Hawassa college of health sciences
Nursing Research Methodology
For Post Basic Bsc Comprehensive
Nursing Students
By Sisay Cherinet (MPH)
Feb, 2025 G.C
Nursing Research Methodology Module
Syllabus
• Program - Post Basic BSc Comprehensive Nursing
• Module Title - Nursing Research Methodology
• Module Code - Nurs M4203
• Status of the Module: Core
• ECTS - 5
• Target group - Second Year BSc. nursing Students
• Year - II
• Prerequisites - All core courses
• Duration - 20 weeks
Module summary
• Duration 10 weeks
• Total classroom-based teaching hrs.
• (Lecture, 9 weeks, 2hr/week, Total=18 hr.)
• Exam =1week
Module Description:
• This module is designed for the post basic BSc Nursing students to
have basic theoretical and practical background in research
methodology.
• This course will enable the students to understand the
methodological aspects of research process and operationalize how
to write research proposal (Scientific writing), data collection,
organization, analysis and interpretation.
• Furthermore, it gives the students the opportunities to disseminate
and utilize research findings
Module Objective
• At the end of this module, learners will be able to
describe and apply basic research method to
investigate health problems at as it applies to nursing
to the improve quality of care, promote the health status
of patients and families, and prevent an emergency and
critical illness conditions.
Learning Outcomes
To meet the above module objective the student will be expected to:
• Explain the concept of research and nursing research
• Describe the different types of research
• Identify a research problems
• Write literature review text
• Develop research objectives
• Distinguish the different types of nursing research designs
• Select study population
• Identify different types of sampling methods
• Outline different types of data collection methods
• Differentiate different methods of data analysis
• Analyze ethical issues in research processes
• Develop a research proposal
• Point out different ways of referencing
• Prepare work plan and budget break down
• Prepare a research report
• Describe how to utilize research findings for
evidence-based nursing practice
Teaching-Learning Methods
• Interactive lecture and discussion
• Small group learning activities: assignment, exercise,
proposal writing
• Individual reading
• Student presentation
• Critical appraisal of articles
Learning materials
• AV aids (LCD and computer, writing board and chalk)
• Computers with appropriate statistical software like
EPI info, SPSS .
• Handouts of lecture materials
Assessment Methods
Formative assessment
• Exercise and assignment
• Student presentation
• Critical appraisal
Summative assessment
Written Exam -----------------------------------50%
Assignment/ and or student presentation ----20%
Research proposal ------------------------------30%
Course Syllabus
1st week
1. Introduction to research
Research and nursing research
Importance of research
Types of research
Steps in research process
Research topic selection
2-3rd weeks
2. Identification and delimitation of research problems
Identification and prioritization of research problem
Writing study background and problem statement and significance
of the study
• 4th week .
3. Literature Review
Importance of literature review
Approaches to literature review (Induction and deduction)
Different ways acknowledging scientific papers and referencing
Conceptual frame work of study
• 5th week
4. Objective writing
General objective
Specific objectives
• 6-9th week
5. Methodology
Introduction
What is research?
• Research is the systematic collection, analysis and
interpretation of data to generate new knowledge or to
answer a certain question or solve a problem or add body
of knowledge
Research is a systematic search for information and new
knowledge
What is Nursing Research?
• Research is systematic inquiry that uses disciplined
methods to answer questions or solve problems or to
generate new knowledge
• Goal of research is to develop, refine, and expand a
body of knowledge
• Nurses are increasingly engaged in disciplined studies
that
Benefit the profession and its patients
Contribute to improvements in the entire health care
system
• What is Nursing Research?
Nursig Research is systematic inquiry designed to
develop knowledge about issues of importance to the
nursing profession, including nursing practice,
education, administration and informatics
• Clinical Nursing Research designed to generate
knowledge:
To guide nursing practice
To improve the health and quality of life of nurses
´clients
6 Examples of Nursing Research Questions
• What are the factors that determine the length
of stay of patients in the intensive care unit
undergoing coronary artery bypass graft
surgery (Doering et al 2001)
• How do adults with acquired brain injury
perceive their social interactions and
relationships (Paterson & Stewart 2002)
Rationale for a research
Rationale answer the question why spending
time doing a research/thesis?
Generate/advance knowledge
To investigate/understand a problem/theory:
addressing a gap
Any practical strengthening Public Health/
clinical services
Evaluate performance (project)
Types of research… based on use
• Basic/pure research is necessary to generate new
knowledge & technologies to deal with major unresolved
health problems
• Applied research is necessary to identify priority problems
and to design and evaluate Policies and programs that will
deliver the greatest health benefit, making optimal use of
available resources
Other classifications…based on type of data
Quantitative: based on the measurement of quantity or
amount
– Applicable to phenomena that can be expressed in
terms of quantity
• Is more concerned with questions about: how much? How
many? How often? To what extent? etc
Qualitative: concerned with Qualitative phenomena
(those relating to involving quality or kind)
• Is concerned with finding the answers to questions which
begin with: Why? How? In what way?
Health research
Research that supports health development
A health system may be described as: A set of cultural
beliefs about health and illness that forms the basis for
health- seeking and health-promoting behavior
The institutional arrangements within which that
behavior occurs; and
The socioeconomic (political), physical context for those
beliefs & institutions
They include: The individual, family and the community
Health system research cont.…
Health related sectors: education,
agriculture, etc.
