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

Kang, Minsoo; Ragan, Brian G.; Park, Jae-Hyeon

doi:10.4085/1062-6050-43.2.215

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

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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The selected 6-block randomization method may not be optimal for randomization, and the 4-block randomization method could have been a more optimal technique for this study.
“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]
The Block Randomization section says blocks are best used in smaller increments because balance is easier to control, and lists both 4 and 6 as possible block sizes for two groups. It does not evaluate the citing study’s 60 participants or conclude that a block size of 6 was suboptimal and 4 would have been optimal for that study. Page numbers were not provided in our copy. (LLM, conf=0.85)
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Abellaneda‐Pérez, K., Vaqué‐Alcázar, L., Dídac Vidal-piñeiro, A., Jannati, A., Solana, E., Bargalló, N., Santarnecchi, E., Pascual‐Leone, Á., & David Bartrés-faz, A. (2018) · NeuroImage · doi:10.1016/j.neuroimage.2018.11.036 · Cited by 55 · see citing works
“A simple randomization procedure was used M AN US CR IP T AC CE PT ED 8 (Altman & Bland, 1999; Kang et al., 2008).”
Teaching of evidence-based medicine to medical students in Mexico: a randomized controlled trial
Mendiola, M. S., Kieffer-Escobar, L. F., Marín-Beltrán, S., Downing, S. M., & Schwartz, A. (2012) · BMC Medical Education · doi:10.1186/1472-6920-12-107 · Cited by 59 · see citing works
“The randomization was done by the medical school with a computer generated list, using the block randomization method with blocks of two to ensure equal sample sizes [24].”
Method
Consolidated guidance for behavioral intervention pilot and feasibility studies
Pfledderer, C. D., von Klinggraeff, L., Burkart, S. A., Bandeira, A. D. S., Lubans, D. R., Jago, R., Okely, A. D., van Sluijs, E. M. F., Ioannidis, J. P. A., Thrasher, J. F., et al. (2024) · Pilot and Feasibility Studies · doi:10.1186/s40814-024-01485-5 · Cited by 65 · see citing works
Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults
Theurich, S., Fischmann, H., Shimabukuro‐Vornhagen, A., Chemnitz, J. M., Holtick, U., Scheid, C., Skoetz, N., & von Bergwelt‐Baildon, M. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009159.pub2 · Cited by 56 · see citing works
Treating Insomnia with High Risk of Depression Using Therapist-Guided Digital Cognitive, Behavioral, and Circadian Rhythm Support Interventions to Prevent Worsening of Depressive Symptoms: A Randomized Controlled Trial
Leerssen, J., Lakbila-Kamal, O., Dekkers, L. M. S., Ikelaar, S. L. C., Albers, A. C. W., Blanken, T. F., Lancee, J., van der Lande, G. J. M., Maksimovic, T., Mastenbroek, S. E., et al. (2022) · Psychotherapy and Psychosomatics · doi:10.1159/000520282 · Cited by 54 · see citing works
High-Rosmarinic Acid Spearmint Tea in the Management of Knee Osteoarthritis Symptoms
Connelly, A. E., Tucker, A. J., Tulk, H. M. F., Catapang, M., Chapman, L., Sheikh, N., Yurchenko, S., Fletcher, R., Kott, L. S., Duncan, A. M., et al. (2014) · Journal of Medicinal Food · doi:10.1089/jmf.2013.0189 · Cited by 54 · see citing works
Assessing differential responders and mean changes in muscle size, strength, and the crossover effect to 2 distinct resistance training protocols
Dankel, S. J., Bell, Z. W., Spitz, R. W., Wong, V. H. Y., Viana, R. B., Chatakondi, R. N., Buckner, S. L., Jessee, M. B., Mattocks, K. T., Mouser, J. G., et al. (2019) · Applied Physiology, Nutrition, and Metabolism · doi:10.1139/apnm-2019-0470 · Cited by 52 · see citing works
“…would not be able to predict the group assignment for all subsequent individuals who were randomly assigned to a group based on quartiles of dominant arm 1RM strength using a covariate adaptive randomization program that was supplied by the authors of a previous paper (Kang et al. 2008).”
