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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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 13,317
Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design
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
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Schwartz, D., & Lellouch, J. (1967) · Journal of Chronic Diseases · doi:10.1016/0021-9681(67)90041-0 · Cited by 1,185
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Recombinant Human Interleukin 1 Receptor Antagonist in the Treatment of Patients With Sepsis Syndrome: Results From a Randomized, Double-blind, Placebo-Controlled Trial
Fisher, C. J. (1994) · JAMA · doi:10.1001/jama.1994.03510470040032 · Cited by 790
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NEWELL, D. J. (1992) · International Journal of Epidemiology · doi:10.1093/ije/21.5.837 · Cited by 715
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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
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Amundson, A. W., Johnson, R. L., Abdel, M. P., Mantilla, C. B., Panchamia, J. K., Taunton, M. J., Kralovec, M. E., Hebl, J. R., Schroeder, D. R., Pagnano, M. W., et al. (2017) · Anesthesiology · doi:10.1097/aln.0000000000001586 · Cited by 87
Efficacy vs Effectiveness Trial Results of an Indicated “Model” Substance Abuse Program: Implications for Public Health
Hallfors, D. D., Cho, H., Sanchez, V., Khatapoush, S., Kim, H. M., & Bauer, D. J. (2006) · American Journal of Public Health · doi:10.2105/ajph.2005.067462 · Cited by 88
A randomized clinical trial of cognitive behavioural therapyversusshort-term psychodynamic psychotherapyversusno intervention for patients with hypochondriasis
Sørensen, P. S., Birket‐Smith, M., Wattar, U., Buemann, I., & Salkovskis, P. M. (2010) · Psychological Medicine · doi:10.1017/s0033291710000292 · Cited by 86
“We used a modified intention-to-treat (ITT) analysis with exclusion unrelated to non-compliance, withdrawal or losses to follow-up (Fergusson et al. 2002).”
Method
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Guo, Y., Lane, D. A., Wang, L., Chen, Y., Lip, G. Y. H., the mAF‐App II Trial investigators, Eckstein, J., Thomas, G. N., Feng, M., Xuejun, L., et al. (2019) · International Journal of Clinical Practice · doi:10.1111/ijcp.13352 · Cited by 86
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Vallentin, M. F., Granfeldt, A., Klitgaard, T. L., Mikkelsen, S. S., Folke, F., Christensen, H. C., Povlsen, A. L., Petersen, A. H., Winther, S., Frilund, L. W., et al. (2024) · New England Journal of Medicine · doi:10.1056/nejmoa2407616 · Cited by 87
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Guo, Y., Hong, Y. A., Cai, W., Li, L., Hao, Y., Qiao, J., Xu, Z., Zhang, H., Zeng, C., Liu, C., et al. (2020) · Journal of Medical Internet Research · doi:10.2196/16715 · Cited by 82
“The intention-to-treat principle was applied to all analyses [31].”
Recommendations for the Design and Analysis of Treatment Trials for Alcohol Use Disorders
Witkiewitz, K. A., Finney, J. W., Harris, A. H. S., Kivlahan, D. R., & Kranzler, H. R. (2015) · Alcoholism Clinical and Experimental Research · doi:10.1111/acer.12800 · Cited by 81
White‐blood‐cell‐containing allogeneic blood transfusion and postoperative infection or mortality: an updated meta‐analysis
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Langston, A. L., Campbell, M., Fraser, W. D., MacLennan, G., Selby, P. L., Ralston, S. H., & for the PRISM Trial Group (2007) · Calcified Tissue International · doi:10.1007/s00223-006-0184-2 · Cited by 80
“In total, 1,331 patients were enrolled in the PRISM study, but seven were excluded postrandomization because they did not meet the entry criteria and were enrolled into the trial in error [11].”
Background
Feeling Thanks and Saying Thanks: A Randomized Controlled Trial Examining If and How Socially Oriented Gratitude Journals Work
O’Connell, B. H., O’Shea, D. E., & Gallagher, S. M. (2017) · Journal of Clinical Psychology · doi:10.1002/jclp.22469 · Cited by 92
Wound cleansing for pressure ulcers
Moore, Z. E. H., & Cowman, S. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004983.pub3 · Cited by 78
How to spot bias and other potential problems in randomised controlled trials
Lewis, S. C. (2004) · Journal of Neurology Neurosurgery & Psychiatry · doi:10.1136/jnnp.2003.025833 · Cited by 77
“There are some circumstances when the exclusion of patients does not bias the results.”
