1.
OBSERVATIONAL STUDIES
A. DESCRIPTIVE STUDY
DESCRIBE DIESEASE BY
TIME
PLACE
PERSON
B. ANALYTICAL STUDIES
ECOLOGICAL STUDY
CROSS SECTIONAL STUDY
CASE-CONTROL STUDY
COHORT STUDY
2. EXPEREMENTAL STUDIES
RANDOMIZED CONTROLLED TRIAL (RCT)
FIELD TRIAL
COMMUNITY TRIAL
Cohort Study:
Key Point:
Presence or absence of risk factor
is determined before outcome
occurs.
Cohort studies
Rate
Rate difference
Rate Ratio (strength of association)
Case control studies
No calculation of rates
Proportion of exposure
Cohort studies
longitudinal
Prospective studies
Forward looking study I
Incidence study
starts with people free of disease
assesses exposure at “baseline”
assesses disease status at “follow-up”
Prospective cohort studies
Framingham study of cardiovascular disease, 1948
Japanese atomic bomb survivors, 1946
Colorado Plateau uranium miners, 1950s
Retrospective cohort studies
Aniline-dye occupational cohort, 1954
Prospective cohort study
Retrospective (historical) cohort study
Combination of Retrospective and
Prospective cohort study.
Cohort Study
DZ
E
DZ
Healthy
People DZ
E
-
DZ
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
Time
When there is good evidence of exposure and
disease.
When exposure is rare but incidence of disease
is higher among exposed
When follow-up is easy, cohort is stable
When ample funds are available
Frame work of Cohort studies
Disease Status
Total Yes No
Study
Exposure
Yes a+b a b cohort
Status
No Comparison
c+d c d cohort
N a+c b+d
exposed
unexposed
General consideration while selection
of cohorts
Both the cohorts are free of the disease.
Both the groups should equally susceptible
to disease
Both the groups should be comparable
Diagnostic and eligibility criteria for the
disease should be defined well in advance.
Selection of study subjects
Obtaining data on exposure
Selection of comparison group
Follow up
Analysis
General population
Whole population in an area
A representative sample
Special group of population
Select group
occupation group / professional group (Dolls study )
Exposure groups
Person having exposure to some physical, chemical or
biological agent
e.g. X-ray exposure to radiologists
Personal interviews / mailed questionnaire
Reviews of records
Dose of drug, radiation, type of surgery etc
Medical examination or special test
Blood pressure, serum cholesterol
Environmental survey
By obtaining the data of exposure we can
classify cohorts as
Exposed and non exposed and
By degree exposure we can sub classify cohorts
Internal comparison
Only one cohort involved in study
Sub classified and internal comparison done
External comparison
More than one cohort in the study for the purpose of
comparison
e.g. Cohort of radiologist compared with
ophthalmologists
Comparison with general population rates
If no comparison group is available we can compare
the rates of study cohort with general population.
Cancer rate of uranium miners with cancer in
general population
To obtain data about outcome to be determined
(morbidity or death)
Mailed questionnaire, telephone calls, personal
interviews
Periodic medical examination
Reviewing records
Surveillance of death records
Follow up is the most critical part of the study
Some loss to follow up is inevitable due to
death change of address, migration, change of
occupation.
Loss to follow-up is one of the draw-back of the
cohort study.