Method
Comparison of the effects of velocity-based vs. traditional resistance training methods on adaptations in strength, power, and sprint speed: A systematic review, meta-analysis, and quality of evidence appraisal
Orange, S. T., Hritz, A., Pearson, L. T., Jeffries, O., Jones, T. W. A., & Steele, J. (2022) · Journal of Sports Sciences · doi:10.1080/02640414.2022.2059320 · Cited by 49 · see citing works
“Future studies should follow best practice guidelines for trial randomisation procedures (Kang et al., 2008).”
Background
Patients With Chronic Spinal Pain Benefit From Pain Neuroscience Education Regardless the Self‐Reported Signs of Central Sensitization: Secondary Analysis of a Randomized Controlled Multicenter Trial
Malfliet, A., Kregel, J., Meeus, M., Danneels, L. A., Cagnie, B. J., Roussel, N. A., & Nijs, J. (2018) · PM&R · doi:10.1016/j.pmrj.2018.04.010 · Cited by 45 · see citing works
“Participants were randomly assigned into an educational group, using a stratified permuted block allocation (block size of 4), with stratification factors being treatment center (Ghent or Brussels), dominant pain location (low back or neck), and gender (male or female) [45,46].”
Method
Randomization: beyond tossing a coin
Ferreira, J. C., & Patino, C. M. (2016) · Jornal Brasileiro de Pneumologia · doi:10.1590/s1806-37562016000000296 · Cited by 44 · see citing works
Efficacy of a modern neuroscience approach versus usual care evidence-based physiotherapy on pain, disability and brain characteristics in chronic spinal pain patients: protocol of a randomized clinical trial
Dolphens, M., Nijs, J., Cagnie, B. J., Meeus, M., Roussel, N. A., Kregel, J., Malfliet, A., Vanderstraeten, G., & Danneels, L. A. (2014) · BMC Musculoskeletal Disorders · doi:10.1186/1471-2474-15-149 · Cited by 44 · see citing works
“Participants will then be randomized to either control or experimental group (1:1 ratio) using a stratified permuted block allocation with stratification factors being treatment center (Ghent or Brussels), dominant pain location (low back or neck) and gender (male or female) and with a block size of four [34,35].”
Method
Comparison of effectiveness of three distraction techniques to allay dental anxiety during inferior alveolar nerve block in children: A randomized controlled clinical trial
Aditya, P. V. A., Prasad, M. G., Nagaradhakrishna, A., Raju, N. S., & Babu, D. N. (2021) · Heliyon · doi:10.1016/j.heliyon.2021.e08092 · Cited by 44 · see citing works
Can we improve pain and sleep in elderly individuals with transcranial direct current stimulation? – Results from a randomized controlled pilot study
Harvey, M.-P., Lorrain, D., Martel, M., Bergeron-Vézina, K., Houde, F., Seguin, M., & Léonard, G. (2017) · Clinical Interventions in Aging · doi:10.2147/cia.s133423 · Cited by 42 · see citing works
“49,50 This is particularly true for small-sample-size studies, as conventional simple randomization methods can generate imbalances in base-line characteristics among groups.”
Effects of Marine Omega-3 Fatty Acids on Serum Systemic and Vascular Inflammation Markers and Oxidative Stress in Hemodialysis Patients
Kooshki, A., Taleban, F. A., Tabibi, H., & Hedayati, M. (2011) · Annals of Nutrition and Metabolism · doi:10.1159/000329727 · Cited by 41 · see citing works
“Thirty-four adult hemodialysis patients (21 men and 13 women) in the age range of 19–76 years were selected using convenience sampling from the hemodialysis unit of Vaseii Hospital in Sabzevar, Iran. Patients enrolled in the study did not have inflammatory diseases, infectious diseases including hepatitis, and none of…”
Method
Effects of Personal Protective Equipment on Metabolism and Performance During an Occupational Physical Ability Test for Federal Highway Police Officers
Marins, E. F., Cabistany, L. D., Farias, C., et al. (2018) · The Journal of Strength and Conditioning Research · doi:10.1519/jsc.0000000000002892 · Cited by 41 · see citing works
“First, this study used an approach of randomization of samples (coin toss), which is not considered the best form (20).”
