Home > Research > Publications & Outputs > DELTA 2 guidance on choosing the target differe...

Links

Text available via DOI:

View graph of relations

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

Research output: Contribution to journalJournal article

Published

Standard

DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. / 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: BMJ, Vol. 363, 363, 05.11.2018.

Research output: Contribution to journalJournal article

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, 'DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial', BMJ, vol. 363, 363. https://doi.org/10.1136/bmj.k3750

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). DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. BMJ, 363, [363]. https://doi.org/10.1136/bmj.k3750

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. / DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. In: BMJ. 2018 ; Vol. 363.

Bibtex

@article{5f99b7a0b4a2492c899a98d87595c1a5,
title = "DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial",
abstract = "Randomised controlled trials are considered to be the best method to assess comparative clinical efficacy and effectiveness, and can be a key source of data for estimating cost effectiveness. Central to the design of a randomised controlled trial is an a priori sample size calculation, which ensures that the study has a high probability of achieving its prespecified main objective. Beyond pure statistical or scientific concerns, it is ethically imperative that an appropriate number of study participants be recruited, to avoid imposing the burdens of a clinical trial on more patients than necessary. The scientific concern is satisfied and the ethical imperative is further addressed by the specification of a target difference between treatments that is considered realistic or important by one or more key stakeholder groups. The sample size calculation ensures that the trial will have the required statistical power to identify whether a difference of a particular magnitude exists. In this article, the key messages from the DELTA 2 guidance on determining the target difference and sample size calculation for a randomised controlled trial are presented. Recommendations for the subsequent reporting of the sample size calculation are also provided. {\textcopyright} 2018 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to.",
keywords = "adult, article, calculation, comparative effectiveness, controlled study, cost effectiveness analysis, female, human, male, probability, randomized controlled trial, sample size",
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 = "10.1136/bmj.k3750",
language = "English",
volume = "363",
journal = "BMJ",
issn = "0959-8138",
publisher = "British Medical Association",

}

RIS

TY - JOUR

T1 - DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial

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 - Randomised controlled trials are considered to be the best method to assess comparative clinical efficacy and effectiveness, and can be a key source of data for estimating cost effectiveness. Central to the design of a randomised controlled trial is an a priori sample size calculation, which ensures that the study has a high probability of achieving its prespecified main objective. Beyond pure statistical or scientific concerns, it is ethically imperative that an appropriate number of study participants be recruited, to avoid imposing the burdens of a clinical trial on more patients than necessary. The scientific concern is satisfied and the ethical imperative is further addressed by the specification of a target difference between treatments that is considered realistic or important by one or more key stakeholder groups. The sample size calculation ensures that the trial will have the required statistical power to identify whether a difference of a particular magnitude exists. In this article, the key messages from the DELTA 2 guidance on determining the target difference and sample size calculation for a randomised controlled trial are presented. Recommendations for the subsequent reporting of the sample size calculation are also provided. © 2018 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to.

AB - Randomised controlled trials are considered to be the best method to assess comparative clinical efficacy and effectiveness, and can be a key source of data for estimating cost effectiveness. Central to the design of a randomised controlled trial is an a priori sample size calculation, which ensures that the study has a high probability of achieving its prespecified main objective. Beyond pure statistical or scientific concerns, it is ethically imperative that an appropriate number of study participants be recruited, to avoid imposing the burdens of a clinical trial on more patients than necessary. The scientific concern is satisfied and the ethical imperative is further addressed by the specification of a target difference between treatments that is considered realistic or important by one or more key stakeholder groups. The sample size calculation ensures that the trial will have the required statistical power to identify whether a difference of a particular magnitude exists. In this article, the key messages from the DELTA 2 guidance on determining the target difference and sample size calculation for a randomised controlled trial are presented. Recommendations for the subsequent reporting of the sample size calculation are also provided. © 2018 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to.

KW - adult

KW - article

KW - calculation

KW - comparative effectiveness

KW - controlled study

KW - cost effectiveness analysis

KW - female

KW - human

KW - male

KW - probability

KW - randomized controlled trial

KW - sample size

U2 - 10.1136/bmj.k3750

DO - 10.1136/bmj.k3750

M3 - Journal article

VL - 363

JO - BMJ

JF - BMJ

SN - 0959-8138

M1 - 363

ER -