Research

methodology and
medical
statistics
 Part a
Research
methodology
 CHAPTER I: historical background

 Brief Historical Background of Research in Ayurveda

Knowledge of Ayurveda was recollected by Lord Brahma and ultimately it reached
mankind with the sole motto of health maintenance and health restoration.
Ayurveda Acharyas are equivalent to modern era scientists who unfolded the Trisutra
Ayurveda and enhanced the knowledge by various scientific methodologies.
Chronological analysis of Vedas, Upanishads and Samhitas reveal that Acharyas enriched
and expanded the knowledge of Ayurveda with the passage of time through their
theoretical and practical expertise.
Ayurveda is evidence based medical science. The knowledge of Ayurveda is eternal. Lord
Brahma is regarded as the creator of the world and primary researcher. He recollected
the knowledge of Ayurveda. It was an unscripted knowledge which was passed to Daksha
Prajapati. He learnt it word to word and imparted it to Ashwini Kumaras. They were twin
brothers popularly known as “Physicians of Gods”. Ashwini Kumaras enriched the same
with their theoretical and practical expertise and then surpassed this science to
Indra. But during that era, diseases started dominating the planet and people affected.
So, Bhardwaja approached Indra, and Indra showered Bharadwaja with knowledge of
Ayurveda. This is the first time Ayurveda descended to earth from the divine world.

Historical record of Ayurveda begins with a medical conference in the Himalayan

Mountains described in the collection of medical writing called Charaka Samhita. The
historical conference was a milestone in the history of medicine.
Ancient Ayurvedic knowledge was in the form of Trisutra (Hetu, Linga, Aushdha). With
the passage of time, Rishis enfolded the Trisutra and enhanced the knowledge by various
scientific methodologies. Even in this present era, Ayurveda is blessing the world with its
tremendous practical applicability in healthy and diseased state. It proves that research
in Ayurveda is a continuous process since ancient time to present era.

 Research during the Vedic Period:

Basic concepts of Ayurveda are mentioned in Mantras of Vedas; especially Rigveda
and Atharvaveda. Exploration of Vedic literature in terms of research reveals that
there is mention of 67, 82 and 289 Aushadha Dravyas in Rigveda, Yajurveda and
Atharvaveda respectively.

Names of diseases mentioned in Rigveda are Rajyakshma, Grahani, Prishtamaya,

Hridroga, Charma Roga, etc.

Artharvaveda classifies diseases into two types Shapthya and Varunya and also
mentions names of several diseases like Kasa, Harima, Kilasa, Jalodara, Gandamala,
Mutraghata, Ashmari, Arbuda, Vishamajwara, etc.
 Rigveda mentioned Tridoshas & Tridhatu. In addition to this, Atharvaveda has
clearly mentioned four types of Vayu, Pitta is regarded as Mayu, and Balasa term
has been used for Kapha. All this indicate the research process going on between
the time period of first Veda (Rigveda) and last Veda (Atharvaveda).

Three types of Aushadha Dravyas i.e. Divya, Parthiva and Apya are mentioned.
Organ transplantation, Sanjivani therapy and Rasayana are specifically mentioned
in Rigveda.
Aushadha Sukta of Rigveda is immensely important. It clearly describes the
morphology, habitat, types and uses of Aushadha Dravyas.
Atharvaveda has description of digestive fire, digestive process and seven Dhatu
metabolisms. In Atharvaveda, Yuktivyaparasharya and Daivavyapashraya treatment
principles are mentioned as well.
Furthermore, Visha Vigyan, Shalakya Tantra, Bhoota Vidya, Rasayana and Vajikarna
knowledge had been attained by physicians up to Atharvaveda period.

 Research during the Upanishad Period:

The Upanishad part of Vedas are ancient Sanskrit texts that contain some of the
critical philosophical concepts and ideas of Hinduism.
Dasha Pranayatana, Tridosha Siddhanta, Chatushpada Siddhanta are prominent
during the Upanishad era.
Chhandogya Upanishad describes the process of assimilation of food and drink.
Ingested food is divided into three parts. Coarsest part becomes faeces; the part
which is medium becomes flesh and finest one nourishes the mind.
Physicians of Upanishad era knew about Rasa and Kitta parts of Ahararasa.
Physiology of heart, etiology of diseases, Shodasha Kala Purusha, specific dietetics
for best progeny have also been described; all such descriptions are not possible
without research in these fields.

 Research during the Samhita Period /

Evidences of Researches in Ayurvedc Classics:
1) Charak Samhita
- It is the oldest and the most authentic treatise on Ayurveda. It is a classical
textbook describing Astanga Ayurveda with focus on Kayachikitsa.
- Medical ethics and etiquette are the professional values and protocols that
bind medical practitioner such as physicians, doctors, nurses, primary health
care providers and other health care practitioners to the best practices in the
profession. These are discussed in Charaka Samhta under headings such as
“Padachatushtaya”, “Vaidyavritti”, etc.
- Concept of Rasayana & Vajikarana and their clinical applications are
introduced.
- Study of microbes, its afflictions and management is dealt under “Krimi”.
- Concept of public health and its consequence and possible ways to control
them are dealt under the heading of “Janapadoddhvamsa”.
 - Symposiums of ancient Acharyas; ancient sages, desirous of knowledge about
not cleared topics assembled and proposed the different issues for discussion
among themselves. Seven symposiums are found in Charaka Samhita.
- The ancient concept of evidence is based on fourfold testing.
Classical methods are: Pratyaksha, Anumana, Aptopadesha and Yukti Pramana.
- Siddhanta concept is an evidence of ancient research method which is
systematic, critical and which makes use of various examinations and
reasoning to establish truth or fact.
Siddhanta is of four types:
i) Sarvatantra Siddhanta (common to all branches of knowledge)
ii) Paritantra Siddhanta (specific to a given branch of knowledge)
iii) Adhikarana Siddhanta (truth implied by a given context)
iv) Abhyupagama Siddhanta (hypothesis / prostulate)

2) Sushruta Samhita
- Importance is given to surgical and anatomical information of the body.
- Surgical teaching and training methodology, establishment of a hospital and
surgical theater, etc.
- Concept of communicable diseases and different methods of disease
communication (Samsargajanya Vyadhi).
- Concept of Shat Kriya Kala with reference to different stages before onset of
the disease.
- Garbhavakranti vishayak Parishad is the only symposium found in Sushruta
Samhita.

3) Astanga Hridaya
It is a treatise regarded as a summary of Charaka and Sushruta Samhita with
selected additions from other Ayurvedic writers like Agnivesha, Bhela and
Harita to make the knowledge of Ayurveda easier understandable and up-to-
date.

4) Madhava Nidana
This treatise focuses mainly on Nidana Panchaka of various diseases.

5) Bhavaprakasha Nighantu
- Introduction of many new Dravya which cannot be found in other classical
texts are mentioned in Bhavaprakasha Nighantu.
- Introduction of substitute herbs (pratinidhi dravya) for originally prescribed
drugs in Brihata Traya.

6) Sharngadhara Samhita
- The main subject of this classical text is concerned with pharmaceutical
preparations.
- Systemic description of respiration process is available.
 7) Kashyapa Samhita
- This treatise has focused on Kaumarabhritya which includes topics such as
obstetrics, midwifery and pediatric diseases.
- Ayupariksha in relation to anthropometric measurements of a child was
described in depth in order to assess not only the longevity but also the luck of
future life.
- Administration of processed gold in children is a unique practice mentioned
in Kashyapa Samihta as Suvarnaprashana.

 Research during the Modern Period:

The beginnings of modern research in Ayurveda can be traced to the pre-colonial
period and the first encounters of Europeans with indigenous healthcare systems in
India. The Portuguese physician Garcia de Orta was the first European to describe
drugs from Ayurvedic pharmacopoeias.
Hendrik Van Rheede, the Dutch Governor of Malabar, commissioned the work on
the Hortus Malabaricus, which documents the medicinal wealth of plants in Kerala.
Much of the research that followed has been from a medical historical, linguistic
and philological point view.

 Brief Historical Background of Research in Contemporary Medical Science

Medical research, also known as biomedical research or experimental medicine,
encompasses a wide array of research, extending from "basic research" (also called
bench science or bench research), – involving fundamental scientific principles that may
apply to a preclinical understanding – to clinical research, which involves studies of
people who may be subjects in clinical trials. Within this spectrum is applied research, or
translational research, conducted to expand knowledge in the field of medicine.

The earliest narrative describing a medical trial is found in the Book of Daniel, which
says that Babylonian king Nebuchadnezzar ordered youths of royal blood to eat only red
meat and wine for three years, while another group of youths ate only beans and water.
The experiment was intended to determine if a diet of vegetables and water was
healthier than a diet of wine and red meat. At the experiment endpoint, the trial
accomplished its prerogative: the youths who ate only beans and water were noticeably
healthier.
Scientific curiosity to understand health outcomes from varying treatments has been
present for centuries, but it was not until the mid-19th century when an organizational
platform was created to support and regulate this curiosity. In 1945, Vannevar Bush said
that biomedical scientific research was "the pacemaker of technological progress", an
idea which contributed to the initiative to found the National Institutes of Health (NIH) in
1948, a historical benchmark that marked the beginning of a near century substantial
investment in medical research.
 CHAPTER iI: Introduction to research

 Research
 Etymology:
Re- cerchier (to search) from old French -> recerché / recercher -> Research
The earliest recorded use of the term ‘Research’ was in 1577.
The word ‘Research’ is composed of two syllables -> “re” and “search”.
“Re” is a prefix meaning again, a new or over again.
“Search” is a verb meaning to examine closely and carefully, to test and try, or to
probe.

 Definition:
- The Advanced Learner’s Dictionary of Current English defines research as
“a careful investigation or inquiry specially through search for new facts in any
branch of knowledge.”

- The Merriam-Webster Online Dictionary defines research as “a studious inquiry or

examination; especially investigation or experimentation aimed at the discovery
and interpretation of facts, revision of accepted theories or laws in the light of new
facts, or practical application of such new or revised theories or laws.”

- Clake and Clarke: “Research is a careful, systematic and objective investigation

conducted to obtain valid facts, draw conclusions and established principles
regarding and identifiable problem in some field of knowledge.”

