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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. 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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Berlim, M. T., den Eynde, F. V., & Daskalakis, Z. J. (2012) · Psychological Medicine · doi:10.1017/s0033291712002802 · Cited by 167
“If provided, intention-to-treat data, using a method such as ‘ last observation carried forward’, were preferred over data from completers (Fergusson et al. 2002).”
MethodFergusson, D. A., Khanna, M. P., Tinmouth, A. T., & Hébert, P. C. (2004) · Canadian Journal of Anesthesia/Journal canadien d anesthésie · doi:10.1007/bf03018302 · Cited by 159
Self-citationAntibiotic treatment for 7 versus 14 days in patients with bloodstream infections
The BALANCE Investigators (2025) · New England Journal of Medicine · doi:10.1056/nejmoa2404991 · Cited by 158
Cheng, H. Y., Chair, S. Y., & Chau, J. P. C. (2018) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2018.07.005 · Cited by 158
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“12 13 15 It is difficult to draw any conclusions about the role of VATS versus conventional lobectomy because the only study included in this review was small and the analysis was not by intention to treat.”
BackgroundEffects of Splinting on Wrist Contracture After Stroke
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“[13].”
Self-citationShared decision making in patients with low risk chest pain: prospective randomized pragmatic trial
Hess, E. P., Hollander, J. E., Schaffer, J. T., Kline, J. A., Torres, C. A., Diercks, D. B., Jones, R., Owen, K. P., Meisel, Z. F., Demers, M., et al. (2016) · BMJ · doi:10.1136/bmj.i6165 · Cited by 157
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Reducing Noninfectious Risks of Blood Transfusion
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“Heterogeneity of studies, use of intention-to-treat as opposed to as-treated analysis, and exclusion of recent studies have all been suggested as causes of the discordant results.(63,68,69) Although the volume of evidence has increased, clarity on the role of universal leukoreduction has not.”
ResultNeal, D. E., Metcalfe, C., Donovan, J., Lane, J. A., Davis, M., Young, G., Dutton, S., Walsh, E. I., Martin, R. M., Peters, T. J., et al. (2019) · European Urology · doi:10.1016/j.eururo.2019.10.030 · Cited by 161
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“According to internationally accepted criteria[1], the EDSMC determined that 8 of”
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One-year follow-up of a therapeutic lifestyle intervention targeting cardiovascular disease risk
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Surgery for local and locally advanced non-small cell lung cancer
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Shared decision making for patients with type 2 diabetes: a randomized trial in primary care
Branda, M. E., LeBlanc, A., Shah, N. D., Tiedje, K., Ruud, K. L., Houten, H. V., Pencille, L. J., Kurland, M. J., Yawn, B. P., & Montori, V. M. (2013) · BMC Health Services Research · doi:10.1186/1472-6963-13-301 · Cited by 144
“We excluded 2 ineligible patients incorrectly enrolled (excluded without knowledge of their allocation or outcome [20]), and 2 patients enrolled to the usual care arm of the aspirin decision aid (an arm that was discontinued early in the trial due to poor feasibility without any patients allocated to the intervention…”
BackgroundVasopressin in Pediatric Vasodilatory Shock: A Multicenter Randomized Controlled Trial
Choong, K. L. M., BOHN, D. J., Fraser, D. D., Gaboury, I., Hutchison, J. S., Joffe, A. R., Litalien, C., Menon, K., McNamara, P. J., & Ward, R. (2009) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.200902-0221oc · Cited by 144
“These postrandomization exclusions did not contribute to any statistical comparisons except for the baseline characteristics (27).”
BackgroundBlomberg, S. N. F., Christensen, H. C., Lippert, F. K., Ersbøll, A. K., Torp-Petersen, C., Sayre, M. R., Kudenchuk, P. J., & Folke, F. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2020.32320 · Cited by 144
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Berlim, M. T., den Eynde, F. V., & Daskalakis, Z. J. (2013) · Depression and Anxiety · doi:10.1002/da.22060 · Cited by 147
“[48] If provided, intention-to-treat data, using a method such as “last observation carried forward,” were preferred over data from completers.[49] The differential efficacy of HF-rTMS and ECT as well as their acceptability for MD was investigated by odds ratios (OR),[50] Hedges’ g, and the number needed to treat (NNT…”
MethodBerlim, M. T., McGirr, A., den Eynde, F. V., Fleck, M. P., & Giacobbe, P. (2014) · Journal of Affective Disorders · doi:10.1016/j.jad.2014.02.016 · Cited by 140
“If provided, intention-to-treat data for depression scores were preferred over data from completers (Fergusson et al., 2002).”
MethodBerlim, M. T., McGirr, A., dos Santos, N. R., Tremblay, S., & Martins, R. (2017) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2017.02.015 · Cited by 144
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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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