Biostats- Melissa Wells Flashcards
What is the Belmont Report?
Belmont report = basic ethical principles underlying proposed regulations for research
What are the three principles underlying the Belmont Report?
- Respect for persons (informed consent)
- Beneficence (assessment of potential risks and benefits)
- Justice (selection of people to be in the research)
What can be determined from an observational study?
Associations or correlations
NO CAUSALITY
What is an observational study?
a type of study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (no treatment is given)
What is a cross sectional study?
- a type of observational study
- one point in time where independent and dependent variables are measured at the same time
What are the three types of longitudinal studies? and how are they different?
- Trend- measure changes in population over time (ex: a survey of a college freshman each year)
- Cohort- measures change and follows a particular population over time (not necessarily the SAME people though)- prospective (followed for longitudinal time period)
- Panel- measure changes in the SAME people over time
Qualitative study characteristics and some examples
- High validity
- analysis of less structured data (open ended response, etc)
- Focus groups, qualitative personal interviews, visual methodology
Quantitative characteristics
- High reliability
- Often coupled with generalizable sampling procedures
Mixed methods include…
both qualitative and quantitative aspects of study
Type of nomothetic causation
- Correlation/Association
- Temporal Order (A before B)
- Non-spuriousness (correlation, but not associated)
What are the three main parts of the “classical experiment”?
- Independent and dependent variable
- Pre-testing & Post-testing
- Control and experimental groups
What is investigated in phase I of clinical trials?
- Safety
- Side-effects
- Metabolism
Note: usually done on healthy volunteer, check metabolism in actual person
What is investigated in phase II of clinical trials?
- Ideal dosing
Note: Need patients with condition
What is investigated in phase III of clinical trials?
- Experimental vs. control
“Hallmark of Clinical Trials”
What is investigated in phase IV of clinical trials?
Continued evaluation of FDA-approved therapy (Post-market study)
What is the Hawthorne effect?
When researcher behavior affects behavior
What is a double blind study?
research and respondents don’t know which treatment is the control or experimental
What is external invalidity?
Applicability to real world, the sample population isn’t really representative of the real world.
What is internal invalidity?
anything other than the stimulus that influences results (history, change in maturation, testing, instrumentation, etc)
What is a case-control study?
- type of observational study
- a comparison of people who have a condition and/or receive a treatment (cases) with another group of people who are not affected by the condition (control)
- needs to be RETROSCPECTIVE
Four methods/types of non-probability sampling?
- Purposive
- Convenience
- Snowball
- Quota
What is a good way to avoid sampling bias??
Use a probability sample (a random sample)
What is the goal of probability sampling?
to a create a sample as REPRESENTATIVE of the population as possible
Element vs. population
element = individual members of population