Randomized Control Trials (RCT) Questions and answers.

RCT An experimental study where a tratment group is compared to a control group, and subjects are randomly assigned to each group. Known as the gold standard because it is a true experimental design and has all three elements - control, randomization, and manipulation. These seek to identify cause and effect between variables Independent Variable The condition, intervention, or characteristic that will predict or cause a specific outcome. May have several levels. Ex. for treatment: OT vs. usual care (2 levels) a.k.a predictor variable Brainpower Read More Dependent Variable A response or effect that is presumed to vary depending on the independent variable. Dependent variables DO NOT have levels. Example study: Comparison of OT vs. usual care (1 independent variable) for hand pain and disability(2 dependent variables) a.k.a. outcome variable Randomization Reduces sample bias, increases internal and external validity of a study, and individual subject differences should be balanced in each group. Pitfalls of Randomization Subject may not like the group they are assigned to and so drop out of the study, may not be compliant with treatment, or investigator could skew so that a participant goes into one group rather than another Double-Blind Study to minimize bias Neither the subjects nor the investigators know the group assignment until all the data are collected. Impractical for OT research bc all people are being treated by a therapist Single-Blind Study Only the investigator or the people doing the nmeasurements are blinded. More typically done in rehab research Intention-to-Treat Analysis (ITT) The data are analyzed according to the subjects' original random assignments, regardless if it's where they actually ended up. This approach ideally includes all subjects, even dropouts. They guard against the potential for bias if dropouts are related to outcomes or group assignment and preserves the original balance of random assignment CONSORT Consolidated Standards of Reporting Trials A method for accurately reporting what happens to the subjects throughout the study. Includes a checklist and a flowchart. They are done specific to each RCT journal article and allows investigators to make sure that all necessary info has been included in the report