Research Methodology

- an overview
Dr. Biju George
Asst. Professor
Dept of Community Medicine
Research Methodology
What is Research
It is the systematic process of collecting
and analyzing information (data) in order
to increase our knowledge regarding a
particular topic.
Why we need to excel in this
NATURE OF SCIENTIFIC RESEARCH
Systematic enquiry and accumulation of
evidence leading to new knowledge
Meticulous experimentation and recording
of new facts
Observations and systematisation of facts
Analysis of facts and formulation of new
theories
SCIENTIFIC METHOD
Objective observation
Logical reasoning
Formulation of hypothesis fitting the data
Predict other possibilities
Repeat the experiments
HISTORY OF MEDICAL RESEARCH
I7th century
William Harvey and circulation
Thomas Sydenham and clinical observations
18
th
century
James Lynd and lime treatment of Scurvy
Edward Jenner and Vaccination
19
th
century
Claude Bernard and physiology
Louis Pasteur and microboiology
Robert Koch and tuberculosis
TYPES OF MEDICAL RESEARCH
Basic research
Applied research
Descriptive
Analytical
Quantitative research
Qualitative research
MEDICAL RESEARCH IN THE
NEW MILLENNIUM
The age of molecular medicine?
Unique confluence of molecular biology and
information technology
Emergence of a biotechnology revolution
Characteristics of Research
+Directed towards thesolutionof a problem.
+Based upon observable experience or empirical
evidence.
+Demands accurate observation and description.
+Involves gathering new datafrom primary
sources or using existing datafor a new purpose.
+Activities are characterized by carefully designed
procedures.
+Requires expertisei.e., skill necessary to
carryout investigation, search the related literature
and to understand and analyze the data gathered.
Characteristics of Research
+It is objective and logical applying every
possible test to validate the data collected and
conclusions reached.
+Involves the quest for answers to unsolved
problems.
+It requires courage.
+It is characterized by patient and unhurried
activity.
+It is carefullyrecorded and reported.
1 Purpose clearly defined.
1 Research process detailed.
1 Research design thoroughly planned.
1 High ethical standards applied.
1 Limitations frankly revealed.
1 Adequate analysis for decision makers needs.
1 Findings presented unambiguously.
1 Conclusions justified.
1 Researchers experience reflected.
CRITERIA OF A GOOD RESEARCH
WHY DO RESEARCH ?
Excitement of making new discoveries
Driven by passion
In search of recognition
Publish and succeed
BENEFITS FROM RESEARCH
Develops a critical attitude
Chance to study subject in depth
Learns to use the library/ WWW
Develops critical faculty
Acquires special skills and interests
Makes friends and learns from others
Leads to higher degree
PROBLEMS IN RESEARCH
Uncontrollable variables
Human tendencies
Time and money
Lack of computer skills
Lack of scientific training in the methodology of
research
Insufficient interaction between research institutions and
peripheral institutions
Lack of code of conduct
Poor library management and functioning
Difficulty of timely availability of published data.
Ignorance
Research for the sake of research.
Basic steps of doing a
research
Find a topic
Formulate questions
Define population
Select design & measurement
Gather evidence
Interpret evidence
Tell about what you did and found out
RESEARCH PROCESS
Define
Research
Problem
Review
Concepts
And
theories
Review
Previous
Research
findings
Formulate
hypothesis
Design
Research
(Including
Sample
Design)
Collect
Data
(Execution)
Analyse
Data
(Test
Hypothesis
if any)
Interpret
and
report
I
II
III
IV
V
VI
VII
STEP-1
Research problem
What is a research problem?
+ The term problem means a question or issue
to be examined.
+ Research Problem refers to some difficulty
/need which a researcher experiences in the
context of either theoretical or practical
situation and wants to obtain a solution for the
same.
How do we identify research
problem?
^Patient complaints
^ Conversation with other health professionals
^Relevant reading of published material
^ Health records and reports.
