MIZAN-TEPI UNIVERSITY

COLLEGE OFMEDICINE AND HEALTH SCIENCE

DEPARTMENT OF PUBLIC HEALTH

PROGRAM MPH SUMMER: YEAR III

GROUP ASSIGNMENT COURSE TITLE: RESEARCH METHODOLOGY

INSTRUCTORS : M.r ADANE ASEFA (Ass’t prof, MPH)

August, 2024
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 PREPARED BY

§Seblewongel Dejene ID No GSS/016/13

§Kindualem Fanta ID No GSS /006/13

§ Abebe Adane ID No GSS/010/13

§Yonas Andarge ID No GSS /009/13

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Outlines
ØObjectives
ØTypes of study design
ØObservational study
ØExperimental study
ØApproach in selecting study design
ØAcknowledgement
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Objectives

At the end of this presentation participants will expected to

• Differentiate different Types of study design

• Appreciate observational study design

• Appreciate experimental study design

• Know Approach to selecting study design

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 fundamental of research approaches
Qualitative Studies vs Quantitative Studies

• Qualitative Studies Focus on understanding depth, context,

and meaning

§ Detailed descriptions and interpretations of participants’

perspectives

• Ideal for exploring complex issues and generating hypotheses.

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Quantitative Studies

• To quantify variables and examine relationships or differences among

them, often to test hypotheses.

• Numerical data that can be measured and analyzed statistically

• Generalizable findings that can be applied to larger populations;

useful for establishing patterns, relationships, and causality.

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Cont…

• Both approaches can complement each other and are often used in
mixed-methods research to provide a more comprehensive
understanding of a research question.

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Descriptive vs Analytic
Descriptive Studies
• To describe characteristics of a population or phenomenon.

• Observing and detailing the "who, what, where, and when."

• Provides a snapshot of the situation but does not establish cause-

and-effect relationships.
• Generate hypotheses

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Analytic Studies
ØTo examine relationships between variables and determine cause-and-
effect links.

ØInvestigating the "why and how" behind observed phenomena.

ØConcentrate on understanding relationships and testing hypotheses

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 observational vs experimental
Observational Studies
o No Intervention: Researchers do not influence or change the variables; they
simply observe what occurs naturally.

oLimitations: Cannot establish causation; results may be influenced

by confounding variables.

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Intervention (Experimental) Studies

• Active Intervention: Researchers manipulate one or more variables

to observe the effect on outcomes

• Actively test hypotheses by manipulating variables

• Essential for establishing causal relationships.

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 Prospective Vs Retrospective studies
vBased o the direction of data collection and study timing.
Prospective Studies
• Researchers follow participants forward in time from a defined point to
observe outcomes.
Advantages
• Ability to establish temporal relationships (i.e., exposure precedes
outcome).

• Control over data collection methods.

• Reduces recall bias since data is collected in real-time.

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 Retrospective Studies
• In retrospective studies, researchers look back in time to examine existing
data or outcomes that have already occurred.
• Information is gathered from past records, surveys, or databases
Advantages
• Generally quicker and less expensive than prospective studies
• Useful for studying rare diseases or outcomes since researchers can
identify cases that have already occurred
ØBoth study types have their unique strengths and applications in research
depending on the research question and available resources
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study designs

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14
 Ecological studies

vAn ecological study is an observational study that is

characterized by trying to relate exposure and disease
at the region and population level, rather than at the
individual level.

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 The interactions between ‘human activities’ and ‘the environment’

Environment
Water
Air
Soil and
minerals

Human activities
Energy production
Transport
Agriculture Wastes pollutants
recreation Air pollutant
domestic and Water pollutant
personal activities Soil pollutant

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Radioactive wastes 16
 Cross-sectional studies

• Cross-sectional studies are types of observational

studies in an empirical study (e.g., survey, content
analysis) that is carried out, or data is collected at one
given point in time

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 Cross-sectional studies…
• Case and out come occurred at point in time and no directional

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 Advantages of cross-sectional
• Good design for hypothesis generation
• Can estimate overall and specific disease prevalence
• Can estimate exposure proportions in the population
• Can study multiple exposures or multiple outcomes or
diseases
• Relatively easy, quick and inexpensive
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 Limitation of cross-sectional
• Impractical for rare diseases
• chicken egg dilemma- which came first, chicken or the
egg?
• Weak temporal relation ship
• Prevalence-incidence bias
• Confounding is difficult to control
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 Case-control studies
• A study that compares two groups of people: those with
the disease or condition under study (cases) and a very
similar group of people who do not have the disease or
condition (controls)
• Case –control studies retrospectively or back ward
direction.
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 Advantages of a case-control study
v May be the only way to study etiology of rare diseases
vCan study multiple etiologic factors simultaneously
vLess time-consuming and inexpensive
v If assumptions are met, associations and risk estimates
are consistent with other types of studies.

