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. © 2010 Wiley Periodicals, Inc. Res Nurs Health 33:355–368, 2010
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Data were analyzed using intention-to-treat principles (participants were not excluded based on engagement).
“Data were analyzed using intention-to-treat principles (ie, participants were not excluded based on engagement) [104].”
From Testing the efficacy of a multicomponent, self-guided, smartphone-based meditation app: Three-armed randomized controlled trial (2020) · cites this paper as [104]
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- Authors
- Polit, D. F., & Gillespie, B. M.
- Affiliations
- Griffith University (AU)
- Corresponding author
- Polit, Denise F.
- ORCID
- Gillespie, Brigid M.
- Venue
- Research in Nursing & Health
- Publisher
- Wiley
- Published
- 2010-06
- Volume
- 33
- Issue
- 4
- Pages
- 355-368
- ISSN
- 0160-6891 (ISSN-L)
- 1098-240X
- OpenAlex
- W2015967910
- Cited by
- 129
- References
- 59
- Citations by year
- 2026: 6 · 2025: 13 · 2024: 5 · 2023: 6 · 2022: 3 · 2021: 20 · 2020: 15 · 2019: 7 · 2018: 5 · 2017: 9 · 2016: 5 · 2015: 7 · 2014: 13 · 2013: 3 · 2012: 8
- FWCI
- 4.09
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Research in Nursing & Health (publishedVersion)
- PubMed (publishedVersion)
- Griffith Research Online (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- intention-to-treat analysis, randomized controlled trials, participant retention, internal validity, CONSORT guidelines, trial design, data analysis, trial reporting
- MeSH terms
- Data Collection, Data Interpretation, Statistical, Humans, Terminology as Topic, Research Design, Software Design, Nursing Research, Intention to Treat Analysis
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