Research

Introduction to the Course

for residents at AHSU

Group I
October 2024
Year I Semester I Year I Semester II Year II Semester I

Basic theory of research/ Area of concentration, objective creation, Research methods and Ethics of research,
epidemiology Writing up Introduction Methods writing-up, quest.

Within five weeks time Within the whole semester Within the whole semester

Interactive lectures 2 days lecture + 3 days Practice, writing. 2 days lecture + 3 days Practice, writing.

Relatively less practical Practical writing up, mentors involved Practical writing up, mentors involved

Traditional evaluation Evaluated by Mock-defense Evaluated by Mock-defense + IRB submis

 Year II Semester II Year III Semester I Year III Semester II

Data collection tool development, and data Data management and analysis, and writing Writing up and presentation of
collection up of dissertation thesis dissertation thesis

Within the whole semester Within the whole semester Within the whole semester

2 days lecture + 2 days Writing

2 days lecture + 3 days Practice, writing. 5 days lecture + 5 days Practice, writing.
up/ presentation.

Practical questionnaire, data collection Practical data analysis, and writing up Practical writing up

Evaluated by availability of pure data Evaluated by Mock defense Evaluated by Actual defense
 Year IV Semester I & II

Manuscript writing up

Within the whole year

2 days lecture + 2 days Practice, writing.

Practical writing up

Evaluated by research day (conference) +

submission of manuscript
 Course Organization
Concepts and
principles
Sampling methods
Concepts of disease
and types of variables
and health measures
Measures of disease
Basics of occurrence
Validating screening
and diagnostic tools
Research
Measures association
in health and impact
(epidemiology)
Evaluation of
evidence and Epidemiological
causations study designs

Qualitative
Explorative and designs
hypothesized objectives
Negussie D., 2024 5
 Learning Objectives

By the end of this course, students will be able to:

• Measure concepts of health and disease, including the calculation and
interpretation of rates, ratios, and proportions [prevalence and incidence].

• Describe and apply sound sampling methods (probabilistic vs.

non-probabilistic) to ensure the sample represents the source population.

• Develop skills in analytical techniques for measuring associations and

impact, including calculating effect size.

• Recognize and apply basic quantitative (descriptive and analytic) and

qualitative research designs.

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 Cont…
• Identify the appropriate objectives for utilizing qualitative research
methods and explorative analytic, quantitative designs.

• Critically appraise for evaluation of evidence and causations, with

issues of bias, chance, confounding

• Analyze the validity and reliability of screening tools and

diagnostic methods for clinically important diseases.

• Critically appraise research articles for causality, identifying

possible limitations related to bias, chance, and confounding factors.

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 Methods of Instruction
• Lectures, followed by a practical session

• In-class assignments,

• Take-home assignments,

• Group discussions

• Continuous daily assessment

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 Requirements
1. Full participation in class/ tutorial time

2. Taking Notes while in class and tutorials

3. Doing the exercise given

4. Having a simple calculator/ Laptop computer

5. Reading reference materials

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 Course reference
1. Friis, R.H. and Sellers, T., 2020. Epidemiology for public health practice. 6th Ed. Jones &
Bartlett Learning. Publishers.

2. Aschengrau, A. and Seage, G.R., 2013. Essentials of epidemiology in public health. 4th
Ed. Jones & Bartlett Publishers.

3. Szklo, M. and Nieto, F.J., 2014. Epidemiology: beyond the basics. 4th Ed. Jones &
Bartlett Publishers.

4. Booth, W.C., Colomb, G.G. and Williams, J.M., 2009. The craft of research. 4th Ed.
University of Chicago press.

5. Creswell, J.W. and Creswell, J.D., 2017. Research design: Qualitative, quantitative, and
mixed methods approaches. 3rd Ed. Sage publications.

6. Galvan, J.L. and Galvan, M.C., 2017. Writing literature reviews: A guide for students of the
social and behavioral sciences. Routledge.

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 Graduate Education
• Students should take greater responsibility
– Read more …Read more…and more
– Individual [and group] practicing of exercise
– Practicing what learnt at workplace

• Instructor/ books/ YouTubes responsibility…..……

……..…… to guide a student to the desired track

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 Assessments
Continuous assessment [two forms, have 60% weight]

1) Home take assessment

– A group of questions will be given

– Each home-take will contribute to the continuous assessment

2) Daily assessment that will be given to see student understanding

– It will be give through online, ODK
–
– It would be completed individually [5-10 minutes]

3) Final assessment [formal final exam have 40% weight]

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 1. home-take assignments
• Those are exercises given at the individual level

• Group work is allowed as exercise among friends

• You are also able to counsel your instructors

• Work with three to five individual friends [together]

• Then, work individually for submission.

