Title |
Specifying the target difference in the primary outcome for a randomised controlled trial: guidance for researchers
|
---|---|
Published in |
Trials, January 2015
|
DOI | 10.1186/s13063-014-0526-8 |
Pubmed ID | |
Authors |
Jonathan A Cook, Jenni Hislop, Douglas G Altman, Peter Fayers, Andrew H Briggs, Craig R Ramsay, John D Norrie, Ian M Harvey, Brian Buckley, Dean Fergusson, Ian Ford, Luke D Vale |
Abstract |
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 imperative that an appropriate number of participants should be recruited. Despite the critical role of the target difference for the primary outcome in the design of randomised controlled trials, its determination has received surprisingly little attention. This article provides guidance on the specification of the target difference for the primary outcome in a sample size calculation for a two parallel group randomised controlled trial with a superiority question. |
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Netherlands | 2 | 7% |
Australia | 1 | 4% |
United States | 1 | 4% |
Ireland | 1 | 4% |
Germany | 1 | 4% |
Unknown | 11 | 41% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 14 | 52% |
Scientists | 7 | 26% |
Practitioners (doctors, other healthcare professionals) | 4 | 15% |
Science communicators (journalists, bloggers, editors) | 2 | 7% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 3 | 3% |
Australia | 2 | 2% |
France | 1 | <1% |
Germany | 1 | <1% |
United States | 1 | <1% |
Unknown | 111 | 93% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 26 | 22% |
Other | 16 | 13% |
Student > Ph. D. Student | 13 | 11% |
Student > Master | 11 | 9% |
Professor | 8 | 7% |
Other | 25 | 21% |
Unknown | 20 | 17% |
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Medicine and Dentistry | 44 | 37% |
Psychology | 10 | 8% |
Mathematics | 9 | 8% |
Nursing and Health Professions | 6 | 5% |
Economics, Econometrics and Finance | 5 | 4% |
Other | 19 | 16% |
Unknown | 26 | 22% |