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Zak, Epidemiology > Lectures 7-9 > Flashcards

Lectures 7-9 Flashcards

(55 cards)

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0
Q

Population

A

All individuals making up a common group

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1
Q

What is the study method-selection based on…?

A 
Type of research question (hypothesis)
Validity of acquired information
Efficiency & practicality
Cost/finances
Ethics of research question
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2
Q

Sample

A

A subset or portion of the full population (representatives)

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3
Q

Null Hypothesis

A

States there is NO (true) difference between the groups being compared

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4
Q

Alternative Hypothesis

A

States there IS (true) a difference between the groups being compared

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5
Q

Observational Study

A

Lets nature take its course and we observe outcomes

“natural”

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6
Q

Interventional Study

A

Investigators select interventions/exposure…force something to be done
“experimental”

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7
Q

T/F: Observational studies can demonstrate causation

A

False, Interventional studies demonstrate causation

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8
Q

Pre-clinical phase of interventional study

A

Prior to human investigation (bench/animal research)

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9
Q

Phase 1 of interventional study

A

New drug/device/procedure
Humans used for first time in short duration (few weeks) to assess safety, toxicity, & pharmacokinetics
Can’t tell long term side-effects
Small number of people (<100)

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10
Q

Phase 2 of interventional study

A

New drug/device/procedure
Utilize patients with the condition of interest to expand on phase 1 and assess efficacy in diseased population (few weeks to months)
Number of people ~100-300

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11
Q

Phase 3 of interventional study

A

New drug/device/procedure
Used in patients with condition of interest to determine safety and efficacy for longer duration (months to years)
Number people ~1,000-3,000
Superiority vs. Non-inferiority vs. Equivalency formats

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12
Q

Phase 4 of interventional study

A

Post-marketing (occurs after product is on the market)
Determine long-term effects in large population of disease patients
Largest number of people

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13
Q

Advantages of Interventional Trials

A 
Shows causation (cause precedes effect)
Only design used by FDA for "approval" process
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14
Q

Disadvantages of Interventional Trials

A

Cost
Complexity/Time
Ethical Considerations
Generalizability (is study population similar to general population and will findings be applicable to them)

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15
Q

Simple Interventional Study Design

A

Divides subjects into at least 2 groups

Randomized once

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16
Q

Explanatory

A

Explains effectiveness of intervention

*Problem is that only certain people get to play the game

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17
Q

Pragmatic

A

Let everyone with the condition be in the study

*More people can play the game, more like real life

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18
Q

Factorial Interventional Study Design

A

Divides subjects into at least 2 groups and sub-divides each of those groups into at least 2 groups
Randomized more than once
Takes more people

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19
Q

Parallel Interventional Study Design

A

Groups simultaneously and exclusively managed
No switching groups after initial randomization
(Simple & Factorial study designs are also parallel)

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20
Q

Cross-Over Interventional Study Design

A

Individuals can cross from one group to another during the study

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21
Q

Wash-Out Period

A

Time when you “clear” your system to be as drug free as possible when entering a group/study to limit errors/side-effects that aren’t typical

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22
Q

Disadvantages of Cross-Over Design

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A 
Only suitable for long-term conditions
Longer duration of study
Carry-over effects during wash-out
Treatment-by-period interaction
Complexity in data analysis
23
Q

Primary Outcome/Endpoint of Interventional Study

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A

Most important/key outcome, main research question

24
Secondary Outcome/Endpoint of Interventional Study
Lesser importance, yet still valuable
25
Tertiary Outcome/Endpoint of Interventional Study
Much less importance, but still valuable
26
Composite Outcome/Endpoint of Interventional Study
Combines multiple endpoints into a single outcome
27
Direct Endpoints vs. Surrogate Markers
Direct Endpoints: death, stroke, heart attack, preventing need for dialysis, etc. Surrogate Markers: blood pressure, cholesterol, etc.
28
Types of sample selection/group allocation for interventional studies
Non-random: Subjects don't have an equal probability of being selected or assigned to each intervention group Random: Subjects do have an equal probability of being assigned to each intervention group
29
Purpose of Randomization
Make groups as equal as possible based on known or unknown important factors Attempts to reduce bias Equality NOT guaranteed
30
T/F: Saying, "There was no significant difference between groups" means the randomization failed.
False, it means the randomization worked
31
Blocked Randomization
Ensures groups are equal in number
32
Stratified Randomization
Need factor tested to be in equal numbers in each group
33
Single-Blind Study
Subjects are not informed to which intervention they are receiving
34
Double-Blind Study
Neither investigators nor subjects are informed to which intervention the subjects are receiving
35
Open-Label Study
Everyone knows which intervention each subject is receiving
36
Post-hoc Survey
Used to assess adequacy of blindness | Blinding should be a 50/50 random mix of correct knowledge of which intervention the subject was receiving
37
Placebo/Dummy Therapy
Fake treatment made to look just like active treatment *Double-Dummy: more than 1 placebo Need 2 placebos if method of ingestion is different for medicines
38
Placebo-Effect
Improvement of condition by power of suggestion & care provided *Can be 30-50% increase
39
Hawthorne-Effect
Desire of subjects to "please" investigators by reporting positive results, regardless of treatment allocation
40
Run-In/Lead-In Phase
Used to... Asses protocol compliance "Wash-out" existing medication Determine amount of placebo-effect
41
What are the 4 Principles of Bioethics?
Autonomy: Self-rule/determination, be able to make decisions on their own accord Beneficence: To benefit or do good for the patient (not society) Justice: Equal/fair treatment regardless of patient characteristics Nonmaleficence: Do no harm
42
Consent
Agreement to participate based on being fully informed and mentally capable/of legal age
43
Assent
Agreement to participate based on being fully informed and mentally capable NOT of legal age (children)
44
What did the Belmont Report contain?
3 guiding principles 1) Respect for persons: research should be voluntary/autonomous 2) Beneficence: risks are justified by potential benefits 3) Justice: risks and benefits are equally distributed
45
Who determines ethical conduct?
Institutional Review Board (IRB): role is to protect human subjects from undue risk
46
Equipoise
Genuine confidence that an intervention may be worthwhile in order to use it in humans
47
What agency "puts teeth" behind IRB?
Office of Human Research Protections: administers and enforces regulations
48
3 levels of IRB review are?
Full Board: used for all interventional trials with more than minimal patient risk (medication related studies) Expedited: used with minimal risk and no patient identifiers Exempt: low/no risk, no patient identifiers, environmental studies
49
What does the Data Safety & Monitoring Board (DSMB) do?
In charge of reviewing study data as study progresses to assess for undue risk or benefit
50
Assessing adherence (compliance) of interventional studies
Drug levels Pill counts Bottle counter-tops
51
Methods of improving adherence (compliance)
Frequent follow-up visits/communication Treatment alarms/notifications Medication blister packs or dosage containers
52
What are the 3 ways of managing drop-outs?
1) Include them anyway 2) Ignore them 3) Treat them as "treated"
53
Explain the "include them anyway" method
Use what information you have gathered and keep their statistics in the study either by using last assessment for all future assessments or by converting all past and future assessments to base-line recording
54
Explain "ignore them" method
Only report data for subjects who took the complete dosage, leave out any drop-outs

Zak, Epidemiology (16 decks)

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