The first step in the research process
definition of the problem involves
two activities:
Identification / Selection of the
Problem
Formulation of the Problem
Identification / selection of the
research problem
This step involves identification of a
few problems and selection of one out of
them, after evaluating the alternatives
against certain selection criteria.
Sources of problems
Reading
Academic Experience
Daily Experience
Exposure to Field Situations
Consultations
Brainstorming
Research
Intuition
Definition / formulation of the
research problem
Formulation is the process of refining the
research ideas into research questions and
objectives.
Converting the selected research
problem/topic/idea into a scientifically
researchable question. It is concerned with
specifying exactly what the research problem
is.
There are two ways of stating a problem:
1) Posting question / Research Question
2) Making declarative statement / Objective
STEP-2
REVIEW OF LITERATURE
+Literature Review is the documentation of a
comprehensive review of the published and
unpublished work from secondary sources of data in
the areas of specific interest to the researcher.
+The main aim is to find out problems that are already
investigated and those that need further investigation.
REVIEW OF LITERATURE
+It is an extensive survey of all available past studies
relevant to the field of investigation.
+It gives us knowledge about what others have found
out in the related field of study and how they have
done so.
PURPOSE OF REVIEW
=To gain a background knowledge of the research
topic.
=To identify the concepts relating to it, potential
relationships between them and to formulate
researchable hypothesis.
=To identify appropriate methodology, research design,
methods of measuring and techniques of analysis.
=To identify data sources used by other researchers.
=To learn how others structured their reports.
How to conduct the Literature
Survey?
4Identify the relevant sources.
4Extract and Record relevant information.
4Write-up the Literature Review.
SOURCES OF LITERATURE
* Books and J ournals
* Electronic Databases
Bibliographic Databases
Pubmed
Google scholar
Abstract Databases
Full-Text Databases
* Govt. and agency Reports
* Research Dissertations / Thesis
STEP-3
HYPOTHESIS
A hypothesis is an assumption about relations
between variables.
Hypothesis can be defined as a logically conjectured
relationship between two or more variables
expressed in the form of a testable statement.
Relationships are conjectured on the basis of the
network of associations established in the theoretical
framework formulated for the research study.
STEP- 4
1Research Design is the framework or blueprint
for collecting the information needed for your
research in the best possible way.
1Research Design is the conceptual structurewithin
which research is conducted; it constitutes the
blueprint for the collection, measurement and
analysis of data.
FUNCTIONS OF RESEARCH
DESIGN
Three important functions of research design are:
+It provides blueprint.
+It limits boundaries of research activity.
+It enables investigation to anticipate potential
problems.
FEATURES OF A GOOD RESEARCH
DESIGN
-It should be flexible.
-It should be appropriate.
-It should be efficient.
-It should be economical.
-It should minimize bias.
-It should maximize the reliability of data collected.
-It should give the smallest experimental error.
Classification of Study Designs
Source: Grimes DA, Schulz KF. Lancet 2002; 359: 58
Experimental designs
Two or more than 2 groups
One group Standard treatment/
Placebo
Other group(s)- New treatment
Decision of treatment type depend
on the investigators
Randomized controlled trial
Controlled- since control groups
and biases are controlled
Randomized- process to reduce
selection bias and ensure
comparability between group
Randomization by
Coin tossing, dice
Random tables
Random number generators
Randomized controlled trial
Cohort design
Cohort- group with same
characters
One or more group followed over
time
Incidence of outcome in the
group(s) are noted and compared
Relative risk is calculated
Cohort design
Case control design
Start from effect to cause
Group of people with outcome and
group of people without outcome
are compared.
Exposure factor in each group is
analyzed and compared.
Calculate the odds ratio
Case control design
Descriptive Studies
Study of the occurrence and
distribution of disease
In Terms of
Cross sectional studies
Cross-Sectional studies
Describes prevalence
Measure the character under study
in the population at the point of
examination
Can measure cause and effect at
the same time. But causal relation
may be biased
Case series and case study
Description of a series of cases.
