Choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial - the development of the DELTA² guidance.

ABSTRACT:

Background

A key step in the design of a randomised controlled trial is the estimation of the number of participants needed. The most common approach is to specify a target difference in the primary outcome between the randomised groups and then estimate the corresponding sample size. The sample size is chosen to provide reassurance that the trial will have high statistical power to detect the target difference at the planned statistical significance level. Alternative approaches are also available, though most still require specification of a target difference. The sample size has many implications for the conduct of the study, as well as incurring scientific and ethical aspects. Despite the critical role of the target difference for the primary outcome in the design of a randomis

SUBMITTER: Sones W 

PROVIDER: S-EPMC6180499 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature