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Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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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 -