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 Limitation of a case-control study
ØDoes not estimate incidence or prevalence
Ø Relative risk is only indirectly measured
ØBoth selection and information biases
Ø Usually cannot study rare exposures
Ø Temporal relationship b/n exposure and disease can be difficult
to document
ØHard to decide when disease was actually acquired
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Case-control ….

Exposed

Cases(diseased)
Not exposed p
Study
o
populati
p
Exposed on
Control(non ul
diseased) at
io
Not exposed
n

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 Cohort studies
• A cohort study is a type of epidemiological study in which a group of people
with a common characteristic is followed over time to find how many reach a
certain health outcome of interest (disease, condition, event, death, or a
change in health status or behavior).

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 Cohort Study
Types:-
• Prospective

• Rétrospective

• Ambi-direction

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Advantages of cohort Studies
ØGood for rare exposures
ØFeasible for rare exposure
ØGood for multiple outcomes
Ø Direction of cause and effect clear
ØReduce bias related to recall of exposure
ØRisk can be calculated
ØTemporality (cause-effect) can be established
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 Limitation of Cohort Studies
• Not good for rare outcomes
• Loss to follow-up
• Changing exposure status
• Expensive and take a long time
• Inefficient for studying rare conditions.
• Required Large sample sizes
• Over a long period: changes may occur in the
environment
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 Cohort study diagram
Time
Investigation direction
Disease develop
Free of exposed Not disease develop
disease
Disease develop
Not expound
Not disease develop

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 Interventional/ Experimental
oInvestigator assigns subjects to exposure and non-exposure
and makes follow up to measure for the occurrence of a disease

oIt is usually prospective

oVery expensive

oDifficult to overcome ethical issue

oMeasure of association is using Relative risk

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 Types of Experimental studies

• Clinical trial(Randomized controlled )

• field trial

• community trial

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Types…

Ø Randomized controlled (Clinical) trial

. Patients are used as study subjects
. Treatment is used as an exposure
. Recovering (survival) from a disease is the outcome

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Randomized controlled (Clinical) trial
• Is considered the strongest research design for evaluating
the effects of health interventions
• Have a long history in clinical medicine
• Gold standard of epidemiological study design
• High status and validity
• Can pick up small and modest effects

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 Clinical Trial
ØHas 4 Phases:-
• Phase I: clinical pharmacology and toxicity
• Phase II: Initial Assessment of Efficacy
• Phase III: Full-scale Evaluation of Treatment Efficacy
• Phase IV: Postmarking Surveillance

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 Phases
ØPhase I
• Studies assess the safety of a drug
• 1st experiment in human for new drug, schedule, or combination
• Primary concern: Safety
• Goal: define the maximum tolerated dose (MTD) in a dose-escalation
study
• Typically required 15-30 patients

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Phases…

ØPhase II- studies test the efficacy of a drug or device

• Small randomized, controlled, blinded, usually, a group of 25 to 100 patients

• Tests tolerability and different doses

E.g., optimal dosage without side effects

• Applied to patients with relevant illness

• Goal - Identify suitable formulation of drug

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Phases…
ØPhase III
• Referred to as clinical trial
• Evaluation of efficacy of drug
• Usually randomized, blinded, controlled trial
• If successful, licensed and marketed
ØPhase IV
• Large studies after approval of drug
• Often observational, study long-term effects
• Long term efficacy, rate of serious side effects
• Evaluate drug in “real life”, additional uses
• Phase IV is looking at safety over time
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 Time

Direction of inquiry
Recover
Experimental
Patients group Not recovering
Population with a
disease
Recover
Non–experimental
group Not recovering
Manipulation by investigator
Selection of people to be exposed or not-exposed
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 ØProvide minimizing the effect of confounding
Strength Clinical Trials
ØAvoid bias in allocation to exposure groups

ØBest design for detecting small to moderate effects that may be

clinically important

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• Ethical issues needLimitations
to be consideredClinical Trials
• Usually time consuming and costly

• Lengthy trials run the risk of loss to follow up (LTF)

• Some subjects will fail to adhere to the protocol

• Non-adherence will cause an underestimated measure of association

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 Field trial
• Healthy people are used as study subjects,
• Health promotion (preventive interventions) are
used as an exposure
• Occurrence of new disease is the outcome

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• Have to be conducted in the ‘field’ rather than in hospitals or clinics.

•Features of Field
Carried out among Trialsor groups of people
individuals

• The group may be a household, a block of houses, a school or a whole

community.

• Field trials in which whole communities are the unit of allocation are
called community trials.

