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

• Published in: Journal of athletic training Vol. 43; no. 2; pp. 215 - 221
• Main Authors: Kang, Minsoo, Ragan, Brian G, Park, Jae-Hyeon
• Format: Journal Article
• Language: English
• Published: United States National Athletic Trainers Association 01.03.2008; The National Athletic Trainers' Association, Inc
• Subjects: Aging (Individuals); Clinical trials; Clinical Trials as Topic; Communications; Control Groups; Data Interpretation; Evidence Based Practice; Evidence-Based Medicine; Female; Humans; Injuries; Male; Medical research; Outcome Assessment (Health Care); Random Allocation; Randomized Controlled Trials; Regression (Statistics); Research methodology; Researchers; Scientific Research; Statistical Analysis; Studies; Validity; stratified randomization; covariate adaptive randomization; minimization; block randomization; simple randomization
• ISSN: 1062-6050; 1938-162X
• DOI: 10.4085/1062-6050-43.2.215

To review and describe randomization techniques used in clinical trials, including simple, block, stratified, and covariate adaptive techniques. 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. 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.