Method
Effect of a 90 g/day low-carbohydrate diet on glycaemic control, small, dense low-density lipoprotein and carotid intima-media thickness in type 2 diabetic patients: An 18-month randomised controlled trial
Chen, C., Huang, W., Chen, H.-C., Chang, C., Lee, L., Chen, H., Kang, Y.-D., Chie, W., Jan, C.-F. J., Wang, W.-D., et al. (2020) · PLoS ONE · doi:10.1371/journal.pone.0240158 · Cited by 41 · see citing works
Effects of pain education on disability, pain, quality of life, and self-efficacy in chronic low back pain: A randomized controlled trial
Sidiq, M., Muzaffar, T., Janakiraman, B., Masoodi, S. R., Vasanthi, R. K., Ramachandran, A., Bansal, N., Chahal, A., Kashoo, F. Z., Rizvi, M. R., et al. (2024) · PLoS ONE · doi:10.1371/journal.pone.0294302 · Cited by 47 · see citing works
“Random sequences within each block were generated using index cards folded in opaque envelopes for randomization [25].”
Method
Coffee Consumption and Risk of Hypertension in Adults: Systematic Review and Meta-Analysis
Haghighatdoost, F., Hajihashemi, P., Romeiro, A. M. D. S., Mohammadifard, N., Sarrafzadegan, N., de Oliveira, C. M., & Silveira, É. A. (2023) · Nutrients · doi:10.3390/nu15133060 · Cited by 43 · see citing works
“A smaller case number cannot provide enough power to find the expected effect size, which is in concordance with our results as the confidence interval for studies with smaller case number was wider than those with more cases [65].”
Result
A multimodal deep learning approach for the prediction of cognitive decline and its effectiveness in clinical trials for Alzheimer’s disease
Wang, C., Tachimori, H., Yamaguchi, H., Sekiguchi, A., Li, Y., Yamashita, Y., & Initiative, F. A. D. N. (2024) · Translational Psychiatry · doi:10.1038/s41398-024-02819-w · Cited by 39 · see citing works
“3, we proposed an AI-based randomization method in which the prediction of cognitive decline outputted by the AI model was used as the strati ﬁ cation index in strati ﬁ ed randomization [23, 24].”
Method
A pilot randomised controlled trial of a multimodal supportive care (ThriverCare) intervention for managing unmet supportive care needs in men with metastatic prostate cancer on hormonal treatment and their partner/caregivers
Paterson, C. C., Primeau, C., & Nabi, G. (2018) · European Journal of Oncology Nursing · doi:10.1016/j.ejon.2018.10.007 · Cited by 38 · see citing works
Effect of a synbiotic on the response to seasonal influenza vaccination is strongly influenced by degree of immunosenescence
Przemska-Kosicka, A., Childs, C. E., Enani, S. M., Maidens, C. M., Dong, H., Bindayel, I. A., Tuohy, K. M., Todd, S., Gosney, M., & Yaqoob, P. (2016) · Immunity & Ageing · doi:10.1186/s12979-016-0061-4 · Cited by 37 · see citing works
“Subjects were randomized by a research nurse not involved in the analysis according to gender, age and BMI to receive the probiotic or placebo by covariate adaptive randomization [35].”
Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community
Paola, A. D., Lincoln, T., Skiest, D. J., Desabrais, M., Altice, F. L., & Springer, S. A. (2014) · Contemporary Clinical Trials · doi:10.1016/j.cct.2014.09.002 · Cited by 36 · see citing works
“To control for covariates potentially associated with the outcomes, covariate adaptive randomization was used [45-47].”
