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67 Cards in this Set

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2 major categories of study designs
parallel design & cross over design
pre-experimental study designs
case study
one group pre- & post- test
static group comparison

limited usefulness & are usually preliminary studies that lead to more rigorous study designs
true experiemntal study designs
pre- post- test w/ control group
post-test only w/ control group
solomon four group design
cross over design
quasi experimental study designs
time series
non-equivalent control group

are excellent designs if selection problem can be controlled
epidemiologic study designs
descriptive or case series
case-control
cross-sectional studies
cohort studies
*primitive research design
*intervention occurs & observation is made
*doesn't control for threats to internal validity
*advantage-good for identifying problems for future research
*disadvantages-no control for internal validity
one-shot case study
*this design impllies an increased sample size (more than one subject)
*collects data before & after an intervention or experiment
no control group & results are worthless
*advantages-before measures allows for established baseline to be established; comparison can be made w/ 1st measure
*disadvantages-little control so internal validity still prob
one group pre- post-test
*differences is 2 different groups vs same group in prev design
*assumes both groups are same at outset
*no randomization
*advantages-both maturation & history effects are controlled for IF the groups were the same at outset, there is no guarantee they were; testing & reactive effects are controlled
*disadvantages-selection bias & mortality are major concerns
static group comparison
*randomization
*2 groups w/ pre & post measures
*we are able to better attribute any change shoud to intervention
*advantages- controls for history, maturation, & testing effects, but you have not removed this concern
*disadvantages-doesn't control for reactive effect to testing; history problems
pre- post- test w/ control group
similar to pre- post- test w/ control group w/ addition of 2 groups added that are not pre tested
* controls for reactive effect to testing
*allows researchers to tease out the differences due to intervention X
*ANOVA - a powerful parametric test, is used to partition the between group & within group variances; adds costs to studies & controls for everything
*very stron test design, but not always practical
solomon four group design
*also very strong design
*testing effect & reactive effects are not a problem
*since we have no initial score, we can't be sure that changes are due to intervention X
post test only w/ control group
*every subject gets every treatment & data is collected
*order in nwhhich they receive treatment varies
*must have wash-out period between treatments
*each subject becomes their own control
*eliminates concern over equality of experimental & control subjects
& can have same # of subects as # of treatments
latin square or cross over design
*expansion of latin square
*will not see this very often b/c large sample sizes are required = expensive
*pts leave trial
*strong design that minimizes variance component
counter balanced design
*most commonly used w/ retrospective data
*no randomization, but samples are enerally so large, we can elimante this concern
*problems occur when extrapolating to an even larger group
*seasonality is a concern
time series
*better than time series
*provides a control group
*concern over equality of control group
*still no randomization
*typically analyzed using ANOVA w/ trend analysis component
multiple time series
*same design as pre- post- test w/ control group but no randomization
*focus on how groups are selected
*self selection is a problem
non-equivalent control group
study of the distribution & determinants of diseases & injuries in human populations

concerned w/ frequencies, groups, & factors
epidemiology
study of effects of drugs in humans
clinical pharmacology
study of use & effects of drugs in large numbers of people
pharmacoepidemiology
the investigator studies the impact of varying some factor that s/he controls
experimental studies
contrasts in outcomes between the study groups are observed & analyzed, not created expeirmentally
observational studies
rates that measure how many people will develop a disease, its the number of new cases
incidence
rates that measure the number of people in a population who have the diseas
prevalence
people diagnosed as having the disease are compared w/ people who do not have the disease

