Randomized Controlled Trials Flashcards

1
Q

What is a RCT?

A

Test whether an intervention works by comparing it to a control condition

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2
Q

Describe an RCT?

A

Population –> Study sample –> Randomized –> Intervention/control –> outcome

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3
Q

What is cluster randomized?

A

Where we take groupings of individuals and randomize them

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4
Q

What is a cross over RCT?

A

Where take start/stop treatment and give the randomized groups the opposite therapy

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5
Q

What is the importance of an RCT design?

A

The study must be designed before it is executed

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6
Q

Why is it important to make sure that study is designed before it begins?

A

Limits bias

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7
Q

What is important with an RCT design with respect to population?

A

Who we want to study and where do we get them from

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8
Q

What is the importance of inclusion/excuslion criteria

A

Helps with ensuring data points are similar

Can limite generalizability

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9
Q

What is the importance of sample size?

A

With respect to the power measurement. Where we want to have a balance of power.

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10
Q

If the Sample size is too low what occurs?

A

Underpowered and data is not as backed

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11
Q

What if the sample size is too high?

A

unnecessary exposure and more resource intensive

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12
Q

By increasing the sample size what are we decreasing?

A

Chance

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13
Q

With respect to the intervention what is an important point in all RCT studies?

A

It needs to be specific very specific

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14
Q

What is important with respect to the treatment of controls/comparison groups?

A

Must be treated exactly the same way as the intervention group- the only different that can be present is the intervention

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15
Q

What are the differences between hard endpoints vs surrogate endpoints

A

Hard endpoints a definitive things that occur such as death, MI, stroke

Where surrogate endpoints are like blood pressure where it can lead to it

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16
Q

What is the primary endpoint

A

Main result that is measured at the end of the study to seee the effect of the intervention

17
Q

What is the secondary endpoint

A

Additional results of interest but not the main focus.

We should not interpret these as the study was not designed around them, hence future RCT could be directed towards validating this secondary endpoints that are observed

18
Q

What is a composite endpoint?

A

A primary endpoint that contains several events (MACE)

19
Q

What are the benefits of composite endpoints?

A

Less subjects needed

20
Q

What are the disadvantages of composite endpoints

A

Hard to determine the true effect of the intervention on each of the event types
Look at specific results for breakdown

21
Q

What does randomization help to minimize?

A

Confounding

22
Q

What is the main point with randomization?

A

Randomization minimizes confounding

23
Q

What is complete randomization?

A

No limitations just straight up randomization

Wont necessarily get equal numbers in each of the groupW

24
Q

What is block randomization

A

Used to force balance in the number of subjects in each group

25
Q

What is Stratified randomization?

A

Used to achieve similarities in certain baseline characterisitics

Stratify via age

Stratify via clinic

26
Q

What is Intention to treat?

A

Analyzing the data for all patients and according to the group they were originally ranomzied to

27
Q

What is “Per protocol”

A

analyzing data only from subjects who completed the study or followed protocol exactly

28
Q

Why is intention to treat better?

A

Preserves the valye of randomization

29
Q

Once randomized

A

ANALYZE

30
Q

What is main point of incorporating blinding into a study?

A

Blinding reduces bias

31
Q
A