EPIDEMIOLOGICAL RESEARCH METHODS

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Contents
SECTION 1: RECALL ............................................................................................................................................... 3
USES OF EPIDEMIOLOGY ....................................................................................................................................... 3
Characteristic Features of epidemiological Methods ........................................................................................... 3
SECTION 2: METHODS OF EPIDEMIOLOGICAL RESEARCH .................................................................................... 5
3 Ds in Epidemiological Methods:......................................................................................................................... 5
2.1- DESCRIPTIVE EPIDEMIOLOGY ........................................................................................................................ 6
PURPOSE OF DESCRIPTIVE EPIDEMIOLOGY .......................................................................................................... 6
2.1.1. CASE STUDIES(CASE SERIES)........................................................................................................................ 6
2.1.2. CROSS-SECTIONAL STUDY ........................................................................................................................... 6
CROSS-SECTIONAL STUDY ADVANTAGES.............................................................................................................. 7
CROSS-SECTIONAL STUDY DISADVANTAGES ........................................................................................................ 7
2.1.3. CORRELATIONAL STUDY DESIGN ................................................................................................................ 7
2.2. ANALYTICAL STUDIES ..................................................................................................................................... 7
OBSERVATIONAL VS EXPERIMENTAL STUDIES...................................................................................................... 9
2.2.1. OBSERVATIONAL STUDIES........................................................................................................................... 9
2.2.1.1. COHORT STUDY. ....................................................................................................................................... 9
2.2.1.2. CASE-CONTROL STUDY........................................................................................................................... 10
2.2.1.3. CROSS-SECTIONAL STUDY. ..................................................................................................................... 11
2.2.2. EXPERIMENTAL STUDIES ........................................................................................................................... 12
2.2.3.1 UNCONTROLLED EXPERIMENTAL STUDIES ............................................................................................. 13
2.2.3.2 CONTROLLED EXPERIMENTAL STUDIES .................................................................................................. 13
A. METHODOLOGY ...................................................................................................................................... 13
B. STUDY POPULATION ............................................................................................................................... 13
ADVANTAGES OF EXPERIMENTAL STUDIES .................................................................................................... 13
DISADVANTAGES ............................................................................................................................................. 13
Limitations of epidemiology ............................................................................................................................... 16
Measurement of disease .................................................................................................................................... 17
 Mortality ..................................................................................................................................................... 17
 Morbidity (incidence and prevalence) ........................................................................................................ 17
 distribution.................................................................................................................................................. 17
Formulation of an etiological hypothesis ........................................................................................................... 17
Community Trial.................................................................................................................................................. 17
IN CONCLUSION .................................................................................................................................................. 17

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SECTION 1: RECALL
Epidemiology is the study (scientific, systematic, data-driven) of the distribution
(frequency, pattern) and determinants (causes, risk factors) of health-related states and
events (not just diseases) in specified populations (patient is community, individuals viewed
collectively), and the application of (since epidemiology is a discipline within public health)
this study to the control of health problems.
In other words, it is the study of incidence, prevalence and distribution of illness or
disease in a given population. It is a hybrid Science

Features of a disorder or Disease

1. Incidence: frequency of occurrence of an event or a condition in relation to population under

examination. Refers to the number of cases that occurs for a given period of time

2. Prevalence: total number of cases of a disease or disorder in a specific population at a point in

time. May be currently or during the lifetime (point prevalence and life-time prevalence)

USES OF EPIDEMIOLOGY
1. to determine, describe, and report on the natural course of disease, disability, injury, and
death
2. to aid in the planning and development of health services and programs
3. to provide administrative and planning data
4. to study the cause (or etiology) of disease(s), or conditions, disorders, disabilities, etc.
5. to determine the primary agent responsible or ascertain causative factors
6. to determine the characteristics of the agent or causative factors
7. to determine the mode of transmission I to determine contributing factors
8. to identify and determine geographic patterns

