Research Methods

Alemu T.

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 Research Methods

The methods of a research project is the core of

the study.
The following are important questions to
consider when beginning to prepare a research
design for a research proposal.

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 Research Methods …
What do I want to measure?
 How can I measure it?
 Where should I measure it?
 What will I do with the answers collected?
 How can I check whether my methods for measuring
are correct before beginning a large study?
 What professional and non-professional staff do I
need to carry out this study?
 What types of logistical support do I need?
 Are there any ethical problems related to the study?
 How can I avoid introducing biases into the study?
 What constraints may affect this study?

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Components of a research design that should be
addressed in the method section:

 Study area, Study period, Study design,

Population, Sample size determination and
sampling procedures, Variables, Data collection,
Data processing and analysis, Ethical
considerations, Data quality assurance, and
Operational definitions
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Study area
Location, Physical features (climate,
altitude...), Population size and
composition
Infrastructures -education, health,
communication…
Economy

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Study period
Time required to conduct the study

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Study Design
A study design is the process that guides
researchers on how to collect, analyze and
interpret observations.
It is a logical model that guides the
investigator in the various stages of the
research.

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Selection of study design depends
on:

 State of knowledge
 Type of information you want to obtain
 The nature of the problem
 The resources available
 personal experience
 Audience
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Selection of study design depends
on …

The knowledge and creativity of the

researcher
Sample to be taken
Purpose of the research
Access of study subject.

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 1) the research problem
Research problems call for specific
approaches

E.g. If the problems calls for:

a) the identification of factors that influence
an outcome
b) the utility of an intervention, or
c) knowing the prevalence of diseases

Then a quantitative approach is best

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 The research problem …
If a concept or phenomenon needs to be
understood because little research has
been done on it,

Qualitative approach is preferred

 Qualitative research is exploratory and is useful

when the researcher does not know the
important variables to examine

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 Types of study design
Non-intervention (Observational studies):
◦ in which the researcher just observes and
analyses researchable objects or situations but
does not intervene;
Intervention studies
◦ in which the researcher manipulates objects or
situations and measures the outcome of his
manipulations (e.g., by implementing intensive
health education and measuring the improvement
in immunization rates.)

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Study designs could be

Exploratory/fact finding
Descriptive

Analytical/ explanatory

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 Exploratory studies
An exploratory study is a small-scale study of
relatively short duration, which is carried out
when little is known about a situation or a
problem.
It is used to gain initial insight

It may include description as well as

comparison.
E.g.-assessment of needs of HIV patients on
ART using in-depth interview

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Descriptive studies
document the magnitude, distribution and
trends over time
Purpose: To characterize the amount and
distribution of disease and other health
related conditions within a population.

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 Cont’d

Descriptive studies generally precede

analytic studies designed to investigate
determinants of disease.

Thus, descriptive studies often help to

generate research hypotheses.

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Designing descriptive studies

Defining a population of interest

 Recruiting a representative sample
 Measuring the health characteristic of
interest

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Descriptive Study Designs

• INDIVIDUALS level

 Case reports
 Case series
 Cross sectional surveys
POPULATIONS (GROUPS)

◦ Ecologic (aggregate) studies

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 Case Reports

Case Report?
a careful, detailed report by one or more
clinicians of the profile of a single patient.

◦ One of the first steps in outbreak investigation

◦ Often useful for hypothesis generating and
examining new diseases, but conclusions about
etiology cannot be made.
Strengths- useful for hypothesis generation.

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 Case report …
Limitations:
• No appropriate comparison group
• Cannot be used to test for presence of a valid
statistical association
• Since based on the experience of one person:
 presence of any risk factor maybe purely coincidental

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Case Series
Case series ?

 Collection of individual case reports

occurring within a fairly short period of
time.

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Case series …
Strengths:

• Used as an early means to identify the

beginning or presence of an epidemic.

• Can suggest the emergence of a new

disease (i.e. AIDS)

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Case series …
Limitations:

• Lack of an appropriate comparison group

• Cannot be used to test for presence of a

valid statistical association

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Correlational/ecological studies?

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 Ecological studies
Does not provide individual data
presents average exposure level in the
community
Examples, hypertension rates and average
per capita salt consumption in two
communities

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Cont’d
Strengths- it is quick, inexpensive and
often uses available data
Limitations -inability to link exposure
with disease outcome at individual level
◦ lack of ability to control for effects of
potential confounding factors
◦ it may mask a non-linear relationship between
exposure and disease.

