The DOI matches its Crossref record; 17 of the 19 references it cites were found in a registry or an index.
Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis
Open accessAbstract
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. 17”
From RoB 2: a revised tool for assessing risk of bias in randomised trials (2019) · cites this paper as [17]
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“Despite this, this style of analysis is less likely to show a positive treatment effect [94].”
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“…(patients who were randomised), the full analysis (FA) set (previous ITT population excluding participants who failed to meet major entry criteria 6 and participants with no data post-randomisation or with missing primary outcome), and the per-protocol set (previous FA population, excluding…”
Metadata
- 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
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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.
What counts as a claim ›How we measure confidence ›How we check this ›
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