Exam 2 Flashcards
What are the kinds of descriptive studies
Cross-sectional, single case report, case series, and some ecologic studies
What are the 2 types of analytic studies
Observational and experimental
What are the kinds of observational studies
Case-control, cohort, and some ecologic studies
What are the kinds of experimental studies
Clinical trial and community trial
What are the 3 purposes of descriptive epidemiology
Identify possible health problems, characterize the amount and distribution of health/disease within a population, and generate an etiologic hypothesis
What are the 2 purposes of analytic epidemiology
Identify causes or determinants of health problems and test the etiologic hypothesis
What are the characteristics of experimental design
Controls who is exposed to a factor of interest (Manipulation/M) and assigns subjects randomly to study groups (Randomization/R)
What are the 4 characteristics of clinical trials
Experimental (M and R), tests efficacy of preventative/therapeutic measures, focuses on the individual, and prospective
What are the 4 characteristics of community trials
Quasi-experimental (M only), designed to produce health/behavioral changes in a target population (usually tests health programs, etc.), focuses on community (compares one to another, hard to randomize), and prospective
What kind of calculation can be done for clinical trials
Incidence rates, relative risk, incidence rate ratios, and odds ratio
What is another term for clinical trial
Randomized control trial (RCT)
What are the two types of clinical trials
Prophylactic (prevent disease) and therapeutic (improve health)
What is the timeline of clinical trials
Start with subjects who lack positive history of outcome of interest but are at risk, then include at least 2 time points to determine eligibility/treatment allocation as well as the number of new cases
What is the clinical end point
The outcome of interest in both the intervention and control groups (e.g. rates of disease, death, or recovery)
What is blinding/masking
Single-blind = participants don’t know if they’re intervention or placebo
Double-blind = participants and researchers don’t know if subjects are intervention or control (involves 3rd party)
What are 2 reasons for having phases in clinical trials
To protect public from a potentially deleterious intervention and satisfy the urgent needs for new interventions
What happens in Phase I Clinical Trials
New intervention tested in adult volunteers (usually less < 100 people) –> Must show successful demonstration of response on a small-scale)
What happens in Phase II Clinical Trials
100-200 subjects are selected from the target population for the intervention –> Antibody responses and clinical reactions are examined
What happens in Phase III Clinical Trials
Assesses protective efficacy in target population (at least 1000 people) –> License to manufacture can be granted after this phase
What is efficacy
How does an intervention perform under tightly controlled, ideal situations (compares incident rate of disease in intervention population with control population)
What is effectiveness
How does an intervention perform in the real world
What happens in Phase IV Clinical Trials
Post-marketing research to gather more information about risks and benefits from a drug (effectiveness and safety)
What can community trials help determine
The potential benefit of new policies and programs
What is the timeline for community trials
Determine eligible communities willing to participate, collect baseline measures, use a variety of measures (e.g. disease rates, knowledge, attitudes, and practices), communities randomized and followed over time, and measure outcomes of interest
What is temporality
The timing of information about cause and effect (e.g. did we ask about exposure at the same time, before, or after disease)
What is a cohort
A population group or subset that is followed over a period of time
What are other terms for cohort studies
Prospective or longitudinal studies
What are the basic timelines for cohort studies
Start with patients not positive for outcome of interest but at risk, include at least 2 observation points to determine exposure status/eligibility and number of new cases
What kinds of calculations can be done with cohort studies
Incidence rates, relative risk, incidence rate ratios
What are outcome measures of cohort studies
Discrete events (single events with multiple occurrences), levels of disease markers, and changes in disease markers (rate of change, change in level within time)
What are the 2 kinds of cohort studies
Population-based (exposures unknown until first period of observation when info is collected) or exposure-based (look at exposure first, usually 1:1 ratio)
What is a limitation of population-based cohort vs. exposure-based cohort
They aren’t efficient for rare exposures
What are temporal differences in cohort designs
Prospective vs. retrospective
What are the 3 applications of cohort studies
Studies chronic disease etiology, risk estimation, and hypothesis testing
What is attrition
Subjects lost to follow-up
What are relative measures of effect
Divide disease frequencies from one another (e.g. relative risk, incidence rate ratio, and odds ratio)
What are absolute measures of effect
Subtract disease frequencies from one another (e.g risk difference)
What information is garnered from relative measures of effect
The strength of the relationship between exposure and disease
What information is garnered from absolute measures of effect
The public health impact of an exposure
What are effect measures
A quantity that measures the effect of a factor on the frequency or risk of a health outcome
What is relative risk (risk ratio) and when can it be used
Ratio of risk of disease or death among exposed to risk among the unexposed
What does relative risk tell you
If the risk of disease is different among the exposed as compared to the nonexposed
What is relative risk interpretation
Exposed have X times the risk of disease compared to non-exposed
The risk of disease is X% higher/lower among exposed compared to nonexposed
What is an Incidence Rate Ratio (IRR) and when can it be used
The ratio of incidence rate (uses person time) among the exposed to the incidence rate among the nonexposed
What does Incidence Rate Ratio tell you
If the rate of disease is different among exposed compared to nonexposed
What is interpretation for Incidence Rate Ratios
Exposed have X times rate of disease compared to nonexposed
The rate of disease is X% higher/lower among exposed compared to nonexposed
What is Risk Difference
Difference between incidence of disease in the exposed group and the incidence of disease in the nonexposed group
What is another term for Risk Difference
Attributable Risk
What does Risk Difference tell you
The number of cases of disease that would be eliminated in the exposed group if the exposure was eliminated