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Epidemiological methods
Non-experimental Experimental studies =
studies = Observational Interventional studies:
studies:
- Involve an active trial to
-Investigator does not change disease determinant
intervene. by the investigator who
-the investigator observes controls the exposure.
natural course of events, -Investigator allocates the
observing who is exposed exposure and follows the
and who is not, who is subjects.
diseased and who is healthy. - Participant are identified on
-the non-experimental studies the basis of their exposure
can be either descriptive or status and followed to
analytical. determine whether they
develop the outcome or not.
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Correlational
Population
studies
Cross
Descriptive sectional
surveys
Cohort studies
Analytical
Clinical trials
Experimental
Community
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Descriptive Epidemiological studies
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□ Person: Who is getting sick?
□ Place: Where is the sickness occurring?
□ Time: When is the sickness occurring?
1- Case Report:
Example:
Intestinal obstruction was reported in a young child.. Documents
showed that this child received Rota virus vaccine three months ago. A
detailed report about this unusual event and exposure was published in
a medical journal. The investigator formulated a hypothesis that Rota
virus vaccine may have been responsible for the rare occurrence of this
event.
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The features of the Case Report:
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2-Case Series:
It is the only study which depends on Routine Surveillance.
What is surveillance?
Example of the case series study:
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Correlation between one of climatic indicator
(Temp.) & frequency of cerebrovascular storks.
80
+ve Correlation (r = +1)
60
40
20
0
10°C 15°C 20°C 25°C 30°C 35°C 40°C
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The average number of mammography per year for woman
above 50 & the mortality from cancer breast
60
40
20
0
3 4 5 6 7 8 9
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The limitations of correlation studies:
1.As the value of exposure is quantified by the
average, it is impossible to link the exposure & the
disease in a particular individual. It is not possible to
tell that the person who gets cerebro-vascular stroke
is the one who is exposed to high temperature.
Parasitic Infection
Pattern of Diet
Mothers Awareness
Mothers Education
(Confounding factors)
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4- Cross sectional study (Prevalence study):
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Example:
Questions:
Draw the flow chart.
Tabulate the data.
Write the title of the table.
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Consumption of high
caloric diet with obesity
n=20
The flow Chart:
Consumption of high
Caloric diet without obesity
n=60
Secondary Sample
school pupils n=400
No consumption of high
Caloric diet with obesity
n=16
No consumption of high
Caloric diet without obesity
n=304
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Distribution of the studied sample of secondary school
pupils in the city X during the year 2004 according to
consumption of high caloric diet & obesity.
Consumption of With Without Total
high caloric diet obesity obesity
Yes 20 60 80
No 16 304 320
Total 36 364 400
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Prevalence of obesity among those consumed high caloric diet (P1 ) =
20 X 100 = 25%
80
16 X 100 = 5%
320
The prevalence rate =
The total number of all cases (old and new) in certain area at a given time X 100
The total number of population in the same area and time
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The uses of cross-sectional study:
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The Limitations of the cross-sectional study:
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Correlational
Population
studies
Cross
Descriptive sectional
surveys
Cohort studies
Analytical
Clinical trials
Experimental
Community
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Analytical epidemiology
(Finding the cause-effect)
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ANALYTICAL STUDIES
It is formed of 2 comparative groups.
E Cases Controls
X Present DISEASE Absent
Prospective
(Cohort)
P
O
S
Present
Exposed a b
U
R
E
Absent
Not exposed c d
Mausner, 1985
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WERE WERE NOT WERE WERE NOT
EXPOSED EXPOSED EXPOSED EXPOSED
“CASES” “CONTROLS”
Design of a Case-Control Study
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Case Control Studies
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The features of case control Study
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Benefits of case control study:
1- Suitable :
to test the hypothesis that the disease of interest is caused
by an exposure.
for diseases with long latency period.
to study rare diseases
2- Easy, rapid, & cheap (compared withy prospective cohort)
3- Requires few subjects.
4-Can examine multiple exposure factors for a single disease.
5-Estimation of the risk (odds Ratio)
6-Minimal ethical problems.
7- No attrition problem.
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Limitations of case control study:
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What is Bias?
Bias is any systematic error in the determination of
the association between the exposure and the disease.
Types of Bias:
•Recall bias.
•Bias due confounding factors.
•Selection bias.
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Selection bias: The cases may not represent
those in the general population.
Example:
The health awareness about the association
between CHD and smoking influences the
selection of cases. Smokers at the time of onset of
CHD are more likely to attend the health care
facilities than those with similar symptoms who
are non smokers. This results in an artificially high
proportion of cases of CHD among smokers.
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Confounding factors:
Factors other than the studied one that disturb
relation between the studied exposure &
disease of interest.
Parasitic Infection
Pattern of Diet
Mothers Awareness
Mothers Education
(Confounding factors)
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Recall (Interview) Problems
Limitations in recall
Recall bias
One group (e.g., mothers with child with
birth defect) may clearly remember (recall)
an event (e.g., mild respiratory infection)
Other group (e.g., mothers with healthy
child) may not recall any such event
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Matching
Concern that cases & controls may differ in
characteristics or exposures other than that
observed in the study
To overcome this problem, we can match cases in
controls in regard to potential factors of concern
Matching selects controls that are similar to cases
in characteristics such as age, race sex,
socioeconomic status, occupation, etc.
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Matching
Group matching (frequency matching)
proportion of
controls with a given
characteristic (variable) is identical to
proportion of cases with the same characteristic
Example:
An investigator selected 200 patients with basal cell carcinoma (BCC)
admitted to X hospital during the year 2004, and 200 subjects free from
the disease as a control from general population. Both groups were
interviewed to obtain information on history of exposure to sunrays
Those with history of exposure were 120 among cases and 40 among
the control .
Past Present
The direction of the study
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The Independent variable :
The Exposure to Sun Rays .
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Distribution of patients with BCC admitted to X hospital
& their controls during 2004 according to history of
exposure to sunrays.
History of exposure to sunrays BCC Cases Control
Yes 120 40
No 80 160
Total 200 200
Estimation of the risk:
Rate of exposure to sun rays among the cases= 120X100 = 60%
200
Rate of exposure to sun rays among control= 40X100 = 20%
200
Because 60% > 20 %
So there is an association between BCC and exposure to sun rays
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Calculation & interpretation of Odds ratio:
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Interpretation of the Odds ratio:
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Cohort study has 2 types:
Prospective cohort study: All data will be collected in the
future
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Concept of a cohort
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Known by a variety of names
Prospective study
Longitudinal study
Incidence study
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Cohort
Cause
Effect
RF
(Disease)
exposure
Case control
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Cohort Studies
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Retrospective
A fourfold table (Case-Control)
E Cases Controls
X Present DISEASE Absent
Prospective
(Cohort)
P
O
S
Present
Exposed a b
U
R
E
Absent
Not exposed c d
Mausner, 1985
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Prospective cohort
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3- Selection of comparison group:
Internal comparison: the same cohort that enters
the study may be classified into several comparison
groups according to the degree of exposure
(smoking, cholesterol) before the development of the
disease in question.
External comparison: if all of my cohort is exposed
to the risk factor (radiologist, so we compare with
ophthalmologist, this would make external
comparison).
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Comparison with the rates of the general
population e.g. mortality experience of the
exposed group is compared with mortality
experience in the general population
(comparing the mortality rate of asbestos
workers with the mortality rate in the general
population).
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4- Follow up:
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Benefits of cohort study:
Persons developed
Persons not exposed to BCC (n=4)
Sunrays
n=400
Persons don't develop
BCC (n=396)
Present Future
Direction of the study
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Tabulation of data:
Calculation of Risk:
1- Relative Risk (RR).
2-Attributable risk percent (ARP).
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Estimation of risks:
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Relative Risk
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1
No relation
Protective between exposure
Risk
& disease
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In the previous example:
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Attributable Risk
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Concept of Attributable Risk
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2- Attributable risk percent (ARP):
ARP = ( Ie - I0 )X100
(Ie)
Design:
Children exposed and not exposed tobacco smoke in their
homes Follow them in time for disease
occurrence.
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Start Outcome
Family smoker Diseased
500 children 300
Exposed
Children Not diseased
(<12 yrs) 1 year 200
1000 Family non-smoker Diseased
500 children 120
Not exposed
Not diseased
380
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Rate: Incidence rate
60
24 = 2.5
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Cohort Study (cont.)
Relative Risk:
Smoking
- Lung Cancer mortality: RR=18.57
- Myocardial infarction mortality: RR=1.35
Information:
S. cholest.level
Bl.pressure , weight
Cig. Smoking Abdikarim A(Epide)JHSC
Occupation Based Studies to study
effect of exposures
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OBJECTIVE: To identify risk factors for breast cancer
among female survivors of childhood cancer.
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PARTICIPANTS: Among 6068 women in the CCSS, 95
women had 111 confirmed cases of breast cancer.
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RESULTS:
Breast cancer risk was increased in survivors who
were treated with chest radiation therapy
(standardized incidence ratio, 24.7 [95% CI, 19.3 to
31.0]) and survivors of bone and soft-tissue sarcoma
who were not treated with chest radiation therapy
(standardized incidence ratios, 6.7 and 7.6,
respectively).
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Survivors of childhood sarcomas and those who
received chest radiation therapy are at risk for
secondary breast cancer. When assessing a survivor's
risk, clinicians should consider primary diagnosis,
previous radiation therapy, family cancer history, and
history of thyroid disease.
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Case-control or Cohort.
How to choose?
When the outcome is rare start with it.
So case-control study.
Search for possible incriminated exposures
retrospectively
When the exposure is rare start with it.
So cohort study.
Follow them up compared with those unexposed
When the exposure is new follow it up. Socohort
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Cancer lung &Smoking
Case-control Cohort
- One group already have - Start by a cohort selected
ca.lung “cases” from population living in a
- 2nd healthy group “controls” locality.
- Comparing smoking status - Individuals in this cohort
“smoker or not & duration of divided into exposed
smoking in past history of “smoker” & non-exposed
both groups” “non-smoker”
- Then these 2 groups followed
for some period of time to
find out who among both
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B. Experimental (Intervention) studies:
(Proving cause-effect relationship)
Active trial to change disease determinant
by the investigator who allocates the
exposure & follows the subjects.
a) Clinical trials:
It is usually used to assess efficacy of a new line of ttt (a
new drug for example) or to compare 2 types of ttts:
surgical or medical.
Diseased subjects are randomly allocated into 2 groups,
"ttt” group (who are given the new drug) and "control
group" (who are given the usual ttt or no ttt in placebo).
Results are assessed by comparing health improvement
of the 2 groups at end of trial.
Example: surgical or medical treatment of peptic ulcer
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EXPERIMENTAL STUDY
Random Allocation ?
Yes No
Randomized Non-Randomized
Controlled trial Controlled trial
(RCT)
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Randomization: assigned to ttt & control group.
Matching: matched pair design to arrange ttt &
control groups similar for the main variables such
as age, sex. Matching determine data analysis.
Cross–over design: In a clinical trial of short term
benefits it may be appropriate to use participants as
their self-controls.
Single & double–blind designs: single blind when
the participants don’t know the preparation while in
double blind method, both investigator &
participants do not know, only (designer) knows.
“Triple blind: subjects & investigators &
statisticians”
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b) Community trials:
Involve people who are not diseased (but presumed likely
to be at risk) and the sample is drawn from the community.
Data collection takes place in the field.
For example: in studies carried out to assess the efficacy
of new vaccines. The participants are divided into 2
groups: one who is the experimental group (will take the
new vaccine) and the 2nd is the control group (will not take
the vaccine).
The participant will be followed to compare the level of
occurrence of the disease in both groups. Therefore, these
groups should be alike as much as possible in all aspects
other than ttt /intervention received.
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Hierarchy of major study designs
RCT Interventional
Cohort Observational
Case control
Cross sectional
Validity Abdikarim A(Epide)JHSC
Exercise1:-
Description of 35 patients with thyroid cancer
are regarding past history of exposure to
radiation and response to surgical treatment
Feedback:-
Case series
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Exercise2:-
Patients admitted for uterine prolapse were age
and social class-matched with fellow patients
without prolapse and surveyed as to chronic
constipation history to assess the possible
association of chronic constipation and uterine
prolapse.
Feedback 2:-
Case-control study
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Exercise3:-
A 39-year old man who presents with mild sore
throat, fever, malaise and headache was treated with
penicillin for presumed streptococcal infection.
He returned after a week with hypotension, fever and
abdominal pain .
A diagnosis of Rocky Mountain spotted fever was
made and he responded good to chloramphenicol.
Feedback 3:-
Case report
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Exercise4:-
A total of 298 who have minor operations during
March 1980 in one hospital, half of them are known
and recorded to be exposed to hepatitis B
contaminated vials discovered and half of them to
vials free of this pollution are followed up starting
from July 2000 till 2010 to diagnose liver cancer.
Feedback 4:-
Retrospective cohort
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Exercise 5:-
500 patients were classified according to their
body mass index (obese or not) and
simultaneously according to having knee
osteoarthrosis
Feedback of Exercise5:-
Prospective cohort
study Abdikarim A(Epide)JHSC
Exercise 7:-
An oncologist determined that 75 out of 100
randomly selected leukemia patients had
experienced exposure to ionizing radiation while 60
out of 100 randomly selected healthy individuals
who did not differ from patient with respect to age
or sex had experienced exposure to ionizing
radiation .
Feedback of Exercise7:-
Case-control study
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Exercise 8:-
In one of two capital cities of two adjacent
governorates, health education & strict application
of helmets use for motorcycle drivers were done &
in the other city no application of such awareness or
law & then the incidence of head injury among
motorcycle drivers was found for a year
Feedback 8:-
Community trial
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Exercise 9:-
A team of clinical researchers decide to investigate
if ovarian cancer responds better to Taxol than to
conventional chemotherapy. They choose suitable
patients & randomize to Taxol & control groups
(subjects are alike, apart from the exposure to which
therapy).