Calculation of incidence rates among exposed
and non exposed groups
Estimation of risk
Calculate
measure of frequency:
Cumulative incidence
- Incidence proportion
- Attack rate (outbreak)
Incidence density
end of follow-up
exposed
unexposed
Disease Status
Yes No Total
Study
Exposure
Yes a b a+b cohort
Status
No Comparison
c d c+d cohort
a+c b+d N
a
INCIDENCE EXPOSED =---------
a+b
c
INCIDENCE non EXPOSED =---------
c+d
Absolute measures
Risk difference (RD = AR) Ie - Iue
Relative measures
Relative risk (RR)
Rate ratio
Risk ratio
Ie
Iue
Ie = incidence in exposed
Iue= incidence in unexposed
Relative Risk
incidence of disease among exposed
RR =
Incidence of disease among non-exposed
` a/a+b
= _________
c/c+d
Attributable risk (AR)
AR = the amount of disease incidence that can
be attributed to a specific exposure
Difference in incidence of disease between exposed and
non-exposed individuals
Incidence in non-exposed = background risk
Amount of risk that can be prevented
Attributable fraction (AF)
AF = the proportion of disease incidence that can be
attributed to a specific exposure (among those who
were exposed)
AR divided by incidence in the exposed X 100%
32
Attributable Risk Fraction
Incidence of disease among exposed –
incidence of disease among non exposed
AF =
Incidence of disease among exposed
a/a+b – c/c+d
AF =
a/a+b
Attributable Risk( Risk different)
Incidence of dis.exposed – incid. of dis. non exposed
AR = a/a+b – c/c+d
a/a+b – c/c+d
Attrib.Risk Fraction=
( AF) a/a+b
34
Presentation of cohort data:
Population at risk
Does HIV infection increase risk of developing TB
among a population of drug users?
Population Cases
(f/u 2 years)
HIV + 215 8
HIV - 289 1
Source: Selwyn et al., New York, 1989
Presentation of cohort data:
Person-years at risk
Tobacco smoking and lung cancer,
England & Wales, 1951
Person-years Cases
Smoke 102,600 133
Do not smoke 42,800 3
Source: Doll & Hill
Presentation of data:
Various exposure levels
Source: Doll & Hill
Perlu digaris bawahi :
Only cohort studies (including clinical
trials) can yield incidence and relative
risk.
The odds ratio, (a case-control study) will always be
greater than the relative risk.
For rare diseases, the odds ratio will be close to the
relative risk.
Smoking Lung cancer Total
YES NO
YES 70 6930 7000
NO 3 2997 3000
73 9927 10000
Find out RR and AR for above data
Incidence of lung cancer among smokers
70/7000 = 10 per 1000
Incidence of lung cancer among non-smokers
3/3000 = 1 per thousand
RR = 10 / 1 = 10
Incidence of lung cancer among smokers
70/7000 = 10 per 1000
Incidence of lung cancer among non-smokers
3/3000 = 1 per thousand
RR = 10 / 1 = 10
(lung cancer is 10 times more common among
smokers than non smokers)
AF = 10 – 1 / 10 X 100= 90 %
(90% of the cases of lung cancer among smokers are
attributed to their habit of smoking)
Smoking Lung cancer Total
YES NO
YES 70 6930 7000
NO 3 2997 3000
73 9927 10000
Find out RR and AR for above data
42
Incidence of lung cancer among smokers
70/7000 = 10 per 1000
Incidence of lung cancer among non-smokers
3/3000 = 1 per thousand
RR = 10 / 1 = 10
(lung cancer is 10 times more common among
smokers than non smokers)
AF = 10 – 1 / 10 X 100
= 90 %
(90% of the cases of lung cancer among smokers are
attributed to their habit of smoking)
43
44
Excess
Risk
Risk
100
80 AR = Risk among risk
factor positives
60
40
Risk among risk
20 factor negatives
0
+ -
Risk Factor
45
Risk among - Risk among
risk factor risk factor
positives negatives
AF = X 100%
Risk among
risk factor
positives
46
Relative risk and odds ratio are important as
measures of the strength of association
Important for deriving causal inference
Attributable risk is a measure of how much disease
risk is attributed to a certain exposure
Useful in determining how much disease can be
prevented
Therefore:
Relative risk is valuable in etiologic studies of disease
Attributable risk is useful for Public Health guidelines and
planning
47
Strengths
Weaknesses
We can find out
incidence rate and risk
losses to follow-up
More than one disease
often requires large
related to single sample
exposure ineffective for rare
can establish cause - diseases
effect long time to complete
good when exposure
is rare
expensive
minimizes selection
Ethical issues
and information bias
exposed
PENELITIAN
BERHENTI
unexposed
55
THANK YOU
