Study Design 101
Randomized Controlled Trial
A study design that randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference between the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied.
- Good randomization will "wash out" any population bias
- Easier to blind/mask than observational studies
- Results can be analyzed with well known statistical tools
- Populations of participating individuals are clearly identified
- Expensive in terms of time and money
- Volunteer biases: the population that participates may not be representative of the whole
- Loss to follow-up attributed to treatment
Design pitfalls to look out for
An RCT should be a study of one population only.
Was the randomization actually "random", or are there really two populations being studied?
The variables being studied should be the only variables between the experimental group and the control group.
Are there any confounding variables between the groups?
To determine how a new type of short wave UVA-blocking sunscreen affects the general health of skin in comparison to a regular long wave UVA-blocking sunscreen, 40 trial participants were randomly separated into equal groups of 20: an experimental group and a control group. All participants' skin health was then initially evaluated. The experimental group wore the short wave UVA-blocking sunscreen daily, and the control group wore the long wave UVA-blocking sunscreen daily.
After one year, the general health of the skin was measured in both groups and statistically analyzed. In the control group, wearing long wave UVA-blocking sunscreen daily led to improvements in general skin health for 60% of the participants. In the experimental group, wearing short wave UVA-blocking sunscreen daily led to improvements in general skin health for 75% of the participants.
van Der Horst, N., Smits, D., Petersen, J., Goedhart, E., & Backx, F. (2015). The preventive effect of the nordic hamstring exercise on hamstring injuries in amateur soccer players: a randomized controlled trial. The American Journal of Sports Medicine, 43(6), 1316-1323. https://doi.org/10.1177/0363546515574057
This article reports on the research investigating whether the Nordic Hamstring Exercise is effective in preventing both the incidence and severity of hamstring injuries in male amateur soccer players. Over the course of a year, there was a statistically significant reduction in the incidence of hamstring injuries in players performing the NHE, but for those injured, there was no difference in severity of injury. There was also a high level of compliance in performing the NHE in that group of players.
Natour, J., Cazotti, L., Ribeiro, L., Baptista, A., & Jones, A. (2015). Pilates improves pain, function and quality of life in patients with chronic low back pain: a randomized controlled trial. Clinical Rehabilitation, 29(1), 59-68. https://doi.org/10.1177/0269215514538981
This study assessed the effect of adding pilates to a treatment regimen of NSAID use for individuals with chronic low back pain. Individuals who included the pilates method in their therapy took fewer NSAIDs and experienced statistically significant improvements in pain, function, and quality of life.
Now test yourself!
Study Design 101 by Himmelfarb Health Sciences Library is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License.