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BPS Final Exam > Study Designs and Methodology > Flashcards

Study Designs and Methodology Flashcards

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?

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?

A
  • a group with “something” in common

- or it could be based on exposure status

25
Q

What is a cross-sectional study?

A
  • 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
Q

When should we think of a cross sectional study?

A

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

27
Q

Are all national studies cross sectional?

A
  • yes
  • *so, if the company or whatever entity is that is doing the study starts with an “N”, then it is cross sectional!!!
28
Q

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

A

-phase 0 or 1

29
Q

Phase 0

A
  • assess drug target actions and PK’s in non-therapeutic

- “does the drug mechanistically do what we think it does”?

30
Q

Phase 1

A
  • Assess the safety/tolerance and PK’s of one or more dosages
  • healthy ppl
  • “does the drug work?”
31
Q

What 4 things are looking for in the question stem to figure out which phase we are in?

A
  • Purpose
  • population studie
  • sample size
  • Duration
32
Q

Phase 2

A
  • assess effectiveness
  • diseased volunteers
  • larger N
  • Short to medium duration
33
Q

Phase 3

A
  • efficacy is paramount
  • assess effectiveness
  • diseased volunteers
  • larger N
  • Longer duration
  • last phase the drug is at to try to get it approved
34
Q

Phase 4

A
  • after they are approved and on the market
  • assess long term safety, effectiveness, optimal use
  • diseased volunteers
  • population N
  • Longer duration
35
Q

What is the deal with simple studies?

A
  • there is only 1 randomization step
  • can have as many groups as it needs
  • but there will be only 1 randomization process!!!
36
Q

what are factorial studies

A
  • randomized into an initial group, then further randomly divided into a sub group
  • multiple randomizations
37
Q

What does parallel mean?

A
  • subjects exclusively managed in a single treatment group
  • NO switching groups after initial randomization
  • no crossing over on the picture
38
Q

Cross-over, what does it mean?

A
  • the subjects forcibly switched to other treatment group after initial treatment assignment
  • they will always have a picture where the lines cross
39
Q

What do we need to do before we make the groups switch in a cross over study?

A

-a 2 week washout period…

40
Q

Which studies are better at proving causation?

A

-prospective studies

41
Q

What is the most common kind of bias?

A

-selection bias: “who can be in this study”?

42
Q

In group allocation procedures, what does random mean?

A
  • subjects have equal probability of being assigned to each of the pre-defined intervention groups
  • random number generator program/software/application
43
Q

What does non random mean?

A

-some investigator-developed way to select patients

44
Q

What is the purpose of randomization?

A
  • to make all groups as equal as possible; based on known confounders
  • *table 1 needs to have high P values
45
Q

What is simple randomization

A

-equal probability for allocation into one of the study groups

46
Q

What is blocked randomization?

A
  • Ensures balance within each intervention group

- when researchers want to assure that all groups are equal in size

47
Q

What is stratified randomization?

A

-ensures balance within KNOWN CONFOUNDING VARIABLES

48
Q

What does single blind mean?

A

-study subjects are not informed which intervention group they are in, yet investigators are permitted to know

49
Q

what is double blind?

A
  • 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
Q

What is open-label (unmasked/unblinded)?

A

-study subjects and researchers know what intervention is being receeived

51
Q

What can we do when they quit or die or drop out of the study for whatever reason?

A
  • include them: intent to treat

- Exclude them: per protocol

52
Q

What does intent to treat result in?

A
  • preserves the randomization process
  • preserves baseline characteristics and group balance at baseline which controls for known and unknown confounders
  • maintains statistical power
53
Q

What does per protocol rsult in?

A
  • biases estimates of effect

- can limit generalizability!!!! (ultrra adherent)

54
Q

What is the IRB?

A

-protects the study subjects before the study even gets started

55
Q

What does the DSMB do?

A
  • protects the subjects after the study starts

- they will shut it down if bad things are happening

BPS Final Exam (12 decks)

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