HOW TO WRITE A
RESEARCH
PROJECT?
Dr. Sayanti Bandyopadhyay
Senior Resident
Department of Community Medicine
IQ City Medical College & Hospital. Durgapur
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THE DEFINITION OF RESEARCH
⮚ A quest for knowledge through diligent search or investigation or
experimentation aimed at the discovery and interpretation of new
knowledge. (WHO 2001)
⮚ Searching for explanation of events, phenomena & relationships
⮚ What, how and why things occur?
⮚ What are the factors associated with a problem?
⮚ A systematic and scientific process
⮚ Planned, orderly and creative
⮚ Always leads to more questions
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Title of a study
• Title should be clear and informative
• Must be in SPICED format
• Should not contain any abbreviation like ICDS, WRA etc.
• Maximum length is 25 words [According to WBUHS guideline]
• Descriptive or neutral title is preferred for thesis
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Six elements of a good title:
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Example
“The Effect of Calcium and Vitamin D Supplementation in elderly with Low
Back Pain: A Randomized Controlled Trial in A Tertiary Care Hospital”
S- Tertiary care hospital
P- Elderly
S
P
I- Calcium and Vitamin D Supplementation
I
C- with low back pain C
E- The Effect E
D- Randomized Controlled Trial
D
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How anemic are our adolescent girls ? A study of IDA in West
Bengal .
Example of an improper title
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Objective
It is a concrete statement-
⮚Specifics the overall purpose of the study
⮚ Achievable, taking into consideration the available resources and
time
⮚ Mutually exclusive, with no repetitions or overlaps
⮚ Stated in action verbs that could be evaluated e.g. to enlist, to
identify, to measure, to compare, etc.
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SMART OBJECTIVE
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Action verbs for a good objective [Bloom’s Taxonomy]
Knowledge [Recollect Comprehension [revealing Evaluation [judging a programme
information] understanding of facts] systematically based on prefixed
criteria ]
Enlist Estimate Assess
Enumerate Classify Evaluate
Identify Explain Measure
To enlist the causes of iron To estimate the proportion To evaluate the status of IFA tablets
deficiency anemia among of IDA among WRA in a consumption among WRA in a
WRA in a village village village
Saha I, Paul B. Essentials of Biostatistics & Research Methodology. 3 rd ed. Kolkata, India: Academic Publishers; 2020. p. 200-41.
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Types of Objective
General objective is a broad statement of purpose reflecting the conditions one
wants to achieve at some future point of time.
Specific objectives are the specific steps of the research project encompassing
logical and well sequenced components.
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Types of Specific Objectives
• Objective directly linked to the research title is called primary objective
• The objective which are added to get some more information but not
directly linked to title is called secondary objective
✔Primary objectives 🡪 (bound to be achieved)
✔Secondary objectives 🡪 (incidental by products of the study)
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Example
• General Objective-
To determine vision related quality of life in patients with cataract
• Specific Objectives-
1. To measure quality of life in patients with visually disabling cataract
using the Indian Visual Function Questionnaire
2. To compare quality of life scores between patients with low vision and
those with blindness due to cataract
3. To compare quality of life scores between patients with low vision due
to cataract and those with low vision due to other causes
1& 2 - Primary objectives
3 – Secondary objective 12
Elements of an objective
• Activity : The description of the task aimed at, expressed by an appropriate
action verb
• Content : Specifies the subject in relation to which the task is to be
performed
• Condition : The circumstances in which the act must take place i.e., resources
supplied and restrictions applied
Saha I, Paul B. Essentials of Biostatistics & Research Methodology. 3 rd ed. Kolkata, India: Academic Publishers; 2020. p. 200-41.
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Example
Activity Content
To estimate the proportion of Iron Deficiency Anemia among
Women of reproductive age group in a village, Nadia.
Condition
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Background of the study
• Introduction
• Rationale / justification of the present study
• Gaps in existing knowledge, present status of problem
• Expected outcome from the present study
• Review of literature [ROL]
Introduction
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INTRODUCTION
⮚ Problem statement of the selected topic
⮚ Rationale and relevance of the research
⮚ The research questions should be written in the introduction
⮚ Expected outcome should be written here
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• At the beginning, there is considerable amount of general
information.
• Slowly, the focus narrows and the information becomes specific.
• Rationale is written at the end of introduction
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Example: A cross sectional study on assessment of iron deficiency
anemia among under five children in a rural area of Hooghly.
