Epidemiological Study Designs

DR NAUMAN ARIF
PhD Scholar Public Health, MS Epidemiology, MPH, CHR
Coordinator Epidemiology / CHR
Faculty Khyber Medical University
Clinical Research Facilitator CPSP
drnauman@kmu.edu.pk
A Systematic and Scientific Process of Data

O Collection RESEARCH is

O Analysis &

O Interpretation

To find solutions to a problem.

Sunday, April 9, 2023 DRNAUMAN@KMU.EDU.PK

 STUDY DESIGNS

Descriptive study designs Analytical study designs

(hypothesis formulation) (hypothesis testing )

Individual based studies Population based studies Observational studies Experimental studies

Case report Ecological Case control RCT’s

Case series cohort Quassi Experimental

Cross-sectional Cross-sectional
4
5
https://libguides.winona.edu/c.php?g=11614&p=61584

6
Descriptive study designs
•Descriptive studies is the systematic collection and presentation of data at
a single point in time to give a clear picture of a particular situation and
can be carried out on a small or large scale.

•Descriptive studies are those studies as a result of which researchers

develop hypothesis
Types of descriptive study designs
Descriptive studies are of two types
Individual based studies
Population based studies
Individual based studies
1. Case report:
A detailed report of an unusual / unique disease or health condition by a physician or researcher
in a single person is called case report.
2. Case series:
A detailed report of an unusual / unique disease or health condition by a physician or researcher
in multiple persons is called case series.
Multiple unusual / unique cases all with the same characteristics are explained in a published
form in known as case series.
3. Cross sectional studies:
Cross sectional study is the single examination of a cross section of a population
at one point in time, the result of which can be applied to the whole population.

Population based studies:

Ecological studies:
Ecological studies are those study designs in which the unit of observation is the
population or community not individuals
1. Case Report
•A case report is a detailed report of the symptoms, signs, diagnosis, treatment,
and follow-up of an individual patient.
•Case reports usually describe an unusual or novel occurrence and as such,
remain one of the cornerstones of medical progress and provide many new
ideas in medicine.
•Some reports contain an extensive review of the relevant literature on the topic.
•The case report is a rapid short communication between busy clinicians who
may not have time or resources to conduct large scale research.
What are the reasons for publishing a case report?
The most common reasons for publishing a case are the following:
•An unexpected association between diseases or symptoms
•An unexpected event in the course observing or treating a patient
•Findings that shed new light on the possible pathogenesis of a disease or an
adverse effect
•Unique or rare features of a disease
•Unique therapeutic approaches; variation of anatomical structures
Most journals publish case reports that deal with one or more of the following:
•Unusual observations
•Adverse response to therapies
•Unusual combination of conditions leading to confusion
•Illustration of a new theory
•Question regarding a current theory
•Personal impact.
Structure of a case report
Different journals have slightly different formats for case reports. It is always a good
idea to read some of the target journals case reports to get a general idea of the
sequence and format.
In general, all case reports include the following components:
•Abstract
•Introduction
•Case
•Discussion
Some journals might require literature review.
Structure of a case report
Abstract
The abstract should summarize the case, the problem it addresses, and the message
it conveys.
Abstracts of case studies are usually very short, preferably not more than 150 words.

