BASICS OF

RESEARCH METHODOLOGY

By
Dr. Sohail Saadat
Assistant Professor
DIKIOHS-DUHS
LEARNING OUTCOMES
After the course, the participants will be able to:
 Understand and appreciate better the scientific research methods

 Give a precise statement about a problem to be investigated and

about the objectives of research into the problem

 Frame pertinent hypotheses, which can then be tested by

scientific methods to produce valid and useful results

 Construct a research proposal by selecting and applying the

appropriate research design and methods

 Execute the research

 It is a document that explicitly states the
reasoning behind and the structure of a research
project.

 The aim of writing a protocol is to describe in

great detail the thinking behind the proposed
study and the exact methodology.
 It clarifies the research questions/topic
 It encourages you to plan the project
 It allows you and all involved to see the total process of
your project and to monitor its progress
 It acts as a reminder of the initial structure and aims of
the project
 It is necessary if you need to apply for funding or ethical
approval
 To ensure the study is well thought through an
adequately planned
 To allow the study to be evaluated for scientific and
ethical factors prior to starting
 To ensure that the investigators complete the study as
planned
 To allow others to complete the study for the original
investigator, If necessary
 To enable others to repeat the study
 Title
 Brief introduction/Background
 Aim and objectives
 Research design
 Methodology
 Sampling Technique
 Data collection method
 Data source
 Data analysis
 Timetable
 Ethics
 References
 A descriptive title is a very important feature of
the protocol
 The project title should be as short as possible.
 It should be focused
Dow University of Health
Sciences
COMMUNITY DENTISTRY
DEPARTMENT
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Protocol for
BDS Undergraduate Research
Group members
Batch year
 What previous research has been done
 What has been learned?
 What mistakes had been made?
 What was done well?
 What was done badly?
 Write the problem statement, showing an understanding
of the research phenomena and revealing your purpose.
 Showing importance of the research question
 Possible implication of the study result
The introduction is the part of the research
protocol that provides readers with the
background information for the research or a
brief description to introduce the area of the
proposed research of work.
 A review of the relevant literature showing the
work done previously in the area

 It should establish the need for the research and

indicate that the writer is knowledgeable about the
area.
 The literature review accomplishes several important
things.
 It shares with the reader the results of other studies that are
closely related to the study being reported.
 It relates a study to the larger, ongoing dialogue in the
literature about a topic, filling in gaps and extending prior
studies.
 It provides a framework for establishing the importance of
the study, as well as a benchmark for comparing the results
of a study with other findings.
 It “frames” the problem earlier identified.
 The aims of the study are the questions that are being
answered

 The objectives are the steps it is necessary to go through

to answer the questions

 The aims are extremely important, They should

be clear and most importantly, should not attempt
to answer too much.
 In descriptive studies, aims and objectives are
often sufficient. However in analytical studies it
is usually necessary to also formulate a
hypothesis
 Are carefully constructed statements about a phenomenon in
the population.

 Are often constructed and tested to identify causes of disease

and to explain the distribution of disease in populations.

 Are supposed to be formulated before the data has started to

be gathered.

 Types of Hypothesis:
 Null hypothesis (Ho)/ No relationship/ No difference
 Alternative hypothesis (HA)/ one that claims a difference
 In a clinical trial that has the aim of comparing
the caries preventive effectiveness of two tooth
pastes:

 The objectives should be to measure and compare

the caries increment in two groups of children
 There is difference in caries preventive
effectiveness of two tooth pastes.

 There is no difference in caries preventive

effectiveness of two tooth pastes
 The null hypothesis is used because it is
impossible to prove something, one can only
disprove an accepted hypothesis.

 Statistical tests are used to identify the chance of

the observed results occurring.
 This is a description of the conduct, data collection,
management and analysis of the research and should
be clearly described
 In a protocol, the methods should be stated in future
tense.
 Subheading include
 Study Design
 Sampling
 Sample size
 Data collection
 Data analysis
 The first important point is to choose an
appropriate study type
 •Cross-sectional
 Observational studies •Routinely collected data
*Descriptive studies •Case series
•Case report

*Analytical studies •Case control

•cohort

 Experimental or Interventional studies

*Randomized controlled trials
*Community trails
*Natural Experiments
* Systematic Reviews
 The second important point is to describe upon
the population that would be appropriate for the
study
 to consider whether and how a sample should be
drawn
Random Sampling Non-Random
Simple Random Sampling Sampling
Systematic Sampling Quota Sampling
Simple Stratified Sampling Purposive/Judgment
Cluster Sampling Sampling
Multi-Stage Sampling Snowball Sampling
Convenience
Sampling
 The aims choice of study design and selected
population or sample will provide information on
both the type of data and the frequency with
which they need to be collected

 Example: Two tooth paste effectiveness

comparison
 What is to be measured?
 The collected data should be Valid , Reliable and
unbiased.
 Valid means that the data measure something that
truly exists accurately
 Reliable means if measurements are taken at different
occasion the same answer is obtained
 Unbiased means neither the subject nor the examiner
influences the finding
Reliability includes:
 assessments of the same observer at

different times - INTRA-OBSERVER

RELIABILITY

assessments of different observers at the

same time - INTER-OBSERVER
RELIABILITY
Kappa is a widely used test of inter or
intra-observer agreement (or
reliability) which corrects for chance
agreement.
 Unbiased: neither the subject
nor the examiner influences
the finding
 Single blind Study: subjects
do not know whether they are
in the treatment group or not.
 Double blind study: Neither
the subject nor the
Researcher are aware.
 Cannot be described in protocol
 Conclusions should relate back to the aims and
objectives and not to other matters.
 A description of plans for protecting human
subjects (participants rights, safety and well
being) if appropriate
 Information about whether study subjects will be
placed at risk as a result of the study
 Under what circumstances informed consent will be
required
 Provision for maintaining confidentiality of
information on study subjects
 Satisfactory scientific design
 Information given is adequate and
comprehensible
 Proposed subjects are competent to give consent
 That the consent is voluntary
 Risks and benefits are fully explained
 Issues of confidentiality and data protection are
adequately handled.
 Project task, milestones and timeline briefly
described
 A chart with target dates for accomplishing key tasks
can help with scheduling the time needed to complete
the study report.
 The protocol should conclude with the references
in proper bibliographic format
 Vancouver a ‘numbered’ style, follows the rules
established by the International Committee Of
Medical Journal Editors