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2. Daily assessment
• Continuous assessment technic of student evaluation is important for
taking the 60% weighted assessment.

• It will assess how students understand class given on daily level.

• It also assess the attendance of students

• Both evaluation could give us how you are following the course

• Final assessment using final exam also will have 40% weight.

14
 Cont…
• The continuous assessment technique will use the Open Data Kit (ODK)
platform for assessment.

• The ODK is an online digital apparatus that is usually used for data
collection.

• The ODK is made using a smartphone or tablet.

• After completing the daily class, at the end of the class, you will be given
5-10 questions from the class offered on that day
• The 5-10 questions should be answered and sent to a server within 10-15
minutes.

• Questions given emphasis in class will be used for the continuous

assessment
15
 What do we need for continuous assessment?
1. A smartphone or a tablet.

2. Downloading ODK-collect on our smartphone

3. Capture the questions from the QR code

4. Answer all questions and send them to the server.

16
1. Devices
• Apparatus that can read the XLSform
• Simple smart form or tablets with android system
is needed
• Data is collected from those devices
• Android
The device can send data to the central server
whenphone
smart connected
or tablet to Wi-Fi or mobile data

17
The device
• The device should have ODK collect [Open Data Kit].

• ODK collect is an apparatus in smart phone used for

direct data entry

• ODK-collect can be downloaded or transferred from

other smart phone having the apparatus

• It can be downloaded using Play (google) Store or

transferred using Xender

18
1) Play (Google) store
• To download an apparatus [smart phone], you need Play
Store.
• The play store need google account [you need Gmail
account]
• By opening the google play store you are able to download
free applications (ODK collect is one)
• Write the name of the apparats (application) on the search
place and return, [i.e.. write ‘ODK collect’
• [choose and run it when you find what you want]
19
 The smart phone
1) Connect to internet (Wi-Fi or data)

2) Click the play store and write ODK collect

3) Make a search by turning ok

ODK
4) You will find “ODK-Collect”, and click it andcollect
wait until it is
downloaded and installed.

5) When complete means, you are one step forward

20
 1. Uploading the questionnaire
• The questionnaire will be taken from the
configured computer using a QR code

1. Using QR code

21
Open the ODK
1. When clicking ODK-collect for the
first time, the following form comes

• Now it is ready for scanning

Click the “Configure with QR code”
• It asks for scanning the apparatus

• Once scanned the apparatus will

resemble as follows
22
The default ODK format
1. Click the ‘Start new form’
(2)
It is used to open the questionnaire
2. Click the ‘Drafts’
It is used to edit or continue previously
incomplete part of the questionnaire

It is used when there is a discontinued

interview and saved [not discarded].

A number of editable questions will be

displayed on the right side of the form
23
 Cont…
3. Click the “Ready to Send” form
It is used to send a completed questions
• Number of completed questions will be (2)
displayed on the right side under bracket (5)

• It is usually done while having Wi-Fi or

data, and presence of completed questions
• It is usually done also at the end of data
collection day, after completing 3-10 questions, All the questions will
when having Wi-Fi access. be sent to the cloud
• When clicked the ‘Send’
🡺 Select all the questions and click the ‘send selected
24
 How to relate
smart form vs central server
2) For other times, when you want
to change

2b. Click the Add project

25
Cont…
4. Click on the Reconfigure with QR Code,
🡺 Both “Scan” and QR Code appear

5. Click on the
Now it is time to scan a QR Code,

6. Click on the
QR Code to transfer to others
7. Now it is time others
This figure will come to scan the QR Code
26
 How to relate
smart form vs central server
2) For other times, when you want
to change

2a. Click the setting

3. Click the
Project management 27
Cont…
🡺 Both “Scan” and QR Code appear

5. Click on the
Now it is time to scan a QR Code,

6. Click on the
QR Code to transfer to others 7. Now it is time others
to scan the QR Code
This figure will come
28
 Opening the questionnaire
Now click the
“Start new form” Select the questionnaire
you want to collect the
data
• You will see all
questionnaires
you selected

29
Flow of interview

30
Introduction to Research I
 What is a research
• A systematic search to discover new information or gain insights into a
specific topic or question.

• It involves a systematic methodological approach to gathering and

analyzing data related to the research question or hypothesis.

• The investigation focuses on exploring areas where knowledge is

incomplete, uncertain, or unknown.

• Research relies on evidence, data collection, and factual analysis to reach

conclusions or generate new understanding.