compares cases & controls w/ regard to some element in their past
retrospective studies
starts with group of people (cohort) all considered to be free of a given disease, but who vary in their exposure to a supposed noxious factor
prospective studies
-similar to one-shot case study
-report of single pts
-exposed to drug & experienced a particular, usually adverse, outcome
-not typically useful to document causation
-can be very useful in challenge-rechallenge situations (adverse events)
case report
-collection of pts, all have single exposure, whose clinical outcomes are then evaluated & described
-can be collections of pts w/ single outcome, whose antecedent exposures are then examined
-similar to one-shot case study
-simple, descriptive account of interesting characteristics observed in group of pts
-generally involves subjects seen over short period of time in single setting
-no control subjects
-useful for quantifyng the incidence of an adverse reaction
case series
-epidemiologic study where subjects are selected on the basis of whether they do or don't have particular disease
-subject selection
-usually retrospective in nature
-good study design for rare disease
-relatively efficient in time & costs comared to clinical trials
-has the largest # of possible biases or errors
case-control
-analyze data collected on a group of subjects at one time rater than over a period of time
-designed to determine "what is happening" right now
-think survey
-focus on point in time (prevalence studies)
cross-sectional studies
-epidemiologic study in which an exposed group to a drug or disease is compared to an unexposed group, & both gropus are followed over a period of time, to determine the unintended drug effect on the incidence rate for both groups
-think forward looking
cohort studies
the target to which investigators generate study results
population
the object about which the researcher wishes to draw conclusions based on the study
unit of analysis
method used to select the sampling units
sampling design
list of sampling units from which the sample is selected i.e. phone books, pt records membership lists
sampling frame
how study participants are selected to enter the study; has more to do wtih external validity issues
random selection
how study participants are assigned to each treatment in study
random assignment
probability sampling
*all sampling units have known, non-zero, probability of being selected
*sampling designs are best methods to obtain an unbiased sample that can be generalized to a larger population
*random procedures to select a sample
*random sampling doens't guarantee a representative sample (more true for small sample..as samples get larger they are more representative of the population)
*simple random sampling
*systemic sampling
*cluster sampling
*stratified sampling
non probability sampling
*probability of selecting sample unit is not known
*not everyone in the study's population has an equal opportunity to be selected
*more likely to yield a biased sample & may not represent the population of interest & thus not generalizable
*more convenient, less expensive, less time consuming
*convenience sampling
*snowball sampling
*quota sampling
*purposive sampling
population characteristics, analysis
precision of estimates
availabl resources
response rate of a survey
study design
sample size determination
-every unit in population has equal probability of being included in sample
-used when population is homogeneous
-assign number to each unit in population from 1 to N
-desired sample size N
-select (n) different random #s between 1 & N using a random number table
simple random sampling
-selects every kth unit after random start
-easier than simple random sampling
-be cautious of cyclical patterns that may coincide w/ sampling interval
-randomly choose interval (k) independent of sampling frame
-randomly choose starting point between 0 & k & then choose every kth unit (ie k=10, randomly choose a # between 0 and 9. that will be starting point & from there you choose every 10th unit)
systematic sampling
-breaks population into groups or clusters
-cluster can be natural groupings such as neighborhoods
-randomly select sample of clusters using simple random of systematic sampling technique
cluster sampling
-population is divided into non-overlapping groups or categores (strata)
-independent simple random samples are drqen for each stratum
-increases the representation of populations that are small proportions of total
-can be proportional stratified sample or disproportional stratified sample
stratified sampling
selects from each strata a sample size from each strata proportional to that strata's composition in population. this allows for direct generalization from the entire sample to the population
proportional stratified sample
this sample does not take into account the proportion of each strata in the population. this can lead to one or more strata within the population to be underrepresented. unlike a proportioned sample, a disproportionate stratified samples doesnot allow researchers to make direct generalizations .
disproportioanl stratified sample
-relies on availabe subjects
-people met on street, volunteers, captive audiences
-quick & easy but does get whole representative of population
convenience sampling
-specifies desired characteristics & selects for a sample appropriate ratios of population that fit the desired characteristics
-similar to stratified sampling, but NO random selection
-may use any methods to select a sample to fulfill assigned quota
quota sampling
-relies on information from other subjects to identify additional subjects for study inclusion (ie referrals)
-those subjects provide leads to more subjects
-useful for studying populations that are difficult to identify or access
snowball sampling
-elements are selected based on expert judgment
-used when sample size is small & simple random sampling may not represent the most representative elements
-used to identify pts for clinical trails that have appropriate disease state for trial
purposive sampling
two types of surveys
cross sectional & longitudinal survey
surveys can...
-describe single variables
-show relationships between variables
-study effects of treatments
-study longitudinal changes by collecting data at different points of tiime
-make comparisons between groups
cross sectional survey
most common
-standardized data is collected from a predetermined population (short period of time)
-importnat to identify appropriate subjects to suppply desired information
-generally difficult to survey the entire target population
longitudinal survey
multipurpose survey
-follows a single sample w repeated surveys over period of time
-in addition to the core questions, non-core questions may be asked to account for latest developments & iinterests
-trend studies
type of question:

how satisfied are you w/ PHA 444?
attitude
type of question:

true/false: vitamins help with your health
knowledge
type of question:

how often do your kids take their vitamins?
behavior questions
type of question:

IQ, age, race
attributes
type of question:

what should be done in order to educate consumers about generic drug products?
open ended question
type of question:

in your opinion what is the biggest barrier to etting consumers to use generic drug products?
open ended question
type of question:

how did you find out you received generic drug?

a-pharmaicst told me
b-MD told me
c-both rx& md told me
d-read label
close ended question
type of question:

how likely are you to ask for generic drug?
a-very likely
b-somewhat likely
c-unsure
d-somewhat unlikely
e-very unlikely
close ended w/ ordered choices example
type of question:

how did you find out you received generic drug
a-pharmacist told me
b-MD told me
c-both rx & MD told me
d-read label
e-other_____-
partially closed example
type of question:

please rank following from most likely to least in terms of who you would ask about an over the counter medication? (1 = most likely, 5 = least likely)

__pharmacist
__MD
__nurse
__family member
__good friend
rank ordered example
survey type of question:

if you have used generic drugs, how satisfied are you w/ their performance?
a-highly satisfied
b-mildly satisfied
c-neither satisfied nor dissatisfied
d-midly dissatisfied
e-highly dissatisfied
attitude example
survey type of question:

true/false: generic drugs are as safe as trade name drugs
knowledge example
if you pay for your own prescriptions out of your own pocket, do you ...
a-request trade name product
b-request generic product
c-have no preference
behavior example
type of question:

are you currently married?
a-yes
b-no
attribute example