The international sector (bilateral) and
multilateral donor agencies
Essential features of health research
1. Should focus on priority problems
2. It should be action oriented
3. An integrated multidisciplinary approach is
required 4. The research should be
participatory in nature
5. Research must be timely
Essential features…
6. Emphasis should be placed on
comparatively simple, short-term designs
that are likely to yield practical results
relatively quickly
7. The principle of cost-effectiveness is
important in the selection of research
projects
8. Results should be presented in formats
most useful for administrators, decision-
makers and the community
The research process format
An overview of a research process
Pre planning stage
Data collection and analysis stage
Report Writing Stage
Dissemination stage
Utilization
Main components of any
research work
I. Preparing a research proposal
II. Fieldwork (i.e., data collection)
III. Analyzing data and preparing a research
report
Components of a research proposal
Topic
Summary
Introduction (background, statement of
problem, significance)
Literature review
Objectives
Methods and materials
Work Plan
Budget
References
Annex
Research title/topic
• The broad general area expected to
investigate
• It is a broad idea or concept from which many
problems may be delineated
• Is the gateway to the contents of a
thesis/article
• It is the first part of a thesis that readers see,
and reviewers read
Topic…
A successful research starts with a good topic
How can you decide what to pick?
FINER
– Feasible
– Interesting
– Novel
– Ethical
– Relevant
Topic…
It should go with the objective and tell what
your study is about and where it will be done.
Title of a good research should/be
– Short, accurate and concise
– Informative, appropriate and catchy
– Make the central objective of the study
clear to the reader
– Specify : What? who ? Where?
Criteria for selecting a research
topic
1. Relevance: The topic you choose should
be a priority problem:
• Questions to be asked include:
How large or widespread is the problem?
Who is affected?
How severe is the problem?
Criteria for selecting a
research topic …..
2. Avoidance of duplication:
Investigate whether the topic has been
researched.
3. Feasibility:
Consider the complexity of the problem and the
resources you will require to carry out the study.
4. Political acceptability:
It is advisable to research a topic that has the
interest and support of the authorities.
This will facilitate the smooth conduct of the
research and increases the chance that the
results of the study will be implemented.
Criteria for selecting a
research topic….
5. Applicability of possible results and
recommendations
6. Urgency of data needed
How urgently are the results needed for making a
decision?
Which research should be done first and which can
be done late?
7. Ethical acceptability
We should always consider the possibility that we
may inflict harm on others while carrying out
research.
Therefore, it will be useful to review the proposed
Scales for rating research topics
• Rating research topics should be based on the
existing data and not on mere assumptions.
Relevance
1 = Not relevant
2 = Relevant
3 = very relevant
Avoidance of duplication
1 = Sufficient information already available
2 = Some information available but major issues not
covered
3 = No sound information available on which to base
problem-solving
Scales for rating research
topics …
Feasibility
1 = Study not feasible considering available
resources
2 = Study feasible considering available resources
3 = Study very feasible considering available
resources
Political acceptability
1 = Topic not acceptable
2 = Topic somewhat acceptable
3 = Topic fully acceptable
Scales for rating research
topics …
Applicability
1 = No chance of recommendations being implemented
2 = Some chance of recommendations being implemented
3 = Good chance of recommendations being implemented
Urgency
1 = Information not urgently needed
2 = Information could be used but a delay of some months
would be acceptable
3 = Data very urgently needed for decision-making
Ethical acceptability
1 = Major ethical problems
2 = Minor ethical problems
3 = No ethical problems
Topic…
Example:
Assessment of prevalence and associated factors
of malaria in adult population in Shashemene
town, Southern Oromia, Ethiopia, 2025
Exercise:
Develop your own short, accurate and concise,
informative, appropriate and catchy title in a group
of five students
Summary
Summary: presents the whole proposal in short
Is put at the beginning of the proposal and
prepared after writing proposal is finalized
It comprises of statement of problem &
justification, general objective, methodology
(study population, sample size, data collection
techniques, data analysis), work plan and
budget
Identification and prioritization
of a research problem
A problem properly stated is half
solved.
John Dewey
“If I had only one
hour to save the
world, I’d spend
55 min. defining the
problem and
5 minutes finding a
solution.”
© TCDSS 2013
A research problem
a) Problem identification
If the answer to the research question is
obvious, we are dealing with a management
problem that may be solved without further
research
A number of research questions could be
presented that may be posed at the various
levels of the health system.
Research problem…
A situation or circumstance that requires a solution
to be described, explained, or predicted
It is an unsatisfactory situation that wants you to
confront
Is an area of conflict, concern, or controversy (a gap
between what is wanted and what is observed)
Include the most relevant reference that supports
the claim.
Whether a problem requires research depends on three conditions
I)There should be a perceived difference or discrepancy
between what it is & what it should be.
II) The reason(s) for this difference should be unclear (so
that it makes sense to develop a research question); and
III)There should be more than one possible & plausible
answer to the question (or solution to the problem).
Additional conditions…
Can you study the problem?
– Do you have access to the research site?
– Do you have the time, resources, and
skills to carry out the research?
Should you study the problem?
– Does it advance knowledge?
– Does it contribute to practice?
Will your study fill a gap?
