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Basic Course in Biomedical Research
Handbook

Dr. Tanmay Mehta

MD-DNB-MNAMS Microbiology,
Advanced Course in Medical Education (ACME),
Post Graduate Diploma in Clinical Trial Management (PGDCTM), ICRI,
Clinical Research training Course, NIH (USA),
Protecting Human Research participants, NIH (USA)
Assistant Professor, Smt. NHL Municipal Medical College, Ahmedabad, India

1
About Basic Course in Biomedical Research:

In order to improve the research skills of Indian medical postgraduate (PG) students and teachers in medical
institutions, the Board of Governors (BoG) in supersession of Medical Council of India (MCI) has
recommended a uniform research methodology course across the country. The online course, “Basic Course
in Biomedical Research”, is offered by ICMR-National Institute of Epidemiology (ICMR-NIE), Chennai
(www.nie.gov.in).

The course explains fundamental concepts in research methodology. The course includes 23 Lectures covering
conceptualization of a research study, epidemiological and bio-statistical considerations in designing a
research study, planning and conducting a research study, writing a research protocol and publication ethics.
The learning materials include video lectures, presentation slides, example accompaniment (explains the
different concepts and steps involved in a health research using a single example throughout the course),
reading materials and assignments.

About Basic Course in Biomedical Research Handbook by Dr. Tanmay Mehta:

 Covers all 23 chapters of Basic course in Biomedical Research by ICMR

 Segregation of each chapter into topics for better understanding.
 Topic wise self-assessment of MCQs with answers and explanation.
 Highlighted important points.
 Supplementation of literature wherever applicable.
 Charts, figures and tables for better understanding and recall.

Reference sources for the book:

1. Basic course in Biomedical Research course material, offered by ICMR-National Institute of Epidemiology
(ICMR-NIE), Chennai
2. World Health Organization. Health research methodology: a guide for training in research methods.
Manila: WHO Regional Office for the Western Pacific; 2001: p. 1-10.
3. Bonita R, Beaglehole R, Kjellstrom T. Basic epidemiology. 2nd ed. Geneva: World Health Organization;
2006: p. 15-23.
4. Coggon D, Rose G, Barker DJP. Epidemiology for the uninitiated. 4th ed. London: BMJ publishing
Group; 1997.
5. Campbell MJ, Swinscow TDV. Statistics at square one. 9th ed. BMJ Publishing Group; 1997.
6. Hudelson PM. Qualitative research for health programmes. Geneva: World Health Organisation; 2004.

2
 Index
Section I : Conceptualizing a research study

1 Introduction to health research ….4

2 Formulating research question, hypothesis and objectives….21
3 Literature review….38

Section II : Epidemiological considerations in designing a research study

4 Measures of disease frequency….57
5 Descriptive study designs….75
6 Analytical study designs….89
7 Experimental study designs….114
8 Validity of epidemiological studies….135
9 Qualitative research methods: An overview….149

Section III: Bio-statistical considerations in designing a research study

10 Measurement of study variables….164
11 Sampling methods….180
12 Calculating sample size and power….198

Section IV: Planning a research study

13 Selection of study population….214
14 Study plan and project management….231
15 Designing data collection tools….248
16 Principles of data collection….267
17 Data management….280
18 Overview of data analysis….297

Section V: Ethical issues in conducting a research study

19 Ethical framework for health research….314
20 Conducting clinical trials….332

Section VI: Writing a research protocol

21 Preparing a concept paper for research projects….347
22 Elements of a protocol for research studies….358
23 Publication ethics….371

3
 1
Introduction to health research
Theoretical & Applied
Preventive &
Therapeutic
Benchbased &
Dimensions
Bedside
Exploratory &
Confirmatory
Implementation &
Translational
Planning

Principles Team work Scientific

Ethical (absolute
3 Reviews
mandatory)
Systemic data
Regulatory
collection
Draw meaningful
Process cocnclusion and make
appropriate decisions
Evidence based
actions
Human host

Study variables Environment

Health care
infrastructure
New/additional info

Confirm available info

find cause-effect
Scope
relationship
Test new drugs/tools

Evaluate programs
Qualitative &
Quantitative
Observational &
Study designs
Experimental
Retrospective &
Health research Prospective
Justification
Clear research
question
Critical Planning Standard case
definitions
Representative sample (External
validity/generalizability)
Adquate sample size
Random error by
minimize by increasing sample size and precision
chance
Errors minimised by
Systemic error due to
improving study
bias
design
affect study variable
and outcome
Confounders minimised by study
design and stratified
Challanges negatively affact
analysis
variable outcome
relationship by
Effect modifiers aware of outcome
affacting them by
literature review and
Pilot study exclude them

Participants
Data collection
Study methods and instruements
measurements
Measurement tools

Analysis plan

QC and QA

Health improvement

Occurence prediction

Focus Prevention

Treatment

Program intervention

1
Dimensions of health research:
• Theoretical research and applied research
o Health research is conducted for theoretical purposes and when we have
some good evidence created out of that we go for applied research.
• Preventive and therapeutic research
o preventive technologies as they emerge, they have to be tested out through
research methods as well as newer therapeutic options become available
they need to be tested out through research methods.
• Bench based research (animals) and bedside research (human)
o Study done in a laboratory setting using animals is bench based
research.
• Exploratory research and confirmatory research
o In exploratory research, we do not know much about it right in the
beginning, but what we try to do is employ various methods and try to
figure out if we can get some clues for further research. Clues that have
been obtained are strengthened or additional information of practical
significance are obtained in confirmatory Research.
• Implementation research and translational research

o Implementation research is the scientific inquiry into questions concerning

implementation—the act of carrying an intention into effect, which in health
research can be policies, programs, or individual practices (collectively
called interventions).
▪ It is the study of methods to improve the uptake, implementation, and
translation of research findings into routine and common practices. I
▪ t is used as a general term for research that focuses on the question
‘What is happening?’ in the design, implementation, administration,
operation, services, and outcomes of an intervention – eg: smoking
cessation intervention, nutritional supplementation to pregnant
mothers, incentives for treatment completion, etc.
▪ Implementation Research is needed to know how implemented
government programs are functioning and if any mid course
corrections are necessary or to decide in which areas we need
specific angles of the programs to be strengthened and so on.

2
 ▪ Implementation research is a scientific inquiry that seeks to
understand the acceptability and functionality of a health
program
o Translational research is when research findings are moved from the
researcher’s bench to the patient’s bedside and community.
▪ This refers to knowledge transfer from basic to clinical research
and subsequently to practice settings and communities, for better
health outcomes.
▪ Transnational research basically talks about the earlier concept of
bench to bed side. This is a process of development of
technologies for human benefit and human welfare.
▪ Example: Drug development, vaccine development – This
involves initial laboratory work and then it finally reaches the
community.
▪ Other examples are biomarkers of disease progression, treatment
outcomes.