Characteristic Features of epidemiological Methods

1. Largely used as correlational design
2. Includes survey and interview technique
3. Finding prevalence and incidence of disease or disorder.
4. Planning for healthcare
5. Understanding health trends
6. Understanding cause of disease
7. Planning for treatment/intervention

Two Broad Types of Epidemiology:

1 descriptive epidemiology: examining the distribution of disease in a population, and

observing the basic features of its distribution. Descriptive epidemiology is antecedent to
analytical epidemiology: analytical epidemiology studies require information to

 know where to look------place distribution

 know when the disease is occurring----time distribution
 Who is getting the disease----persons distribution
 develop viable hypotheses

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 Three essentials characteristics of disease that we look for in descriptive studies are ...

 Person-

 age, gender, ethnic group

 genetic predisposition
 concurrent disease
 diet, physical activity, smoking
 risk taking behavior
 SES, education, occupation

 Place-
 presence of agents or vectors
 climate I geology
 population density
 economic development
 nutritional practices
 medical practices
 Time-
 calendar time
 time since an event
 physiologic cycles
 age (time since birth)
 seasonality
 temporal trends

2 Analytical method

• Case-control studies • Cohort studies: Prospective and Retrospective

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SECTION 2: METHODS OF EPIDEMIOLOGICAL RESEARCH

Epidemiological Research Method is a method of study incidence and prevalence of disease in a
given population.

3 Ds in Epidemiological Methods:
D1: Disease frequency D2: Distribution of disease D3: Determinants of disease

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2.1- DESCRIPTIVE EPIDEMIOLOGY

PURPOSE OF DESCRIPTIVE EPIDEMIOLOGY

• To generate hypothesis
• To permit evaluation of trends in health & disease and comparisons among
countries and subgroups within countries.
• To provide a basis for planning, provision and evaluation of health services
• To identify problems to be studied by analytical methods and to suggest areas
that may be fruitful for investigation

2.1.1. CASE STUDIES(CASE SERIES)

• Case reports:documents unusual medical occurrence and can represent the first
clues to the formulation of hypothesis, generally report a new or unique findings
and previous undescribed disease.
• Case series: collection of individual case reports which may occur within a fairly
short time, and experience of a group of patients with similar diagnosis.

Advantages

• Useful for hypothesis generation

• Informative for very rare disease with few established risk factors
• Usually of short duration.

Disadvantages

• Cannot study cause and effect relationships

• Cannot assess disease frequency

2.1.2. CROSS-SECTIONAL STUDY

• It is also called epidemiologic study or prevalence study

• It analyses (describes)data collected on a group of subjects at one point in time
rather than over a period of time. i.e they survey exposure and disease at a
single point in time.
• Both exposure and outcome variables are been evaluated at the same point in
time(without any inbuilt directionality)
• Most sophisticated descriptive study
• It answers the question “WHAT IS HAPPENING RIGHT NOW?”

With
subjects outcome
Without
outcome

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Question: “what is happening?”

no direction of inquiry

CROSS-SECTIONAL STUDY ADVANTAGES

• Best for determining the status quo(prevalence)

• Quick
• Relatively inexpensive

CROSS-SECTIONAL STUDY DISADVANTAGES

• Only a snapshot at a time leading to a misinformation

• Response rate may be low ,with result not representative of the population
• Weakest observational design, (it measures prevalence, not incidence of disease).
Prevalent cases are survivors
• The temporal sequence of exposure and effect may be difficult or impossible to
determine
• Usually don’t know when disease occurred
• Rare events a problem. Quickly emerging diseases a problem

2.1.3. CORRELATIONAL STUDY DESIGN

• A study comparing incidence/prevalence of one event against another on a

global scale
• Measures that represent characteristics of entire populations are used to
describe the disease in relation to some factor of interest (such as age, calendar
time, food consumption, drug use and utilization of health services)

ADVANTAGE

• Compares events among nations

DISADVANTAGE

• Doesn’t compare individuals, so it might lead to overgeneralization.