Introduction
The introduction gives a brief overview of the problem that the case addresses,
citing relevant literature where necessary. The introduction generally ends with a
single sentence describing the patient and the basic condition that he or she is
suffering from.
Case
This section provides the details of the case in the following order:
•Patient description
•Case history
•Physical examination results
•Results of pathological tests and other investigations
•Treatment plan
•Expected outcome of the treatment plan
•Actual outcome.
The author should ensure that all the relevant details are included and unnecessary
ones excluded.
Discussion
This is the most important part of the case report; the part that will convince the journal that
the case is publication worthy. This section should start by expanding on what has been said in
the introduction, focusing on why the case is noteworthy and the problem that it addresses.
This is followed by a summary of the existing literature on the topic. (If the journal specifies a
separate section on literature review, it should be added before the Discussion). This part
describes the existing theories and research findings on the key issue in the patient's condition.
The review should narrow down to the source of confusion or the main challenge in the case.
Finally, the case report should be connected to the existing literature, mentioning the message
that the case conveys. The author should explain whether this corroborates with or detracts
from current beliefs about the problem and how this evidence can add value to future clinical
practice.
Conclusion
A case report ends with a conclusion or with summary points, depending on the journal's
specified format. This section should briefly give readers the key points covered in the case
report. Here, the author can give suggestions and recommendations to clinicians, teachers, or
researchers. Some journals do not want a separate section for the conclusion: it can then be the
concluding paragraph of the Discussion section.
Patient consent
Informed consent in an ethical requirement for most studies involving humans,
so before you start writing your case report, take a written consent from the
patient as all journals require that you provide it at the time of manuscript
submission. In case the patient is a minor, parental consent is required. For
adults who are unable to consent to investigation or treatment, consent of
closest family members is required.
Patient anonymity is also an important requirement. Remember not to disclose
any information that might reveal the identity of the patient. You need to be
particularly careful with pictures, and ensure that pictures of the affected area
do not reveal the identity of the patient.
Examples
Reinfection of COVID-19 in Pakistan: A First Case Report
Hanif M, Haider MA, Ali MJ, Naz S, Sundas F. Reinfection of COVID-19 in Pakistan: A First Case Report. Cureus. 2020 Oct
26;12(10):e11176. doi: 10.7759/cureus.11176. PMID: 33262913; PMCID: PMC7689968.

First documented reinfection of SARS-COV-2 in second wave from Pakistan

Ul-Haq Z, Khan A, Fazid S, Noor F, Yousafzai YM, Sherin A. First documented reinfection of SARS-COV-2 in second wave
from Pakistan. J Ayub Med Coll Abbottabad. 2020 Oct-Dec;32(Suppl 1)(4):S704-S705. PMID: 33754536.
20
2. Case Series
A detailed report of an unusual / unique disease or health condition by a physician or
researcher in multiple persons is called case series.
Multiple unusual / unique cases all with the same characteristics are explained in a
published form in known as case series.
According to the latest version of the Dictionary of Epidemiology, a case series is defined
as “a collection of patients with common characteristics used to describe some clinical,
pathophysiological or operational aspects of a disease, treatment or diagnostic procedures”.
A case report is the smallest publishable unit in the medical literature while a case-series is
an aggregation of several similar cases.
The general number of cases reported in a case series range from 20 to 50, but may vary
from as few as 5 to as many as more than 100.
Ecological studies
An ecological study is one where the unit of observation and analysis is a group
rather than an individual.

Instead of observing individual measurements in study participants, aggregate

measures that represent an entire population are used.
Ecological Study
■ An ecological study is one in which the units of analysis are

populations or groups of people, rather than individuals

■ Example
 Study of leukemia incidence and exposure to volatile organic chemicals by town
 Study of prostate cancer mortality and dietary consumption of lycopene in
tomatoes by country
■ Gives inference on the association between exposure and outcome at the population
level (culture, religion, geography, climate, etc.) rather than at an individual level (genes,
individual behaviors)

J Fagliano, M Berry, F Bove and T Burke. (1990). Drinking water contamination and the incidence of leukemia: an
ecologic study. American Journal of Public Health, Vol. 80, Issue 10 1209-1212.
Grant WB. (1999). An ecologic study of dietary links to prostate cancer. Altern Med Rev. Jun;4(3):162-9. 10
Example
Figure 10.6 is an example of an
ecological study. The percentage of
people who smoke in each country is
the exposure and the mortality rate
from stroke in each country is the
outcome.
Ecological studies simply measure exposure and outcomes in populations, such
as a district, county, region, country.
For a non health example, you might find that medical schools (population)
which took students with higher A-level grades (exposure) had more honors
students (outcome) at finals.
However this doesn’t necessarily mean that it is the students with the higher
entry grades that achieved honors as the two are not necessarily linked.
Other study designs can directly test this hypothesis.
Annual per capita Chocolate consumption &
Nobel laureates per 10 million population
Correlation between Dietary Fat Intake and Breast Cancer by Country
250 USA