3
Dimensions of health research:

Which of the following best describes a study done in a laboratory setting using
animals?
a) Translational research
b) Bench-based research
c) Theoretical research
d) Preventive research
Answer: b) Bench-based research

Which of the following will best describe the scientific inquiry that seeks to
understand the acceptability and functionality of a health program?
a) Basic science research
b) Translational research
c) Clinical research
d) Implementation research
e) None of the above
Answer: d) Implementation research

Which of the following disciplines contribute to health research?

a) Bio-medical research
b) Biostatistics
c) Social science research
d) All of the above
Answer: d) All of the above

4
Principles of Health research:
• Planning stage is critical – spend enough time and involve the right people in
planning.
o If we do not spend enough time and if we do not involve the right kind of
people in planning the research study, it is very likely that some of the issues
that we could have earlier prevented or they get missed which we could have
prevented in the real sense.
• Team work is critical.
o Team work is really critical in research, very rarely solo research succeeds.
o Assigning roles and responsibilities to the team members is one of the
fundamental principles of a research.
• Three levels of review are essential
1. Scientific review:
o It focuses on novelty, rationality, justification of the research.
2. Ethics review:
o It primarily concerns regarding human subjects protection involved in the
research.
▪ Informed consent document and procedure
▪ Competence of researcher and institute conducting research
▪ Care and support during and after completion of research
o People who are participating in the research are described as human subjects
or human participants and we should do nothing that can really harm them in
the long run or in the short run. So, ethics review ensures that this does not
happen.
o Ethics committee approvals is absolutely mandatory before initiating a
study.
o Both scientific and ethics review and approval are mandatory before
starting any study. However, some institutes may not have a scientific
review committee. In that case, the ethics committee may play a dual role.
3. Regulatory review:
o These are certain ‘in country’ procedures or ‘in country’ reviews dealing with
foreign funding, sample shipment requirements, intellectual property
protection, exchange of visitors involved in research.

5
o These are also mandatory aspects and it is important that the regulatory
committees do review that aspect as well.

6
Principles of Health research:

Which of the following review is NOT essential before initiating a clinical trial?
a) Scientific review
b) Peer review
c) Regulatory review
d) Ethics review
Answer: b) Peer review

State whether true or false. Assigning roles and responsibilities to the team
members is one of the fundamental principles of a research
a) True
b) False
Answer: a) True

Before initiating a study involving primary data collection, the Principal

Investigator must ensure that various approvals are obtained. Which of the
following approvals is absolutely mandatory?
a) Scientific committee approval
b) Ethics committee approval
c) Technical committee approval
d) Regulatory authority approval
Answer: b) Ethics committee approval

Before initiating the study, the Principal Investigator must ensure that various
approvals are obtained. Which of the following approvals is/are absolutely
mandatory?
a) Scientific committee approval
b) Ethics committee approval
c) Technical committee approval
d) Regulatory authority approval
e) All
Answer: b) Ethics committee approval

7
Which of the following is not part of ethics review of a project?
a) Informed consent document and procedure
b) Competence of researcher and institute conducting research
c) Sharing and protection of intellectual property
d) Care and support during and after completion of research
Answer: c) Sharing and protection of intellectual property

Issues regarding shipment of samples and transfer of data outside the country are
examined by:
a) Regulatory review
b) Ethics review
c) Scientific review
d) None
Answer: a) Regulatory review

Which of the following are examined as part of regulatory review?

a) Information regarding transfer of funds and utilization of funds
b) Shipment of samples and transfer of data outside the country
c) Sharing and protection of intellectual property
d) All of the above
Answer: d) All of the above

8
Process of health research:
Any research is a process and it contains multiple components and each and every
component in this process is of critical importance.
• Ensure that data is collected systematically
o We have to collect data with a specific purpose and for that data to be of high
quality, the data collecting instruments also have to be appropriately
designed.
• Draw meaningful conclusions & Make appropriate decisions.
o If the data quality is good, then we can draw meaningful conclusions based
on that and then we can make appropriate decisions.
• Take appropriate actions for prevention and control of diseases, conditions: Evidence
based actions.
o Once appropriate decisions are made, the policy planners and the program
managers of the country , decide, whether this is the right time to take these
particular learning’s from research to appropriate actions which can be
employed at an individual level or at a mass level.
• These should help in reduction of suffering and ultimately improve health and
well-being of the community

9
Study variables in health research:
When we talk about the kind of information that we collect in research, it can have wide
range of breadth and depth as well. There could be multiple angles which are require to
be collected, we call all those like study variables. We have to collect correct information
on those study variables when we carry out health research.
• Human host: healthy, susceptible, with disease, dead
o There is some information which is required to be collected with respect to
the human host for example, and they can be some times healthy, they can be
sometimes susceptible to a particular condition or they can be suffering from
a particular disease, some of them may have died because of the that
particular disease also.
o We have to figure out, how we can get the required information from these
kinds of subjects from these various kinds of host
• Surrounding environment and society: climatic factors, housing, vectors,
animals, socio-cultural practices, family structure.
o Diseases usually have multi factorial origin. The environment and the society
play significant roles in occurrence of diseases.
• Health care infrastructure and delivery
o The access to health is a critical component. if people are not able to access
health in time, complications and the death rates are unusually high in nature.

10
Scope (objectives) of health research:
• Estimation of disease burden in a population
• Predicting progression of disease in a patient
• Getting additional or new information:
o Are more of diphtheria and pertussis cases reported among adults in the recent
times?
▪ We used to know that these were the diseases of childhood earlier but now, it
has been seen that some rare instances the cases in adults are also getting
reported, so we need to figure out why this is happening? And where is it
happening?
o What are the differences in full genome structure of HBV and HEV?
▪ It could have implications in terms of understanding pathogenic impact in
human and decision making with respect to development of vaccine against
these viruses.
• Verifying and confirming available information:
o Here is where, most of the research that happens in our country is now-a-days
happening.
o Are etiologies of pediatric pneumonia different in the children aged 5 or less in
developed and resource limited countries?
o Have the incidence and complications of diabetes changed with increasing
consumption of pre-cooked and packaged food?
• To find out cause and effect relationship:
o Does presence of a particular co-receptor [cause] on CD4 cells protect against
HIV infection [effect]?
o Are breast cancers [effect] more common in breast implant [cause] recipients?
• Testing new drugs, vaccines, tools or interventions for prevention, treatment and
control of a disease:
o Can INH prophylaxis delay onset of tuberculosis in HIV infected persons?
o Will introduction of smokeless stoves result in reduction of respiratory morbidity
and mortality in rural areas?
• Evaluating ongoing programs and assessing feasibility of new programs:
o Is injectable iron sucrose a better alternative to deal with pregnancy related
anemia than oral iron?

11
 o Will the Integrated Disease Surveillance Program be able predicting the
epidemics of influenza and bird flu in India?
• Improving health of the population

12
Scope (objectives) of health research:
Health research is usually focused on which of the following areas?
a) Estimation of disease burden in a population
b) Prevention of common diseases in the community
c) Evaluation of public health programs
d) All the above
Answer: d) All the above

A researcher wants to study the relationship between COVID-19 infection in

pregnancy and birth weight. Currently, there is no evidence on this topic. Which of
the following options is the scope of this health research?
a) Verifying and confirming known information
b) Getting additional or new information
c) Evaluating ongoing programs
d) All of the above
Answers: b) Getting additional or new information

Which of the following areas can be included in health research?

i. Improving the health of the population.
ii. Predicting progression of a disease in a patient
iii. Prevention of various diseases
iv. To explore various societal, community based and programmatic interventions
for disease prevention and control
a) i and ii
b) i, ii and iv
c) All of the above
d) None of the above
Answer: c) All of the above

13
Making the right choice of study design:
• Qualitative studies or Quantitative studies
o Qualitative study requires person to person interviews or discussion in focus
groups or just say free listing or observations. It mostly is observational in
nature and open ended.
o Quantitative studies are mostly based on structured questionnaires, which
are previously thought of and only the questions with very specified options
of answers that can be made available are used or employed in the study.
• Observational studies or Experimental studies
o In epidemiological terms, observational studies are those wherein the
investigators do not change the environment in which the study
participants are living.
o In the experimental studies, the participants are exposed to some kind of an
intervention at the will of the investigators.
• Retrospective studies or Prospective studies
o In retrospective studies, the information on the outcome that we are trying to
study is already available.
o In a prospective study we only start the study with people who are at risk or
who are susceptible to a particular disease , also have a comparator arm or
control group, comparison group and then follow these two groups to find out
how many people in either of these two groups develop a particular disease,
which they were free off at the beginning of the study. So outcome happens
in the future and it is called as a Prospective study design.