• The ultimate goal is to advance knowledge, solve problems, or inform

decision-makers in the specific field of study.

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 Issues of Clinical/ Public Health Importance
Consider:
• Magnitude of the problem: measured by incidence and prevalence of
the problem in the public.
• Seriousness of the problem: measured by
– Morbidity [severity in symptom, hospitalization]
– Mortality [case fatality rate]
– Disability [quality of life]
• Impact of the disease on the health, social, and economic welfare of
people affected by the problem [social, economic, health burden].

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 Medicine vs. Epidemiology
Clinical Medicine Epidemiology
Focus Individuals Populations

Main Goal Diagnosis and Treatment Prevention and Control

Questions What is wrong with this What are leading causes of illness,
patient? death or disability in this population?

What treatment is What intervention can be done to

appropriate? reduce them?

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 Scientific Method
Applied to Patient and Community
Step Clinician Epidemiologist

Data base History, Surveillance,

physical exam descriptive epi

Assessment Differential dx Inference

Hypothesis Diagnostic studies Analytical epi

testing

Action Treatment Community intervention

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 Single Overriding Objective:

Everything we do must directly improve

the health of the people!

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 Basic Epidemiologic Approach
• Observe
• Count cases (events)
• Describe
Descriptive
– Time, place, person Epidemiology
– Calculate rates
• Develop hypothesis
• Compare rates Analytical
• Test hypothesis Epidemiology
• Implement actions (control, prevention)

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 Nature of Epidemiology
• It is a toolkit of methods for:
– Answering public health or clinical questions

– Identifying relationships between exposure and

outcome

– Assessing the efficacy of interventions (solutions

to alleviate public health problems)

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 Fundamentals of Research Assumptions
• Diseases (or health-related events) do not occur at
random or by chance.

• Diseases (or health-related events) have causal or

preventive factors that can be identified

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Concepts of disease
and health measures
 Research in health
• Research is a systematic investigation aimed at discovering new
information, facts, or insights about a “specific topic or question.”

• The specific topic or question is the “health problem” phenomenon

among the public.

• Research within the health phenomena aims at a disease of interest

to the researcher and public health importance.

• Therefore, knowledge of the concept of health and disease and its

measurement is crucial.
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 How to assess?
A A
ABCDEFGHIJK Short and long
B B
Possible Diagnosis term C
C
causes, consequences D
D
E A health E
Determinants Direct/ indirect F
F problem
G effects (organs) G
Possible H
H
preventive Medication Change in I
I
factor quality of life J
J ABCDEFGHIJK
K K

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 Concepts of Disease and Health
Health:
• Health is a state of complete physical, mental, and social well-being,
not merely the absence of disease or infirmity.
Disease
• Disease is a condition that impairs normal bodily functions

• In research, we usually focus on a health-related problem [disease]

or its known major determinants.
• The health-related problem is usually considered the outcome while
conditions that we search in research are called possible contributing
or related factors [Determinants]

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 Health-related problem Vs determinants
Health-related problem
• Any condition, illness, or factor that negatively impacts an individual's physical
or mental well-being.
• A disease or a problem having physiological or psychological dysfunction
– Eg hypertension, diabetic mellitus, depression, HIV, Malaria, etc

Determinants of a disease
• Any factor (condition) that influences or contributes to the development or
prevention of a health-related problem.
• A condition or factor that is present could increase or decrease the chance of the
occurrence of a health-related problem
E.g., Having multiple sexual partners for STDs [HIV]
Condom use for STDs [HIV]
Living in low-land for Malaria etc
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 Dichotomized form of Disease [Health related Problem]
• A condition that has only two options is a dichotomous [eg, sex, disease, death]
Present (Diseased):
✔ Individuals who have the specific disease or meet the specific diagnostic criteria.

Absent (Non-Diseased):
✔ Individuals who do not have the disease or do not meet the diagnostic criteria.

In research, we should usually focus on studying only one disease at a time.

At any given time, a person will either have or not have a specific disease.

For example, if we are interested in HIV status, a person either has or does not have HIV.
The person may have other diseases, but we should only focus on the disease of
interest, not the other conditions.
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 Disease [health-related problem]
• Confirming the presence of a disease [measurements]
– Diagnostic measurements [BP, BMI]

– Laboratory tests [Agents, Chemicals, indicators]

– Radiology findings, Pathology (autopsy), verbal autopsy

– Clinical diagnosis [History + Physician Examination + Lab. + Rad.]

