Lesson: Randomized Controlled Trial Flashcards
What is a randomized control 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 group in a randomized controlled trial (RCT ) is the outcome variable being studied.
Purpose of RCTs?
-It is the gold standard for studying causal relationships bc eliminate bias
-it facilitates blinding
-it permits the use of probability theory
Medical treatment achieve mischief less dramatic results
What is placebo effect?
The positive response to a treatment without active substance
What are types of randomization?
-Simple(complete) randomization: there is an eligible participant, the investigator’s flips a coin to determine participants goes into intervention or control group.
-Blocked Randomization: reduces the risk that different numbers of people will be assigned to the treatment and control. The order is chosen randomly at the beginning of the block.
-stratified randomization: treatment and control group are balanced on important prognostic factors that can influence the study outcome.
What is allocation concealment?
Is performed when the treatment allocation system is set up so that the person enrolling participants does not know in advance which treatment the next person will get.
It is necessary for randomization to be successful in an RCT
What is treatment fidelity?
Describes whether the interventionist delivered the treatment as planned (follow protocol, well trained PIs, quality monitoring)