With summarization of the
characters in the study group
Case study description of a single
case of unusual importance.
STEP- 5
DATA COLLECTION
The task of data collection begins after the research problem
has been defined and research design has been developed.
While deciding the method of data collection to be used for
the study, the researcher should keep in mind two types of
data viz., primary and secondary.
The primary dataare those which are collected afresh and for
the first time and thus happen to be original in character.
The secondary dataare those which have already been
collected by someone else and which have already been
passed through the statistical process.
METHODS OF COLLECTING
PRIMARY DATA
Observation
Questionnaire
Schedule
Measurements
METHODS OF COLLECTING
SECONDARY DATA
;Secondary data may either be publishedor
unpublisheddata.
1. OBSERVATION METHOD
Observations are a way to collect information by watching
participants or activities in action.
The information obtained under this method relates to what
is currently happening, which is collected by way of
investigators own direct observation without asking from
the respondent.
METHODS OF COLLECTING PRIMARY
DATA
OBSERVATION METHOD
Types of observations
-Structured vs Unstructured observation
-Participant vs Non-participant observation
-Disguised vs Non-disguised observation
2. Interview method
Interview is a face-to-face interaction between
two or more persons for a particular purpose.
3. Questionnaire method
Prepared questionnaire given to participants and
asked to fill.
3. Measurements
For eg Hb, FBS, BMI
STEP- 6
Analytic methods
Depend on the objective and
variables under study
May need some statistical
background to understand higher
level analytic methods
Statistical software make life easy
Analytic methods
Descriptive methods
Mean + SD, Median + IQR
Proportion
Comparative methods
Chi square test
t test
ANOVA
Modeling methods
Regressions
STEP- 7
Interpret and report writing
Write the results in the simplest
form
Results discussed in the context of
known information from other study
Try to place your result in the
context of current information
Keep In Mind That
No study is perfect
Measurement involves making
choices
Be Critical About Numbers
Every statistic is a way of summarizing
complex information into relatively
simple numbers.
How did the researchers arrive at these
numbers?
How was the number produced and
what is their bias?
How was the key terms be defined & are
they different from standard one and
how this can affect results?
Be Critical About Numbers
How was the measurement made, is
their any better way?
What type of sample was gathered &
how does that affect result?
Is the statistical result interpreted
correctly?
If comparisons are made, are they
appropriate?
Are there any other competing reasons
for the obtained results?
Getting Started
Read to learn; read to analyze
About research methodology
Studies on similar topics
Interesting studies
Getting Started
Forge partnerships
At some point you will need to
leave the comfort zone of reading
and literature gathering and
Data Documentation in
Clinical Studies
Need to document
Without documentation no one
believes
Accurate Results
Re analysis
Legal issues
Data Documentation in
Clinical Studies
Things to document (compulsory)
Consent form
Clinical data sheet
Patient information form

Data Documentation in
Clinical Studies
Consent form
Voluntary
Fully informed
Written

Data Documentation in
Clinical Studies
Consent should contain
Title of the work
Name of investigators
Affiliated institution
Contact address of investigators
What they need to do
What all invasive procedures
Expected benefits and harm
Data Documentation in
Clinical Studies
Signed Consent form
Has to be kept even after
completion of research / publication
10 yrs
Data Documentation in
Clinical Studies
Clinical data sheet
Questionnaire / schedule
Careful Preparation
Entry in to form
Data entry in to software
Data Documentation in
Clinical Studies
Data entry
General software Excel
Specialized software SPSS, Epi
info
Excell
First row for variable name
Enter one subjects information in a row
As far as possible numeric entry only
No need to enter units
Row wise From A -> XFD(~20,000)
Colum wise From 1 -> 10,48,576
Questions?