14
Making the right choice of study design:

Which of the following is NOT a type of study design?

a) Qualitative study
b) Observational study
c) Retrospective study
d) Translational study
Answer: d) Translational study

Which of the following is not a type of study design?

a) Qualitative study
b) Observational study
c) Retrospective study
d) Pilot study
Answer: d) Pilot study

15
Some critical considerations in planning phase:
Planning is a very critical stage in research. Following considerations have to be kept in
mind during planning stage:
• There should be adequate justification to conduct the research study.
o as research involves investment in terms of money, time and manpower.
• Clear and focused research question.
• Standard and unambiguous case definitions of study variables and outcomes.
o For example, if you are looking at cancer cervix then what we call as
carcinoma in-situ and what we call as invasive cancer has to be known to
everybody, who is involved in that particular research.
• Sample and sample size: It has two dimensions
o Sample should be qualitatively representative of the population in which the
study is being conducted (External validity or generalizability).
▪ In simple terms, it means that if we are able to just generalize the
findings of our study which are based on a particular sample
adequately and comfortably to the whole population from which the
sample was drawn.
o Sample size should be adequate to enable enough power to draw
meaningful inferences. Adequate sample size is a prerequisite for
implementation of research.

16
Some critical considerations in planning phase:

Which of the following is NOT a component of a research study?

a) Setting up the institute scientific committee
b) Calculating sample size
c) Development of a study tool
d) Framing the research question
Answer: a) Setting up the institute scientific committee

Which of the following is NOT a critical consideration in planning a health

research?
a) Adequate justification
b) Clear and focussed research question
c) Standard case definitions
d) Financial gain
Answer: d) Financial gain

Identify the CORRECT statement about implementation of a research

a) Research findings must be approved by the funder
b) Research finding must be error free
c) Adequate sample size is a prerequisite
d) Pilot study can be done during data analysis stage
Answer: c) Adequate sample size is a prerequisite

What is appropriate for sample and sample size?

a) Should be representative of the population [External validity or generalizability]
b) Should be adequate [power to draw meaningful inferences]
c) Both 'a' and 'b'
d) Neither 'a' nor 'b'
Answer: c) Both 'a' and 'b'

17
Which of the following statements are correct regarding defining inclusion and
exclusion criteria in a study protocol?
a) They should be vague because this will allow greater and easy enrollment
b) They should be very specific
c) They should be very large in number
d) It is not important to define exclusion criteria in a clinical trial
Answer: b) They should be very specific

18
Errors in Research:
• Research can never be free of errors, but errors can be predicted and minimized
• Random error representing wrong result due to chance:
o unknown sources of natural variation that can distort findings in either
direction
o Random errors can be minimized by
▪ increasing sample size reduces intra-individual variation
▪ increasing precision
• Systematic error signifying wrong result (erroneous estimate of exposure’s effect)
due to bias:
o mostly due to variation that would distort the results in one direction
o Can be minimized by improving study design

19
Errors in Research:

Which of the following statements is NOT correct regarding errors in a health

research?
a) Random error is due to chance
b) Systematic error is due to bias
c) Random errors can be eliminated by improving study design
d) Bias distorts the study results in one direction
Answer: c) Random errors can be eliminated by improving study design

What effect does increasing the sample size have upon the random error?
a) It increases the random error
b) It has no effect on the random error
c) It reduces the random error
d) None of the above
Answer: c) It reduces the random error

Any systematic error in the design, conduct or analysis of a study that results in an
erroneous estimate of an exposure's effect on the risk of disease is called:
a) Confounding
b) Bias
c) Interaction
d) Stratification
Answer: b) Bias

20
Challenges in designing and implementation of research studies:
• In a scenario when we desire to study the relationship between a variable and an
outcome
o Confounders:
▪ Confounder is an extraneous factor that can independently affect the
study outcome. (Affect both study variable as well as outcome)
▪ It is associated with the exposure but is not an intermediate step in the
causal pathway between exposure and outcome.
▪ Example: A study is planned to estimate the prevalence of coronary
heart disease (CHD) among adult smokers and non-smokers in a
village. Here, hypertension is a confounder since irrespective of
smoking habit people with hypertension are more likely to have
coronary heart diseases. Also, there is a relationship between smoking
and hypertension; smokers are more likely to have hypertension.
▪ Confounders Effect can be minimized by
• proper study design
• stratified analysis
o Effect modifiers:
▪ Effect modifier is an exposure variable that differentially modifies the
observed effect of a risk factor on outcome either positively or negatively
▪ Can alter [generally negatively] the relationship between the study
variable and outcome by independently affecting outcome
▪ Good to be aware of them through adequate literature review and not
to include them in the study, Literature review is is the best source
of information on 'effect modifiers' while exploring cause and effect
relationship in a research study.
▪ Example: Socio-economic status can be considered as an effect
modifier. Since the association between Obesity and CHD could vary
in different strata ie. low, middle and high socio-economic status.

21
Challenges in designing and implementation of research studies: Confounder and
effect modifier

What is true about Confounders?

a) They affect both study variable as well as outcome
b) Their effect can be minimized by proper study design and through stratified analysis
c) Both 'a' and 'b'
d) None of the above
Answer: c) Both 'a' and 'b'

Which is the best source of information on 'effect modifiers' while exploring cause
and effect relationship in a research study?
a) Deductive thinking
b) Thorough review of literature
c) Intelligent guessing
d) Discussing with experienced researchers
Answer: b) Thorough review of literature

A study was conducted to assess the extrapyramidal side effects of a new

antipsychotic drug in patients with schizophrenia. Many of these patients were
smokers and some of them were on anticholinergic drugs. What was the role of the
anticholinergic drugs in this study?
a) Confounder
b) Random Variable
c) Effect Modifier
d) Independent Variable
Answer: c) Effect Modifier

22
The following statements describe confounding and effect modification. Which of
the statement is/are correct?
a) In a study of relationship between coffee drinking and oro-pharyngeal cancer;
smoking is a confounder
b) In a study to explore relationship between hepatitis B infection and post-infection
hepatic sequelae, habit of alcohol drinking acts as an effect modifier and patients with
this habit may be excluded from the study
c) 'a' and 'b' are correct
d) 'a' and 'b' are wrong
Answer: c) 'a' and 'b' are correct

23
Study methods and measurements: Major issues
• Pilot study
o They are small scale studies.
o They are conducted for developing and testing adequacy of research
instruments.
o They establish whether the sampling frame and technique are effective.
• Study participants: Inclusion and exclusion criteria, recruitment targets and strategies
• Data collection instruments
• Measurements tools and assay
• Plan for statistical analysis
• Quality control and assurance at all levels

Focus of health research:

• How can health of the population be improved?
• Can we predict occurrence of a disease in an individual?
• How can various diseases be prevented?
• How can we effectively cure the diseases and reduce the associated morbidity and
mortality?
• What are various societal, community based and programmatic interventions for
disease prevention and control?

