Problem Statement and Problem Analysis-Merged

Problem Statement and
Problem Analysis
BMI 3213 Research Methodology
By, Khairiah Abdul Hamid

Selecting a problem
Content Defining the problem
Techniques involved in defining

the problem
Introduction
To develop and articulate research questions that are related to the purpose of
the study
Introduction
• A well-written problem statement defines the problem and helps

identify the variables investigated in the study
• It provides the rationale of the study AND uses the data and
research to confirm the need to address the problem in the study
Articulating your problem statement is the
most important step to justify the purpose
of your research.
Your goal is to make the readers understand the research gap

THE WAY YOU DO.
A Problem Statement Should Have ….
Identification of key
Identification of over- concepts & terms,
Identification of what
Clarity and precision arching question and key articulation of study’s
would be studied
factors / variables boundaries, some extent
of generalizability,
Conveyance of more
Conveyance of study’s No use of unnecessary than mere gathering of
importance (…’so what?’) jargon data providing a
snapshot
Should include:
• A clear statement that the problem
exists
• Evidence that supports the existence
of the problem
Statement of the • Evidence of an existing trend that

has led to the problem
Problem • Definitions of major concepts and
terms (in a different subsection)
• A clear description of the setting
• Probable causes related to the
problem
• A specific and a feasible statement
The area of conflict, concern or
controversy (a gap between what
is wanted and what is observed)
Research
Problem
Should include the most relevant
reference that support the claim
When designing a
‘Problem Statement’,
keep asking yourselves…
‘Why does this topic warrant an

investigation?’
‘What drives the investigation?’

Your problem should be …
Clinically
Interesting Feasible
significant
Meaningful
Background and Justification
Introduction of
• The evidence and relevance from
literature and published / archival data
Problem Statement
showing the problem exists (at least 2
references).
• Should also include theoretical basis for
the study
in a
Deficiencies in the Evidence
• Include a brief discussion that details
Research Proposal the area of need (in relation to the
problem) and the deficiency or lack of
evidence in the literature
Audience
• Discuss who is affected and who benefits
Definition of Terms
• Provide complete scientific definitions and appropriate references if
necessary. Include as many terms / variables as needed.
Purpose of the Study

• Create a sentence that begins with ‘The purpose of this study is …’
• Clearly identify and define the central concepts or ideas of the study
Flow of Ideas in Problem Statement
Deficiencies in the
Research Problem
• Subject area • Evidence from the Evidence • How will addressing
literature the problem help
• Concern / issue • Evidence from • What is missing in researchers,
• Something that practical experience the evidence? educators, policy
needs solution • What do we need to makers and others?
know more about?
Relating the
Justification of
Topic Discussion to the
Research Problem
Audiences
Introduced in the first paragraphs that includes general
subject matter
!Must be introduced so that the reader can relate to it

Research
Topic Consideration of topic selection: personal interest,
organizational support, ethical issues, study relevance,
field contribution, time constraints, breath & scope,
economic factors, etc.
Sources: research databases, journals, reference books,

dissertations, conferences, workshops, courses,
workplace, expert consultations, etc.
To establish the importance of
the topic / area / practices
Why is the
Research
To create reader interest
Problem
Important?
To focus reader’s attention on
how the study will add to the
literature
Stating the Research Problem
Introduced in the Identify an issue:

opening paragraph research-based
(i.e. something that problem or practical
needs a solution) problems
Common pitfall: 
Refer the problem
defining the problem
using the literature
based on the solution
How is the Problem different from other parts?
Research Problem • An educational issue / a problem in the study
Research Topic • Broad subject matter being addressed in a study
Study Purpose • Major intent / objectives of the study
• Question the researcher would like answered /

Research Questions addressed in the study
Justifying the Importance of Research Problem
Based on,
• What other researchers have found
• Personal or workplace experiences
• Experiences that others have had in their workplaces
Locating the Research Problem
In an existing research articles, the opening paragraphs will address:

• The issue / problem
• The controversy that leads to the need to conduct the current
study
• The concern being addressed behind the current study
• ‘The problem being addressed in the study is …’
Identifying the Research Gap /
Problem
Three (3) Quick Tips
Look for …
1. Lack or insufficient studies on a particular topic / area
• Geographical, population, etc.
2. Lack of understanding / knowledge in a field (i. e. controversies)
• Conflicting theories, disagreement between researchers on the effect /
approach / solution to a problem, etc.
3. Problems / limitations in previous studies
• Things that could be improved – methodology, data collection method,
data analytical method, etc.
Assessing the Research Problem:
The feasibility to conduct a research, based on the identified

research problem – ask yourselves:
• Can you study the problem?
• Do you have access to the research site?
• Do you have the time, resources, skills and expertise to carry out the
research?
• Should you study the problem?
• Does it advance knowledge? Or does it contribute to practice?
• A realistic time frame
• Availability of participants
Feasibility • Equipment and facility space

• $$
Considerations • Research experience, interest,
skill and expertise
• Ethical considerations
Assessing the Research Problem:
Will the study fill the gap / void in the existing literature?
Will the study replicate a past study but examine a different participants and
employ a different research site?
Will the study extend past research / examine the topic more thoroughly?
Will the study give voice to people not heard / silenced / rejected by the society?
Will the study inform / warrant practice?

Identifying Deficiencies in the Evidence
• What do we still need to know?

• What else do we need to know to improve practice?
Identifying the Audience
‘Who will profit from reading this study?’

• Other researchers
• Practitioners
• Policy makers
• Special populations (e. g. parents, students, clinicians, etc.)
Helpful Phrases when Writing Problem Statement
• ‘It is known that …’

• ‘Researchers have demonstrated that …., but….’
• ‘Debate exists about ….’
• ‘…is controversial because …’
• ‘What remains unknown is ….’
• ‘There is a paucity of literature examining …’
• ‘This initial understanding fails to consider …’
• It is helpful to state the consequences of filling OR not filling the
gap / void that you wanted to address in the current study
• ‘This understanding will … [help to answer the problem]’
Thank you for your
attention
Email: khairiah@kpjuc.edu.my
Introduction to Research
BMI3213 Research Methodology

Khairiah Abdul Hamid

What is research?
To know, to understand.
A process of systematic,
methodical & ethical inquiry
and investigation to (possibly)
solve practical problems &
increase knowledge.
Purpose? To understand,
describe, predict, or control a
phenomenon.
Could arise from
Problem Gaps in professional knowledge
Statement /
Uncertainty in practices
Research
Question Need of warrant in change of practice
Government initiatives

Research
Question
A clear, focused, concise, complex
& arguable question around
which you center & conduct
your research.
Why is it essential?
• Helps to focus in research
• Determines the specificity of a
well-developed research

How to develop a RQ?
• List and choose an interesting topic that you’re
familiar with (current trends, technological
advancements, etc.)
• Prelim research on the topic
• Consider your audience. This helps determines
the specificity of your study.
• Start asking questions. Evaluate & hypothesize.
Ask yourselves,
• Why was this problem identified?
• How bad is the problem?
• Who is affected?
• Where is the problem?
• What is the impact of the problem?
• How do you anticipate the study to help
overcome the problem?

An RQ should be
• Feasible (adequate N & technical expertise, time- & $$-affordable,
manageable)
• Interesting (intriguing to investigators, peers & (preferably)
community)
• Novel (confirms/extends previous findings)
• Ethical (!!)
• Relevant (to scientific knowledge, clinical & health policy, future
research)

• Clarity
• Unclear
‘Why are social networking sites harmful?’
RQ e.g.
• Clear
‘How are online users addressing privacy
issues on Facebook?’
RQ e.g.
• Focus
• Unfocused
‘How does human brain respond
to different frequency of sound?’
• Focused
‘How does frequency of pure
tones affect the intensity of brain
activation?’
RQ e.g.
• Complexity
• Too simple
‘How are doctors addressing diabetes in
Malaysia?’
• Appropriately complex
‘What are the common traits of diabetic patients in
Malaysia and how can it be used to aid the medical
community in the disease prevention?’

Poor research question
Poor study design
Potential futile situation
Ruin the chance of acquiring clinical significance
?? Potential of publication ??
The primary RQ
forms the basis of (preferably, 1 RQ
research objectives for 1 study)
& hypotheses.
Research Hypothesis
Developed from RQ, ‘a declarative statement about nature of

relationship between two/more variables.’
Purpose? To make an inference about the population of interest on

the basis of a random sample taken from that population.
Should be stated at beginning of study to guide research objectives

Makes a prediction of the expected outcome in a given situation
‘With extraneous variable kept constant, how does manipulation of

independent variable influences the behavior of dependent variable?’
• “how does attention in class influence students exam marks, provided all students are
equally intelligent and study at the same time for the same period?”
Research Objective
Defines the specific aims of the study
An active statement about how the study is

going to answer the RQ
Should be clear, measurable & accurate
Stated at the beginning of the study

Importance of Research
Ask yourselves,
• Why is this study important?
• What are the implications from it?
• How does it link to other knowledge?
• What use might it have for others in the related field or for
public?
• How could it contribute to the society or population?

Functions of Research
To develop, refine and extend scientific base of
knowledge for higher quality
Enhance the body of professional knowledge
Provide foundation for evidence-based practices
For expansion of knowledge for continuation of growth

in particular discipline

To enhance professional identity
Refine & eliminate old knowledge that

have no effect in determining outcomes
Identify cost-effective approach to

improve current practices

Research Design
Types:
1. Case report
2. Case series
3. Case control
4. Cross-sectional
5. Cohort study
6. Clinical trial
….

