Literature DB >> 18345348

Issues in outcomes research: an overview of randomization techniques for clinical trials.

Minsoo Kang1, Brian G Ragan, Jae-Hyeon Park.   

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.

Entities:  

Keywords:  block randomization; covariate adaptive randomization; minimization; simple randomization; stratified randomization

Mesh:

Year:  2008        PMID: 18345348      PMCID: PMC2267325          DOI: 10.4085/1062-6050-43.2.215

Source DB:  PubMed          Journal:  J Athl Train        ISSN: 1062-6050            Impact factor:   2.860


  18 in total

Review 1.  Generation of allocation sequences in randomised trials: chance, not choice.

Authors:  Kenneth F Schulz; David A Grimes
Journal:  Lancet       Date:  2002-02-09       Impact factor: 79.321

2.  Gold is not always good enough: the shortcomings of randomization when evaluating interventions in small heterogeneous samples.

Authors:  Eve Blair
Journal:  J Clin Epidemiol       Date:  2004-12       Impact factor: 6.437

3.  It's time for evidence.

Authors:  Christopher D Ingersoll
Journal:  J Athl Train       Date:  2006 Jan-Mar       Impact factor: 2.860

4.  Minimisation: the platinum standard for trials?. Randomisation doesn't guarantee similarity of groups; minimisation does.

Authors:  T Treasure; K D MacRae
Journal:  BMJ       Date:  1998-08-08

5.  The choice of a balanced allocation method for a clinical trial in otitis media with effusion.

Authors:  G A Zielhuis; H Straatman; A E van 't Hof-Grootenboer; H J van Lier; G H Rach; P van den Broek
Journal:  Stat Med       Date:  1990-03       Impact factor: 2.373

6.  Minimization: a new method of assigning patients to treatment and control groups.

Authors:  D R Taves
Journal:  Clin Pharmacol Ther       Date:  1974-05       Impact factor: 6.875

Review 7.  Treatment allocation methods in clinical trials: a review.

Authors:  L A Kalish; C B Begg
Journal:  Stat Med       Date:  1985 Apr-Jun       Impact factor: 2.373

8.  How many stratification factors are "too many" to use in a randomization plan?

Authors:  T M Therneau
Journal:  Control Clin Trials       Date:  1993-04

9.  A treatment allocation procedure for sequential clinical trials.

Authors:  C B Begg; B Iglewicz
Journal:  Biometrics       Date:  1980-03       Impact factor: 2.571

Review 10.  The method of minimization for allocation to clinical trials. a review.

Authors:  Neil W Scott; Gladys C McPherson; Craig R Ramsay; Marion K Campbell
Journal:  Control Clin Trials       Date:  2002-12
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  96 in total

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Authors:  Honglin Dong; Ian Rowland; Linda V Thomas; Parveen Yaqoob
Journal:  Eur J Nutr       Date:  2013-01-10       Impact factor: 5.614

6.  BIOENERGETIC DIFFERENCES DURING WALKING AND RUNNING IN TRANSFEMORAL AMPUTEE RUNNERS USING ARTICULATING AND NON-ARTICULATING KNEE PROSTHESES.

Authors:  M Jason Highsmith; Jason T Kahle; Rebecca M Miro; Larry J Mengelkoch
Journal:  Technol Innov       Date:  2016-09

7.  Efficacy of the FIFA 11+ Warm-Up Programme in Male Youth Football: A Cluster Randomised Controlled Trial.

Authors:  Oluwatoyosi B A Owoeye; Sunday R A Akinbo; Bosede A Tella; Olajide A Olawale
Journal:  J Sports Sci Med       Date:  2014-05-01       Impact factor: 2.988

8.  Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn's Disease, a Randomized Controlled Trial.

Authors:  Timna Naftali; Refael Mechulam; Amir Marii; Gila Gabay; Asaf Stein; Miriam Bronshtain; Ido Laish; Fabiana Benjaminov; Fred M Konikoff
Journal:  Dig Dis Sci       Date:  2017-03-27       Impact factor: 3.199

9.  Extended-Release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living With HIV With Opioid Use Disorders Transitioning to the Community: Results of a Double-Blind, Placebo-Controlled Randomized Trial.

Authors:  Sandra A Springer; Angela Di Paola; Marwan M Azar; Russell Barbour; Breanne E Biondi; Maureen Desabrais; Thomas Lincoln; Daniel J Skiest; Frederick L Altice
Journal:  J Acquir Immune Defic Syndr       Date:  2018-05-01       Impact factor: 3.731

10.  High-Definition and Non-invasive Brain Modulation of Pain and Motor Dysfunction in Chronic TMD.

Authors:  Adam Donnell; Thiago D Nascimento; Mara Lawrence; Vikas Gupta; Tina Zieba; Dennis Q Truong; Marom Bikson; Abhi Datta; Emily Bellile; Alexandre F DaSilva
Journal:  Brain Stimul       Date:  2015-06-23       Impact factor: 8.955

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