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Epi Exam Two > Interventional Study Design > Flashcards

Interventional Study Design Flashcards

1
Q

Rank the Research Evidence Pyramid, from most evidence to least evidence (first 5)

A
  1. Systematic Reviews/Meta-Analyses
  2. Interventional/Pragmatic
  3. Cohort
  4. Case-Control
  5. Cross-Sectional
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2
Q

Interventional study designs are considered?

A

Experimental

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3
Q

There is researcher-forced group allocation in which study design?

A

Interventional

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4
Q

Randomization processes are commonly utilized to accomplish what in interventional studies?

A

researcher-forced group allocation

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5
Q

Observational Study designs are considered?

A

Natural

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6
Q

There is not researcher-forced group allocation in this study design?

A

Observational

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7
Q

This study design is useful for unethical study designs using forced interventions

A

Observational

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8
Q

Most observational study designs are not able to prove what?

A

Causation

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9
Q

What are the key differences of interventional studies compared to observational studies?

A
  1. forced group allocations
  2. investigator selects interventions
  3. can demonstrate causation
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10
Q

What are the four differentiators of interventional studies?

A
  1. Purpose/focus
  2. Population Studied (healthy/diseased?
  3. Sample Size
  4. Duration
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11
Q

Describe the pre-clinical phase

A

Bench or animal research

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12
Q

Describe Phase 0

A
  1. Asses drug-target actions by giving a single or few doses.
  2. Healthy volunteers
  3. Very small N (<20)
  4. Very short duration
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13
Q

Describe Phase 1

A
  1. Assess safety/tolerance and pharmacokinectics of one or more dosages.
  2. Healthy or diseased volunteers (dependent on the disease)
  3. Small N (20-80)
  4. Short duration
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14
Q

Describe Phase 2

A
  1. assess effectiveness (expands on phase 1 purpose)
  2. Diseased volunteers *may have narrow inclusion criteria for isolation of effects
  3. Larger N (100-300)
  4. Short-to-Medium duration
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15
Q

Describe Phase 3

A
  1. Assess effectiveness
  2. Diseased volunteers
  3. Larger N (500-3000)
  4. Longer duration
    * Last phase before FDA approval*
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16
Q

Describe Phase 4

A

Post FDA approval

  1. Assess long-term safety, effectiveness, optimal use
  2. Diseased volunteers
  3. Population N
  4. Wide-range of durations
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17
Q

What are the advantages of Interventional Trials?

A

Cause precedes effect (can show causation)

Only designed used for FDA approval process

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18
Q

What are the disadvantages of Interventional Trials?

A

Cost
Complexity/Time
Ethical considerations
Generalizability or External Validity

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19
Q

A single randomization process that is commonly used to test a single hypothesis at a time is what kind of interventional study?

A

Simple

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20
Q

What is a factorial interventional study?

A

Divides subjects into at least 2 groups and then further subdivides each of the groups into at least 2 additional sub groups

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21
Q

Why are factorial studies used to test multiple hypothesis at the same time?

A
  1. Improve efficiency for answering clinical questions
  2. Increases N
  3. Increases complexity
    But, increases risk of drop-outs and may restrict generalizability of results.
    Shown as (2x2 or 3x3x2)
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22
Q

What is a Parallel interventional study?

A

Groups simultaneously and exclusively managed
No switching of intervention groups after initial randomization
All simple and factorial study designs are also parallel

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23
Q

What is a Cross-Over or Self-Control Interventional Study?

A

Groups serve as their own control by crossing over from one intervention to another during the study.
Allows for smaller total N
Each patient contributes additional data
Between & Within- Group comparisons are possible

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24
Q

What is a Wash-Out?

A

Complete switching of groups in Cross-Over studies. Used in the middle of a study to wash out previous treatment.

