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Epidemiology > General Methodological Concepts of Research > Flashcards

General Methodological Concepts of Research Flashcards

1
Q

What is the most useful and appropriate study design?

A

It Depends…on the question and the perspective

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2
Q

Quantitative

A

Numbers used to represent data

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3
Q

Qualitative

A

Words used to represent data

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4
Q

Two types of Quantitative Studies

A
  1. Interventional

2. Observational

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5
Q

Interventional

A

Forced allocation to study groups

  • Already picked the groups and subjects are forced into one of them.
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6
Q

Observational

A

No forced allocation to study groups

  • Patients preselect which group they will go in
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7
Q

What is study design selection based on?

A
  • Perspective of research question
  • Ability/desire of researcher to force group allocation (randomization)
  • Ethics and methodology
  • Efficiency & practicality (time/resource commitment)
  • Costs
  • Validity of acquired information (internal validity)
  • Applicability of acquired to non-study patients (Generalizability)
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8
Q

Null Hypothesis

A
  • Research prospective that states that there will be no difference between the groups being compared
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9
Q

What are the 3 various statistical-perspectives that can be taken by the researcher?

A
  • Superiority
  • Noninferiority
  • Equivalency
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10
Q

Alternative Hypothesis

A
  • Research perspective that states the will be a true difference between the groups being compared
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11
Q

Type 1 Error

A

Rejecting of the null when you shouldn’t have

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12
Q

Type 2 Error

A

Not rejecting the null when you should have

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13
Q

Population

A
  • All individuals that make up a common group. A sample can be obtained from it
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14
Q

Sample

A

A subset or part of the full, complete population

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15
Q

What is the study population selection based on?

A
  • Research Hypothesis/Question
  • Population of interest
  • Groups of individuals most useful and applicable to answer the research question
  • Inclusion & Exclusion selection criteria (interventional)
  • Case & Control group OR Exposed + Nonexposed group selection criteria (observational)
  • Ethics
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16
Q

Equipoise

A
  • Genuine confidence that an intervention may be worthwhile (risk vs. benefit) in order to use in humans
  • Believe that the data is valuable and any risks clearly don’t outweigh the benefits.
17
Q

What are the four key principles of bioethics.

A
  • Autonomy
  • Justice
  • Benevolence
  • Nonmaleficence
18
Q

Autonomy

A

Patient gets the right to decide whether to participate or not.

They must be fully educated at a level that they understand

19
Q

Beneficence

A
  • To benefit, or do good for, the patient (not society)
20
Q

Justice

A
  • Equal + fair treatment regardless of patient characteristics
21
Q

Nonmaleficence

A
  • Do no harm.
  • Researchers must not
    • Withhold information
    • Provide false information
    • Exhibit professional incompetence
22
Q

What is the Belmont Report?

A

The Guiding principles that researchers should be aware of.

23
Q

What are the 3 guiding principles of the Belmont Report?

A
  • Respect for persons - research should be voluntary
  • Beneficence - risk justified by potential benefits
  • Justice - risks and benefits equally distributed
24
Q

What is Consent?

A
  • Agreement to participate, based on being completely informed.

Age 18 to give consent

Must be mentally capable

25
Q

What is assent?

A
  • Agreement to participate, based on being completely informed, given by those not able to give legal consent.

Age: Children and adolescent, under 18

Must be mentally-capable

26
Q

What does IRB stand for?

A

Institutional Review Board

27
Q

What is the role of the IRB?

A
  • makes the decision on whether research should occur before it starts
28
Q

What is the sole purpose of the IRB?

A
  • To protect the health and well being of study participants
29
Q

List the levels of IRB Review

A
  • Full board
  • Expedited
  • Exempt
30
Q

Full Board

A
  • used for ALL interventional trials with more than minimal risk to patients
31
Q

Expedited

A

Minimal risk and/or no patient identifiers

32
Q

Exempt

A
  • No patient identifiers
  • low/no risk
  • de-identified
33
Q

What is the main different between the 3 levels of review?

A
  • Number of members & time for committee review

- Level of detail to Documentation needed for review

34
Q

Who decides the level of review?

A

The IRB

35
Q

Who keeps up with reviewing the study after it has started?

A
  • Data Safety & Monitoring Board (DSMB)

Epidemiology (12 decks)

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