Health research aims at finding answers or practical solutions at individual and

community levels
• At individual level:
o Promote healthy behavior, prevention at individual level, early diagnosis,
adequate and appropriate treatment, rehabilitation
• At community level:
o Improve community behavior and practices, prevention and control programs,
support to affected people, stigma reduction

24
Study methods and measurements: Major issues

Which of the following statements is not true in case of pilot study?

a) They are conducted for developing and testing adequacy of research instruments
b) They establish whether the sampling frame and technique are effective
c) Ethics committee approves the main study only after successful completion of the
pilot study
d) They are small scale studies
Answer: c) Ethics committee approves the main study only after successful
completion of the pilot study

The policy makers want to know whether introduction of pentavalent vaccine in the
national program is resulting in reduction in the number of Hemophilus influenza
cases. Which of the following studies will they have to conduct to find an answer?
a) Case-control study
b) Field trial
c) Ecological study
d) Case series
Answer: b) Field trial

The policy makers want to know whether introduction of a new rotavirus vaccine in
the national immunization programme is resulting in reduction of morbidity and
mortality from rotavirus disease. Which of the following studies will they have to
conduct to find an answer?
a) Case-control study
b) Ecological study
c) Field randomized trial
d) Case-series
Answer: c) Field randomized trial

25
 2
Formulating research question, hypothesis and objectives

THE LIFE CYCLE OF RESEARCH:

1. Identify data needs (uncertainty)
2. Spell out the research question
3. Formulate the study objectives
4. Plan the analysis
5. Prepare data collection instruments
6. Collect data
7. Analyze data
8. Draw conclusions
9. Formulate recommendations
10. Inform stakeholders

Data Need

Inform Research
stakeholders Question

Recommendation Objective

Analysis
Conclusion
planning

Data Collection
instrument
Analyze data
(tool)
preparation
Collect data
What is the first step in the life cycle of research?
a) Spell out the research question
b) Formulate the objective of the study
c) Identify the data needs
d) Choose the study design
Answer: c) Identify the data needs

In the life cycle of research, ‘spelling out the research question’ is followed by-
a) Preparing data collection instrument
b) Formulating study objectives
c) Collecting data
d) Formulating recommendations
Answer: b) Formulating study objectives

Which of the following is an element of life cycle of research?

a) Identify data needs and spell out the research question
b) Formulate the objective and design the study
c) Draw conclusion and give recommendation to stakeholders
d) All of the above
Answer: d) All of the above

Among the following, which is the last step in the life cycle of research?
a) Spell out the research question
b) Formulate the objective of the study
c) Formulate recommendations
d) Choose the study design
Answer: c) Formulate recommendations
 Definition

Significance of clear
RQ

Translating
uncertainity into RQ

Identify data needs

(uncertainity) Sources of RQ
Descriptive RQ Measure quanitiy
Research question
(RQ) 2 types (Categories)
of RQ
Comarison group/
Analytical RQ
6 steps of concieving intervention to test RH
a RQ with example
Feasible

Interesting

5 elements of RQ
Novel
(FINER)

Ethical

Only for analytical RQ Relevant

Life cycle of research
Research Hypothesis Summary and for
Simple
(RH) statastical signifance

Characteristics of RH Specific

Stated in advance

Scientific terms

Limited axis

Clear about type

Translating RQ to RO
(DRQ/ARQ)
Estimate (DRQ)
Good and bad
Only one verb
examples of RO
Research objectives Determine (ARQ)
(RO) Primary / Secondary

Answer it
2 ways to deal with
poor RO
Reframe it
RESEARCH QUESTION:
What is research question?
• Research question is an ‘Uncertainty (data needs)’ about something in the population
that the investigator wants to resolve by making measurements in the study
population.

Significance of a clear research question:

• We need a clear question facilitates to
o Choose the most optimal design
o Identify
▪ who should be included (Participants)
▪ what the outcomes should be, and (Outcomes)
▪ when the outcomes need to be measured (Time)
• If your research question is wrong, no good hard work will save your work. If your
research question is right, you have an opportunity to do a good job
A clear research question is required in order to facilitate the following:
a) To choose an optimal study design
b) To identify the outcomes that need to be measured
c) To decide when the outcomes need to be measured
d) All the above
Answer: d) All the above

A clear research question facilitates to do the following:

a) Choose the most optimal design
b) Identify who should be included as study population
c) Specify the outcomes that should be measured
d) All of the above
Answer: d) All of the above

A research question states about what the results of the study might ultimately
contribute to that particular field of science
a) True
b) False
Answer: b) False
Translating uncertainty to research question:
• A Research question is all about refining your ideas into systematic process of
framing a question.
• It begins with the general uncertainty about a health issue in the context of health
research and then it is narrowed down into a concrete researchable issue.
• To translate uncertainty to research question
o Frame the problem in specific terms (clinical/public health)
o Focus on one issue at a time
o Write in everyday language
o Use more than one operational verb, if needed
o Link the question to the potential action that would be taken once the question
is answered
o State as a question.
• A research question sets out clearly what the investigator wants to know and
definitely not what he or she may do or what this results will ultimately contribute to
that particular field of science.
The process of refining the "ideas" into research questions begins with general
uncertainty about a health issue and narrow down to a specific, concrete
researchable issue
a) True
b) False
Answer: a) True
Sources of research questions:
There are many sources from which the research questions or ideas can arise from.
• Mastering the published literature
o Continue review of work of others in the area of interest
• Being alert to new ideas and techniques
o Attending research meetings / conferences
o Having a skeptical attitude about prevailing beliefs
o Applying new technologies to old issues
• Keeping the imagination roaming
o Careful observation
o Teaching and interacting with students
o Tenacity to go to bottom of things
• Choosing a guide/mentor who can help you
Which of the following is NOT an ideal source of a research question?
a) Reviewing the published literature
b) Attending conferences where latest findings are shared
c) Observing keenly in the out-patient clinic
d) Mining existing datasets for research question
Answer: d) Mining existing datasets for research question

Source(s) of research question is/are:

a) Published literature
b) Being alert to new ideas
c) Careful observation and teaching
d) All of the above
Answer: d) All of the above
Two categories of research questions:
1. Descriptive questions:
a. Involve observations to measure quantity (disease burden, prevalence)
b. No comparison groups / interventions
2. Analytical questions:
a. Involve comparisons / interventions to test a hypothesis

• A single research study can be designed to answer both descriptive and

analytical questions.
o However, one may have to state descriptive element as the primary objective
and analytical part as secondary objective of the study.
Which of the following is TRUE for a ‘Descriptive Research Question’?
a) Involves observations to measure a quantity
b) Involves comparison groups
c) Tests the efficacy of interventions
d) Requires hypothesis testing
Answer: a) Involves observations to measure a quantity

State whether true or false. A research study is conducted to estimate the

seroprevalence of COVID-19 in Ahmedabad city during April-June 2020. This is an
example of analytical research question.
a) True
b) False
Answer: b) False

If your objective is to estimate the prevalence of a health problem in a community

in 2019, Identify the type of research question this study is addressing
a) Analytical research question
b) Descriptive research question
c) Hypothetical research question
d) Experimental research question
Answer: b) Descriptive research question
6 Steps of conceiving a research question:
1. Review of state-of-art information from the literature (literature review)
2. Raise a question based on review of literature.
3. Decide whether it is worth investigating by peer-review
4. Define measurable exposures & outcomes
5. Sharpen the initial question based on the above steps
6. Refine the question by specifying details

Let us understand this by an example:

