General Methodological Concepts of Research

Question 1

What is justice?

Answer 1

equal and fair treatment regardless of patient characteristics

Question 2

Study population selection is based on what?

Answer 2

ethics

equipoise

Question 3

What is systematic random sampling?

Answer 3

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

Question 4

What are interventional study designs?

Answer 4

studies considered experimental

investigator select interventions (exposure)

Question 5

What is a full board review?

Answer 5

used for all interventional trials with more than minimal risk to patients

Question 6

What is a sample?

Answer 6

a subset or portion of the full, complete population

Question 7

What is consent?

Answer 7

agreement to participate, based on being fully and completely informed (given by mentally capable individuals of legal consenting age)

Question 8

What is stratified simple random sampling?

Answer 8

stratify sampling frame by desired characteristics, then use simple random sampling to select desired sample size

Question 9

Ethical determination performed by ________

Answer 9

Institutional review board (ethics committee)

Question 10

What is the example of non probability sampling schemes?

Answer 10

quasi systematic or convenience sample

Question 11

What are most observational study designs not able to prove?

Answer 11

causation

Question 12

What is stratified disproportionate random sampling?

Answer 12

disproportionally utilizes stratified simple random sampling when baseline population is not as the desired proportionals percentages to the referent population

Question 13

What is an expedited review?

Answer 13

minimal risk and/or no patient identifiers

Question 14

What is quasi systematic or convenience sample?

Answer 14

decide on what fraction of population is to be sampled and how they will be sampled

Question 15

What is study population selection based on?

Answer 15

research hypothesis/question

population of interest

Question 16

What is nonmaleficence?

Answer 16

do no harm

Researcher must not: withhold info, provide false info, exhibit professional incompetence.

Question 17

What is assent?

Answer 17

agreement to participate, based on being fully and completely informed, given by mentally capable individuals not able to give legal consent (children)

Question 18

What is the data safety and monitoring board?

Answer 18

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/benefit between groups

Question 19

What are observational study designs?

Answer 19

study designs considered natural

researchers observe subject elements occurring naturally or selected by individual

Question 20

What is multi stage random sampling?

Answer 20

uses simple random sampling at multiple stages towards patient selection

Question 21

What are examples of a probability sampling scheme?

Answer 21

simple random sampling
systematic random sampling 
stratified simple random sampling
stratified disproportionate random sampling 
multi stage random sampling 
cluster multi stage random sampling

Question 22

What is a population?

Answer 22

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

Question 23

What is IRB’s role?

Answer 23

protect human subjects from undue risk

Question 24

What is autonomy?

Answer 24

self rule/self determination

the participant must decide for ones self and have full and complete understanding of the risks and benefits

Question 25

What is a probability sample?

Answer 25

(most common) | every element in the population has a known (non-zero) probability of being included in sample

Question 26

What is simple random sampling?

Answer 26

assign 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 of listed numbers

Question 27

What is a null hypothesis?

Answer 27

a research perspective which state there will be no (true) difference between the groups being compared

Question 28

In what study design are there researcher forced group allocation?

Answer 28

interventional

Question 29

What are study design selection based on?

Answer 29

``` hypothesis randomization ethics of methodology time/resource commitment costs internal validity external validity; generalizability ```

Question 30

What is the office of human research protections?

Answer 30

agency that administers and enforces the regulations

Question 31

What is internal validity?

Answer 31

methods inside the study | --assessments

Question 32

What are the four key principles of bioethics?

Answer 32

autonomy beneficence justice nonmaleficence

Question 33

What are the three levels of IRB review?

Answer 33

full board expedited exempt

Question 34

What are main differences between 3 levels of review?

Answer 34

number of members and time for committee review/approval | level of detail to documentation needed for review

Question 35

What is an exempt review?

Answer 35

no patient identifiers, environmental studies, use of existing data/specimens

Question 36

What is equipoise?

Answer 36

genuine confidence that an intervention may be worthwhile in order to use it in humans

Question 37

What is beneficence?

Answer 37

to benefit, or do good for, the patient

Question 38

What guiding principles does the Belmont report contain?

Answer 38

respect for persons beneficence justice

Question 39

What is cluster multi stage random sampling?

Answer 39

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