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

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DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial Suzie Cro. / Cook, J.A.; Julious, S.A.; Sones, W.; Hampson, L.V.; Hewitt, C.; Berlin, J.A.; Ashby, D.; Emsley, R.; Fergusson, D.A.; Walters, S.J.; Wilson, E.C.F.; Maclennan, G.; Stallard, N.; Rothwell, J.C.; Bland, M.; Brown, L.; Ramsay, C.R.; Cook, A.; Armstrong, D.; Altman, D.; Vale, L.D.

In: Trials, Vol. 19, No. 1, 606, 05.11.2018.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Harvard

Cook, JA, Julious, SA, Sones, W, Hampson, LV, Hewitt, C, Berlin, JA, Ashby, D, Emsley, R, Fergusson, DA, Walters, SJ, Wilson, ECF, Maclennan, G, Stallard, N, Rothwell, JC, Bland, M, Brown, L, Ramsay, CR, Cook, A, Armstrong, D, Altman, D & Vale, LD 2018, 'DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial Suzie Cro', Trials, vol. 19, no. 1, 606. https://doi.org/10.1186/s13063-018-2884-0

APA

Cook, J. A., Julious, S. A., Sones, W., Hampson, L. V., Hewitt, C., Berlin, J. A., Ashby, D., Emsley, R., Fergusson, D. A., Walters, S. J., Wilson, E. C. F., Maclennan, G., Stallard, N., Rothwell, J. C., Bland, M., Brown, L., Ramsay, C. R., Cook, A., Armstrong, D., ... Vale, L. D. (2018). DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial Suzie Cro. Trials, 19(1), [606]. https://doi.org/10.1186/s13063-018-2884-0

Vancouver

Author

Cook, J.A. ; Julious, S.A. ; Sones, W. ; Hampson, L.V. ; Hewitt, C. ; Berlin, J.A. ; Ashby, D. ; Emsley, R. ; Fergusson, D.A. ; Walters, S.J. ; Wilson, E.C.F. ; Maclennan, G. ; Stallard, N. ; Rothwell, J.C. ; Bland, M. ; Brown, L. ; Ramsay, C.R. ; Cook, A. ; Armstrong, D. ; Altman, D. ; Vale, L.D. / DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial Suzie Cro. In: Trials. 2018 ; Vol. 19, No. 1.

Bibtex

@article{e09294ffb5ce4f4693dfe75d16a8c8c3,
title = "DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial Suzie Cro",
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. {\textcopyright} 2018 The Author(s).",
keywords = "adult, article, attention, calculation, consensus, Delphi study, female, human, male, randomized controlled trial (topic), sample size, scientist, systematic review",
author = "J.A. Cook and S.A. Julious and W. Sones and L.V. Hampson and C. Hewitt and J.A. Berlin and D. Ashby and R. Emsley and D.A. Fergusson and S.J. Walters and E.C.F. Wilson and G. Maclennan and N. Stallard and J.C. Rothwell and M. Bland and L. Brown and C.R. Ramsay and A. Cook and D. Armstrong and D. Altman and L.D. Vale",
year = "2018",
month = nov,
day = "5",
doi = "10.1186/s13063-018-2884-0",
language = "English",
volume = "19",
journal = "Trials",
issn = "1745-6215",
publisher = "BIOMED CENTRAL LTD",
number = "1",

}

RIS

TY - JOUR

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

AU - Cook, J.A.

AU - Julious, S.A.

AU - Sones, W.

AU - Hampson, L.V.

AU - Hewitt, C.

AU - Berlin, J.A.

AU - Ashby, D.

AU - Emsley, R.

AU - Fergusson, D.A.

AU - Walters, S.J.

AU - Wilson, E.C.F.

AU - Maclennan, G.

AU - Stallard, N.

AU - Rothwell, J.C.

AU - Bland, M.

AU - Brown, L.

AU - Ramsay, C.R.

AU - Cook, A.

AU - Armstrong, D.

AU - Altman, D.

AU - Vale, L.D.

PY - 2018/11/5

Y1 - 2018/11/5

N2 - 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. © 2018 The Author(s).

AB - 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. © 2018 The Author(s).

KW - adult

KW - article

KW - attention

KW - calculation

KW - consensus

KW - Delphi study

KW - female

KW - human

KW - male

KW - randomized controlled trial (topic)

KW - sample size

KW - scientist

KW - systematic review

U2 - 10.1186/s13063-018-2884-0

DO - 10.1186/s13063-018-2884-0

M3 - Journal article

VL - 19

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 606

ER -