 Synonyms:
- ‘Research’ as a noun: Investigation, Experimentation, Testing, Exploration,
Analysis, Fact-finding, Examination, Scrutiny, Probing
- ‘Research’ as a verb: Investigate, conduct, study, enquire into, probe, explore,
analyze, examine, scrutinize, inspect, review, assess, read

 Biomedical or Medical Research:

Medical research, also known as biomedical research or experimental medicine,
encompasses a wide array of research, extending from "basic research" (also called
bench science or bench research), – involving fundamental scientific principles that
may apply to a preclinical understanding – to clinical research, which involves
studies of people who may be subjects in clinical trials. Within this spectrum is
applied research, or translational research, conducted to expand knowledge in the
field of medicine.
 Objectives of Research:
Objective is something that is aimed at to achieved.
- To discover new facts.
- To verify and test important theories.
- To analyze an event or process or phenomenon to identify the cause and effect
relationship.
- To develop new scientific tools, concepts and theories to solve and understand
scientific and non-scientific problems.
- To find solution to scientific, non-scientific and social problems.

 Purpose of Research:
Purpose is the reason for which something is done or created or for which
something exists.
Research in whatever field of inquiry has four purposes; i.e. describing, explaining
& predicting phenomena and ultimately controlling events.

1-2) Describing & Explaining: It is the attempt to understand the world we live
in. Research is concerned with acquiring knowledge, establishing facts and
developing new methods.

3) Prediction: In research, predictions are usually stated as hypotheses, i.e.

clear unambiguous statements which can be subjected to scientific
verification or refutation.
Unambiguous -> not open to more than one interpretation.

4) Control: This follows from our knowledge and the successful verification of
hypotheses. Control represents the way in which research can be applied to
real problems and situations, thus helping us to shape our environment.

 Acronym of RESEARCH – Characteristics of Ideal Research:

R = Review of literature
E = Economical
S = Scientific and Specific
E = Ethical
A = Achievable and Applicable
R = Reviewed thoroughly
C = Creative (novelty)
H = Hypothesis proven
 Anusandhana

 Nirukti:
अनु = to follow, along, along with, connected with
सन्धान = assembling, meeting, union, aiming at, perceiving, compounding -> in
regard to appropriate knowledge
Anusandhana means to follow appropriate knowledge which is perceived &
compounded.

 Paribhasha:
कार्यकारणमावस्र् द्रव्र्ाणाां गुणकमयण ोः ।
परीक्षस्र् स्थापन सम्र्क् अनसु न्धानम् उच्र्ते ॥ (PV Sharma)
Anusandhana is the study of cause and effect relationship between Dravya Guna &
Dravya Karma after several observations and through verifiable examinations to
arrive at a final conclusion.

 Paryaya:
अनुसन्धान = research
शध = validation, inquiry
सांश धन = discovery
गवेषण = literal meaning is “the search for the missing cows”. It implies the
search for the missing links between the cause and the effect.
अन्वेषण = desire to search
आधारन्वेषण = basic research
पर्ेषण = to search from all the dimensions
परीष्टि = investigation or inquiry
कल्पना = idea, hypothesis, investigation
मागयण = act of seeking or searching
वीचर्न = inquiry, research
 CHAPTER Iii: research in ayurveda

 Introduction
-> Refer to Anusandhana

The Central Council for Research in Ayurvedic Sciences (CCRAS), an Autonomous body
under Ministry of AYUSH, Govt. of India is an apex body in India for undertaking,
coordinating, formulating, developing and promoting research on scientific lines in
Ayurvedic Sciences.

 Scope of Research in Ayurveda

Scope of research in Ayurveda is done to synergize the ancient and the contemporary
sciences so that the results of such a joint venture will benefit mankind medically,
economically and ethically.

The broad scope of research in Ayurveda comprises:

- Clinical Research
- Fundamental Research
- Pharmacology Research (Pre-clinical Safety/Toxicity and Biological Activity Studies)
- Medicinal Plant Research (Medico-Ethno Botanical survey, Cultivation, Pharmacognosy)
- Drug Standardization Research
- Literary Research & Documentation

 Need of Research in Ayurveda

Need of research in traditional systems of medicine, including Ayurveda, has been felt at
all levels after the Alma-Ata Declaration of WHO.
In this modern era of science and technology, there is no space for blind faith in tradition
classical texts. The faith has been replaced by skepticism and only the truth established
by a systematic and unbiased method of experimentation and analysis is accepted.
In short, the facts supported by figures (statistics) convince the people about validity of
any concept.
Thus, Ayurveda faces a great challenge to prove its authenticity and validity. The
concepts of Ayurveda system of medicine are being re-evaluated in the modern scientific
parameters and revised accordingly as per the need of time.
However, modern research in Ayurveda has not been very rewarding for Ayurveda itself.
Much of it uses Ayurveda to extend modern bioscience.
“Ongoing Ayurvedic research is proceeding in such a way that it is of more value to
modern medicine than Ayurveda. It doesn’t strengthen Ayurveda and Ayurvedic practice.
Ayurvedic research outcomes have not tirckled down to professional’s use: neither do
they benefit Ayurveda students or practitioners.”
Prof. Em. Ram. Harsh Singh
 Porf. RH Singh always believed that Ayurveda requires a two-pronged research
enterprise:
i) Research in the science of Ayurveda: A critical literary and conceptual study of
Ayurveda basic concepts viz. Dosha, Dhatu, Mala, Agni, Ama, Ojas, Srotas, etc. is
necessary. This part of the study will need collaboration between senior Ayurvedic
and Sanskrit scholars, and scientists’ expert in fundamentals. The goal would be to
describe “Ayurvedic biology” objectively.

ii) Research on therapeutics of Ayurveda: It is done to find out better treatment

modalities for the existing diseases and for newer disease; to standardize the
treatment procedures scientifically and to establish dose, duration, indication and
side-effect profile of any given drug.

 Importance of Research in Ayurveda

- The word ‘Research’ also means to ‘search again’, that, which was lost due to various
reasons, which was already discovered and proved by our ancient Ayurvedic scholars.
- Only the facts supported by figures (statistics) established by careful investigations,
observations and experimental studies convince the people about validity of any
concept.
- Ayurveda is gaining global acceptance. Interest in Ayurveda and its public demand is
rapidly increasing. Such demand can only be fulfilled by developing an appropriate
research methodology.
- Research is important to further improve safety, standardization and quality control for
Ayurveda products and practices.

 Utility of Research in Ayurveda

Acharya Charaka mentions that every individual is unique and thus a physician should
examine each and every person as a separate unit making it practically impossible to
conduct research in Ayurveda having the main aim to achieve standardization among a
group of individuals.
The reverse pharmacology approach is a variation of research in Ayurveda which
suggests that research should begin at the clinic and proceed to the lab, unlike the
process in biomedicine where drugs are first developed in the lab and then applied to
clinical practice. In Ayurveda, more than often, it is a case of understanding how
medicines already-in-use work, rather than developing new drugs that have never been
used and therefore need testing.
Research in Ayurveda must ensure that its tenets are easily understood by all branches
of science to establish the rightful place of Ayurveda in the modern era.
A comprehensive approach in prescribing a customized line of treatment for each ailing
individual, according to his constitution, life-style and environment should be developed.
 CHAPTER Iv: types of Research

The appropriate choice in study design is essential for the successful execution of
biomedical and public health research. Research is generally divided into primary and
secondary research.
Primary research relies upon data gathered from original research expressly for that
purpose. Secondary research relies on single or multiple data sources that are not
collected for a single research purpose.

Classification of Research:
Purpose of the Study
1) Basic / Pure research
2) Applied research
Elements of Enquiry Role of the Investigator
1) Qualitative research 1) Observational research
2) Quantitative research 2) Interventional research
3) Mixed research

 Types of Research based on Purpose of Study:

1) Basic / Pure research
Gathering knowledge for the sake of knowledge is termed as ‘basic’ or ‘pure’
research.
Basic research is experimental or theoretical work undertaken primarily to
acquire new knowledge of the underlying foundations of phenomena and
observable facts, without any particular application or use in view.
Basic research is purely driven by the curiosity and desire to expand
knowledge. This type of research tends not to be directly applicable to the real
world in a direct way, but enhances our understanding of the world around us.
It is usually conducted to develop theories, principles and laws that are found
in different subjects / areas.
Basic medical research (experimental research) includes animal experiments,
cell studies, biochemical, genetic and physiological investigations, and studies
on the properties of drugs and materials.
Projects classified under “Science in Ayurveda Project” are the best examples
of Fundamental or Basic research in Ayurveda:
- Exploring functional genomics basis for medicinal properties of plants
for balancing the Doshas.
- Genomic Variation Analysis and Gene Expression Profiling of Prakriti.
- Scientific Validation of Ayurvedic Rasayana Therapy.
- Evaluation of Amalaki Rasayana on DNA repair and Immune Profile in
Human Subjects.
- Physico-Chemical Properties of Ayurvedic Metal-based Drugs: A Case
study on Rasa Sindura.
- Immunological and metabolic effect of Panchakarma.
 2) Applied research
Applied research is an investigation for ways of using scientific knowledge to
solve practical problems; not merely for the sake of gaining new knowledge.
The goal of applied research is to improve human conditions. It focuses on
analysis and solving social and real-life problems. This research is generally
conducted on a large-scale basis and is expensive.
Examples of applied research are:
- How does tobacco use in various forms affect humans?
- How can obesity be prevented?
- In what ways can depression be managed without medication?
- Is violence in the media and in video games damaging children’s
mental health?

TYPE OF PURE RESEARCH APPLIED RESEARCH

RESEARCH
PURPOSE Creation of new knowledge or
expansion of the current knowledge
without concerns to applicability.
CONTEXT Self-initiated in order to expand the
of knowledge in certain areas.
METHODS Internal validity can be specified as
the main point of concern for
fundamental researchers.
Creating of new knowledge to
achieve a solution of specific
problems.
Research objectives are set by
clients or sponsors as a solution to
specific problems they are facing.
Applied studies are usually more
concerned with external validity.

 Types of Research based on Elements of Enquiry:

1) Qualitative research
Qualitative research is collecting, analyzing and interpreting data by observing
what people do and say. It is much more subjective and uses various methods
of collecting information, mainly individual, in-depth interviews and focus
groups. It typically relies on the following methods for gathering information:
Participant observation, Non-participant observation, Field notes, Reflexive
journals, Structured interview, Semi-structures interview, Unstructured
interview, Analysis of documents and materials.

