Methodology & Study Design

Question 1

2 categories of general study design

Answer 1

qualitative

quanitative

Question 2

2 categories of numerical studies

Answer 2

quantitative studies

interventional or observational

Question 3

random or forced allocation to study groups

Answer 3

interventional study

Question 4

no random or forced allocation to study groups

Answer 4

observational study

Question 5

types of experimental studies

Answer 5

pre-clinical/animal studies

phase 0 - 4

Question 6

in general observational studies cannot ______ ?

Answer 6

prove causality

interventional can

Question 7

types of observational studies in order of increasing evidence

Answer 7

case report/series
ecological
cross-sectional
case-control
cohort

Question 8

what is the most useful and appropriate study design?

Answer 8

it depends

the best study design is the one that best answers the primary question of the research hypothesis

Question 9

what criteria are considered when choosing study design? (7)

Answer 9

perspective of hypothesis
ability to randomize
ethics
practicality/efficiency
cost
validity of data
applicability (generalizability)

Question 10

population vs. study population

Answer 10

study population = sample size

Question 11

3 perspectives taken by the null hypothesis

Answer 11

superiority
noninferiority
equalness

Question 12

types of sampling schemes

Answer 12

probability samples

non-probability sampling

Question 13

types of probability sampling (6)

Answer 13

simple random sampling
systematic rs
stratified simple rs
stratified disproportionate rs
multistage rs
cluster multistage rs

Question 14

type of non-probability sampling

Answer 14

quasi systematic or convenience sampling

Question 15

random number generator use

Answer 15

simple random sampling

Question 16

sampling by choosing every 5th number given by a random number generator

Answer 16

systematic random sampling

Question 17

sampling that stratifies by desired characteristics then uses a random number generator

Answer 17

stratified simple random sampling

Question 18

use of stratified simple random sampling on a population that does not have the desired proportional percentages

Answer 18

stratified disproportionate random sampling

weighted sampling

Question 19

simple random sampling at multiple stages

Answer 19

multi-stage random sampling

Question 20

simple random sampling at multiple stages within a cluster of the desired element

Answer 20

cluster multi-stage random sampling

Question 21

some known or unknown order to the sampling which can introduce bias

Answer 21

quasi systematic sampling also called convenience sampling

Question 22

what does external validity represent?

Answer 22

the ability to generalize the findings to the population

Question 23

define equipoise

Answer 23

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

confidence that the benefits outweigh the risks

Question 24

what is the difference between consent and assent?

Answer 24

consent you can give yourself

assent is given by a legal guardian

in both ways you must be mentally capable of knowing what you are being enrolled in

Question 25

what must be met in order for a study to begin? what subject does this represent?

Answer 25

principles of bioethics ethics

Question 26

principles of bioethics

Answer 26

autonomy beneficence justice Nonmaleficence

Question 27

define autonomy principle of bioethics

Answer 27

participants must be able to decide for themselves and must be able to understand the risks and benefits w/o influence, coercion, financial manipulation, etc.

Question 28

define beneficence principle of bioethics

Answer 28

the intervention must be to improve the individual not society

Question 29

define justice principle of bioethics

Answer 29

equal and fair treatment regardless of patient characteristics ex. gender, age, race, etc.

Question 30

define Nonmaleficence principle of bioethics

Answer 30

do no harm

Question 31

3 things the researcher must not do.....according to the Nonmaleficence principle of bioethics

Answer 31

withhold info from patient provide false info to patient exhibit professional incompetence

Question 32

issuing of the Belmont report

Answer 32

1978 | issued by the national commission for protection of human subjects of biomedical and behavioral research

Question 33

the Belmont report

Answer 33

3 guiding principles of research methods 1. respect for persons 2. beneficence 3. justice

Question 34

Belmont - respect for persons

Answer 34

research is voluntary and subjects can be anonymous

Question 35

beneficence - Belmont report

Answer 35

the potential benefits outweigh the risks

Question 36

justice - Belmont report

Answer 36

risks and benefits are equally distributed

Question 37

who determines if a study is ethical?

Answer 37

IRB | also called ethics committee

Question 38

what does IRB stand for?

Answer 38

institutional review board

Question 39

what is IRB's goal?

Answer 39

to protect the subject

Question 40

what are levels of IRB review?

Answer 40

1. exempt 2. expedited 3. full board

Question 41

key concepts of exempt level

Answer 41

use of existing data no personal identifiers virtually no risk

Question 42

key concepts of expedited level

Answer 42

very low risk no invasive interventions no personal identifiers

Question 43

key concepts of full board level

Answer 43

used for all interventional studies higher than minimal risk entire board reviews methods

Question 44

who enforces the rulings of the IRB?

Answer 44

OHRP

Question 45

what does OHRP stand for?

Answer 45

office of human research protections

Question 46

who monitors that study during it's conductance?

Answer 46

DSMB

Question 47

what does DSMB stand for?

Answer 47

data safety and monitoring board

Question 48

role of DSMB

Answer 48

not involved in study conduct just review data as it comes it to make sure it complies with ethical principles harm of the study can be positive or negative

Question 49

what are the two types of harm that DSMB can use to shut down a study?

Answer 49

positive ---- the benefits are so good that it is unethical to not allow the placebo group to have access to it negative ---- the consequences are so great that it is unethical to continue putting the subjects at risk