– Screening tests [lab or measurements]

– Symptoms and severity of symptoms [depression, pain etc…]

🡺 In research, we should use the best and available diagnostics in the area

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 Disease confirmation in research
• A disease or health-related problem should be measured using the
best available diagnostic method.

• If a measurement method is widely used by many researchers, the

method is considered as a standard measurement.

• The use of a standard measuring tool for a disease is advisable and

important, because it allows comparisons with other studies.

• If we are unable to use the standard or internationally accepted

diagnostic tools, an operational definition can be used.

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 Operational definition
• An operational definition is a description of the measurement of a disease
of interest when we are not using the international method of diagnosis.

• When a disease has an international measurement of diagnosing it, if we

are using it, then we may not need an operational definition

• However, if the international measurement is not available, we may use

another available method (which may be relatively good but not definite
diagnostic).
🡺 At such a time, we should have an operational definition.

• Operational definition briefly describes how study subjects were considered

as having the disease and as not having a disease
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 Measures of disease occurrence
• Disease occurrence can be measured using measures of frequency

• Measures of frequency are made using simple ❶ counting, ❷ratio,

❸proportion, or ❹ rate.

1. Counting
• It is through simple counting of people with an event [e.g., disease].

• It is a common descriptive measure and is the first step in measuring

or calculating ratios, proportions, and rates
🡺 E.g. 200 cases of malaria in a small village, etc.

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 Simple count

There are 15 cases

with illness
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 2. Ratio
• A ratio is the relative size of two quantities groups
• It quantifies the magnitude of occurrence of
something in relation to another.
• One character divided by another characteristics
• One group vs another group

• Example: Sex ratio, [Male to female ratio]

Odds ratio (OR), Relative risk (RR)

Negussie D., 2024 51

 Cont….
• No specific relationship is necessary between the numerator and
denominator
(numerator NOT necessarily included in the denominator)

▪ Either the numerator or denominator is set usually to ONE (1).

▪n:y or n/n: y/n or 1 to y/n

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 3. Proportion
▪ It is the comparison of a part to the whole population

▪ Numerator MUST BE INCLUDED in the denominator

▪ Its result ranges between 0 and 1 or (0–100%)

▪ Percentage = Proportion x 100

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 4. Rate
• Rate: measures the occurrence of an event in a
population over time.

• It is like a proportion, But it also adds the time dimension

Cervical cancer cases in menopausal women in 2000

Total number of menopausal women in 2000

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 Cont….
Observed in 2006
2
----- = 0.02 / year
100
Total population in 2006 = 2 per 100 Person in a year

• Rate may be expressed in any power of 10

(100, 101, 102, 103, 10n)

• 100, 1,000, 10,000, 100,000

• It is bécasse we have to describe it in the number of people

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 2. Measures of disease occurence
There are two types of measures :
1. Prevalence
Which measures a population’s disease status
(two forms)
1. Point Prevalence 2. Period prevalence
2. Incidence
Assesses frequency of disease onset (two forms)

2. Cumulative incidence/ incidence proportion

3. Incidence density or incidence rate

Negussie D., 2024 56
 1. Prevalence
• It is the proportion of a population affected by a disease at
a given time.
Number of cases of a disease at a specific time
Mid-year population at the specified time

• It is expressed as a percentage, per thousand, per hundred

thousand
• HIV/AIDS in city X in 2023:
Population 210,000
Cases 3,200
Prevalence 1.5% or 15 per thousand population
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 1. Point Prevalence
• It is the proportion of a population that is affected by disease at a given
point in time

• The amount of disease in a population usually changes constantly

• Thus, may not be useful for the assessment of diseases with short
generation period

• When we do a survey assessing the presence of disease at the time of a

survey, the prevalence we are assessing will be point prevalence

• If we assess the occurrence of a disease within a month time, it is not a

point prevalence
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 2. Period prevalence
• Period prevalence would be preferred if we want to know how much
disease is present over a longer period of time.

• We use mid-year population if we consider there will be a change in the

number of population (usually if it is longer time, counted in years)

Number of cases of a disease at a specific time

Mid-year population at the specified time

total population + total population

Mid-year population = at starting at the end +

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2
59
 Example
A total of 100 people were at risk of disease x, which has no lifetime immunity
and is not a killer disease.

t1 t2

• What is the prevalence of disease X during time t1?

• What type of prevalence is it?

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 Example
A total of 100 people were at risk of disease x, which has no lifetime immunity
and is not a killer disease.

t1 t2

• What is the prevalence of disease X during time between t1 and t2?

• What type of prevalence is it?

