Concepts Of Research

Question 1

Numbers are used to represent data in what study design?

Answer 1

Quantitative

Question 2

Qualitative study design are represented by what?

Answer 2

Words

Question 3

What are the two subsets of quantitative study design?

Answer 3

Interventional and Observational

Question 4

Forced allocations on study groups is what study design and methodology

Answer 4

Interventional

Question 5

No forced allocation to study groups describe which study design?

Answer 5

Observational

Question 6

Investigator-selects interventions (exposures) in which study design?

Answer 6

Interventional - considered experimental

Question 7

Researchers observe subject-elements occurring naturally or selected by individual — considered natural

Answer 7

Observational

Question 8

Useful for unethical study designs using forced interventions

Answer 8

Observational

Question 9

Most observational studies are not able to prove what?

Answer 9

Causation

Question 10

This helps frame study intent and can direct researcher to selecting and developing an effective study design to answer question

Answer 10

Research Question: (I wonder if… statement)

Question 11

Study design can be selected based on? (7 things)

Answer 11

• Perspective of research question (hypothesis)
• Ability/Desire of researcher to force group allocation (randomization)
• Ethics of methodology
• Efficiency & Practicality
• Costs
• Internal Validity
• External validity;generalizability

Question 12

Difference between population and sample in human studies?

Answer 12

Population is the total

Sample is a portion of the full, complete population

Question 13

Study population selection is based on?

Answer 13

Research Hypothesis
Population of Interest
Inclusion & Exclusion selection criteria (interventional studies)
Case & Control group or Exposed & Non-exposed group selection criteria (Observational studies)
Desired vs. Logical vs. Plausible selection criteria
(Note: these impact generalizability (external validity))

Question 14

A research perspective which states there will be no true difference between the groups being compared is a description of what?

Answer 14

Null Hypothesis

Question 15

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

Answer 15

Superiority
Noninferiority
Equivalency

Question 16

Ho is I am not superior

Answer 16

Superiority

Question 17

Ho is I am worse

Answer 17

noninferiority

Question 18

Ho is I am not equal

Answer 18

Equivalency

Question 19

What is a probability sample?

Answer 19

Every element in the population has a known probability of being included in sample

Question 20

What is simple random sampling?

Answer 20

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

Question 21

Systematic Random sampling

Answer 21

Assign random numbers, sort, select highest or lowest number, then systematically take every Nth number.

Question 22

What is Stratified Simple Random Sampling?

Answer 22

Stratify sampling frame by characteristic, then use simple random sampling

Question 23

What is stratified disproportionate random sampling

Answer 23

Disproportionately utilizes stratified simple random sampling when baseline population is not at desired proportional percentages to the referent population

Question 24

Multi-Stage Random Sampling

Answer 24

Uses simple random sampling at multiple-stages towards patient selection.

Question 25

Cluster Multi-Stage Random sampling

Answer 25

Same as Multi-stage random sampling but all elements clustered together are selected for inclusion IE all clinics in a zip-code.

Question 26

Non-probability sampling scheme?

Answer 26

Quasi-systematic or Convenience samples

Question 27

What are Quasi-systematic samples

Answer 27

Decide on what fraction of population is to be sampled and how they will be sampled. IE all persons whose last name begins with M-Z There can be selection bias

Question 28

Which outcomes are most important?

Answer 28

Patient-oriented vs Disease oriented | Individual vs combined

Question 29

What is Internal Validity

Answer 29

Inside the study, assessments (measurements) that were tested scientifically-rigorous and standardized.

Question 30

What is Equipoise?

Answer 30

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

Question 31

What are the four key principles of bioethics?

Answer 31

Autonomy Beneficence Justice Nonmaleficience

Question 32

What is autonomy?

Answer 32

Self-rule

Question 33

What is beneficence?

Answer 33

To benefit the patient

Question 34

What is justice?

Answer 34

Equal and Fair treatment no matter what

Question 35

What is nonmaleficence?

Answer 35

Do no harm

Question 36

What is the Belmont report?

Answer 36

``` issued by National Commission for protection of Human Subjects of Biomedical and Behavioral Research. 1978 Contains 3 guiding principles Respect for persons Beneficence Justice ```

Question 37

What is consent?

Answer 37

Agreement to participate, based on being fully and completely informed and of legal consenting age.

Question 38

What is Assent?

Answer 38

Agreement to participate, based on being fully and completely informed, given by mentally-capable individuals not able to give legal consent

Question 39

Ethical Determination performed By?

Answer 39

Institutional Review Board (IRB) AKA ethics committe

Question 40

What is the IRB's role?

Answer 40

Protect human subjects

Question 41

What must all human subject studies undergo prior to study initiation?

Answer 41

Reviewal by the IRB

Question 42

Who administers and enforces IRB regulation?

Answer 42

Office of Human Research Protections (OHRP)

Question 43

What are the three levels of IRB review?

Answer 43

Full board- more than minimal risk to pt Expedited - minimal risk to pt Exempt - no risk and no identifiers

Question 44

This independent group reviews the study as it progresses to continue assessing risk?

Answer 44

DSMB - Data safety and monitoring board.