Research Variables
Measurable characteristic that varies.
1. Dependent variable shows the effect of
manipulating/introducing the independent variables
2. Independent variable is those that researcher has control
over.
3. Intervening variable refers to abstract processes that is
not directly observable
4. Control variable is a factor kept constant throughout the

study
5. Extraneous variable is factor that may have an effect on
dependent variable(s) but not controlled.
Data
Rationale Research Research Conclusion &
collection
behind study objectives design limitation
& analysis
Instrumen
t
Problem Research
Sampling developm
statement hypothesis
ent & pilot
tests

Thank you. Questions?

Research
Techniques
Introduction
The researcher poses several

hypotheses to analyse the
cause and effects of specific
variables in order to predict and
explain certain phenomenon
(Creswell 2009)
The questions you should be asking
yourselves, before you start the research:
What is the base of your research?
What new questions / observations that

Questions? you have?
Are you investigating a phenomenon?
Are you trying to imply the effectiveness of

an intervention in a larger population?
Research Question
START with research question.
What is a Research Question?

‘A question that stimulates a response
in a scientific enquiry.’
Quantitative Design
• Starts with observation that needs further explanations and
theories.
• Predictions are made to answer the hypotheses.
• Quantitative research design involves structurally scientific
methods, utilising deductive reasoning in forms of
hypotheses
(Price & Oswald 2009)
• The outcome measured is factual and based on
data-driven information from specific
measurement instrument(s) rather than
perception.
(Frankfort-Nachmias & Nachmias 2008)
• Goal: To draw relationships between dependent &
independent variables, assisting researcher to make
generalisation that predicts / explains certain
phenomenon.
Measurements
Nominal
• e.g. female / male, age categories, BMI group
Ordinal
• e.g. college education

• 1 – secondary school
• 2 – certificates
• 3 – diploma
• 4 – bachelor’s degree
• 5 – master’s degree
• 6 - PhD
3. Interval
• E.g. test scores
• A: 80% to 100%
• B: 60% to 79%
• C: 50% to 59%
• D: 40% to 49%
• E: 0% to 39%
QUANTITATIVE QUALITATIVE
Research question is Research question is broad
specific and narrow and general
Data is collected from Data collection involves
participants words (texts) and images
(photos)
Characteristics Data is analysed using

statistical methods
-
The enquiry is conducted Enquiry is conducted in a

in unbiased & objective subjective manner
manner
Quantitative Qualitative
Research problem identification
Involves description of trends / Little is known about the

explanation of relationship problem, needs detailed
between variables understanding about a
phenomenon
Literature review
Differences? Major role in suggesting RQ to Minor role in suggesting RQ
be asked to be asked
Justifies the RQ & the need for Justifies the importance of

the direction of the study studying the RQ
Purpose of research
Specific & narrow General & broad
Seek measurable, observable data Seek to understand participants’

on variables experience
Data collection
Differences? Uses instruments with preset

questions and responses
Uses general emerging questions for
participants to generate responses
From large number of samples From small number of samples

Data analyses & interpretation
Usually involves data Text analyses
analyses
Describes trends, Describes themes
compare group
differences, relates
Differences? two/more variables
Consists comparison States larger meaning
with prior results & of findings
predictions
Research report & evaluation
Tend to use standard Flexible, emerging structure

structure and and evaluation criteria
evaluation criteria
Differences? Objective & unbiased

approach
Subjective & biased approach
Thank you :)
Qualitative Research Technique
Khairiah Hamid
By the end of lecture, students should be
able to …
• define qualitative research
• describe types of qualitative research
• describe the flow of a qualitative research, from
designing method, data collection & analysis, and
report writing
Qualitative Research
• Commonly called ‘Interpretive research’.
• Methods → relies heavily on thick verbal descriptions of a
particular social context being studied
• Useful for describing / answering Qs about localised
occurrences / contexts & the perspectives of a participants
toward events / beliefs / practices
• !useful when little is known (helpful process in exploring)
• Making the familiar strange, > examined & better understood
Qualitative Research Types
Historical research • Grounded theory
Ethnography • Phenomenology
Case study • Symbolic interactions
Ethology • Action research
ethnomethodology
Descriptions of Types
Historical Research
• Data is readily available, studied to understand & interpret
past events
Ethnography
• Studies cultural patterns & perspectives of participants in
their natural settings
Case Study
• Examines characteristics of a particular entity / person /
phenomenon
Ethology
• Compares origins, characteristics & culture of different
societies
Ethnomethodology
• Studies how people make sense of their everyday activities
to behave in socially accepted ways
Grounded Theory
• Investigates how inductively-derived theory about
phenomenon is grounded in the data of a particular setting
Phenomenology
• Considers how the experience of particular participants
exhibits a unique perspective
Symbolic Interaction
• Investigates how people construct meaning & shared
perspectives by interacting with others
Action Research
• Teacher-initiated, school-based research, used to improve
the practitioner’s practice by doing / changing something
Generally…
• Uses a long time in the field (fieldwork)
• Researchers - as main instrument of data collection
• Data analysis → from interpretative lenses
• Uses expressive language & voice in explanations
• Seeks depths of perspective through ongoing analysis (i.e.
waves of data)
• Judged in terms of believability, trustworthiness, coherence
& logics underlying researcher’s interpretation
Qualitative Research
General characteristics
• Data sources – real-world situations
• Data – descriptive
• Emphasises a holistic approach (processes & outcomes)
• Data analysis – inductive
• Describes meaning of research findings from perspective
of research participants
• Uses inductive reasoning:
• Develop generalisations from a limited number of specific
observations / experiences
• Highly dependent on the number & representativeness of
specific observations to make generalisation
Qualitative Research Issues
1. Gaining entry?
• Access depends on researcher’s personal characteristics
& how others perceive the researcher
• May require ~negotiation & compromise with a
gatekeeper
• Trust → EARNED. Not given.
2. Contacting participants
• To gain access
• To deal with gatekeeper
• Issues of building trust & ensuring confidentiality &
anonymity
3. Selecting participants
• Goal → to get deepest possible understanding of setting
being studied
• To identify participants who can provide info about the
topic & setting being studied
• Fraught with difficulties in identifying & selecting an
appropriate N (that can provide useful info)
• Utilises purposive sampling
• Number of participants → sufficient, when
• selected participants represent range of potential participants in
the setting &
• point at which data gathered begins to be redundant
• Threats to validity?
• Observer bias
• Observer effects
4. Strategies to enhance validity & to reduce bias
• Time extension for observation
• More participants to make study more representative
• Focus upon building participant trust to access > detailed &
honest data
• Identify biases & preferences, seek by asking others
• Compare field notes & impressions from independent
observations with other researchers
• After completed observations, participants can be offered
opportunity to validate accuracy of verbatims
• Journalise one’s own reflections, concerns & uncertainties
during the study
• Carefully examine unusual / contradictory results for
explanations
5. Leaving the field
• ?when bond is formed with participants, how to leave the
setting
• Time constraints
• When is amount of data is sufficient?
Qualitative Research Methods
Interviews
• Informal – researcher to recollect discussion
• Unstructured – at respondent’s pace & subjects to vary
by interviewee to an extent (e.g. ethnography)
• Semi-structured – uses interview guide
• Structured – uses identical stimuli & adheres to schedule
Semi-structured interviews (focus group method)
• Recruited to discuss
• One focus group = one (1) unit of analysis
• Complement surveys: 1st step in tapping critical
questions to be used in a survey
• Identify why people feel certain way & elucidate steps in
their decision making process
• Ideal size: 6 to 12 persons & one moderator / note-taker
• !Series of groups for validity
• Often segmented to expected meaningful differences
(e.g. disease status, gender, etc.)
• !fine line between leading too much and not getting
people to contribute
• No right / wrong answers
• Tapes → usually transcribed verbatim
• Text → sorted into themes by >2 researchers (to ensure
validity)
• Themes are compared with field notes taken by other
researchers
• Thematic coding factors: frequency, specificity, emotion,
extensiveness
Structured interviews
Questionnaire
1. Face-to-face interviews
2. Self-administered questionnaires
3. Telephone interviews
Face-to-face interviews
Advantages Disadvantages
• Can be used with bedridden, • Intrusive & reactive
illiterate patients, etc.
• Cost time & money
• Can elicit more in-depth response /
fill-in info if participants does not • Difficult to locate respondents
understand the qs for callbacks
• Different data collection techniques