Q: Should diabetics do exercise daily?
1. Literature review: Review of state-of-art information from the literature
• one reviews a literature as to what is the effect of exercise on human body to
begin with.
• Literature shows exercise reduces blood sugar level and body fat, exercise
improves protection against developing complications due to diabetes.
• So, definitely it is worth investigating.
2. Raise a question based on review of literature.
• let us raise a question based on our review of literature.
• Can exercise help control blood sugar level?
• Sounds better than the earlier question, but definitely this is vague.
• We need to refine it especially,
i. what do you mean by exercise?
ii. What do you mean by blood sugar level?
3. Peer review: Decide whether it is worth investigating by peer-review
• Then we go in to the literature and talk to people, peer group and talk to
investigators who was special expertise in this areas and decide
o What is the level of reduction in blood sugar?
▪ Fasting or random or post-prandial (after food)
o What are optimal type, frequency, intensity and duration of exercise?
o What are the risks? What are the other benefits?
4. Define measurable exposures & outcomes
• Exposure: Exercise
i. Pre-determined physical activity comprising of any body movement
produced by skeletal muscle, resulting in an increase in energy
expenditure
ii. Atleast one session of 60 minutes every day for one year
iii. Could be specific: walking, jogging or cycling or aerobics
• Outcome: Fasting blood sugar level
5. Sharpen (narrowing/specifying) the initial question based on the above steps
• Among diabetics, does physical activity for one hour daily help in reducing
fasting blood sugar level?
6. Refine the question by specifying details
• Specify
i. Study population
ii. Operational definitions of variables (exposure and outcome)
iii. Study design.
• What is extent of walking practiced by diabetics (type 2 diabetes) regularly?
[Descriptive question]
• In order to improve management of type 2 diabetes, we wish to know
whether brisk walking by diabetics for atleast one hour daily reduce fasting
blood sugar level as compared to those who do not? [Analytical question]
Which of the following is NOT a step in framing an ideal research question?
a) Literature review
b) Peer review
c) Broadening the initial question
d) Defining measurable outcomes
Answer: c) Broadening the initial question

The following are the steps in framing a research question.

I. Review of state-of-art information
II. Define measurable exposures & outcomes
III. Raise a question
IV. Decide worth investigating by peer-review
Choose the correct sequence of framing a research question from below.
a) I, II, III, IV
b) II, IV, III, I
c) I, III, IV, II
d) III, I, II, IV
Answer: c) I, III, IV, II
5 elements of good research question:
• A good research question should pass ‘so what?’ test. This test comprises of five
elements, it is called FINER as an acronym.
o Is this research question Feasible to answer?
▪ Adequate number of participants, technical expertise & resources.
• whether we will get adequate number of study participants.
• Do we have technical expertise to do this study?
• Do you have resources both material and manpower to do this?
o Is this Interesting to answer?
▪ Does it really enthuse people to engage in this particular research?
▪ Is it worth doing it?
o Is it Novel?
▪ Does it Confirms, refutes or extends previous findings?
▪ Does it provides new information?
o Is it Ethical to do studies around this research question?
▪ Amenable to a study that ethics committee will approve
o Is it Relevant?
▪ Advance scientific knowledge, improve practice, influence policy
Which of the following characteristics best describe a good research question?
a) Feasible, Novel, Ethical
b) Feasible, Noble, Ethical
c) Ethical, Novel, Intuitive
d) Fantastic, Novel, Relevant
Answer: a) Feasible, Novel, Ethical

Which of the following statements is incorrect?

a) A good research question should be Feasible, Interesting, Novel, Ethical and Relevant
b) A good research question should be in epidemiological terms
c) A good research question facilitates to choose optimal design
d) A good research question will focus on one issue
Answer: b) A good research question should be in epidemiological terms

Which of the following statement is incorrect about a good research question?

a) Research question should advance scientific knowledge, improve practice,
influence policy
b) Research question should be approved by the ethics committee
c) Research question should confirms, refutes or extends previous findings
d) Feasibility should not be a criterion while developing research question
Answer: d) Feasibility should not be a criterion while developing research
question

All the following are components of 'FINER ' criteria for a research question
EXCEPT
a) Feasible
b) Reliable
c) Novel
d) Ethical
Answer: b) Reliable
RESEARCH HYPOTHESIS:
What is research hypothesis?
• A hypothesis is an assumption of the relationship between two or more
variables.
• Purely descriptive questions DO NOT require hypothesis
• A hypothesis is stated only for analytical questions with comparison groups.
o For experimental or analytic studies, the research question must be translated
into the form of a hypothesis.
o It is the researcher’s best guess or prediction of the outcome.
o It is specific version of the research question
▪ summarizing the main elements of the study such as sample,
exposure and outcome.
▪ Establishes basis for test(s) of statistical significance
o The hypothesis is developed after the research question has been formulated
and refined and guides the development of the research protocol.
o If following terms are contained in your research question, this is an
analytical question that needs a statement of hypothesis.
▪ greater or less than,
▪ causes,
▪ leads to,
▪ compared with,
▪ more likely than,
▪ associated with,
▪ related to,
▪ similar to or
▪ correlated with
Example:
• Analytical research question:
o In order to improve management of type 2 diabetes, we wish to know whether
brisk walking by diabetics for atleast one hour daily reduce fasting blood
sugar level as compared to those who do not?
• Research hypothesis:
o Among diabetics (type 2 diabetes) from the study area, who do brisk walking
 for atleast one hour daily results in average reduction of 10 mg% of fasting
blood sugar level as compared to those who do not.

Null Hypothesis:
• The null hypothesis states that there is no association between the dependent and
independent variables in the study population (there is no difference between the
experimental and control groups)

Research question and research hypothesis are same?

• No.
• Research question: It is quite simply a question that the researcher intends to address.
A good research question assists in developing a protocol, guides and directs the
development of the specific inclusion criteria and facilitates effectiveness in the
literature search.
• Research hypothesis: Unlike a research question, hypothesis is a precise statement of
prediction which is testable. The researcher can develop their own hypothesis on the
grounds of the available information by conducting a literature review.
• By conducting the research in a systematic way the hypothesis can be proved or
disproved.
Which of the following is stated mainly for statistical purpose?
a) Research question
b) Objectives
c) Research hypothesis
d) All of the above
Answer: c) Research hypothesis

Purely descriptive research questions do not require a hypothesis

a) True
b) False
Answer: a) True

As per the following objectives a hypothesis should be stated for which study?
a) To determine the association of maternal smoking during pregnancy with respiratory
infectious disease morbidity and mortality in infants
b) To estimate the lifetime prevalence of mental health morbidities among elderly people
in India
c) To describe the pattern of physical activity among school going children aged 6-18
years
d) To describe the temporal and spatial trends of mortality due to cardiovascular diseases,
by age and sex in India during 2009-2019
Answer: a) To determine the association of maternal smoking during pregnancy
with respiratory infectious disease morbidity and mortality in infants
Characteristics of good hypothesis:
• Simple
o One exposure
o One outcome
• Specific
o No ambiguity about study participants/variables
• Stated in advance
o Written at outset
o Focused on primary objective
Characteristics of a good hypothesis are all, EXCEPT:
a) There should be no ambiguity about the study variables
b) It should be stated ‘a priori’
c) It can be revised based on the study findings
d) It should specify one exposure and one outcome
Answer: c) It can be revised based on the study findings

All the following are characteristic of good research hypothesis EXCEPT

a) Research hypothesis should be simple
b) Research hypothesis should be devoid of any ambiguity about study participants and
variables
c) Research hypothesis should be focused on primary objective
d) Research hypothesis should be written once the study is completed
Answer: d) Research hypothesis should be written once the study is completed
FORMULATE STUDY OBJECTIVES
Aim vs objective:
• “Aim” or "Goal" is generally stated as broad and refer to ultimate outcome of a
research project (therefore, may refer to long-term);
• Many use the term "Aim" interchangeably with that of "Objective". However, we
recommend the use of the term Objective.
• You may convert research question into research objectives.
• They are stated in technical terms (clinical/medical).
• It is preferable to label them as primary (addressing the key question and primary
methods of sampling and sample size) and secondary objectives.
• Objectives are framing the research questions in scientific and epidemiological
terms.
• They can be primary and secondary.
• Objective should denote the descriptive and analytical nature of the study explicitly.
• Depending on the research interest, you may wish to "estimate" a quantity ("use") as
the primary objective and may wish to "determine" association ("factors" for use) as
secondary objective.

