Exam 2 : Lecture General Methodlogical Concepts Of Research

Question 1

What is the most useful and appropriate study design?

Answer 1

It depends on question being asked and the desired perspective

Question 2

Quantitative

Answer 2

Numbers

Question 3

Qualitative

Answer 3

Words (highly, likely, not likely)

Question 4

Quantitative studies can be divided into two groups, what are they?

Answer 4

Interventional

Observational

Question 5

Interventional study design

Answer 5

Forced allocation

Question 6

Observational study design

Answer 6

No forced allocation to study group

Question 7

How is a study design selected?

Answer 7

Based on:
Perspective (hypothesis)
Ability/desire of researcher to force group allocation (randomization)
Ethics of methodology
Efficiency & practicality (time/ resource commitment)
Cost
Validity of acquired info (internal validity)
Application of acquired info to non-study patients (external validity; generalizability)

Question 8

Null hypothesis

Answer 8

Research perspective which state there will be NO (true) difference between the groups being compared

Question 9

Researchers either reject or don’t reject the null hypothesis based on results, T or F

Answer 9

True

Question 10

What hypothesis is the most conservative and commonly utilized?

Answer 10

Null

Question 11

Superiority means

Answer 11

Better than the other

Question 12

Equivalency means

Answer 12

Just as good

Question 13

Noninferiority means

Answer 13

Novel treatment “not worse?”

Good for when we cant use a placebo, so we compare to another known drug

Question 14

Opposite of null hypothesis

Answer 14

Alternative hypothesis

Question 15

Alternative hypothesis

Answer 15

Research prospective which states there WILL be a (true) difference between groups

Question 16

Errors of Accepting or rejecting the null:

Answer 16

Type I

Type II

Question 17

Type I

Answer 17

False positive
Don’t reject the null even though its false
Alpha error

Question 18

Types II

Answer 18

False neg
Reject the null even though its true
Beta error

Question 19

Forced group allocation is what study design?

Answer 19

Interventional

Considered experimental

Question 20

Investigator selects interventions (exposure)

Answer 20

Interventional

Question 21

Researchers observe. NO forced group allocation. What study design is this?

Answer 21

Observational

Natural

Question 22

Most observational study designs are able to prove causation. T or F?

Answer 22

False

They are mostly NOT able to prove causation

Question 23

Interventional phases

Answer 23

Phase 0
Phase 1
Phase 2
Phase 3
Phase 4

Question 24

Observational phases

Answer 24

Case report/series
Ecological
Cross sectional
Case control
Cohort

Question 25

Human studies include these sizes

Answer 25

Population | Sample

Question 26

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

Answer 26

Population

Question 27

Subset or portion of the full, complete population

Answer 27

Sample

Question 28

What are study population selections based on?

Answer 28

``` Research hypothesis Population of interest Group of individuals most useful and applicable to answer the research question Inclusion and exclusion Ethics ```

Question 29

Does inclusion/ exclusion, case/control, and expose/ nonexposed impact generalizability?

Answer 29

Yes | External validity

Question 30

Principles of bioethics MUST be met. T or F

Answer 30

True

Question 31

Equipoise

Answer 31

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

Question 32

4 principles of bioethics?

Answer 32

Autonomy Beneficence Justice Nonmaleficence

Question 33

Self-ruling/ self determining, participants must decide for oneself, without outside influence (no coercion, reprisal, financial manipulation) HAVE TO HAVE FULL & COMPLETE UNDERSTANDING OF RISKS & BENIFITS

Answer 33

Autonomy

Question 34

Benefit, or do good for, the patient, not society

Answer 34

Beneficence

Question 35

Equal and fair treatment regardless of patient characteristics

Answer 35

Justice

Question 36

Do no harm. Researchers must not - with hold info - Provide false info - exhibit professional incompetence

Answer 36

Nonmaleficence

Question 37

Guiding principles that researchers have to be aware of

Answer 37

Belmont report

Question 38

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

Answer 38

Belmont report

Question 39

Belmont report contain 3 principles what are they?

Answer 39

Respect for person Beneficence Justice

Question 40

Research should be voluntary

Answer 40

Respect for person

Question 41

Research risks are justified by potential benifits

Answer 41

Beneficence

Question 42

Risks and benefits of research hare equally distributed

Answer 42

Justice

Question 43

Legally able to give permission

Answer 43

Consent

Question 44

Not legally old enough to agree to a study

Answer 44

Assent

Question 45

Who determines if a study is ethical

Answer 45

Institutional Review Broad (IRB) | Referred to as the ethics committee

Question 46

Only a few human studies must be review by an IRB prior to study initiation. T or F

Answer 46

False. ALL studies have to be reviewed

Question 47

DHHS

Answer 47

Department of health and human services develop ethics laws

Question 48

How is IRB regulated?

Answer 48

Federal statutes

Question 49

Rules are referred to as _________________

Answer 49

Common federal rules

Question 50

OHRP

Answer 50

Office of human research protections | -administers and enforces the regulations

Question 51

Levels of IRB review and differences

Answer 51

Full Expedited Exemp

Question 52

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

Answer 52

Full board

Question 53

Minimal risk and or no patient identifiers

Answer 53

Expedited

Question 54

No patent identifiers, low/no risk, de identified dataset analysis, environmental studies, use of existing data/specimens (de-identified)

Answer 54

Exempt

Question 55

DSMB

Answer 55

Data safety and monitoring board

Question 56

Data safety and monitoring board

Answer 56

Semi-independent committee not involved with the conduct of the study but charged with reviewing study data as study processes, to asses for undue RISK/Benefit between groups

Question 57

Strength of recommendation

Answer 57

A B C

Question 58

Strength of rec: A

Answer 58

Consistent, good quality patient-oriented evidence

Question 59

Strength of Rec: B

Answer 59

Inconsistent or limited quality patient oriented evidence

Question 60

Strength of Rec: C

Answer 60

Consensus, disease-oriented evidence, usual practice, expert opionion, or case series for studies of diagnosis

Question 61

order of CHEST guidelines

Answer 61

``` 1A 1B 1C 2A 2B 2C ```