Switzerland

Incidence Rate per 100,000

Canada
Germany
Italy UK Denmark
Israel Sweden France
Australia New Zealand
Norway
Finland
Yugoslavia Spain
Romania Poland
Hu
Hong Kong ngary

Japan

0
600 1600
Per Capita Supply of Fat (calories)
Source: Prentice, Kakar, Hursting, et al., Aspects of the rationale for the Womens’ Health Trial. JNCI 80:802-
814, 1988. 11
3. Cross Sectional study
•A cross-sectional study is a survey of a defined population at a single point in
time.
•Cross sectional study is the single examination of a cross section of a population
at one point in time, the result of which can be applied to the whole population.
•Cross-sectional studies often measure the prevalence of the disease and are also
known as prevalence studies.
•In cross-sectional studies the measurement of exposure and the outcome are
made at the same point.
•Pakistan demographic and health survey, National Nutrition Survey, Multiple
indicator cluster survey, Pakistan economic survey
Advantages
Cross sectional studies are easy to conduct and of short duration.
Cross sectional studies are economical
Cross sectional studies are useful for determining the prevalence or burden of
disease of a specified population.
Prevalence (not incidence)
Fast/Inexpensive - no waiting!
No loss to follow up
Associations can be studied
Disadvantages
Cross sectional studies only provide a snapshot in time of a situation in which
data regarding both exposure to the risk factors and the presence or absence of
disease are collected simultaneously.
Difficult to determine temporal relationship of a presumed cause and effect.
Cannot determine causality
Cannot study rare outcomes
Design Defined
Begin with: Population

Gather data on exposure and disease

Four
Exposed; Exposed; Not Not Exposed;
Groups
Have Do Not Exposed; Do Not Have
Are
Disease Have Have Disease
Possible
Disease Disease
 Disease No Disease Disease No Disease
Exposed a b Exposed a b
Not Not
Exposed c d Exposed c d

Prevalence of exposure in Prevalence of disease

Disease and No Disease in Exposed compared
to Not Exposed
a b a c
vs. vs.
a+c a+b c+
b+ d d
Approaches to analysis of cross sectional
studies
Research Question
Is the regular consumption of Red Bull
associated with improved academic
performance among U.S. medical students?
Study Design
Cross-sectional study of UCSF medical students taking USMLE
Step 2

Questionnaire administered when registering for USMLE 2

◦ Primary predictor: self-report of >3 cans Red Bull per week for the
previous year
◦ Covariates: Age, sex, undergraduate university, place of birth

Outcome: Score on USMLE Step 2

Cross-sectional study: structure

Red Bull consumption

USMLE Score

time
Cross-sectional Study:
Descriptive value:
◦ How many UCSF medical students drink Red Bull?
◦ What is the age and sex distribution of UCSF medical students who drink Red
Bull?
Analytic value:
◦ Is there an association between regular Red Bull consumption and test scores
among UCSF med students?
◦ Univariate
◦ Multivariate (controlling for “confounders”)

Other cross-sectional surveys:

◦ National Health and Nutrition Exam Survey (NHANES)
◦ National Oral health survey
 Design of a Cohort Study
Identify:
Exposed Not exposed

follow:

Develop Do not Develop Do not

disease develop disease develop
disease disease

3
 Design of a Cohort Study
Begin with: Defined population

Non-randomize
d

Identify :
Exposed Not exposed

follow:

Develop Do not Develop Do not

disease develop disease develop
disease disease
3
 Comparison of Experimental vs.
Observational
Experimental
Study
Observational
(Randomized trial) (Cohort
study)

