Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Interventional study designs are considered?

A

Experimental

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

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

A

Interventional

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

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

A

researcher-forced group allocation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Observational Study designs are considered?

A

Natural

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

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

A

Observational

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

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

A

Observational

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Most observational study designs are not able to prove what?

A

Causation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What are the four differentiators of interventional studies?

A
  1. Purpose/focus
  2. Population Studied (healthy/diseased?
  3. Sample Size
  4. Duration
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Describe the pre-clinical phase

A

Bench or animal research

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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*
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What are the advantages of Interventional Trials?

A

Cause precedes effect (can show causation)

Only designed used for FDA approval process

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

What are the disadvantages of Interventional Trials?

A

Cost
Complexity/Time
Ethical considerations
Generalizability or External Validity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

What is a Lead-In Phase?

A

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
Q

What are the disadvantages of Cross-Over study designs? (6)

A
  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
Q

What are the outcomes of an Interventional Study Design?

A
  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
Q

What are POEM’s?

A 
Patient-Oriented Endpoints, most clinically relevant
Examples 
1. Death
2. Stroke
3. Hospitalization 
4. Preventing need for dialysis
29
Q

What are DOE’s?

A

Disease-Oriented outcomes
examples
1. Blood Pressure
2. Cholesterol

30
Q

What is non-random group allocation?

A

Subjects don’t have an equal probability of being assigned to each group

31
Q

What is Random Group Allocation?

A

Subjects do have an equal probability of being assigned to each group

32
Q

What is the most commonly utilized group allocation?

A

Random

33
Q

T/F Randomization in Interventional?

A

T

34
Q

What is the purpose of Randomization?

A

To make groups as equal as possible

35
Q

What is Table 1 customarily used for?

A

To show group characteristics

36
Q

What is not guaranteed in Randomization?

A

Equality of Groups

37
Q

What do P-values show?

A

Documentation of equality

38
Q

What are three forms of randomization?

A
  1. Simple
  2. Blocked
  3. Stratified
39
Q

What is simple randomization?

A

Equal probability for allocation within one of the study groups

40
Q

What is blocked randomization?

A

Ensures balance within each intervention group.

41
Q

What is stratified randomization?

A

Ensures balance with known confounding variables. IE Age, Gender *Can also select levels to be balanced within each interfering factor (cofounder)

42
Q

What is Single-Blind Masking?

A

Study Subjects are not informed which intervention group they are in

43
Q

What is Double-Blind Masking?

A

Neither investigators nor study subjects know which intervention group they are in

44
Q

What is Open-Label (unmasked/unblinded) masking?

A

Study subjects and investigators know what intervention is being received.

45
Q

Post-hoc survey’s asses what?

A

Adequacy of blinding

46
Q

What are two forms of blinding?

A
  1. Placebo

2. Double- Dummy

47
Q

What is Placebo Blinding?

A

Inert treatments made to look identical to active treatments

48
Q

What is double-dummy blinding?

A

More than 1 placebo used. Used when you want to make sure groups don’t know which group they are in.

49
Q

What is the Placebo-Effect?

A

Feeling improvements of being treated, which treatment is inert.

50
Q

What is the Hawthorne-Effect?

A

Subjects acting differently because they know they are being watched.

51
Q

When is Post-Hoc sub-group analysis not appropriate?

A

When not prospectively planned

52
Q

When is Post-Hoc sub-group analysis appropriate?

A

When it is prospectively planned, or used for hypothesis generation for future studies.

53
Q

When determine sample size, what do you want to do?

A

Add in anticipated drop-out or loss to follow-up rates

54
Q

What is Intent to treat?

A

Most conservative way to manage drop-outs. IE Convert all subsequent yet missed assessments for a subject to a null-effect.

55
Q

What does intent to treat result in?

A
  1. Preserves randomization
  2. Preserves baseline characteristics and group balance at baseline.
  3. Maintains statistical power
56
Q

What is Per-Protocal or Efficacy-Analysis

A

A way to ignore drop-outs, compliance must be pre-defined.

57
Q

What is as-treated?

A

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
Q

What is the impact of per-protocol results in drop-out decisions?

A

Reduces generalizability

59
Q

How can we asses Adherence?

A
  1. Drug levels
  2. Pill counts at each visit
  3. Bottle counter-tops
60
Q

How can we improve adherence?

A
  1. Frequent follow-up visits
  2. treatment alarms
  3. Medication blister packs or dosage containers

Epi Exam Two (6 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions