Fitz9. Ch3: Epidermiology

Question 1

Provide the highest proof of an effect by minimizing bias but does not generalize well to all members of the population

Most commonly used and recognized of the experimental studies

Answer 1

Clinical trials

Question 2

How patients interact with their health care and disease

Answer 2

Patient oriented research

Question 3

How an individual receives health care

Answer 3

Health services research

Question 4

Course of the disease

Answer 4

Natural history of disease

Question 5

How an individual is affected by an illness

Answer 5

Burden of disease

Question 6

Observation of primary interest

Answer 6

Outcome

Question 7

Strongest association between a risk factor or intervention and an outcome

Answer 7

Causal association

Question 8

Likelihood of developing a disease

Answer 8

Risk factor

Question 9

Measure efficacy

Answer 9

Explanatory studies

Question 10

How well an intervention works in the real world

Answer 10

Effectiveness

Question 11

Study repeated using the same study design would find the same results

Answer 11

Internally valid

Question 12

Study was repeated using many other study designs will represent reproducible results

Answer 12

Externally valid

Question 13

Disease status or having a risk factor of interest

Prospective study
Follows a Group of patients over time and monitors the effect of a risk factor or exposure on the development of an outcome

Answer 13

Cohort

Question 14

Retrospective

Answer 14

Case-control study

Question 15

Experimental Phase studies
1
2
3
4

Answer 15

1. Normal Humans; evaluate drug’s safety, dose, tolerability, PK, PD
2. With disease; INITIAL efficacy studies
3. / pivotal studies: COMPARATIVE efficacy studies (treatment versus placebo)
4. / post marketing studies/ effectiveness: general population; FDA approval for marketing

Question 16

Large sample studies or Peto studies that focus on understanding how an intervention works in the routine clinical settin

Answer 16

Pragmatic trials

Question 17

Scale for grading quality of evidence and strength of recommendation

Answer 17

GRADE scale (Grading of Recommendations, Assessment, Development and Evaluation)

Question 18

Scale for grading the evidence for diagnostic Tests, prognostic markers. And harm

Answer 18

OCEBM Scale (Oxford Centre for evidence-based medicine)

Question 19

Frequency of disease relevant for chronic diseases

Answer 19

Prevalence

Question 20

New cases

Answer 20

Incidence

Question 21

Difference between EFFICACY and effectiveness

Patient selection,
Motivated patients and adherence to research protocol,
Investigators,
Clinical response determined at,
Maximize validity

Answer 21

EFFICACY in an ideal setting
Patient selection is stringent
Highly motivated patients and strict adherence to research protocol,
Highly trained Investigators,
Clinical response determined at short term time,
Maximize internal validity