Population Population

Random allocation Other-than-random allocation

Group A Group B Group A Group B

4
 Cohort Study

Totals

Exposed a+ b
First,
identify Not
exposed c+d

4
 Cohort Study
Then, follow to see whether
Disease
Disease does not
develops develop Totals

Exposed a b a+ b
First,
Not
identify exposed c d c+d

4
Cohort Study Calculate
Then, follow to see whether and
Disease compare
Disease does not Incidence
develops develop Totals of
disease

a
Exposed a b a+ b
First, a+ b
identify Not c
exposed c d c+d c+ d

a c
 Incidence in  Incidence in not
exposed a + b exposed c + d
4
 Cohort Study Calculate
Then, follow to see whether
Do not
Develop develop Incidence
CHD CHD Totals of
disease
Smoke 84
cigarettes 84 2916 3000
First, 3000
select Do not 87
smoke 87 4913 5000
cigarettes 5000

84
 0.028  Incidencein'smoke cigarettes'
3000
87
 0.0174 =Incidencein 'notsmoke cigarettes '
5000 7
 Types of Cohort Studies
■ Prospective cohort study
 Concurrent cohort study or longitudinal study
■ Retrospective cohort study
 Non-concurrent cohort or historical cohort study

= Investigator

10
Time Frames for a Hypothetical
Prospective Cohort Study Conducted in 2000
Defined population
2000
Non-randomize
Prospective d

Not
Exposed
exposed

No No
Disease Disease
disease disease

46
Time Frames for a Hypothetical
Retrospective Cohort Study ConductedRetrospective
in 2000
Defined population
1980
Non-randomized

Not
Exposed
exposed

No No
Disease Disease
disease disease 2000
47
Differentiating between Prospective and Retrospective
■ Prospective cohort study
 Investigator
€ Starts the study (from the beginning) with the
identification of the population and the exposure
status (exposed/not exposed groups)
€ Follows them (over time) for the development of
disease
€ Takes a relatively long time to complete the study (as
long as the length of the study)

48
Differentiating between Prospective and Retrospective
■ Retrospective cohort study
 Investigator
€ Uses existing data collected in the past to identify the population
and the exposure status (exposed/not exposed groups)
€ Determines at present the (development) status of disease

 Investigator spends a relatively short time to:

€ Assemble study population (and the exposed/not exposed
groups) from past data
€ Determine disease status at the present time (no future
follow-up)

49
Combined Prospective and Retrospective Cohort Study
■ Investigator uses existing data collected in the past to:
 Identify the population and the exposure status
(exposed/not exposed groups)
 Follow them into the future for the development of the
disease
■ Investigator
 Spends a relatively short time to assemble study population
(and the exposed/not exposed groups) from past data
 Will spend additional time following them into the future for the
development of disease

50
Example of a Prospective Cohort Study: Framingham
Study
Defined Framingham
Prospective study population
1948
Non-randomize
d

Not
Exposed
exposed

No No
Disease Disease
disease disease
51
Framingham Study
Objectives
To study the impact of several factors on
incidence of cardiovascular diseases
Exposures
Blood pressure, smoking, body weight,
diabetes, exercise, etc.

Multiple Outcomes
Coronary heart disease, stroke, congestive
heart failure, peripheral arterial disease

52
Framingham Study as a Cohort Study
■ The study started with a defined population
 Investigators started by identifying a new population
and did not use existing data to identify the population
and the exposure groups
■ There were several hypotheses to be tested
 Different exposures and different outcomes
■ For each exposure, investigators identified the “exposed” and
the “not exposed” groups
■ For each exposure, the participants were followed for the
development of disease
■ Different exposures were studied, as well as different
diseases
53
Derivation of the Framingham Study Population
Men Women Total
Random sample 3074 3433 6507

