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Zak, Epidemiology > Lectures 7-9 > Flashcards

Lectures 7-9 Flashcards

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

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

A

Most important/key outcome, main research question

24
Q

Secondary Outcome/Endpoint of Interventional Study

A

Lesser importance, yet still valuable

25
Q

Tertiary Outcome/Endpoint of Interventional Study

A

Much less importance, but still valuable

26
Q

Composite Outcome/Endpoint of Interventional Study

A

Combines multiple endpoints into a single outcome

27
Q

Direct Endpoints vs. Surrogate Markers

A

Direct Endpoints: death, stroke, heart attack, preventing need for dialysis, etc.
Surrogate Markers: blood pressure, cholesterol, etc.

28
Q

Types of sample selection/group allocation for interventional studies

A

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
Q

Purpose of Randomization

A

Make groups as equal as possible based on known or unknown important factors
Attempts to reduce bias
Equality NOT guaranteed

30
Q

T/F: Saying, “There was no significant difference between groups” means the randomization failed.

A

False, it means the randomization worked

31
Q

Blocked Randomization

A

Ensures groups are equal in number

32
Q

Stratified Randomization

A

Need factor tested to be in equal numbers in each group

33
Q

Single-Blind Study

A

Subjects are not informed to which intervention they are receiving

34
Q

Double-Blind Study

A

Neither investigators nor subjects are informed to which intervention the subjects are receiving

35
Q

Open-Label Study

A

Everyone knows which intervention each subject is receiving

36
Q

Post-hoc Survey

A

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
Q

Placebo/Dummy Therapy

A

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
Q

Placebo-Effect

A

Improvement of condition by power of suggestion & care provided
*Can be 30-50% increase

39
Q

Hawthorne-Effect

A

Desire of subjects to “please” investigators by reporting positive results, regardless of treatment allocation

40
Q

Run-In/Lead-In Phase

A

Used to…
Asses protocol compliance
“Wash-out” existing medication
Determine amount of placebo-effect

41
Q

What are the 4 Principles of Bioethics?

A

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
Q

Consent

A

Agreement to participate based on being fully informed and mentally capable/of legal age

43
Q

Assent

A

Agreement to participate based on being fully informed and mentally capable NOT of legal age (children)

44
Q

What did the Belmont Report contain?

A

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
Q

Who determines ethical conduct?

A

Institutional Review Board (IRB): role is to protect human subjects from undue risk

46
Q

Equipoise

A

Genuine confidence that an intervention may be worthwhile in order to use it in humans

47
Q

What agency “puts teeth” behind IRB?

A

Office of Human Research Protections: administers and enforces regulations

48
Q

3 levels of IRB review are?

A

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
Q

What does the Data Safety & Monitoring Board (DSMB) do?

A

In charge of reviewing study data as study progresses to assess for undue risk or benefit

50
Q

Assessing adherence (compliance) of interventional studies

A

Drug levels
Pill counts
Bottle counter-tops

51
Q

Methods of improving adherence (compliance)

A

Frequent follow-up visits/communication
Treatment alarms/notifications
Medication blister packs or dosage containers

52
Q

What are the 3 ways of managing drop-outs?

A

1) Include them anyway
2) Ignore them
3) Treat them as “treated”

53
Q

Explain the “include them anyway” method

A

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
Q

Explain “ignore them” method

A

Only report data for subjects who took the complete dosage, leave out any drop-outs

Zak, Epidemiology (16 decks)

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