Criteria for Prioritizing
Problems for Research
1. Relevance
2. Novelty (avoidance of duplication)
3. Feasibility
4. Political acceptability
5. Applicability
6. Urgency
7. Ethical acceptability
8. Interest
Introduction
It is part of the research illustrating what is
known and unknown
It also tells us details (including methods) of
the topic to be studied
It also describe us what this research topic will
add to the science
It mainly contains: background, statement of
the problem, significance, literature, objective
Background
It is the first session demonstrating about
what is happening in the reality
It usually takes almost one page to one and
half a page
It is description of the reality, related to the
problem
Cont.…
It is by book, describing the reality of the
problem at global, regional, and local level
Definitions of problem, major briefings, how
things to the problem are reacted, what
process are made etc. is illustrated.
The flow of writing need to have attraction
(chronological)
Statement of the problem
A very specific statement which clearly
identifies the problem being studied;
It will usually identify the key variables as well as
give some information about the scope of the
study
Is the foundation for the further dep't of the
research proposal (objectives, methodology,
work plan, etc.);
Formulation of problem statement takes place
after an initial review of related literature
Information in the problem of the statement
1. A brief description of
– The problem (outcome) is a public health
important
– A public health importance of problem can
be demonstrated by its severity, [related to
morbidity (hospitality), mortality (how killer
it is)
– A public health importance of problem is
based on its impact on [health, social,
economic and physical]
Information…
2. A brief description of the distribution of
the problem in different population
– Description of the problems distribution
by person, place and time
– Population [size, distribution and
severity]:
who is affected, where, since when, and
what are the consequences for those
affected and for the services).
Information…
3. A brief description of the major factors that may
influence the problem and how each factor
influences
– Description of factors that influence the
problem positively (risk factors considered as
contributing for the occurrence of the
problem)
[risk, aggravating factors]
– Description of factors, that may influence the
problem negatively [factors the prevent or
inhibit occurrence of the problem]
Information…
4. Finally, the researcher should try to show, the
study is important for lack of knowledge gap
– It could be through demonstrating the
absence of a similar research by study
population (community)
– Absence/ or limited research of the same
type within the study area (developing
world/ country)
– Absence/ or limited number of research
having similar methods (e.g. design)
Summary of a problem
statement
It should state the
• Magnitude/frequency of the problem
• Distribution (global, regional, national) in
terms of person, place, and time
• Probable risk factors/causes of the problem
• Possible solutions
• Unanswered questions/gap
Significance of the study
Should answers the following questions
How will the results be used, and who will be
the
beneficiaries?
Program relevance: Intervention relevance
Policy relevance
Research relevance
Public/ Community relevance
Literature review
Literature review is part of the introduction
where a literature is described/ illustrated.
In the context of a research paper, the
literature review is a critical synthesis of
previous research.
A literature review discusses published
information in a particular subject area within
a certain time period
A literature review can be just a simple
summary of the sources
Functions of a literature
It provides theoretical background
Prevents duplicating what has already been done
It enables you to refine research methodology
It enables you to define your contribution to
knowledge
It enables you to contextualise your findings
(familiarize you with the subject matter)
Function…
It provides with convincing arguments for
why your particular research project is
needed
Note: You always need to reference all the
literatures that you refer to in your review
Organizing literature review
Topical order:- organize by main topics or
issues; emphasize the relationship of the
issues to the main “problem”
Chronological order:- organize the literature
by the dates + place + person of the research
published
Problem-Cause-Solution Order:- Organize
the review so that it moves from the problem
to the solution
Conceptual framework
• A preconceived perspective based on lit
review
• Proposed relationships to be tested
• Organizes your research ideas
• Guides your research, your review
• Identify study variables, their relationships
• Variables can be determining, confounding,
and outcome variables…etc
• Can guide the intervention protocol for a
proposed study (guides lit review, the
analysis, data collection, what to relate
Conceptual framework
• Formulates research questions
• Provides knowledge base on the
relationships, direction of the research,,,,,
• Tells us what external and internal env’t are
involved
• Organizes information got from a lit review
• Shows your contribution
• Informs your research questions, goals
• Helps to justify the research problem
Conceptual framework
Summary on conceptual framework
• A collection of interrelated concepts, ideas, theories,
assumptions on which you ground your research
• Guides your research, what you are measuring,
indicates variables. How they are related each other?
• Informs the boundaries of the search
• Organizes your research ideas
• Guides data collection, data analysis, the write up,
all the research components
• Must do a conceptual design after Literature
Review (as concluding remark with brief description)
• Or you may adapt or modify existing one
Research question/hypothesis
• A formal statement of the expected
relationships among variables
• It is a tentative and formal prediction about
the relationship between two or more
variables in the population being studied,
• It must be testable
• It should be consistent with the existing body
of knowledge
Research question/hypothesis
• It should be stated as concisely as possible
• Example: There is significant difference
between district “A” and district“B” with
respect to their malaria prevalence rates
Research objectives
• Summaries what is to be achieved by the study
1. The general objective:
• states what researchers expect to achieve in
general terms.
2. Specific objectives:
• break down of general objective into smaller,
logically connected parts.
• should systematically address:
– the various aspects of the problem and
– the key factors that are assumed to
influence or cause the problem.
• They should specify what you will do in your
study
Objectives…
• Example: In a study of malaria in under five in
shashemene,
General objective
To determine the prevalence and associated factors of
malaria among under five children in Shashemene town,
Oromia, Ethiopia, 2024
Specific objectives
To determine the prevalence of malaria among under five
children in Shashemene town, Oromia, Ethiopia, 2024
To identify factors associated with malaria among under
five children in Shashemene town, Oromia, Ethiopia, 2024
Note: Objectives should start with action verbs: to
determine, to identify, to calculate, to explore, to compare,
to describe, to establish….etc.