Respondents 2024 2445 4469

Volunteers 312 428 740

Respondents free of
CHD* 1975 2418 4393

Volunteers free of CHD 307 427 734

Total Free of CHD 2282 2845 5127

* CHD = coronary heart
disease 54
Follow-Up of Participants

■ Risk factors and the development of cardiovascular events

were evaluated every two years by medical history, medical
record review, and physical examination
■ All diagnoses were verified without knowledge of risk factors
by Framingham examiners who reviewed medical records
and death certificates
■ Approximately three percent of the subjects were lost to
follow-up for mortality during the first 45 years of the study

20
 Timeline of Milestones from the
Framingham Study
■ 1948: start of the Framingham Heart Study
■ 1960: cigarette smoking found to increase risk of heart disease
■ 1961: cholesterol, blood pressure, and ECG abnormalities found to increase risk of
heart disease
■ 1965: first Framingham Heart Study report on stroke
■ 1967: physical activity found to reduce risk of heart disease; obesity to increase the risk
■ 1970: high blood pressure found to increase the risk of stroke
■ 1974: diabetes found to be associated with cardiovascular disease
■ More milestones: www.framingham.com/heart/timeline.htm

http://www.framingham.com/heart/timeline.htm 21
 Book
■ A Change of Heart: How the
People of Framingham,
Massachusetts, Helped Unravel
the Mysteries of
Cardiovascular Disease

57
Average Annual Incidence of Coronary Heart Disease by
Weight, Gender, and Age Group
20
Women

Rate per 1,000

10

0
30

20
Men

10

0
40-49 50-59 60-69 70-79
Above median weight Age group
Below median weight
58
Average Annual Incidence of Coronary
Heart Disease by Systolic Blood Pressure
30

Rate per 1,000

25

20

15

10

0
<120 120–139 140–159 160–179 180+
Men
Women
Systolic blood pressure, mm Hg
59
CHD Risk Assessment Based on Relationship Between
HDL and LDL Cholesterol Men 50–70 Years

Average risk

Relative Risk
2

0
HDL < 26 100 160 220
mg/dl HDL <
56 mg/dl HDL LDL cholesterol
< 86 mg/dl (mg/dl)Study Update. Hosp Pract (Off Ed) 1990;25:119-127. 25
Source: Kannel WB. CHD Risk Factors: a Framingham
Types of Potential Bias in Cohort
Studies
■ Selection bias
 Select participants into exposed and not exposed groups
based on some characteristics that may affect the
outcome
■ Information bias
 Collect different quality and extent of information from
exposed and not exposed groups
 Loss to follow-up differs between exposed and not
exposed (or between disease and no disease)
■ Misclassification bias
 Misclassify exposure status or disease status
61
When Is a Cohort Study Warranted?
■ When the (alleged) exposure is known
■ When exposure is rare and incidence of disease among
exposed is high (even if the exposure is rare, determined
investigators will identify exposed individuals)
■ When the time between exposure and disease is relatively short
■ When adequate funding is available
■ When the investigator has a long life expectancy

62
 Review
■ What are the differences in the study design between
prospective cohort study and retrospective cohort study?
■ What are the differences in the study design between
randomized clinical trial study and cohort study?
■ Why is cohort study preferred for studying rare
exposure?

63
 Cohort Studies
Dr Nauman Arif
PhD Scholar, MS Epidemiology, MPH
Coordinator Epidemiology
Khyber Medical University
drnauman@kmu.edu.pk
 Design of a Cohort Study
Identify:
Exposed Not exposed

follow:

Develop Do not Develop Do not

disease develop disease develop
disease disease

6
 Design of
Begin with:
a Cohort Study
Defined population

Non-randomize
d

Identify :
Exposed Not exposed

follow:

Develop Do not Develop Do not

disease develop disease develop
disease disease
6
 Comparison of Experimental vs.
Observational
Experimental StudyObservational
(Randomized trial) (Cohort
study)

Population Population

Random allocation Other-than-random allocation

Group A Group B Group A Group B

6
 Cohort Study

Totals

Exposed a+ b
First,
identify Not
exposed c+d

6
 Cohort Study
Then, follow to see whether
Disease
Disease does not
develops develop Totals

Exposed a b a+ b
First,
Not
identify exposed c d c+d

6
 Cohort Study
Then, follow to see whether
and
Calculate

Disease compare
Disease does not Incidence
develops develop Totals of
disease

a
Exposed a b a+ b
First, a+ b
identify Not c
exposed c d c+d c+ d

a c
 Incidence in  Incidence in not
exposed a + b exposed c + d
7
 Cohort Study Calculate
Then, follow to see whether
Do not
Develop develop Incidence
CHD CHD Totals of
disease
Smoke 84
cigarettes 84 2916 3000
First, 3000
select Do not 87
smoke 87 4913 5000
cigarettes 5000

84
 0.028  Incidencein'smoke cigarettes'
3000
87
 0.0174 =Incidencein 'notsmoke cigarettes '
5000 7
 Types of Cohort Studies
■ Prospective cohort study
 Concurrent cohort study or longitudinal study
■ Retrospective cohort study
 Non-concurrent cohort or historical cohort study

= Investigator

10
 Time Frames for a Hypothetical
Prospective Cohort Study Conducted in
2000
Prospective Defined population
2000
Non-randomize
d

Not
Exposed
exposed

No No
Disease Disease
disease disease

73
 Time Frames for a Hypothetical
Retrospective Cohort Study Conducted
in 2000Defined population Retrospective
1980
Non-randomized

Not
Exposed
exposed

No No
Disease Disease
disease disease 2000
74
 Differentiating between Prospective an
■
Retrospective
Prospective cohort study
 Investigator
€ Starts the study (from the beginning) with the
identification of the population and the exposure
status (exposed/not exposed groups)
€ Follows them (over time) for the development of
disease
€ Takes a relatively long time to complete the study (as
long as the length of the study)

75
 Differentiating between Prospective an
■
Retrospective
Retrospective cohort study
 Investigator
€ Uses existing data collected in the past to identify the
population and the exposure status (exposed/not
exposed groups)
€ Determines at present the (development) status of
disease
 Investigator spends a relatively short time to:
€ Assemble study population (and the exposed/not
exposed groups) from past data
€ Determine disease status at the present time (no
future follow-up)

76
 Combined Prospective and
■
Retrospective Cohort Study
Investigator uses existing data collected in the past to:
 Identify the population and the exposure status
(exposed/not exposed groups)
 Follow them into the future for the development of the
disease
■ Investigator
 Spends a relatively short time to assemble study
population (and the exposed/not exposed groups) from
past data
 Will spend additional time following them into the future
for the development of disease

77
Study: Framingham
Study
Defined Framingham
Prospective study population
1948
Non-randomize
d

Not
Exposed
exposed

No No
Disease Disease
disease disease
78
Framingham Study
Objectives
To study the impact of several factors on
incidence of cardiovascular diseases

Exposures
Blood pressure, smoking, body weight,
diabetes, exercise, etc.

Multiple Outcomes
Coronary heart disease, stroke, congestive
heart failure, peripheral arterial disease

79
■
Framingham Study as
The study started with a defined population
a Cohort Study
 Investigators started by identifying a new population
and did not use existing data to identify the population
and the exposure groups
■ There were several hypotheses to be tested
 Different exposures and different outcomes
■ For each exposure, investigators identified the “exposed” and
the “not exposed” groups
■ For each exposure, the participants were followed for the
development of disease
■ Different exposures were studied, as well as different
diseases

80
Derivation of the Framingham Study
Population Men Women Total
Random sample 3074 3433 6507

Respondents 2024 2445 4469

Volunteers 312 428 740

Respondents free of
CHD* 1975 2418 4393

Volunteers free of CHD 307 427 734

Total Free of CHD 2282 2845 5127

* CHD = coronary heart

disease 81
 Follow-Up of Participants
■ Risk factors and the development of cardiovascular events
were evaluated every two years by medical history, medical
record review, and physical examination
■ All diagnoses were verified without knowledge of risk factors
by Framingham examiners who reviewed medical records
and death certificates
■ Approximately three percent of the subjects were lost to
follow-up for mortality during the first 45 years of the study

20
 Timeline of Milestones from the
Framingham Study
■ 1948: start of the Framingham Heart Study
■ 1960: cigarette smoking found to increase risk of heart disease
■ 1961: cholesterol, blood pressure, and ECG abnormalities found to increase risk of
heart disease
■ 1965: first Framingham Heart Study report on stroke
■ 1967: physical activity found to reduce risk of heart disease; obesity to increase the risk
■ 1970: high blood pressure found to increase the risk of stroke
■ 1974: diabetes found to be associated with cardiovascular disease
■ More milestones: www.framingham.com/heart/timeline.htm

http://www.framingham.com/heart/timeline.htm 21
■
Book
A Change of Heart: How the
People of Framingham,
Massachusetts, Helped Unravel
the Mysteries of
Cardiovascular Disease

84
Weight, Gender, and Age
Group
20
Women

Rate per 1,000

10

0
30

20
Men

10

0
40-49 50-59 60-69 70-79
Above median weight Age group
Below median weight
85
Coronary Heart Disease by
Systolic Blood Pressure

30

Rate per 1,000

25

20

15

10

0
<120 120–139 140–159 160–179 180+
Men
Women
Systolic blood pressure, mm Hg
86
 CHD Risk Assessment Based on
Relationship Between HDL and LDL
Cholesterol Men 50–70 Years
3

Average risk

Relative Risk
2

0
HDL < 26 100 160 220
mg/dl HDL <
56 mg/dl HDL LDL cholesterol
< 86 mg/dl (mg/dl)Study Update. Hosp Pract (Off Ed) 1990;25:119-127. 25
Source: Kannel WB. CHD Risk Factors: a Framingham
 Types of Potential Bias in Cohort
■
Studies
Selection bias
 Select participants into exposed and not exposed groups
based on some characteristics that may affect the
outcome
■ Information bias
 Collect different quality and extent of information from
exposed and not exposed groups
 Loss to follow-up differs between exposed and not
exposed (or between disease and no disease)
■ Misclassification bias
 Misclassify exposure status or disease status

88
■
When Is a Cohort Study
When the (alleged) exposure is known
Warranted?
■ When exposure is rare and incidence of disease among
exposed is high (even if the exposure is rare, determined
investigators will identify exposed individuals)
■ When the time between exposure and disease is
relatively short
■ When adequate funding is available
■ When the investigator has a long life expectancy

89
■
Review
What are the differences in the study design between
prospective cohort study and retrospective cohort study?
■ What are the differences in the study design between
randomized clinical trial study and cohort study?
■ Why is cohort study preferred for studying rare
exposure?

90
Group work 2
Case-cohort study design
https://online.stat.psu.edu/stat507/lesson/7/7.2/7.2.1

Case cross over study design.

https://online.stat.psu.edu/stat507/lesson/7/7.2/7.2.2

Nested case control study design.

91
Reading materials
Research Methods
https://online.stat.psu.edu/stat507/lesson/welcome-stat-507

Epidemiology Of Study Design (updated April 2021)

https://www.ncbi.nlm.nih.gov/books/NBK470342/

Epidemiological Study Designs: Traditional and Novel Approaches to Advance Life Course Health Development
Research
https://www.ncbi.nlm.nih.gov/books/NBK543721/

Introduction to Epidemiological Studies (2018)

https://sci-hub.do/https://link.springer.com/protocol/10.1007/978-1-4939-7868-7_1

Quality and transparency of research

https://www.equator-network.org/ 92
Systematic reviews and meta analysis

https://www.cochranelibrary.com/cdsr/about-cdsr

https://www.covidence.org

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