Translating research questions to objectives:

• Frame and write in scientific/epidemiological terms and language
• Take the question in a few limited axis
• Be clear about the type of question:
o Descriptive questions (Measuring a quantity)
▪ Use the verb “Estimate”
• E.g., Estimate prevalence of physical activity
o Analytical/experimental questions (Testing a hypothesis)
▪ Use the verb “Determine”
• E.g., Determine whether exercise reduces blood sugar level
• Make use of no more than one verb for each objective
o ‘To study” is a very poor statement of objective and its use is not recommended.
• Sort as primary and secondary
o The analytical research question: In order to improve management of type 2
diabetes, we wish to know whether brisk walking by diabetics for at least one
hour daily reduces fasting blood sugar level as compared to those who do
not?
▪ Primary objective: Determine the effect of brisk walking for at least
one hour daily on fasting blood sugar level of patients with type 2
diabetes compared those who do not.
Which of the following statement about study objective/s is FALSE?
a) Objectives are stated in scientific terms
b) Objectives can be primary and secondary
c) Each objective is written using multiple verbs
d) Objectives should be specific
Answers: c) Each objective is written using multiple verbs

How can the given study objective be improved? “To understand the anemia in
pregnancy”
a) Using appropriate action verb
b) Specifying the outcome measure
c) Specifying the study setting and time period
d) All the above
Answer: d) All the above

Which of the following verbs is preferably used in the statement of objectives of an

analytical research study?
a) Estimate
b) Determine
c) Study
d) Describe
Answer: b) Determine

The verb "estimate" is used in the objective of analytical research studies

a) True
b) False
Answer: b) False
Which of the following verb is used in the statement of objective of a descriptive
research study?
a) Estimate
b) Determine
c) Examine
d) Compare
Answer: a) Estimate

Identify the type of research question if the objective of a study is " To determine
the effect of tobacco cessation services on tuberculosis treatment outcomes among
patients with tuberculosis under National Tuberculosis Elimination Program"?
a) Descriptive research question
b) Hypothetical research question
c) Analytical research question
d) Experimental research question
Answer: c) Analytical research question
Examples of good and bad study objectives
• Example 1:
o Determine importance of sedentary lifestyle among diabetics (bad)
o Estimate prevalence of physical activity among diabetics (good)
o The word determine is not particularly suited for this particular statement
because it seems to be descriptive studies. Therefore, estimate prevalence of
physical activity among diabetics is ideally suited for this statement of
objective.
• Example 2:
o Assess physical activity and diabetic complications (bad)
o Estimate effect of physical activity on the rate of diabetic complications
(good)
o Assess physical activity and diabetic complications. I think they are trying to
do again a descriptive study. Therefore, estimating the effect of physical
activity on the rate of diabetic complications in a group of diabetes is what
they are doing. So, the word estimate is preferable.
• Example 3:
o Evaluate depression and diabetes (bad)
o Determine whether depression is more common among diabetics as
compared to healthy individuals (good)

Find and deal with a poor or irrelevant research question:

• Try to answer it
o The answer may be of no use of anyone
o There may be no answer
• Try to reframe it
 03
Literature Review

• Research is a systematic investigative process to increase our existing knowledge

about your concern subject of interest or to revise our existing knowledge.
• Research may be basic or applied.
o Basic research is increasing an existing knowledge.
o Applied research is that applying this basic research to develop new
processes, new products, new knowledge or throw your light over an
unknown area.

Literature review (LR)

What is it? Ethical concerns in

Why needed? Write up LR
(Not just summary) LR

Honest
Saves time and Information Critical appraisal
Process: Introduction presentation
work seeking (Most imp)
without distortion

Knows the subject Select unbiased Emperical Scholarly highlight

Information retrival Organize
better and valid articles literature weakness

Cite the
Suggest new Database Scholarly not too
Summarize Summary source/reference
research (PubMed) critical
accurately

Tabulate and
indexing (MeSH) Boolean query Compare methods, Lacunae
results

AND: connect New research

different concepts question

OR: connect same

concept

NOT: Exclude
concept
Why we require a literature review?
• It saves time and work of researcher.
o For example, when you want to develop a questionnaire for a physical activity.
So, you review a literature, you can come across an already existing
standardized, regionalized questionnaire for physical activity. So, you can use
that which you no need to spend lot of time to develop your new questionnaire
to measure the physical activity of an individual.
• It helps to know the subject matter better.
o Literature review is an important step in any health research because this is an
important link between what is known and what is not known.
• It suggest new research topics, questions & methods to the researcher.
o By reading the existing articles you may find certain lacunae in the existing
knowledge, which makes you to carry out your new research. So, it will aid
you to carry out a new question, it aids you to develop new research questions,
it aids you to develop new methods of an existing known subject.
• It identifies lacunae in the existing knowledge about a topic.
• The literature review is mainly helpful for writing the introduction, methods and
discussion section of a manuscript.
Need of literature review:

Why should we need to do a literature review?

a) Save yourself from work
b) Know the subject matter better
c) Suggest new research topics, questions and methods
d) All of the above
Answer: d) All of the above

All the following about literature review is correct EXCEPT:

a) It identifies lacunae in the existing knowledge about a topic
b) It saves valuable time for a researcher
c) It helps the researcher in arriving the conclusion of a study
d) It suggests the researcher about new research topics
Answer: c) It helps the researcher in arriving the conclusion of a study

While drafting a scientific manuscript, literature review is useful on the following

section EXCEPT:
a) Introduction
b) Methods
c) Results
d) Discussion
Answer: c) Results
What is a literature review?
Literature review is not just a summary presenting existing knowledge concisely.
1. Information seeking
a. Scan the literature efficiently using manual or computerized methods to
identify a set of potentially useful articles and books. (Systemic literature
search)
2. Critical appraisal of retrieved studies.
a. It is the most important step in literature review
b. It is the ability to apply principles of analysis to identify those studies which
are unbiased and valid which is useful for you.
Process:
It is organized research and a systematic process.
• Organize the collected information and relate it to the concerned research question.
• Synthesize the results of organized information collected by summarizing, what is and
what it is not known. (present existing knowledge concisely)
• Identify the lacunae in the literature.
• Develop new research question.

Reference Management Software to arrange the literature chronologically:

• Several reference management software are available that can arrange the
literatures chronologically.
• Some of these are Zotero, Mendeley, RefWorks, Endnote, Citationsy.
• However, among these Zotero is one of the open source reference management
software.
Literature review:

Literature review is a well thought out and organized search for all literature
published on a particular topic in a library or online database.
a) True
b) False
Answer: b) False

Which of the following is INCORRECT about literature review for a proposed study?
a) Begins with a systematic literature search
b) Involves critical appraisal of retrieved studies
c) Presents existing knowledge concisely
d) Guides the findings of the proposed study
Answer: d) Guides the findings of the proposed study

A researcher conducts a review of literature to identify a set of potentially useful

articles and books related to their research topic. This process is known as-
a) Indexing
b) Critical appraisal
c) Data management
d) Information seeking
Answer: d) Information seeking

The process of scanning the literature efficiently using manual or computerized

methods to identify a set of potentially useful articles and books is called as
a) Information seeking
b) Critical appraisal
c) Database management
d) Information retrieval
Answer: a) Information seeking
In literature review method of identifying studies which are unbiased and valid is
known as critical appraisal.
a) True
b) False
Answer: a) True

