RESEARCH METHODS

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 Research method:
Research method consists of:

a body of knowledge that reflects the general philosophy

and purpose of the research process

the assumptions and values that serve as rationale for

research
the general approach of data collection and analysis

and the standards used for interpreting data and reaching

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conclusions. 10/29/2020
 Study/research designs
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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 Cont’d……
It is concerned with the planning of research and

specifies the hypotheses or questions to be studied, the

data to be collected, the methods of data collection,
and analysis.
It is the “blueprint” of research that lays out the strategy

and framework for the conduct of research, integrating

different phases of the research activities and providing
the basic direction.
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 Selection of study design
 In selecting the design of the study, consider:

The state of knowledge about the problem

The type of information you want to obtain

The nature of the problem and its environment

The resources available for the research

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 Cont’d……
The knowledge and creativity of the researcher

Sample to be taken

Method of analysis to be used

Purpose of the research

Access of study subject

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 Characteristics of research methods
Research method can be classified as:

Primary or secondary (sources)

Quantitative or qualitative (depth)

Cross sectional or longitudinal (time)

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 Choosing of appropriate research Methods
depends on:
1. Research purpose

Example
 If researcher is conducting an exploratory research
in which they had little knowledge about the subject
matter
Qualitative research method such as
 Case-study
 Field observation
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 Cont’d…
If we are conducting a descriptive study:- Survey method

is preferred
If explanatory (Causal):- Experimental, quasi

experimental or longitudinal research method may be

considered
If evaluation of program/project:- Evaluation research

method can be used

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 Cont’d…
2. Available Resources
 Knowledge, Money, Time, Support and analytical
skills

3. Access to research subject

 Subject willingness

 Subject attrition

 Subject educational status

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 Cont’d…

4. Combined research methods

 Researchers should not be confined to one
method for a particular study, because a
combination of methods can be more effectively
fulfill the research purpose.

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 Major Types of Study
Design

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 Study
Study Designs
Designs

Descriptive
Descriptive Analytic
Analytic

Correlational Cross-sectional Observational Interventiona

Interventional
Correlational Cross-sectional Observational

Case-Report/Series
Case-Report/Series Experimental
Case-Control
Case-Control Experimental

Comparative
Cross-sectional Quiz/Experimental
Quiz/Experimental

Cohort
Cohort
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 Study design cont’d….
 Non-intervention (Observational) studies
 The researcher just observes and analyses
researchable objects or situations but does
not intervene.

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 Cont’d…..
 Intervention studies

 The researcher manipulates objects or

situations and measures the outcome of his

manipulations
 Example: By implementing intensive health
education and measuring the improvement in
immunization rates.
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 Cont’d……
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 may include description as well as comparison.

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 Exploratory studies

For example:
A national AIDS Control Programme wishes to establish
counseling services for HIV positive and AIDS patients,
but lacks information on specific needs patients have for
support.
To explore these needs, a number of in-depth
interviews are held with various categories of patients
(males, females, married and single) and with some
counselors working on a programme that is already under
way.

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 Exploratory studies cont’d….
When doing exploratory studies we describe the needs of

various categories of patients and the possibilities for

action.
We may want to go further and try to explain the

differences we observe (e.g., in the needs of male and

female AIDS patients) or to identify causes of problems.
Then we will need to compare groups.

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 Cont’d…
If the problem and its contributing factors

are not well defined it is always advisable to

do an exploratory study before embarking
on a large-scale descriptive or comparative
study.

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 Descriptive studies
Descriptive studies document the magnitude,
distribution and trends over time of health related
conditions and other issues of interest in a defined
population.
The wealth of material obtained in most descriptive

studies allows the generation of hypotheses, which

can then be tested by analytical or experimental

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designs. 10/29/2020
 Designing descriptive studies

Important steps include:

1. Defining a population of interest

2. Recruiting a representative sample
3. Measuring the health characteristic
of interest

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 Types of Descriptive Study

1. Case report/ Case series

2. Ecological / Corelational

3. Cross sectional study

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 Case Report
 A descriptive case report study is a detailed

profile of a subject or set of subjects and

their clinical or laboratory experience.
 Providing clues to identifying a new
disease or adverse health effect from an
exposure or clinical experience.
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 Case report cont’d…
Example: One case of pulmonary embolism

observed 5 weeks after oral contraceptive

usage - first clue the association between oral
contraceptive and increased risk of venous
thrombosis

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 Case series
 Reports a series of cases of a specific condition, or a
series of treated cases.
 Used as an early means of identifying the presence

of epidemic
 Example: Five homosexual males who developed a
rare pneumonia. This case report study led to the
eventual discovery of HIV.
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 Case report/Case Series
Strength