Procedures in Descriptive studies

1. Define the population to be studied

2. Defines the disease
3. Describe the disease by: Time, place and person
4. Measurement of disease
5. Comparing with known indices
6. Formulation of hypothesis

2.2. ANALYTICAL STUDIES

As noted earlier, descriptive epidemiology can identify patterns among cases and in
populations by time, place and person. From these observations, epidemiologists
develop hypotheses about the causes of these patterns and about the factors that

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increase risk of disease. In other words, epidemiologists can use descriptive

epidemiology to generate hypotheses, but only rarely to test those hypotheses. For that,
epidemiologists must turn to analytic epidemiology.

Key feature of analytic epidemiology =Comparison group

The key feature of analytic epidemiology is a comparison group.

Consider a large outbreak of hepatitis A that occurred in Pennsylvania in 2003.(38) Investigators

found almost all of the case-patients had eaten at a particular restaurant during the 2–6 weeks
(i.e., the typical incubation period for hepatitis A) before onset of illness. While the investigators
were able to narrow down their hypotheses to the restaurant and were able to exclude the food
preparers and servers as the source, they did not know which particular food may have been
contaminated. The investigators asked the case-patients which restaurant foods they had eaten,
but that only indicated which foods were popular. The investigators, therefore, also enrolled and
interviewed a comparison or control group — a group of persons who had eaten at the restaurant
during the same period but who did not get sick. Of 133 items on the restaurant’s menu, the most
striking difference between the case and control groups was in the proportion that ate salsa (94%
of case-patients ate, compared with 39% of controls). Further investigation of the ingredients in
the salsa implicated green onions as the source of infection. Shortly thereafter, the Food and Drug
Administration issued an advisory to the public about green onions and risk of hepatitis A. This
action was in direct response to the convincing results of the analytic epidemiology, which
compared the exposure history of case-patients with that of an appropriate comparison group.

When investigators find that persons with a particular characteristic are more likely
than those without the characteristic to contract a disease, the characteristic is said to
be associated with the disease. The characteristic may be a:
 Demographic factor such as age, race, or sex;
 Constitutional factor such as blood group or immune status;
 Behavior or act such as smoking or having eaten salsa; or
 Circumstance such as living near a toxic waste site.
Identifying factors associated with disease help health officials appropriately target
public health prevention and control activities. It also guides additional research into
the causes of disease.

Thus, analytic epidemiology is concerned with the search for causes and effects, or the
why and the how. Epidemiologists use analytic epidemiology to quantify the association
between exposures and outcomes and to test hypotheses about causal relationships. It
has been said that epidemiology by itself can never prove that a particular exposure
caused a particular outcome. Often, however, epidemiology provides sufficient evidence
to take appropriate control and prevention measures.

Epidemiologic studies fall into two categories: experimental and observational.

NOTE

• There must be a comparison group

• No control No conclusion(NCNC)

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OBSERVATIONAL VS EXPERIMENTAL STUDIES

• Observational studies

Allow nature to take its cause; the investigator measures but does not intervene

• Descriptive study: focuses on the description of the occurrence of a disease in a

population
• Analytical study analyses relationships between health status and other
variables
• Experimental or interventional studies: involve an active attempt to change a
disease determinant(e.g an exposure or a behaviour) or the progress of a
disaese (through treatment)
• The studies are based on a grp which has had the experience compared with
control grp which has not had the experience.

2.2.1. OBSERVATIONAL STUDIES

In an observational study, the epidemiologist simply observes the exposure and disease
status of each study participant. John Snow’s studies of cholera in London were
observational studies. The two most common types of observational studies are
cohort studies and case-control studies; a third type is cross-sectional studies.