– open-ended qs, visual aids, etc.
• Certainty about who answered the
qs
Self-administered questionnaires
• Post-office locates participants • No control over participants
interpretation
• Everybody gets same qs
• Low response rates
• Researcher can ask more
complex qs • Uncertainty about who are the
respondents
• No response effect (to divulge
more info / impress • Useless with illiterate
interviewer) populations / hard-to-reach
populations
• Can be computer-based
Telephone interviews
• Combo (face-to-face + self- • Changing demographics → more
administered interviews) cellphones (may miss certain
population segments)
• Inexpensive & convenient
• Survey must be short or people
• Safe for interviewers will not be interested
• No call lists → presenting
increasing challenge
Interview do’s & don’ts
Do… Don’t…
• Listen more & talk less • Use leading questions
• Follow up on unclear info & probe • Interrupt
more deeply into what is revealed
• Be judgmental about / react to
• Keep interviewee(s) focused interviewee’s opinions / views / beliefs
• Ask for concrete details • Engage in debate
• Tolerate silence / space & allow time to
think
• Record everything the interviewee says
/ note impressions & non-verbal
behavior
Qualitative Research Steps
1. Proposal
2. Intensive participant in a field setting
3. Collect detailed data
4. Synthesize & interpret meanings of data
5. Write research report
Proposal
• Defines area, setting & context of study
• Specifies kinds of data to be collected
• Describes methods
• Provides rationale of undertaking the study
• Identifies study’s potential contribution(s)
Intensive participation in field setting
• Approach to participation – overt / covert
• Requires experiencing the situation from the perspective
of an observer / participant
Data collection & analysis
• Tools: Observation & interviews, and/or personal / official
documents, photographs, recordings, drawings, emails,
informal conversations
• Multiple data sources are normative
• Records descriptive data + reflective notes (what has been
heard, experienced, thought about, etc.)
• Field notes
• NO assumptions
• See through participants’ eyes
• Immediate write-up following observations
• Detail is critical – date, site, time, topic, diagrams
• List keywords first, then outline one’s observations
• Separate descriptive& reflective sections
• Use memos – hunches, questions, insights after observation
• Interviews (via notes-jot / tape recording)
• Purpose – to explore & probe interviewee’s responses to gather
in-depth data
• Inquires into interviewee’s attitudes, interests, feelings, concerns,
values
• Meaning is jointly constructed between both sides (not only part
of interviewee)
• Alert for openings in responses for more deeply
• Start with mundane qs to more sensitive & complex qs
Synthesize / Interpret meanings of data
• Formidable task – data are thick, deep, voluminous &
unorganised
• Involves systematic & iterative process of searching,
categorising & integrating data → to emerge understanding
• Field notes: deconstructing data into pieces →
reconstructing data pieces into categories → identify
patterns for understanding, synthesis & interpretation
• Four (4) step iterative process of data management
1. Reading & memoing to familiarise & identify main themes
2. Examining for detailed descriptions
3. Classifying the data i.e. categorisation, coding, grouping
4. Interpreting & synthesizing the organised data into general
conclusions
Criteria for data analysis
1. Credibility & plausibility
• Study was conducted to ensure that subject was accurately
identified & described
2. Transferability
• Results are generalisable to others in original research context or
beyond
3. Including a methods section
• Provide in-depth description of processes & methods used
Strategies for data analysis
1. Constant comparison method
• Compares new vs. prior evidences to identify similarities /
differences between observations
2. Negative case & discrepant data methods
• Search for contradictory / variant / disconfirming data that
provides alternative perspective on a category / pattern
3. Analytic induction
• Developing / testing a theory to generalise study findings
Writing the research report
• Provide a setting where data were collected
• Identify characters who provided infos
• Describe social action in which characters are engaged
• Offers interpretation of what the social action means to the
characters
• Follows APA guidelines
Thank youuuuuuuuuuuuuuuuuuuuuuuu.
Quantitative Research Design
Introduction
What is a research design?
The overall strategy to integrate the different

components of the study in a coherent & logical
way, where the research problem can be
addressed effectively. It constitutes the
blueprint of the collection, measurement and
analysis of data.
!!
Your research question / problem

determines the type of design you
shall use, NOT the other way
round.
Division
QUANTITATIVE QUALITATIVE
Experimental Ground theory

Survey Ethnographic
Correlational Narrative
Meta-analyses
Quantitative Study: Types
Experimental Design
When to use? When the possible cause and effect
between two variables are to be established.
Outcome /
Independent
variable Influences Dependent
variable
e.g. How does cocktail noise influence the
cognitive distraction?
Properties Manipulation
• Refers to conscious control of independent
variable by the researcher (through treatment /
intervention) to observe its effect on the
dependent variable
• The researcher varies the independent variable &
observes the effect of its manipulation on the
dependent variable of interest
• Example?
Properties Control
• Refers to use of control group & controlling the
effects of extraneous variables on the dependent
variable of interest
• Subjects in control & experimental groups are the
same in number & characteristics, but the
controls do not receive any treatment /
intervention at all.
• Comparison is being made on the effect of
treatment / intervention
Properties Control (cont’d)
• In healthcare & nursing research, keeping the

control group from treatment / intervention is
unethical. However, could compare with
existing conventional method vs. treatment /
intervention of interest.
Properties Randomisation
• Every subject has an equal chance of being
assigned to either experimental / control group
→ Random assignment
✓ Eliminates chance of systemic bias
✓ Minimises the threat of internal validity of the
study
✓ Eliminates the effect of extraneous variables on
dependent variables
Properties Randomisation (cont’d)
• On average, the characteristics of the subject

in both groups are similar. Thus, influence of
extraneous variables on dependent variable is
eliminated by dispersing the variability of the
subject characteristics equally.
Types
1. Basic design
2. Factorial design
3. Repeated-measures design
4. Clinical trials
5. Quasi experimental design
Basic design
Tries to prove / disprove a hypothesis
mathematically, with statistical analyses.
Basic design = true experimental design

Criteria
• The sample groups must be assigned randomly
(to control or experimental group)
• There must be a viable control group
• Only one variable tends to be manipulated and
tested → independent variable
Results is statistically analysed thus Can be almost perfect, due to the
allow minimal argument complete control of representatives,
not representing the real condition
Easier replication for validation No guarantee that sample could
generate ‘natural’ behavior under
experimental condition
Manipulation of only one variable Difficult & expensive to set up.
allows yes/no answer
Results can be too accurate, thus
disallowing complete rejection /
acceptance of hypothesis
Factorial design
Often used to understand the effect of two / more
independent variables upon a single dependent
variable.
• Traditionally, only one variable is studied at a time.
However, in many cases, two factors could be
interdependent.
• e.g. Effects of education methods, under influence
of socioeconomic status & background
• …thus, factorial design it is.
• Researcher manipulates two / more independent
variables simultaneously to observe their effects
on the dependent variables.
• Facilitates testing of several hypothesis at a
single time
• Example?
• Typical design: 2×2 or 2×3 factorial
Example
A researcher wants to observe the effect of two
different protocols of mouth care on
prevention of VAP when performed at
different frequency per day
Independent variables / 2×2 Level of frequency

type of experimental
treatments (α) 2×3 of the treatment (β)
Frequency of Protocols of the mouth care
mouth care Chlorhexidine (α1) Saline (α2)
4-hourly (β1) α1…β1 α2…β1

Pros Cons
Preliminary studies to link Difficulties on experimenting
between two variables whilst with > two factors / many
reducing possibility of levels. Thus, meticulous
experimental error & planning.
confounding variables
Allows many levels of analysis
(relationships between variables
+ single / isolated analysis on
effect of manipulated variables)
Repeated measures
Justification?
Independent measures design has different
participants in each condition. However, there is
potential error from individual differences
between groups of participants that took part in
the different conditions. And, if there is small
sample number, data could be use uneconomically
(over/under) represented.
…thus, repeated measures design it is.
• Same subjects are tested on two / more separate
occasions.
• Example? Same subject, two (2) stimuli. To
determine time-to-react to audio (bell) and visual
(flash of light) stimulus.
• But, must control confounding variables (e.g.
practice effects / fatigue → order effects)
• Needs counterbalancing.
What is counterbalancing?
Example
Participants reacted less quickly to light, maybe because of
unfamiliarity / fatigue / < practice.
Participants reacted more quickly to light, maybe because
after lots of trials / had prior practices.
Thus? To control effects of fatigue / boredom &
practice, half participants would be tested with visual
condition FIRST, half participants with audio condition
FIRST.
Groups Condition Remarks
Audio Visual
Group AAudio AVisual Aaudio starts
A first
Group BAudio BVisual Bvisual starts
B first
Individual differences are Range of potential uses is
removed (as a potential smaller.
confounding variable*)
Requires fewer participants Order effects, but minimised by
counterbalancing
*potential confounding variables → disadvantages of independent measures

Clinical trials
Most clinical trials aim to estimate the magnitude or
differences of treatment effects.
A good clinical design should …
• Quantify & reduce errors due to chance
• Reduce / eliminate bias (via randomisation)
• Yield clinically relevant estimates of effects & precision
• Be simple in design & analysis
• Provide high credibility, reproducibility & external validity
• Influence future clinical practice
Controlled
clinical trial
(CCT)
Clinical Trial
Randomised
controlled trial
(RCT)
CCT
• Tests a specific drug / treatment involving two /
more groups of patients with the same disease.
• The experimental group receives drug / treatment
of interest, the control group receives alternatives /
placebo / no treatment.
• Two groups are followed to compare differences in
outcomes / effect (to assess the effectiveness /
safety of the drug / intervention)
RCT
• Subjects are randomly assigned to any one of
experimental (receiving intervention of interest)
& control groups (receiving alternatives / no
intervention).
• They are followed to see differences in effect /
outcome.
• RCT determines whether cause-effect relation
exists between the intervention & the outcome.
Control treatment
Group
Outcome
Sample 1
population Group
Outcome
2
New treatment
Features of a well-designed RCT
• Samples are appropriate to the hypothesis being
tested, so results are appropriately generalisable.
Sufficient N to have high probability of
detecting a clinical difference (if it truly exists).
• Effective (concealed) randomisation of
subjects, to eliminate selection bias & minimise
confounding variables)
• Both groups treated identically, except for
intervention of interest. Blinded assignment of
groups to the participants by researcher.
• Patients are analysed within the group to which
they were located, irrespective of outcomes
• Analysis focuses on testing the RQ (hypothesis),
rather than ‘trawling’ to find a difference.
‘Randomised’ controlled trial
• Random assignment of subjects to either group
→minimise confounding variables
• Concealed randomisation from researchers
• Stratified randomisation ensures a potential
baseline confounding variable to be equally
distributed within two groups
Quasi-experimental Research
• Involves manipulation of independent variable to
observe the effect on dependant variable.
• BUT. Lacks randomisation and/or control group
• Generally used to establish the causality, where
researchers are not able to randomly assign the
subjects to groups OR have no control group for the
experimental study.
• Independent variable is not manipulated in complete-
controller situations
Two common types
Non-randomised
Time-series design
control group design
Non-randomised control
group design
• = non-equivalent control group design
• No randomisation in selecting both groups
• Dependent variables are observed in experimental
AND control groups before the intervention
• Later, experimental group receives treatment, but not
control group. Post-test observation of dependent
variables is done for both groups to assess the effect
of treatment on experimental group
Non-randomised control group design
Experimental
Pre-test Intervention Post-test
group
Control
Pre-test Post-test
group
Time-series design
• Aims to measure effects of a treatment over a
long period of time
• Measurement are done multiple times after each
administration of intervention, throughout the
course of experiment
• Generally, it is a single-subject research, due to
small number of samples needed
Pre-test observation
Experimental
O1 O2 O3
group
O3 O2 O1 Intervention
Post-test observation
Example
• Pain level assessment of patients with LBP. 3
weeks of pre-intervention pain assessment,
followed by intervention (special exercise) to
reduce the pain level. 3 weeks of post-
intervention pain assessment was done again.
More practical and feasible, due No control over extraneous
to absence of large N, variables influencing the
randomisation & control group dependent variable
Suitable to real-world/ Results are less reliable & weak
environmental natural setting for establishment of causal
relationship between variables
Conclusion
‘Skillful statistical analysis