The ability to apply the principles of analysis to identify those studies which are
unbiased and valid is called as
a) Critical appraisal
b) Information seeking
c) Information management
d) Systematic Review
Answer: a) Critical appraisal

Choose the correct sequence of the steps of systematically doing literature search
from below
a) Organize the information, identify the lacunae, develop the research question,
synthesize the results
b) Identify the lacunae, develop the research question, synthesize the results, organize the
information
c) Develop the research question, synthesize the results, organize the information,
identify the lacunae
d) Organize information, synthesize the results, identify the lacunae, develop the research
question
Answer: d) Organize information, synthesize the results, identify the lacunae,
develop the research question
Information seeking:
• Scan the literature efficiently using manual or computerized methods to identify a set
of potentially useful articles and books. (Systemic literature search)

Information retrieval:
• Identifying a subset of documents whose content is most relevant to user’s need (user
defined query system structure) within a large document collection (Database
organization/management).
• It is well thought out and organized search for all literature published on a particular
topic in a library or online database.
• Information retrieval (IR) is finding material (usually documents) of an unstructured
nature (usually text) that satisfies an information need from within large collections
(usually stored on computers).
• The information retrieval system is made up of two components:
o the indexing system and
o the query system.
• Indexing is a data structure technique that allows you to quickly retrieve records from
a database file. Indexing is a component of the information retrieval system.
• Database → Indexing → Query System

What is the difference between information seeking and information retrieval?

• Information retrieval is a process of identifying an information (or an article) from a
large database by a set of queries, which is a relevant for researchers need.
• Information seeking process is like "searching with a plan" or a method of searching.
o It scans the literature efficiently using manual or a computerized method to
identify a set of potentially useful articles, valid resources over an existing
subject.
o If you want to search for some information in this MEDLINE data base, then
you type few key words in the "search" section, which would help in
retrieving the information related to those words in that database.
o The process of a precise request for information retrieval with database and
information systems is called as "Query System" and the search process is
called Information seeking which will result in Information retrieval.
Information retrieval:

The process of identifying, within a large document collection, a subset of

documents whose content is most relevant to user's need is called as
a) Information retrieval
b) Information management
c) Systematic Review
d) Narrative Review
Answer: a) Information retrieval

A researcher wants to study the effect of physical activity on reduction of systolic

blood pressure among patients with hypertension. The researcher has identified a
subset of documents which are most relevant to the research question within a large
document collection. This process is known as-
a) Information management
b) Critical appraisal
c) Information retrieval
d) Literature organization
Answer: c) Information retrieval

A researcher wants to assess effects of polyunsaturated fatty acids (PUFA) on

diabetes prognosis. For this, the researcher searches related articles in PubMed and
Google scholar. This process is known as
a) Information retrieval
b) Indexing
c) Critical appraisal
d) Data management
Answer: a) Information retrieval
Database:
• Database is the organized collection of articles, abstracts, scientific proceedings,
books, and citations used for the purpose of literature review.
• All the information about a scientific knowledge in electronized and/or non-
electronized form (books or journals or conference proceedings) are collectively
called as a database.
• Example: e-library, collection of citations.

Appropriate databases to search:

At following places, you can do a query search specifically by an indexing mechanism
and the required information can be retrieved from these databases.
• For General information about specific health related event or a disease
• Web Search Engines
▪ Google
• We cannot rely entirely on that.
• Health on Net (HON) certified sites
▪ There is an accreditation mechanism by a non-profit organization
called Health on Net, this is called HON certified websites.
▪ This HON certified websites are those accredited websites, where you
can get certain means of an authorized, certain means of reliable
information about your specific health related events that is about
general information, but by a professional, by a researcher.
• For Specific query (information)
• Specific scientific databases: They are huge databases of scientific citations,
biomedical citations.
▪ PubMed (MEDLINE)
▪ EMBASE
▪ TOXNET
▪ LILACS
▪ Trip Pro
▪ Scopus
▪ Google Scholar database
• Archived full text articles
 • Free Open Access
• Fee Based – From Libraries
▪ e-library
▪ physical library
• Systematic reviews/ Meta-analysis / EBMs
(the highest level of evidence currently available)
• Cochrane Library: collection of systematic reviews and meta analysis.
• Map of Medicine

PubMed:
• The most popular database is PubMed.
• PubMed is a huge database, comprising of more than 25 million citations f
biomedical literature.
• PubMed is maintained by National Center for Biotechnology Information situated
in US National Library for Medicine under National Institute of Health.
• PubMed is free and open to access.
• Each and every PubMed, it is a collection of abstracts and full text articles.
o Each abstract has a link out resource, where the full text article is available.
o There are certain articles where you can freely access in PubMed, through a
portal called PMC, which is called PubMed Central. So, through this PubMed
Central portal you can see the free full text articles about your concerned topic
of interest or your research question.
• There is a good tutorial which is available in the landing page of the PubMed.
• Apart from that, this US National Library of Medicine is maintaining their own set
of defined-predefined vocabulary called MeSH, which is called Medical Subject
Headings.
o MeSH (Medical Subject Headings) is the National Library of Medicine
(NLM) controlled vocabulary thesaurus used for indexing articles for
PubMed.
o It consists of sets of terms naming descriptors in a hierarchical structure that
permits searching at various levels of specificity.
o It is used for indexing and searching of biomedical and health-related
 information.
o Here you can see keywords under any abstract. If your keyword is in
concordance with NLM defined vocabulary called MeSH, then your article has
higher chances of getting identified by a set of systematic query mechanism. So,
that is why MeSH terminologies are very important.
Database:

The organized collection of articles, abstracts, scientific proceedings, books, and

citations used for the purpose of literature review, is known as-
a) Database
b) Data management
c) Critical appraisal
d) Index
Answer: a) Database

A __________ is a collection of articles, abstracts, scientific proceedings, books,

citations etc. that is organized so that it can easily be accessed while doing literature
review
a) Database
b) Critical appraisal
c) Hard disk
d) Index
Answer: a) Database

All the following are examples of databases EXCEPT

a) MEDLINE
b) EMBASE
c) CINAHL
d) Google scholar
e) None of the above
Answer: c) CINAHL

Medical Subject Headings is a controlled vocabulary thesaurus used for indexing

articles in:
a) PubMed
b) Google scholar
c) Scopus
d) Health on Net
Answer: a) PubMed
Which of the following about PubMed is incorrect?
a) PubMed comprises more than 25 million citations for biomedical literature
b) Citations may include links to full-text article from PubMed Central
c) PubMed is developed and maintained by the National Centre for Biotechnology
Information (NCBI), at the U.S. National Library of Medicine (NLM)
d) PubMed is a paid service provider for searching of literature
Answer: d) PubMed is a paid service provider for searching of literature

In the National Library of Medicine (NLM), MeSH means:

a) Medical Services Heading
b) Medical Subject Heading
c) Medical Subject Helpline
d) Medicine Services Helpline
Answer: b) Medical Subject Heading

Which of the following about MeSH is incorrect?

a) MeSH thesaurus is controlled vocabulary produced by the National Library of
Medicine
b) It consists of sets of terms naming descriptors in a hierarchical structure that permits
searching at various levels of specificity
c) It is used for indexing and searching of biomedical and health-related information
d) MeSH is used for EMBASE database
Answer: d) MeSH is used for EMBASE database
Indexing:
• Indexing is a component of the information retrieval system.
• Indexing is a data structure technique that allows researchers to quickly retrieve
records from a database file.
• It helps you to identify what you are trying to search, like a last page of your text
book.
• Indexing helps you to collect required information from the database by means of set
of user defined queries
• It covers all the terms in the database
o Common and frequent terms
o Used as delimiters

