Sample size re-estimation in crossover trials: application to the AIM HY-INFORM study.

ABSTRACT:

Background

Crossover designs are commonly utilised in randomised controlled trials investigating treatments for long-term chronic illnesses. One problem with this design is its inherent repeated measures necessitate the availability of an estimate of the within-person standard deviation (SD) to perform a sample size calculation, which may be rarely available at the design stage of a trial. Interim sample size re-estimation designs can be used to help alleviate this issue by adapting the sample size mid-way through the trial, using accrued information in a statistically robust way.

Methods

The AIM HY-INFORM study is part of the Informative Markers in Hypertension (AIM HY) Programme and comprises two crossover trials, each with a planned recruitment of 600 participants. The ob

SUBMITTER: Wych J 

PROVIDER: S-EPMC6889633 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature