Exam 4 Topics

Question 1

What is a primary study?

Answer 1

Collection of original data

Ex: Cross-sectional, RCT’s, cohort studies

Question 2

What is a secondary study?

Answer 2

Review and analysis of previous studies

Ex: Meta-analysis, Systemic Reviews

Question 3

A study in which the investigators publishes clinical trial results utilizing the collection of original data is an example of what kind of study?

Answer 3

Primary Study

Question 4

A Meta-analysis is an example of what kind of study?

Answer 4

Secondary study because it reviews and analyzes previously collected data

Question 5

What is primary prevention?

Answer 5

Prevent development of disease

Ex: lower risk factors of CHD in those without apparent disease

Question 6

What is secondary prevention?

Answer 6

Early identification and treatment to reduce complications and disease progression

Ex: risk factor reduction in those with CHD

Question 7

What is tertiary prevention?

Answer 7

Rehabilitation/functional restoration of those with end organ damage, as well as reduction in risk factors for disease progression

Ex: Cardiac rehabilitation for CHD

Question 8

What is efficacy?

Answer 8

Does the Rx work under ideal, “laboratory” conditions?

Question 9

What is efficacy?

Answer 9

Does Rx work in “real-life” situations?

Question 10

What is the difference between efficacy and effectiveness?

Answer 10

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

Question 11

What is efficiency?

Answer 11

It may be effective, but is it worth it?

Question 12

What is the problem with non-randomized designs?

Answer 12

Increased opportunity for self-selection

*Need to be cautious in interpreting cause and effect

Question 13

What are Phase I studies?

Answer 13

Small (20-80 subjects) clinical pharmacologic studies focusing on safety, dosage ranges and toxic effects

Efficacy

Question 14

What are Phase II studies?

Answer 14

Clinical investigations of 100-300 subjects for safety and efficacy —> refinement and extension of phase I

Question 15

What are Phase III studies?

Answer 15

RCT’s may have hundreds or thousands of subjects recruited from many locations. Focus moves towards effectiveness.

Question 16

What are Phase IV studies?

Answer 16

Long-term safety, adherence, packaging (combined pills)

Generally non-randomized, Effectiveness

Question 17

What is the number needed to treat (NNT)?

Answer 17

Is the number of patients you need to treat to prevent one additional bad outcome (death, stroke, etc.)

Question 18

What is the equation to calculate the number needed to treat (NNT)?

Answer 18

NNT = 1/ARR

ARR = Absolute Risk Reduction

Question 19

What is the number needed to harm (NNH)?

Answer 19

Is the number of patients you have to treat before you can expect at least one to have an adverse outcome or side effect

Question 20

In general, you want a ______ NNT and _______ NNH if possible.

Answer 20

Low, High

Question 21

True or False: Randomized Trials are considered the ideal design for evaluating both the effectiveness and the side effects of new forms of interventions.

Answer 21

True

Question 22

What are historical controls?

Answer 22

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.

Question 23

Lower rates of vaccines not only leave vulnerable individuals at risk, but also affect ________________

Answer 23

Herd Immunity

Question 24

What is Herd Immunity?

Answer 24

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

Question 25

What levels of prevention fall under the public health sector?

Answer 25

Primary Prevention, and a small bit of some secondary prevention

Question 26

What levels of prevention fall under primary care?

Answer 26

Primary, secondary, and tertiary prevention

Question 27

What levels of prevention fall under speciality care?

Answer 27

Tertiary prevention along with some secondary prevention techniques

Question 28

Health education programs have what level of impact on individuals?

Answer 28

Minimal impact on individual freedoms

Question 29

What is the purpose of health screenings?

Answer 29

Early detection and treatments *minimal impact on individual freedoms to participate

Question 30

Regulations have what level of impact on individual's?

Answer 30

Significant impact on individual freedoms

Question 31

What kinds of bias' can arise when an investigator is assessing their own program?

Answer 31

conscious and subconscious biases

Question 32

Define "process" measure

Answer 32

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)

Question 33

What is efficacy?

Answer 33

Does the agent or intervention work under ideal laboratory conditions (controlled environment such as an RCT for a new medication)

Question 34

What is effectiveness?

Answer 34

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

Question 35

What is efficiency?

Answer 35

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

Question 36

What is the equation for NNH?

Answer 36

NNH = 1/ARI (absolute risk increase)

Question 37

What are the typical research designs in the evaluation of health care services?

Answer 37

Randomized Control Trial Non-randomized trails Historical Control

Question 38

Outline common errors made in the interpretation of research evaluating health care services?

Answer 38

- Self selection if not an RCT - Historical controls assume nothing else changes - Patient condition/severity - Are characteristics of the group comparable? What about methods?

Question 39

What are some health care service outcome endpoints?

Answer 39

M&M, QOL, functional status, patient perceptions on health status