Cited by 710Statistical Methods in Clinical TrialsAdvanced Causal Inference TechniquesMeta-analysis and systematic reviews

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Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis

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Fergusson, Dean, Aaron, Shawn D, Guyatt, Gordon, Hébert, Paul·2002·BMJ

DOI 10.1136/bmj.325.7365.652PMC PMC1124168

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Abstract

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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“Four patients were erroneously enrolled and therefore excluded after randomization.(33) Overall, 96 BC patients were assigned to NDTI and 98 to UC.”
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Background
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“[13] If these are included, then explicit best and worst case analyses perhaps should have been performed, with imputations explained [14]”
Background
Effects of Variety Support on Exercise‐Related Well‐Being
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Method
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“Multiple imputations of missing data will be performed for intention-to-treat (ITT) analyses [37].”
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“Following the intention-to-treat principle, all patients receiving at least one dose of study medication will be included in the analysis with group allocation as randomized; patients violating inclusion criteria or meeting exclusion criteria due to information that was not available at study entry will be excluded po…”
Method
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Which patients to include in the analysis?
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Self-citation
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“Intentionto-treat (Fergusson et al. 2002) analyses are reported throughout with post-treatment data carried forward for the two participants who did not attend the follow-up appointment.”
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“based on all randomly assigned patients except those withdrawing consent for use of all trial data and those not fulfilling inclusion criteria and never receiving the intervention [12].”
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“This minimises the influence of withdrawals and patients lost to follow-up and likely prevents type 1 errors [31].”
Background
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“org 5 gold standard for assessing superiority of an intervention (20, 21).”
Background
Beyond Randomized Controlled Trials in Attempted Suicide Research
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“Patients deemed to meet exclusion criteria after randomization, but before the patient–clinician disposition discussion, were classified as postrandomization exclusions.(10)”
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Reporting Methodological Items in Randomized Experiments in Political Science
Boutron, I., John, P., & Torgerson, D. (2010) · The Annals of the American Academy of Political and Social Science · doi:10.1177/0002716209351518 · Cited by 15
“The recommended strategy is an ITT analysis, an investigation of results of RCTs that compares all participants in the groups to which they were originally randomly assigned (Fergusson et al. 2002; Hollis and Campbell 1999; Schulz et al. 1996).”
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Background
Cryopreserved platelets compared with liquid-stored platelets for the treatment of surgical bleeding: protocol for two multicentre randomised controlled blinded non-inferiority trials (the CLIP-II and CLIPNZ-II trials)
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Authors: Fergusson, D., Aaron, S. D., Guyatt, G., & Hébert, P.
Affiliations: McMaster University (CA)
Corresponding author: Fergusson, Dean
ORCID: Fergusson, Dean
Hébert, Paul
Venue: BMJ
Publisher: BMJ
Published: 2002-09-21
Volume: 325
Issue: 7365
Pages: 652-654
ISSN: 0007-1447 (ISSN-L)
0959-8138
1468-5833
DOI: 10.1136/bmj.325.7365.652
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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Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis

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