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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Background
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Background
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Self-citation
Preparing reports for publication and responding to reviewers' comments
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Self-citation
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“Following existing recommendations [30], the principal investigator will decide on exclusion while unaware of any consequences of enrollment, including the patient's allocation or outcomes.”
Method
Detailed statistical analysis plan for the target temperature management after out-of-hospital cardiac arrest trial
Nielsen, N., Winkel, P., Cronberg, T., Erlinge, D., Friberg, H., Gasche, Y. G., Hassager, C., Horn, J., Hovdenes, J., Kjærgaard, J., et al. (2013) · Trials · doi:10.1186/1745-6215-14-300 · Cited by 39
Best (but oft-forgotten) practices: intention-to-treat, treatment adherence, and missing participant outcome data in the nutrition literature
Johnston, B. C., & Guyatt, G. H. (2016) · The American Journal of Clinical Nutrition · doi:10.3945/ajcn.115.123315 · Cited by 36
Self-citation
Cancer Clinical Trials: Development and Implementation
Vail, D. M. (2007) · Veterinary Clinics of North America Small Animal Practice · doi:10.1016/j.cvsm.2007.06.007 · Cited by 38
Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: study protocol for a multicenter randomized trial
Hess, E. P., Wyatt, K. D., Kharbanda, A. B., Louie, J. P., Dayan, P. S., Tzimenatos, L. S., Wootton‐Gorges, S. L., Homme, J. L., Pencille, L. J., LeBlanc, A., et al. (2014) · Trials · doi:10.1186/1745-6215-15-253 · Cited by 38
“Though every effort will be made to minimize post-randomization exclusions, patients will be excluded if they are found to meet exclusion criteria that were not recognized at the time of enrollment or they choose to withdraw [33].”
Background
Long-term outcomes in patients with severe sepsis randomised to resuscitation with hydroxyethyl starch 130/0.42 or Ringer’s acetate
Perner, A., Haase, N., Winkel, P., Guttormsen, A. B., Tenhunen, J. J., Klemenzson, G., Müller, R., Åneman, A., & Wetterslev, J. (2014) · Intensive Care Medicine · doi:10.1007/s00134-014-3311-y · Cited by 37
“The analyses were done in the modified intention-to-treat population defined as all randomised patients (n = 804) except those who could be excluded post-randomisation without risk of bias [23] (n = 4; two were randomised without consent and we decided during the trial to exclude two other patients who were erroneousl…”
The reverse propensity score to detect selection bias and correct for baseline imbalances
Berger, V. W. (2005) · Statistics in Medicine · doi:10.1002/sim.2141 · Cited by 37
Loss to Analysis in Randomized Controlled Trials in CKD
Deo, A., Schmid, C. H., Earley, A., Lau, J., & Uhlig, K. (2011) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2011.04.023 · Cited by 37
Metformin versus placebo in combination with insulin analogues in patients with type 2 diabetes mellitus—the randomised, blinded Copenhagen Insulin and Metformin Therapy (CIMT) trial
Lundby‐Christensen, L., Tarnow, L., Boesgaard, T. W., Lund, S. S., Wiinberg, N., Perrild, H., Krarup, T., Snorgaard, O., Gade-Rasmussen, B., Thorsteinsson, B., et al. (2016) · BMJ Open · doi:10.1136/bmjopen-2015-008376 · Cited by 37
“Further, a per protocol analysis was performed (exclusion of participants not fulfilling the criteria for participation, never receiving the allocated trial medication or having major deviations to the protocol (not meeting to at least four visits).(21) The statistical model used for analysis of hypoglycaemic events w…”
Prevention of alcohol use in older teens: A randomized trial of an online family prevention program.
