Exam 4 Topics Flashcards
What is a primary study?
Collection of original data
Ex: Cross-sectional, RCT’s, cohort studies
What is a secondary study?
Review and analysis of previous studies
Ex: Meta-analysis, Systemic Reviews
A study in which the investigators publishes clinical trial results utilizing the collection of original data is an example of what kind of study?
Primary Study
A Meta-analysis is an example of what kind of study?
Secondary study because it reviews and analyzes previously collected data
What is primary prevention?
Prevent development of disease
Ex: lower risk factors of CHD in those without apparent disease
What is secondary prevention?
Early identification and treatment to reduce complications and disease progression
Ex: risk factor reduction in those with CHD
What is tertiary prevention?
Rehabilitation/functional restoration of those with end organ damage, as well as reduction in risk factors for disease progression
Ex: Cardiac rehabilitation for CHD
What is efficacy?
Does the Rx work under ideal, “laboratory” conditions?
What is efficacy?
Does Rx work in “real-life” situations?
What is the difference between efficacy and effectiveness?
Efficacy can be defined as the performance of an intervention under ideal and controlled circumstances, whereas effectiveness refers to its performance under ‘real-world’ conditions
What is efficiency?
It may be effective, but is it worth it?
What is the problem with non-randomized designs?
Increased opportunity for self-selection
*Need to be cautious in interpreting cause and effect
What are Phase I studies?
Small (20-80 subjects) clinical pharmacologic studies focusing on safety, dosage ranges and toxic effects
Efficacy
What are Phase II studies?
Clinical investigations of 100-300 subjects for safety and efficacy —> refinement and extension of phase I
What are Phase III studies?
RCT’s may have hundreds or thousands of subjects recruited from many locations. Focus moves towards effectiveness.