Objectives…
The formulation of objectives help to:
• Focus the study
• Organize the study in clearly defined parts
• Properly formulated, specific objectives will
facilitate
– the development of your research methodology
– will help to orient the collection, analysis,
interpretation and utilization of data
Research methods and materials
Study area
Includes details of the socio-demographic
characteristics of the area including (location from
central, population, health facilities and other sectors
as schools, roads, etc., climate livelihood and so on
Study design
The investigator`s overall strategy for answering the
research question
The blueprint/roadmap that will guide the research.
Refers to the plan, structure, and strategy of research
Various types of designs have
– Strengths and weakness
Methods can't…
Research designs/approaches
1. Quantitative Methods
The study of phenomena that lend themselves
– to precise measurement and quantification
– often involve a rigorous and controlled
design
2. Qualitative Methods
The investigation of phenomena,
– typically in an in-depth and holistic fashion,
– through the collection of rich narrative
materials
– using a flexible research design
3. Mixed
Quantitative EPI Study designs
Populations Ecologic/correlational
Descriptive Case reports/case series
Individuals
Cross-sectional
Case-control
Observational
Prospective
Cohort
Analytical Retrospective
Experimental Clinical trials
Methods can't…
Experimental designs
Are the strongest of all research designs
– in terms of internal validity
Before considering an experimental design,
you need to ask the following:
– Is it possible to precisely categorize the
people, places, or things in your study?
– Is it possible to select random people,
places, or things in your study?
– Is the process of random selection into
experimental and control groups ethical and
legal?
Methods can't…
Characteristics of a true experiment
• Manipulation—researcher does something
to some subjects (introduces an intervention
or treatment
• Control—researcher introduces controls
• Randomization: Researcher assigns
subjects to groups at random
• Blinding: being unaware of the intervention
Methods can't…
Population
1. Source population
The population of interest, to which the
investigators would like to generalize the
results of the study, and from which a
representative sample is to be drawn.
2. Study population
The population included in the sample
Study Unit: the unit on which information is
collected.
Methods can't…
Variables of the study
1. Dependent variable
is a variable that is used to describe or
measure the problem under study
Also called as an outcome or y-variable
1. Independent variables
the variables that are used to describe or
measure the factors that are assumed to
cause or at least to influence the problem
Also called as explanatory or x-variables
Operational definition of variables
Operational definition
– The way a variable is measured in the study
– Tells how you will measure the concept in
the study
Example: Assessment of workplace violence
and associated factors among nurses working
in the hospitals of Hawassa, Sidama, Ethiopia,
2024
•Workplace Violence: when a nurse had
experienced one physical and/or verbal
abuse/sexual WPV within the previous year.
Operational definition…
•Physical Violence: when a nurse experienced
any beating, kicking, slapping, stabbing,
shooting, pushing, biting, spit on, and/or
pinching, from others (ICN, 2003)
• Verbal abuse: occurs when a nurse is cursed
or swore at, yelled or shouted at, or
threatened (Jira, 2015)
• Sexual violence: includes attempted rape
and/or performed rape with sexual
harassment (ICN, 2003)
Validity and reliability of a
measurement tool
Validity
Refers to the degree of closeness between a
measurement and the true value of what is
being measured
Internal Validity
The extent to which it is possible to make an
inference that a relationship is causal
The extent to which the instrument is really
measuring what it intends to measure
Validity and reliability can't…
External Validity
The extent to which the research findings can
be generalized to the wider population of
interest and applied to different settings
(generalizability)
Reliability (or precision)
The degree of closeness between repeated
measurements of the same value
Validity and reliability cont.….
The sources of variation resulting in poor reliability
include:
• Variation in the characteristic of the subject being
measured. E.g. blood pressure
• The measuring instruments e.g. questionnaires
• The persons collecting the information (observer
variation)
• Inter-observer variation: differences between
observers in measuring the same observation
• Intra-observer variation: differences in measuring
the same observation by the same observer on
different occasions.
Sample size and sampling methods
The process of selection of a number of study
units from a defined study population
Why sampling? Population is too large
Advantages of sampling
Speed
Cost
Time
Quality
Feasibility
Sampling cont.….
Taking sample consider
What is the group of people from which we
want to draw a sample?
How many people do we need in our sample?
How will these people be selected?
Methods of sampling
A. Non-probability sampling methods
Subjects are selects based on purpose
Limited generalizability/ no random
selection
Subjects have no equal chance to be
included in the study
Techniques
1. Convenience sampling: the study units
that happen to be available at the time of
Methods cont.….
2. Quota Sampling: it starts with
systematically setting “Quota” to represent
subgroups of a population
Then data is collected to meet the predefined
Quota
3. Snowball Sampling: the researcher begins
by identifying someone who meets the
inclusion criteria of the study
Then the study subject would be asked to
recommend others who s/he may know who
also meet the criteria
4. Judgmental or Purposive Sampling: the
researcher chooses the sample based on who he/she
think would be appropriate for the study.
Methods cont.…
B. Probability sampling
• All units of the population should have an
equal or at least a known chance of being
included in the sample.
• A sampling frame exists or can be compiled.
• Involve random selection procedures.
• Generalization is possible
Methods cont.…
Techniques
1. Simple Random Sampling (SRS)
2. Systematic Random Sampling
3. Stratified Sampling
4. Cluster Sampling
5. Multistage Sampling
Error in sampling
What is error?
Types of error
1. Sampling error: Errors introduced during
selection of study subjects.
– They cannot be avoided or totally
eliminated.
2. Non-sampling error: a type of systematic
error in the design or conduct of a sampling
procedure results in distortion of the sample
- Observational error
- Respondent error/none response
- Errors in editing and tabulation of data …etc.
Sample size determination
In a research, we must decide how many
people needed to be studied in order to
answer the study objectives
If the study is too small we may fail to detect
important effects, or may estimate effects too
imprecisely.
If the study is too large then we will waste
resources
Sample size cont.…
• The eventual sample size is usually a
compromise between what is desirable and
what is feasible.
• The feasible sample size is determined by
the
availability of resources
• It is also important to remember that
resources are not only needed to collect the
information, but also to analyze it
Sample size cont.…
♦ Sample size determination mainly depend on
– Objective of the study (outcome variable)
– Design of the study
– Plan for statistical analysis
– Degree of precision required for
generalization
– Degree of confidence with which to
conclude
Sample size formula for single
population proportion
♦ Where
n=sample size required
α= The level of significance which
can be obtain as 1-confidence
level.
p= Population Proportion
d=Maximum acceptable
difference or margin of error
zα/2 = The value under standard
normal table for the given value
of confidence level
88
Information Needed to
Calculate sample Size
1) A reasonable estimate of the key proportion
(p) to be studied.
Example:- If a study aims to estimate
prevalence of stunting the estimate of
proportion will be the current prevalence of
stunting which is 47%.
If no estimate of proportion of interest exist
then usually 50% is taken (i.e., conservative).
Why?
89
Depending on the nature of the study 10 –
Information Needed to Calculate
Sample Size
2) The degree of accuracy required.
That is the allowed deviation from the true
proportion in the population as a whole.
It can be within 1% or 5%, etc.
The accuracy (d) is also referred to as the
margin of error
The Design effect for complex cluster
sampling Common values multiply n by 1.5, 2,
3, …5
3) Confidence level required.
Usually specified as 95% or 99%.
90
Information Needed to Calculate
Sample Size
4) The size of the population that the
sample is to represent.
If it is more than 10,000 the precise
magnitude is not likely to be very
important.
But, if the population is less than 10,000
then a smaller samplen
f size
n
i may be
n
required. (correction factor) N
1 i
91
Sample size for single
proportion...
Example
• A researcher wants to estimate the
prevalence of stunting in Hawassa with a
95% confidence level to estimate the
proportion within 5% margin of error, how
large a sample should be drawn? (The
current prevalence of stunting which is
47%). 2
Z p (1 p )
n 2
d
= (1.96)2 0.47(1 – 0.47)/(0.05)2
= 382.77 ≈ 383 under five children
92
Sample size to estimate a single
population proportion …
Class Exercise
• A researcher is interested to determine the
prevalence of family planning use in Addis
Ababa city. A previous study indicates the
prevalence is around 55%. If the researcher is
interested to determine the sample size with
95% CI and 5% of margin of error
A. what number of women of reproductive age
should be included into his study?
B. In the above exercise if the population
number is 5000, what will be n?
93
Sample Size For Single Mean
• If the main objective of the study is to
estimate single population mean, use the
Formula: 2
2
Z1 2 Z
2
n
n 2
2 d
• Where
d
– is an estimate of the SD of the population
for the variable under study.
– d is the margin of error
Z1
– is the value of the standard normal
2
variable at (1- )% confidence level.
94
Sample size to estimate single
population mean...
Example 1:
• A researcher is interested to determine the mean
blood glucose level among high school students.
A previous study indicates the mean is 85mg/dl
with standard deviation of 15mg/dl. If the
researcher is interested to determine the sample
size with 95% CI and tolerates 2 mg/dl margin of
error, what number of students should be
included into his
2
study?
Z 2
2
1.96 x15
n 216
d 2
95
Sample size for double population
proportions:- case-control studies or
others
Where
n1 = number of cases required (i.e. n2 = r n1)
n2 = number of controls required
r = ratio of controls to cases
zα = 1.96 for 95% confidence level
p1 + p 2
p=
= 1.64 for 95% power 2
zβ = 1.28 for 90% power
= 0.84 for 80% power
p1 = proportion of exposure among cases
p
p 2– p =
= proportion of exposure
Minimum meaningful among controls
difference in proportions between
1 2
case and control groups 96
Example:
♦ How many cases and controls do you need
assuming…
– 80% power
– You want to detect an odds ratio of 2.0 or
greater
– An equal number of cases and controls
(r=1)
– The proportion exposed in the control
group is 20%
– Proportion of cases exposed is 33%
97
Data collection techniques
1. Observation
• A qualitative method
• Excellent approach to discover behaviors
• Usually takes longer time (critical
observation)
• Liable to “Observational bias”
98
Techniques cont.…
2. Survey through Interview
• A quantitative approach in which a
standardized questionnaire is used
Advantage
– Quick and inexpensive,
– Responses from different respondents is
comparable,
– Easy to quantify and analyze, precise
– Useful in describing quantifiable
characteristics of a large population,
99
Techniques cont.…
3. Self Administered Questionnaire
• A quantitative method in which a standardized
questionnaire, to be filled by the respondents
themselves, is used.
Advantage
• Quick and inexpensive,
• Responses from different respondents is
comparable,
• Useful in describing quantifiable characteristics
of a large population,
• Very large and representative samples are
feasible,
• Standardized questions make measurement 100
Techniques cont.…
4. Focus Group Discussion (FGD)
• A qualitative method to obtain in-depth information
on concepts and perceptions about a certain topic
through group discussion of approximately 6–12
persons, guided by a facilitators.
