Research in nursing & health
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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. ⋯ 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.