Byrnes, H. F., Miller, B. A., Grube, J. W., Bourdeau, B., Buller, D. B., Wang‐Schweig, M., & Woodall, W. G. (2019) · Psychology of Addictive Behaviors · doi:10.1037/adb0000442 · Cited by 37
A 3-arm randomized clinical trial comparing interscalene blockade techniques with local infiltration analgesia for total shoulder arthroplasty
Panchamia, J. K., Amundson, A. W., Jacob, A. K., Sviggum, H. P., Nguyen, N. T. V., Sánchez‐Sotelo, J., Sperling, J. W., Schroeder, D. R., Kopp, S. L., & Johnson, R. L. (2019) · Journal of Shoulder and Elbow Surgery · doi:10.1016/j.jse.2019.05.013 · Cited by 37
Effectiveness of information technology–enabled ‘SMART Eating’ health promotion intervention: A cluster randomized controlled trial
Kaur, J., Kaur, M., Chakrapani, V., Webster, J. L., Santos, J. A., & Kumar, R. (2020) · PLoS ONE · doi:10.1371/journal.pone.0225892 · Cited by 39
“ITT minimizes type I error and gives an unbiased estimate of the treatment effect because of dilution caused by noncompliance [60,61].”
Background
Prenatal fortified balanced energy-protein supplementation and birth outcomes in rural Burkina Faso: A randomized controlled efficacy trial
de Kok, B., Toe, L. C., Hanley‐Cook, G., Argaw, A., Ouédraogo, M., Compaoré, A., Vanslambrouck, K., Dailey-Chwalibóg, T., Ganaba, R., Kolsteren, P. W., et al. (2022) · PLoS Medicine · doi:10.1371/journal.pmed.1004002 · Cited by 39
“Postrandomization, we excluded women without a confirmed pregnancy using the ultrasound examination, women with GA�21 completed weeks, and multifetal pregnancies [20].”
Method
N-acetylcysteine is associated with increased blood loss and blood product utilization during cardiac surgery*
Wijeysundera, D. N., Karkouti, K., Rao, V., Granton, J. T., Chan, C. T., Raban, R., Carroll, J. A., Poonawala, H., & Beattie, W. S. (2009) · Critical Care Medicine · doi:10.1097/ccm.0b013e31819ffed4 · Cited by 37
“Two were excluded because they met exclusion criteria before randomization (25): severe renal insufficiency (creatinine concentration of 513 mol/L in N-acetylcysteine arm) and N-acetylcysteine within 24 hours before surgery (placebo arm).”
Evidence‐Based Dermatology
Bigby, M. E., & Williams, H. C. (2010) · Wiley eBooks · doi:10.1002/9781444317633.ch7 · Cited by 38
Why have meta‐analyses of randomized controlled trials of the association between non‐white‐blood‐cell‐reduced allogeneic blood transfusion and postoperative infection produced discordant results?
Vamvakas, E. C. (2007) · Vox Sanguinis · doi:10.1111/j.1423-0410.2007.00959.x · Cited by 35
Preventive Neuromuscular Training for Young Female Athletes: Comparison of Coach and Athlete Compliance Rates
Sugimoto, D., Mattacola, C. G., Bush, H., Thomas, S. M., Foss, K. D. B., Myer, G. D., & Hewett, T. E. (2016) · Journal of Athletic Training · doi:10.4085/1062-6050-51.12.20 · Cited by 36
Evaluating a two-step approach to sexual risk reduction in a publicly-funded STI clinic: Rationale, design, and baseline data from the Health Improvement Project-Rochester (HIP-R)
Carey, M. P., Vanable, P. A., Senn, T. E., Coury-Doniger, P. A., & Urban, M. A. (2008) · Contemporary Clinical Trials · doi:10.1016/j.cct.2008.02.001 · Cited by 36
“Third, because non-attendance at the intensive intervention can make the detection of intervention effects even more challenging, both “intent-to-treat” [76] and “as treated” [77] analyses will be conducted.”
