General Methodological Concepts of Research Flashcards

1
Q

What is the most used study design and method? (general)

A

Quantitative

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2
Q

What is a main difference between interventional and observational quantitative studies?

A

interventional is forced allocation to study groups while observational is not forced- it is based on nature.

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3
Q

what study design is considered experimental, clinical study, human study?

A

Interventional

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4
Q

What is an observational study design?

A

Researches observe the subject that are naturally selected to those groups- NO forced allocation to groups

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5
Q

Does an observational study or interventional study “prove” causation?

A

Interventional

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6
Q

What is the foundational basis of the research evidence pyramid?

A

In vitro research and animal research

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7
Q

What is the most useful and appropriate study design?

A

It depends on the research being done, and what they are asking

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8
Q

What is a research question?

A

It is the purpose or statement for the experiment, it helps frame the study intent and can direct how a researcher forms the study

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9
Q

What are a few things that study design and method selection are based on?

A
Perspective of the research question
Ethics of methodology selected
Efficiency and practicality
Costs
Internal validity
External Validity
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10
Q

Differentiate between a population and sample?

A

Population is all of the individuals who make up a common group, while a sample is a smaller portion of the population. Ex: Population is 130 COB students but research is done on 20% of them only.`

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11
Q

What is generalizability?

A

The ability to apply the results of the study to everyone who fits the criteria. External Validity

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12
Q

Describe a null hypothesis.

A

There will be no difference between the two groups being studied. It is the most conservative option and what is trying to be disproved. Reject or fail to reject the null.

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13
Q

What are the three statistical perspectives taken by a researcher in regards to null hypothesis?

A

Superiority
Noninferiority
Equivalency

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14
Q

What is a type one error?

A

False positive- pregnant male

Rejecting null and claiming there is a difference when there truly wasn’t

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15
Q

What is a type two error?

A

False negative- pregnant woman told she is not

failing to reject null when there is a difference

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16
Q

What is the difference between prospective and retrospective studies?

A

the difference is whether or not the outcome is known at the start

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17
Q

Define prospective study?

A

Groups are followed into the future to asses outcomes

Used by ALL interventional studies

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18
Q

What is a retrospective study?

A

outcomes have already occurred, the goal is to assess the past history to associate an exposure, faster than prospective, majority but not all of observational studies.

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19
Q

What are ambidirectional studies?

A

Combination of retro and prospective studies

Uses a retrospective design to look at difference in occurrences but adds future data.

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20
Q

What are probability samples?

A

Everyone in the population has an equal probability of inclusion

21
Q

What is Simple Random Sampling?

A

Assign random numbers to participants and draw to put them into groups. Completely random, flip of the coin chance

22
Q

Stratified Simple Random Sampling?

A

Stratify sampling frame by characteristics such as gender or age and then use simple random sampling

23
Q

What is Multi-Stage Random Sampling?

A

Uses simple random sampling at multiple stages.

Region-City-House/Clinic/Hospital- Individual/occurrence

24
Q

What is Non-Probability Sampling Scheme?

A

Quasi-Systematic or Convenience- NOT completely random or fully probabilistic
Ex: all whose last name is A-M or M-Z, all who attend clinics on MWF, Referred by peers

25
Q

What is a concern with Non Probability Sampling Scheme?

A

There is some type of order to the randomness which could introduce selection bias

26
Q

What is a primary outcome?

A

Key outcome of the study answers the main research question

27
Q

What is a secondary research question?

A

Accidental findings, still important but not the main question. Such as finding out side effects of the main study drug

28
Q

Patient presents with a persistent cough, low O2 saturation, when questioned they inform you they are a 3 pack a day smoker. Smoking is what kind of causal factor in development of lung cancer?

A

Component

29
Q

While attending a conference a speaker states that for every two minutes of sitting a person does it takes one minute off of their life. He presents data that showed 50% increase mortality among the 12 people studied. Which part of hills criteria is iffy?

A

Consistency or plausibility

30
Q

What is one way to achieve high external validity?

A

selecting a large sample

31
Q

A researcher was testing drug X. They note that people who take it have a rash after four weeks, one year into the study they notice acute lung infections due to low WBC’s. What kind of study is this?

A

Tutors say Ambidirectional- I thought Prospective

32
Q

70 high school freshman, 63 sophomores, 34 juniors and 83 seniors are randomly chosen for a study. What kind of sampling is this?

A

Stratified random sampling

33
Q

What is the most important type of outcome?

A

Patient oriented (other choice was disease oriented)

34
Q

What is a downside to combined outcomes?

A

They don’t tell you specifics- did the majority of people suffer a major bleed or did they die?

35
Q

What is internal validity?

A

Methods used inside the study is it reproducible, is it clinically applicable and usable?

36
Q

What is Equipoise?

A

Confidence that an intervention is worth while the benefits out weight the harm

37
Q

What are the four key principles of bioethics?

A
  1. Autonomy: participants must decide themselves no outside influence
  2. Beneficence: benefit the individual (not society)
  3. Justice: fair and equal treatment of every patient
  4. Nonmaleficence: do no harm, dont withold info, provide false info, or be incompetent
38
Q

What is the Belmont Report?

A

Ethical Conduct of research standards. Issued by national commission for protection of human subjects of biomedical behavioral research. It has 3 principles

39
Q

What are the three principles of the Belmont Report?

A

Respect for persons
Beneficence
Justice

40
Q

What is consent vs assent?

A

Consent is agreement to participate- fully informed and of legal age to consent
Assent is agreement to participate based on fully informed- consent is given by capable adults typically in case of kids

41
Q

What does the IRB do?

A

They review studies before they start to determine if they are fit to begin. They protect the interests of the participants.

42
Q

What is CFR?

A

Common Federal Rules- rules developed by the department of health and human services (DHHS) for the IRB to implement

43
Q

Who enforces the CFR’s?

A

OHRP Office of human research protection

44
Q

What are the three differences between the levels of review by the IRB?

A

Number of members who review
Time it takes
Level of documentation needed to be reviewed

45
Q

What type of study uses a full board IRB review?

A

ALL interventional studies with more than minimal risk to patients. Collect a lot of information, drug trials

46
Q

What kind of study uses an expedited level of review?

A

Minimal moderate risk to patient with or without patient identifiers.

47
Q

What kind of study uses exempt level of review?

A

Low no risk no patient identifiers, data without ID, environmental studies, using existing data or specimens

48
Q

What is the DSMB?

A

Data Safety and Monitoring Board. 3rd party who are not involved with conduct of study but review the data as it progresses to determine if they can continue. Can stop if overly positive or negative results

49
Q

What are buzz words for interventional studies?

A

Randomized or phase #