RESEARCH METHODS

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.
• Several classifications of study types are
possible, depending on what research
strategies are used.

• Types design depend questions to be studied, the data to

be collected, the methods of data collection, and analysis.

• It is the ‘blueprint’ to carry out research activates

 Types of Study design

Populations Ecologic

Descriptive Case-series
Individuals
Cross-sectional

Case-control

Observational
Prospective
Cohort
Analytical Retrospective

Intervention Clinical trials

3
 1. Descriptive studies:
• Descriptive studies may be defined as studies that
describe the patterns of disease occurrence and other
health-related conditions by person, place and time
• Person (age, sex, martial status, educational level),
place (rural and urban) and time (year, season)
 Descriptive continued….
• It focus on frequency or magnitude of disease and trends over time
and place
 Types of descriptive studies
a) Case reports and case series:
• a careful, detailed report by one or more
clinicians of the profile of a single patient.
• The individual case report can be
expanded to a case series, which
describes characteristics of a number of
patients with a given disease.
b) Ecological studies:
• 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
 Descriptive study….
c) Cross-sectional studies
• A cross-sectional (prevalence) study provides
information concerning the situation at a given
time.
• In this type of study, the status of an Individual
with respect to the presence or absence of both
exposure and disease is assessed at the same
point in time.
• Usually involve collection of new data
• provide “snapshot” of health experience
 Cont..

Limitations of cross sectional study

• In general, measure prevalence rather than
incidence
• not good for studying rare diseases or
diseases with short duration; also not ideal for
studying rare exposures
• “Chicken and egg dilemma” /temporal
inference problem
 2. Analytic studies
• Analytic studies may be defined as 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.
• It focus on assessing
determinants, associated
factors, contributing factors or risk factors
and proofing cause and effect relationship
• Analytic study designs can be divided into two
broad design strategies:
• Observational (cohort, case-control)
• Intervention ()
 Cont..
Cohort studies:
• Study groups identified by exposure status
prior to ascertainment of their disease
status.
• Both exposed and unexposed groups followed
in identical manner until they develop the
disease under study, they die, the study
ends, or they are lost to follow-up
• Disease free exposed and non-exposed
people are followed up and then outcome
events are picked up when they occur
• Measure and compare the incidence of
disease in two or more study cohorts (groups)
Cont..
 Cont..

Cohort study

Population
at risk Disease among
exposed?
Exposed
Usually prospective

Not Exposed Disease among

non-exposed?
 Cont..

Types of Cohort Studies

 Based on the starting point of the study

 Prospective

 Retrospective (historical)

13
 Prospective

Prospective Cohort Study

Exposure Study starts Disease
occurrence occurrence

ill
+ -
+ +
exp exp
- -

Selection based Prospective assessment

on exposure of disease

14
 Retrospective
Retrospective cohort studies

Disease
Exposure occurrence Study starts

time

• Disease outbreak following a gathering

• Occupational exposure in mine workers

15
 Cont..
c) Case-control studies:
• Group of subjects with the disease (cases) and group of
subjects without the disease (controls) are identified
• Information, about previous exposures are obtained for
cases and controls, and frequency of exposure
compared for the two groups
Intervention
studies
 Intervention studies
• The researcher manipulates a situation and
measures the effects of this manipulation.
• 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
 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.
• 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
 Cont..
• At community level, where health research is
frequently undertaken, we experience not only
ethical but also practical problems in
carrying out experimental studies.
• In real life settings, it is often impossible to
assign persons at random to two groups, or to
maintain a control group.
• Therefore, experimental research designs
may have to be replaced by quasi-
experimental designs.
 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
 Cont….
• 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.)
Study design ….
Hierarchy of Epidemiologic Study Design

01/17/202 25
5
 Sampling
• Sampling is method by which number of study units are
selected from a defined study population
• The population is too large for us to consider collecting
information from all its members
• Instead we select a representative sample from
population
When taking a sample, we will be confronted
with the following questions:

a) What is the group of people from which we want to draw

a sample?

b) How many people do we need in our sample?

c) How will these people be selected?