Background
Improved resilience following digital cognitive behavioral therapy for insomnia protects against insomnia and depression one year later
Cheng, P., Kalmbach, D. A., Hsieh, H.-F., Castelan, A. C., Sagong, C., & Drake, C. L. (2023) · Psychological Medicine · doi:10.1017/s0033291722000472 · Cited by 35
“A critical weakness of the traditional ITT approach is its high susceptibility to type II error when attrition rate is high (Fergusson et al., 2002; Hollis & Campbell, 1999).”
Effect of Fluorescence Visualization–Guided Surgery on Local Recurrence of Oral Squamous Cell Carcinoma
Durham, J. S., Brasher, P. M. A., Anderson, D. W., Yoo, J. J., Hart, R., Dort, J. C., Seikaly, H. R., Kerr, P., Rosin, M. P., & Poh, C. F.-Y. (2020) · JAMA Otolaryngology–Head & Neck Surgery · doi:10.1001/jamaoto.2020.3147 · Cited by 35
Physiologic effects of stress dose corticosteroids in in-hospital cardiac arrest (CORTICA): A randomized clinical trial
Mentzelopoulos, S. D., Pappa, E., Malachias, S., Vrettou, C. S., Giannopoulos, A., Karlis, G., Adamos, G., Pantazopoulos, I. N., Megalou, A. J., Louvaris, Z., et al. (2022) · Resuscitation Plus · doi:10.1016/j.resplu.2022.100252 · Cited by 40
Comparison of reperfusion regimens with or without tirofiban in ST-elevation acute myocardial infarction
Martínez‐Ríos, M. A., Rosas, M., González, H., Peña‐Duque, M. A., Martínez‐Sánchez, C., Gaspar, J., García, H. H., Gaxiola, E., Delgado, L., Carrillo, J., et al. (2004) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2003.10.005 · Cited by 35
Randomized Trial Comparing the Primary Patency following Cutting Versus High-Pressure Balloon Angioplasty for Treatment of de Novo Venous Stenoses in Hemodialysis Arteriovenous Fistulae
Rasuli, P., Chennur, V. S., Connolly, M. J., Hadziomerovic, A., Pomerleau, F. E., Ryan, S. E., French, G. J., O’Kelly, K., Aina, R., Champagne, P., et al. (2015) · Journal of Vascular and Interventional Radiology · doi:10.1016/j.jvir.2015.08.024 · Cited by 34
Percutaneous patent foramen ovale closure for secondary stroke prevention
Tsivgoulis, G. K., Katsanos, A. H., Mavridis, D., Frogoudaki, A., Vrettou, A., Ikonomidis, I., Parissis, J., Deftereos, S. G., Karapanayiotides, T., Palaiodimou, L., et al. (2018) · Neurology · doi:10.1212/wnl.0000000000005739 · Cited by 35
“Attrition bias was considered as high if the percentage of missing outcome data was more than 20% or unbalanced between arms, low if reported losses to follow-up were 5% or lower, and unclear if missing data ranged between 5% and 20%.(17) In the “other bias” category, we included all other potential sources of bias, i…”
Background
Do probiotics prevent antibiotic-associated diarrhoea? Results of a multicentre randomized placebo-controlled trial
Rajkumar, C., Wilks, M., Islam, J., Ali, K., Raftery, J. P., Davies, K. A., Timeyin, J., Cheek, E., Cohen, J., Wright, J. E., et al. (2020) · Journal of Hospital Infection · doi:10.1016/j.jhin.2020.01.018 · Cited by 35
“The groups were analysed as intention to treat including patients that did not meet all inclusion and exclusion criteria [23].”
Method
Prevalence, causes, and outcome at 2 years of age of newborn encephalopathy
Marlow, N., & Budge, H. (2005) · Archives of Disease in Childhood Fetal & Neonatal · doi:10.1136/adc.2004.057059 · Cited by 34
“The whole episode of care, whether or not the infant ended up receiving ECMO or not, was then reported including an intention to treat analysis”
Background
Leukodepletion of autologous whole blood has no impact on perioperative infection rate and length of hospital stay
Frietsch, T., Karger, R., Schöler, M., Huber, D., Bruckner, T., Kretschmer, V., Schmidt, S., Leidinger, W., & Weiler‐Lorentz, A. (2008) · Transfusion · doi:10.1111/j.1537-2995.2008.01804.x · Cited by 34
“Outcome “Intention-to-treat” analysis “Per-protocol” analysis LD AWB (n = 488) Non-LD AWB (n = 463) p Value LD AWB (n = 255) Non-LD AWB (n = 226) p Value LOS (days) 14 (7-36) 14 (8-55) 0.”