• Advantage:
– Excellent approach to gather information on in-
depth attitudes and beliefs of a group,
– Group dynamics might generate more ideas
– Provides an excellent opportunity to probe &
explore,
– Participants are not required to read or write,
– Extract sensitive issues which are not commonly raised
– It facilitates the exploration of collective memories.
101
Data
Summarization/organization
• Categorical data
• Summarized using frequency and
percentage
• Table and graphs are used to present the
data
• Quantitative data
• Numeric summary measures are used
• Mean and standard deviations are
102
Data processing and analysis
Before running formal analysis data should be
– Checked for completeness
– Categorized
– Coded
– Transformed if needed
103
Data analysis
• Perform descriptive analysis to summarize the
data
– Frequency, percentages, numeric summary
measures
Correlations: Correlation quantifies the degree
and direction to which two variables are related
• Correlation does not fit a line through the data
points
• Compute a correlation coefficient that tells how
104
much one variable tends to change when the
Correlation cont.….
• Very often we are interested to know what
association, if any, exists between two
variables
• One way to determine this is to calculate
what is called the correlation coefficient
• A commonly used index which measures the
degree of relationship between two
variables
• This is known as Pearson Correlation
Correlations cont.….
• Definition: Given n pairs of value of x & y,
sample correlation coefficient, denoted by r,
𝑟 =∑ (𝑥𝑖 − 𝑥̅)(𝑦𝑖 − 𝑦̅) / √∑ (𝑥𝑖 − 𝑥̅) 2 ∑ (𝑦𝑖
is defined as
− 𝑦̅ )2
Properties of r
. It is always between -1, 1
. No unit (only whole number)
. If r is close to 1= strong positive relationship
. If r is close -1 = strong negative relationship
Correlations cont.…
Assumptions of correlations:
The variables are assumed to be
independent
- randomly selected from the population
The two variables follow bivariate normal
distribution
- association of data is homoscedastic
The relationship between the two variables
is linear
- as y increases, so does x and vice versa
Example
• A study is conducted involving 5 students to
investigate the association between statistics
and science tests
• The question arises here; is there a
relationship between the degrees gained by
the 5 students in statistics and science tests?
• mean(x)= 94/5=18.8 mean(y)= 20.8
Student 1 2 3 4 5
Statistics 20 23 8 29 14
(x)
Science (y) 20 25 11 24 23
solution
x y (𝑥𝑖 − 𝑥̅) (𝑥𝑖 − 𝑥̅)2 (𝑦𝑖 − 𝑦̅) (𝑦𝑖 − 𝑦̅)2 (𝑥𝑖 − 𝑥̅)(𝑦𝑖 − 𝑦̅)
20 20 1.2 1.44 -0.8 0.64 0.96
23 25 4.2 17.64 4.2 17.64 17.64
8 11 -10.8 116.64 -9.8 96.04 105.84
29 24 10.2 104.04 3.2 10.24 32.64
14 23 -4.8 23.04 2.2 4.84 10.56
94 103 0.2 262.8 -1 129.4 167.64
Solution cont.…
𝑟 =∑ (𝑥𝑖 − 𝑥̅)(𝑦𝑖 − 𝑦̅) / √∑ (𝑥𝑖 − 𝑥̅) 2 ∑ (𝑦𝑖 − 𝑦̅ )2
= 167.64/√262.8√129.4
= 167.64/(16.21)(11.37)
= 167.64/184.30
= 0.909
• The calculation shows a strong positive correlation
(0.909) between the student's statistics and science
degrees.
• Generally the student who has a high degree in
statistics has high degree in science and vice versa.
Regression
• Is the method of establishing relationship between two
variables in the presence of cause-effect scenario
• Biologically, the independent variable (IV)
should be a cause, while the response (DV) should be an
effect
• IVs are characteristics that can be measured directly;
these variables are also called predictor or explanatory
variables used to predict or to explain the behavior of
the dependent variable.
• DV is a characteristic whose value depends on the
values of independent variables.
Regression cont.…
• Objective
– Data description
– Investigate hypothetical model for biological system
– Prediction
• Before moving to formal analysis, we need to
use scatter plot and observe the pattern.
• Scatter diagram helps choose the curve that
best fits the data
Regression cont.…
Scatter plots are used to:
• Depicts the pattern of the data on the plane.
• Shows whether x and y are related or
independent.
• Shows ranges for x and y
• Shows unique observations
• Suggests what type of models you can fit to
the data
Regression cont.…
Assumption of simple linear regression
• Independence of observations
• Linear relationship between variable
• Uniformity of variance (homoscedasticity)
• There is no autocorrelation between
variables
• The error term is normally distributed
Regression
Two types of models:
1. Deterministic:
yi = B0 + 1xi
2. Probabilistic
yi = Bo + 1xi+ i
Regression cont.…
1. Linear regression
1.1 Simple Regression Model
• It is a statistical method that allows us to study
relationships between two continuous
(quantitative) variables
• In a cause and effect relationship, the IV is the
cause, and the DV is the effect
• Least squares linear regression is a method for
predicting the value of a dependent variable y,
based on the value of an independent variable x
Regression cont.…
𝐲 = 𝛽0 ± 𝛽1 𝒙1 𝜷𝟏 = 𝒏 ∑ 𝒙𝐲 – ∑ 𝒙 ∑ 𝐲/𝒏 ∑ 𝒙𝟐 −
(∑ 𝒙)𝟐
i.e •
𝜷𝟎 = 𝑦̅ – 𝜷𝟏𝒙̅
Where,
•
• x independent variable
𝒏 Number of cases or individuals
• 𝛽1 The Slope of the
• y dependent variable
∑ 𝒙𝐲 Sum of the product of
•
•
• 𝜷𝟎 The intercept point of
regression line
∑ 𝒙 = Sum of independent
dependent and
•
the regression line and the variable
y axis.