 Sampling methods

A.Non-probability sampling
methods

B. Probability sampling methods

Non-probability sampling methods
1. Convenience sampling:
• study units that happen to be available at the time of
data collection are selected by convenience.
2. Quota sampling:
• investigator include as many people as he can find until
he has filled his quota (sample size for different
category).
3. Purposeful sampling (used for qualitative studies):
• Limited number of key informants selected to get in-
depth information and focus group discussion
4. Snowball sampling is used when the population you
want to research is hard to reach, or there is no sampling
frame. Example : drug addicts, homeless people, or sex
workers

• The above sampling methods do not claim to be

representative of the entire population.
 Probability sampling methods
• This method provide equal chance for all samples

1. Simple Random Sampling (SRS):

• This is the most basic scheme of random
sampling
• To select a simple random sample you need to:
• Make a numbered list of all the study units
from 1 to N (Where N is the Size of the
population).
• Select the required number of sampling
units, using a “lottery” method or a table of
random numbers
 Cont..
2. Systematic Sampling:
• Individuals are chosen at regular intervals(K-interval) (for example,
every 5th, 10th, etc.) from the sampling frame.
• For example, a systematic sample is to be selected from 1000
students of a school. The sample size is decided to be 100. The
sampling fraction is: 100/1000 = 1/10.
• The number of the first student to be included in the sample is
chosen randomly by picking one out of the first ten pieces of paper,
numbered 1 to 10. If number 5 is picked, every tenth student will be
included in the sample, starting with student number 5, until 100
students are selected.
• Students with the following numbers will be included in the sample:
5,15, 25, 35,45, . . . , 985, 995.
• Unlike SRS, systematic sampling can be
conducted without a sampling frame (useful in
some situations where a sampling frame is not readily
available)
 Cont..
4. Stratified Sampling:
• To make sample to be representative, we might need
groups of study units with specific characteristics (for
example, residents from urban and rural areas).
• Random or systematic samples of a predetermined size
will then have to be obtained from each group (stratum).

Some of the reasons for stratifying the population

may be:
• Different sampling schemes may be used in different
strata, e.g. Urban and rural
• Conditions may suggest that prevalence rates will vary
between strata
• Administrative reasons may make it easier to carry out
the survey through an organization with a regional
structure.
 Cont…
5. Cluster sampling:
• When a list of groupings of study units is available (e.g.
villages, etc.)
• The selection of groups of study units (clusters) instead
of the selection of study units individually is called
cluster sampling.
• Clusters are often geographic units (e.g. districts,
villages) or organizational units (e.g. clinics).
6. Multi-Stage Sampling:
 This method is appropriate when the population is
large and widely scattered.
 The number of stages of sampling is the number of
times a sampling procedure is carried out
 Different sampling method may be applied in each
stage
 a) Sampling error (i.e., random error)
• Consists of random deviations from the true value, which
can occur in any direction.
• It can be minimized by increasing the size of the
sample
• It is opposite of reliability (i.e., Precision or
repeatability)
Reliability (or precision): refers to the repeatability of
a measure, i.e., the degree of closeness between repeated
measurement.
• It is about, if the same thing is measured several times,
how close are the measurements to each other?
• The sources of variation resulting in poor reliability
include:
a. Variation in the characteristic of the subject being
measured. Example: blood pressure
b. The measuring instruments, e.g. questionnaires
c. The persons collecting the information (observer
variation): inter-observer and intra-observer
variation
 b) Non Sampling error (i.e., bias)
• Bias is the opposite of validity
• Consists of systematic deviations from the true value,
always in the same direction
• It is possible to eliminate or reduce the non-sampling error
(bias) by careful design of the sampling procedure

• Validity:
• This refers to the degree of closeness between a
measurement and the true value of what is being
measured
• Validity addresses the question, how close is the
measured value to the true value?

Accuracy is validity plus reliability

Examples of types of bias in sampling
include:
• Accessibility bias, seasonability bias, self-
reporting bias, volunteer bias, non-response bias
etc.
• Non-response bias refers to failure to obtain
information on some of the subjects included in the
sample to be studied
• Significant bias would come if a non response rate is a
significant proportion( above 15%) and if it differ
significantly from respondents.
• Non-response can be minimized by various method
• Training data collectors (on respectful approach,
repeated attempt on absence)
• Giving incentive to participants
• Considering non response rate during sample size
calculation