Very useful for hypothesis generation

Important link between clinical medicine and epidemiology

One of the first steps in outbreak investigation

Limitation

Report is based on single or a few patients, which can happen by

coincidence
Lack of an appropriate comparison group
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 Corelational / Ecological studies
Measures that represent characteristics of the

entire populations are used to describe disease

in relation to some factor of interest such as sex,
utilization of services, etc.
E.g. Hypertension rates and capital salt
consumption compared between two communities

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 Corelational / Ecological studies cont’d….
Data from entire populations are used to compare

disease frequencies between different groups during

the same period of time or in the same population at
different points in time.
Example: Countries with low cigarette consumption

have lower lung cancer rates than those countries

with high cigarette consumption.
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 Corelational study cont’d…….
Strength
Done quickly and inexpensively, often using available
information
Limitation
Inability to link disease with exposure in particular
individuals
Lack of ability to control for the effect of confounder
factor
Data represent average exposure level rather than actual

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individual level 10/29/2020
 Cross sectional study
A cross-sectional study is a study in which disease

and exposure statuses are measured simultaneously

in a given population.
Cross-sectional studies can be thought of as providing

a "snapshot" of the frequency and characteristics

of a disease in a population at a particular point in
time.

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 Cross sectional study…
They provide a prevalence rate at a particular point

in time (point prevalence) or over a period of time

(period prevalence).
The study population at risk is the denominator for

these prevalence rates.

The distribution of a disease, disability, and

nutritional status is assessed.

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 Cont’d….
A cross-sectional study can be either analytical or
descriptive, according to its purpose.
If data are collected both on exposures and
outcomes of interest, and if the data are analyzed so
as to demonstrate differences either between
exposed and non-exposed groups, with respect to
the outcome, or
between those with the outcome and those without
the outcome, with respect to the exposure, then this
is an analytical cross-sectional study.

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 Cont’d….
If the information collected is purely of a descriptive

nature, not involving the comparison of groups

formed on the basis of exposure or outcome status,
then this is a descriptive cross-sectional study.
Often a cross-sectional study may have both

descriptive and analytical components.

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 Cross sectional study…
Strength

 They are relatively quick and inexpensive

 Shows relative distribution of conditions

 Often provides early clues for hypothesis

generation.

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 Cross sectional study…
Limitation :

 Weakness for establishing causation since

uncertainty on whether exposure preceded
disease.
 Ineffective for rare disease/case

 May not be representative of all cases

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 Analytic studies

Analytic studies: is studies used to test hypotheses

concerning the relationship between a suspected

risk factor and an outcome and to measure the
magnitude of the association and its statistical
significance.
Analytic study designs can be divided into two broad

design strategies: Observational and intervention.

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 Observational studies
No human intervention involved in assigning study

groups; simply observe the relationship between exposure

and disease.
Subject to many potential biases, but by careful design

and analysis, many of these biases can be minimized.

Examples of observational studies: comparative cross-

sectional, cohort and case control studies.

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 Observational studies cont’d…..
Comparative cross-sectional studies:
Depending on the purpose of a given study, a
cross-sectional survey could have an analytical
component

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 Cohort Study

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 Cohort study
Dictionary definition of “cohort”

Group of people who have something in common

when they are assembled.

A group of individuals that are all similar in some

trait and move forward together as a unit

Designated group of people who are followed or

traced for a particular period of time

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 Cohort study…
Cohort study: is the observation of a cohort (or
cohorts) over time to measure outcome's.
Longitudinal, follow-up studies

Groups are defined on the basis of exposure to risk

factors.
At the beginning free from the disease

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 Cohort study…
Used in hypothesized relation ship explored by case

control studies.
Minimize potential bias

Choices:

 Hypothesis being tasted

 Resource

 Current state of knowledge

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 General Design of a Cohort Study

Defined Population Study Sample

Representative Sample?
Target Pop:
NO
Population Exposed
at Risk Yes

Not Exposed NO

Yes

Time Disease/Outcome
Present?
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 Types of cohort studies
Based on temporal r/ship b/n the initiation of the study and

occurrence of the disease cohort studies divided into two:-

o Prospective

 Relevant event may or may not have occurred, outcome

certainly not.
o Retrospective

 Relevant events occur before, outcome may or may not

happen at present .
 Both classify subjects based on risk.
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 Time and Cohort Studies

Past Present Future

Cohort Follow-up = Historical (retrospective)

Assembled
Cohort Follow-up
Prospective =
Assembled
Mixed Cohort
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 Cohort Design
Study Sample

Nonrandomized

Exposed Not Exposed

Disease No disease Disease No disease

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 Cohort study…
Sometimes bidirectional

Short and Long term outcomes

Choices

Based on scientific and resource considerations.

