown, Louise; Ramsay, Craig R; Cook, Andrew; Armstrong, David; Altman, Doug G; Vale, Luke D.

In: Trials, Vol. 19, No. 606, 05.11.2018.

Research output: Contribution to journalArticle

Harvard

Cook, JA, Julious, SA, Sones, W, Hampson, LV, Hewitt, CE, Berlin, JA, Ashby, D, Elmsley, R, Fergusson, DA, Walters, SJ, Wilson, ECF, MacLennan, GS, Stallard, N, Rothwell, JC, Bland, JM, Brown, L, Ramsay, CR, Cook, A, Armstrong, D, Altman, DG & Vale, LD 2018, 'DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial', Trials, vol. 19, no. 606. https://doi.org/10.1186/s13063-018-2884-0

APA

Cook, J. A., Julious, S. A., Sones, W., Hampson, L. V., Hewitt, C. E., Berlin, J. A., ... Vale, L. D. (2018). DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials, 19(606). https://doi.org/10.1186/s13063-018-2884-0

Vancouver

Cook JA, Julious SA, Sones W, Hampson LV, Hewitt CE, Berlin JA et al. DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials. 2018 Nov 5;19(606). https://doi.org/10.1186/s13063-018-2884-0

Author

Cook, Jonathan A ; Julious, Steven A ; Sones, William ; Hampson, Lisa V ; Hewitt, Catherine Elizabeth ; Berlin, Jesse A ; Ashby, Deborah ; Elmsley, Richard ; Fergusson, Dean A ; Walters, Stephen J ; Wilson, Edward CF ; MacLennan, Graeme S ; Stallard, Nigel ; Rothwell, Joanne C ; Bland, John Martin ; Brown, Louise ; Ramsay, Craig R ; Cook, Andrew ; Armstrong, David ; Altman, Doug G ; Vale, Luke D. / DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. In: Trials. 2018 ; Vol. 19, No. 606.

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@article{a6c5c617b0e34844b74430db066dbb9e,
title = "DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial",
abstract = "BackgroundA 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 journalsMethodsThe 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 DiscussionThe 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.",
author = "Cook, {Jonathan A} and Julious, {Steven A} and William Sones and Hampson, {Lisa V} and Hewitt, {Catherine Elizabeth} and Berlin, {Jesse A} and Deborah Ashby and Richard Elmsley and Fergusson, {Dean A} and Walters, {Stephen J} and Wilson, {Edward CF} and MacLennan, {Graeme S} and Nigel Stallard and Rothwell, {Joanne C} and Bland, {John Martin} and Louise Brown and Ramsay, {Craig R} and Andrew Cook and David Armstrong and Altman, {Doug G} and Vale, {Luke D}",
note = "{\circledC} The Author(s). 2018",
year = "2018",
month = "11",
day = "5",
doi = "10.1186/s13063-018-2884-0",
language = "English",
volume = "19",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central Ltd.",
number = "606",

}

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TY - JOUR

T1 - DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial

AU - Cook, Jonathan A

AU - Julious, Steven A

AU - Sones, William

AU - Hampson, Lisa V

AU - Hewitt, Catherine Elizabeth

AU - Berlin, Jesse A

AU - Ashby, Deborah

AU - Elmsley, Richard

AU - Fergusson, Dean A

AU - Walters, Stephen J

AU - Wilson, Edward CF

AU - MacLennan, Graeme S

AU - Stallard, Nigel

AU - Rothwell, Joanne C

AU - Bland, John Martin

AU - Brown, Louise

AU - Ramsay, Craig R

AU - Cook, Andrew

AU - Armstrong, David

AU - Altman, Doug G

AU - Vale, Luke D

N1 - © The Author(s). 2018

PY - 2018/11/5

Y1 - 2018/11/5

N2 - BackgroundA 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 journalsMethodsThe 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 DiscussionThe 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.

AB - BackgroundA 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 journalsMethodsThe 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 DiscussionThe 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.

U2 - 10.1186/s13063-018-2884-0

DO - 10.1186/s13063-018-2884-0

M3 - Article

VL - 19

JO - Trials

T2 - Trials

JF - Trials

SN - 1745-6215

IS - 606

ER -