Research - II
SYSTEMATIC
Because there is a definite set of
procedures and steps which you will
follow.
There are certain things in the
research process which are always
done in order to get the most
accurate results.
Research - III
ORGANIZED
in that there is a structure or
method in going about doing
research.
It is a planned procedure, not
a spontaneous one. It is
focused and limited to a
specific scope.
Research - IV
FINDING ANSWERS
is the end of all research.
Whether it is the answer to a
hypothesis or even a simple
question, research is successful
when we find answers
Sometimes the answer is no, but
it is still an answer.
Research - V
QUESTIONS
Are central to research. If there
is no question, then the answer
is of no use
Research is focused on relevant,
useful, and important questions
Without a question, research
has no focus, drive, or purpose.
Research - VI
It is an attempt by careful enquiry,
experimentation, study,
observation, analysis and
recording to:
discover new facts, knowledge
and information,
develop new interpretations of
facts, knowledge or information,
or discover new means of
applying existing knowledge.
Types of Research
Disciplinary research (focus on
Theory)
Biomedical Research (focus on
Organisms)
Clinical Research (focus on
Individuals)
Health Services Research (focus on
Systems)
Public Health Research (focus on
Community)
Basic (Primary) Research
A theoretical or
experimental investigation
to advance scientific
knowledge where
immediate practical
application is not a direct
objective.
Quality Research
Quality of any research study
depends on how well both
design and execution phases of
the project are accomplished.
There is a positive relationship
between the research protocol
and overall quality and
acceptance of the resulting
research study
Components of a Research Protocol
A descriptive title
The name, titles, degrees,
addresses and affiliations of the
investigators and co-investigators
Introduction & Background
Literature review
Justification/ Rationale
Study objective and /or research
questions
The Components of Protocol-II
Study Methodology
Study population and its
recruitment
Study design
Study setting
Study duration
Components (contd.)
Sample size determination
Sampling strategy
Variable list
Methods of data collection
Data collection tools
Plan of Analysis
The components (contd.)
Ethical considerations & humane
subject protection
Quality control
Expected benefits from the study
Operational plan & budgeting
Plan of dissemination of results
References
Biographical information on
investigator and institution
Study Title
It should be brief and
explanatory.
Better to include type of study
and setting.
Like `A case-control study of
risk factors of acute hepatitis
B in Al-Qassim`.
Introduction & Background
Relevant details about
the problem.
The pathophysiology of
the disease, global
burden, similar settings
and then local (if
available)
Literature Review
A description about what other
in this field in other countries
and in your country has done.
Literature review should be in
depth to identify potential
cofounders and effect
modifiers and to determine the
areas in which knowledge is
needed.
Study Objective/Research Question
It should identify the
immediate purpose of study
and be very clear.
Objective always start with
`to` (word of accomplishment)
Like `To identify the risk
factors of acute Hepatitis B in
Qassim`
Research Question
The Research Question is
expressed in ideas & concepts
Research Design is the plan of
how the research will be carried
out
Hypothesis: sets of ideas or
concepts
Question comes as a flash of
inspiration; or may arise from
routine observed events
Exploring the Question
Having identified a Question
Investigate the Background of
question
Has someone else had a go at
answering it
Is the answer known
Has someone formulated it in a
better way
Sample Questions
Do Non-Steroidal anti-inflammatory
agents cause cancer
Are patients who complain of
dizziness likely to suffer from a
serious disease
Is Asthma more common in only
children
Is there an association between H.
Pylori and Coronary artery disease
Design
What you want to do, how you are
going to recruit subject, & how
to follow :
Randomized controlled clinical trial
Cohort Study
Case Control Study
Cross-sectional Study
Case series
Case reports
Study population & its recruitment
Description of study
population
Inclusion and exclusion
criteria (Exclusion criteria
apply after those who are
included in study).
Study Setting
Description of the setting whether
it is a community or a hospital
In case of hospital what are the
important characteristic of
this/these hospital which type of
patient visit this; what is its
catchment area, how big it is and
what diagnostic and treatment
facilities it have. Is it a special
centre for some specific disease.
Sampling strategy
How sampling will be
done; whether is random
(type of random sampling)
or convenient sampling.
How cases and controls
will be identified.
Methods of Data Collection
What method you are going to
apply as records, questionnaire
and in person interview, mailed
questionnaire etc
What test you are applying and
what is reason for applying this
test.
Specificity & sensitivity of the
test, if some new test is to be
applied.
Plan of analysis
How you are going to analyze your
data. For what you are looking for
and which statistical method will
apply.
Whether you run descriptive
analysis or go for hypothesis
testing and may be multivariate
analysis.
It is better to get help from
biostatistician for sample size and
data analysis.
Other Considerations
Expected benefits from the study
Who will and how benefit from the study
Operational plan & budgeting
Detail time line and budget for the study
Plan of dissemination of results
How the findings will be shared
with others: presentations, publishing
results in journal etc.
Dissemination of Results
How the findings will be
shared with others
presentations,
publishing results in
journal etc.
STEP 1
Statement of :
What is bothering you or what are you
interested in
An idea that needs to be verified
A problem that needs to be solved
A technique that needs improvement
A hypothesis that needs to be proved
A solution that needs to be bettered
A gap in knowledge that needs to be
filled
STEP 2
Review of literature
What has been written or done on the
subject
Helps you understand your concern /
questions better
Tells you how other people have done
the study
Also tells you what the results of other
studies were
If review already answers your
question (s) then you may not need to
do the study on this subject
STEP 3
Defining the objectives
precisely and concisely
in the light of what has
been done or what is
known (literature
review)
STEP 5
What is the hypothesis (statement
of belief)?
Are you seeking a hypothesis by
trying to find a relationship
between many variables or are
you testing a hypothesis?
Your study question or
hypothesis will determine the
methodology including the study
design
STEP 6
Determine the importance of the
study
Rationale of the study….why do
you want to do the study
How will your study benefit
New discovery?
Add to existing knowledge?
Improve services?
STEP 7
Develop a detail methodology in
consultation with a statistician and
other disciplines you plan to use
Where……site of study
What……..study subjects
When…….Sequence of work
How
Study design
Data collection instrument
Data collection methods
Data analysis method
Quality check of data collected
STEP 8
Can valid conclusions be drawn by
the methods you plan to use?
In other words, what is the validity of
the measuring instruments/methods?
Is the number of subjects,
observations statistically adequate
and is the method of sampling used
correct
Has all the possible effort been made
to remove / reduce bias in the
designing and sampling of the study?
STEP 9
Determine the feasibility of the study
Can the study be done
In the time available
In the resources available
Will it require help from other
disciplines (laboratory, radiology,
medical records dept etc)…..will this
help be available
Will you require help to gain
permission from other sources….will
permission be given etc etc