A randomized clinical trial (RCT) is an experimental trial in which subjects are randomly assigned into different groups which then receive different interventions. RTCs have at least two groups: a group that receives the intervention being tested and a control group that receives a different intervention or no intervention at all.
There are four steps to a randomized clinical trial: enrollment, allocation, follow-up, and analysis. During enrollment, participants agree to participate in the experiment. Trial administrators assess participants to make sure they meet basic qualifying criterion. During the allocation phase, participants are randomly assigned to their trial groups. Here, trial administrators make sure each group is balanced, reflecting similar numbers in terms of gender, age, ethnicity, and other demographic factors. After allocation, subjects receive the intervention. The third step is follow-up where administrators collect data from subjects. Finally, administrators analyze the data and report their findings.
The reason randomized clinical trials are considered the gold standard is because the process reduces many forms of testing bias, including sampling bias, selection bias, and confirmation bias:
With other variables equal between groups, on average, any differences in outcome can be attributed to the intervention. (Gail Sullivan, MD)
There was a study that focused on smoking reduction with oral nicotine inhalers, which was a double-blind, randomized clinical trial of efficacy and safety (British Medical Journal). In another case, there was a study that focused on motivational interviewing prior to cognitive behavioral treatment for social anxiety disorder, which was a randomized controlled trial (J Affect Discord). Additionally, there was a study that observed the effects of muscle energy technique on pain, range of motion, and function in patients with post-surgical elbow stiffness. Thus was also a randomized controlled trial (Hong Kong Physiotherapy Journal).
All of these are linked below.
https://www.ncbi.nlm.nih.gov/pubmed/31156315
https://www.ncbi.nlm.nih.gov/pubmed/31158718
Tuesday, August 20, 2019
Discuss the steps taken for randomized clinical trials. Why are these steps considered the gold standard in research? Give two examples of such trials. Explain how randomized clinical trials provide evidence of causation over association. Be specific.
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