Sample size recalculation based on the prevalence in a randomized test-treatment study.

ABSTRACT:

Background

Randomized test-treatment studies aim to evaluate the clinical utility of diagnostic tests by providing evidence on their impact on patient health. However, the sample size calculation is affected by several factors involved in the test-treatment pathway, including the prevalence of the disease. Sample size planning is exposed to strong uncertainties in terms of the necessary assumptions, which have to be compensated for accordingly by adjusting prospectively determined study parameters during the course of the study.

Method

An adaptive design with a blinded sample size recalculation in a randomized test-treatment study based on the prevalence is proposed and evaluated by a simulation study. The results of the adaptive design are compared to those of the fixed des

SUBMITTER: Hot A 

PROVIDER: S-EPMC9317230 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature