General Methodological Concepts Of Research Flashcards

1
Q

What are the two types of Study Design?

A

Interventional study design

-Investigator-selects interventions (exposure)

Observational Study design

  • Researchers “observe” subject-elements occurring naturally or selected by individual
  • Most observational study designs not able to prove causation
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2
Q

What is the most useful and appropriate study design?

A

It depends on the question being asked and the desired perspective.

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3
Q

Study design selection based on:

A
  • Perspective of research question (Hypothesis)
  • Ability/Desire of researcher to force group allocation (randomization)
  • Ethics of methodology
  • Efficiency and Practicality (time/resource commitment)
  • Costs
  • Validity of acquired information (Internal Validity)
  • Applicability of acquired info to non-study patients (External Validity)
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4
Q

What is a population?

A

All individuals making up a common group; from which a sample (smaller set) can be obtained, if desired.

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5
Q

What is a sample?

A

A subset or portion of the full, complete population (“representatives”)

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6
Q

Study population selection based on:

A
  • Research Hypothesis/Question
  • Population of Interest
  • Inclusion and Exclusion selection criteria (Interventional studies) and Case and Control group OR Exposed and Non-exposed group selection criteria (Observational studies)
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7
Q

What is a Null Hypothesis?

A

A research perspective which states there will be NO (true) difference between the groups being compared.

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8
Q

What various statistical-perspectives can be taken by the researcher for a Null Hypothesis?

A
  • Superiority
  • Non-inferiority
  • Equivalency
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9
Q

What is a Probability sample?

A

-Every element in the population has a known (non-zero) probability of being included in sample

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10
Q

What is simple random sampling?

A

-Assigns random numbers, then take randomly-selected numbers to get desired sample size

OR

-Assign random numbers,then sequentially-list numbers and take desired sample size from top (or bottom) of listed numbers

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11
Q

What is systematic random sampling?

A

-Assign random numbers, then randomly sort these random numbers, then select highest (or lowest) number, then systematically, by a pre-determined sampling-interval take every Nth numbers to get desired sample size.

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12
Q

What is stratified simple random sampling?

A

-Stratify sampling frame by desired characteristic (e.g., Gender), then use Simple Random sampling to select desired sample size.

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13
Q

What is Stratified Disproportionate Random sampling?

A
  • Disproportionately utilized Stratified Simple random sampling when baseline population is not at the desired proportional percentages to the referent population.
  • Stratified sample “weighted” to return sample population back to baseline population
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14
Q

What is Multi-Stage random sampling?

A

-Uses Simple Random sampling at multiple stages towards selection

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15
Q

What is Cluster Multi-Stage random sampling?

A

-Same as Multi-Stage Random sampling but ALL “elements” clustered together (at any stage) are selected for inclusion

Ex: ALL Clinics in a zip code or ALL Households in a community

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16
Q

What is “Quasi-Systematic” or “Convenience” Samples?

A

-Decide on what fraction of population is to be sampled and how they will be sampled.

17
Q

What are the key principles of bioethics?

A
  • Autonomy
  • Beneficence
  • Justice
  • Nonmaleficence
18
Q

What is Autonomy?

A

-Self-rule/Self-determination.

Participants must:

  • Decide for ones-self, without outside influences
  • Have full and complete understanding of the risks and benefits
19
Q

What is Beneficence?

A

-To benefit, or do good for, the patient (not society)

20
Q

What is Justice?

A

-Equal and Fair treatment regardless of patient characteristics

21
Q

What is Nonmaleficence?

A

-Do no harm

  • Researchers must not:
    • Withhold information
    • Provide false information
    • Exhibit professional incompetence
22
Q

What are the guiding principles in the Belmont Report?

A
  • Respect for persons
    • Research should be voluntary, subjects autonomous
  • Beneficence
    • Research risks are justified by potential benefits
  • Justice
    • risks and benefits of the research are equally distributed
23
Q

What are consent and assent?

A

Consent is an agreement to participate, based on being fully and completely informed (given by mentally-capable individuals of legal consenting age (i.e., adults; age 18 in most states)

Assent is the same but the individuals are NOT able to give legal consent.