Exam 2 Flashcards
(123 cards)
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