Intention-to-treat in randomized controlled trials: recommendations for a total trial strategy

Abstract

Intention-to-treat (ITT) in randomized controlled trials involves keeping participants in the treatment groups to which they were randomized regardless of whether they withdraw following randomization. Intention-to-treat is a strategy for maintaining the integrity of randomization and strengthening the trial's internal validity. Although ITT is advocated by the Consolidated Standards of Reporting Trials (CONSORT) guidelines, there is confusion about what ITT means and little specific advice on how to achieve it. The purpose of this article is to present definitions of ITT and to suggest strategies for implementing ITT as a total design strategy in nursing clinical trials. Recommendations are offered regarding study planning, study design, subject retention, sampling, data collection, data analysis, and reporting within the context of ITT.