CANNOT
overcome basic design flaws.’
Thank youuuuuuuuuuuuuuuuu. Questions?
Non-Experimental Quantitative Research
Overview
Why non-experimental?
• Many variables in social sciences cannot be manipulated,
because they are naturally existing attribute variables (e.g.
gender, socioeconomic status, learning style, traits)
• Unethical practice to randomly assign individuals to different
treatment condition
In non-experimental design, ..
• researcher explores relationships / differences among the
variables
• requires clear, concise RQ / hypothesis based on theoretical
framework
• the strengths of evidence – not as strong, due to 1)
independent variable not manipulated, 2) subjects not
randomised, 3) no control group
Classifications
Survey studies Relationship / difference
• Descriptive studies
• Exploratory • Correlational
• Comparative • Developmental
– Cross-sectional
– Longitudinal,
prospective, cohort
– Retrospective, ex post-
facto, case control
Surveys
• Collect detailed descriptions of existing variables → use them
to justify & assess current conditions / practices
• Aim: to improve
• Descriptive & exploratory surveys:
– Characteristics of particular groups / institutions / situations
– Frequency of a phenomenon’s occurrence
• Types of variables: opinions, attitudes, facts (attribute of
individuals)
• Provide basis for further development of programs /
interventions
• Comparative surveys: to determine differences between
variables
• Data collection: by questionnaires / interview
Great deal of info from Superficial information →
large population in $$ no causation
If sample is representing Needs great deal of
population, small N can expertise
accurately picture the
population
Time-consuming
A well-constructed survey can provide a wealth of
data about a particular phenomenon of interest,
even though causation is not being examined.
Relationship & Differences Studies
• For deeper insights into a phenomenon
Correlational
• Examines relationship between two/more
variables
• Researcher is…
– not testing whether one variable causes the other
/ how different one variable is from another
– testing whether a variable co-vary with the other
– interested in quantifying the strength of
relationship between variables OR testing a
hypothesis / RQ about a specific relationship
Example?
Horgas et al. 2008
• Objective: to examine relationship among race
(black & white) and functional disability (physical &
social functioning) in older adults
• Methods: Tested multiple variables (pain, race and
disability) to assess relationship among these
variables in the sample
• Results: Having greater functionality-limiting
medical diagnoses was associated with increased
pain (thus, variables are related to outcome)
•Increased flexibility in studies •Unable to manipulate the
on complex relationships among variables of interest
variables •No randomisation in sampling
•Efficient & effective method of •Unable to determine causal
data collection relationship (due to lack of
•Potential for evidence-based manipulation, control &
application in clinical settings randomisation
•Potential foundation for future •Strength & quality of evidence
experimental studies → limited by associative nature
•Framework for exploring the of relationship between
relationship between variables variables
(that cannot be manipulated) •Misuse → if researcher claimed
a causal relationship between
variables
• Given level of evidence, there are limitations in
the ability to generalise the findings. BUT,
authors usually conclude with recommendations
for future studies
• Inability to draw causal statements should NOT
lead to assumption that this design is weak.
• for clinical research because many phenomena
of clinical interest is beyond researchers’ ability
to manipulate, control & randomise.
Developmental
• Use a time perspective
• Researchers is concern with
– Existing status
– Relationship & differences among phenomena at one point in time
– Changes that result from elapsed time
• Three (3) types: Cross-sectional; longitudinal / prospective; and
retrospective.
Cross-sectional studies
• Examines data at one point in time, where data is collected on
only one occasion with same subjects
• Purpose? To explore potential relationships between & among
variables, NOT to test causality
• Can explore relationships & correlations OR differences &
comparisons OR both
risk factor,
disease
risk factor,
disease
Population Sample
risk factor,
disease
risk factor,
disease
• ×× does not provide sequential info (?before
& ?after)
• E.g.
Association between smoking status &
CAD among Malays.
Sample of
Sample of Malay non-
smokers population smokers
Prevalence of CAD?
Reasons to use cross-sectional studies
• Assessing prevalence of a disease
• Seeking info on general attitudes towards a number of things
in society (drinking / smoking)
• Exploring links between variables (poor diet & overweight)
Longitudinal / prospective / cohort studies
• Involves data collection from same group at different points in
time
• Also explores relationships / differences
• Referred to as repeated measure studies
• Multiple time measurement periods allowed researchers to
study functional changes over a time period.
Study design – cohort study
Condition
develops
Variable
present
Condition does
not develop
Population Sample
Condition
develops
Variable absent
Condition does
not develop
• E.g.
To see the effects of jering consumption
on diabetes in a population
Present Future
Jering-free Diabetic
diet
Non-diabetic
Diabetic
Jering diet
Non-diabetic
Advantages
• Separate follow-up of each subjects, thus serves as his / her
own control
• Increased depth of responses
• Early trends in data can be analysed
• Assessment of changes over time
• Differences & relationships can be explored
Disadvantages
• Long duration of data collection
• High cost
• Internal validity threats (testing & mortality – present &
unavoidable)
• Lost subjects to follow-up (death / attrition) → sample bias →
affects internal & external validity, OR generalisability
Longitudinal studies begin in the present and end in
the future; Cross-sectional studies look at a
broader perspective of a cross section of the
population at a specific point in time
Retrospective / Ex post facto / case control studies
• The dependent variable already has been affected by
the independent variable, x
• Researchers? Aim to link present events to past
events
• Or causal-comparative / comparative studies
• Researchers hypothesize ..
– **x is related to & a determinant of y
– But x (the presumed cause) is not manipulated, &
subjects are not randomly assigned to groups
**x is cigarette smoking, y is lung cancer

• Thus?
– A case group who have experienced x in a normal
situation is located, and a control group who have
not experienced x is chosen
– Behavior, performance or condition of two groups
is compared
Groups (non-random) Independent variable Dependent variable
Case group: cigarette X (cigarette smoking) ye
smokers
Control group: vc (No lung cancers)
Non-smokers
• E.g.
Are those with diabetes less likely to
have consumed jering?
Past Present
High jering consumption Diabetic
group
Low jering consumption
High jering consumption

Normal group
Low jering consumption
• Offers higher level of control > correlational
studies → confidence by researchers
– E.g. samples of lung tissues were taken, → able to
establish differential effects of cigarette smoking
on lung tissues
– BUT. Still unable to draw causal linkage
• Impact / effects of relationship cannot be
estimated accurately
– To find case vs. control groups that only differ in
variables of interest is DIFFICULT
References
• LoBiondo-Wood, G. & Haber, J. (2010) Nursing research: Methods and critical
appraisal for evidence-based practice (7th Ed.) Mosby, Elsevier.
• Gerrish. K. & Lacey, A. (2006) The research process in nursing (5th Ed.) Blackwell
Science Ltd.
• Maltby, J, Williams, G., McGarry J & Day, L. (2010) Research methods for nursing
and healthcare. Pearson Education Ltd.
Thank you. Questions?
MAJOR STEPS
IN
QUANTITATIVE
STUDY
Nurul Mawaddah
Mohammad
Learning outcomes:
At the end of this lecture, students should be able to:
1. Describe five phases for conducting effective research

2. Formulate a significant research question
3. Select a proper research design
4. Identify population to be studied
5. Designing the sampling plan
6. Specifying methods to measure the research variables
7. Conducting a pilot study and making revisions
8. Collecting data & preparing data for analysis
2
RESEARCH
• Systematic collection, analysis and interpretation of
data to answer certain questions to solve problems
• It is crucial to follow cascading scientific steps when
conducting research
RESEARCH FLOW
Some idea of a problem situation for study
Conduct search for past studies
Research questions and formulate hypothesis
Determine methods
Write proposal
Commence study
Data collection
Data analysis
Write up
Presentation / publication
Own observation
RESEARCH FLOW
Suggestion from others
News item Some idea of a problem situation for study
Own records
Other studies Conduct search for past studies
Determine methods
Write proposal
Commence study
Data collection
Data analysis
Write up
RESEARCH FLOW
Literature
Some idea of a problem situation for study
search
Conduct search for past studies
Literature
search
Determine methods
Write proposal
Commence study
Data collection
Data analysis
Write up
Topic
• Choose an interesting topic that:
– Up to what level of knowledge
– Gap of knowledge
• Rationale of that particular topic

