Concepts of research

Question 1

Interventional studies

Answer 1

Study designs considered experimental
Researcher-forced group allocation
Randomization commonly used
Investigator assigns exposures

Question 2

Observational studies

Answer 2

Designs considered natural

Most observational studies not able to prove causation

Question 3

An observational study with no comparison group would be called

Answer 3

Descriptive study

Question 4

Study design selection based on

Answer 4

Perspective of research question/hypothesis
Desire of researcher to force group allocation
Ethics of methodology
Efficiency and practicality
Costs
Validity of acquired information
External validity/generalizability

Question 5

Study population selection based on

Answer 5

Hypothesis
Population of interest
Inclusion & exclusion selection criteria (interventional)
Case&control group or exposed/non exposed group selection criteria (observational)

Question 6

Null hypothesis

Answer 6

A research perspective which states there will be no true difference between the groups being compared

Question 7

Type 1 error

Answer 7

False positive

Question 8

Type 2 error

Answer 8

False negative

Question 9

Probability samples

Answer 9

Every element in the population has a known (non-zero) probability of being included in a sample

Question 10

Simple random sampling

Answer 10

Assign random numbers, then take randomly selected numbers to get sample size or
Assign random numbers, sequentially list numbers and take sample size from top or bottom of list

Question 11

Systematic random sampling

Answer 11

Assign random numbers, randomly sort numbers, select highest or lowest number and then take every Nth number from there

Question 12

Stratified simple random sampling

Answer 12

Stratify sampling frame by desired characteristics (e.g., gender) then use simple random sampling to select sample size

Question 13

Stratified disproportionate random sampling

Answer 13

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

Stratified sample is weighted to return sample population back to baseline

Question 14

Multi-state random sampling

Answer 14

Uses simple random sampling at multiple-stages toward patient selection
Regions/counties
Zip codes
Household
Individuals

Question 15

Cluster multi-stage random sampling

Answer 15

Same as multi-stage but all elements clustered together (at any stage) are selected for inclusion
All clinics in a zip code
All households in a community

Question 16

Quasi-systematic or convenience samples

Answer 16

Decide on what fraction of population is to be sampled and how they will be sampled
All persons with last name M-Z
All persons attending clinic every M/W/F for 6 months

Question 17

Concern of quasi-systematic or convenience samples

Answer 17

There is some known or unknown order to the sample generated by the selected scheme which may introduce selection bias

Question 18

Patient oriented outcomes vs disease oriented

Answer 18

Patient oriented outcomes are most important and useful

Question 19

Internal validity

Answer 19

Methods inside study
Assessments (measurements)
Accurate and reproducible

Question 20

Study population selection based on

Answer 20

Ethics

Equipoise

Question 21

Equipoise

Answer 21

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

Question 22

4 Key principles of bioethics

Answer 22

Autonomy
Beneficence
Justice
Nonmaleficence

Question 23

Autonomy

Answer 23

Participants must decide for ones-self, without outside influences- No coercion, financial manipulation
Patients must have full and complete understanding of the risks and benefits

Question 24

Beneficence

Answer 24

To benefit, or do good for, the patient (not society)

Question 25

Justice

Answer 25

Equal and fair treatment regardless of patient characteristics

Question 26

Nonmaleficence

Answer 26

Do no harm, researchers must not withhold info, provide false info

Question 27

Belmont report 3 guiding principles

Answer 27

Respect for persons
Beneficence
Justice

Question 28

Consent

Answer 28

Agreement to participate given by mentally capable individuals of legal consenting age

Question 29

Assent

Answer 29

Agreement to participate given by mentally capable individuals NOT of legal consenting age. Must have parental/guardian consent as well

Question 30

Ethical conduct of studies determined by

Answer 30

Institutional review board or ethics committee

Question 31

IRBs role

Answer 31

Protect human subjects from undue risk

All human subjects studies must be reviewed by IRB prior to study initiation

Question 32

Office of human research protections

Answer 32

Agency that administers and enforces the regulations of IRB