2.2.1.1. COHORT STUDY.

A cohort study is similar in concept to the experimental study. In a cohort study the
epidemiologist records whether each study participant is exposed or not, and then
tracks the participants to see if they develop the disease of interest. It’s a
LONGITUDNAL STUDY (like cohort study) because it’s a study over a period of time

Note that this differs from an experimental study because, in a cohort study, the
investigator observes rather than determines the participants’ exposure status. After a
period of time, the investigator compares the disease rate in the exposed group with the
disease rate in the unexposed group. The unexposed group serves as the comparison
group, providing an estimate of the baseline or expected amount of disease occurrence
in the community. If the disease rate is substantively different in the exposed group
compared to the unexposed group, the exposure is said to be associated with illness.

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The length of follow-up varies considerably. These studies are sometimes called follow-
up or prospective cohort studies, because participants are enrolled as the study begins
and are then followed prospectively over time to identify occurrence of the outcomes of
interest.

An alternative type of cohort study is a retrospective cohort study. In this type of study
both the exposure and the outcomes have already occurred. Just as in a prospective
cohort study, the investigator calculates and compares rates of disease in the exposed
and unexposed groups. Retrospective cohort studies are commonly used in
investigations of disease in groups of easily identified people such as workers at a
particular factory or attendees at a wedding. For example, a retrospective cohort study
was used to determine the source of infection of cyclosporiasis, a parasitic disease that
caused an outbreak among members of a residential facility in Pennsylvania in 2004.

ADVANTAGES OF COHORT

• There is no bias
• The risk can be calculated bcos the incidence can be calculated
• It is effective for studying rare exposures
• It allows the study of the natural history of the disease
• It assists in determining the temporal relationship between the etiological factor
& the disease

Disadv of cohort study

• It takes a long time

• It is expensive
• Large no of subjects are needed
• There could be changes in the standard methods or diagnostic criteria

2.2.1.2. CASE-CONTROL STUDY.

In a case-control study, investigators start by enrolling a group of people with disease
(at CDC such persons are called case-patients rather than cases, because case refers to
occurrence of disease, not a person). As a comparison group, the investigator then

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enrolls a group of people without disease (controls). Investigators then compare

previous exposures between the two groups. The control group provides an estimate of
the baseline or expected amount of exposure in that population. If the amount of
exposure among the case group is substantially higher than the amount you would
expect based on the control group, then illness is said to be associated with that
exposure. The study of hepatitis A traced to green onions, described above, is an
example of a case-control study. The key in a case-control study is to identify an
appropriate control group, comparable to the case group in most respects, in order to
provide a reasonable estimate of the baseline or expected exposure.

Advantages of case control

• It is relatively easy to carry out bcos we go back to existing records in the

hospital
• It is also rapid and inexpensive
• It requires comparatively few subjects
• It can assist one in studying different etiological factors
• One does not need an ethical clearance
• There is no risk to the subject

Disadvantages of case control

 It introduces bias
 To select an appropriate control could be difficult
 It may be difficult to distinguish between the cause of a disease and an associated
factor

2.2.1.3. CROSS-SECTIONAL STUDY.

In this third type of observational study, a sample of persons from a population is
enrolled and their exposures and health outcomes are measured simultaneously. The
cross-sectional study tends to assess the presence (prevalence) of the health outcome at
that point of time without regard to duration. For example, in a cross-sectional study of
diabetes, some of the enrollees with diabetes may have lived with their diabetes for
many years, while others may have been recently diagnosed.

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From an analytic viewpoint the cross-sectional study is weaker than either a cohort or a
case-control study because a cross-sectional study usually cannot disentangle risk
factors for occurrence of disease (incidence) from risk factors for survival with the
disease. (Incidence and prevalence are discussed in more detail in Lesson 3.) On the
other hand, a cross-sectional study is a perfectly fine tool for descriptive epidemiology
purposes. Cross-sectional studies are used routinely to document the prevalence in a
community of health behaviors (prevalence of smoking), health states (prevalence of
vaccination against measles), and health outcomes, particularly chronic conditions
(hypertension, diabetes).

