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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“Excluding patients from an analysis does not necessarily bias the results, provided that certain requirements are met, for instance that intention-to-treat applies to all randomised patients [49].”
Background
Standardised feeding regimens: hope for reducing the risk of necrotising enterocolitis
Premji, S. (2005) · Archives of Disease in Childhood Fetal & Neonatal · doi:10.1136/adc.2004.063198 · Cited by 9
Rationale for randomized controlled trials and for intention‐to‐treat analysis in transfusion medicine: are they one and the same?
Vamvakas, E. C. (2008) · Vox Sanguinis · doi:10.1111/j.1423-0410.2008.01089.x · Cited by 9
Interventions to address mathematics anxiety: An overview and recommendationsPreprint
Petronzi, D., Hunt, T. E., & Sheffield, D. (2021) · PsyArXiv (OSF Preprints) · doi:10.31234/osf.io/a46eh · Cited by 13
Trial analysis by treatment allocated or by treatment received? Origins of ‘the intention-to-treat principle’ to reduce allocation bias: Part 2
Chalmers, I., Matthews, R., Glasziou, P., Boutron, I., & Armitage, P. (2023) · Journal of the Royal Society of Medicine · doi:10.1177/01410768231203936 · Cited by 9
Comparative effectiveness of disease-modifying therapies for highly active relapsing-remitting multiple sclerosis despite previous treatment – a systematic review and network meta-analysis
Köhler, M., Paul, F., Janke, K., Sturtz, S., Preukschat, D., Ostlender, S., Kerekes, M. F., & Kaiser, T. (2025) · BMC Neurology · doi:10.1186/s12883-025-04338-7 · Cited by 8
“Two reviewers assessed the risk of bias for all relevant studies using criteria commonly applied to RCTs [40– 49].”
Effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: statistical analysis plan for a randomized controlled trial
Rasmussen, R. S., Juhler, M., & Wetterslev, J. (2014) · Trials · doi:10.1186/1745-6215-15-228 · Cited by 8
“Analyses will be conducted according to the modified intention-to-treat principle [6].”
Method
A prospective controlled randomized multicenter study to evaluate the severity of compensatory sweating after one-stage bilateral thoracic sympathectomy versus unilateral thoracic sympathectomy in the dominant side
Hamilton, N. N., Tedde, M. L., Wolosker, N., Aguiar, W. W. S., Ferreira, H. P. D. C., de Oliveira, H. A., Lima, A. M. R., Westphal, F. L., de Oliveira, M. V. B., Riuto, F. D. O., et al. (2020) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2020.100618 · Cited by 8
Pentoxifylline in the Treatment of Cutaneous Leishmaniasis: A Randomized Clinical Trial in Colombia
Castro, M. D. M., Cossio, A., Navas, A., Fernández, O. L., Valderrama, L., Cuervo‐Pardo, L., Marquez-Oñate, R., Gómez, M. A., & Saravia, N. G. (2022) · Pathogens · doi:10.3390/pathogens11030378 · Cited by 8
“Therefore, the risk of bias for excluding these patients is low [34].”
