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Pharmacoepidemiology

TOPICS
Principle of Pharmacoepidemiology

Measurement in Pharmacoepidemiology

Pharmacoepidemiology study design

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Principle of Pharmacoepidemiology

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Epidemiology EPI+DEMOS+LOGOS

 ( )

Diagnosis test


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 ( )
(Pharmacoepidemiology)
The study of the use of and the effect of drugs in large numbers of people

 ( )



Clinical latrogenesis
Social latrogenesis
Pre-marketing control
Post-marketing control


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Measurement in Pharmacoepidemiology

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(Trend)



Measures of frequency
Incidence ( ): Incident cases
Prevalence () prevalent cases
Epidemiological estimation /
Risk ( )
Rate ()
Ratio ( )
.

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1. Measure of magnitude ( )
Number or Rate of Morbidity, Mortality, Disability

2. Measure of association ( )
Odds ratio (OR), Risk ratio (RR)
3. Measure of impact ( )
Attributable fraction, etc.

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Measures of frequency
Incidence ( ) new cases
Prevalence () existing cases

(new cases + old but currently ill)

2
Incidence: measure the risk of diseases or health-related problems

(Prevention and Control)
.

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Measures of frequency
Prevalence: measure the burden of diseases or health-related problems


(Planning for
treatment)

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The relationship between Prevalence and Incidence
1.
2. (Incidence)
Prevalence

3. (Incidence)
Prevalence

4. (Incidence)
Prevalence Incidence /

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Relationship of Incidence and Prevalence

P= Prevalence ( )
I = Incidence ( )
D = Duration of the disease ()

P=IxD

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A (incidence) 10
3 ( 3 )
(prevalence) ??
( - )

= x
= 10 x 3
= 30


10

10 + 10 2 = 20

10 + 10 2 + 10 3 = 30

10 ( ) + 10 2 + 10

3 + 10 4 = 30
30

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Epidemiological estimation

Ratio = a/b or a : b
: = 4 : 1 80% : 20%

Rate = a x K
(a+b)

80% = x 100
( )
( + )

Proportion = a

a+b+c

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Ratio ( )

.. 2551 = 20 1 : 999
.. 2551
19,980

Proportion ( )

.. 2551 = 20 1 1000
.. 2551
20,000

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(rate) = (numerator) x K
(denominator)

= axK
a+b

a a + b
K 100 1,000
10,000 100,000

3
1. (numerator)
2. (denominator)
3. (time)
.

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x 100
+

20 x 100
(20+19,980 )

= 0.1 100

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 (maternal mortality rate)

1000

= () x 1000
(Maternal Mortality Rate)
()

( )

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Incidence Rate
Incidence = /
=

Incidence Rate =

= x 1000

= x 1000

(/)
.

( /)
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Incidence Rate
2
1. () = x 1000

2. () =
( )

x 1000

1

(episodes) (person)
.

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 Person-time
Person time at risk

100 1
1 1
person time at risk
2 2 person time at risk
3 1 person time at risk 1
.

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 100 1
30 1 1
Death rate
= Number of Death / all at risk
( )
= 30/100 = 0.3 or 30%
Death rate
= Average speed of dying
( )
=
= 0.35 per rat month (35%)
30
85 rat months
70 1
person time
70+15 = 85 (Incidence density = 85)
.

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Prevalence Rate
= /

Prevalence

Prevalence Rate
=
=

/
x 1000

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Prevalence Rate
2
1. (Point prevalence rate)
2.
(Period prevalence rate)

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1. (point prevalence rate)

= x 1000

= 1000

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2. (Period prevalence rate)

= x 1000

= 1000

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(Prevalence) 2547
= 2547 2547 x 1000

2547
= 1000

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 (Health Indices)
1. (Measures of morbidity)
Incidence and Prevalence
2. (Measure of mortality)

2.1 (crude mortality rate)

2.2 (Age specific mortality rate)

2.3 (Disease specific mortality rate)

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 (Measures of morbidity)

2

(Incidence)
(Incidence rate)

(Prevalence)
(Prevalence rate)
.

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 (Measure of mortality)
1. (crude mortality rate)
2. (Age specific mortality rate)
3. (Disease specific mortality rate)

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 (crude mortality rate)

= x 1000

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 (Age specific mortality rate)

25-34 = 25-34 x 1000

25-34
Systemic lupus
erythematosus 15-44 45-65


.

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 (Disease specific mortality rate)

= x 1000

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Pharmacoepidemiology study design

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Exposure
( ) ( )

Outcome (dependent variable), response

exposure

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(time sequence)

(nature of study)

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1.
(cross-sectional study)
(retrospective study)
(prospective study)
(retrospective-prospective study)

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2.
2.1
(observational study)

2.2
(experimental study)

(descriptive study)

(analytic study)
.

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STUDY DESIGN :

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STUDY DESIGN :

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STUDY DESIGN :

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 (analytic study)
(analytic study)

(observational study)

exposure exposure

.

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 (analytic study)

(magnitude of effect/point estimation)

(precision/interval estimation/statistical significance)
(parameter) (target
population)

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Cohort study

(induction period)
(incubation period)
.

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Cohort study

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Cohort study :


Total

a
c
a+c

b
d
b+d

Total
a+b
c+d

= a / ( a + b )
= c / ( c + d )

Risk Ratio = risk exposure = a / (a + b)

risk un-exposure
c / (c + d)
.

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 Risk ratio

Total

42
43
85

80
302
382

Total
122
345
467

RE = 42 / 122
= 34.43 %
RU = 43 / 345
= 12.46 %
RR = 34.43 / 12.46 = 2.76
2.76
.

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 Risk ratio
shigellosis

9
7

16
113

25
120

RR = 6.2
RE = 9 / 25 = 36 %
RU = 7 / 120 = 5.83 %
RR = 36 / 5.83 = 6.2
6.2

.

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Case-control study

Case
Control

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Case-control study

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Case-control study
Odds Ratios

()
()

a
c

()
( )
Odds
.

b
d
=
=
=
=

a/(a+c)
c/(a+c)
[a/(a+c)] / [c/(a+c)]
a/c
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Case-control study

Odds Case-control study

Odds (case) = a/c
Odds (control) = b/d

Odds ratio = odds case / odds contriol = (a/c) / (b/d)

= ad / bc

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 Case-control study
50
100

40 20

Odds Ratio (OR) =

40
10
50

ad/bc =

20
80
100

40x 80
20 x 10

= 16

16
.

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Cross-sectional study

1

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 Cross-sectional Study

HIV/AIDS

179 89 (
14 , 75 ) 90 ( 3 ,
87 )

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14
3
17

75
87
162

89
90
179

Prevalence () = 14 / 89 = 15.7%
Prevalence () = 3 / 90 = 3.3%
Prevalent ratio = 15.7% / 3.3% = 4.7
Prevalent difference = 15.7% 3.3% = 12.4%
.

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(experimental study)
exposure
2 exposure
outcome 2

Exposure

Outcome

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 (experimental study)

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 (experimental study)

1. Clinical trial
2. Field trial

3. Community trial (Community intervention study)

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Clinical trial

Exposure


Outcome

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Field trial

Exposure


Outcome

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Community trial

Exposure


Outcome

68

85
100
185

40
35
75

125
135
260

Success rate = = 85/125 = 0.68

Success rate = = 100/135 = 0.74

= 0.68 / 0.74 = 0.92

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(Experimental)

(Descriptive Study)

(Cross-sectional)

(Observational)


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(Analytical Study)

Cohort
Case-control
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