1st : Prevalence and problem statement in world
2nd : Prevalence and problem statement in India
3rd : Prevalence and problem statement in West Bengal and Hooghly
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Rationale of the study
• Generally the last part of introduction
• The necessity of the study in current scenario is stated here
• The justification of the study terms of knowledge gap, paucity of
studies etc. is discussed
• The ultimate importance of the study must be clear to all from
rationale part
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Review of literature
Proposal development
•Research need, rationale, justification, objectives etc.
Proposal writing
•For methodological issues like sample size, study tools, questionnaires, operational definitions
etc.
Data collection
•Study procedures, sampling technique, software etc.
Data analysis and Report writing
•Statistical analysis and discussion section for comparing with other studies.
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Literature Review: Must Include --
❑ What is the existing knowledge related to the topic?
❑ In what ways had the problem been approached by others [International,
national , local studies], and what were the results?
❑ What are the lacunae/gap in the existing knowledge?
❑ Different methodologies/intervention adopted by other researchers
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Importance of the ROL
Saha I, Paul B. Essentials of Biostatistics & Research Methodology. 3 rd ed. Kolkata, India: Academic Publishers; 2020. p. 200-41.
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Different types of literature available:
Three main types -
• Published / formal literature
• Grey literature
• Unpublished literature
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Materials and Methods
Study type Selection criteria
Study design Study tools and techniques
Study area Study variables
Study settings Operational definition
Study period Methods of data collection
Study population Workplan
Sample size Statistical analysis
Sampling technique Ethical approval
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Study type and study designs
1) Observational studies:
a. Descriptive studies – time, place, person distribution
b. Analytical studies
(i) Ecological (co relational) – population as unit of study
(ii) Cross-sectional (prevalence) – individuals as unit of study
(iii) Case-control (case reference) – individuals as unit of study
(iv) Cohort (Follow up) – individuals as unit of study
2) Experimental studies (Intervention studies)
a. Randomized controlled trials (clinical trial) – patients as unit of study
b. Field trials (community intervention studies) – healthy people as
unit of study
c. Community trial - communities as unit of study
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Saha I, Paul B. Essentials of Biostatistics & Research Methodology. 3 rd ed. Kolkata, India: Academic Publishers; 2020. p. 200-41.
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STUDY AREA
•In terms of its location, population, occupation, and relevant socio-demographic
features as well as, prevalent health problem in that area
•Example: If the study was conducted in a hospital, then highlight the hospital in terms of
situation, catchment area, total beds, different departments etc
STUDY SETTING
• Focuses the specific place/site within the study area where the study is actually going
to take place
•Example: A ward/OPD/immunization clinic etc. within a medical college
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Study period
• The period of data collection and total duration
of study is mentioned in the protocol.
• Total minimum duration of thesis is 18 months
for 3 years MD/MS course.
• Total minimum duration of data collection
period is 12 months for 3 years MD/MS course.
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STUDY POPULATION
❖ The population upon which the study will be conducted
❖ The study population and the study sample are different
❖ Study Sample: Subjects among the study population on whom the study will
actually be done
❖ E.g. If we are interested to find out the nutritional status among under five
children in a village, then total under five children will be the study population.
And suppose researcher selects 50 under-five children for data collection. Then
those 50 children will be study sample.
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Selection criteria
⮚ Criterion used for selection of the study subjects
⮚ Inclusion criteria are characteristics of the subjects that are considered for
inclusion in the study
⮚ Exclusion criteria are those conditions, whose presence will exclude the
subjects from entering in the study.
Exclusion criteria cannot be the reverse of inclusion criteria
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Example : In a study among the adult tobacco users in a particular area,
the following selection criteria was used-
Inclusion criteria
• All the adult population both men and women, who are current users of
tobacco, either in the form of smoke or smokeless, residing in the specified area
permanently for 2 years or more
Exclusion criteria
• Current tobacco users who were seriously ill.
• Current tobacco users not willing to participate
• Current tobacco users who were absent despite 3 home visits
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Sample size calculation
• Cochran’s Formula:
n = [( Z1-α/2)2 x P x (1- P)] /L2
n- Sample size
( Z1-α/2) – Standard normal deviate
P – Expected population proportion 33
Types of Sampling Methods
Sampling method
Probability Non-probability
1. Simple Random
1. Purposive/Judgemental
2. Systematic Random
2. Convenience
3. Stratified Random
3. Quota
4. Cluster
4. Self-selection/ Volunteer
5. Multistage Sampling
5. Snow ball
6. Multiphase Sampling
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Saha I, Paul B. Essentials of Biostatistics & Research Methodology. 3 rd ed. Kolkata, India: Academic Publishers; 2020. p. 200-41.