In summary, the purpose of an analytic study in epidemiology is to identify and quantify

the relationship between an exposure and a health outcome. The hallmark of such a
study is the presence of at least two groups, one of which serves as a comparison group.
In an experimental study, the investigator determines the exposure for the study
subjects; in an observational study, the subjects are exposed under more natural
conditions. In an observational cohort study, subjects are enrolled or grouped on the
basis of their exposure, then are followed to document occurrence of disease.
Differences in disease rates between the exposed and unexposed groups lead
investigators to conclude that exposure is associated with disease. In an observational
case-control study, subjects are enrolled according to whether they have the disease or
not, then are questioned or tested to determine their prior exposure. Differences in
exposure prevalence between the case and control groups allow investigators to
conclude that the exposure is associated with the disease. Cross-sectional studies
measure exposure and disease status at the same time, and are better suited to
descriptive epidemiology than causation.

• A group of affected people is compared to unaffected people(the control)

2.2.2. EXPERIMENTAL STUDIES

In an experimental study, the investigator determines through a controlled process the
exposure for each individual (clinical trial) or community (community trial), and then
tracks the individuals or communities over time to detect the effects of the exposure.
For example, in a clinical trial of a new vaccine, the investigator may randomly assign
some of the participants to receive the new vaccine, while others receive a placebo shot.
The investigator then tracks all participants, observes who gets the disease that the new
vaccine is intended to prevent, and compares the two groups (new vaccine vs. placebo) to
see whether the vaccine group has a lower rate of disease. Similarly, in a trial to prevent
onset of diabetes among high-risk individuals, investigators randomly assigned enrollees
to one of three groups — placebo, an anti-diabetes drug, or lifestyle intervention. At the
end of the follow-up period, investigators found the lowest incidence of diabetes in the
lifestyle intervention group, the next lowest in the anti-diabetic drug group, and the
highest in the placebo group

• Studies in which 1 grp is deliberately subjected to an experience compared with

a control group with no similar experience
• The gold standard in medicine bcos it proves causality
• Can be controlled or uncontrolled

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2.2.3.1 UNCONTROLLED EXPERIMENTAL STUDIES

• Intervention is not compared with a control

• The aim is to confirm that the Intervention made a difference

2.2.3.2 CONTROLLED EXPERIMENTAL STUDIES

• In this study, a drug or procedure is compared to:

1. Another drug
2. Procedure
3. Placebo
4. Previously accepted tx

• The aim is to proove the difference due to tx

• Blind trial-single or double

• Control could be:

A. METHODOLOGY

1. Concurrent or parallel: randomized or non- randomized(quasi)

2. Sequential control: self controlled or cross over
3. External control

B. STUDY POPULATION

1. Clinical trials
2. Field trials
3. Community trials

ADVANTAGES OF EXPERIMENTAL STUDIES

• Best study type

• Greatest proof of causality
• Gold standard for other design
• Least bias
• Proves best tx or procedure efficacy

DISADVANTAGES

• Greatest expense
• Long duration
• Unproven facts adopted by community can hinder study acceptance

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Table: Summary of advantages and disadvantages of the main analytical

epidemiological studies
Study type Advantages Disadvantages

Cohort  Can be performed  Are time-consuming

retrospectively or and costly (especially
prospectively; can be used prospective studies);
to obtain a true (absolute)  Can study only those
measure of risk (relative risk factors measured
risk); at the beginning of the
 Can study many disease study;
outcomes; are good for  Can be used only for
studying rare risk factors. common diseases;
 May have losses to
follow-up.

Case-control  Case-control studies are  Can obtain only a

very useful when a study relative measure of
must be done quickly or risk (odds ratio)
inexpensively or the (however odds ratios
disease being studied is are similar to risk
rare (prevalence <1%) ratios for rare
such as Legionnaires' diseases);
Disease.  are subject to recall
 Many risk factors can be bias;
considered and this makes  selection of controls
case-control studies useful may be difficult;
for generating hypotheses temporal relationships
concerning the causes of a may be unclear; can
disease [1]. study only one disease

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outcome at a time.