Qualitative research can be further classified into:

i) Phenomenology is a form of research in which the researcher attempts to
understand how one or more individuals experience a phenomenon.
ii) Ethnography focuses on describing the culture of a group of people which
includes attributes, values, norms, practices, language and material things.
iii) Case study focuses on providing detailed account of one or more cases; e.g.
we may study a classroom that was given a new curriculum for technology use.
iv) Grounded theory is based on the observations of data from which it was
developed.
v) Historical research allows one to discuss past events in the context of the
present condition, and allows one to reflect and provide possible solutions.
 2) Quantitative research
Quantitative research refers to the systematic empirical investigation of
quantitative properties and phenomena and their relationships. The process of
measurement is central to quantitative research because it provides the
fundamental connection between empirical observation and mathematical
expression of quantitative relationships.

3) Mixed research
Mixed research or the term ‘mixed methods’ refers to an emergent
methodology of research that advances the systematic integration, or mixing /
combining of qualitative and quantitative data within a single investigation.

 Types of Research based on Role of the Investigator:

Clinical study is a research study using human subjects to evaluate biomedical or
health-related outcomes. The two types of clinical studies are observational study
and interventional study.

1) Observational research
Observational research, also called epidemiological studies, are those where
the investigator is not acting upon study participants, but instead observing
natural relationships between factors and outcomes.
E.g.: The researcher is simply observing the answers of a survey without
influencing the outcome in any way. Another example of an observational
study would be if a researcher was trying to determine the effects that eating
strictly organic foods has on overall health.

2) Interventional research
Interventional research, also called experimental study or clinical trials, are
those where the researcher intercedes as part of the study design. These are
often specifically tailored to evaluate direct impacts of treatment or preventive
measures on diseases.
In this type of research, participants are assigned to receive one or more
interventions (or no intervention) so that researchers can evaluate the effects
of the interventions on biomedical and health-related outcomes.
Participants may receive diagnostic, therapeutic, or other types of
interventions.
E.g.: A study in which the investigator randomly assigns the participants to
receive either aspirin or a placebo for a specific duration to determine whether
the drug has an effect on the future risk of developing cerebrovascular events.
 A randomized controlled trial (RCT) is a type of scientific experiment (e.g. a clinical
trial) or intervention study that aims to reduce certain sources of bias when testing the
effectiveness of new treatments; this is accomplished by randomly allocating subjects to two
or more groups, treating them differently, and then comparing them with respect to a
measured response. One group - the experimental group - receives the intervention being
assessed, while the other - usually called the control group - receives an alternative
treatment, such as a placebo or no intervention. The groups are monitored under conditions
of the trial design to determine the effectiveness of the experimental intervention, and
efficacy is assessed in comparison to the control. There may be more than one treatment
group or more than one control group.
The trial may be blinded, meaning that information which may influence the
participants is withheld until after the experiment is complete. A blind can be imposed on
any participant of an experiment, including subjects, researchers, technicians, data analysts,
and evaluators. Effective blinding may reduce or eliminate some sources of experimental
bias.
A well-blinded RCT is often considered the gold standard for clinical trials. Blinded
RCTs are commonly used to test the efficacy of medical interventions and may additionally
provide information about adverse effects, such as drug reactions. A randomized controlled
trial can provide compelling evidence that the study treatment causes an effect on human
health.
 CHAPTER v: research process

Research should be a process that converts data into information, information into
knowledge and knowledge into wisdom.

Research methods are understood as all those methods / techniques that are used for
conduction of research.
Research methodology is a way to systematically solve the research problem. It is
understood as a science of studying how research is done. As part of it, various steps are
adopted by the researcher.

 Seven Stages / Steps of Research Process:

1) Selection of the Topic
2) Review of the Literature
3) Formulation of Hypothesis
4) Aims and Objectives
5) Material and methods
6) Observations and Results
7) Methods of Communication of Research

1) Selection of the Topic / Research Question

Usually, selection of the topic for research depends on the following aspects:
- Interest: One should select a topic of great interest to sustain the motivation.
- Magnitude: It is important to select a topic that one can manage within the
time and resources which are at disposal.
- Recent trends: Choosing a topic of current interest or recent trends provides
bright and promising opportunities for young researchers to get post-doctoral
fellowship or a position in leading institutions.
- Level of expertise: Adequate level of expertise for the task is essential.
- Relevance: The study should add to the existing body of knowledge, bridge
current gaps and be useful in policy formulation.
- Availability of data: Before finalizing the topic, availability of data must be
checked.
- Ethical issues: How ethical issues can affect the study population and how
ethical problems can be overcome should be thoroughly examined.
- Expenses: Expenses required for the research are to be estimated.
- Time period: One should have an idea about the time period which is
required for the whole research process.
- The selected topic should neither be too narrow, nor too broad. It should be
clear and practically possible.
- The selected problem should address 6 questions: What, Who, Where, When,
Why and How.
 Hulley and colleagues have suggested the use of the FINER criteria in the
development of a good research question:

F = Feasible -> Adequate number of subjects

Adequate technical expertise
Affordable in time and money
Manageable in scope

I = Interesting -> Getting the answer intrigues the investigator, peers

and community

N = Novel -> Confirms, refutes or extends previous findings.

E = Ethical -> Amenable to a study that institutional review board will approve.

R = Relevant -> To scientific knowledge

To clinical and health policy
To future research

2) Review of the Literature / Literature Survey

- Literature survey is a collection of research publications, books and other
documents related to the chosen research topic.
- Literary review is a part of research study which sets the broad context of the
study. Sources for literary review include: Books, articles, abstracts, reviews,
dissertations, websites, databases, etc.
- It sets the scope of the study and establishes the theoretical framework.
- Review of the literature helps to:
-> Sharpen the question, reformulate it or define other closely related
problems.
-> Get a proper understanding of the chosen problem.
-> Acquire proper theoretical and practical knowledge to investigate.
-> Show how the problem under the study relates to previous research
studies.
-> Know whether the proposed problem has already been solved.
3) Formulation of Hypothesis
- Hypothesis is a scientifically reasonable prediction.
- Hypothesizing is done only after survey or relevant literature and learning the
present status of the field of research. The hypothesis can be formulated
based on previous researches and observations.
- A hypothesis should always explain what is expected to happen. It should be
clear and understandable, be testable, be measurable and contain an
independent and dependent variable.
- A hypothesis is usually written in the form of an if/then statement. This
statement gives a possibility (if) and explains what may happen because of the
possibility (then). The statement could also include ‘may’.

Examples of hypothesis statements:

-> Bacterial growth may be affected by moisture levels in the air.
-> If UV light can damage the eyes, then maybe UV light is a cause of
blindness.
-> If garlic repels fleas, then a dog that is given garlic every day will not
get fleas.

4) Aims and Objectives

Aims are what one hopes to achieve by the end of the research. They should
be clear and concise statements, but expressed in general terms.
Objectives are how one intends to achieve those aims. They will include the
specific means of answering the research question that have been posed and
details of the key issues involved.
Aim is the ‘What’ and Objective is the ‘How’ of the research.

S.M.A.R.T. research objectives:

S = Specific -> Avoid general statements, include details about what is going
to be done.
M = Measurable -> There should be a definable outcome.
A = Achievable -> A less ambitious but completed objective is better than
an over-ambitious one that cannot possibly be achieved.
R = Realistic -> Logistics factors to be considered are: Time, expense, skills,
access to sensitive information, participant’s consent, etc.
T = Time constrained -> Be aware of the time-frame of the project.
5) Material and Methods
Generally, materials and methods are discussed together.
It describes WHAT WAS DONE and HOW IT WAS DONE.
This section should include a concise description of the materials, procedures,
and equipment used; including how the study was conducted, how data were
collected, and what statistical and/or graphical analyses were undertaken.
There should be enough detail so that someone else could repeat the study.
It should be arranged in a logical manner; it must be written in paragraph
form; so the materials and methods are included within the logical and/or
chronological order of use.
Description of items must include:
- Brand names of equipment
- Concentrations and quantities of solutions
- Organisms studied, their scientific names, numbers, size, sex, etc.
- Location of study site(s), if any, noting size of the site(s) and other
physical characteristics and geography.
- Primary materials used.
- Diagrams of methods or site maps may be included.
- Formula, algorithm, etc.
- Statistical analyses

6) Observations and Results

Observations are systematic data collections. Researchers use all of their
senses to examine people in controlled or natural settings or naturally
occurring situations. Observations of a field setting involves: prolonged
engagement in a setting or social situation; clearly expressed, self-conscious
notations of how observing is done; imparting attention in ways that is in some
sense ‘standardized’: recording one’s observations.
Guidelines for carrying out an observation are:
Be unobtrusive, Be objective and Be scientific.

Types of observational methods:

i) Controlled Observation: The researcher decides where the
observation will take place, at what time, with which participants, in
what circumstances.

ii) Natural Observation: The researcher observes and records the

spontaneous behavior of participants in natural surroundings.

iii) Participant Observation: The researcher joins in and becomes part

of the group which is observed to get a deeper insight; it is a variant of
natural observation.
 Results are the findings of the study based upon the methodology which was
used to gather the information. The results section should state the findings of
the research arranged in a logical sequence without bias or interpretation.
Results should be described clearly and in a way that professionals related to
the topic, upon reading or hearing the research results are able to interpret
them correctly, and assess their implications for work.

7) Methods of Communication of Research

After the statistical results are calculated and analyzed, the findings need to be
communicated. Relying on word of mouth alone or simply writing a summary
report will not help to make needed changes in clinical practice and will not
energize new people to conduct or participate in research.