Background
Improved physical fitness of cancer survivors: A randomised controlled trial comparing physical training with physical and cognitive-behavioural training
May, A. M., van Weert, E., Korstjens, I., Hoekstra‐Weebers, J. E. H. M., van der Schans, C. P., Zonderland, M. L., Mesters, I., van den Borne, B. H. P., & Ros, W. J. G. (2008) · Acta Oncologica · doi:10.1080/02841860701666063 · Cited by 77
Effects of Physician-Nurse Substitution on Clinical Parameters: A Systematic Review and Meta-Analysis
Martínez-González, N. A., Tandjung, R., Djalali, S., Huber-Geismann, F., Markun, S., & Rosemann, T. J. (2014) · PLoS ONE · doi:10.1371/journal.pone.0089181 · Cited by 76
“last value carried forward) to take into account all patients who began the intervention regardless of protocol violations, drop-outs or loss of follow-up [11,12].”
Background
Weight loss prior to pregnancy and subsequent gestational weight gain: Prepare, a randomized clinical trial
LeBlanc, E. S., Smith, N. X., Vesco, K. K., Paul, I. M., & Stevens, V. J. (2020) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2020.07.027 · Cited by 76
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Tsivgoulis, G. K., Triantafyllou, S., Palaiodimou, L., Grory, B. M., Deftereos, S., Köhrmann, M., Dilaveris, P., Ricci, B., Tsioufis, K., Cutting, S., et al. (2022) · Neurology · doi:10.1212/wnl.0000000000200227 · Cited by 72
A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator
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N-acetylcysteine for preventing acute kidney injury in cardiac surgery patients with pre-existing moderate renal insufficiency
Wijeysundera, D. N., Beattie, W. S., Rao, V., Granton, J. T., & Chan, C. T. (2007) · Canadian Journal of Anesthesia/Journal canadien d anesthésie · doi:10.1007/bf03026790 · Cited by 74
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Bauer, C. A., Berry, J. L., & Brozoski, T. J. (2017) · Laryngoscope Investigative Otolaryngology · doi:10.1002/lio2.76 · Cited by 73
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Repa, A., Binder, C., Thanhaeuser, M., Kreissl, A., Pablik, E., Huber-Dangl, M., Berger, A., & Haiden, N. (2017) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2017.11.012 · Cited by 73
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Landorf, K. B., Keenan, A., & Herbert, R. (2004) · Journal of the American Podiatric Medical Association · doi:10.7547/0940542 · Cited by 73
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Shoshani, A., Mifano, K., & Czamanski‐Cohen, J. (2015) · Quality of Life Research · doi:10.1007/s11136-015-1148-7 · Cited by 72
“However, given that the participants who dropped out of the study did not complete the followup questionnaires and had certain constraints that prevented them from participating in the intervention, they could be excluded from the remaining analyses without a high risk of increasing bias [33, 34].”
Interventions for basal cell carcinoma of the skin
Thomson, J., Hogan, S., Leonardi‐Bee, J., Williams, H. C., & Bath-Hextall, F. J. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003412.pub3 · Cited by 77
Shortened treatment regimens versus the standard regimen for drug-sensitive pulmonary tuberculosis
Angeline Grace, G., Mittal, A., Jain, S., Tripathy, J. P., Satyanarayana, S., Tharyan, P., & Kirubakaran, R. (2019) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012918.pub2 · Cited by 72
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Carroll, C., Stevenson, M., Scope, A., Evans, P., & Buckley, S. C. (2011) · Health Technology Assessment · doi:10.3310/hta15360 · Cited by 71
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Cipriani, A., Barbui, C., Brambilla, P., Furukawa, T. A., Hotopf, M. H., & Geddes, J. R. (2006) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v67n0601 · Cited by 71
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Boswell‐Ruys, C. L., Lewis, C., Wijeysuriya, N. S., McBain, R. A., Lee, B. B., McKenzie, D. K., Gandevia, S. C., & Butler, J. E. (2020) · Thorax · doi:10.1136/thoraxjnl-2019-213917 · Cited by 70
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Pretsch, P. K., Spees, L. P., Brewer, N. T., Hudgens, M. G., Sanusi, B. O., Rohner, E., Miller, E. M., Jackson, S., Barclay, L. B., Carter, A., et al. (2023) · The Lancet Public Health · doi:10.1016/s2468-2667(23)00076-2 · Cited by 70
Effectiveness and application of an online leadership intervention to promote mental health and reduce depression-related stigma in organizations.
