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Specifying the target difference in the primary outcome for a randomised controlled trial: guidance for researchers.

Abstract:

BACKGROUND: Central to the design of a randomised controlled trial is the calculation of the number of participants needed. This is typically achieved by specifying a target difference and calculating the corresponding sample size, which provides reassurance that the trial will have the required statistical power (at the planned statistical significance level) to identify whether a difference of a particular magnitude exists. Beyond pure statistical or scientific concerns, it is ethically imp...

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Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1186/s13063-014-0526-8

Authors


More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Sub department:
Centre for Statistics in Medicine
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Sub department:
Centre for Statistics in Medicine
Role:
Author
More from this funder
Name:
Medical Research Council
Funding agency for:
Cook, J
Grant:
G1002292
G0601938
More from this funder
Name:
Health Technology Assessment
Publisher:
BioMed Central
Journal:
Trials More from this journal
Volume:
16
Issue:
1
Pages:
526
Publication date:
2015-12-01
DOI:
EISSN:
1745-6215
Language:
English
Pubs id:
pubs:506888
UUID:
uuid:6a1d3ddb-e1e9-425c-adb7-420387c15517
Local pid:
pubs:506888
Source identifiers:
506888
Deposit date:
2015-12-01

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