Communication can be formal or informal and can occur in a multitude of

presentations. Way to promote and disseminate research findings include:
- Publication of findings in scholarly journals.
- Presentation at national or local professional conferences.
- Written clinical summary statements.
- Presentations at journal clubs.
- Dissertations

When creating an effective communication plan of the research, following

should be considered:
- Goals and objectives of the research should be specific and clearly
mentioned.
- The audiences that will most benefit from the study’s findings should be
targeted and not be overloaded with statistical analysis. Appropriate language
should be used geared toward the targeted audience.
- The most effective routes for communication are written, electronic, verbal
and graphic mediums or a combination of the same.
 CHAPTER vI: Role of the pramanas as
research tools

The scientific study of the roots and paths of knowledge is Epistemology. This term
comes from the Greek “episteme”, meaning “knowledge”, and “logos”, meaning “study” or
“science of”. The study of epistemology focuses on the means for acquiring knowledge and
how we can differentiate between truth and falsehood.

The concept of Pramanas in Ayurveda can be compared with Epistemology. The word
“Pramana” comes from “Pramaa Karanam”. “Prama” means true knowledge, and “Karanam”
can be loosely translated as the “special causative factor”. So Pramana are the means of
knowledge or that by which knowledge is gained. It also stands for testimony, proof and
evidence.

Different schools of thought and philosophy rely on different Pramanas to explain

their principles. The following five Pramanas are the major ones:
1) Pratyaksha
2) Anumana
3) Yukti
4) Upamana
5) Aptopadesha

These five were accepted as the source of reliable knowledge. These are essential in every
step of research process. Pramanas are also called as Pariksha in Ayurveda; which denotes
scientific investigation. So, Pramanas can be considered as scientific tools of research.

Pramanas as per Pramanas as per

Acharya Charaka Acharya Sushruta
Pratyaksha Pratyaksha
Anumana Anumana
Yukti Upamana
Aptopadesha / Shabda Aptopadesha / Agama
 Role of Pratyaksha Pramana as Research Tool
Pratyaksha Pramana is the means of obtaining true knowledge through direct
perception. The knowledge born out of the contact between the sense organs their
respective objects is called Pratyaksha.

Nyaya Darshana unravels the six stages involved in the perception process. These
steps are termed as Sannikarsha (contact). This is again a scientific systematic exposition
involving the observation from the gross/superficial to the minute/in depth.
These six points of contact are:
1) Samyoga: Conjoined -> The first step that includes the contact of the substance
with the sense organ.

2) Samyukta Samavaya: Inherently joined -> The second step involving the contact of
the quality of the substance. This is the perception of shape, size, colour, etc. which
are inherently present with the substance.

3) Samyukta Samaveta Samavaya: Inherence in the inherently joined -> The third
step perceives the degree of the quality, like the intensity of redness in watermelons.

4) Samavaya: Inherence -> The perception of sound, touch, etc.

5) Samaveta Samavaya: Inherently inherent -> The perception of the quality of

sound. The intensity of sound with regards to pitch, frequency and wavelength is
perceived in this stage.

6) Visheshana Visheshya Bhava: Relation of the qualification and qualified -> The
non-existence (absence) is perceived at this stage.

The most widely approved method of validation is the direct perception as it is

directly perceived by the research scholar. Through the sense organs, the observer
directly fulfills the desire to know the fact. However, as the sense organs have a
restricted scope and range coupled with the other external factors like the overlapping
between the similar entities, the direct perception may be hindered. Some of these
hindrances are overcome by making use of the modern scientific innovations in the form
of aids and devices that augment the scope of direct perception. The entities beyond the
reach of senses like the microorganisms or breathing sounds are now perceived through
devices like a microscope and stethoscope.
The direct perception is the source of knowledge for the present only as it is directly
perceived by the senses. However, the true knowledge which is attained cannot be
restricted to the present only, it is valid for the past, present and future.
This paves the way for the other means of attaining the valid & true knowledge.
Pratyaksha is essential to obtain knowledge through other Pramanas as well.
 Role of Anumana Pramana as Research Tool
Anumana Pramana is the means of obtaining true knowledge by inference.
The inference is defined as that which is preceded by the perception.
The procedure of inferring unknown knowledge from the known facts is Anumana.
It is classified into three varieties based on the inference of all the three stages of time,
i.e. past, present and future.
1) Vartamana (Present) -> Inference of a hidden fire from the presence of smoke.
2) Atita (Past) -> Inference of sexual intercourse from the presence of pregnancy.
3) Angata (Future) -> Inference of a fruit from the presence of seed.

Inference is an indirect method of validation valid for all the stages of time. It is based on
the pragmatic logic and reasoning. The research plan also expects the inference as the
main factor. The establishment of the relation between cause and effect is the aim of
logical reasoning known as research.

Anumana is also classified into two types:

1) Svartha-anumana (to provide knowledge for oneself)
2) Parartha-anumana (to provide knowledge to others)

1) Svartha-anumana
Svartha-anumana Pramana is the inference of knowledge from one’s own perspective
of observation by previous experiences.
Example: While circumnavigating repeatedly around a hill, in few specific areas of the
hill, a person quite often sees fumes emerging along with fire. Having observed the
incidence of association of fume and fire many times, the same person when
happens to see only the fumes over a different spot of the hill, with the help of his
prior knowledge, infers that from his own perspective that it is firing over that new
area of place over the hill where he saw the fumes alone. It is because of his
conception (due to previous experiences of having seen both the fumes and the fire
together), that “Where ever fire is present, there are fumes. Likewise, where there
are fumes, there must be a fire.”

2) Parartha-anumana
Parartha-anumana Pramana is the process of explaining one’s inference to someone
else with the help of Panchavayava Vakya to make the other person aware about it.
It is a method of explaining valid knowledge to someone else, or a tool for convincing
someone through proper reasoning and logic.

Panchavayava Vakya with Example:

i) Pratijna = Statement -> The mountain is on fire.
ii) Hetu = Cause -> It is inferable because of the presence of fumes.
iii) Udaharana = Example -> There are fumes present in a kitchen fire.
iv) Upanaya = Discussion -> The same is applicable for the mountain.
v) Nigamana = Conclusion -> Where there are fumes, there is a fire.
 Application of Panchavayava Vakya:
Panchavayava Vakya is an excellent model of research in Ayurveda and the
contemporary sciences. The five points of examination are:
i) Hypothesis (Pratijna)
Formulation of hypothesis is the proposition of the research problem. The
hypothesis is framed which is to be studied systematically in due course of the
research activity.

ii) Materials & Methods (Hetu)

The research plan that describes the materials and methods which would
suffice the research activity.

iii) Experimentation & Demonstration (Udaharana)

The demonstrations and experimental study are undertaken at this stage
which give scientific data that can be utilized later on.

iv) Discussion (Upanaya)

It includes the interpretation of the collected data. The possible relation
between the cause and effect is drawn logically.

v) Conclusion (Nigama)
The final conclusion deals with the approval or the rejection of the hypothesis.

 Role of Yukti Pramana as Research Tool

Yukti Pramana is accepted as a separate Pramana by Acharya Charaka.
It is the conclusion drawn on the basis of Pratyaksha and Anumana. Yukti is a part of
Anumana or logical inference, but the difference in Anumana and Yukti is that Anumana
is related with one subject or process whereas Yukti has multidimensional aspects.
The rational and fruitful combination of several factors is known as Yukti Pramana.
The wisdom which perceives objects as the result of the combination of multiple
causative factors is called Yukti. Through Yukti a person can attain the valid knowledge of
past, present and future.

Yukti helps in rational inference based on direct observation of experiments or tests.

As per the criteria of good research, good research is logical; this implies that research is
guided by the rules of logical reasoning, and the logical process of induction & deduction
are of great value in carrying out research. Scientific method which is adopted to search
for facts is also utilization of Yukti. The scientific method is a systematic step by step
procedure following the logical process of reasoning.
 Role of Upamana Pramana as Research Tool
Upamana Pramana is the means of obtaining new knowledge by comparing the similarity
with an already known thing. Upamana describes knowledge imparted by means of
analogy. The analogy is the knowledge of the unfamiliar by the virtue of similarity with
the well-known.

An analogical argument is an explicit representation of a form of analogical reasoning

that cites accepted similarities between two systems to support the conclusion that
some further similarity exists. In general, such arguments belong in the category of
ampliative reasoning, since their conclusions do not follow with certainty but are only
supported with varying degrees of strength.
Analogical reasoning is fundamental to human thought. Historically, analogical reasoning
has played an important, but sometimes mysterious, role in a wide range of problem-
solving contexts. The explicit use of analogical arguments, since antiquity, has been a
distinctive feature of scientific, philosophical and legal reasoning.

 Role of Aptopadesha Pramana as Research Tool

Aptopadesha Pramana is an authoritative statement.
Apta describes someone who is learned and is free from defects of Rajas & Tamas,
devoid of doubt, indirect and partial acquisition, attachment and aversion. Apta always
cite the truth. The instructions of Apta are known as Aptopadesha which is regarded as a
Pramana and hence it a trustworthy tool for obtaining valid knowledge.

In the present day, the reliable and factual statements of the experienced persons in
their respective knowledge areas are considered to be authentic and are therefore a
valid and approved source of knowledge.
One of the qualities of a researcher is that he/she should acquire existing knowledge and
training in physical & mental skills which are necessary to do the activities implied in
research. The existing knowledge of science can be acquired through authoritative
statements. So, in the process of research, the review of literature can also be
considered as part of Aptopadesha.
 CHAPTER viI: ethics in research

Ethics is defined as moral principles that govern a person's behaviour or the conducting of an activity.
Research ethics provides guidelines for the responsible conduct of research. In addition, it
educates and monitors scientists conducting research to ensure a high ethical standard.
Bioethics is the study of the ethical issues emerging from advances in biology and medicine.

The following is a general summary of some ethical principles in research:

Honesty: Honestly report data, results, methods and procedures, and publication status. Do
not fabricate, falsify, or misrepresent data.

Objectivity: Strive to avoid bias in experimental design, data analysis, data interpretation,
peer review, personnel decisions, expert testimony, and other aspects of research.

Integrity: Keep your promises and agreements; act with sincerity; strive for consistency of
thought and action.

Carefulness: Avoid careless errors and negligence; carefully and critically examine your own
work and the work of your peers. Keep good records of research activities.

Openness: Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

Respect for Intellectual Property: Honor patents, copyrights, and other forms of intellectual
property. Do not use unpublished data, methods, or results without permission. Give credit
where credit is due. Never plagiarize.

Confidentiality: Protect confidential communications, such as papers or grants submitted for

publication, personnel records, trade or military secrets, and patient records.