Method
What’s in a title? An assessment of whether randomized controlled trial in a title means that it is one
Koletsi, D., Pandis, N., Polychronopoulou, A., & Eliades, T. (2012) · American Journal of Orthodontics and Dentofacial Orthopedics · doi:10.1016/j.ajodo.2011.12.020 · Cited by 37 · see citing works
Comparison of Proprioceptive Training and Muscular Strength Training to Improve Balance Ability of Taekwondo Poomsae Athletes: A Randomized Controlled Trials.
Yoo, S.-H., Park, S.-K., Yoon, S., Lim, H.-S., & Ryu, J.-S. (2018) · Europe PMC (PubMed Central) · Cited by 36 · see citing works
Evidence-based medicine: an overview of key concepts.
Carter, M. J. (2010) · PubMed · Cited by 36 · see citing works
Clinical, histological, immunohistochemical, and biomolecular analysis of hyaluronic acid in early wound healing of human gingival tissues: A randomized, split‐mouth trial
Pilloni, A., Marini, L., Gagliano, N., et al. (2023) · Journal of Periodontology · doi:10.1002/jper.22-0338 · Cited by 35 · see citing works
Randomised Controlled Trials in WOHP Interventions: A Review and Guidelines for Use
O’Shea, D. E., Connell, B. O., & Gallagher, S. M. (2015) · Applied Psychology · doi:10.1111/apps.12053 · Cited by 35 · see citing works
Whey protein lowers systolic blood pressure and Ca-caseinate reduces serum TAG after a high-fat meal in mildly hypertensive adults
Fekete, Á. A., Giromini, C., Chatzidiakou, Y., Givens, D. I., & Lovegrove, J. A. (2018) · Scientific Reports · doi:10.1038/s41598-018-23333-2 · Cited by 35 · see citing works
“The volunteers were randomised by an independent researcher using an Excel-based randomisation program 23 , who was also responsible for treatment allocation.”
Antenatal sildenafil administration to prevent pulmonary hypertension in congenital diaphragmatic hernia (SToP-PH): study protocol for a phase I/IIb placenta transfer and safety study
Russo, F. M., Benachi, A., Mieghem, T. V., Hoon, J. N. J. M. D., Calsteren, K. V., Annaert, P., Tréluyer, J., Allegaert, K., & Deprest, J. A. (2018) · Trials · doi:10.1186/s13063-018-2897-8 · Cited by 35 · see citing works
“To ensure a balance in sample size across groups over time, a block size randomization of 8 with equal numbers for each group is chosen [41, 42].”
Method
Effect of an ‘implementation intention’ intervention on adherence to oral anti-diabetic medication in Brazilians with type 2 diabetes
Trevisan, D. D., São‐João, T. M., Cornélio, M. E., Jannuzzi, F. F., Sousa, M. R., Rodrigues, R. C. M., & Lima, M. H. M. (2019) · Patient Education and Counseling · doi:10.1016/j.pec.2019.10.003 · Cited by 35 · see citing works
“com website and random size blocks method [25] was used to prepare a numerical sequence of 100 participants that was concealed from the investigators.”
Method
Virtual Simulation in Nursing Education: Headset Virtual Reality and Screen-based Virtual Simulation Offer A Comparable Experience
Azher, S., Cervantes, A., Marchionni, C., Grewal, K., Marchand, H., & Harley, J. M. (2023) · Clinical Simulation in Nursing · doi:10.1016/j.ecns.2023.02.009 · Cited by 34 · see citing works
Can propensity score matching replace randomized controlled trials?
