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RCT

randomized clinical trial

2 most important aspects of RCTs

treatment artificially manipulated
subjects randomly assigned

What do you start with in a RCT?

a defined population that fits certain criteria

What do you do with your selected population in RCTs?

randomly divide them into groups such as new vs old drug or placebo vs drug

Why must you use a control group?

Control group necessary to determine whether an
observed outcome is a true effect of the treatment
or would have occurred in the absence of the
therapy under evaluation.

What can happen if you do not have a concurrent control group?

changes in patient characteristics
• changes in the natural history of disease
• changes in diagnostic criteria or therapy
• improvements in health care

What does randomization allow?

a higher likelihood that the groups are comparable in both known and unknown characteristics
- gives validity

What does randomization prevent?

selection bias

What biases does patient blinding prevent?

post randomization selection
attrition
information

post randomization selection bias

placebo group patients may eat healthier or exercise more

Attrition bias

those that know they are on a placebo are more likely to drop out

information bias

groups receiving tx are more likely to report AEs than placebo groups

Why blind the HCP?

prevents paying more attention to tx group

Why blind data analysts?

prevents the use of particular statistical methods in order to favor one group or the other

When would you use stratification?

when you know of a particular trait that will affect the outcome - gender, age, etc

What are the two types of crossover studies?

planned
unplanned

Planned crossover

randomized -> new treatment vs current treatment -> pts are then switched to the opposite treatment

washout period

the time for the effects of the first treatment option to subside before crossing over

unplanned crossover

randomized - tx option 1 vs tx option 2 -> pts them switch due to various factors

dropouts

refuse to comply or just drop out

dropins

pts accidentally include themselves in a tx option group that they were not assigned

triple blinded

pts
health care providers
analysts

Gold standard

triple blinded placebo controlled randomized clinical trial

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