General Methodological Concepts of Research (Lecture 1)

Question 1

Quantitative

Answer 1

Numbers used to represent data (pain scale)

Question 2

Qualitative

Answer 2

Words used to represent data (word cloud)

Question 3

Types of Quantitative Study Designs

Answer 3

Interventional and Observational

Question 4

Interventional Study Design

Answer 4

Considered experimental; investigator selects exposure; there IS researcher-forced group allocation

Question 5

Observational Study Design

Answer 5

Considered natural; researchers “observe” subject-elements occurring naturally or selected by individual (naturally or freely); usually not able to prove causation and there is NO researcher-forced allocation

Question 6

Research Question

Answer 6

An “I wonder if…” statement; helps frame study intent and can direct researcher to selecting and developing an effective study design to answer question

Question 7

Population

Answer 7

All individuals making up a common group from which a sample can be obtained if desired

Question 8

Sample

Answer 8

A subset or portion of the full, complete population; useful when studying the complete population is not feasible; random processes commonly utilized to draw sample

Question 9

Null Hypothesis (Ho)

Answer 9

A research perspective which states there will be no true difference between the groups being compared; most conservative and commonly utilized; researchers either reject or don’t reject this perspective based on data or results

Question 10

Superiority Study

Answer 10

Better than the alternative or comparison group

Question 11

Noninferiority Study

Answer 11

At least not worse than alternative or comparison group

Question 12

Equivalency

Answer 12

Equal to alternative or comparison group

Question 13

Alternative Hypothesis (H1)

Answer 13

A research perspective which states there will be a true difference between the groups being compared

Question 14

Probability Samples

Answer 14

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

Question 15

Simple Random Sampling

Answer 15

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 or bottom of listed numbers

Question 16

Systematic Random Sampling

Answer 16

Assign random numbers, then randomly sort these random numbers, then select highest or lowest number, then systematically, by a pre-determined sampling-interval take every Nth numbers to get desired sample size

Question 17

Stratified Simple Random Sampling

Answer 17

Stratify sampling frame by desired characteristic, such as gender or age, then use simple random sampling to select desired sample size

Question 18

Stratified Disproportionate Random Sampling

Answer 18

Disproportionately utilizes stratified simple random sampling when baseline population is not at the desired proportional percentages to the referent population; stratified sample weighted to return sample population back to baseline population; useful for over-sampling

Question 19

Multi-Stage Random Sampling

Answer 19

Uses simple random sampling at multiple stages towards patient selection; multiple rounds of random sampling

Question 20

Cluster Multi-Stage Random Sampling

Answer 20

Same as multi-stage random sampling but ALL elements clustered together (at any stage) are selected for inclusion

Question 21

Non-Probability Sampling Schemes

Answer 21

Quasi-systematic or convenience samples; not really, completely random or fully probabilistic; decide on what fraction of population is to be sampled and how they will be sampled

Question 22

Internal Validity

Answer 22

“Inside” the study; assessments, measurements; objective rather than subjective assessments; scientifically accurate and reproducible

Question 23

Equipoise

Answer 23

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

Question 24

Autonomy

Answer 24

self-rule/self-determination; participants must decide for ones self, without outside influences and have full and complete understanding of the risks and benefits

Question 25

Beneficence

Answer 25

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

Question 26

Justice

Answer 26

Equal and fair treatment regardless of patient characteristics

Question 27

Nonmaleficence

Answer 27

Do no harm; researchers must not withhold information, provide false information, or exhibit professional incompetence

Question 28

Belmont Report

Answer 28

Issued by National Commission for Protection of Human Subjects of Biomedical and Behavioral Research in 1978; contains 3 guiding principles; respect for persons, beneficence, and justice

Question 29

Consent

Answer 29

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

Question 30

Assent

Answer 30

Agreement to participate, based on being fully and completely informed, given by mentally capable individuals NOT able to give legal consent (children, adolescents); consent has to be given by parent or legal guardian and actual participants must give assent

Question 31

Institutional Review Board (IRB)

Answer 31

Determines if research is ethical and safe; protects the potential participants from undue risks; all human subject studies must be reviewed by an IRB prior to study initiation

Question 32

Full Board

Answer 32

Used for ALL interventional trials with more than minimal risk to patients

Question 33

Expedited

Answer 33

Minimal risk and/or no patient identifiers

Question 34

Exempt

Answer 34

No patient identifiers, low/no risk, deidentified dataset analysis, environmental studies, use of existing data/specimens

Question 35

Data Safety and Monitoring Board (DSMB)

Answer 35

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