Background
Epinephrine vs placebo in neonatal resuscitation: ROSC and brain MRS/MRI in term piglets
Andersen, H. B., Andersen, M. H., Andelius, T. C. K., Pedersen, M. V., Løfgren, B., Pedersen, M., Ringgaard, S., Kyng, K. J., & Henriksen, T. B. (2022) · Pediatric Research · doi:10.1038/s41390-022-02126-4 · Cited by 9
Estudio aleatorizado sobre la posición de electrodos en la cardioversión eléctrica electiva de la fibrilación auricular
Muñoz-Martínez, T., Castañeda-Saiz, A., Vinuesa-Lozano, C., Aretxabala-Kortajarena, N., Dudagoitia-Otaolea, J. L., Diarasarri, S. I., Ruiz-Zorrilla, J. M., Hernández-López, M., & Castillo-Arenal, C. (2009) · Medicina Intensiva · doi:10.1016/j.medin.2009.10.004 · Cited by 8
Helicobacter pylorieradication treatment for gastric carcinoma prevention in asymptomatic or dyspeptic adults: systematic review and Bayesian meta-analysis of randomised controlled trials
Terasawa, T., Hamashima, C., Kato, K., Miyashiro, I., Yoshikawa, T., Takaku, R., & Nishida, H. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-026002 · Cited by 8
Vasopressin and methylprednisolone for in-hospital cardiac arrest — Protocol for a randomized, double-blind, placebo-controlled trial
Andersen, L. W., Sindberg, B., Holmberg, M. J. J., Isbye, D. L., Kjærgaard, J., Zwisler, S. T., Darling, S., Larsen, J. M., Rasmussen, B. S., Løfgren, B., et al. (2021) · Resuscitation Plus · doi:10.1016/j.resplu.2021.100081 · Cited by 8
“In a double-blind trial, this approach is unbiased while increasing precision.(22)”
Method
Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan
Adhikari, N. K. J., Pinto, R. L., Day, A. G., Masse, M.-H., Ménard, J., Sprague, S., Annane, D., Arabi, Y. M., Battista, M., Cohen, D., et al. (2022) · JMIR Research Protocols · doi:10.2196/36261 · Cited by 10
“…did not receive the assigned intervention; (3) blinding was maintained; and (4) 2 members of the steering committee blinded to allocation agree that the participant was mistakenly randomized after review of information from medical records available at the time of randomization [21,22].”
Self-citation
Monitoring Training Progress During Exercise Training in Cancer Survivors: A Submaximal Exercise Test as an Alternative for a Maximal Exercise Test?
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. (2010) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2009.11.018 · Cited by 8
“21 Changes in outcome variables from baseline to postinter-vention were analyzed using linear mixed-effects models.”
Method
The Quality of Randomized Clinical Trials in the Field of Surgery: Studies on Laparoscopic versus Open Appendectomy as an Example
Sadr‐Azodi, O., & Andrén‐Sandberg, Å. (2009) · Digestive Surgery · doi:10.1159/000229992 · Cited by 8
“Thus, it is the responsibility of the investigators to make sure that a planned study has sufficient precision and statistical power to test a given hypothesis.When analyzing the results of a randomized trial, investigators may be tempted to exclude some particular individuals, such as those erroneously included in a…”
Background
The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in polio survivors: protocol for a randomised controlled trial
Murray, D., Meldrum, D., Moloney, R., Campion, A., Horgan, F., & Hardiman, O. M. (2012) · BMC Neurology · doi:10.1186/1471-2377-12-157 · Cited by 8
The Dilemma of the Level of the Inferior Mesenteric Artery Ligation in the Treatment of Diverticular Disease: A Systematic Review of the Literature
Cirocchi, R., Mari, G. M., Amato, B., Tebala, G. D., Popivanov, G., Avenia, S., & Nascimbeni, R. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11040917 · Cited by 8
“The analysis of RCTs was performed by the intention-to-treat analysis [15] and the Mantel–Haenszel method [16].”
Method
Pre-randomization and de-randomization in emergency medical research: new names and rigorous criteria for old methods
Hallstrom, A. P., & Paradis, N. A. (2005) · Resuscitation · doi:10.1016/j.resuscitation.2004.10.008 · Cited by 8
“Although uncommon in the ordinary course of clinical trials, there are instances when inclusion criteria have been obtained but not evaluated prior to randomization, and subsequently, after the information was evaluated, patients not meeting inclusion criteria were dropped from the trial [9,10].”