Responsible Publication: Publish in order to advance research and scholarship, not to

advance just your own career. Avoid wasteful and duplicative publication.

Responsible Mentoring: Help to educate, mentor, and advise students. Promote their
welfare and allow them to make their own decisions.

Respect for Colleagues: Respect your colleagues and treat them fairly.

Social Responsibility: Strive to promote social good and prevent or mitigate social harms
through research, public education, and advocacy.

Non-Discrimination: Avoid discrimination against colleagues or students on the basis of sex,

race, ethnicity, or other factors that are not related to their scientific competence and
integrity.
Competence: Maintain and improve your own professional competence and expertise
through lifelong education and learning.

Legality: Know and obey relevant laws and institutional and governmental policies.

Animal Care: Show proper respect and care for animals when using them in research. Do not
conduct unnecessary or poorly designed animal experiments.

Human Subjects Protection: When conducting research on human subjects, minimize harms
and risks and maximize benefits; respect human dignity, privacy, and autonomy.

 Importance of Ethics in Research:

- Promote the aims of research, such as knowledge, truth, and avoidance of error.
- Promote the values that are essential to collaborative work, such as trust,
accountability, mutual respect, and fairness.
- To ensure that researchers can be held accountable to the public.
- To build public support for research. People are more likely to fund a research project if
they can trust the quality and integrity of research.
- Moral and social values, such as social responsibility, human rights, animal welfare,
compliance, responsibility, and public health & safety are promoted.

 Institutional Ethics Committee (IEC):

The Institutional Ethics Committee of the Indian Institute of Public Health-Delhi (IIPH-D),
constituted in February 2011, is recognized as a registered body by the Drug Controller General
of India (DCGI) under the Central Drugs Standard Control Organization, Government of India.
The purpose of the IEC is to protect human subjects through ensuring highest ethical standards
and conduct in all research carried out under the auspices of IIPH-D.

The IEC is headed by a Chairperson and supported by 12 other members including the
Member Secretary. The composition of the IEC is a mix of members from different disciplines
including public health specialist, eminent scientist, medical doctors/clinicians, pharmacologist,
microbiologist, biostatistician, epidemiologist, legal expert and lay person.

As recommended in the Indian Council of Medical Research (ICMR) guidelines, the basic
responsibility of the IEC is “to ensure a competent review of all ethical aspects of the project
proposals received by it in an objective manner”. Guided by the recommendations of the ICMR,
the IEC of IIPH-D endeavours to protect and promote the dignity, rights and wellbeing of
potential research participants; ensure that universal ethical values and international scientific
standards are adhered to and contextualized to suit the local context; to advise, educate and
train the IIPH-D research community periodically; and to apprise its ethics committee member on
any updates.
 Ethics in Animal Research:
The ethical assessments related to the use of animals in research are wide-ranging. It is
generally thought that it may be necessary to use laboratory animals in some cases in
order to create improvements for people, animals or the environment. At the same time,
the general opinion is that animals have a moral status, and that our treatment of them
should be subject to ethical considerations.
Such views are reflected in the following positions:
i) Animals have an intrinsic value which must be respected.
ii) Animals are sentient creatures with the capacity to feel pain, and the interests of
animals must therefore be taken into consideration.
iii) Our treatment of animals, including the use of animals in research, is an
expression of our attitudes and influences us as moral actors.

Guidelines regarding Ethics in Animal Research:

The guidelines primarily address the «researcher» but apply to any person involved
when animals are used for research, including funding and approval bodies, which are
also responsible for making ethical assessments of projects involving experiments on
animals. The guidelines cover «laboratory animals», as defined in the
Regulations Relating to the Use of Animals in Research, but also cover all animals that
are otherwise impacted by research activities.

1) Respect for animals' dignity

Researchers must have respect for animals' worth, regardless of their utility value, and
for animals' interests as living, sentient creatures.

2) Responsibility for considering options

Researchers are responsible for studying whether there are alternatives to experiments
on animals. Alternative options must be prioritized if the same knowledge can be
acquired without using laboratory animals. If no good options are available, researchers
should consider whether the research can be postponed until alternative methods have
been developed. When justifying experiments on animals, researchers therefore must be
able to account for the absence of options and the need to acquire knowledge.

3) The principle of proportionality: responsibility for considering and balancing

suffering and benefit
Researchers must consider the risk that laboratory animals experience pain and other
suffering and assess them in relation to the value of the research for animals, people or
the environment. The possible benefits of the study must be considered, substantiated
and specified in both the short and the long term. The responsibility also entails an
obligation to consider the scientific quality of the experiments and whether the
experiments will have relevant scientific benefits. Suffering can only be caused to
animals if this is counterbalanced by a substantial and probable benefit for animals,
people or the environment.
4) Responsibility for considering reducing the number of animals
Researchers are responsible for considering whether it is possible to reduce the number
of animals the experiment plans to use and must only include the number necessary to
maintain the scientific quality of the experiments and the relevance of the results.

5) Responsibility for minimizing the risk of suffering and improving animal welfare
Researchers are responsible for assessing the expected effect on laboratory
animals. Researchers must minimize the risk of suffering and provide good animal
welfare. Suffering includes pain, hunger, thirst, malnutrition, abnormal cold or heat,
fear, stress, injury, illness and restrictions on the ability to behave normally/naturally.
Researchers must not only consider the direct suffering that may be endured during the
experiment itself, but also the risk of suffering before and after the experiment, including
trapping, labelling, anaesthetizing, breeding, transportation, stabling and euthanizing.

6) Responsibility for maintaining biological diversity

Researchers are responsible for ensuring that the use of laboratory animals does not
endanger biological diversity. This means that researchers must consider
the consequences to the stock and to the ecosystem as a whole. The use of
endangered and vulnerable species must be reduced to an absolute minimum.

7) Responsibility when intervening in a habitat

Researchers are responsible for reducing disruption and any impact on the
natural behaviour of individual animals, including those that are not direct subjects
of research, as well as of populations and their surroundings.

8) Responsibility for openness and sharing of data and material

Researchers are responsible for ensuring that there is transparency about
research findings and facilitating the sharing of data and material from experiments on
animals. Such transparency and sharing are important in order to avoid
unnecessary repetition of experiments.

9) Requirement of expertise on animals

Researchers and other parties who handle live animals must have adequately updated
and documented expertise on animals. This includes specific knowledge about the
biology of the animal species in question, and a willingness and ability to take care of
animals properly.

10) Requirement of due care

There are national laws and rules and international conventions and
agreements regarding the use of laboratory animals, and both researchers and
research managers must comply with these. Any person who plans to use animals in
experiments must familiarize themselves with the current rules.
 CHAPTER viiI: evidence based medicine

The concept of evidence based medicine (EBM), defined as the “integration of best
research evidence with clinical expertise and patient values”, has been gaining popularity in
the past decade. The practice of EBM involves a process of lifelong self-directed learning in
which caring for patients creates the need for important information about clinical and other
health care issues. EBM recognizes that the research literature is constantly changing. What
the evidence points to as the best method of practice today may change next month or next
year. The task of staying current, although never easy, is made much simpler by
incorporating the tools of EBM such as the ability to track down and critically appraise
evidence, and incorporate it into everyday clinical practice.

The work of people in the field of pediatrics and child health centers on the problems
of children and their families and careers. Questions about diagnosis, prognosis, and
treatment often arise and sometimes the answers to these questions need to be sought.
EBM allows the integration of good quality published evidence with clinical expertise and the
opinions and values of the patients and their families or caregivers. Deciding on how to treat
patients should not be based solely on the available evidence. Other factors such as personal
experience, judgement, skills, and more importantly patient values and preferences must be
considered.
The practice of EBM should therefore aim to deliver optimal patient care through the
integration of current best evidence and patient preferences, and should also incorporate
expertise in performing clinical history and physical examination.

The most important reason for practicing EBM is to improve quality of care through
the identification and promotion of practices that work, and the elimination of those that
are ineffective or harmful.
EBM promotes critical thinking. It demands that the effectiveness of clinical interventions,
the accuracy and precision of diagnostic tests, and the power of prognostic markers should
be scrutinized and their usefulness proven. It requires clinicians to be open minded and look
for and try new methods that are scientifically proven to be effective and to discard methods
shown to be ineffective or harmful.

Steps of EBM -> 5A’s Steps:

EBM is practiced in five sequential steps:
Step 1: A1 -> Ask a clinical question to identify a key problem.
Step 2: A2 -> Acquire/Access the best evidence (medical knowledge) possible.
Step 3: A3 -> Appraise the evidence (make sure it is applicable to the population and
question asked.)
Step 4: A4 -> Apply the evidence to daily clinical practice.
Step 5: A5 -> Assess your performance.
Components of EBM / EBM Triad:
1) Researched-based evidence
2) Clinical expertise
3) Patient’s values & preferences / expectations
 CHAPTER iX: scientific writing

Scientific writing is a technical form of writing that is designed to communicate scientific

information to other scientists. Depending on the specific scientific genre - a journal article, a
scientific poster, or a research proposal, for example - some aspects of the writing may
change, such as its purpose, audience, or organization.

 Nine Major Rules for Preparing a First Draft in Scientific Writing:

1) Work to understand your sources.
2) Do not directly quote from your sources.
3) Do not plagiarize.
4) Support all statements of fact and opinion with evidence.
5) Think about where you are going before you begin to write.
6) Practice summarizing information.
7) Write to illuminate, not to impress.
8) Always distinguish fact from possibility.
9) Allow time for revision.

 Steps / Stages of Scientific Writing:

1) Prewriting: It includes anything which is done before the draft such as
thinking, taking notes, talking to others, brainstorming, outlining, gathering
information, etc.
2) Drafting: Putting ideas into sentences & paragraphs to fully explain & support.
3) Revising: Think more deeply about the readers’ needs and expectations.
4) Editing: Checking for things such as grammar, mechanics and spelling.
5) Publishing: It is the process of communicating the document to others.

 Format of Scientific Writing -> IMRaD:

The structure or format of a scientific article is denoted by the acronym IMRaD;
Introduction, Methods, Results, and Discussion.
Each sub-heading refers:
Introduction -> What is the question?
Methods -> How was it studied?
Results -> What was found?
and
Discussion -> So what?
IMRaD Aspects to be covered
Introduction - The research question
- The importance of the study
- Brief summary of the issue or public health problem
- Concise review of pertinent literature
- Study approach
- What will your article contribute?