– Keywords;
– What
– Where
– When
– Who
– Which
– Why
– How
7
PHASE I
THE
CONCEPTUAL
PHASE
8
Brink et al. (2006)
• Conceptualization…..
• Process of developing and refining abstract ideas
9
Brink et al. (2006)
• Early steps in a quantitative study typically have a strong
conceptual or intellectual element. These activities includes
reading ,conceptualising, theorising and reviewing ideas with
colleagues or supervisors
• During this phase researchers call on such skills as creativity,

deductive reasoning and a firm grounding in previous research
on the topic of interest
10
st
1 phase of original research
• Divided into 4 steps:
1)Formulation of research problem/research questions, determine

the purpose of the study
2)Searching and review the literature relating to the regarding
research problem and develop a framework
3)Defining the theoretical framework of the research
4)Formulation of hypothesis and objectives which should be verified
in research
11
1. Formulation of research question
• According to the definition, the problem is something that you like to
know more about or a question you like to answer
• Researchers begin with identifying an interesting significant research
problem and formulating research questions
• In developing the research questions, researchers must attend to
substantive issues, clinical issues, methodological issues and ethical
issues
• Formulation of research question is frequently recognized as the
most difficult and the most important part of research project
12
Formulation of research question cont….
• To identify a scientific problem, discover the sources
that relate to the topic and seek for the problems that are
raised in the search
• Write down the problems that were find. Choose one

that would be interesting and feasible to solve
13
Formulation of research question cont….
• The challenge in developing an appropriate research question is;
– in determining which clinical uncertainties could or should be studied
– also rationalizing the need for the investigation
• Appropriate methods include;

– systematically searching the literature
– in-depth interviews and focus groups with patients
– interviews with experts in the field
– in addition, awareness of current trends and technological advances can
assist with the development of research questions
14
Good research question: FINER
• FINER criteria outline the important aspects of the question in general
15
Tool : Research Question
16
2. Literature review
• A process of searching information
• About certain issue / topic / question
• What has already known
• And what questions not yet answered
• A vital process before starting a study / research
• A good literature review depends on how good the literature search is
17
Why literature review?
• The aims of literature review are to get an insight and a view of the
works of others
• In the literature review, researchers might be able to find a study that is
quite similar. It helps to find and select appropriate measurement
instruments and also to anticipate common problems in research
• Look at the theories, arguments, conclusions, similarities and the
differences which closely related to the work. Therefore, researchers can
decide which ideas or information that are important to emphasis on
• Compare also different authors views on an issue and at the same time
put those with similar conclusions in groups, note the
disagreement areas and conclude by summarizing what the
literature says
18
3. Development of the theoretical
framework of the research
• The theoretical framework in a study works as a map for the research. It is
presented in the early section of a dissertation and provides the rationale
for conducting the research and to investigate a particular research
problem
• Consider the theoretical framework as a conceptual model that establishes
a sense of structure that guides the research
• It provides the background that supports researchers investigation and
offers the reader a justification for the study of a particular research problem
• It includes the variables that the researchers intend to measure and the
relationships that were seek to understand. Essentially, this is where the
researchers describe a “theory” and build the case for investigating that
theory
19
Cancer patients with
Conceptual implantable venous access
port (IVAP)
Framework Surgical reports:
Socio-demographic
Insertion site,
characteristics:
insertion side,
Age, weight, sex, race Ward of care
Prognostic factors of (IVAP)
Clinical reports:
Co-morbidity: removal due to
complications Types of cancer, division of
Diabetes mellitus, cancer types, main cancer site,
hypertension, respiratory cancer stage, cancer metastases,
system disease, liver disease, cancer relapsed, chemotherapy
kidney disease treatment, surgery, radiotherapy
Seven years follow-up
Event Censored
Removal of IVAP due to Death
complications Patient loss to follow-up
On-going chemotherapy
20
Figure 3: Conceptual frameworks of prognostic factors of IVAP removal due to complications.
4. Formulation of hypothesis &
objectives
• It a statement of researcher’s expectations and predictions about
relationships among study variables
• The research questions identifies the study concepts and asks how
the concepts might be related, a hypothesis is predicted answer
• Hypotheses are more specific predictions about the nature and
direction of the relationship between two variables
• In general, research objectives describe what we expect to achieve
by a project
21
Main Objectives
• Aim or purpose of the chosen area of research
• Broad general statement
• Overall aim of the study
• Eg: To determine the prevalence of cleft palate babies
and its factors associated with cleft palate babies among
pregnant women
22
Specific objectives
• More specific objectives
• Break down of general objective into some specific objectives
– Eg To determine the prevalence of cleft palate babies in
Kelantan
– To determine the socio-demographic characteristics
associated with cleft palate babies among pregnant mothers in
Kelantan
– To determine the association between clinical characteristics
of pregnant mothers with cleft palate babies in Kelantan
23
Specific objectives
• SMART
– S Specific
– M Measurable
– A Achievable,
– R Reliable, Relevant
– T Time Related, time bound
• Eg To determine the prevalence of cleft palate babies in Kelantan
• To determine the socio-demographic characteristics associated
with cleft palate babies among pregnant mothers in Kelantan
• To determine the association between clinical characteristics of
pregnant mothers with cleft palate babies in Kelantan
24
Hypothesis
• Each specific objective is matched with a hypothesis
• More specific prediction about the nature and direction of the relationship
between two variables ;
– dependent vs independent variable
– It is developed in order to provide basis for statistical analysis
– H0
– HA
• Eg H0 : There is no significant association between cleft palate babies and
the socio-demographic characteristics among pregnant mothers in Kelantan
• Eg HA : There is a significant association between cleft palate babies and
the socio-demographic characteristics among pregnant mothers in Kelantan
25
PHASE II
THE DESIGN &

PLANNING
PHASE
26
Phil Ender, 1998
• The aim of this phase of research is to prepare general
plan of real research
• The researchers make decision about the methods they

will use to address the research question
• If the methods used to collect the data are flawed, then

evidence from the study may have little value
27
The design & planning phase
• The design & planning should be involved following steps:
1. Selecting a research design
2. Developing protocol for intervention
3. Identifying the population to be studied
5. Specifying methods to measure the research variables
6. Developing methods to safeguard human and animal’s right
7. Reviewing and finalizing the research plan
28
1. Selecting the research design
• It is a overall plan for obtaining the research questions. Many
experimental or non experimental research designs are available
• Researchers select a specific design and identify strategy to
minimize the bias
• Research design indicates how often the data will be collected,
what type of comparisons will be made and where the study will
take place
29
2. Developing protocol for
intervention
• In experimental research ,researchers actively intervene, which
means that participants are exposed to different treatment
conditions
• An intervention protocol for the study must be developed,
specifying exactly what the bio feedback treatment would entail
and what alternative condition would be.
• The goal of well articulated protocol is to have all people in each
group treated in the same way.(in non- experimental research,
this step is not necessary)
30
3. Identifying the population to be
studied
• A population is all the individuals or objects ,with common or
defined characteristics
• Quantitative researchers must specify the population to be
studied
31
• In a quantitative study, samples adequacy is assessed by its size
and representativeness
• The sampling plan identifies how the sample will be selected and
recruited and how many subjects will be there
32
5. Specifying methods to measure
research variables
• Quantitative researchers must develop the methods to measure
the research variables accurately
• Sources of data may include people, literature, documents, and
ﬁndings (for example, from sources such as laboratory data or
measurements of vital signs)
• Data also may be collected from interviews, questionnaires, direct
measurement, or examinations (such as physical or
psychological tests)
33
6. Developing methods to safeguard
human & animal’s right
• The study should be adhered to ethical principles
• Each aspect of the study needs to be scrutinized to determine
whether the right of the participants have been adequately
protected
• A formal presentation to an ethics committee is often required
34
7. Reviewing & finalizing the
research plan
• Before collecting the data, researchers often take steps to that
plans will work smoothly
• Researchers also have their research plan critiqued by peers,
supervisors, consultants or other reviewers before implementing
it
• Researchers taking financial support submit proposal to funding
source, and reviewers usually suggest improvement
35
PHASE III
THE EMPIRICAL
PHASE
36
The empirical phase
• In many studies empirical phase is the most time consuming
part of the investigation. Data collection requires many weeks
or months. Nonetheless, the amount of time spent, however,
varies from study to study.
• Empirical phase includes the following steps:
1. Collecting the data
2. Preparing the data for analysis
37
1. Collecting the data
• This step proceeds according to established plan
• The plan specifies when and where the data will be
collected, procedure for describing the study to
participants and methods for recording information
38
2. Preparing the data for analysis
• Data collected in a quantitative study are rarely amenable to
direct analysis (preliminary steps are needed)
• One such step is coding (translating the verbal data into the
numeric data)
• Another preliminary steps involves entering the data into
computer files @ software for analysis
39
PHASE IV
THE ANALYTICAL
PHASE
40
The analytical phase
• It includes analysis and interpretation, which is the fourth
major phase of a project
• Statistical procedures are used to analyse the data and provide
answers to the research question
• This phase include the following steps:
1. Analysing the data
2. Interpreting the results
41
1. Analysing the data
• Quantitative researchers analyse their data through
statistical analysis, which includes simple as well as
complex procedures
• Use of computers @ software has made easy the use of
statistical data
42
2. Interpreting the results
• It involves making the sense of study results and
examining their implications
• Researchers attempt to explain the findings in light of
prior evidence theory, their own clinical experience and in
the light of adequacy of methods, they used in the study
43
PHASE V
THE
DISSEMINATION
PHASE
44
The dissemination phase
• Researchers responsibilities are not completed until the study
results are disseminated
• This phase include the following steps:
1. Communicating the findings
2. Utilizing the findings in the practice
45
1. Communicating the findings
• It includes the preparation of research report that summarizes the
findings
• Through publications and presentations, the researcher explains the
results of the study and links them to the existing body of knowledge in
the literature
• Research report can take various forms-
– Dissertation
– Journal articles
– Conference presentation
46
2. Utilizing the findings in the
practice
• The concluding step of a high quality study is to plan for the
use of evidence in practice setting
• The researchers must include in their research report, how
the research report can be utilized in the clinical settings
• The researcher also describes the implications of the study
and suggests directions for further research
47
48
ETHICAL ISSUES IN HEALTH
SCIENCE RESEARCH
Norhayati Mohd Zain
BSc Diagnostic Imaging
& Radiotherapy (Hons), UKM
MHSc Diagnostic Imaging, UKM
Nuremberg War Crimes Trial
The Nuremberg War Crimes Trial following World War II

