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Epidemiology -- Zach H. > Class #15: General Methodological Concepts of Research > Flashcards

Class #15: General Methodological Concepts of Research Flashcards

1
Q

What is the Null Hypothesis (H0)?

A

A research perspective which states there will be NO (true) difference between the groups being compared.
>most conservative and commonly utilized
>various statistical-perspectives can be taken by the researcher:
-superiority
-noninferiority
-equivalency

**Researchers either accept or reject this perspective, based on results (data analysis) **

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2
Q

What is the alternative hypothesis (H1)?

A

A research perspective which states there will be a (true) difference between the groups being compared.

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3
Q

What are the two main types of study design? Also, what is the main difference between the 2?

A

Observational – study designs considered “natural”

Interventional – study designs considered “experimental”

**The main difference -> in observational there is NO researcher-forced group allocation.
in interventional there is researcher-forced group allocation.

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4
Q

What are the 5 sub-sets under observational study design?

A 
Observational 
  >cases (reports/series)
  >ecological
  >cross-sectional
  >case-control
  >cohort
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5
Q

What are the 5 sub-sets under interventional study design?

A 
Interventional
  >pre-clinical
  >phase 1
  >phase 2
  >phase 3
  >phase 4
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6
Q

What be the study design used if the investigator did not assign exposures?

A

Observational Study

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7
Q

What would the experimental design be if a researcher did assign exposures?

A

Experimental Study

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8
Q

What are the 6 things that study design selection is based on?

A
  • Perspective of Research Question (hypothesis)
  • Ability/Desire to force group allocation (randomization)
  • Ethics of methodology
  • Efficiency & Practicality
  • Costs
  • Validity of acquired information (internal & external)
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9
Q

If the study design of an experiment is an observational study, what would be the 3 types of analytical study design if the author wanted to compare study groups?

A
  1. Cohort Study
  2. Case-Control Study
  3. Cross-Sectional Study
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10
Q

During an observational study when the author is comparing between groups, what type of analytical study is being performed when looking at exposure and outcome at the same time?

A

Cross-Sectional Study

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11
Q

What is the definition of population?

A

All individuals making up a common group; from which a sample (smaller set) can be obtained, if desired.
>not to be confused with the “study population”, which is simply the final group of individuals selected for a study.

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12
Q

What is the definition of sample?

A

A subset or portion of the full, complete population (“representatives”).
>useful when studying the complete population is not feasible
>random processes commonly utilized to draw sample

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13
Q

What are the 4 key principles of bioethics?

A
  1. Autonomy
  2. Beneficence
  3. Justice
  4. Nonmaleficence
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14
Q

What are the 4 sub-sets in human studies that study population selection is based on?

A
  1. Research Hypothesis/Question
  2. Inclusion & Exclusion selection criteria (interventional studies) & Case and Control group OR Exposed and Non-Exposed group selection criteria (observational studies).
    >desired vs. logical vs. plausible selection criteria
    >these absolutely impact generalizability!
    - external validity
  3. Ethics
    >principles of bioethics MUST be met…
    - some don’t agree with use of placebo if a treatment is available
    >recall Null Hypothesis perspectives…
    - superiority
    - noninferiority
    - equivalency
  4. Equipoise - genuine confidence that an intervention may be worthwhile (risk vs. benefit) in order to use it in humans
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15
Q

What is the requirement for a participant in a study to have autonomy?

A

Have self-rule/self-determination. Thus, participants must have full and complete understanding of the risks and benefits, and decide for ones-self, without outside influences.

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16
Q

What must researchers do to comply with nonmaleficence in a human study?

A

Researchers must not:

 - withhold information
 - provide false information
 - exhibit professional incompetence
17
Q

What report is the ethical conduct of research methodology based on?

A

1978; issued by National Commission for Protection of Human Subjects of Biomedical and Behavioral Research

18
Q

What are the 3 guiding principles in ethical conduct of research methodology?

A
  1. respect for persons
    • research should be voluntary, subjects autonomous
  2. beneficence
    • research risks are justified by potential benefits
  3. justice
    • risks and benefits of the research are equally distributed
19
Q

What is the definition of consent and assent?

A

Consent -> 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 -> Agreement to participate, based on being fully and completely informed, given by mentally-capable individuals NOT able to give legal consent (i.e., children and adolescents)
-children or adults not capable of giving consent requires the consent of the parent or legal guardian and the assent of the potential study subject.

20
Q

Who determines what is ethical in conduct of research?

A

Institutional Review Board (IRB)
- sometimes referred to internationally as the “ethics committee”
- IRB’s role is to protect human subjects from undue risk (research not complying with principles of bioethics)
- all human subject studies MUST be reviewed by an IRB prior to study initiation
> observational and interventional studies (all use humans)

21
Q

What agency administers and enforces the regulations of the IRB?

A

Office of Human Research Protections (OHRP)

22
Q

What are the 3 levels of IRB review?

A
  1. Full Board - used for ALL interventional trials with more than minimal/no risk to patients.
    >all medication-related studies
  2. Expedited - minimal risk and/or no patient identifiers
  3. Exempt - no patient identifiers, low/no risk, de-identified dataset analysis, environmental studies, use of existing data/specimens (de-identified)
23
Q

What is the Data Safety & Monitoring Board (DSMB)?

A

Semi-Independent Committee not involved with the conduct of the study but charged with reviewing study data AS STUDY PROGRESSES, to assess for undue risk or benefit.

 - pre-determined review periods (interim analysis)
 - can stop study early, for either overly-positive or overly-negative findings
24
Q

What are the two methodology of human studies?

A

Outcomes

  • patient-oriented best
  • individual vs. combined

Internal Validity
- assessments (measurements)
> scientifically-rigourous and standardized
* objective better than subjective assessments
> valid, accurate and reproducible

Epidemiology -- Zach H. (12 decks)

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