• ∑ 𝐲 = Sum of dependent
• ∑ 𝒙𝟐 = Sum of square
variable.
independent variable
Least square method
Definition: of all the curves that goes through
the points (in the scatter diagram), the one
that minimize ei2 is called the least square
regression line
ei = yi – ýi
Least square line
𝐲 = 𝛽0 ± 𝛽1 𝒙1
𝜷𝟏 = 𝒏 ∑ 𝒙𝐲 – ∑ 𝒙 ∑ 𝐲/𝒏 ∑ 𝒙𝟐 − (∑ 𝒙)𝟐
Regression cont.…
1.2 Multiple Regressions Model
• Multiple regression is an extension of simple
linear regression
• It is used when we want to predict the value of a
DV based on the value of two or more IVs
• Multiple regression allows you to determine the
overall fit (variance explained) of the model and
the relative contribution of each of the
• y = 𝜷𝟎 ± 𝜷𝒊 𝑿𝒊 … … … … ± 𝜷𝒏 𝑿𝒏 ± ei
predictors to the total variance explained
Example
• The height in inches of eight fathers & their
oldest sons are given as follows. What is
regression line?
Father (x) Oldest sons (y)
63 65
64 67
70 69
72 70
65 64
67 68
68 71
66 63
Solutions
b1= n∑ xy- ∑x ∑y/ n∑x2-(∑x)2
= 8(35955)-(533)(537)/8(35843)-(535)2 =
0.6644
a= 𝑦̅ - b1𝑥̅ = 537/8-0.6644(535/8)= 22.67
ý = a+b1’x
ý = 22.67+0.6647x (equation of the
simple linear regression line)
Regression cont.…
2. Logistic regression
• Methods used to find the best fitting model that
describes the relationship between binary outcome
and IVs
• Commonly used to model categorical, in particular
dichotomous DV with explanatory variables
• Predicts the probability of an outcome based on a
set of independent variables (continuous or
categorical)
Regression cont.…
• The response variable is able to assume only two
possible values, 1 is typically used to represent a
success and 0 a failure
Objectives of logistic regression
• Prediction
• Estimating a magnitude of outcome/exposure
relationships
• Control for confounding
Regression cont.…
• In logistic regression we model log odds of disease or
outcome of interest, and the models are referred to
as logistic models
• log odds = α + β*Exposure
• In logistic regression, we express the association
with predictors by Odds Ratio (OR)
Odds of disease = Probdisease/Probnodisease = P/(1-P)
• OR = expβ
• β is a measure of the effect of exposure
Example using data for logistic
regression analysis
• Diarrhea in 60 <5 children as an outcome variable
(yes = 15, no = 45)
• Age, sex, educational status of mother, household
income, presence of latrine, presence of hand
wash, type of water source as an explanatory
variables using SPSS/Stata
• Interpret the results
The chi-squared test (X2 )
• The chi-squared (X2) test statistics is widely
used in the analysis of contingency tables/2x2/
• It compares the actual observed frequency in
each group with the expected frequency
• The chi-squared test allows us to test for
association between categorical variables
• A significant p-value (p<0.05) implies presence
of association between variables
Contingency table for X2
(X2 )…
• Test Statistic: X2-test with df = (r-1)x(c-1)
Assumptions of the X2 - test
• Data must be categorical
• The data be a frequency/counts
• The chi-squared test assumes adequate sample
size
• It assumes measures/observations are
independent of each other
Rules for X2 - test
• No expected counts less than 5
• No exp. counts less than 2, and 80% of counts > 5
Examples
Two sets of frequencies
• Observed (O) = number of subjects in our sample
that fall into the various categories of the variable
of interest
• Expected (E)= number of subjects in our sample
that we would expect to observe if the Ho about the
variable is true
E = Row total x Column total
=120*36/300=14.4
Overall total
Observed frequencies vs. Expected
frequencies
Examples…
Research ethics
• Ethics is a branch of philosophy dealing with
standards of conduct, and moral judgment
• Ethics is also defined as the distinction between what
ought to be and what won’t, between right or
wrong, good or bad
• Bioethics is the study of ethical, social, and legal
issues that arise in biomedicine and biomedical
research
Concerned with the degree to which research
procedures adhere to professional, legal, and social
obligation to the study participants.
Importance of health research
ethics
• Promote the aims of research, such as knowledge,
truth, and avoidance of error
• Promote the values that are essential to collaborative
work, such as trust, accountability, mutual respect,
and fairness.
• Help to ensure that researchers can be held
accountable to the public
• Promote a variety of other important moral and social
values, such as social responsibility, human rights,
animal welfare, compliance with the law, and health
and safety.
Ethical principles
1. Confidentiality:
• Involve collecting and storing data relating to
individuals and groups, such data, if disclosed to third
parties, may cause harm or
distress
• The researcher needs to know :
– which types of information can or cannot be shared with a
third part with/without the consent of the study
participant.