Background
Platelet-Rich Plasma for Chronic Tennis Elbow: Letters to the Editor
Aspenberg, P., & Ranstam, J. (2014) · The American Journal of Sports Medicine · doi:10.1177/0363546513512784 · Cited by 8
“However, as it stands we do not believe that PRP has demonstrated that it adds anything to the use of nonoperative approaches such as watchful waiting16 or a progressive exercise program1,4,5,10,15 or indeed local anesthetic at 12 weeks, as stated in their own data.13 Therefore, until there is clear evidence of additi…”
BackgroundInfluential
Adding A Structured Educational Session to the Rehabilitation Program of Soccer Players Following Anterior Cruciate Ligament Reconstruction: A Feasibility Study
AlMuhaya, A. H., Albarrati, A., Alhowimel, A., & Alodaibi, F. (2023) · International Journal of Sports Physical Therapy · doi:10.26603/001c.68141 · Cited by 10
Intention-to-Treat Analysis in Clinical Research
Armijo-Olivo, S. L., da Silva, J. B., de Castro‐Carletti, E. M., de Oliveira‐Souza, A. I. S., Pelai, E. B., Mohamad, N., Baghbaninaghadehi, F., Dennett, L., Steen, J. P., Kumbhare, D. A., et al. (2024) · American Journal of Physical Medicine & Rehabilitation · doi:10.1097/phm.0000000000002444 · Cited by 8
“…of their compliance with the treatment of interest, the results could likely be biased toward the null hypothesis (underestimation of true effects) 29 in presence of noncompliance compared with what it would have achieved if every participant followed the assigned treatment plan and, hence,…”
Video call-based cognitive behaviour therapy for adults with common mental health conditions: a systematic review and meta-analysis
Ebrahimjee, A., Hodsoll, J. P., Valmaggia, L., Hickling, L. M., & Riches, S. (2024) · The Cognitive Behaviour Therapist · doi:10.1017/s1754470x2400028x · Cited by 10
“…the inclusion of which provides a more reliable estimate of clinical effectiveness, mirroring clinical practice (i.e. non-compliance, protocol violations, attrition while preserving sample size and minimising Type 1 errors and bias related to incomplete data; Fergusson et al ., 2002; Gupta, 2011).”
Examining the Heterogeneity and Cost Effectiveness of a Complex Intervention by Segmentation of Patients with Chronic Obstructive Pulmonary Disease
Sørensen, S. S., Jensen, M. B., Pedersen, K. M., & Ehlers, L. H. (2017) · Value in Health · doi:10.1016/j.jval.2017.08.001 · Cited by 7
“These two intervention patients were excluded from further analysis to enhance precision of the CUA estimates [24].”
BackgroundMethod
Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial
Nørskov, A. K., Lundstrøm, L. H., Rosenstock, C. V., & Wetterslev, J. (2014) · Trials · doi:10.1186/1745-6215-15-173 · Cited by 7
“Main analyses will be according to ITT adjusted for cluster and stratification variables.”
MethodInfluential
Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial
Mercier, R. J. (2017) · Obstetrics and Gynecology · doi:10.1097/aog.0000000000002386 · Cited by 7
One-year outcome of the sevoflurane in acute myocardial infarction randomized trial
Lavi, S., Alemayehu, M., McCarty, D., Warrington, J. C., & Lavi, R. (2015) · Canadian Journal of Anesthesia/Journal canadien d anesthésie · doi:10.1007/s12630-015-0456-2 · Cited by 7
Detection of Outliers Due to Participants’ Non-Adherence to Protocol in a Longitudinal Study of Cognitive Decline
Dugravot, A., Sabia, S., Shipley, M. J., Welch, C. A., Mika Kivimaki, B., & Singh‐Manoux, A. (2015) · PLoS ONE · doi:10.1371/journal.pone.0132110 · Cited by 7
Consolidation chwemotherapy after concurrent chemoradiotherapy vs. chemoradiotherapy alone for locally advanced unresectable stage III non-small-cell lung cancer: A meta-analysis
Chang, X., Wang, Z., & Yang, L. (2016) · Molecular and Clinical Oncology · doi:10.3892/mco.2016.910 · Cited by 7
“Finally, an assessment was made as to whether the trial results used intention-to-treat analysis (30,31).”