Retrospective cohort:-

More quickly and Long latency

Incomplete and lack variables

Information lack for potential confounders.

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 Cohort study…
Selection of comparison group:

Subjects similar in all other factors, except the

determinant factors
Internal comparison with in the cohorts

Special comparison group

General populations

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 Cohort study…
Sources of exposure data

Records

Interviewing and questionnaire

Direct physical examination (P/E) and or blood

testing
Direct measurement of air/water

Combinations of the above

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 Cohort study…
Sources of outcome data

Routine surveillance

Death certificate

Periodic examination

Discharge reports

Interviewing

Pathologic examination

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 Measures in Cohort Studies
Doesn’t Incidence
Develops Develop Rates of
Disease Disease Totals Disease
a
Exposed a b a+b
a+b

Not c
c d c+d
Exposed c+d

Relative Risk (RR) = Iexp / Inon-exp = [a/(a+b)] / [c/(c+d)]

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 Cohort study…
Interpretation

 The role of chance

 Bias

Selection bias less in prospective Cohort

While in retrospective Cohort, selection bias

possible

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 Cohort study…
Misclassification bias by exposure

Non deferential vs differential

Ascertainment of outcomes of interest

 Confounding

 Effect of non participation

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 Cohort study…
Strengths

Particularly important when exposure is rare.

Can examine multiple factors with a single

exposure
Can show temporal relationships

Minimizes bias in ascertaining exposure

Allows direct measurement of incidence

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 Cohort study…
Weakness

Inefficient for evaluation of rare diseases

Expensive and time consuming

Retrospective requires adequate records

Validity affected by losses to follow up

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 Case Control Study

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 Case-control Studies

It is usually retrospective

Identify one group of subjects with disease

(cases) and one group without disease

(controls), then look back historically to
identify differences in predictor variables
[exposure (s)]

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 Case control ….
Mostly cannot provide estimates of prevalence

or incidence
diseased are sampled

Rather, provide estimate of association between

presence or absence of disease and predictor

variables

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 Case control ….
Here, we wait for people to develop the disease; then

look at the level of the risk factor in a group of case

subjects compared to a group of healthy or control
subjects.
If the level of the assumed risk factor is higher in

the cases, it implies an association between risk

factor and diseased.
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 Case-Control Studies
Cases: Disease
Controls: No disease

Exposure
Disease

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 Cont’d…..
Case-Control studies represent one form of analytic

study that provides information on the relationship

between causal factors and injuries.

In a case-control study, subjects who have been

injured are identified and their past exposure to

suspected causal factors is compared with that of

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controls (persons who have not been injured). 10/29/2020
 Cont’d….
Many case-control studies ascertain exposure from

personal recall, using either a self administered

questionnaire or an interview.
The validity of such information will depend in part

on the subject matter.

People may be able to remember recent events quite

well. On the other hand, long term recall is generally

less reliable.
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 factor present
Cases
(disease)
Case-Control Design
factor absent
Study
population
factor present Controls
(no disease)
factor absent
present
past

time

63 Study begins here

10/29/2020
 General Approach
Define Research Question

Identify Case Population

Identify Control Population

Measure Variable

Compare the exposure variable in both cases and

controls

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 Basic Idea

Cases – Should represent all cases in the

population
Controls – Should represent all persons without

disease in the population

The big question - Is the risk factor more

common in the cases than in the controls?

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 Sources of Cases and Controls

Population-Based

Cases – from Registry (fed by population)

Controls – from General Population

Hospital-Based

Cases - selected group that made it to hospital

Controls – as above

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 Cont’d…..
Only cohort studies (including clinical trials) can

yield incidence and relative risk.

The odds ratio, (e.g., from a case-control study)

will always be greater than the relative risk.

For rare diseases, the odds ratio will be close to

the relative risk.

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 Advantages
Efficiency for rare disease

Generating hypotheses

Reasonably powerful study design in study base

well defined
Efficient design with regard to cost and time

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 Disadvantages
Can’t determine incidence or prevalence

Information bias:

 Recall bias is possible

Sampling bias:

 Cases not representative of all those with disease, since missed,

misdiagnosed or dead would not be studied.

 Also people with access to care are over represented.

