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Flashcards in Study Designs and Methodology Deck (55)
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1

What are the 2 kinds of studies?

-interventional studies
-Observational studies

2

Quantitative?

-Numbers used to represent data

3

Interventional

-forced group-allocation
-the researchers are intervening!

4

Observational

-No forced group allocation
-we just observe what's going on

5

What will the right answers be on interventional?

-Phase 0, 1, 2, 3, 4

6

What will the right answers on observational?

-Cross sectional
-Case control
-Cohort

7

What is that pyramid for increasing strength of evidence?

-the more we control things, the stronger it is
-so animal and in vitro research are at the bottom of the pyramid
-systematic reviews, meta analyses, and interventional trials are at the top

8

If a study is prospective, what does that mean?

-outcome is NOT yet know at the start of the study

9

Retrospective

-outcome IS already known at the start of the study

10

Ambidirectional (both perspectives in the same study

-first looking retrospectively, then looking prospectively for additional outcome occurrences

11

Which studies can be prospective?

-all interventional phases
-The cohort one for observational

12

What is the null hypothesis

-there will be no difference between the groups being compared

13

What are the 2 key questions to selecting a correct study design?

-Is researcher forcing group allocation
-For observational studies, how were groups ORGANIZED

14

If the research is forcing group allocation, what kind of study will we have?

-an interventional kind
-if the answer is no, then it's observational

15

If we see the word "randomized", what do we think of?

-interventional studies

16

in observational studies, how can the groups be organized?

- by disease status
-by exposure status... cohort
-together due to a common factor... cohort
-data collected across large pop.... cross sectional

17

What does a case control do?

-breaks up ppl into groups of ppl who have the disease and ppl who ain't got the disease
-this is screaming case control study

18

What is retrospective?

-when the outcome of a disease is already known

19

In case control studies, what are we looking for?

-exposure to something else and relate that to the disease
-especially when the disease is really rare... makes the study easy because they will all be at a center somewhere

20

What do we know at the start of a caes control study?

-how many people have the disease (the veritcal columns)

21

What is a nested case-control

-a case control study derived from within or out of a cohort or interventional study

22

In a cohort study, how do you separate everybody?

-put people in a group who were on the drug, not on the drug in another group.... but NOT FORCED, they just happen to be on the drug

23

When is cohort design useful?

-when studying a rare exposure
-commonly generates the risk of disease/outcome for each and a Risk Ratio/Relative risk as measure of association

24

What is a cohort?

-a group with "something" in common
-or it could be based on exposure status

25

What is a cross-sectional study?

-examines relationships between disease AND exposure among individuals ina defined study population at a point in time
-a "snap-shot" in time (across the entire study population

26

When should we think of a cross sectional study?

-when the information gathered represents what is going on with disease AND exposures

27

Are all national studies cross sectional?

-yes
-****so, if the company or whatever entity is that is doing the study starts with an "N", then it is cross sectional!!!***

28

If we are studying healthy people, what are the options for an interventional study?

-phase 0 or 1

29

Phase 0

-assess drug target actions and PK's in non-therapeutic
-"does the drug mechanistically do what we think it does"?

30

Phase 1

-Assess the safety/tolerance and PK's of one or more dosages
-healthy ppl
-"does the drug work?"