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A cross-sectional study (survey)
A cross-sectional study?

Snapshot of the health status of

populations at a certain point in time.
Compare prevalence of disease in persons
with and without the exposure of interest
Cross-sectional studies must be done on
representative samples of the population.

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Advantage of Cross-sectional
Provides prevalence estimates of exposure
and disease.
Easier to perform than studies that require
follow-up (hence relatively inexpensive).
Can evaluate multiple risk (and protective)
factors and health outcomes at the same point
in time

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Advantage …
May identify groups of persons at high or
low risk of disease

• Can be used to generate hypotheses about

associations between predictive factors
and disease outcomes

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Limitation of cross-sectional

Temporal sequence between exposure

and disease cannot be established
* i.e. chicken-or-egg dilemma.
Example: In the study of knowledge of
modern contraceptive, did the women
know about it and then start to use it or
did they learn about it because they were
using it.
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Explanatory /Analytical studies
Analytical studies?

At least two variables must be specified

in advance, an exposure and a disease or
health state

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Types of analytical study designs

Observational studies
Interventional study

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Comparative cross-sectional
Example-a survey on malnutrition may wish
to establish:
The percentage of malnourished children in a
certain population;
Socio-economic, physical, political variables
Feeding practices; and
The knowledge, beliefs, opinions

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Cont’d
he will try to determine which socio-
economic, behavioral and other
independent variables may have
contributed to malnutrition.

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Case-control study design

Case-control study design?

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Case-control…

exposed
cases
Not exposed
Study pop

exposed
controls
Not exposed Study begins here

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Selection of cases
A/ Definition- precise definition of cases(clinical,
laboratory and other criteria

B/ Inclusion and exclusion criteria

-cases should be selected to improve validity(ex.
By excluding cases with coexisting disease)
-cases should be restricted to limited time period
and geographic area, age range etc…

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Sources of cases
Hospital (health institution) cases
◦ easy and inexpensive to conduct but prone to
selection bias
Population (community) based cases
◦ avoid selection bias
◦ allows the description of disease in the entire
population
◦ expensive

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 Selection of controls
Consider
◦ comparability with cases
◦ practicability
◦ economic impact
Controls and cases should came from the
same source population

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 Cont’d
The prevalence of exposure among
controls should reflect the prevalence of
exposure in the source population.
The time during which a subject is eligible
to be a control should be the time in which
the individual is also eligible to be a case.

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Sources of controls
Hospital (health institution) controls
Advantages
Easily identified and readily available
Less expensive
More likely than healthy individuals to be
aware of antecedent exposure or events.

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Cont’d
Disadvantages
They are different from healthy people in
many ways
Studies demonstrated that hospitalized
patients are more likely to have the
experience of exposure
A true association might be masked

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Cont’d
General population controls
Advantages
Are generally healthy
Reflect well the population living in the
area
Generalizability is possible

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Cont’d
Disadvantages
Are expensive and time consuming
May not remember exposure status
because of less concern
Less motivated to participate

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Cont’d
Special controls
Special controls are individuals
related to the case in some way
like friends, household members,
neighbor, siblings etc

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Cont’d
Advantages
They are healthy
More likely to be cooperative
Offer a degree of control over some
confounding factors such as ethnicity,
socio-economic status, environmental
factors etc

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Cont’d
Disadvantages
If the study is likely to be similar to
that of the cases, an underestimate of
the true effect may result.

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Cont’d
Sources of exposure data (cases and
controls):
Study subjects (self-report).
Records (preferably completed before the
occurrence of outcome events).
Interviews with surrogates (spouses,
siblings, etc.).

