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Issues in Outcomes Research: An Overview of Randomization Techniques for Clinical Trials
Open accessAbstract
Objective: To review and describe randomization techniques used in clinical trials, including simple, block, stratified, and covariate adaptive techniques. Background: Clinical trials are required to establish treatment efficacy of many athletic training procedures. In the past, we have relied on evidence of questionable scientific merit to aid the determination of treatment choices. Interest in evidence-based practice is growing rapidly within the athletic training profession, placing greater emphasis on the importance of well-conducted clinical trials. One critical component of clinical trials that strengthens results is random assignment of participants to control and treatment groups. Although randomization appears to be a simple concept, issues of balancing sample sizes and controlling the influence of covariates a priori are important. Various techniques have been developed to account for these issues, including block, stratified randomization, and covariate adaptive techniques. Advantages: Athletic training researchers and scholarly clinicians can use the information presented in this article to better conduct and interpret the results of clinical trials. Implementing these techniques will increase the power and validity of findings of athletic medicine clinical trials, which will ultimately improve the quality of care provided.
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“First of all, one of the limitations may be the selected randomization method which was chosen to simply control balance across groups over time for a sample size of 60 participants. As published data suggest, the 6-block randomization method may not be optimal for randomization, as blocks are best used in smaller increments due to easier balance control. Therefore, the 4-block randomization”
From Early Occupational Therapy Intervention post-stroke (EOTIPS): A randomized controlled trial (2024) · cites this paper as [69]
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Nouri, A., Mostafazadeh, P., Javadi, F., Azizpour, A., Hajiabbasoghli, S., Hosseinzadeh‐Attar, M. J., & Ebrahimpour‐Koujan, S. (2026) · Archives of Dermatological Research · doi:10.1007/s00403-025-04497-0 · Cited by 1
“This method of randomization provided an equal number of men and women, as well as normal and overweight patients, who were assigned to the intervention and placebo groups [ 12, 13].”
da Silva, T. B. L., Ordonez, T. N., dos Santos, G., Costa, L. A., Moreira, A. P. B., Bacelar, D. D. S., de Souza, M. A. A., da Silva, S. A., Yassuda, M. S., & Brucki, S. M. D. (2026) · International Psychogeriatrics · doi:10.1016/j.inpsyc.2025.100178 · Cited by 1
Effect of Transcendental Meditation on the Social Emotional Well-Being of Bilingual Teacher-Leaders
Peterson, M., Bleasdale, J. E., & Nidich, S. (2026) · Journal of Education · doi:10.1177/00220574261419506 · Cited by 1
Jemcov, A., Corkum, P. V., Smith, I. M., & Mackinnon, S. P. (2026) · Frontiers in Sleep · doi:10.3389/frsle.2025.1665671 · Cited by 1
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“12 This issue is especially important in rare and complex diseases such as PAH, which has heterogeneous causes, advanced medical interventions, and variable clinical trajectories.”
Buttazzoni, A. N., van Rompay, T. J. L., & Minaker, L. M. (2026) · Journal of Environmental Psychology · doi:10.1016/j.jenvp.2026.103008 · Cited by 1
Seethaler, M., Güntner, L., Lütt, A., & Just, S. A. (2026) · Translational Psychiatry · doi:10.1038/s41398-026-03955-1 · Cited by 1
Methods and Concepts of Epidemiology
Mikolajczyk, R. (2009) · Statistics in the health sciences · doi:10.1007/978-0-387-93835-6_11 · Cited by 1
“Randomization should ensure that the studied groups are comparable and the selection of patients is not influenced by the expectations of the researcher (Kang et al. 2008).”
BackgroundAdvantages of nerve-sparing intrastromal total abdominal hysterectomy
Samimi, D. (2013) · International Journal of Women s Health · doi:10.2147/ijwh.s39631 · Cited by 1
“The founder of randomized controlled trials (Fisher) first introduced the idea of randomization, the academic community has deemed randomization an essential tool for unbiased comparisons of treatment groups.(11) Five years after Fisher’s introductory paper, the first randomized controlled trial involving tuberculosis…”
Quantifying the exact allocation ratios in randomized clinical trials with biased coin randomization
Lin, Y., & Su, Z. (2012) · Computer Methods and Programs in Biomedicine · doi:10.1016/j.cmpb.2012.03.013 · Cited by 1
“[4] M.”
MethodNaemi, R. (2014) · Journal of Clinical Trials · doi:10.4172/2167-0870.1000150 · Cited by 1
“Another method known as covariate adaptive randomization [6] has been commonly used when participants are not all identified before the start of randomisation [7].”
BackgroundMethodResultInfluentialRandomization Procedures: The Case for Strong Encryption
Berger, V. W. (2016) · Biometrics & Biostatistics International Journal · doi:10.15406/bbij.2016.03.00054 · Cited by 1
“This involves minimizing vulnerability to the prediction of future allocations, and selection bias [2].”
BackgroundOmerza, K. E. (2015) · OhioLink ETD Center (Ohio Library and Information Network) · Cited by 1
Zehra, S., & Parveen, S. (2018) · Journal of Endocrine Surgery · doi:10.16956/jes.2018.18.2.132 · Cited by 1
Intermittent fasting & performance: The iFast clinical trial protocol
El‐Outa, A., Ghandour, L., Hamade, H., Borgi, C., Fares, E.-J., Gherbal, T., & Mufarrij, A. J. (2021) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2021.100766 · Cited by 1
“Therefore, after obtaining the mentioned baseline records for the participant, she/he will be digitally randomized into one of the four study arms using block randomization technique [27,28] using RStudio version 1.”
Method
Metadata
- Authors
- Kang, M., Ragan, B. G., & Park, J.-H.
- Affiliations
- Middle Tennessee State University (US)
- University of Northern Iowa (US)
- Korea National Sport University (KR)
- Venue
- Journal of Athletic Training
- Published
- 2008-03
- Volume
- 43
- Issue
- 2
- Pages
- 215-221
- ISSN
- 1062-6050 (ISSN-L)
- PMC
- PMC2267325
- OpenAlex
- W2103799103
- Semantic Scholar
- 76a894a7f31f671125792589418911fc63574599
- Cited by
- 555
- References
- 31
- Citations by year
- 2026: 54 · 2025: 79 · 2024: 90 · 2023: 54 · 2022: 29 · 2021: 33 · 2020: 39 · 2019: 22 · 2018: 26 · 2017: 27 · 2016: 20 · 2015: 16 · 2014: 17 · 2013: 12 · 2012: 15
- FWCI
- 6.61
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Athletic Training (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- UNI ScholarWorks (University of Northern Iowa) (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
- randomization technique, clinical trials, block randomization, stratified randomization, covariate-adaptive randomization, covariate control, evidence-based practice
- MeSH terms
- Clinical Trials as Topic, Female, Humans, Male, Random Allocation, Outcome Assessment, Health Care, Evidence-Based Medicine
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