[2] Class 15: General Methodological Concepts Of Research

Question 1

What does the research evidence pyramid tell us?

Answer 1

The increasing strength of evidence based on design of research

Question 2

What is the most useful and appropriate study design?

Answer 2

It depends

Question 3

Study design uses numbers to represent data

Answer 3

Quantitative

Question 4

Study design uses words to represent data

Answer 4

Qualitative

Question 5

2 forms of quantitative study design

Answer 5

Interventional

Observational

Question 6

Study design forced allocation to study groups

Answer 6

Interventional

Question 7

Study design that does not force allocation to study groups

Answer 7

Observational

Question 8

Study design selection can depend on:

Answer 8

Hypothesis
Force group allocation (randomization?)
Ethics 
Efficiency and practicality
Costs!
Validity of acquired info.-internal
Generalizability=external validity

Question 9

Helps frame study intent and can direct researcher to more effective study design to answer question

Answer 9

“I wonder if..”

Question 10

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

Answer 10

Null hypothesis

Question 11

Statistical perspective that one Tx/exposure is better

Answer 11

Superiority

Question 12

Statistical perspective that tries to prove a Tx/exposure is atleast as good as the other

Answer 12

Noninferiority

Question 13

statistical perspective that one Tx/exposure is equivalent

Answer 13

Equivalency

Question 14

Rejecting the null when you shouldn’t have

Answer 14

Type I error

False positive

Question 15

Not rejecting the null when you should have

Answer 15

Type II error

false negative

Question 16

If there is randomization, what type of study design is being looked at ?

Answer 16

Interventional

Question 17

Study design considered “natural”- subject selected elements
Useful for unethical study designs
No researcher forced group allocation

Answer 17

Observational

Question 18

Can observational study designs prove causation?

Answer 18

Most of the time=NO

Question 19

Interventional study steps increasing evidence:

Answer 19

Pre-clinical [phase 0]
Phase 1
2
3
4

Question 20

Observation study steps increasing evidence:

Answer 20

Case reports/series
Cross-sectional
Ecological
Case-control
Cohort

Question 21

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

Answer 21

Population

Question 22

A subset of the full, complete population

“Representatives”

Answer 22

Sample

Question 23

Study population or sample picked by:

Answer 23

Hypothesis
Population of interest
Most useful group of ppl
Inclusion/exclusion selection criteria [interventional studies]

Case/control or exposed/nonexposed [observational]
Ethics

Question 24

Selection criteria can affect what?

Answer 24

generalizability=

External validity

Question 25

Genuine confidence that an intervention may be worthwhile [risk v. Benefit] in order to use it in humans

Answer 25

Equipoise

Question 26

4 key principles of bioethics:

Answer 26

Nonmaleficence Autonomy Beneficence Justice

Question 27

Self-rule: deciding for oneself w/o outside influence w/ full/complete understanding of risks/benefits

Answer 27

Autonomy

Question 28

To benefit, or do good for, the patient [not society]

Answer 28

Beneficence

Question 29

Equal and fair Tx regardless of patient characteristics

Answer 29

Justice

Question 30

Do no harm. Researchers can't: Withhold info. Provide false info. Exhibit professional incompetence

Answer 30

Nonmaleficence

Question 31

1978 issued by national commission for protection of human subjects of biomedical /behavioral research- summarizes ethical principles and guidelines

Answer 31

Belmont report

Question 32

Belmont report 3 guiding principles:

Answer 32

-Respect for persons- research should be voluntary - Beneficence - Justice

Question 33

Agreement to participate, based on being fully and completely informed- by individual of legal age

Answer 33

Consent

Question 34

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

Answer 34

Assent

Question 35

Who determines if research is ethical?

Answer 35

IRB: Institutional Review Board "ethics committee"

Question 36

Do all human subject studies have to be reviewed by an IRB?

Answer 36

YES!

Question 37

How're IRB regulated?

Answer 37

Federal statutes developed by department of health and human services (DHHS)

Question 38

Who enforces laws/regulations on IRB's?

Answer 38

The office of human research protections (OHRP)

Question 39

Mindset when beginning study w/ regard to null

Answer 39

Mindset is opposite the null...want to set out to prove something, but null says there's no difference

Question 40

What do IRB's look for when reviewing?

Answer 40

``` 4 key principles of bioethics: Autonomy Beneficence Justice Nonmaleficence ```

Question 41

Levels of IRB:

Answer 41

Full board Expedited Exempt

Question 42

Level of IRB: used for ALL interventional trials w/ > minimal risk to patients...ton of documentation:

Answer 42

Full board

Question 43

Level of IRB w/ minimal risk and/or no patient identifiers

Answer 43

Expedited

Question 44

Level of IRB, no patient identifiers, low/no risk, deidentified dataset analysis, environmental studies, use of existing data/specimens [deidentified]

Answer 44

Exempt

Question 45

What is the main differences btw the levels of IRB's:

Answer 45

of members and time for committee review/approval Level of detail to documentation needed for review

Question 46

Who decides the level of IRB?

Answer 46

Data safety and monitoring board (DSMB)

Question 47

Semi-independent committee not involved w/ the conduct of the study but charged w/ reviewing study data as study progresses, to assess for undue risk/benefit btw groups

Answer 47

Data safety and monitoring board (DSMB) -looking out for people in the study.

Question 48

Types of outcomes from a study

Answer 48

Patient-oriented v. Disease oriented Individual v combined outcomes

Question 49

Outcomes that patients view as important

Answer 49

Patient-oriented

Question 50

Can be difficult to discern the outcome if this is used b/c different outcomes can have different rates of occurrence

Answer 50

Combined outcomes

Question 51

Scientifically-rigorous and standardized Objective>subjective Accurate/reproducible/scientifically inside the study

Answer 51

Internal validity

Question 52

What section of the study is most pertinent to internal validity?

Answer 52

Method. Most boring but if the procedure is wrong it is not valid

Question 53

Putting many studies together and making global recommendations from them:

Answer 53

Meta-analyses

Question 54

Similar to a book report on "37" articles

Answer 54

Systematic review