- Question: What is a randomized controlled trial (RCT)? And why should I care?
- Answer: An RCT is one of the strongest types of studies in showing that a drug or a treatment actually improves a symptom or disease. If I have strep throat, I want to know what antibiotic works best in killing the bacteria, & RCTs are one of the best ways to find that answer.
In the simplest kind of RCT, subjects are randomly assigned to 2 groups. One group gets the treatment in which we are interested, & it is called the experimental group. The other group gets either no treatment or standard treatment, & it is called the control group.
Here’s an example from a study to determine whether chewing gum prevents postoperative ileus after laparotomy for benign gynecologic surgery: A total of 109 patients were randomly assigned to receive chewing gum (n=51) or routine postoperative care (n=58). Fewer participants assigned to receive chewing gum … experienced postoperative nausea (16 [31.4%] versus 29 [50.0%]; P=0.049) and postoperative ileus (0 vs. 5 [8.6%]; P=0.032).* There were no differences in the need for postoperative antiemetics, episodes of postoperative vomiting, readmissions, repeat surgeries, time to first hunger, time to toleration of clear liquids, time to regular diet, time to first flatus, or time to discharge. Conclusion? Postop gum chewing is safe & lowers the incidence of nausea and ileus! (Jernigan, Chen, & Sewell, 2014. Retrieve from PubMed abstract)
Do you see the elements of an RCT in above?
Let’s break it down.
- Randomized means that 109 subjects were randomly divided into 2 or more groups. In above case, 51 subjects ended up in a gum chewing group & 58 were assigned to a routine care, no gum group. Randomization increases the chance that the groups will be similar in characteristics such as age, gender, etc. This allows us to assume that different outcomes between groups are caused by gum-chewing, not by differences in group characteristics.
- Controlled means that 1 of the groups is used as a control group. It is a comparison group, like the no-gum , standard care group above
- Trial means that it was a study. The researchers were testing (trying) an intervention and measuring the outcomes to see if it worked. In this case the intervention was gum chewing and the measure outcomes were nausea and ileus.
Why should you care about RCTs? Because RCTs are strong evidence that an intervention works (or doesn’t) for your patients
Critical Thinking Exercise: Go to http://www.ncbi.nlm.nih.gov/pubmed In the blank box at the very top enter a few key words about the problem in which you are interested + RCT. For example: music pain + RCT. Then read 1 or more of the abstracts looking for random assignment (randomized), control group, and whether it was a study (trial). You’re on your way! -Dr.H
*Note: You may remember from other blogs that p<.05 means the difference between groups is probably cause by the intervention—in this case gum chewing.