Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis
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When is it legitimate to exclude randomised patients from the analysis of data in clinical trials? Basing their analysis on the desirability of minimising bias and random error, the authors consider the circumstances when it may be possible to exclude patients, even in an intention to treat trial
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The effect of assignment to intervention should be estimated by an intention-to-treat analysis that includes all randomised participants.
“The effect of assignment to intervention should be estimated by an intention-to-treat analysis that includes all randomised participants. 17”
From RoB 2: a revised tool for assessing risk of bias in randomised trials (2019) · cites this paper as [17]
Intention-to-treat analysis is less likely to show a positive treatment effect.
“Despite this, this style of analysis is less likely to show a positive treatment effect [94].”
From Consumer-based wearable activity trackers increase physical activity participation: systematic review and meta-analysis (2019) · cites this paper as [94]
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- Authors
- Fergusson, D., Aaron, S. D., Guyatt, G., & Hébert, P.
- Affiliations
- McMaster University (CA)
- Corresponding author
- Fergusson, Dean
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2002-09-21
- Volume
- 325
- Issue
- 7365
- Pages
- 652-654
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC1124168
- OpenAlex
- W2000522086
- Cited by
- 708
- References
- 19
- Citations by year
- 2026: 22 · 2025: 26 · 2024: 30 · 2023: 24 · 2022: 46 · 2021: 59 · 2020: 36 · 2019: 37 · 2018: 35 · 2017: 40 · 2016: 34 · 2015: 40 · 2014: 34 · 2013: 27 · 2012: 21
- FWCI
- 17.26
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.bmj.com/company/legal-information/terms-conditions/legal-information/tdm-licencepolicy (tdm)
- Locations
- BMJ (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- intention-to-treat analysis, randomized controlled trials, random error, statistical analysis of clinical trials
- MeSH terms
- Data Interpretation, Statistical, Humans, Randomized Controlled Trials as Topic, Patient Selection
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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