Liau, M. Y. Q., Toh, E. Q., Muhamed, S., Selvakumar, S. V., & Shelat, V. G. (2024) · World Journal of Methodology · doi:10.5662/wjm.v14.i1.90590 · Cited by 34 · see citing works
Autologous whole blood versus corticosteroid local injection in treatment of plantar fasciitis: A randomized, controlled multicenter clinical trial
Karimzadeh, A., Raeissadat, S. A., fam, S. E., Sedighipour, L., & Babaei-Ghazani, A. (2016) · Clinical Rheumatology · doi:10.1007/s10067-016-3484-6 · Cited by 34 · see citing works
The effect of group integrative reminiscence therapy on mental health among older women living in Iranian nursing homes
Ghahfarokhi, M. M., Mohammadian, S. K., & Mohammadinezhad, B. (2017) · Nursing Open · doi:10.1002/nop2.101 · Cited by 34 · see citing works
Idiopathic granulomatous mastitis associated with erythema nodosum may indicate a worse prognosis
Velidedeoğlu, M., Kundaktepe, B. P., Mete, B., et al. (2021) · International Journal of Rheumatic Diseases · doi:10.1111/1756-185x.14218 · Cited by 34 · see citing works
A Neurobehavioral Intervention Incorporated into a State Early Intervention Program is Associated with Higher Perceived Quality of Care Among Parents of High-Risk Newborns
McManus, B. M., & Nugent, J. K. (2012) · The Journal of Behavioral Health Services & Research · doi:10.1007/s11414-012-9283-1 · Cited by 33 · see citing works
Medium-term effects of a two-desk sit/stand workstation on cognitive performance and workload for healthy people performing sedentary work: a secondary analysis of a randomised controlled trial
Schwartz, B., Kapellusch, J. M., Baca, A., & Wessner, B. (2019) · Ergonomics · doi:10.1080/00140139.2019.1577497 · Cited by 33 · see citing works
“…randomised controlled cross-sover trial, 18 office workers randomly recruited via e-mail by regional health insurance were randomly allocated to either an intervention arm (study arm I) or a control arm (study arm II) by means of a covariate adaptive randomisation (Kang, Ragan, and Park 2008).”
Method
Artificial microbiome heterogeneity spurs six practical action themes and examples to increase study power-driven reproducibility
Basson, A. R., LaSalla, A., Lam, G., Kulpins, D., Moen, E. L., Sundrud, M. S., Miyoshi, J., Ilić, S., Theriault, B. R., Cominelli, F., et al. (2020) · Scientific Reports · doi:10.1038/s41598-020-60900-y · Cited by 34 · see citing works
Virtual reality and annotated radiological data as effective and motivating tools to help Social Sciences students learn neuroanatomy
van Deursen, M., Reuvers, L., Duits, J. D., de Jong, G., van den Hurk, M. M., & Henssen, D. J. H. A. (2021) · Scientific Reports · doi:10.1038/s41598-021-92109-y · Cited by 33 · see citing works
To Err is AI: Imperfect Interventions and Repair in a Conversational Agent Facilitating Group Chat Discussions
Do, H. J., Kong, H.-K., Tetali, P., Lee, J., & Bailey, B. P. (2023) · Proceedings of the ACM on Human-Computer Interaction · doi:10.1145/3579532 · Cited by 32 · see citing works
“…in a group) and extroversion personality [36] (i.e., the proportion of extroverted members in a group) were balanced across conditions using covariate adaptive randomization [44] when assigning participants to groups because those two features were known to influence group behavior [27, 68].”
Method
A synbiotic supplement for inflammation and oxidative stress and lipid abnormalities in hemodialysis patients
Kooshki, A., Tofighiyan, T., & Miri, M. (2019) · Hemodialysis International · doi:10.1111/hdi.12748 · Cited by 31 · see citing works
The effect of mindfulness based psychoeducation program on adolescents’ character strengths, mindfulness and academic achievement
Güldal, Ş. T., & Satan, A. (2020) · Current Psychology · doi:10.1007/s12144-020-01153-w · Cited by 31 · see citing works
A teachable moment communication process for smoking cessation talk: description of a group randomized clinician-focused intervention
Flocke, S. A., Antognoli, E., Step, M. M., Marsh, S., Parran, T. V., & Mason, M. J. (2012) · BMC Health Services Research · doi:10.1186/1472-6963-12-109 · Cited by 31 · see citing works
How Should the Agent Communicate to the Group? Communication Strategies of a Conversational Agent in Group Chat Discussions
Do, H. J., Kong, H., Lee, J., & Bailey, B. P. (2022) · Proceedings of the ACM on Human-Computer Interaction · doi:10.1145/3555112 · Cited by 31 · see citing works
“We balanced gender (i.e., proportion of females in a group) and personality [22] (i.e., proportion of extro-verted members in a group) across conditions using covariate adaptive randomization [30] when assigning participants to groups.”