Individually identifiable: they directly identify the individual
**The confidentiality of records that could identify study
participants should be protected, respecting the privacy and
confidentiality rules in accordance with the applicable
regulatory requirements.
Principles cont.…
2. Autonomy/respect for person
a) Respect for autonomy: those who are
capable of deliberation about their personal
choices should be treated with respect for
their capacity for self-determination
b) Protection of persons with impaired or
diminished autonomy: those who are
dependent or vulnerable be afforded security
against harm or abuse
Principles cont.…
3. Beneficence
• Ethical obligation to maximize benefits and to minimize
harms
• ‘Do no harm’
• Harms: prevent physical and psychological
harm to individual study participants
• Benefits: tx., awareness, infrastructure…etc
4. Non-Maleficence
• Minimizing harm
Principles cont.….
5. Justice:
• Refers to the ethical obligation
– to treat each person in accordance with
what is morally right and proper,
– to give each person what is due to him or
her.
• Distributive justice: equitable
distribution of both the burdens and
the benefits of participation in
research.
Principles cont.…
6. Informed consent
• Is a process by which a study participant
voluntarily confirms his or her willingness to
participate in a particular trial/study
Elements of consent
• Information,
• comprehension and
• autonomy of study participants and consent.
Information
• The information should consist of
• statement of objectives/purpose
• invitation to participation (voluntary participation
and withdrawal)
• explanation of procedure (selection criteria)
• description of discomforts & risks
• expected costs and benefit for participation
• availability of provision of care and compensation
in case of injury
• disclosure of alternatives
• confidentiality/privacy, compensation for injury
• offer contact persons for answering questions
Comprehension
• Use local language
• Simple & clear language (understood by
the study participants)
• Short words & sentences
Autonomy of study participants
• Informed consent upholds autonomy or
respect for persons requires :
• legal capacity to give consent
• free power of choice
• Fiduciary relationship (duty to protect)
between investigator and study
participants
• signing of the consent form with written
documentation
• continue to consent when there is
significant new information
Research on/with vulnerable groups
• Vulnerable and less advantaged persons
are:
– persons who are absolutely or relatively
incapable of protecting their interests
– have insufficient power, intelligence,
resources, strength or other needed
attributes to protect their own interests
through informed consent.
• Special populations
– Include: fetuses, pregnant women
prisoners, mental problem and children.
Plagiarism
Using other researchers’ ideas or any parts of
their writing as your own is a serious offence
Is a form of (intellectual) theft and a type of
fraud
It is unethical to use other researchers` idea
or any part of their writing without
recognition or acknowledgement with proper
citation
Work plan
Table 1: work to assess….
s. no Activities will be Responsibl Oct Nov Dec Jun Feb Mar Apr May Jun Jul
performed e body
1 Topic selection PI
2 Topic defense PI
3 Proposal development PI
4 Proposal defense PI
5 Proposal approval and HU
ethical clearance
6 Provide training and PI, SP, DC
conduct pre-test
7 Data collection DC, SP
8 Data clearance ,coding and PI,
entry SP
9 Data analysis PI
10 Thesis writing PI
11 thesis defense PI
12 Final submission and PI
dissemination of the result
13 monitoring and evaluation PI, AD
Budget plan
Table 1: Budget plan for study that will be conducted in shashe, Ethiopia, 2020
Personal Cost –Training for Data Collectors and supervisors
s. no Personnel Quantity duration Per diem Total ETB
1 Data collector 4 diploma nurses 1 days 283 283*4*1 1,132
2 Supervisor 2 BSc public health 1 days 283 283*2*1 566
officer
3 Trainer 1 Principal 1 days 283 283*1*1 283
investigator
4 Sub total 1,981
Personal Cost –Data collection and supervision
s. no Personnel Quantity Per diem/day Total ETB
1 Data collector 4 283 283*4 1,132
(Pretest)
2 Data collector 4 283 283*4*3 3,396
(data collection)
3 Supervisor 2 283 283*3*2 1,698
4 Sub total 6,226
Logistics -- Document and questionnaire duplication
s. no Type Quantity No of pages Cost Total ETB
1 Questionnaire 665 7 1 birr/page 665*7*1 4,655
duplication
2 Document 5 50 1 birr/page 5*50*1 250
Duplication
3 Sub total 4,905
Budget summary
S. no Budget summary Total ETB
1 Total cost 13,111
2 Contingency (5%) 655.55
3 Gross total 13,766.55
146
Referencing
• Referencing/citation is a system used in
your written work to indicate, the sources of
evidence, ideas, theories, facts, or any
other information
• Means of giving recognition for other
researchers' work
147
Why do we use references?
• To find out what is already known
• Find out about your topic in other settings
• Keep up with research methods and findings
• Find out about how others have addressed
your topic
• Get further sources of references
• Quote in our articles
148
Common styles of referencing
Vancouver style
• Each piece of work cited within the text is
identified by a unique number
• The numbers are assigned in the order of
citation
• If a piece of work is cited more than once,
the same citation number must be used
• Getachew B, Payne JB, Vu M, Pillai D, Shah J, Levine H, Berg CJ.
Perceptions of alternative tobacco products, anti_tobacco media, and
tobacco regulation among young adults: a qualitative study. 149
Referencing….
Harvard style
• For in-text citations, references are
identified by the name of the author(s) and
the year of publication.
• In the bibliography, references are ordered
alphabetically rather than numerically
• Endnote, Mendeley or other citation
software used with any of this methods 150
Many thanks!!
151