Shann, C., Martin, A. J., Chester, A., & Ruddock, S. (2018) · Journal of Occupational Health Psychology · doi:10.1037/ocp0000110 · Cited by 69
Calcium channel blockers versus other classes of drugs for hypertension
Zhu, J., Chen, N., Zhou, M., Guo, J., Zhu, C., Zhou, J., Ma, M., & He, L. (2022) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003654.pub6 · Cited by 71
Approach bias modification in inpatient psychiatric smokers
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RESEARCH PARTICIPATION AND THE RIGHT TO WITHDRAW
Edwards, S. (2005) · Bioethics · doi:10.1111/j.1467-8519.2005.00429.x · Cited by 68
How to assess epidemiological studies
ZACCAI, J. H. (2004) · Postgraduate Medical Journal · doi:10.1136/pgmj.2003.012633 · Cited by 66
“Exclusion numbers should be reported. Exclusion is acceptable if study personnel made errors in the implementation of eligibility criteria or if patients never received the intervention in an experimental study.”
Background
Blinding of Outcomes in Trials of Orthopaedic Trauma: An Opportunity to Enhance the Validity of Clinical Trials
Karanicolas, P. J., Bhandari, M., Taromi, B., Akl, E. A., Bassler, D., Alonso‐Coello, P., Comas, D. R., Bryant, D., Smith, S. E., Walter, S. D., et al. (2008) · Journal of Bone and Joint Surgery · doi:10.2106/jbjs.g.00963 · Cited by 65
“Year of publication 1995 14 (8) 1996 15 (9) 1997 16 (9) 1998 17 (10) 1999 8 (5) 2000 23 (13) 2001 19 (11) 2002 26 (15) 2003 13 (8) 2004 20 (12)”
Self-citation
Applying the intention-to-treat principle in practice: Guidance on handling randomisation errors
Yelland, L. N., Sullivan, T., Voysey, M., Lee, K. J., Cook, J. A., & Forbes, A. B. (2015) · Clinical Trials · doi:10.1177/1740774515588097 · Cited by 71
“For example, bias is unlikely to be introduced if ineligible participants are excluded by an independent panel, blinded to treatment group, who review eligibility for all participants based on their status before randomisation.(1,2,20) If exclusions cannot be made in an objective and unbiased manner, then ineligible p…”
Background
Physical activity for smoking cessation in pregnancy: randomised controlled trial
USSHER, M. H., Lewis, S., Aveyard, P. N., Manyonda, I., West, R., Lewis, B. A., Marcus, B. H., Riaz, M. A., Taylor, A. H., Daley, A., et al. (2015) · BMJ · doi:10.1136/bmj.h2145 · Cited by 66
Decentralized care with generic direct-acting antivirals in the management of chronic hepatitis C in a public health care setting
Dhiman, R. K., Grover, G. S., Premkumar, M., Taneja, S., Duseja, A. K., Arora, S., Rathi, S., Satsangi, S., & Roy, A. (2019) · Journal of Hepatology · doi:10.1016/j.jhep.2019.07.006 · Cited by 64
Making Sense of Intention‐to‐Treat
Sainani, K. L. (2010) · PM&R · doi:10.1016/j.pmrj.2010.01.004 · Cited by 62
Outcomes of nutrition knowledge and healthy food choices in 5- to 6-year-old children who received a nutrition intervention based on Piaget's theory
Başkale, H., & Bahar, Z. (2011) · Journal for Specialists in Pediatric Nursing · doi:10.1111/j.1744-6155.2011.00300.x · Cited by 62
A Multicenter Randomized Control Trial Comparing a Novel Intramedullary Device (InterTAN) Versus Conventional Treatment (Sliding Hip Screw) of Geriatric Hip Fractures
Sanders, D. A., Bryant, D., Tieszer, C., Lawendy, A., Macleod, M. D., Papp, S., Liew, A., Viskontas, D., Coles, C. P., Gurr, K. R., et al. (2016) · Journal of Orthopaedic Trauma · doi:10.1097/bot.0000000000000713 · Cited by 63
Continuous Posterior Lumbar Plexus Nerve Block Versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Total Hip Arthroplasty
Johnson, R. L., Amundson, A. W., Abdel, M. P., Sviggum, H. P., Mabry, T. M., Mantilla, C. B., Schroeder, D. R., Pagnano, M. W., & Kopp, S. L. (2017) · Journal of Bone and Joint Surgery · doi:10.2106/jbjs.16.01305 · Cited by 63
Comparison of Carbon-impregnated and Standard ePTFE Prostheses in Extra-anatomical Anterior Tibial Artery Bypass: A Prospective Randomized Multicenter Study
Kapfer, X., Meichelböck, W., & Groegler, F.-M. (2006) · European Journal of Vascular and Endovascular Surgery · doi:10.1016/j.ejvs.2005.12.015 · Cited by 62

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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