Negussie D., 2024 61
 2. Incidence
• The number of ❶new events of a disease in a defined ❷population at risk
within a ❸specified period of time.
• Population at risk is key point here, it is people who can acquire the disease
of interest [healthy people, non-immune people]
❶
Number of NEW cases of disease during a specific period
❸
• Two forms, ❷ Population at risk during such a period
1. Cumulative incidence
2. Incidence density / incidence rate

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 a. Cumulative Incidence
• It assumes that the entire population at onset is at risk and is
followed up for a specified time period
• Usually, done in a closed population [people included in a study
and followed]
x
i s k
People at risk x
R
CI = 3/12 per year
= 0.25 per year

x = 25 % per year

x disease onset
Month 0 Month1
Negussie D., 2024 2 63
 Example
A total of 100 people were available and disease x was counted as follows,
and the disease has no life-time immunity.

t1 t2

1. How many of the population are at risk to the disease x, at the onset?

2. How many new cases acquired the disease between t1 and t2

3. What is the cumulative incidence of disease X during the time between t 1 and t2?
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 b. Incidence Density (rate)
Number of NEW cases of disease during a period

Total Person-time at risk

Rate
Instantaneous concept of rate (= speed)
Denominator:
• It is the sum of each individual’s time at risk (or time free of a disease)
is counted
• Each individual’s time at risk is summed up to give the denominator

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 Incidence (density) rate

• Incidence rate must be taken into account

– Number of new cases who become ill in a population [new cases]

– Time periods experienced by members of the population during

follow-up [summed time at risk, person-time] (denominator).

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 Person- time
• It is the sum of length of time period passed free of illness (at
risk) by each individual member of study.
• People at risk are people who can acquire the disease of interest
[e.g., death, all live people are at risk]
• It accounts for the amount of exposure time of members

• It is a good measure in a dynamic cohort

• Dynamic cohort is a cohort of people leaving and entering a

study at different time period

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 Dynamic (open) cohort study

Birth In-migrants

Death Out-migrants

E. g. Framingham Cardiovascular Disease Study Cohort

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 Person- time [example]
90 91 92 93 94 95 96 97 98 99 00 Time at risk

A 6.0
B x 6.0
C 10.0
D 8.5
E x 5.0

Total years at risk 35.5

-- time followed
ID = 2 / 35.5 person- years
x disease onset = 0.056 person-year
= 56 per 1000 person-years
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 Exercise
In 2020, University of XXX enrolled about 4220 students in the freshman program.
During entry to the university in Sept 2020, voluntary testing for HIV was made and 100
were positive for HIV. A year later, in Sept 2021 re-test was made on the remaining
students and 50 become positive. In Sept 2022, during re-testing, another 50 converted
positive, and finally in Sept 2023, 20 additional students converted positive. (Note: HIV
is not a cure disease; no one has died, or has been dismissed or taken withdrawal)

Q1A. What is prevalence of HIV in Q1B. What is the period prevalence of HIV
A) Sept 2020, between Sept 2021 and Sept 2023?
B) Sept 2021,
C) Sept 2022 and
D) Sept 2023?

70 Negussie D., 2024

 Cont…
Q1C. What is the cumulative incidence of HIV
– Between Sept 2020 and Sept 2021?
– Between Sept 2020 and Sept 2023?
– Between Sept 2022 and Sept 2023

Q1D. What is the incidence density of HIV

– Between Sept 2020 and Sept 2021?
– Between Sept 2020 and Sept 2023?
– Between Sept 2022 and Sept 2023

71 Negussie D., 2024

 Comparing Incidence and Prevalence

Incidence Prevalence
• New cases/ events per period of time • All cases at point/period of time

• Useful to study factors causing • Useful for measuring size of

disease, problem

• Useful in “risk” estimation • Useful for planning

Negussie D., 2024 72

 Relationship between Incidence,
Prevalence and Disease Duration

Incidence

Deaths,
Prevalence
Cure,

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Lost to follow up
73
 Factors influencing Prevalence

Increased By Decreased By
By longer duration of the Shorter duration of the disease
disease
High case fatality
Prolongation of life of patients
without cure Decrease in new cases
(decrease in incidence)
Increase in new cases
(increase in incidence) In-migration of health people

In-migration of cases Out-migration of cases

Out-migration of healthy people Out-migration of susceptible

people
In-migration of susceptible
people
Improved cure rate of cases)
Improved diagnostic facilities
Negussie D., 2024 (better reporting) 74
 Home take exercise

Negussie D., 2024 75

 ODK Collect Continuous assessment

Negussie D., 2024 76

 Lecture note

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