Research Study

Designs
Abid Ullah Shah
Lecturer Cardiology
CMT-BKMC, Mardan
Research Study Design
A research design is a road map/strategy of investigation that
you need to follow during your research journey to find answer
to your research questions as validly, accurately and
economically as possible.

 A plan how you will collect data

 How you will select respondents
 How will you analyse
 How will you communicate findings
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 Classification of Epidemiological
Research/Study Designs

Descriptive Analytical
Research Research
 Descriptive Research

Individual based
Population based

Case reporting

Case series
Ecological
Cross-sectional surveys
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 Analytical Research

Observational/ Experimental/
Non-interventional Interventional

Cohort study Randomized Control

Trials
Case–control study

Cross-sectional study Quassi 5

Study Types
Several classifications of study types are possible, depending
on what research strategies are used.
Generally there are two broad categories:

1. Non-intervention studies

2. Intervention studies
Conti..

1. Non-intervention studies in which the researcher just

observes and analyses researchable objects or situations but
does not intervene
• Descriptive studies
• Comparative (analytical) studies

2. Intervention studies in which the researcher manipulates

objects or situations and measures the outcome of his
manipulations
• Experimental studies
• Quasi-experimental studies.
• Before and after studies
 Objectives at various
levels
Study Types Objectives
1. Knowing the frequency of disease
2. Knowing the distribution
DESCRIPTIVE STUDIES 3. Developing the hypothesis

OBSERVATIONAL 1. Testing the hypothesis

ANALYTICAL 2. Establishing association

EXPERIMENTAL OR 1. Strength of association

INTERVENTIONAL STUDIES 2. Establishing the cause

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Descriptive studies
A Descriptive study involves describing the characteristics of a
particular situation, event or case.

Describe only, not examine association

Carried out on small/large scale

o Small scale, descriptive case studies

o Large scale, descriptive cross-sectional surveys

o A study that covers the total population is called a census.

 Descriptive Studies
1. Case Study or Case Report
• A single patient’s clinical history is described in detail, and then
discussed in relation to the literature.
• Almost always a rare unusual, or atypical case.

2. Case Series
• Two or more patients with similar diagnoses are described.
• These can be either unusual cases or a consecutive series of a more
common diagnosis in which efforts are made to characterize the
series. (e.g. The male female ratio, the age distribution etc.).
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 3. Larger Scale, Cross Sectional
Surveys
• Cross-sectional surveys aim at describing and quantifying the distribution of
certain variables (problem) in a study population at one point of time (one contact
with study population).
• The main outcome is prevalence
• They may cover, for example:
• Physical characteristics of people, materials or the environment, as in
• Prevalence surveys (of contraceptive methods, HIV), or
• Evaluation of coverage (of immunization, health need, extent of unemployment
etc.),
• Socio-economic characteristics of people such as their age, education, marital
status, number of children and income,
• KAP (knowledge, attitude, practices) surveys. 11
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Comparative or analytical studies

 Analytical study attempts to establish causes or risk

factors for certain problems.

 This is done by comparing two or more groups, some

of whom have the problem and some have not.
Types of analytical studies
Cross-sectional comparative studies
• Two groups, one with the problem and another without it,
are taken from the same population and compared for the
presence of the independent variables/influencing factors,
for the problem under study, at one point in time.
 Difference
Cross Sectional Survey (Descriptive Cross Sectional Comparative (Analytical
study) study)
• For example, survey a large number • How many lung cancer and non lung
of college students in terms of cancer populations have smoking
smoking status (risk factor- status and compare the rates.
Exposure/Non-exposure) or any
disease (Diseased/Not diseased).

• Compare and demonstrate differences

• The information collected is purely either b/w exposed/non-exposed
of a descriptive nature, not involving groups with outcome, or b/w those
the comparison of groups formed on with outcome and without the
the basis of exposure or outcome outcome, with exposure.
status.
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 Advantages of cross-sectional

 Outcomes and exposures measured at the same time

 Uncovers associations for further study
 Useful for hypothesis generation
 Quick & cheap (no follow up).
 Best way to determine prevalence
 Questionnaire/interview based
 Useful for assessing practice, attitudes, knowledge, beliefs,
utilisation of services etc.
 Disadvantages of
cross-sectional
 Cannot establish sequence of events (temporal relationship).

 Bias - selection, information

 Not useful for rare exposures or rare outcomes

Case-control studies
Case: Diseased or with problem
Control: Without diseased or with out problem

 In a Case-Control Study the investigator compares one group

among whom the problem that he wishes to investigate is present,
called the study group and

 Compares it with another group without the problem, called the

control group

 Information, about previous exposures are obtained for cases and

controls, and frequency of exposure compared for the two groups.
Diagram of a case-control study
 Advantages

 Quick and inexpensive

 Valuable for studying rare or uncommon conditions.

 Can examine multiple etiologic factors for a given disease.

 A relatively small number of subjects are required

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 Disadvantages
• Inefficient if the exposure is very rare.

• They are limited to one outcome variable.

• Incidence rates or absolute risk estimates cannot be directly derived from

them.

• Do not establish the temporal sequence of events.

• Prone to bias (selection of cases and controls, recall also).

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Cohort studies

• In a Cohort Study, a group of individuals that is exposed to a risk

factor (study group) is compared to a group of matched
individuals not exposed to the risk factor (control group).

• The researcher follows both groups over time and compares the
occurrence of the problem that he expects to be related to the
risk factor in the two groups
Diagram of a cohort study
 Advantages
 Provide strong information about the causation of disease.

 Provide the measurement of the risk of developing disease.

 Exposure can be measured without bias, because at that time the outcomes are not
known; known confounders can be measured (especially in a prospective study).

 Can be used to examine multiple outcomes.

 A range of factors that may influence the outcome (e.g., smoking etc) can be measured.

 Suitable for examining the effects of rare exposures because this group can be
preferentially recruited at the baseline.

 Allows the incidence of the disease to be established. 25

 Disadvantages
 Costly and time consuming.

 May be difficult to accurately define and measure exposure in some circumstances.

 Losses to follow-up are not uncommon and may introduce serious bias.

 Information bias may vary in its effect over the course of data collection.

 Use of the retrospective design is only possible if historical data of adequate quality
are available.

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Experimental studies
 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

(independent variable) on the dependent variable/problem) is
determined.
Diagram of an experimental study
Randomized control trial
Randomization
 Allocation of participants randomly into various groups
Control
 Control group is used to compare the effect of intervention
Trail
 Experiment conduction

 Randomly assigned treatment and comparison groups

 Provide convincing evidence of causation
Conti..
Conti..
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.
Diagram of a quasi-experimental design
Before-after study

Another type of design that is often chosen because it is quite

easy to set up uses only one group in which an intervention is
carried out.

The situation is analyzed before and after the intervention to

test if there is any difference in the observed problem.

Observation done before intervention and observation done

after intervention and than compared
Diagram of a before-after study
Thank
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