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What is a potential problem of an ecologic study? Ecological fallacy: when you make
conclusions about individuals based on population data and the association may exist at the
aggregate level but not the individual level
What is the defining feature of an experimental study? The investigator assigns exposure
to study subjects
All analytical studies begin with ___________________. A hypothesis
Institutional Review Board Reviews study proposals to ensure that studies are being
carried out ethically
What is the Belmont Report? What are the components? Ethical principles and guidelines
for the protection of human subjects of research
,Respect for persons (individuals are autonomous), beneficence (maximize benefits and minimize
harm), and justice (people should be treated equally with respect to opportunity to participate in
research)
Equipose Experimental research should be conducted only when there is genuine
uncertainty about which treatment will work better
Must be sure that your treatment has the potential to benefit participants
How do we categorize experimental studies? Individual vs. community
Preventative vs. therapeutic
Parallel vs. crossover
Simple vs. factorial
Parallel Trials One treatment per treatment group
,One group may be assigned a new therapy and the other an old therapy
One assignment throughout the trial
Crossover Trials Give the treatments to both groups in different orders
One group starts with new treatment and then switches and the other group does the opposite
No control group
Good to see how treatment affects quality of life
Simple Study Design Each group gets one treatment
Factorial Study Design There are multiple treatments given to different groups
Tests one treatment's ability to prevent one outcome and tests another treatment's ability to
prevent a different outcome
, Why is sample size important in an experimental study? In order to have high statistical
power to determine whether there is a difference between treatments being tested
Informed Consent Giving potential participants enough information about a study to
enable them to choose whether they wish to participate
Discuss study, procedures, risks, benefits, privacy, etc.
Get verbal and written consent
How should treatments be assigned in an experimental study? Random assignment
What are the goals of randomization? To achieve baseline comparability between
compared groups on factors related to outcome
Compare groups are the same except for the treatment: equal distribution of known and unknown
characteristics