Study tools:
• Quantitative data:
[Link]/schedule [Predesigned, pretested or validated]
[Link] checklist [Predesigned, pretested or validated]
3. Intervention tools (if applicable)
[Link] Data Sources – census, vital records etc.
Qualitative data: Interview guide, FGD guide etc.
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Study technique
The manner in which data collection is done .
These may be :
❖Interview of the respondents
❖Observation
❖Clinical examination
❖Measurement of blood pressure, anthropometry etc.
❖Scrutiny of records like discharge & bed head tickets
❖Review of the past clinical or pathological reports
❖Description of intervention (if applicable)
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Variables
Pieces of information (data) that are collected in a research study in order to
achieve the objectives.
• Independent /Exposure/ Predictor variable: A variable thought to be cause of
some effect on outcome variable
• Dependent / Outcome Variable: A variable thought to be affected by changes in an
independent variable.
• Example: A study on association of lung cancer with smoking tobacco in rural area.
Here outcome variable is lung cancer and exposure variable is smoking tobacco.
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Operational definitions
Definitions or criteria to be used in the study
Related to-
❑ Key outcomes A cross-sectional study on association of hypertension
❑ Key exposures with physical activity in a rural area of Medinipur.
Example:
❑ Current smokers : A person who smokes at the time of survey and had smoked more than
100 cigarettes in their lifetime, as per WHO criteria. Cigarettes, smoking pipes, cigars, bidi
will be considered as smoked products.
❑ Provide references, if applicable
❑ Clarity and specificity is needed
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Work plan:
• Schematic representation of the procedure that is to be followed
• Example :
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Method of data collection:
• Details of data collection procedure and standard operating
procedures (SOP) followed like measurement of blood pressure,
weight, height etc. as applicable should be written
• Details of the steps should be written and that will ensure data
quality at all stages
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Statistical analysis plan
• Plan for data analysis should to be outlined in details
• Suitable database/ software for entering data should be written
• Software to be used for data analysis (Excel, SPSS, SAS, R etc.)
• Statistical analysis plan (Descriptive, Inferential, Scoring analysis plan)
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Ethical issues - Four Basic Principles
• Autonomy (respect for individual rights)
• Beneficence (all actions intended to benefit others and the
benefits are proportionate to the risks )
• Non-maleficence (first do no harm)
• Justice (equal justice for all)
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Age of child Assent and consent
< 7 years of age Informed written consent from parent /
Legally Acceptable Representative [LAR]
between ≥7yrs and 11 Oral assent from child along with
years of age informed written consent of parent/LAR
between 12 and 18 years Informed written assent from child along
of age with informed written consent of
parent/LAR
≥ 18 years of age Informed written consent of child
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References
• Should include full reference documentation for all books and articles
• Reference management software like Zotero can be used.
• The style format which are commonly adopted : Vancouver, APA etc.
• In WBUHS a student have to use Vancouver style of referencing for thesis.
• Example: Saha I, Paul B. Essentials of Biostatistics & Research Methodology. 3rd
ed. Kolkata, India: Academic Publishers; 2020. p. 200-41. [for a book]
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References
• Saha I, Paul B. Essentials of Biostatistics & Research Methodology. 3rd ed. Kolkata, India:
Academic Publishers; 2020. p. 200-41.
• DLK MD, JGE MD, Wild D, MS SCL. Jekel’s Epidemiology, Biostatistics, Preventive Medicine,
and Public Health: With STUDENT CONSULT Online Access. Elsevier Health Sciences; 2013.
• Kothari CR. Research Methodology: Methods and Techniques. India: New Age
International; 2004.
• Abramson J, Abramson ZH. Research Methods in Community Medicine: Surveys,
Epidemiological Research, Programme Evaluation, Clinical Trials. John Wiley & Sons; 2011.
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Research in a school setting
❖ The researchers should submit the protocol to school authorities and
obtain written approval
❖ Copy of the approval given by the school should be submitted to the EC
❖ Guidelines for consent and assent apply to school based research
❖ If justified, the EC may decide to waive individual consent, depending on
the context and the type of research (e.g collecting only data already with
school authorities like number of children, number availing mid-day meal
services, etc.
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⮚ For children less than 7 years of age, parental consent is sufficient
⮚ For children between 7 (84 months and above) and 11 years of age, oral
assent must be obtained along with counter signature of parent/LAR
⮚ For children between 12 and 18 years of age, written assent must be
obtained in addition to parent/LAR consent
⮚ If a child becomes 12 years old during the course of the study, then written
assent must be obtained in addition to parent/LAR consent
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Type of study
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