Query System:
• Query system is a component of the information retrieval.
• A database is an organized collection of data (articles, abstracts, journals, books).
o For example, MEDLINE is a bibliographic database of life sciences and
biomedical information.
o It includes bibliographic information for articles from academic journals
covering medicine, nursing, pharmacy, dentistry, veterinary medicine, and
health care.
• When an researcher wants to retrieve information in this MEDLINE database, he/she
has to type few key words in the "search" section, which would help in retrieving the
information related to those words in that database.
• The process of a precise request for information retrieval with database and
information systems is called as "Query System".
• The query system in the information retrieval process of literature review is user
defined.
• Literature search is important at the start of study as well as throughout the
project.
Boolean query (searching a database):
• The process of basic searching in a database is called Boolean query.
• It is very common in any search engine (Google or Embase or PubMed).
• This Boolean query is standardized one, which uses this most important
connections called “and” , “or”, “not” queries.
• Example: One database is about lung another database is about infections, which
encompass all infections.
o AND: Connecting different key concepts
▪ “AND’ tells the database that you want records that contain all the
words you specify
▪ On putting a Boolean query of lung and infections, it retrieves the result
of lung and infection, which is those articles, those items which are
specific to lung and infections.
o OR: Connecting synonyms of one key concept
▪ “OR” Boolean operator yields the highest number of results when
used between two given search terms
▪ On putting a Boolean query about lung or infections, it gathers
information about the entire items on lung, entire items on infections
and even the items which is common that is lung and infections, which
is lung infections.
▪ So, we get a huge search of results, when you are putting a query called
lung or infections.
o NOT: Connecting keywords which need to be excluded
▪ On putting a Boolean query called lung not infections, so in this lung
not infections, it totally remove this entire information related to
infections from the whole search including the infections related articles
and items from the lung. So, what you get is results are the items, which
is related to all items, which is related to lung except infections.
Query System:

The query system in the information retrieval process of literature review is

a) User defined
b) Provider defined
c) Conditional
d) Not structured
Answer: a) User defined

Literature searches are important to do at the start of a project; and do not need to
continue throughout the project.
a) True
b) False
Answer: b) False

In the Boolean search strategy AND tells that database that you want records that
contain all the words you specify
a) True
b) False
Answer: a) True

Which of the following search query in PubMed will give relevant articles for the
following question: “What is the burden of gastroenteritis among children?”
a) Gastroenteritis OR children
b) Gastroenteritis AND children
c) Gastroenteritis BUT children
d) Gastroenteritis NOT children
Answer: b) Gastroenteritis AND children
Which of the following Boolean operator will give the highest number of results when
used between two given search terms?
a) AND
b) NOT
c) OR
d) ALL
Answer: c) OR

For which of the following purpose is the Boolean operator ‘OR’ commonly used in
literature search?
a) Connecting synonyms of one key concept
b) Connecting different key concepts
c) Connecting keywords which need to be excluded
d) Connecting keywords to narrow down the results
Answer: a) Connecting synonyms of one key concept

Which of the following search query should be used to find the articles on chest
pain other than angina?
a) Chest pain AND angina
b) Chest pain OR angina
c) Chest pain NOT angina
d) Chest pain EXCEPT angina
Answer: c) Chest pain NOT angina
CRITICAL APPRAISAL (Selecting studies for literature review):
• It is the most important step in literature review
• It is the ability to apply principles of analysis to identify those studies which are
unbiased and valid which is useful for you.
• By means of your Boolean query or by a structured query system, you have collected
your specific articles related to do and organized everything. So, now you need to
read all those articles and critically appraisal it.
o Select articles of good qualities.
o Read and critique studies scholarly, but not be too critical.
▪ for example, an article about the randomized controlled trial about a therapeutic
regimen over lung infections is addressing over only the western population. So,
what you are going to critical appraisal is that the existing evidence is available
over the western population and Asian population is not available. Those articles
whichever is reported about Indian populations are only quasi experimental
studies, here it is scholarly critically appraisal. You are not too critical; you are
not finding a fault on it.
▪ Now, when you do a scholarly critical appraisal on it, you will identify your new
area of research, you will identify what is existing lacunae, existing gap, which
you can try to fill up by doing your new research.
o Compare methods, results, findings of all articles.
▪ When you compare it, you can understand, what is an existing knowledge, about
the different methodologies they have conducted in this particular topic?
o Tabulate information from each study & Compare
▪ You need to tabulate in your form, each study
▪ It helps you to organize.
▪ It helps you to compare the individual studies by itself and with other studies
and it will give you good idea about and it will helps you to critically appraisal
it.
▪ Place all studies chronologically: Recent studies first (at the top initial rows)
and past studies last (at the bottom rows)
 Table of Literature review:
Citation Design Objectives Study Sample Measurable Authors’
population size outcomes & conclusion
results

• Critical appraisal is a process of carefully and systematically examining research to

judge its trustworthiness, and its value and relevance in a particular context.
• Critical appraisal is often carried out using checklists that help signpost areas to look
for while reading a paper.
o There are different types of checklist depending on the type of research.
o Example:
▪ Quality of non-randomized studies of intervention (NRSI) can be
assessed using ROBINS I tool.
▪ For randomized control trials ROBINS 2.0 can be used.
▪ There are checklists available for different types of research to do
critical appraisal of existing literature.
Critical appraisal:
Critical appraisal is done in an organized and systematic manner.
a) True
b) False
Answer: a) True
Writing a literature review:
There are 3 important parts in literature review writeup.
• Introduction:
o Purpose of review
o Organization of review
o Basis for ordering
▪ Most important to least
▪ Earliest to most recent
• Empirical literature:
o Includes quality studies relevant to topic
o Explain each study using paraphrasing rather than direct quotes
o Scholarly, but brief, critique of study’s strengths and weaknesses
• Summary:
o Concise presentation of the research knowledge about a selected topic—
what is known and not known (lacunae of an existing literature).
Ethical concerns in a literature review:
• Results of previous studies are presented honestly without distortion
- It should not be read in between lines and taking only a part of your result as
such.
- This is the most important ethical concern.
• Weaknesses of previous study should be addressed/highlighted scholarly; not
necessary to be highly critical.
- Don’t question the reputation or credibility of study authors.
• Sources (References) should be accurately documented (cited).
- There are different styles to be cite sources.
▪ Vancouver style (most popular)
▪ Harvard style is available
Ethical concerns in a literature review:

Which of the following does not satisfy the ethical principles in conducting a
literature review?
a) Results of previous studies are presented without distortion
b) Weaknesses of previous studies are highlighted
c) Previous studies are accurately cited
d) Reputation of study authors are questioned
Answer: d) Reputation of study authors are questioned

Which of the following is unethical while writing a Literature Review?

a) The contents from the studies should be presented honestly
b) The contents from the studies should not be distorted
c) It is not necessary to address the weakness of the study in a scholarly manner
d) Sources should be accurately documented
Answer: c) It is not necessary to address the weakness of the study in a scholarly
manner
Types of Articles:
• Original Article:
o Original Research is the most common type of journal manuscript used to
publish full reports of data from research.
o It may be called an Original Article, Research Article, Research, or just Article,
depending on the journal.
o The Original Research format is suitable for many different fields and different
types of studies.
o It includes full introduction, methods, results, and discussion section.
• Review article:
o Review Articles provide a comprehensive summary of research on a certain
topic, and a perspective on the state of the field and where it is heading.
o These are often written by leaders in a discipline after invitation from the
editors of a journal.
o Reviews are often widely read (for example, by researchers looking for a full
introduction to a field) and highly cited.
o Reviews commonly cite approximately 100 primary research articles.
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