Using Anonymity and Communal Efforts to Improve Quality of Crowdsourced Feedback
Hui, J. S., Glenn, A., Jue, R., Gerber, E. M., & Dow, S. P. (2015) · Proceedings of the AAAI Conference on Human Computation and Crowdsourcing · doi:10.1609/hcomp.v3i1.13229 · Cited by 33
“ITT analysis includes subjects according to treatment randomly assigned instead of treatment received, essentially ignoring factors after randomization (Fergusson et al. 2002).”
Method
Carrageenan nasal spray may double the rate of recovery from coronavirus and influenza virus infections: Re‐analysis of randomized trial data
Hemilä, H., & Chalker, E. (2021) · Pharmacology Research & Perspectives · doi:10.1002/prp2.810 · Cited by 33
Don't be misled by the orthopedic literature : Tips for critical appraisal
Poolman, R. W., Kerkhoffs, G. M. M. J., Struijs, P. A. A., Bhandari, M., & Evid, O. B. O. T. I. (2007) · Acta Orthopaedica · doi:10.1080/17453670710013636 · Cited by 33
Randomized multicentre feasibility trial of intermediate care versus standard ward care after emergency abdominal surgery (InCare trial)
Vester‐Andersen, M., Waldau, T. E., Wetterslev, J., Møller, M. H., Rosenberg, J., Jørgensen, L. N., Jakobsen, J. C., Møller, A. M., InCare trial group, Gillesberg, I. E., et al. (2015) · British journal of surgery · doi:10.1002/bjs.9749 · Cited by 33
The Intention-to-Treat Analysis Is Not Always the Conservative Approach
Shrier, I., Verhagen, E. A. L. M., & Stovitz, S. D. (2017) · The American Journal of Medicine · doi:10.1016/j.amjmed.2017.03.023 · Cited by 32
High Flow Oxygen Therapy at Two Initial Flow Settings versus Conventional Oxygen Therapy in Cardiac Surgery Patients with Postextubation Hypoxemia: A Single-Center, Unblinded, Randomized, Controlled Trial
Theologou, S., Ischaki, E., Zakynthinos, S. G., Charitos, C., Michopanou, N., Patsatzis, S., & Mentzelopoulos, S. D. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10102079 · Cited by 32
“, absence of moderate hypoxemia at end of SBT); such exclusions could have reduced the precision of treatment effect estimates and study power [33].”
Background
First-line oxaliplatin-based chemotherapy and nivolumab for metastatic microsatellite-stable colorectal cancer—the randomised METIMMOX trial
Ree, A. H., Benth, J. Š., Hamre, H. M., Kersten, C., Hofsli, E., Guren, M. G., Sørbye, H., Johansen, C., Negård, A., Bjørnetrø, T., et al. (2024) · British Journal of Cancer · doi:10.1038/s41416-024-02696-6 · Cited by 33
“Secondary endpoints re ﬂ ected tumour response patterns distinctive for chemotherapy only (tumour shrinkage caused by the cytotoxic mode of action) or the combined-modality treatment (tumour responses translating into various radiologic measures).”