brought to public view the ways German scientists had
used captive human as subjects in oftentimes gruesome
experiments.
From the time immediately after World War II until the early
1990s, there was a gradually developing consensus
about the key ethical principles that should underlie
research endeavor. Two marker events stand out (among
many others) as symbolic of this consensus:
a. Nuremberg Principles
b. Helsinki Declaration
Nuremberg Courtroom
Nuremberg Code
A set of principles for human experimentation set as a

result of the Nuremberg Trials at the end of WWII.
The code was adopted in 1947.
Nuremberg Principles
A set of guidelines for determining what constitutes a

war crime.
Helsinki Declaration
 The Declaration of Helsinki was developed by the

World Medical Association (WMA), in 1964 in
Helsinki, Finland as a set of ethical principles for the
medical community regarding human
experimentation, and is widely regarded as the
cornerstone document of human research ethics. It
expanded on the 10 principles first stated in the
Nuremberg Code (1947).
The Declaration was originally adopted in
June 1964 in Helsinki, Finland and has since
undergone six revisions (the most recent at
the UN General Assembly in October 2008)
and two clarifications, growing considerably
in length from 11 to 32 paragraphs. The
Declaration is an important document in the
history of research ethics as the first
significant effort of the medical community
to regulate research itself, and forms the
basis of most subsequent documents.
Declaration of Oslo
 Adopted by World Medical Association assembly in

Oslo, Norway in 1970 and essentially requires the
physician to maintain respect for human life an all
considerations of therapeutic abortion.
Good Clinical Practice
GCP is a set of rules and guidelines that is provided

by International Conference on Harmonisation (ICH)
– an international body that regulates clinical trials
involving human subjects. . International Conference
on Harmonisation stipulates the technical
requirements for registration of pharmaceuticals for
human use.
GCP guidelines include:
a. Protecting of human rights as a subject in
a clinical trial.
b. Promoting assurance of the safety and
efficacy of the newly developed
compounds.
c. Regulating how clinical trials should be
conducted.
d. Defining the roles and responsibilities of
clinical trial sponsors, clinical research
investigators, and clinical associates.
Tuskegee Syphilis Study, Aalabama
In the 1950s and 1960s, the Tuskegee Syphilis Study
involved the withholding of known effective
treatment for syphilis from African-American
participants who were infected. Events like these
forced the reexamination of ethical standards and
the gradual development of a consensus that
potential human subjects needed to be protected
from being used as 'guinea pigs' in scientific
research.
For forty years between 1932 and 1972, the
U.S. Public Health Service (PHS) conducted
an experiment on 399 black men in the late
stages of syphilis. These men, for the most
part illiterate sharecroppers from one of the
poorest counties in Alabama, were never told
what disease they were suffering from or of
its seriousness. Informed that they were
being treated for “bad blood,” their doctors
had no intention of curing them of syphilis at
all.
Treatment was initially part of the study, and
some patients were administered arsenic,
bismuth, and mercury. But after the original
study failed to produce any useful data, it
was decided to follow the subjects until their
deaths, and all treatment was halted.
Penicillin was denied to the infected men
after that drug became available in the mid-
1940s, and it was still being withheld from
them 25 years later, in direct violation of
government legislation that mandated the
treatment of venereal disease.
The true nature of the experiment had to be
kept from the subjects to ensure their
cooperation. The sharecroppers' grossly
disadvantaged lot in life made them easy to
manipulate. Pleased at the prospect of free
medical care—almost none of them had ever
seen a doctor before—these unsophisticated
and trusting men became the pawns in what
James Jones, author of the excellent history
on the subject, Bad Blood, identified as “the
longest nontherapeutic experiment on
human beings in medical history.”
 By the end of the experiment, 28 of the men had
died directly of syphilis, 100 were dead of related
complications, 40 of their wives had been infected,
and 19 of their children had been born with
congenital syphilis. How had these men been
induced to endure a fatal disease in the name of
science?
Helsinki Declaration
HELLO, YES WE WANT TO BE
GUINEA PIGS!
By the 1990s, the dynamics of the situation changed!

By the 1990s, the dynamics of the situation
changed. Cancer patients and persons with AIDS
fought publicly with the medical research
establishment about the long time needed to get
approval for and complete research into potential
cures for fatal diseases.
In many cases, it is the ethical assumptions of the
previous thirty years that drive this 'go-slow'
mentality. After all, we would rather risk denying
treatment for a while until we achieve enough
confidence in a treatment, rather than run the risk of
harming innocent people (as in the Nuremberg and
Tuskegee events).
But now, those who were threatened with fatal
illness were saying to the research establishment
that they wanted to be test subjects, even under
experimental conditions of considerable risk.
Several very vocal and articulate patient groups who
wanted to be experimented on coming up against an
ethical review system that was designed to protect
them from being experimented on.
While it's not entirely clear, at present, what the
new consensus will be, it is almost certain that it will
not fall at either extreme: protecting against human
experimentation at all costs vs. allowing anyone who
is willing to be experimented on.
Voluntary participation
 The principle of voluntary participation requires that

people not be coerced into participating in research.
This is especially relevant where researchers had
previously relied on 'captive audiences' for their
subjects -- prisons, universities, and places like that.
INFORMED CONSENT
Closely related to the notion of voluntary

participation is the requirement of informed consent.
Essentially, this means that prospective research
participants must be fully informed about the
procedures and risks involved in research and must
give their consent to participate.
NO RISK OF HARM
Ethical standards also require that researchers not

put participants in a situation where they might be at
risk of harm as a result of their participation. Harm
can be defined as both physical and psychological.
CONFIDENTIALITY
There are two standards that are applied in order to

help protect the privacy of research participants.
Almost all research guarantees the participants:
 1. confidentiality -- they are assured that
identifying information will not be made available to
anyone who is not directly involved in the study.
The stricter standard is the principle of
2. anonymity which essentially means that
the participant will remain anonymous
throughout the study -- even to the
researchers themselves. Clearly, the
anonymity standard is a stronger guarantee
of privacy, but it is sometimes difficult to
accomplish, especially in situations where
participants have to be measured at multiple
time points (e.g., a pre-post study).
“RIGHT TO SERVICE”
Increasingly, researchers have had to deal

with the ethical issue of a person's right to
service.
Good research practice often requires the
use of a no-treatment control group -- a
group of participants who do not get the
treatment or program that is being studied.
But when that treatment or program may
have beneficial effects, persons assigned to
the no-treatment control may feel their rights
to equal access to services are being
curtailed.
 Even when clear ethical standards and principles
exist, there will be times when the need to do
accurate research runs up against the rights of
potential participants. No set of standards can
possibly anticipate every ethical circumstance.
Furthermore, there needs to be a procedure that
assures that researchers will consider all relevant
ethical issues in formulating research plans.
 Who will be responsible to make sure the research
carried out is procedurally appropriate, properly
designed and does not infringe on the rights of the
participants?
INSTITUTIONAL REVIEW BOARD
To address such needs most institutions and
organizations have formulated an Institutional
Review Board (IRB), a panel of persons who
reviews grant proposals with respect to ethical
implications and decides whether additional
actions need to be taken to assure the safety
and rights of participants.
By reviewing proposals for research, IRBs also

help to protect both the organization and the
researcher against potential legal implications of
neglecting to address important ethical issues of
participants.
 Ethics committees are advocates for those who take
part in research. Members are charged with ensuring
that research is understood and that individuals are
respected, that the risks and benefits for those
taking part are evaluated, and that the benefits may
subsequently be of value in the local setting. These
principles underlie various guidelines for the
protection of research subjects
 In UKM, an IRB ethics committee, comprising
members taken from the medical, dental, allied
health, pharmacy, legal, religious, statistics,
environmental and research community, meets once
a month on the 1st floor of the PPUKM Clinical
Block. This committee reviews all research projects
that have already been through scientific peer
review; only those judged scientifically sound are
passed.
Ethics Committee
Assessment of risks involves:

