Cited by 555Statistical Methods in Clinical TrialsAdvanced Causal Inference TechniquesMeta-analysis and systematic reviews

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Issues in Outcomes Research: An Overview of Randomization Techniques for Clinical Trials

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Kang, Minsoo, Ragan, Brian G., Park, Jae-Hyeon·2008·Journal of Athletic Training

DOI 10.4085/1062-6050-43.2.215PMC PMC2267325

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Abstract

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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“Simple randomization was considered to be an acceptable method given the intended sample size was above 200 people [76, 77].”
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“Then the following 4 participants are assigned based on the next block [36].”
Background
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“However, the stratified block method is limited in the number of strata (Herbert, 2005; Kang et al., 2008).”
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“The null hypothesis (Kang et al., 2008) was H 0 : m 1 = m 2 and the alternative one was H a : m 1 = m 2 + d; where “d” was the difference between two means and n 1 and n 2 were the sample size for two groups (ENSs and AHNSs) such N = n 1 + n 2 .”
BackgroundMethod
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“To balance various covariates, we performed a multi-block stratified randomization (Kang et al., 2008) to sort eligible participants into either Group 1 or Group 2.”
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“Those who drew odd and even numbers were assigned to the paper-app and app-paper groups, respectively [42].”
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“Subjects can also be randomized based on gender, age, and other characteristics, using a procedure known as stratified randomization.(48) Stratified randomization is often implemented in a two step process that first involves a block randomization scheme and then involves the creation of a randomization list per strat…”
Method
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“The sample size was estimated using the following formula [17]:”
BackgroundMethod
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“[19], this procedure can be described as block randomization, which prevents an unequal number of participants in two groups.”
Method
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“Randomization and HD-tDCS Intervention Among 293 patients assessed for eligibility, we enrolled 28 patients and randomized them into active or sham treatment in a 1:1 ratio using the Taves covariate adaptive randomization method balancing sex and age.(29) We reported the study flow under the Consolidated Standards of…”
Method
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“Randomization was strati ﬁ ed by therapist to minimize any confounding effects of speci ﬁ c therapists and for each therapist to practice manuals for both study arms (38).”
MethodResult
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“Unevenly distributed covariates were not expected to influence the investigated effect, which justifies the selection of a block-based plan 78 .”
Background
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“Participants were subsequently randomized to the BT group, the BTþOR group, or the BTþORþ S group through stratified randomization (i.e., an approach that results in equal-sized study groups that are balanced by covariates; Kang et al. 2008).”
Method
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“Once the block size is determined, the statistician ascertains all possible combinations for each block, each combination containing equal numbers of both study groups.(7) Finally, the blocks are randomly selected to determine each participant’s group assignment.”
Method
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“The sample size was estimated using a predictive formula (Kang et al., 2008), detailed in the Appendix.”
Method
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Background
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“Randomization was based on a single sequence of random assignments using shuffled envelopes.(21) The observers were blinded for each other’s measurements.”
Method
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Background
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BackgroundMethodInfluential
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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)
ORCID: Kang, Minsoo
Park, Jae-Hyeon
Venue: Journal of Athletic Training
Publisher: National Athletic Trainers' Association
Published: 2008-03
Volume: 43
Issue: 2
Pages: 215-221
ISSN: 1062-6050 (ISSN-L)
DOI: 10.4085/1062-6050-43.2.215
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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Issues in Outcomes Research: An Overview of Randomization Techniques for Clinical Trials

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