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D.Kurry Epidemiology KCUMB > General Methodological concepts of Research > Flashcards

General Methodological concepts of Research Flashcards

1
Q

What is the dfference b.w quantitative and qualitative?

A

Quanitative use numbers to represent data (age, pain scales like 1- 10 ect)

Qualiltative uses words to represent data ( open ended commentary groups, and ect. )

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2
Q

What is the difference b/w interventional and observational study designs?

A

Interventional is RESEARCH FORCED allocation into groups

observational is NON FORCED allocation into groups

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3
Q

As interventional studies move from phase 0 to phase 4, what is trend of classification?

A

its based on increasing evidence so phase 0 whould be the least and phase 4 would be the most

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4
Q

What is a population and sample (study subjects) ?

A

Populaton are all individuals making up a common group from which a sample can be obtained if desired

Sample is a subset portion of the full or complete population

Ex: all diabetics in the US is a population however a smaller subset of chunk of that group would be a sample

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5
Q

What does exclusiion and inclusion criteria impact?

A

It affects generalizablity also known as external validity

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6
Q

What is a null hypothesis ?

A

A research POV that states that there will be NO ( true) differnce b/w groups being compared

most common and conservative

Alternative hypothesis is the opposite: POV states that there will be (true) differenceb/w groups being compared

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7
Q

What are the various stastical perspectives of the researcher?

A

Superiority

noninferiority

Equivalency

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8
Q

What is the question asked and null hypothesis of superiority, noninferiority, and equivalency POV of researchers?

A

Superiority

  • Question asked: I wonder if i am superior
  • Null : I will NOT be superior to ________ (placebo)

Inferioirity

  • Question asked: I wonder if I am not worse
  • Null : I am NOT noninferior to ________

Equivelency

  • Question asked: I wonder if I am equal
  • Null : I am NOT equal to ______
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9
Q

What is probability sampling and its different types?

A

Every element in population has a known nonzero probability of being included in a sample . “equal oppourtunity “ “denominator = sample size”

  1. simple random sampling
  2. systematic random sampling
  3. stratified simple random sampling
  4. stratfied disproportionate random sampling
  5. multi stage random sampling
  6. cluster-multistage random sampling
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10
Q

What is simple random sampling?

A
  • completely random process reSulting equal chance

slides

  • assigning random numbers
    • taking randomly selected numbers to get sample size
    • 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

take every nth number (predetermined number) until sample size reached

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12
Q

what is stratIfied simple random sampling?

A

simple sampling based on random selection within each strata desired

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13
Q

what is stratified disproportionate random sampling?

A

IS used when your current sample is not representative of your baseline population. use of weighted stratified sample to return population back to a repersentative sample

Ex: your sample doesnt include asians or not many, you would give wieght to the ones you have or introduce that strata into the sample

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14
Q

What is multi stage random sampling?

A

use of multiple simpler random sampling at multiple stages toward patient selection

ex: City, to zip codes, to communities (randomized at each strata)

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15
Q

What is cluster multi-stage random sampling?

A

B/C hospitals, doctor offices, and ect clustered together w/ in regions sampling will be focused more at that area.

same as multi stage random sampling but all elements are clustered together at any stage are selected for inclusion

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16
Q

What is an example of non probability sampling scheme and what is it?

A

Quasi-systematic or convience samples decided on what fraction of population to be sampled and how they will it will occur.

INTRODUCES SELECTION BIASSSSSSS

ex: only persons with last name begins w/ M - Z

17
Q

review this not that imporant but could be

18
Q

What is Equipoise?

A

A genuine confidence that an intervention may be worthwhile (risk vs benefit) in order to use it in humans

19
Q

What are the four key principles of bioethics?

A

Autonomy

beneficence

justice

nonmaleficence

20
Q

what does autonomy mean?

A

Decide for ones self, without outside influences

Have full and complete understanding of the risks benefits

21
Q

What is beneficence?

A

To benefit, or do good for, the patient

22
Q

What is justice?

A

Equal and fair treatment refardless of patient characteristics

23
Q

What is non maleficence?

A

Do no harm. researches must not withhold info, provide false info, or exhibit professional incompetence

24
Q

What is the belmont report??

A

3 guiding principles

Respect for persons - research should be voluntary, subjects autonomous

beneficence - research risks are justified by its benefits

Justice - risks and benefits of research are equally distributed

1978 issued by national commission for protection of human subjects of biomedical and behavior research

25
Q

What is the difference between consent and assent?

A

consent is the agreement to particpate, based on being fully and completely informed (above 18 in most states)

Assent is the agreement to particpate based on being fully and complete informed by a mentally capable people or indivduals. refers a person who is not able to make descision ( age or mental state)

26
Q

What is the IRB?

A
  • Institutional Review Board.
    • protect human subjects.
    • all studies are review by them must fall under the four keys of bioethics/
27
Q

What is the OHRP?

A
  • The office of human research and protections.
    • Administers and enforces the regulations on research
28
Q

What are the levels of IRB review

(STEM QUESTION ON TEST KNOW THIS IN AND OUT AND APPLY IT)

A
  • FULL BOARD
    • all intervential trials with more than minimal risk (Drugs, blood lvls, advance interventions)
  • EXPEDIATED
    • In b/w the extremes asking questions
      • mental trauma due to surveys
      • blood pressure
      • USUALLY INVOLVES PEOPLE DIRECTLY. THIS SETS IT APART FROM EXEMPT
  • EXEMPT
    • no PT identifiers
    • low risk
    • E;x:survey, personal info, environmental, use of data of thats already collected
29
Q

What is the Data safety and monitoring board?

A

they can intervene after the study is started and shut it down if one side recieved to much benefit or harm

one example: is a cancer trial where the people given the drug are recieving far better and healther effects compared to placebo. in this case it is UNETHICAL to let the other or placebo group suffer

D.Kurry Epidemiology KCUMB (14 decks)

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