Method
The impact of incentives on treatment adherence and attrition: A randomized controlled trial of Parent-Child Interaction Therapy with a primarily Latinx, low-income population
Quetsch, L. B., Girard, E. I., & McNeil, C. B. (2020) · Children and Youth Services Review · doi:10.1016/j.childyouth.2020.104886 · Cited by 30 · see citing works
Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it
Pandis, N., Polychronopoulou, A., & Eliades, T. (2011) · European Journal of Orthodontics · doi:10.1093/ejo/cjq141 · Cited by 30 · see citing works
“Therefore, simple randomization has given way to more precise and unbiased randomization methods (Kang et al., 2008), which will follow.”
Method
Random Allocation in Controlled Clinical Trials: A Review
Egbewale, B. E. (2014) · Journal of Pharmacy & Pharmaceutical Sciences · doi:10.18433/j3sw36 · Cited by 29 · see citing works
“Medical researchers have variously submitted that minimization offers a solution to the limitations of stratification at balancing for multiple prognostic factors in small trials as the procedure makes treatment groups similar in several important features even with small samples [1,18,21,25].”
BackgroundMethod
Fundamentals of Randomization in Clinical Trial
Baghbaninaghadehi, F. (2016) · International Journal of Advanced Nutritional and Health Science · doi:10.23953/cloud.ijanhs.143 · Cited by 29 · see citing works
“Using stratified randomization, investigators can balance the control and treatment groups for age, sex, and other similar covariates [4].”
BackgroundMethodInfluential
Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community
Springer, S. A., Altice, F. L., Herme, M., & Paola, A. D. (2014) · Contemporary Clinical Trials · doi:10.1016/j.cct.2013.12.006 · Cited by 28 · see citing works
“Covariate adaptive randomization [27] assured that covariates potentially associated with outcomes were controlled for in the randomization [28, 29].”
Background
RRApp, a robust randomization app, for clinical and translational research
Tu, C., & Benn, E. K. T. (2017) · Journal of Clinical and Translational Science · doi:10.1017/cts.2017.310 · Cited by 28 · see citing works
“While beyond the scope of our discussion, it is important to note that researchers should pay close attention to certain covariates, like comorbid conditions, when using block randomization since these factors could compromise the process and cause noncomparable groups [12].”
Background
Best Practices for Conducting Observational Research to Assess the Relation between Nutrition and Bone: An International Working Group Summary
Bailey, R. L., Sahni, S., Chocano-Bedoya, P. O., Daly, R. M., Welch, A. A., Bischoff-Ferrari, H. A., & Weaver, C. M. (2018) · Advances in Nutrition · doi:10.1093/advances/nmy111 · Cited by 28 · see citing works
“The sample size not only dictates the cost of collecting data, but also is critical to ensure that true or clinically meaningful associations or effects can be detected (25, 26).”