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Measure of association in case controls study

 Themeasure of association in case control study is

Odds Ratio(OR)

OR odds of disease in exposed

= odds of disease in unexposed

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Measure of association…con
Odds = the chances of something happening

the chances of it not happening

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Measure of association…cont
OR= ad/bc
OR=1=Null hypothesis
OR>1 Exposure is a risk factor
OR<1 Exposure is protective

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Advantages of case-control study

Quick and inexpensive

Relatively simple to carryout
Optimal for the evaluation of rare
diseases
Can examine multiple etiologic factors
for a single disease
Well suited for the evaluation of disease
with long latent period
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Limitations of case-control study

Inefficient for the evaluation of rare

exposure
Cannot directly compute incidence rates
of diseases
Difficult to establish temporal
relationships
Prone to selection and recall bias

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Cohort study design
Cohort?
◦ E.g. Birth cohorts, cohort of smokers, occupational
exposures
Cohort study design
subjects are defined according to their
exposure status

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Cont’d

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Types
Closed vs. Open
◦ Closed cohort: exposure groups are defined at
the start of follow-up and no new members are
added during the follow-up
◦ Open/dynamic cohort: people move in and out
the study

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 Cont’d
Incidence cohort vs. Prognostic (clinical)
◦ Incidence Cohort Study
 To assess incidence of disease
 To identify risk factors for disease onset
 Incidence greater in exposed than non-exposed?
◦ Prognostic Cohort Study
 Follow diseased cohort to assess factors associated
with outcome (recovery or death)
 Goal is to identify explanatory/prognostic factors of
those factors helped to the dev’t of the disease.

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 Prospective vs. Retrospective (Concurrent vs.
Non-concurrent)

Prospective cohort- Healthy cohort (free of the

disease) assembled and followed. More reliable
than retrospective

Retrospective (historical) cohort- the study is

initiated at a point in time after both the exposure
and disease have already occurred.
 It is constructed retrospectively through existing
records

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Cont’d
Can be conducted more quickly and
cheaply
◦ All relevant events have occurred
◦ Efficient for disease with long latency periods
Depend on availability of routine data
◦ Incompleteness
◦ Lack of data on confounding variables

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 Selection of exposed group
The frequency of the exposure in the study
population
The need for obtaining complete and accurate
information
The easiness to collect relevant information and
to follow up
The ability of obtaining sufficient exposed
individuals in a reasonable period of time

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Selection of non- exposed
◦Similar to exposed
◦Control for confounding
factors

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Exposure ascertainment:
• Using pre-existing records
• Conducting interviews and filling
questionnaire

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 Outcome ascertainment
Possible sources are routine surveillance,
death certificate, periodic health
examination, hospital records and autopsy
records.
have affirmed outcome criteria and
standard diagnostic procedures applicable
for exposed and non- exposed groups.

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Measures of association in Cohort Studies

Not Incidence Rates of

Diseased Disease Total Disease

Exposed a b a+b a/a + b

Not
c d c+d c/c + d
Exposed

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Cont’d

Relative Risk (RR) = Iexp / Inon-exp

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

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Advantages of cohort study:
Valuable for rare exposures
Examines multiple effects of a single
exposure
Can elucidate temporal relations
Allows direct measurement of risk
Minimize bias in ascertainment of
exposure

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Limitations of cohort study
Inefficient in evaluation of rare diseases
Expensive
Time consuming
Incompleteness of records
Losses to follow up create problem- leads
to bias

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Interventional studies
The researcher manipulates a situation
and measures the effects of this
manipulation.

Usually(but not always) two groups are

compared

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Two categories of intervention
studies
Experimental studies and
Quasi-experimental studies.

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Experimental studies

Experimental design is the gold standard

study design
It differs from other study designs
◦ The investigator has full control in
administering the factor of interest
◦ Random assignment or allocation of both
study and control subjects

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Classification of experimental
studies
Classification based on the population studied:
◦ Clinical trial- usually in clinical settings and
subjects are patients
◦ Field trial- used in testing drug for preventive
purpose. e.g. vaccine trial
◦ Community trial- unit of the study are group
of people/ community e.g. fluoridation of
water to prevent dental caries

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Quasi-experimental studies
eitherrandomization or control group is
missing however, always includes the
manipulation of an independent variable
which is the intervention. Types
uses two (or more) groups
uses only one group ( ‘BEFORE-
AFTER’ study)

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Problems related to intervention
studies
Ethical issues:
◦ Practices or substances already known to be
harmful should not be used
◦ Therapies known to be beneficial should not be
withheld from any affected person
◦ Investigators have to have a complete
knowledge of the study subjects
◦ The researcher must have informed consent
from each of study subjects
◦ A written research protocol is a must
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Cont’d
Feasibility or practical issues:
Cost

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Thank you

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