Methods - How you address your study question

- Who, what, when, and where
- Recipe that others can repeat
- Type of study design, describe the intervention
- Data sources
- Outcomes to be measured
- Describe analysis
- Statistical tests
- Ethical approval

Results - Detail individuals included and excluded

- Demographic characteristics of study groups
- Results of analyses
- Statistical significance, point estimates, and variability
- Tables and figures
- Consider supplemental digital content for online posting
- Report, but do not interpret the results

Discussion - The point or “so what” of the study

- Summary
- Compare findings with previous literature
- Implications
- Limitations: possible problems with the used methods
- Recommendation for action
- Recommendations for further study
- Conclusions
 CHAPTER X: Information technology,
Data mining and data portals

 Information Technology (IT)

Information technology (IT) is the application of computers to store, study, retrieve,
transmit, and manipulate data or information. It is also defined as “the technology
involving the development, maintenance, and use of computer systems, software, and
networks for the processing and distribution of data.”

Health information technology (HIT) is the application of IT in health and healthcare

management. HIT is defined as “the application of information processing involving both
computer hardware and software that deals with the storage, retrieval, sharing, and use
of health care information, data, and knowledge for communication and decision
making.”
Importance of HIT:
- E-prescribing; IT enables physicians for electronic prescriptions which also give scope to
view patient records, confirm medications and dosages listed on formularies and know
what medications have already been prescribed by other doctors. E-prescribing helps to
eliminate problems with illegible penmanship, reduces pharmacy staff time and avoids
paper waste.
- IT can assist medical education.
- IT has provided development of Electronic Medical Records (EMR); medical information
is converted into a single database. It reduces paper cost and allows healthcare providers
to access patient information rapidly.

 Data Mining
Data mining is a process of extracting and discovering patterns in large data sets
involving methods at the intersection of machine learning, statistics, and database
systems. Data mining is an interdisciplinary subfield of computer science and statistics
with an overall goal to extract information (with intelligent methods) from a data set and
transform the information into a comprehensible structure for further use.
Data mining is the analysis step of "knowledge discovery in databases" process (KDD).
The term "data mining" is a misnomer, because the goal is the extraction of patterns and
knowledge from large amounts of data, not the extraction (mining) of data itself.
Data Mining Elements:
- Extract, transform, and load transaction data onto the data warehouse system.
- Store and manage the data in a multidimensional database system.
- Provide data access to business analysts and information technology professionals.
- Analyze the data by application software.
- Present the data in a useful format, such as a graph or table.
 Data Portal & Database
Portal is a term, generally synonymous with gateway, for a World Wide Web site that is
or proposes to be a major starting site for users when they get connected to the Web or
that users tend to visit as an anchor site.
The basic definition of an open data portal is “A list of datasets with pointers to how
those datasets can be accessed.”

A database (DB) is an electronic filing system or an organized collection of data. A

collection of information organized in such a way that a computer program can quickly
select desired pieces of data.

Data Portals of Biomedicine:

 PubMed
PubMed is a free search engine accessing primarily the MEDLINE database of
references and abstracts on life sciences and biomedical topics. The United States
National Library of Medicine (NLM) at the National Institutes of Health maintain the
database as part of the Entrez system of information retrieval.
From 1971 to 1997, online access to the MEDLINE database had been primarily
through institutional facilities, such as university libraries. PubMed, first released in
January 1996, ushered in the era of private, free, home- and office-based MEDLINE
searching. The PubMed system was offered free to the public starting in June 1997.

https://pubmed.ncbi.nlm.nih.gov/

 Bioinformatics Center (BRC)

The Bioinformatics Resource Centers (BRCs) are a group of five Internet-based
research centers established in 2004 and funded by NIAID (the National Institute of
Allergy and Infectious Diseases.) The BRCs were formed in response to the threats
posed by emerging and re-emerging pathogens, particularly Centers for Disease
Control and Prevention (CDC) Category A, B, and C pathogens, and their potential
use in bioterrorism. The intention of NIAID in funding these bioinformatics centers
is to assist researchers involved in the experimental characterization of such
pathogens and the formation of drugs, vaccines, or diagnostic tools to combat
them.
The main goals of the BRCs are as follows:
1) To create comprehensive databases of reliable, up-to-date bioinformatic data
(genetic, proteomic, biochemical, or microbiological) related to the pathogens of
interest;
2) To provide researchers with easy access to this data through Internet-based
search and data retrieval user interfaces;
3) To provide researchers with relevant, state-of-the art computational tools for
bioinformatic analysis of these data.

https://www.niaid.nih.gov/research/bioinformatics-resource-centers
  Research Information Management Systems (RIMs)
Research Information Management Systems (RIMs), sometimes referred to by an
earlier name, the CRIS (Current Research Information System), is a database or
other information system to store and manage data about research conducted at
an institution.

Examples of RIMs:
https://www.elsevier.com/en-in
https://satn.converis.clarivate.com/converis/portal/overview?lang=en_GB
https://www.symplectic.co.uk/

Data Portals of Ayurveda:

 AYUSH Research Portal
Department of AYUSH has launched the online AYUSH Research portal on
18/04/2011 to serve the scientific community for disseminating the research
findings in the domain of Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa
Rigpa and Homeopathy researchers and allied facilities.
The main aim of this portal is to show-case the research findings in an organized
fashion and to prevent duplication of work; to encourage interdisciplinary research
and generate evidence for wide acceptance of these systems worldwide.

https://ayushportal.nic.in/

 DHARA – Digital Helpline for Ayurveda Research Articles

DHARA is the first comprehensive online indexing service exclusively for research
articles published in the field of Ayurveda.
The word DHARA in Sanskrit means “flow”. It symbolizes the facilitation of the free
flow of information on research in Ayurveda.
The DHARA project was an offshoot of a collaborative initiative between Central
Council for Research in Ayurvedic Sciences (CCRAS), New Delhi; The Ayurvedic Trust
(AVT), Coimbatore and Swiss Ayurveda Medical Academy (SAMA), Switzerland.

http://www.dharaonline.org/Home
 Part B
Medical
statistics
 CHAPTER I: Introduction

 Definitions:
- Statistics is a branch of mathematics dealing with the collection, analysis,
interpretation, presentation, and organization of data.

- Statistics is defined as “Numerical statements of facts in any department of

inquiry placed in relation to each other.”

- Medical statistics deals with applications of statistics to medicine and health

sciences, including epidemiology, public health, forensic medicine, and clinical
research. It is the science of summarizing, collecting, presenting and interpreting
data in medical practice, and using them to estimate the magnitude of associations
and test hypotheses.

- Demography is the statistical study of populations, especially human beings.

It encompasses the study of the size, structure, and distribution of these
populations, and spatial or temporal changes in them in response to birth,
migration, ageing and death.

- Epidemiology is the study and analysis of the patterns, causes, and effects of
health and disease conditions in defined populations.

 Scope of Medical Statistics:

The scope of Medical Statistics can be studied under three headings:
1) Nature of statistics
2) Functions of statistics
3) Limitations of statistics

1) Nature of statistics
According to Tipp “Statistics is both a science and an art.”
As a science, it studies the statistics systematic manner.
As an art, it uses statistics to solve the problems of real life.
Statistics is not a body of substantive knowledge but a body of methods for
obtaining knowledge.
 2) Functions of statistics
i) Simplification of data
ii) Presentation of facts in a definite form
iii) Provision of a technique for making comparisons
iv) Provision of guidance in the formulation of policies
v) Enlarge individual experience
vi) Forecasting of future behavior of epidemics
vii) Evaluation of projects by drawing inferences

3) Limitations of statistics
i) Statistics does not study qualitative phenomena.
ii) Statistical laws are not exact and cannot be universally applied.
iii) Statistics does not study individuals.
iv) Statistics can be misused. Statements supported by statistics are more
appealing and more commonly believed. Statistical methods used by less
expert hands will lead to inaccurate results.

 Importance of Statistics:
- The word statistics is used as singular or plural. Statistics as a singular noun refers
to the various methods adopted for collection, classifications, analysis and
interpretation. As a plural noun, statistics refer to data for facts.

- Statistical methods are applicable everywhere. There is no field of work in which

statistical methods are not applied.

- Economic planning without statistics is bound to be baseless. Statistics serve in

administration, and facilitate the work of formulation of new policies.

- Proper application of statistical methods to the analysis of data arising in the

medical sciences and the interpretation of the results are crucial to the
understanding and underlying medical scientific phenomena and to advancing
knowledge and practice.

- Health statistics provide a clear indicator as to the wellbeing of a population,

individual or country. Statistics in medicine help assess patients and provide insight
into subgroups within a population.

- Researchers use statistical tests to determine results from experiments, clinical

trials of medicine and symptoms of diseases. The use of statistics in medicine
provides generalizations for the public to better understand their risks for certain
diseases, such as links between certain behaviors and heart disease or cancer.
 CHAPTER Ii: Common statistical terms
and notations

 Population & Sample

In statistics, a population is a set of similar items or events which is of interest for some
question or experiment. A statistical population can be a group of existing object or a
hypothetical and potentially infinite group of objects conceived as a generalization of
experience. A common aim of statistical analysis is to produce information about a
chosen population.

In statistics, a sample is a set of data collected and/or selected from a statistical

population by a defined procedure. The elements of a sample are known as sample
points, sampling units or observations.

Example: A sample is the group of individuals who participate in a study, and the
population is the broader group of people to whom the results will apply.

Differences between Population & Sample:

BASIS FOR POPULATION SAMPLE

COMPARISON
MEANING Population refers to the collection
of all elements possessing
common characteristics, that
comprises the universe.
Sample means a subgroup of the
members of population chosen for
participation in the study.

INCLUSION Each unit of the group. Only a handful of units of

population.

CHARACTERISTIC Parameter Statistic

DATA COLLECTION Complete enumeration or census Sample survey or sampling

FOCUS Identifying the characteristics Making inferences about population

 Statistical Data
Data are plain facts, usually raw numbers. Data are the actual pieces of information that
a person collects through a study.
-> Datum (singular form) – a piece of information
-> Data (plural form) – multiple pieces of information

 Types of Data:
1) Qualitative Data
A) Nominal, Attribute, or Categorical Data: The assignment of numbers for
classification purpose. Categorical data represents characteristics such as a
person’s gender, marital status, hometown, or the types of movies they like.
Examples:
- Gender/Sex
- Religion (Buddhist, Islamic, Jewish, Christian, Hindu, etc.)