Background
Effects of synbiotic supplementation on gut microbiome, serum level of TNF-α, and expression of microRNA-126 and microRNA-146a in patients with type 2 diabetes mellitus: study protocol for a double-blind controlled randomized clinical trial
Zeinali, F., Zarch, S. M. A., Mehrjardi, M. Y. V., Kalantar, S. M., Jahan-Mihan, A., Karimi‐Nazari, E., Fallahzadeh, H., Hosseinzadeh, M., Rahmanian, M., Fazeli, M. R., et al. (2020) · Trials · doi:10.1186/s13063-020-04236-y · Cited by 28 · see citing works
Methodology and design of platform trials: a meta-epidemiological study
Pitre, T., Cheng, S., Cusano, E., Khan, N., Mikhail, D., Leung, G., Vernooij, R. W. M., Yarnell, C. J., Goligher, E. C., Murthy, S., et al. (2023) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2023.02.010 · Cited by 27 · see citing works
Comparing the Antiswelling and Analgesic Effects of Three Different Ice Pack Therapy Durations
Kuo, C., Lin, C., Lee, W., et al. (2013) · Journal of Nursing Research · doi:10.1097/jnr.0b013e3182a0af12 · Cited by 27 · see citing works
Effect of alternating postures on cognitive performance for healthy people performing sedentary work
Schwartz, B., Kapellusch, J. M., Schrempf, A., Probst, K., Haller, M., & Baca, A. (2017) · Ergonomics · doi:10.1080/00140139.2017.1417642 · Cited by 27 · see citing works
Training rugby athletes with an external attentional focus promotes more automatic adaptions in landing forces
Widenhoefer, T. L., Miller, T. M., Weigand, M. S., Watkins, E., & Almonroeder, T. G. (2019) · Sports Biomechanics · doi:10.1080/14763141.2019.1584237 · Cited by 27 · see citing works
Cross-education: motor unit adaptations mediate the strength increase in non-trained muscles following 8 weeks of unilateral resistance training
Lecce, E., Conti, A., Vecchio, A. D., Felici, F., di Palumbo, A. S., Sacchetti, M., & Bazzucchi, I. (2025) · Frontiers in Physiology · doi:10.3389/fphys.2024.1512309 · Cited by 26 · see citing works
Peer approaches to self-management (PALS): comparing a peer mentoring approach for disease self-management in African American women with lupus with a social support control: study protocol for a randomized controlled trial
Williams, E. M., Egede, L. E., Oates, J. C., Dismuke, C., Ramakrishnan, V., Faith, T. D., Johnson, H., & Rose, J. (2019) · Trials · doi:10.1186/s13063-019-3580-4 · Cited by 27 · see citing works
Effects of a Gamified, Behavior Change Technique–Based Mobile App on Increasing Physical Activity and Reducing Anxiety in Adults With Autism Spectrum Disorder: Feasibility Randomized Controlled Trial
Lee, D., Frey, G. C., Cothran, D. J., Harezlak, J., & Shih, P. C. (2022) · JMIR Formative Research · doi:10.2196/35701 · Cited by 27 · see citing works
“The major strengths of this study include (1) the use of a covariate-adaptive randomized controlled trial design to control the influence of covariates in the results [99], (2) objective assessment of PA and sedentary time, and (3) relatively good adherence to the study protocol and low attrition.”
Method
Statistical issues in randomised controlled trials: a narrative synthesis
Egbewale, B. E. (2015) · Asian Pacific Journal of Tropical Biomedicine · doi:10.1016/s2221-1691(15)30367-1 · Cited by 26 · see citing works
“For example, as earlier observed[4], treatment differences identified from observational designs, rather than from experimental clinical ARTICLE INFO ABSTRACT”
Result
The combined effects of on-road and simulator training with feedback on older drivers' on-road performance: Evidence from a randomized controlled trial
Sawula, E., Polgar, J. M., Porter, M. M., Gagnon, S., Weaver, B., Nakagawa, S., Stinchcombe, A., & Bédard, M. (2017) · Traffic Injury Prevention · doi:10.1080/15389588.2016.1236194 · Cited by 26 · see citing works
“Participants were then randomized to the BT group, the BT + OR group, or the BT + OR + S group using stratified randomization, an approach that produces equal-sized study groups that are balanced by covariates (Kang et al. 2008).”
Method
Simple randomization may lead to unequal group sizes. Is that a problem?
Shibasaki, W. M., & Martins, R. P. (2018) · American Journal of Orthodontics and Dentofacial Orthopedics · doi:10.1016/j.ajodo.2018.07.005 · Cited by 25 · see citing works

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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