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].”
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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Bone, R. C., BALK, R. A., Cerra, F. B., Dellinger, R. P., Fein, A. M., Knaus, W. A., Schein, R. M. H., & Sibbald, W. J. (1992) · CHEST Journal · doi:10.1378/chest.101.6.1644 · Cited by 13,335
Peto, R., Pike, M. C., Armitage, P., Breslow, N. E., Cox, D. R., Howard, S. V., Mantel, N., McPherson, K., Peto, J., & Smith, P. G. (1976) · British Journal of Cancer · doi:10.1038/bjc.1976.220 · Cited by 2,294
What is meant by intention to treat analysis? Survey of published randomised controlled trials
Hollis, S., & Campbell, F. (1999) · BMJ · doi:10.1136/bmj.319.7211.670 · Cited by 2,160
Explanatory and Pragmatic Attitudes in Therapeutical Trials
Schwartz, D., & Lellouch, J. (2009) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2009.01.012 · Cited by 1,253
Explanatory and pragmatic attitudes in therapeutical trials
Schwartz, D., & Lellouch, J. (1967) · Journal of Chronic Diseases · doi:10.1016/0021-9681(67)90041-0 · Cited by 1,185
Efficacy and Safety of the Oral Neuraminidase Inhibitor Oseltamivir in Treating Acute Influenza
Treanor, J. J., Hayden, F. G., Vrooman, P., Barbarash, R. A., Bettis, R. B., Riff, D. S., Singh, S., Kinnersley, N., Ward, P., Mills, R., et al. (2000) · JAMA · doi:10.1001/jama.283.8.1016 · Cited by 1,019
Intention-to-Treat Analysis: Implications for Quantitative and Qualitative Research
NEWELL, D. J. (1992) · International Journal of Epidemiology · doi:10.1093/ije/21.5.837 · Cited by 715
Houbiers, J. G. A., Brand, A., van de Watering, L. M. G., van de Velde, C. J. H., Hermans, J., Verwey, P. J. M., Bijnen, A. B., Pahlplatz, P. V. M., SCHATTENKERK, M. E., Wobbes, T., et al. (1994) · The Lancet · doi:10.1016/s0140-6736(94)91965-8 · Cited by 381
Vasopressin versus epinephrine for inhospital cardiac arrest: a randomised controlled trial
Stiell, I. G., Hébert, P. C., Wells, G. A., Vandemheen, K. L., Tang, A. S., Higginson, L., Dreyer, J. F., Clement, C. M., Battram, E., Watpool, I., et al. (2001) · The Lancet · doi:10.1016/s0140-6736(01)05328-4 · Cited by 342
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Research works printed but not linked: 1
- 10.1002/(SICI)1097-0258(19980215)17:3<303::AID-SIM764>3.0.CO;2-0 · DOI
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RoB 2: a revised tool for assessing risk of bias in randomised trials
Sterne, J. A. C., Savović, J., Page, M. J., Elbers, R. G., Blencowe, N. S., Boutron, I., Cates, C. J., Cheng, H.-Y., Corbett, M. S., Eldridge, S. M., et al. (2019) · BMJ · doi:10.1136/bmj.l4898 · Cited by 34,787
“The effect of assignment to intervention should be estimated by an intention-to-treat (ITT) analysis that includes all randomised participants.(17) However, estimates of per-protocol effects commonly used in reports of randomised trials are problematic and may be seriously biased.”
BackgroundCochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series
(2008) · doi:10.1002/9780470712184 · Cited by 25,048
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251
(2008) · Cited by 3,790
Targeted Temperature Management at 33°C versus 36°C after Cardiac Arrest
Nielsen, N., Wetterslev, J., Cronberg, T., Erlinge, D., Gasche, Y. G., Hassager, C., Horn, J., Hovdenes, J., Kjærgaard, J., Kuiper, M. A., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1310519 · Cited by 2,764
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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