Complexities, Confounders, and Challenges in Experimental Stroke Research: A Checklist for Researchers and Reviewers
Dirnagl, U. (2010) · Neuromethods · doi:10.1007/978-1-60761-750-1_19 · Cited by 7
The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in Polio survivors: a randomised controlled trial
Murray, D., Hardiman, O. M., Campion, A., Vance, R. C., Horgan, F., & Meldrum, D. (2016) · Clinical Rehabilitation · doi:10.1177/0269215516661225 · Cited by 7
Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial
Presneill, J., Gantner, D. C., Nichol, A., McArthur, C. J., Forbes, A. B., Kasza, J., Trapani, T. V., Murray, L., Bernard, S. A., Cameron, P. A., et al. (2018) · Trials · doi:10.1186/s13063-018-2610-y · Cited by 8
“The main primary and secondary analyses will follow an ITT approach to define the full analysis patient set, based on all randomly assigned patients after the eightpatient run-in period, except those withdrawing consent for use of all trial data and those not fulfilling inclusion criteria and never receiving the inter…”
Method
Effectiveness of triple antibiotic paste as an intra-canal medication for the root canal treatment of non-vital teeth with apical periodontitis: A systematic review
Hamid, E. A., Aziz, S. A., Sadek, H. S., & Ibrahim, A. M. (2018) · F1000Research · doi:10.12688/f1000research.16423.1 · Cited by 7
Financial Incentives for Preventing Postpartum return to Smoking (FIPPS): study protocol for a three-arm randomised controlled trial
USSHER, M. H., Best, C. S., Lewis, S., McKell, J., Coleman, T. J., Cooper, S., Orton, S., & Bauld, L. (2021) · Trials · doi:10.1186/s13063-021-05480-6 · Cited by 7
The Effects of Being Informed About Chemotherapy-Related Cognitive Symptoms With And Without Self-Affirmation on Perceived Cognitive Symptoms of Breast Cancer Patients: A Randomized Prospective, Longitudinal Study
Jacobs, W. L., Schagen, S. B., Brouwer, S. M., Kieffer, J. M., Baas, I. O., Los, M., Sonke, G. S., & Das, E. (2022) · Clinical Breast Cancer · doi:10.1016/j.clbc.2022.03.001 · Cited by 7
Statistical analysis plan for the Standard versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial
Bagshaw, S. M., & Wald, R. (2019) · Critical Care and Resuscitation · doi:10.1016/s1441-2772(23)00524-0 · Cited by 8
Robustness of an Odds‐ratio Test in a Stratified Group Sequential Trial with a Binary Outcome Measure
Srivastava, D. K., Rai, S. N., & Pan, J. (2006) · Biometrical Journal · doi:10.1002/bimj.200610265 · Cited by 7
Evaluating the Internal Validity of a Randomized Controlled Trial
Turlik, M. (2009) · The Foot and Ankle Online Journal · doi:10.3827/faoj.2009.0203.0005 · Cited by 7
Which Randomized Controlled Trials Are Relevant to Clinical Practice?
Collins, J. A. (2005) · Obstetrics and Gynecology · doi:10.1097/01.aog.0000173316.14537.7d · Cited by 7
Treatment for anemia in people with AIDS
Martí-Carvajal, A. J., & Solà, I. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004776.pub2 · Cited by 7
Statistical analysis plan for hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: the ANDROMEDA-SHOCK-2 randomized clinical trial
Orozco, N., García-Gallardo, G., Cavalcanti, A. B., dos Santos, T. M., Ospina-Tascón, G. A., Bakker, J., Morales, S., Ramos, K., Alegría, L., Teboul, J., et al. (2025) · Critical Care Science · doi:10.62675/2965-2774.20250140 · Cited by 6
Comparative effectiveness of diabetes self-management education and support intervention strategies among adults with type 2 diabetes in Texas
Ory, M. G., Han, G., Nsobundu, C., Carpenter, K., Towne, S. D., & Smith, M. L. (2025) · Frontiers in Public Health · doi:10.3389/fpubh.2025.1543298 · Cited by 11
“This ITT analysis was in compliance with the CONSORT statement and employed because it can preserve the baseline balance of the arms and prevent selection bias and confounding (52, 53).”
Effectiveness of motivational interviewing plus cognitive behavioral therapy vs shared decision making for voluntary opioid tapering in patients with chronic pain: the INSPIRE randomized pragmatic trial
Mccormack, L. A., Edlund, M. J., Thomas, S., Wu, L.-T. T., Chelminski, P. R., Archer, K. R., Wagner, L., Hirsch, S. C., Thompson, J. E., Dolor, R. J., et al. (2025) · Pain Medicine · doi:10.1093/pm/pnaf049 · Cited by 7

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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