Nested case-  Investigators can test new  Non-diseased persons,

control hypotheses with data that from whom the
were collected at baseline; controls are selected,
 because the data were may not be fully
collected before the representative of the
outcome occurred, it is original cohort, due to
often possible to know the death or failure to
direction of causation; follow-up cases.
 recall bias should not be a
problem, because the
condition itself would not
have influenced recall;
 design saves both time
and money e.g. if
expensive baseline blood
work results may only be
performed for persons
who subsequently
participate in the nested
case-control study.

Case cohort  Efficient if several types of  Inclusion of "cases" in

cases to compare to same the comparison group
pre-defined cohort can complicate
(comparison group) statistical analysis
 Provides an estimate of compared to case-
the risk ratio. control studies.

Seroprevalence/  Detects latent, subclinical  Unlikely to be used in

infections and carrier isolation during a
seroepidemiology states. Can adjust the Legionnaires' Disease
studies number of cases outbreak. Is usually a
associated with an retrospective or
outbreak and potentially additional study.
identify other sources of
infection.

Advantages of epidemiological Method

1. Find related risk factors 2. Helps in finding mortality rate 3. Helps in finding
morbidity rate 4. Used in large scale studies 5. Economic 6. Used in
government policies

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Limitations of epidemiology

Every epidemiological tool has limitations. Awareness of these limitations is crucial to

making the correct decisions about what to ask of epidemiologists, which studies to
commission, and when and how to interpret findings.

 Of course, epidemiology depends on valid data. Often in emergencies, the ability

to gather data is severely restricted. This may be due to insecurity preventing
survey workers from carrying out data collection or lack of resources preventing
health workers from submitting surveillance data. Lack of access may also be due
to difficulties in communication and transport to remote areas.
 Epidemiology is also constrained by the rapid changes in the health and
nutritional status of many emergency-affected populations. By the time
appropriate data and collected and analyzed, the conclusions and
recommendations derived from these analyses may be out of date.
 Another major limitation of epidemiology is in program evaluation. Policy-
makers sometimes expect that organizations delivering a certain intervention
will be able to demonstrate an "impact" on health that is unequivocally traceable
to that intervention alone. This is often nearly impossible to achieve without
very complex and expensive studies, such as randomized trials, because many
different factors can simultaneously affect a specific health outcome or indicator.
For example, imagine trying to establish a causal link between an agency's
distribution of hygiene kits and deaths due to diarrheal disease in a camp where
many other factors are changing simultaneously, such as the prevalence of
malnutrition, water quantity and quality, excreta disposal, individual behaviour,
etc.
 Finally, perhaps the most important limitation of epidemiology is that
epidemiology and the data gathered by epidemiologic methods are routinely
ignored. Many major decisions during humanitarian relief are not made on the
basis of data or evidence; political concerns, resource limitations, personal
priorities, public relations and many other non-scientific factors may result in
irrational policy or program decisions.

Although perhaps not a limitation of epidemiology itself, one must keep in mind
limitations in the need for epidemiologic evidence. Most interventions
recommended by the Sphere Guidelines and other standard-setting publications
have been demonstrated effective by good scientific studies or by years of
experience. These interventions are not experimental.

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Measurement of disease
 The information should be available in terms of
 Mortality
 Morbidity (incidence and prevalence)
 distribution

Formulation of an etiological hypothesis

 Hypothesis should be formulated in a manner that it can be tested.

Hypothesis should specify the following

 the population- the characteristics of the persons to whom the hypothesis to be

applied
 the specific cause being considered
 the expected outcome
 the dose-response relationship
 the time-response relationship (time between exposure to the cause observed)

Community Trial
 Some communities e.g. districts may have the public health intervention like a
new method of water purification

 Other districts continue with the older methods

 The incidence of water-borne disease can be compared among these districts

IN CONCLUSION

“What you can’t measure you can’t control!” epidemiological study methods are used to
study your health and my health and its determinants, as we join hands to ensure a
healthier us.

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