1. identifying any risks;
2. gauging their probability and severity;
3. assessing the extent to which they can
be minimized;
4. determining whether they are justified
by the potential benefits of the research;
5. determining how they can be managed.
6. how the research will be monitored;
7. provision of services to participants adversely
affected by the research;
8. contact details of a person to receive complaints;
19. how privacy and confidentiality will be protected;
10. the participant’s right to withdraw from further
participation at any stage, along with any
implications of withdrawal, and whether it will be
possible to withdraw data;
11. the amounts and sources of funding for the
research;
12. financial or other relevant declarations of
interests of researchers, sponsors or
institutions;
13. any payments to participants;
14. the likelihood and form of dissemination of the
research results, including publication;
15. any expected benefits to the wider community;
16. any other relevant information, including
research-specific information required.
 Clinical trials are usually scrutinized during the
Ethics Committee meeting. Often times, the
researchers have to defend their proposal by
presenting it orally in front of the Committee.
CLINICAL TRIALS
 A 'clinical trial' is the name commonly given to

research in which a therapeutic, preventive or
diagnostic intervention is tested. Clinical trials are
conducted in accordance with ethical guidelines and
in certain circumstances in accordance with
legislation
World Health Organisation
Definition
 According to the World Health Organisation (WHO),

a clinical trial is ' Any research project that
prospectively assigns human participants or groups
to one or more health-related interventions to
evaluate the effects on health outcomes.'
GOSH, HUMAN AS GUINEA PIG
IS THE WRONG THING, MAN!
Thank You
Norhayati Mohd Zain
• Research refers to a search for knowledge
• Research means a scientific and systematic
search for pertinent information on a specific
topic
• In fact, research is an art of scientific
investigation.
• The purpose of research is to discover answers
to questions through the application of
scientific procedures
• Any Medical • Writing a research
research / Epidemiological proposal is both science
study should have a proper and art.
proposal in written form
before it is actually carried • A good research proposal
out. is based on scientific facts
and on the art of clear
• It is like a blue print of a communication.
building plan before the
construction starts.
• Research title
Writing a formal research • Abstract
proposal should be started • Introduction
by the time one has - Background Research question
decided on the topic for the - Research objective(s)
study. - Hypothesis
- Significance/importance of the
study
- Review of literature
• Methodology
• Time frame and work
schedule/Gantt chart
• Personnel needed / available
• Facilities needed / available
• References
• Normally not more than • Be specific.
15 words.
• Avoid abbreviations,
• Brief phrase describing or prepositions and
reflecting the contents of formulae where possible.
the research.
• Concise and informative.
• Attract the reader’s

attention.
• Introduction- importance of • Results – What is the
your work, the difficulty of answer/findings.
the area, the impact it
might have if successful.
• Problem statement – what
• Conclusion – What are
problem are you trying to the implication of your
solve. What is the scope of answer.
your work.
• Approach - How did you go
about solving or making
progress on the problem.
Did you use simulation,
analytical model or
prototype construction.
What important variables
did you control, ignore or
measure.
Abstract
introduction
Study case
Approach
Results
7
Abstract
The abstract is too long.

Abstract
One page is sufficient

• The problem proposed to • Introduction should be
be studied is introduced in short about one or two
this section. pages.
• It should help the reader to • The problem should be

acquaint with the topic . stated in such a way that
it’s importance and
relevance is realized by
any one who reads it.
• First Stage: general • Third Stage: Statements
statements about a field of that indicate the need for
research to provide the more investigation.
reader with a setting for (Research gap/novelty of
the problem to be the study).
reported.
• Fourth Stage: Very
• Second Stage: More specific statements giving
specific statements about the purpose/objectives of
the aspects of the problem the writer’s study.
already studies by other
researchers. (literature • Fifth stage: Significant of
review) the study.
• This is a very important • Too many objectives to be
and pivotal section and avoided.
everything else in the
study is centered around
• Even just one clearly
it.
stated relevant objective
for a study would be good
• The objective of the enough.
proposed study should be
stated very clearly.
• If there is more than one
• The objective stated objective the objectives
should be specific, can be presented in the
achievable and appropriate order of
measurable importance.
• Hypotheses are more • Refers to the rationale for
specific predictions about the research, or the reason
the nature and direction of why the research is being
the relationship between conducted, including an
two variables. explanation for the design
and methods employed in
• Hypothesis is a source of the research.
questions focused to the
core of the research
problem.
• Answers to the questions

may support (verify) or
reject (phalsify) formulated
hypothesis.
• This section reflects
• It is important to make it
extensive review of
coherent, relevant and
literature done by the
easily readable knowledge.
investigator.
• It helps the investigator to

• In this section what is
gain good knowledge in
already known about the
that field of inquiry.
topic is written including
the lacunae.
• It also helps the
investigator to have insight
• Just quoting the literature
on different methodologies
verbatim will not serve
that could be applied.
the purpose.
• Research methodology is a
way to systematically solve the
• It is essential to discuss
research problem. It may be procedures clearly and
understood as a science of completely with
studying how research is done
scientifically
considerable amount of
details.
• It is necessary for the
researcher to know not only  Study design
the research methods or
techniques but also the  Study population /
methodology. Sampling specifications
 Sample size needed
• Researchers not only need to
know how to develop certain  Instrumentation
indices or tests and how to  Specific procedures
calculate the mean, the mode,
the median or the standard
deviation or chi-square etc.,
Definition: A study design is a
specific plan or protocol for
• It is important to describe
conducting the study, which
which would be the study
allows the investigator to population.
translate the conceptual
•
hypothesis into an operational
• How study subjects would
one.
be selected, randomization
process and other details
• The study design should be • should be given.
clearly stated.
• The study design to be
used should be appropriate
for achieving the objective
of the study.
• It is important to mention • Proposal should include the
in the protocol what would details of all process to be
be the number of sample adopted in the study.
required and how it is
arrived. • A brief description of how the
data will be processed.
• Important to mention in
the protocol how it is • A flow chart of the process.
arrived. • How exposures, outcome
variables and other variables
are going to be measured
should be described in detail.
• What statistical tests of
significance would be used?
The proposal should include The proposal should also
the sequence of tasks to be include the important facilities
performed, the anticipated required / available for the
length of time required for its study namely computers,
completion and the personnel laboratories, special
required. equipment etc.
Carta Gantt
Designing Questionnaire for
Survey Research
Norhayati Mohd Zain

1. What is a questionnaire?
2. How do we get information?
3. 5 steps in designing questionnaires.
4. Kinds of information in a questionnaire.
5. Errors in response
6. Question types
7. Validity & reliability of questionnaire
8. Piloting your questionnaire
9. Likert scale
What is a Questionnaire?
A tool for collecting information. Questionnaire

describes, compares, or explains knowledge,
attitude and practice of a particular group of
people.
Questionnaire designing is a step in a survey
project to get information.
How do we get information?
• Literature search (books, IT)

• Talking and listening to people (lectures,
seminars, conferences, TV, radio, videos)
• Surveys (personal interview, telephone survey,
mail survey, email survey)
“Questionnaires are used in surveys”

Personal Interview
Advantages
Interviewer and interview
are “face to face” and
clarification can be thereon.
Easy to find a target population.
Disadvantages
Interviewer has to travel
(cost & time)
May create non-representative
samples
Telephone interview survey
Advantages
People can be contacted faster.
Can obtain complete answer compared to
mail survey.
Disadvantages
Limited calling time (window 6-9 pm).
People are reluctant to answer phone
survey.
Mail Survey
Advantages
Least expensive.
Allow respondent to answer at leisure
time.
Disadvantages
Waiting time can take weeks or months.
Response can be low due to illiteracy.
E-mail Survey
Advantages
Speed.
Not much cost involved.
Disadvantages
Have to purchase e-mail addresses.
Cannot generalize findings to whole
population.
5 STEPS TO DESIGNING
QUESTIONNAIRES
• 1. Defining the objectives of the survey.
• 2. Determining the sampling group.
• 3. Writing the questionnaire.
• 4. Administering the questionnaire.
• 5. Interpretation of the results.
QUIESTIONNAIRE DESIGN
- general consideration
• Most problems are due to not well defined goals.
• Questionnaires is developed to directly address
goals (objectives) of the survey.
• Goals are developed depending on what you
intend to do with the information to be obtained.
KISS
“Keep It Short and Simple”.
Long questionnaires get less response than short

ones.
STATISTICAL DATA ANALYSIS
• Formulate a plan for doing statistical analysis

during the design stage of the project.
• Know how every question is to be analysed.
“ If you do not know or cannot specify how to

analyse the data from the question, do not write
the question!”
QUESTIONNAIRE PREPARATION
• Start with a well written cover letter. Start with an

introduction or welcome message.
• Have a title for the questionnaire.
• Include a clear and concise illustration on how to
complete the questionnaire.
• Begin with a few non-threatening and interesting
item.
• Use simple language.
Cont……
• Allow a “Don’t know” or “Not applicable”
response to all questions, except for those you
are sure the respondents will have clear answer.
• Place the most important items in the first half of
the questionnaire.
• Group items in coherent categories.
• Include a self-addressed, stamped envelope.
IT IS IMPORTANT THAT YOU……
Do a PILOT study (preferably representing the

target population). If possible, be present with
the respondent (during the pilot study).
have a respondent ID number.