Selection bias:

 concern if study base not well defined

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 Minimizing bias
 Use data collected before outcome occurred

 Standardized, objective variables

 Blind subjects, observers

 Sample cases and controls in the same way

 Matching

 Multiple control groups

 Population-based sample

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 Intervention studies

 The researcher manipulates objects or

situations and measures the outcome of his

manipulations
 Example: By implementing intensive health
education and measuring the improvement in
immunization rates.

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 Cont’d….
Usually (but not always) two groups are compared,

one group in which the intervention takes place (e.g.

treatment with a certain drug) and another group that
remains ‘untouched’ (e.g. treatment with a placebo).
The two categories of intervention studies are:

• experimental studies and

• quasi-experimental studies
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 Experimental Study

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 Experimental studies
An experimental design is a study design that

gives the most reliable proof for causation.

In an experimental study, individuals are

randomly allocated to at least two groups.

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 Cont’d…..
One group is subject to an intervention, or

experiment, while the other group(s) is not.

The outcome of the intervention (effect of the

intervention on the dependent variable/problem) is

obtained by comparing the two groups.

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 Experimental Studies
A method where investigator can “control” the

exposure

Similar to laboratory experiments except living

populations are the subjects

Generally involves random assignment to

groups.
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 Experimental….
Clinical trials are the most well known
experimental design
The ultimate step in testing causal hypotheses

In an experiment, we are interested in the

consequences of some treatment on some

outcome.

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 Experimental ….
The subjects in the study who actually receive

the treatment of interest are called the

treatment group.
The subjects in the study who receive no

treatment or a different treatment are called

the comparison group.

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 Common types of clinical trial
A. Prophylactic trials, e.g. Immunization,
Contraception.
B. Therapeutic trials, e.g. Drug treatment, Surgical
procedure.
C. Safety trials, e.g. Side effects of oral
contraceptives and injectables.

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 Common types of clinical trial cont’d….

D. Risk-factor trials, e.g. proving the etiology of a

disease by inducing it with the putative agent in
animals, or withdrawing the agent (e.g. smoking)
through conclusion.

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 Clinical trial…
Therapeutic trials may be conducted:

To test efficacy (e.g. does a therapeutic agent work

in an ideal, controlled situation?) or

To test effectiveness (e.g. after having established

efficacy, if the therapy is introduced to the population

at large, will it be effective when having to deal with
other co-interventions, confounding, contamination,
etc.
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 Epidemiologic Study Designs
Randomized Controlled Trials (RCTs)

 A design with subjects randomly assigned to

“treatment” and “comparison” groups
 Provides most convincing evidence of relationship

between exposure and effect

 Not possible to use RCTs to test effects of exposures

that are expected to be harmful, for ethical reasons

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 Community intervention trials (CITs)

The major difference between Randomized

Clinical Trials and Community Intervention

Trials is that the randomization is done on
communities rather than individuals.

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 Randomized Clinical Trial approach

 Define treatment and control groups

 Administer exposure to treatment group, but not controls.

 Follow through time and compare rate of disease in

treatment group with rate of disease in control group.

 Investigator is involved during the entire time from

exposure and disease.

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 RANDOMIZATION outcome
Intervention
no outcome
Study
Experimental Design

population
outcome
Control
no outcome
baseline
future

time
86 Study begins here (baseline point)
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 RCT
Disadvantages
Advantages
Randomization balances
 Good internal validity
prognostic factors across but may have poor
groups external validity
Greater likelihood that  Expensive in terms of
patients, staff, and time and money
assessors can be blinded  Frequently, need a large
Blinding minimizes number of patients
observer bias
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 RCT cont’d…..
Advantages
Detailed information on
baseline and subsequent
characteristics of participants
Most statistical tests rest on
assumption of random
allocation
Randomization minimizes
selection bias and
confounding
Dose levels pre-determined
by investigator
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Disadvantages
Potential effective
treatment may be withheld
from some patients, or
some may be exposed to a
dangerous one
Subjects may not comply
(cross-over)
Rare or late adverse
effects of intervention
may not be picked up
10/29/2020
 Quasi-experimental studies

In a quasi-experimental study, one characteristic of

a true experiment is missing, either randomization

or the use of a separate control group.
A quasi-experimental study, however, always includes

the manipulation of an independent variable which is

the intervention.

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 Cont’d….
One of the most common quasi-experimental designs
uses two (or more) groups, one of which serves as a
control group in which no intervention takes place.
Both groups are observed before as well as after the
intervention, to test if the intervention has made any
difference.
This quasi-experimental design is called the ‘non-
equivalent control group design’ because the
subjects in the two groups (study and control groups)
have not been randomly assigned.

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 Thank you!!

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