Cited by 129Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsAdvanced Causal Inference Techniques

Intention‐to‐treat in randomized controlled trials: Recommendations for a total trial strategy

Polit, Denise F., Gillespie, Brigid M.·2010·Research in Nursing & Health

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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Crossref · 10.1002/nur.20386

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Authors
Polit, D. F., & Gillespie, B. M.
Affiliations
Griffith University (AU)
Corresponding author
Polit, Denise F.
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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