2.1 General Methodological Concepts of Research Flashcards
What does Quantitative mean?
Numbers used to represent data
What does Qualitative mean?
Words used to Represent data
What are the two categories that researches study design and methodology can go into?
Interventional and Observational
Pertaining to Interventional and observational, which has forced allocation?
Interventional has forced allocation
What is the definition of interventional study designs?
These are considered experimental. Researchers select interventions (exposure). Forced group allocation.
How is forced group allocation done in interventional studies?
Randomization processes
What is the definition of observation study designs?
Natural. Researchers observe.
What is one thing obsercational study designs are not able to prove?
Causation
What are the 5 interventional study designs from least evidence to most evidence?
Phase 0. Phase 1. Phase 2. Phase 3. Phase 4.
What are the 3 observational study designs from least evidence to most evidence?
Cross-sectional. Case-control. Cohort.
Pertaining to the research pyramid, what are the 12 studies from least evidence to most evidence?
In vitro (test tube), Animal, Case reports, Case series, Ecological, Cross-sectional, Case-control, Cohort, Interventional (exploratory trials) and pragmatic (explanatory) trials, Systematic reviews and meta-analyses.
What is the most useful and appropriate study design?
It depends
What does population mean pertaining to human studies?
All individuals making up a common group, from which a sample can be obtained.
What is sample pertaining to human studies?
A subset or portion of the full, complete population.
What does the Null hypothesis state?
States there will be no true difference between the groups being compared.
What does Superiority mean pertaining to the Null hypothesis?
Im not superior
What does Noninferiority mean pertaining to the Null hypothesis?
Im worse.
What does Equivalency mean pertaining to the Null hypothesis?
Im not equal
What does the alternative hypothesis state?
There will be a true difference between the groups being compared.
What happens if the null hypothesis is rejected?
Alternative hypothesis
What are prospective studies?
Groups followed into future to assess for outcomes of interest (yet to occur at start) and then groups are compared
What studies use prospective?
Interventional studies and some observational
What are restrospective studies?
At the start of the study, outcomes of interest have already occured with goal of assessing past history of some activity (exposure/ treatment).
What are ambidirectional studies?
Uses both retro and prospective
What does probability samples mean?
Every element in the population has a known probability of being included in sample
What are 3 probability sampling schemes?
Simple random, stratified simple random, Muti-stage
What is simple random sampling?
Most common. Like flipping a coin, random generator, everyone gets an equal prob. Assign random #s, then take RANDOMLY-selected #’s to get desired sample size or assign random #’s, then sequentially-list #’s and take desired sample size from top of listed numbers
What is stratified simple random sampling?
Sometimes we want a particular group is represented. Like old n young. Stratified is still simple, still random sample but now we are going to stratify it by that particular group and make sure there is equal number of strata of this in our groups
What is Multi-stage random sampling?
simple random sampling several times in a row. Like in the citites or random zip codes in the cities, or hospitals within that and lets go in there and lets generate a random selection on those
What is equipoise?
Genuine confidence that an intervention may be worthwhile in order to use it in humans
What two things is the study population selection based on?
Ethics and equipoise
What are the 4 key principles of bioethics?
Autonomy, Beneficence, Justice, and Nonmaleficence
What is autonomy?
Pts must decide for ones-self, without influence, have a complete understanding of the risks and benefits.
What is beneficence?
To benefit the pt not society
What is justice?
Equal and fair treatment
What is Nonmaleficence?
Do No harm, researches must not withhold info, provide false info.
What is the Belmont Report?
1978 issued by national commission for protection of human subjects
What are the 3 principles in the Belmont Report?
Respect for persons, beneficence, and justice.
What is consent vs assent?
Consent is aggreement to participate for the above 18, Assent is agreement to participate below 18.
Who gets to decide if research is ethical or not?
IRB
What is the primary goal of the IRB?
Wellness of the pts.
True or False? All human subjects must be reviewed by an IRB BEFORE study.
True
IRBs are regulated by federal statutes developed by who?
the DHHS.
What agency administers and enforces the regulations of IRB?
OHRP.
What are the 3 levels of IRB review?
Full board, Expedited and exempt
When is Full board used?
More than minimal risk to pts. Drawing blood, CT scans, medications.
When is Expedited used?
Minimal risk to pts, no pt identifiers. Asking pts questions.
When is Exempt used?
Lowest risk, just data in records.
Once the study has started who gets involved to make sure everything is going well?
DSMB
What does IRB stand for?
Institutional Review Board
What does DSMB stand for?
Data Safety and Monitoring Board.
What does DHHS stand for?
Department of Health and Human Services
What does OHRP stand for?
Office of Human Research Protections.