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 Uses of Field Trials
• To evaluate interventions aimed at reducing exposure without
necessarily measuring the occurrence of health effects.

• Lower cost, as they do not involve lengthy follow-up or measurement of

disease outcomes.

• To test health education methods, training procedures or other public

health programs.

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 Time

Direction of inquiry
Disease
Intervention
People No disease
Population with
out a
Disease
disease No-intervention
No disease
Manipulation by investigator
Selection of people to be exposed or not-exposed
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 Strengths of Field Trials
qHelpful in assessing the value of new strategies to prevent the risk of
certain diseases in developing countries

qIt can evaluate a single variable in a precisely defined group of people

qReduce bias by comparing two otherwise identical groups

qAble to control selection, confounding and measurement biases

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 Limitations of Field Trials
• Require a greater number of subjects than clinical trials and therefore are
usually much more expensive.

• limits their use to the study of preventives of either extremely common or

extremely serious diseases.

• Often logistically complicated.

• Ethical and practical limitations.

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 Community trial
•Communities as study subjects

•Health promotion (preventive interventions)

are used as an exposure

•Occurrence of new disease is the outcome

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 Feature
• Observational Nature: Researchers observe outcomes without
manipulating the study environment.

• Quasi-Experimental Design: These trials attempt to infer causality from

interventions in the absence of randomization.

• Community-Based: Often conducted at the community level, addressing

public health interventions.

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 Time

Direction of inquiry
Disease
Intervention
No disease
Population Community

Disease
No-intervention
Manipulation by investigator
No disease
Selection of communities to be exposed or not-exposed
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 Strength
• Feasibility: Ideal in situations where true randomization is not possible
or ethical, either by time or design

• Real-World Application: Can be performed within a community as

opposed to in a strictly controlled setting

• Cost-Effectiveness: Generally less expensive and faster to conduct than

randomized controlled trials (RCTs)

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 Limitation
• Confounding Variables: The lack of randomization can lead to imbalances
in baseline characteristics, affecting the study’s internal validity

• Bias: Selection bias, information bias, and confounding are more

challenging to control

• Causal Inference: Establishing causality is more complex, requiring

careful interpretation and robust statistical methods

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 Approaches or Criteria in selecting Study
Design
§ selecting a study design: it's essential to consider several key approaches
and criteria

§ Some important factors to guide your decision for selecting a design

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 Approaches or Criteria
• Research Question
• Type of Data
• Objective of the Study
• Population and Sample
• Time Frame
• Feasibility
• Intervention vs. Observation
• Statistical Analysis
• Bias and Confounding Factors
• Ethical Considerations
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Approaches or Criteria…
ØResearch Question: Clearly define the research question or hypothesis.
complexity and nature of the question often dictate the appropriate design

Ø Type of Data: Determine whether you need qualitative or

quantitative data
Qualitative: Focuses on understanding experiences,
perspectives, or behaviors
Quantitative: Involves measurable data and statistical
analysis
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Approaches or Criteria…
ØObjective of the Study: Identify the study's primary goals

Descriptive: To describe characteristics or outcomes.

Analytical: To establish relationships or causal effects

ØPopulation and Sample: Consider the target population
Is it a specific group or a broader population?

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Approaches or Criteria…
ØTime Frame: Decide on the study duration
Cross-sectional: Data collected at a single point in time.

Longitudinal: Data collected over an extended period to observe changes.

ØFeasibility: Assess practical considerations, such as

Resources (time, budget, personnel)

Access to the target population

Ethical considerations

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Approaches or Criteria…
ØIntervention vs. Observation: Determine whether you
will implement an intervention or observe existing
conditions
Experimental: Involves manipulation of variables (e.g. randomized controlled trials)

Observational: No intervention; simply observe and analyze (e.g. cohort studies, case-
control studies)

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Approaches or Criteria…
Ø Statistical Analysis: Consider the statistical methods
that will be used Some designs lend themselves better to
certain types of analysis (e.g. regression, ANOVA)

Ø Bias and Confounding Factors: Plan for potential biases

and confounding variables that could affect the results

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Approaches or Criteria…
ØEthical Considerations: Ensure the study design adheres to
ethical guidelines, including informed consent and minimizing
harm to participants
qBy systematically evaluating these criteria, researchers can
select a study design that best aligns with their objectives and
constraints, ultimately leading to more valid and reliable
findings
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 AKNOWLEDGEMENT

ØFirst of all, we would like to express Our Gratitude to MTU, college of

Medicine and health science, department of public health for Summer
MPH program.

ØSecondly, we would like to thank you our instructor M.r Adane A. (ASS
prof, MPH) to give us this chance to prepare and practice this
Assignment.

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