Varying the block size does not conceal the allocation
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If some type of restricted randomisation approach is to be used, in particular blocked randomisation or minimisation, then knowledge of the specific details could lead to bias.
“If some type of restricted randomisation approach is to be used, in particular blocked randomisation or minimisation, then knowledge of the specific details could lead to bias.342 343”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [342]
Cites
Randomization and allocation concealment: a practical guide for researchers
Doig, G. S., & Simpson, F. O. (2005) · Journal of Critical Care · doi:10.1016/j.jcrc.2005.04.005 · Cited by 664 · see citing works
Randomization in Clinical Trials: Theory and Practice
Rosenberger, W. F., & Lachin, J. M. (2002) · Cited by 368 · see citing works
Selection Bias and Covariate Imbalances in Randomized Clinical Trials
Berger, V. W. (2005) · Wiley eBooks · doi:10.1002/0470863641 · Cited by 261 · see citing works
Self-citationRandomization in Clinical Trials: Theory and Practice;
Matthews, J. N. S. (2003) · Controlled Clinical Trials · doi:10.1016/s0197-2456(02)00324-0 · Cited by 240 · see citing works
Berger, V. W., Ivanova, A., & Knoll, M. D. (2003) · Statistics in Medicine · doi:10.1002/sim.1538 · Cited by 200 · see citing works
Self-citationDetecting Selection Bias in Randomized Clinical Trials
Berger, V. W., & Exner, D. V. (1999) · Controlled Clinical Trials · doi:10.1016/s0197-2456(99)00014-8 · Cited by 163 · see citing works
Self-citationEnsuring the comparability of comparison groups: is randomization enough?
Berger, V. W., & Weinstein, S. (2004) · Controlled Clinical Trials · doi:10.1016/j.cct.2004.04.001 · Cited by 65 · see citing works
Self-citationAllocation concealment and blinding: when ignorance is bliss
Berger, V. W. (2005) · The Medical Journal of Australia · doi:10.5694/j.1326-5377.2005.tb06974.x · Cited by 22 · see citing works
Self-citationAllocation concealment and blinding: when ignorance is bliss
Hemilä, H. (2005) · The Medical Journal of Australia · doi:10.5694/j.1326-5377.2005.tb06975.x · Cited by 1 · see citing works
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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 · see citing works
Risk of selection bias in randomised trials
Kahan, B. C., Rehal, S., & Cro, S. (2015) · Trials · doi:10.1186/s13063-015-0920-x · Cited by 180 · see citing works
“Although both approaches will help, neither will reduce the risk to an acceptable level [4, 23].”
BackgroundSPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
Balance algorithm for cluster randomized trials
Carter, B., & Hood, K. (2008) · BMC Medical Research Methodology · doi:10.1186/1471-2288-8-65 · Cited by 115 · see citing works
Heidari‐Beni, M., Moravejolahkami, A. R., Gorgian, P., Askari, G., Tarrahi, M. J., & Bahreini, N. (2020) · Phytotherapy Research · doi:10.1002/ptr.6671 · Cited by 103 · see citing works
Ariel, B., & Farrington, D. P. (2009) · Springer eBooks · doi:10.1007/978-0-387-77650-7_21 · Cited by 58 · see citing works
Zhao, W., Weng, Y., Wu, Q., & Palesch, Y. Y. (2011) · Pharmaceutical Statistics · doi:10.1002/pst.493 · Cited by 57 · see citing works
“PBD is the most popular randomization method [20–22].”