B) Ordinal or Ranked Data: One value is greater or less than another, but the
magnitude of the difference is unknown.
Examples:
- Muscle response (none, partial, complete)
- Visual analogue scale
- Socio-economic status

2) Quantitative Data / Interval Data

A) Discrete or Meristic Data: Discrete data is a count that cannot be made
more precise.
Examples:
- Number of petals on a flower.
- Number of children in a family.

B) Continuous Measurements / Data: Continuous data can be divide and

reduced to finer and finer levels.
Examples:
- Height
- Weight
- Light-years
- Blood pressure
 Variable
A variable is any characteristics, number, or quantity that can be measured or counted.
A variable may also be called a data item.
It is called a variable because the value may vary between data units in a population, and
may change in value over time.
Examples: Age, Sex, Business income & expenses, Eye colour, Vehicle type, etc.

 Types:
1) Numeric Variables
Numeric variables have values that describe a measurable quantity as a
number, like ‘how many’ or ‘how much’.
Therefore, numeric variables are Quantitative variables.
a) Continuous variable: Observations can take any value between a certain
set of real numbers.
Examples: Height, Time, Age, Temperature, etc.

b) Discrete variable: Observations can take a value based on a count from a

set of distinct whole values.
Examples: The number of registered cars, Number of business locations,
Number of children in a family, etc.

2) Categorical Variables
Categorical variables have values that describe a quality or characteristic of a
data unit, like ‘what type’ or ‘which category’.
Therefore, categorical variables are Qualitative variables.
a) Ordinal variable: Observations can take a value that can be logically
ordered or ranked.
Examples: Academic grades, Clothing size, etc.

b) Nominal variable: Observations can take a value that is not able to be

organized in a logical sequence.
Examples: Sex, Business type, Eye colour, Religion, etc.
 Normal Distribution
Normal distributions are important in
statistics and are often used in the
natural and social sciences to represent
real-valued random variables whose
distributions are not known. The normal
distributions are a very important class
of statistical distributions.
All normal distributions are symmetric
and have bell-shaped density curves
with a single peak; so it is often called a
“Bell Curve”.

Properties of Normal Distribution:

- The mean, mode and median are all equal.
- The curve is symmetric at the center.
- Exactly half of the values are to the let of the center and the other half to the right.
- The total area under the curve is 1.
 CHAPTER iiI: Collection and
presentation of data

 Collection of Data
Data collection is the process of gathering and measuring information on targeted
variables in an established systematic fashion, which then enables one to answer
relevant questions and evaluate outcomes.

 Main Data Collection Methods:

1) Registration: Registers and licenses are particularly valuable for compete
enumeration, but are limited to variables that change slowly, such as numbers
of fishing vessels and their characteristics.

2) Questionnaires: Forms which are completed and returned by respondents. It is

an inexpensive method that is useful where literacy rates are high and
respondents are operative.

3) Interviews: Forms which are completed through an interview with the

respondent. More expensive than questionnaires, but better for more complex
questions, low literacy or less cooperation.

4) Direct observations: Making direct measurements is the most accurate

methods for many variables, but is often expensive.

5) Reporting: Reporting of activities is the main alternative to making direct

measurements. It requires literacy and cooperation, but can be backed up by a
legal requirement and direct measurements.

The goal for all data collection methods is to capture quality evidence which allows
analysis to lead to the formulation of convincing and credible answers to the questions
that have been posed.
 Presentation of Data
Data presentation is the method by which people summarize, organize and communicate
information by using a variety of tools, such as diagrams, distribution charts, histograms
and graphs.

 Tabular Presentation:
Tabulation is the process of presentation of classified data in a proper order to
facilitate comparison. A statistical table is a presentation of data in vertical columns
and horizontal rows.

Essentials of a Satisfactory Table:

- A table should not be overloaded with details.
- It should be attractive and well balanced. Care should be taken in deciding the size
of a table as well as the proportion of columns and rows.
- It should be complete within itself, containing all necessary explanations.
- Units of measurement must be clearly stated.
- A table should contain all seven parts.

Parts of a Table: - 7
1) Table number
2) Title of the table
3) Captions (column heading) & stubs (row heading)
4) Body of the table
5) Prefatory or Headnote
6) Footnotes
7) Source

Classification
i) Simple or one-way table: It is the simplest table which contains data of one
characteristic only. A simple table is easy to construct and simple to follow.
ii) Two-way table: It is a table which contains data on two characteristics. In such a
case, either stub or caption is divided into two coordinate parts.
iii) Manifold table: It is a table which has more than two characteristics of data.
Manifold tables, though complex, are good in practice as they enable full
information to be incorporated and facilitate analysis of all related facts.
As a normal practice, not more than 4 characteristics should be represented to
avoid confusion.
 Graphical Presentation:
Ideally, every graph should:
- Include a title below the figure providing all relevant information.
- Be referred to as figures in the text.
- Identify figure axes by the variables under analysis.
- Quote the source which provided the data, if required.
- Demonstrate the scale being used.
- Be self-explanatory.

Types of Graphical Presentation:

1) Histogram
2) Frequency polygon
3) Frequency curve
4) Line chart / graph
5) Cumulative frequency diagram
6) Scatter / Dot diagram
7) Normal distribution curve

1) Histogram is defined as a
graphical representation of the
mutually exclusive events. A
histogram is quite similar to the
bar chart. Both are made up of
rectangular bars. The difference
is that there is no gap between
any two bars in the histogram.
The histogram is used to
represent continuous data.

2) Frequency polygon is a type of

graphical representation which gives
better understanding of the shape of
given distribution. Frequency
polygons are used for a similar
purpose as histograms, but the
frequency polygon is helpful for the
purpose of comparing two or more
sets of data. They are said to be the
extension of histograms. When the
midpoints of tops of the rectangular
bars are joined together, the
frequency polygon is made.
3) Frequency curve is a smooth curve which
corresponds to the limiting case of a histogram
computed for a frequency distribution of a
continuous distribution as the number of data
points becomes very large.
It is obtained by joining the points of frequency
polygon by a freehand smoothed curve, unlike
in a frequency polygon, where the points are
joined by straight lines.

4) Line chart / graph is a kind of

graph which represents data in a way
that a series of points are connected
by segments of straight lines.

5) Cumulative frequency diagram is a graph

plotted from a cumulative frequency table. A
cumulative frequency graph is also called an
ogive or cumulative frequency curve.

6) Scatter / Dot diagram is known by many

names, such as scatter plot, scatter graph,
and correlation chart. This diagram is drawn
within two variables, usually the first variable
is independent and the second variable is
dependent on the first variable. The scatter
diagram is used to find the correlation between
these two variables. This diagram helps to
determine how closely the two variables
are related.

7) Normal distribution curve -> Refer to Chapter II, Normal Distribution

 Diagrammatic Presentation:
A diagram is a visual form for presentation of statistical data, highlighting their
basic facts and relationship. Diagrammatic presentation of data translates quite
effectively the highly abstract ideas contained in numbers into more concrete and
easily comprehensible form.

Types of Diagrams:
1) Bar diagram
2) Pie diagram
3) Pictogram
4) Cartogram

1) Bar diagram / Bar chart is a graph that

presents grouped data with rectangular bars
with lengths proportional to the values that
they represent. The bars can be plotted
vertically or horizontally. A vertical bar chart
is sometimes called a Line graph. Only one
type of data are presented with the help of
simple bar diagram. With the help of multiple
bar diagram (multiple bar chart) more than
one type of data can be depicted at a time side
by side to represent 2, 3 or 5 series of values
for comparison. To distinguish various
components from one another, different
colours or shades may be given.

2) Pie diagram / Sector diagram is a circle

whose area is divided into as many different
sectors as there are components of the
whole data. This is done by drawing straight
lines from the center to the circumference
of the circle.
The area of the circular lamina represents
the whole data and it is equivalent to 360°
at the center. The area of each sector is
proportional to the value of the
corresponding components of the data.
3) Pictogram / Pictograph is a symbol
representing a concept, object, activity,
place or event by illustration.
Pictography is a form of writing in which
ideas are transmitted through drawing.
Such pictograms are characterized by
their simplified style, which omits all
details that are unnecessary to the
desired communication.
Pictograms are used in most modern
societies, often serving as signs or instructions
that do not depend on language-specific words.
Because of their graphical nature and fairly
realistic style, they are used in a universal
manner, so as to be more widely understood.
Some of the most universal pictograms are the
ones used for caution in regards to dangerous
materials and environments.

4) Cartogram / Cartograph is a
diagram in which the information is
shown in a geographical distribution
of a map. The map is abstracted in
order to translate the information of
the alternative variable.
 CHAPTER Iv: measures of location /
Central tendency

 Measures of Location
A fundamental task in many statistical analyses is to estimate a location parameter for
the distribution; i.e. to find a typical value or central value that best describes the data.
According to Lawrence J. Kaplan “one of the most widely used set of summary figures is
known as measures of location, which are often referred to as averages, measures of
central tendency or central location.”

 Average:
In colloquial language, an average is a middle or typical number of a list of
numbers. Different concepts of average are used in different contexts.
Often ‘average’ refers to the sum of the numbers divided by how many numbers
are being averaged.
In statistics, an average is defined as “the number that measures the central
tendency of a given set of numbers.”
Averages or Measures are statistical constants which enable us to comprehend in a
single effort the significance of the whole. They give us an idea about the
concentration of the values in the central part of the distribution.

 Percentile:
A percentile (or a centile) is a measure used in statistics indicating the value below
which a given percentage of observations in a group of observations fall.
Example: The 20th percentile is the value (or score) below which 20% of the
observations may be found.

 Measures of Central Tendency

 Arithmetic Mean:
The first measure of central location is the usual “average” that is familiar to
everyone. The mean refers to the number you obtain when you sum up a given set
of numbers and then divide this sum by the total number in the set.
 Median:
The median is the value separating the higher half of a data sample, a population,
or a probability distribution, from the lower half.
The median is the middle of a set of numbers.
Place the data in order, either ascending or descending, and the number in the
exact center of a list is the median.

