General Methodological Concepts of Research Flashcards
What is justice?
equal and fair treatment regardless of patient characteristics
Study population selection is based on what?
ethics
equipoise
What is systematic random sampling?
assign random numbers, then randomly sort these random numbers, then select highest (or lowest) number, then systemically, by a pre determined sampling interval take every Nth numbers to get desired sample size
What are interventional study designs?
studies considered experimental
investigator select interventions (exposure)
What is a full board review?
used for all interventional trials with more than minimal risk to patients
What is a sample?
a subset or portion of the full, complete population
What is consent?
agreement to participate, based on being fully and completely informed (given by mentally capable individuals of legal consenting age)
What is stratified simple random sampling?
stratify sampling frame by desired characteristics, then use simple random sampling to select desired sample size
Ethical determination performed by ________
Institutional review board (ethics committee)
What is the example of non probability sampling schemes?
quasi systematic or convenience sample
What are most observational study designs not able to prove?
causation
What is stratified disproportionate random sampling?
disproportionally utilizes stratified simple random sampling when baseline population is not as the desired proportionals percentages to the referent population
What is an expedited review?
minimal risk and/or no patient identifiers
What is quasi systematic or convenience sample?
decide on what fraction of population is to be sampled and how they will be sampled
What is study population selection based on?
research hypothesis/question
population of interest
What is nonmaleficence?
do no harm
Researcher must not: withhold info, provide false info, exhibit professional incompetence.
What is assent?
agreement to participate, based on being fully and completely informed, given by mentally capable individuals not able to give legal consent (children)
What is the data safety and monitoring board?
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
What are observational study designs?
study designs considered natural
researchers observe subject elements occurring naturally or selected by individual
What is multi stage random sampling?
uses simple random sampling at multiple stages towards patient selection
What are examples of a probability sampling scheme?
simple random sampling systematic random sampling stratified simple random sampling stratified disproportionate random sampling multi stage random sampling cluster multi stage random sampling
What is a population?
all individuals making up a common group; from which a sample (smaller set) can be obtained, if desired
What is IRB’s role?
protect human subjects from undue risk
What is autonomy?
self rule/self determination
the participant must decide for ones self and have full and complete understanding of the risks and benefits
What is a probability sample?
(most common)
every element in the population has a known (non-zero) probability of being included in sample
What is simple random sampling?
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 of listed numbers
What is a null hypothesis?
a research perspective which state there will be no (true) difference between the groups being compared
In what study design are there researcher forced group allocation?
interventional
What are study design selection based on?
hypothesis randomization ethics of methodology time/resource commitment costs internal validity external validity; generalizability
What is the office of human research protections?
agency that administers and enforces the regulations
What is internal validity?
methods inside the study
–assessments
What are the four key principles of bioethics?
autonomy
beneficence
justice
nonmaleficence
What are the three levels of IRB review?
full board
expedited
exempt
What are main differences between 3 levels of review?
number of members and time for committee review/approval
level of detail to documentation needed for review
What is an exempt review?
no patient identifiers, environmental studies, use of existing data/specimens
What is equipoise?
genuine confidence that an intervention may be worthwhile in order to use it in humans
What is beneficence?
to benefit, or do good for, the patient
What guiding principles does the Belmont report contain?
respect for persons
beneficence
justice
What is cluster multi stage random sampling?
same as multi stage random sampling but all ‘elements’ cluster together at any stage are selected for inclusion