MethodZhao, W. (2014) · Statistics in Medicine · doi:10.1002/sim.6266 · Cited by 45 · see citing works
Comparing MTI randomization procedures to blocked randomization
Berger, V. W., Bejleri, K., & Agnor, R. (2015) · Statistics in Medicine · doi:10.1002/sim.6637 · Cited by 35 · see citing works
Self-citationThe impact of selection bias on test decisions in randomized clinical trials
Kennes, L. N., Cramer, E., Hilgers, R.-D., & Heussen, N. M. (2011) · Statistics in Medicine · doi:10.1002/sim.4279 · Cited by 33 · see citing works
Cluster size variability and imbalance in cluster randomized controlled trials
Carter, B. (2010) · Statistics in Medicine · doi:10.1002/sim.4050 · Cited by 33 · see citing works
A review of randomization methods in clinical trials
Berger, V. W., & Antsygina, O. (2015) · Clinical Investigation · doi:10.4155/cli.15.53 · Cited by 20 · see citing works
Self-citationBerger, V. W. (2014) · Science and Engineering Ethics · doi:10.1007/s11948-014-9576-2 · Cited by 15 · see citing works
“As one example, Berger (2006d) evaluated a trial (Bookman et al. 2004) examining the safety and efficacy of a topical solution, relative to an oral treatment, to relieve the symptoms of osteoarthritis of the knee, that Towheed (2006) subsequently rated as a perfect Jadad score of 5/5.”
Self-citationClark, L., Burke, L., Carr, R. M., Coleman, E., Roberts, G., & Torgerson, D. J. (2021) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2021.09.009 · Cited by 14 · see citing works
El-Raheem, A. E.-R. M. A., & Hosny, M. M. (2023) · AIMS Mathematics · doi:10.3934/math.2023960 · Cited by 4 · see citing works
“PBD is the most commonly used randomization design; see McEntegart [16], Berger [17], and Pond et al. [18].”
MethodRisk of selection bias assessment in the NINDS rt-PA stroke study
Garg, R., & Mickenautsch, S. (2022) · BMC Medical Research Methodology · doi:10.1186/s12874-022-01651-4 · Cited by 3 · see citing works
“Berger has popularized a statistical test to detect randomization subversion which was not performed and could support or deny the results of the reported assessment [9, 11, 12, 15, 27].”
ResultBerger, V. W. (2013) · Contemporary Clinical Trials · doi:10.1016/j.cct.2013.09.017 · Cited by 2 · see citing works
Self-citationConcealing Block Sizes Is Not Sufficient
Berger, V. W., & He, X. (2015) · Clinics in Orthopedic Surgery · doi:10.4055/cios.2015.7.3.422 · Cited by 2 · see citing works
Self-citationFailure to Look Beyond Blocks Is a Mistake
Berger, V. W. (2015) · Methods of Information in Medicine · doi:10.3414/me15-04-0002 · Cited by 2 · see citing works
Self-citationReview of Randomization Methodsin Clinical Trials
Berger, V. W., & Grant, W. C. (2014) · Chapman & Hall/CRC eBooks · doi:10.1201/b17716-4 · Cited by 1 · see citing works
Self-citationGuyatt, G. H., & Alexander, P. E. (2013) · doi:10.4155/ebo.13.429 · Cited by 1 · see citing works
Doig, G. S., & Simpson, F. O. (2006) · Journal of Critical Care · doi:10.1016/j.jcrc.2006.01.003
Garg, R., Acosta, G. T., Mickenautsch, S., & Berger, V. W. (2025) · PLoS ONE · doi:10.1371/journal.pone.0315342
Self-citation
- Authors
- Berger, V. W.
- Affiliations
- National Cancer Institute (US)
- Corresponding author
- Berger, Vance W.
- Venue
- Journal of Critical Care
- Publisher
- Elsevier BV
- Published
- 2006-06
- Volume
- 21
- Issue
- 2
- Pages
- 229
- ISSN
- 0883-9441 (ISSN-L)
- OpenAlex
- W2030317490
- Cited by
- 23
- References
- 9
- Citations by year
- 2025: 2 · 2023: 1 · 2022: 1 · 2021: 1 · 2020: 1 · 2015: 5 · 2014: 3 · 2013: 3
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Critical Care (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- block size, allocation concealment, subversion, minimization, stratification, randomization methods, clinical trials
- MeSH terms
- Humans, Random Allocation, Randomized Controlled Trials as Topic, Patient Selection
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