Method
A randomized clinical trial of oral hygiene care programmes during stroke rehabilitation
Dai, R., Lam, O., Lo, E. C. M., Li, L. S. W., & McGrath, C. P. J. (2017) · Journal of Dentistry · doi:10.1016/j.jdent.2017.04.001 · Cited by 31
Evaluating the short-term and long-term effects of an internet-based aural rehabilitation programme for hearing aid users in general clinical practice: a randomised controlled trial
Malmberg, M., Lunner, T., Kähäri, K. R., & Andersson, G. (2017) · BMJ Open · doi:10.1136/bmjopen-2016-013047 · Cited by 32
Forced fluid removal in intensive care patients with acute kidney injury: The randomised FFAKI feasibility trial
Berthelsen, R. E., Perner, A., Jensen, A. K. G., Rasmussen, B. S., Jensen, J. S., Wiis, J., Behzadi, M. T., & Bestle, M. H. (2018) · Acta Anaesthesiologica Scandinavica · doi:10.1111/aas.13124 · Cited by 31
“Days alive and without vasopressors/inotropes, median (IQR) 86 (2-87) 53 (2-88) .”
Background
Oxygen in the ICU
Ferguson, N. D. (2016) · JAMA · doi:10.1001/jama.2016.13800 · Cited by 31
INHALEd nebulised unfractionated HEParin for the treatment of hospitalised patients with COVID‐19 (INHALE‐HEP): Protocol and statistical analysis plan for an investigator‐initiated international metatrial of randomised studies
van Haren, F. M. P., Richardson, A., Yoon, H., Artigas, A., Laffey, J. G., Dixon, B., Smith, R. J., Vilaseca, A., Barbera, R. A., Ismail, T. I., et al. (2020) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.14714 · Cited by 29
Exercise Increases Insulin Sensitivity and Skeletal Muscle AMPK Expression in Systemic Lupus Erythematosus: A Randomized Controlled Trial
Benatti, F. B., Miyake, C. N. H., Dantas, W. S., Zambelli, V. O., Shinjo, S. K., Pereira, R. M. R., Silva, M. E. R., de Sá‐Pinto, A. L., Borba, E. F., Bonfá, E., et al. (2018) · Frontiers in Immunology · doi:10.3389/fimmu.2018.00906 · Cited by 30
PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients
O"Toole, R. V., Stein, D. M., Frey, K. P., O’Hara, N. N., Scharfstein, D. O., Slobogean, G. P., Taylor, T. J., Haac, B. E., Carlini, A. R., Manson, T. T., et al. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-041845 · Cited by 29
Transdiagnostic efficacy of a group exercise intervention for outpatients with heterogenous psychiatric disorders: a randomized controlled trial
Zeibig, J., Seiffer, B., Sudeck, G., Rösel, I., Hautzinger, M., & Wolf, S. (2021) · BMC Psychiatry · doi:10.1186/s12888-021-03307-x · Cited by 30
Preliminary analysis of short term financial implications of a prevention bonus program: First results from the German statutory health insurance
Stock, S., Stollenwerk, B., Klever-Deichert, G., Redaèlli, M., Büscher, G., Graf, C. A., Möhlendick, K., Mai, J., Gerber, A., Lüngen, M., et al. (2008) · Sozial- und Präventivmedizin · doi:10.1007/s00038-008-7026-0 · Cited by 29
“Critics of the intention to treat analysis on the other hand argue, that this approach is too cautious and more susceptible to type II error [ 33 ; 34; 35].”
Background
Effectiveness of sleep deprivation in treating acute bipolar depression as augmentation strategy: a systematic review and meta-analysis
Ramirez-Mahaluf, J. P., Rozas-Serri, E., Ivanovic-Zuvic, F., Risco, L., & Vöhringer, P. A. (2020) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2020.00070 · Cited by 28
Design and Preliminary Results of a Pilot Randomized Controlled Trial on a 1:1:1 Transfusion Strategy: The Trauma Formula-Driven Versus Laboratory-Guided Study
Nascimento, B., Rizoli, S., Rubenfeld, G. D., Lin, Y., Callum, J., & Tien, H. C. N. (2011) · The Journal of Trauma: Injury, Infection, and Critical Care · doi:10.1097/ta.0b013e318232e591 · Cited by 27

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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