Exam 2 : Lecture General Methodlogical Concepts Of Research Flashcards
What is the most useful and appropriate study design?
It depends on question being asked and the desired perspective
Quantitative
Numbers
Qualitative
Words (highly, likely, not likely)
Quantitative studies can be divided into two groups, what are they?
Interventional
Observational
Interventional study design
Forced allocation
Observational study design
No forced allocation to study group
How is a study design selected?
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)
Null hypothesis
Research perspective which state there will be NO (true) difference between the groups being compared
Researchers either reject or don’t reject the null hypothesis based on results, T or F
True
What hypothesis is the most conservative and commonly utilized?
Null
Superiority means
Better than the other
Equivalency means
Just as good
Noninferiority means
Novel treatment “not worse?”
Good for when we cant use a placebo, so we compare to another known drug
Opposite of null hypothesis
Alternative hypothesis
Alternative hypothesis
Research prospective which states there WILL be a (true) difference between groups
Errors of Accepting or rejecting the null:
Type I
Type II
Type I
False positive
Don’t reject the null even though its false
Alpha error
Types II
False neg
Reject the null even though its true
Beta error
Forced group allocation is what study design?
Interventional
Considered experimental
Investigator selects interventions (exposure)
Interventional
Researchers observe. NO forced group allocation. What study design is this?
Observational
Natural
Most observational study designs are able to prove causation. T or F?
False
They are mostly NOT able to prove causation
Interventional phases
Phase 0 Phase 1 Phase 2 Phase 3 Phase 4
Observational phases
Case report/series Ecological Cross sectional Case control Cohort
Human studies include these sizes
Population
Sample
All individuals making up a common group; from which a sample can be obtains if desired
Population
Subset or portion of the full, complete population
Sample
What are study population selections based on?
Research hypothesis Population of interest Group of individuals most useful and applicable to answer the research question Inclusion and exclusion Ethics
Does inclusion/ exclusion, case/control, and expose/ nonexposed impact generalizability?
Yes
External validity
Principles of bioethics MUST be met. T or F
True
Equipoise
Genuine confidence that an intervention may be worthwhile (risk vs benefits) in order to use it in humans
4 principles of bioethics?
Autonomy
Beneficence
Justice
Nonmaleficence
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
Autonomy
Benefit, or do good for, the patient, not society
Beneficence
Equal and fair treatment regardless of patient characteristics
Justice
Do no harm. Researchers must not
- with hold info
- Provide false info
- exhibit professional incompetence
Nonmaleficence
Guiding principles that researchers have to be aware of
Belmont report
1978, issued by national commission for protection of human subjects of biomedical and behavioral research
Belmont report
Belmont report contain 3 principles what are they?
Respect for person
Beneficence
Justice
Research should be voluntary
Respect for person
Research risks are justified by potential benifits
Beneficence
Risks and benefits of research hare equally distributed
Justice
Legally able to give permission
Consent
Not legally old enough to agree to a study
Assent
Who determines if a study is ethical
Institutional Review Broad (IRB)
Referred to as the ethics committee
Only a few human studies must be review by an IRB prior to study initiation. T or F
False. ALL studies have to be reviewed
DHHS
Department of health and human services develop ethics laws
How is IRB regulated?
Federal statutes
Rules are referred to as _________________
Common federal rules
OHRP
Office of human research protections
-administers and enforces the regulations
Levels of IRB review and differences
Full
Expedited
Exemp
Used for ALL interventions trials with more than minimal risk to patients
Full board
Minimal risk and or no patient identifiers
Expedited
No patent identifiers, low/no risk, de identified dataset analysis, environmental studies, use of existing data/specimens (de-identified)
Exempt
DSMB
Data safety and monitoring board
Data safety and monitoring board
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
Strength of recommendation
A
B
C
Strength of rec: A
Consistent, good quality patient-oriented evidence
Strength of Rec: B
Inconsistent or limited quality patient oriented evidence
Strength of Rec: C
Consensus, disease-oriented evidence, usual practice, expert opionion, or case series for studies of diagnosis
order of CHEST guidelines
1A 1B 1C 2A 2B 2C
