Category Archives: RCT

“Should you? Can you?”

ApplesOranges2Quasi-experiments are a lot of work, yet don’t have the same scientific power to show cause and effect, as do randomized controlled trials (RCTs).   An RCT would provide better support for any hypothesis that X causes Y.   [As a quick review of what quasi-experimental versus RCT studies are, see “Of Mice & Cheese” and/or “Out of Control (Groups).”]

So why do quasi-experimental studies at all?  Why not always do RCTs when we are testing cause and effect?  Here are 3 reasons:

#1  Sometimes ETHICALLY the researcher canNOT randomly assign subjects to a control Smokingand an experimental group.  If the researcher wants to compare health outcomes of smokers with non-smokers, the researcher cannot assign some people to smoke and others not to smoke!  Why?  Because we already know that smoking has significant harmful effects. (Of course, in a dictatorship, by using the police a researcher could assign them to smoke or not smoke, but I don’t think we wanna go there.)

#2 Sometimes PHYSICALLY the researcher canNOT randomly assign subjects to control & Country of Originexperimental groups.   If the researcher wants to compare health outcomes of
individuals from different countries, it is physically impossible to assign country of origin.

#3 Sometimes FINANCIALLY the researcher canNOT afford to assign subjects randomly PiggyBankto control & experimental groups.   It costs $ & time to get a list of subjects and then assign them to control & experimental groups using random numbers table or drawing names from a hat.

Thus, researchers sometimes are left with little alternative, but to do a quasi-experiment as the next best thing to an RCT, then discuss its limitations in research reports.

Critical Thinking: You read a research study in which a researcher recruits the 1st 100 patients on a surgical ward January-March quarter as a control group.  Then the researcher recruits the 2nd 100 patients on that same surgical ward April-June for the experimental group.  With the experimental group, the staff uses a new, standardized pain script for better pain communications.  Then the pain communication outcomes of each group are compared statistically.

  • Is this a quasi-experiment or a randomized controlled trial (RCT)?
  • What factors (variables) might be the same among control & experimental groups in this study?
  • What factors (variables) might be different between control & experimental groups that might affect study outcomes?
  • How could you design an ethical & possible RCT that would overcome the problems with this study?
  • Why might you choose to do the study the same way that this researcher did?

For more info: see “Of Mice & Cheese” and/or “Out of Control (Groups).”

Quasi- wha??

Two basic kinds of research design exist:  

  1. Experimental design in which
    • the researcher manipulates some variable,randomized
    • the participants are randomly assigned to groups, &
    • one group is a control group that gets a placebo or some inert treatment so that outcomes in that group can be compared to the group(s) that did get the treatment.
  2. Non-experimental design in which the researcher doesn’t manipulate anything, but just observes & records what is going on.   Some of these are descriptive, correlational, case, or cohort study designs for example.

One particularly interesting “experimental” design is one in which 1 or 2 of the experimental design ideal requirements as listed above are missing.  These are called quasi-experimental designs.

thinking3In a quasi experimental design

  • The researcher manipulates some variable, but….
  • Either the participants are NOT randomly assigned to groups
  • &/OR there is no control group.

A quasi-experimental design is not as strong as a true experiment in showing that the manipulated variable X causes changes in the outcome variable Y.  For example, a true experimental study with manipulation, randomization, and a control group would create much stronger evidence that hospital therapy dogs really reduced patient pain and anxiety.  We would not be as confident in the results of a quasi-experimental design examining the exact same thing.  In the next blog, we’ll examine why.

For more info:  Check out earlier blog:    “What is an RCT anyway?” at https://discoveringyourinnerscientist.com/2015/01/23/whats-a-randomized-controlled-trial/Idea2

Critical thinking:  Go to PubMed & use search terms “experiment AND nurse” (without the quotation marks).  Open an interesting abstract and look for the 3 elements of a classic experimental design. Now look for “quasi experiment AND nurse” (without the quotation marks.)  See what element is missing!

True or False: Experiment or Not

Experiments are the way that we confirm that one thing causes another.   If the study is not an experiment (or combined experiments in a meta-analysis), then the research does not show cause and effect. imagesCALQ0QK9

Experiments are one of the strongest types of research.

So…how can you tell a true experiment from other studies?   Hazel B can tell you in 4:04 and simple language at https://www.youtube.com/watch?v=x2i-MrwdTqI&index=1&list=PL7A7F67C6B94EB97E

Go for it!

[After watching video:  Note that the variable that is controlled by the researcher is call the Independent variable or Cause variable because it creates a change in something else. That something else that changes is the Dependent variable or Outcome variable.]Learning

CRITICAL THINKING:  

  1. Based on the video, can you explain why true experiments are often called randomized controlled trial (RCT)?
  2. Take a look at The Effect of the Physical and Mental Exercises During Hemodialysis on Fatigue: A Controlled Clinical Trial, that is free in full-text via PubMed. How does it meet the criteria of a true experiment as described by Hazel B in the video?

FOR MORE INFORMATION:   Go to “What’s an RCT Anyway?” (https://discoveringyourinnerscientist.wordpress.com/2015/01/23/whats-a-randomized-controlled-trial/ )

Telling the Future: The Research Hypothesis

What is a research hypothesis?   A research hypothesis is a predicted answer; an educated guess.  It is a statement of the outcome that a researcher expects to find in an experimental study.Hypothesis

Why care?  Because it tells you precisely the problem that the research study is about!  Either the researcher’s prediction turns out to be true (supported by data) or not!
A hypothesis includes 3 key elements: 1) the population of interest, 2) the experimental treatment, & 3) the outcome expected.  It is a statement of cause and effect. The experimental treatment that the researcher manipulates is called the independent or cause variable.  The result of the study is an outcome that is called the dependent variable because it depends on the independent/cause variable.

For example, let’s take the hypothesis “Heart failure patients who receive exmeds2perimental drug X will have better cardiac function than will heart failure patients who receive standard drug Y.”  You can see that the researcher is manipulating the drug (independent variable) that patients will receive.  And patient cardiac outcomes are expected to vary—in fact cardiac function is expected to be better—for patients who receive the experimental drug X.

Ideally that researcher will randomly assign subjects to an experimental group that receives drug X and a control group that receives standard therapy drug Y.   Outcome cardiac function data will be collected and analyzed to see if the researcher’s predicted answer (AKA hypothesis) is true.

In a research article, the hypothesis is usually stated right at the end of the introduction or background section.

If you see a hypothesis, how can you tell what is the independent/cause variable and the dependent/effect/outcome variable?question   1st – Identify the population in the hypothesis—the population does not vary (& so, it is not a variable).   2nd – Identify the independent variable–This will be the one that is the cause & it will vary.  3rd – Identify the dependent variable–This will be the one that is the outcome & its variation depends on changes/variation in the independent variable.

PRACTICE:  What are the population, independent variable(s) & dependent variable(s) in these actual research study titles that reflect the research hypotheses:

FOR MORE INFORMATION:  See SlideShare by Domocmat (n.d.) Formulating hypothesis at http://www.slideshare.net/kharr/formulating-hypothesis-cld-handout

 

What’s an RCT anyway?

  • 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.