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BPS Final Exam > Study Designs and Methodology > Flashcards

Study Designs and Methodology Flashcards

(55 cards)

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1
Q

What are the 2 kinds of studies?

A
  • interventional studies

- Observational studies

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2
Q

Quantitative?

A

-Numbers used to represent data

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3
Q

Interventional

A
  • forced group-allocation

- the researchers are intervening!

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4
Q

Observational

A
  • No forced group allocation

- we just observe what’s going on

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5
Q

What will the right answers be on interventional?

A

-Phase 0, 1, 2, 3, 4

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6
Q

What will the right answers on observational?

A
  • Cross sectional
  • Case control
  • Cohort
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7
Q

What is that pyramid for increasing strength of evidence?

A
  • 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
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8
Q

If a study is prospective, what does that mean?

A

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

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9
Q

Retrospective

A

-outcome IS already known at the start of the study

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10
Q

Ambidirectional (both perspectives in the same study

A

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

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11
Q

Which studies can be prospective?

A
  • all interventional phases

- The cohort one for observational

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12
Q

What is the null hypothesis

A

-there will be no difference between the groups being compared

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13
Q

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

A
  • Is researcher forcing group allocation

- For observational studies, how were groups ORGANIZED

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14
Q

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

A
  • an interventional kind

- if the answer is no, then it’s observational

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15
Q

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

A

-interventional studies

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16
Q

in observational studies, how can the groups be organized?

A
  • by disease status
  • by exposure status… cohort
  • together due to a common factor… cohort
  • data collected across large pop…. cross sectional
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17
Q

What does a case control do?

A
  • 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
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18
Q

What is retrospective?

A

-when the outcome of a disease is already known

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19
Q

In case control studies, what are we looking for?

A
  • 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

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20
Q

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

A

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

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21
Q

What is a nested case-control

A

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

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22
Q

In a cohort study, how do you separate everybody?

A

-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

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23
Q

When is cohort design useful?

Study These Flashcards
A
  • 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
Q

What is a cohort?

Study These Flashcards
A
  • 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?"
31
What 4 things are looking for in the question stem to figure out which phase we are in?
- Purpose - population studie - sample size - Duration
32
Phase 2
- assess effectiveness - diseased volunteers - larger N - Short to medium duration
33
Phase 3
- efficacy is paramount - assess effectiveness - diseased volunteers - larger N - Longer duration - last phase the drug is at to try to get it approved
34
Phase 4
- after they are approved and on the market - assess long term safety, effectiveness, optimal use - diseased volunteers - population N - Longer duration
35
What is the deal with simple studies?
- there is only 1 randomization step - can have as many groups as it needs - but there will be only 1 randomization process!!!
36
what are factorial studies
- randomized into an initial group, then further randomly divided into a sub group - multiple randomizations
37
What does parallel mean?
- subjects exclusively managed in a single treatment group - NO switching groups after initial randomization - no crossing over on the picture
38
Cross-over, what does it mean?
- the subjects forcibly switched to other treatment group after initial treatment assignment - they will always have a picture where the lines cross
39
What do we need to do before we make the groups switch in a cross over study?
-a 2 week *washout* period...
40
Which studies are better at proving causation?
-prospective studies
41
What is the most common kind of bias?
-selection bias: "who can be in this study"?
42
In group allocation procedures, what does random mean?
- subjects have equal probability of being assigned to each of the pre-defined intervention groups - random number generator program/software/application
43
What does non random mean?
-some investigator-developed way to select patients
44
What is the purpose of randomization?
- to make all groups as equal as possible; based on known confounders - ****table 1 needs to have high P values***
45
What is simple randomization
-equal probability for allocation into one of the study groups
46
What is blocked randomization?
- Ensures balance within each intervention group | - when researchers want to assure that all groups are equal in size
47
What is stratified randomization?
-ensures balance within KNOWN CONFOUNDING VARIABLES
48
What does single blind mean?
-study subjects are not informed which intervention group they are in, yet investigators are permitted to know
49
what is double blind?
- neither investigators nor study subjects are informed which intervention group subjects are in - post study survey's can be used to assess adequacy of blinding
50
What is open-label (unmasked/unblinded)?
-study subjects and researchers know what intervention is being receeived
51
What can we do when they quit or die or drop out of the study for whatever reason?
- include them: intent to treat | - Exclude them: per protocol
52
What does intent to treat result in?
- preserves the randomization process - preserves baseline characteristics and group balance at baseline which controls for known and unknown confounders - maintains statistical power
53
What does per protocol rsult in?
- biases estimates of effect | - can limit generalizability!!!! (ultrra adherent)
54
What is the IRB?
-protects the study subjects before the study even gets started
55
What does the DSMB do?
- protects the subjects after the study starts | - they will shut it down if bad things are happening

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