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.
What are Phase IV studies?
Long-term safety, adherence, packaging (combined pills)
Generally non-randomized, Effectiveness
What is the number needed to treat (NNT)?
Is the number of patients you need to treat to prevent one additional bad outcome (death, stroke, etc.)
What is the equation to calculate the number needed to treat (NNT)?
NNT = 1/ARR
ARR = Absolute Risk Reduction
What is the number needed to harm (NNH)?
Is the number of patients you have to treat before you can expect at least one to have an adverse outcome or side effect
In general, you want a ______ NNT and _______ NNH if possible.
Low, High
True or False: Randomized Trials are considered the ideal design for evaluating both the effectiveness and the side effects of new forms of interventions.
True
What are historical controls?
Comparison groups from the past, where we go back to the records of the patient with the same disease who were treated before the new therapy was created.
Useful if the disease is uniformly fatal and new treatment is available, where environmental factors need to be ruled out.
Lower rates of vaccines not only leave vulnerable individuals at risk, but also affect ________________
Herd Immunity
What is Herd Immunity?
Resistance of a group of people to an attack by a disease to which a large proportion of the members of the group are immune
Assumes that immunity from vaccine or infection is lasting
What levels of prevention fall under the public health sector?
Primary Prevention, and a small bit of some secondary prevention
What levels of prevention fall under primary care?
Primary, secondary, and tertiary prevention
What levels of prevention fall under speciality care?
Tertiary prevention along with some secondary prevention techniques
Health education programs have what level of impact on individuals?
Minimal impact on individual freedoms
What is the purpose of health screenings?
Early detection and treatments
*minimal impact on individual freedoms to participate
Regulations have what level of impact on individual’s?
Significant impact on individual freedoms
What kinds of bias’ can arise when an investigator is assessing their own program?
conscious and subconscious biases
Define “process” measure
We decide what constitutes the components of good care
Cons:
- Expert panel recommendations change over time (for example placing neonates on 100% oxygen)
- Don’t ensure that the patient is benefiting (measuring patients blood pressure at each visit)
What is efficacy?
Does the agent or intervention work under ideal laboratory conditions (controlled environment such as an RCT for a new medication)
What is effectiveness?
How well does the agent or intervention work in real-life
For example, if a medication was found to be efficacious in clinical trials but tastes horribly the public won’t take it and benefit
What is efficiency?
If the agent is found to be effective, what is the cost benefit ratio
Cost includes not only money, but also discomfort, pain, absenteesim, disability, and social stigma
What is the equation for NNH?
NNH = 1/ARI (absolute risk increase)
What are the typical research designs in the evaluation of health care services?
Randomized Control Trial
Non-randomized trails
Historical Control
Outline common errors made in the interpretation of research evaluating health care services?
- Self selection if not an RCT
- Historical controls assume nothing else changes
- Patient condition/severity
- Are characteristics of the group comparable? What about methods?
What are some health care service outcome endpoints?
M&M, QOL, functional status, patient perceptions on health status