Kinds of Information in a
Questionnaire
1. Factual
2. Knowledge
3. Opinions & Attitudes
4. Practice (Behavior)
Factual
1. Personal Characteristics
age
sex
salary per year
education
Knowledge
• Concern is not to put the respondent on the spot

or force him to give contradictory answer.
• Try to avoid informing the respondent during the
course of the interview and testing him on this
new knowledge.
Opinions
What people think about some issues or

problems at a given point in time.
Attitude
An opinion on a single dimension of a topic is not predictive
of any action in that direction.
Opinions on a variety of dimensions of a topic provide
better indicator, and collectively can be considered a
measure of the “attitude” or “disposition to act” in a
certain way. Results should be interpreted with caution if
they are to be used to estimate how he will actually
behave.
These “sets of questions” are usually called scales.
Caution: Scales which work on one population do not
necessarily work on another so caution should be taken
in lifting a scale from one study to be applied to another.
Awareness
• Tests public awareness and recognition of

services, policies, information and publicity
material eg, did you know that the library is now
open evenings and weekends?
Questions Wording
Avoid questions that are insufficiently specific.
Are you satisfied with the core
curriculum at KPJUC? The answer would not be
useful. Consider the dimensions: content,
hours.
Use simple language. Use the most common term

for clarity of meaning but not slang terms and
never poor usage.
Avoid ambiguity. Example: Are you making poor
grades because needed reference works are
not available in the library?
Avoid vague words. Example: sometimes, often,

rarely..
How many alcohol did you drink during past week?
A. none B. a few C. Several D. Many
A. Zero B. 1-5 C. 6-10 D. 11-20 E. >20
Avoid presuming questions: How many
cigarettes do you smoke in a day? Before
finding out whether or not the respondent
smokes.
Avoid hypothetical questions: Would you have
your chest x-ray annually if this service were
provided free by the student health service?
Questions involving memory.
often need for suggested reference for
recall (possible face-to-face interview sessions).
diary methods – to be used when there
is no other way to get the information; limitations
are to be kept in mind: high rate of incompletion
or non-response, failure of respondents to follow
instructions, need for follow-up visits.
Errors in Response
1. Failure of memory.
2. Guessing, made necessary through lack of
records.
3. Unwillingness to give right answer.
4. Refusal to give any answer.
5. Failure to understand the question.
6. Wrong answers arising from pride, called
“prestige bias” upgrades education,
upgrades income
QUESTION TYPES
• Multiple choice
• Numeric open end
• Text open end
• Rating scales
• Agreement scales
MULTIPLE CHOICE
1. Which academic program do you belong?

□ Biomedical Science
□ Nutrition
□ Dentistry
□ Optometry
Numeric Open End
1. How much do you spend buying book this

year? RM____________
Text Open End
1. How can KTSN student housing department

improve its service to the student community?
_____________________________________
_____________________________________
________________________
________________________________
Rating Scales (Close end)
1. How do you rate your academic programme?

□ Excellent
□ Good
□ Fair
□ Poor
Rating Scales (Close end)
1. On a scale where 5 is excellent and 1 as poor,
how would you rate your interest in the
following courses?
English _____
Pathology _____
Anatomy _____
Applied Biostatistics _____
Agreement Scale (Close end)
1. How do you agree with the following

statements?
Agree Disagree Don’t
know
Students in FSK are hard working

Lecturers in FSK are always boring
Examples of formats for presenting questionnaire items
Boynton, P. M et al. BMJ 2004;328:1312-1315

Copyright ©2004 BMJ Publishing Group Ltd.
Qualities of Good Questions
1. Evokes the truth.

2. Questions must be non-threatening.
3. Anonymity is important.
4. Confidentiality.
A good question can accommodate all
possible answers
• Asking a question that does not accommodate

all possible responses can confuse and frustrate
respondents!
What brand of computer do you
have?
IBM PC □
Apple □
…or
Do you own an IBM PC? (Circle: Yes / No)
Do you own an Apple computer

(Circle: Yes / No
Or….. Provide more information than
previous questions
Do you own a computer? (Tick one or more)
IBM PC □
Apple □
Do not own a computer □
Other brands (state your brand)
_________
FOLLOW COMFORTABLY FROM
PREVIOUS QUESTIONS
• Group similar questions

• Transition of question should be smooth
Questionnaire Development
Measuring Validity & Reliability
Definition of Validity
 Instrument measures what it is intended to

measure:
 Appropriate
 Meaningful
 Useful
 Enables a performance analyst or evaluator
to draw correct conclusions
Types of Validity
Face
Content
Criterion
Concurrent
Predictive
Construct
Face Validity
• It looks OK
• Looks to measure what
it is supposed to
measure
• Look at items for
appropriateness
– Client
– Sample respondents
• Least scientific validity
measure
Looks Good To Me
Content-Related Validity
• Organized review of
format and content of
Balance instrument
– Comprehensiveness
– Adequate number of
questions per objective
– No voids in content
Definition Sample Content Format • By subject matter
experts
Criterion-Related Validity
Subject Instrument A Instrument B • How one measure

Task Observation
stacks-up against
another
Inventory Checklist
John yes no – Concurrent = at same
time
Mary no no
– Predictive = now and
Lee yes no future
Pat no no • Independent sources
Jim yes yes that measure same
Scott yes yes phenomena
Jill no yes
• Seeking a high
Usually expressed as a correlation coefficient correlation
(0.70 or higher is generally accepted as
representing good validity)
Construct-Related Validity
• A theory exists explaining

Prediction 1 - Confirmed
how the concept being
measured relates to other
T
H
concepts
Prediction 2 - Confirmed
E • Look for positive or
O
R negative correlation
Y Prediction 3 - Confirmed • Often over time and in
multiple settings
Usually expressed as a correlation
Prediction n - Confirmed coefficient (0.70 or higher is generally
accepted as representing good validity)
Definition of Reliability
 The degree to which measures obtained with an

instrument are consistent measures of what the
instrument is intended to measure
 Sources of error
 Random error = unpredictable error which is primarily
affected by sampling techniques
 Select more representative samples
 Select larger samples
 Measurement error = performance of instrument
Types of Reliability
Test-Retest
Equivalent Forms
Internal Consistency
Split-Half Approach
Kuder-Richardson Approach
Cronbach Alpha Approach
Test-Retest Reliability
• Administer the same instrument twice to the same

exact group after a time interval has elapsed.
• Calculate a reliability coefficient (r) to indicate the
relationship between the two sets of scores.
– r of+.51 to +.75 moderate to good
– r over +.75 = very good to excellent
TIME
Equivalent Forms Reliability
• Also called alternate or parallel forms

• Instruments administered to same group at same time
• Vary:
Response Set: Stem:
-- Order -- Order
-- Wording -- Wording
• Calculate a reliability coefficient (r) to indicate the relationship

between the two sets of scores.
– r of+.51 to +.75 moderate to good
– r over +.75 = very good to excellent
Internal Consistency Reliability
Split-Half Kuder-Richardson (KR)

 Break instrument or sub-  Treats instrument as
parts in ½ -- like two whole
instruments
 Correlate scores on the  Compares variance of
two halves total scores and sum
of item variances
Best to consult statistics book and
Cronbach Alpha
consultant and use computer software  Like KR approach
to do the calculations for these tests
 Data scaled or ranked
Reliability and Validity
So Fair Fair Good Good

unreliable reliability reliability reliability reliability
as to be and fair but invalid but invalid and good
invalid validity validity
The bulls-eye in each target represents the information that is desired.

Each dot represents a separate score obtained with the instrument. A
dot in the bulls-eye indicates that the information obtained (the score)
is the information the analyst or evaluator desires.
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Problem Statement and

By, Khairiah Abdul Hamid

Content Defining the problem

Techniques involved in defining

• A well-written problem statement defines the problem and helps

Your goal is to make the readers understand the research gap

Statement of the • Evidence of an existing trend that

‘Why does this topic warrant an

‘What drives the investigation?’

Purpose of the Study

!Must be introduced so that the reader can relate to it

Sources: research databases, journals, reference books,

Introduced in the Identify an issue:

Research Problem • An educational issue / a problem in the study

Research Topic • Broad subject matter being addressed in a study

Study Purpose • Major intent / objectives of the study

• Question the researcher would like answered /

In an existing research articles, the opening paragraphs will address:

The feasibility to conduct a research, based on the identified

Feasibility • Equipment and facility space

Will the study inform / warrant practice?

• What do we still need to know?

‘Who will profit from reading this study?’

• ‘It is known that …’

BMI3213 Research Methodology

BMI3213 Research Methodology

BMI3213 Research Methodology

BMI3213 Research Methodology

BMI3213 Research Methodology

BMI3213 Research Methodology

BMI3213 Research Methodology

Poor study design

Potential futile situation

Ruin the chance of acquiring clinical significance

Developed from RQ, ‘a declarative statement about nature of

Purpose? To make an inference about the population of interest on

Should be stated at beginning of study to guide research objectives

Makes a prediction of the expected outcome in a given situation

‘With extraneous variable kept constant, how does manipulation of

Defines the specific aims of the study

An active statement about how the study is

Should be clear, measurable & accurate

Stated at the beginning of the study

BMI3213 Research Methodology

BMI3213 Research Methodology

Enhance the body of professional knowledge

Provide foundation for evidence-based practices

For expansion of knowledge for continuation of growth

BMI3213 Research Methodology

Refine & eliminate old knowledge that

Identify cost-effective approach to

BMI3213 Research Methodology

BMI3213 Research Methodology

4. Control variable is a factor kept constant throughout the

BMI3213 Research Methodology

BMI3213 Research Methodology

The researcher poses several

What new questions / observations that

Are you trying to imply the effectiveness of

What is a Research Question?

• e.g. female / male, age categories, BMI group

• e.g. college education

Characteristics Data is analysed using