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25
What is a Lead-In Phase?
All study subjects blindly given one or more placebos for initial therapy to determine new baseline of disease. can *WASH OUT* existing medication. *can determine amount of placebo-effect*
26
What are the disadvantages of Cross-Over study designs? (6)
1. only suitable for long-term uncurable conditions 2. Duration of study for each subject is longer 3. Carry-over effects during crossover 4. Treatment-by-Period interaction 5. Smaller N requirement only applicable if within-subjects variation less than between-subjects variation 6. Complexity in data analysis
27
What are the outcomes of an Interventional Study Design?
1. Primary - Most important 2. Secondary/Tertiary/Etc - Lesser importance, Possible for future hypothesis generation 3. Composite - Combines multiple endpoints into a single outcome. *Can be considered Primary outcome, if so, secondary outcomes are individual outcome elements*
28
What are POEM's?
``` Patient-Oriented Endpoints, most clinically relevant Examples 1. Death 2. Stroke 3. Hospitalization 4. Preventing need for dialysis ```
29
What are DOE's?
Disease-Oriented outcomes examples 1. Blood Pressure 2. Cholesterol
30
What is non-random group allocation?
Subjects don't have an equal probability of being assigned to each group
31
What is Random Group Allocation?
Subjects do have an equal probability of being assigned to each group
32
What is the most commonly utilized group allocation?
Random
33
T/F Randomization in Interventional?
T
34
What is the purpose of Randomization?
To make groups as equal as possible
35
What is Table 1 customarily used for?
To show group characteristics
36
What is not guaranteed in Randomization?
Equality of Groups
37
What do P-values show?
Documentation of equality
38
What are three forms of randomization?
1. Simple 2. Blocked 3. Stratified
39
What is simple randomization?
Equal probability for allocation within one of the study groups
40
What is blocked randomization?
Ensures balance within each intervention group.
41
What is stratified randomization?
Ensures balance with known confounding variables. IE Age, Gender *Can also select levels to be balanced within each interfering factor (cofounder)
42
What is Single-Blind Masking?
Study Subjects are not informed which intervention group they are in
43
What is Double-Blind Masking?
Neither investigators nor study subjects know which intervention group they are in
44
What is Open-Label (unmasked/unblinded) masking?
Study subjects and investigators know what intervention is being received.
45
Post-hoc survey's asses what?
Adequacy of blinding
46
What are two forms of blinding?
1. Placebo | 2. Double- Dummy
47
What is Placebo Blinding?
Inert treatments made to look identical to active treatments
48
What is double-dummy blinding?
More than 1 placebo used. Used when you want to make sure groups don't know which group they are in.
49
What is the Placebo-Effect?
Feeling improvements of being treated, which treatment is inert.
50
What is the Hawthorne-Effect?
Subjects acting differently because they know they are being watched.
51
When is Post-Hoc sub-group analysis not appropriate?
When not prospectively planned
52
When is Post-Hoc sub-group analysis appropriate?
When it is prospectively planned, or used for hypothesis generation for future studies.
53
When determine sample size, what do you want to do?
Add in anticipated drop-out or loss to follow-up rates
54
What is Intent to treat?
Most conservative way to manage drop-outs. IE Convert all subsequent yet missed assessments for a subject to a null-effect.
55
What does intent to treat result in?
1. Preserves randomization 2. Preserves baseline characteristics and group balance at baseline. 3. Maintains statistical power
56
What is Per-Protocal or Efficacy-Analysis
A way to ignore drop-outs, compliance must be pre-defined.
57
What is as-treated?
a way to manage drop-outs, treating them as treated. Ignores group assignments, allows subjects to switch groups by putting subject in group they spent the most time in.
58
What is the impact of per-protocol results in drop-out decisions?
Reduces generalizability
59
How can we asses Adherence?
1. Drug levels 2. Pill counts at each visit 3. Bottle counter-tops
60
How can we improve adherence?
1. Frequent follow-up visits 2. treatment alarms 3. Medication blister packs or dosage containers

Epi Exam Two (6 decks)

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