Example:

 Mode:
The mode is the most common number in a set of data. The mode is found by
collecting and organizing the data in order to count the frequency of each result.
The result with the highest occurrences is the mode of the set.

Example: The mode of 1, 2, 2, 3, 5 and 6 is 2.

Some data sets have no mode, like this one: 1 2 3 4 5 6.
Others have multiple modes, like this one: 1 1 2 3 3.
 CHAPTER V: variability and its
measurement

Variability is the extent to which data points in a statistical distribution or data set
diverge from the average, or mean, value as well as the extent to which these data
points differ from each other.

 Types of Variability:
1) Biological variability: The natural variability in a lab parameter due to
physiologic differences among subjects and within the same subject over time.

2) Real variability: When the difference between two readings, observations or

values of classes or samples is more than the defined limits in the universe, it is
said to be real.

3) Experimental variability: Differences or errors in the experiments. This may be

due to subjective or objective defects of the observer or defects in the
instruments or due to sample selected for the study.

 Commonly used measures of variability:

1) Range
Range is defined as “the difference between the maximum and minimum
values of the data.”
Symbolically, Range is written as below:
‘L’ as largest item and ‘S’ as smallest items,
Then Range = L – S
The coefficient of range is the relative measure of range.

Example:
Problem -> The following data show the weights (in pounds) of 25 boys.
108, 104, 120, 108, 110, 125, 103, 112, 99, 115, 114, 96, 116, 100, 129, 117,
119, 121, 112, 111, 120, 111, 121, 101, 109 -> Find the range of data.

Arrange data in ascending order -> 96, 99, 100, 101, 103, 104, 108, 109, 110,
111, 111, 112, 112, 114, 115, 116, 117, 119, 120, 120, 121, 121, 125, 129

Lowest value / observation = 96

Highest value / observation = 129
Range = 129 – 93 = 33
2) Standard Deviation
Standard deviation (SD) is a quantity expressing by how much the members of
a group differ from the mean value for the group.
Standard deviation is a statistical term used to measure the amount of
variability around an average. The larger the variability is, the higher is the
standard deviation.

Standard deviation (also represented by the Greek letter sigma σ or the Latin
letter S) is a measure that is used to quantify the amount of variation of a set
of data values.
SD is also known as “root-mean square deviation” as it is the square root of
means of the squared deviations from the arithmetic mean.

The formula for standard deviation (SD) is:

3) Standard Error
A standard error (SE) is the standard deviation of the sampling distribution of a
statistic. Standard error is a statistical term that measures the accuracy with
which a sample represents a population.
In statistics, a sample mean deviates from the actual mean of a population;
this deviation is the standard error.

The formula for standard error (SE) is:

 CHAPTER vi: Introduction to
probability and test of significance

The term probability is derived from Latin ‘probabilitas’, from ‘probabilis’ meaning
‘provable’, ‘credible’ – ‘something likely to be true.’
Probability may be defined as the proportion of favorable outcomes to the total number
of possibilities.
Probability is the measure of the likelihood that an event will occur. The higher the
probability of an event, the more certain the event will occur.

Examples:
- When a single die is thrown, there are six possible outcomes:
123456
The probability of any one of them is 1/6.

- There are 5 marbles in a bag; 4 are blue, and 1 is red. What is the probability that a
blue marble gets picked?
Number of ways it can happen: 4 (there are 4 blues)
Total number of outcomes: 5 (there are 5 marbles in total)
So the probability = 4/5 = 0.8

Probability does not tell us exactly what will happen, it is just a guide.
The analysis of events governed by probability is called statistics.

Test of Significance:
Test of significance is a statistical technology used for ascertaining the likelihood of
empirical data, and from there, for inferring a real effect, such as a correlation between
variables or the effectiveness of a new treatment.
A typical test of significance comprises two elements:
i) Calculation of the probability of the data.
ii) Assessment of the statistical significance of that probability.

Steps in testing for Statistical Significance:

i) State the research hypothesis
ii) State the null hypothesis
iii) Select a probability of error level
iv) Select and compute the test for statistical significance
v) Interpret the results
 CHAPTER viI: parametric and
non-parametric tests:
Testing of hypothesis

Hypothesis testing in statistics is a way to test the results of a survey or experiment to

see if they are meaningful. Basically, it is a test to check whether the results are valid by
figuring out the odds that the results may have happened by chance. If the results
happened by chance, the experiment will not be repeatable.

In statistical hypothesis testing, a type I error is the rejection of a true null hypothesis
(also known as a "false positive" finding or conclusion; example: "an innocent person is
convicted"), while a type II error is the non-rejection of a false null hypothesis (also
known as a "false negative" finding or conclusion; example: "a guilty person is not
convicted").

Parametric test is the hypothesis test which provides generalizations for making
statements about the mean of the parent population.
Non-parametric test is defined as the hypothesis text which is not based on underlying
assumption, i.e. it does not require population’s distribution to be denoted by specific
parameters.

BASIS FOR COMPARISON PARAMETRIC TEST NON-PARAMETRIC TEST

MEANING A statistical test in which specific A statistical test used in the
assumptions are made about the case of non-metric
population parameter. independent variables.

BASIS OF TEST STATISTIC Distribution Arbitrary

MEASUREMENT LEVEL Interval or ratio Nominal or ordinal

MEASURE OF CENTRAL Mean Median
TENDENCY
INFORMATION ABOUT Completely known Unavailable
POPULATION
APPLICABILITY Variables Variables and attributes

CORRELATION TEST Pearson Spearman

COMMONLY USED TESTS ‘Z’ test, Student’s ‘t’ test: paired Chi-square test, Fisher’s exact
and unpaired, ‘F’ test, ANOVA test, McNemar’s test, Wilcoxon
test test, Mann-Whitney U test
 Parametric Tests:
1) ‘Z’ test
It is a statistical test where normal distribution is applied and is basically used
for dealing with problems relating to large samples when n ≥ 30.
(n = sample size)

2) Student’s ‘t’ test

It is a method of testing hypotheses about the mean of a small sample drawn
from a normally distributed population when the population standard
deviation is unknown.
The ‘t’ test is any statistical hypothesis test in which the test statistic follows a
Student’s t-distribution under the null hypothesis.

3) ‘F’ test
It is a statistical test that is used to determine whether two populations having
normal distribution have the same variances or standard deviation.

4) Analysis of Variance (ANOVA) test

It is a collection of statistical models used to analyze the differences among
group means and their associated procedures.
It is an analysis tool used in statistics that splits the aggregate variability found
inside a data set into two parts: systematic factors and random factors.
In its simplest form, ANOVA provides a statistical test of whether two or more
population means are equal, and therefore generalizes the ‘t’ test beyond two
means.
 Non-parametric Tests / Distribution Free Tests:

Chi-square test / Kye-square test

A chi-square statistic is one way to show a relationship between two categorical
variables. In statistics, there are two types of variables: numerical (countable)
variables and non-numerical (categorical) variables.
The chi-squared statistic is a single number that tells how much difference exists
between observed counts and the expected counts if there was no relationship at
all in the population.
CHAPTER VIII: Introduction to commonly
used statistical software

Statistical software are specialized computer programs for analysis in statistics and
econometrics.
The most commonly used packages for statistical analysis are:

1) MICROSOFT EXCEL
2) SPSS
3) SAS
4) STATA
5) R
6) MINITAB

1) MICROSOFT EXCEL
It is part of the Microsoft Office suite of programs. Version 1.0 was first released in 1985.

Advantages:
- Easy to use and interchanges nicely with other Microsoft products.
- Excel spreadsheets can be read by many other statistical packages.
- Add-on module which is part of Excel for undertaking basic statistical analyses.
Disadvantages:
- Excel is designed for financial calculations, although it is possible to use it for many
other things.
- It cannot undertake more sophisticated statistical analyses without purchase of
expensive commercial add-ons.

2) SPSS
SPSS stands for Statistical Package for the Social Sciences. It was one of the earliest with
Version 1 being released in 1968.

Advantages:
- Easy to learn and use.
- Can use either menus or syntax files.
- Excels at descriptive statistics, basic regression analysis, analysis of variance, and some
newer techniques such as Classification of Regression Trees (CART).
Disadvantages:
- Has few of the more powerful techniques required in epidemiological analysis, such as
competing risk analysis or standardized rates.
3) SAS
SAS stands for Statistical Analysis System. It was developed at the North Carolina State
University in 1966.

Advantages:
- Can use either menus or syntax files.
- More powerful than SPSS.
- Commonly used for data management in clinical trials.
Disadvantages:
- Harder to learn and use than SPSS.

4) STATA
Stata is a more recent statistical package with Version 1 being released in 1985. Since
then, it has become increasingly popular in areas of epidemiology and economics.

Advantages:
- Can use either menus or syntax files.
- More powerful than SPSS; equivalent to SAS.
- Excels at advanced regression modelling.
- Has its own in-built structural equation modelling.
- Has a good suite of epidemiological procedures.
- Researchers around the world write their own procedures in Stata, which are then
available to all users.
Disadvantages:
- Harder to learn and use than SPSS.
- Does not yet have specialized techniques such as CART or Partial Least squares
regression.

5) R
S-plus is a statistical programming language developed in Seattle in 1988. R is a free
version of S-plus developed in 1996.

Advantages:
- Very powerful; easily matches or even surpasses many of the models found in SAS or
Statas.
- Researchers around the world write their own procedures in R, which are then available
to all users.
- Free of charge
Disadvantages:
- Much harder to learn and use than SAS or Stata.
6) MINITAB
Minitab is a command- and menu-driven software package for statistical analysis. It is a
statistical package developed at the Pennsylvania State University in 1972.

Advantages:
- Minitab is a versatile statistics package that is cheaper and requires less disk space than
SPSS and SAS.
- Analysis can be performed using drop-down menus or syntax, accommodating both
beginners and advanced users.
- Simplicity makes it easy to learn for beginners.
- User interface and output available in English, French, German, Japanese, Korean,
Simplified Chinese, and Spanish.
Disadvantages:
- The range of statistical analyses that Minitab can perform straight after installation is
not as wide as in other packages such as SPSS and SAS.
- Minitab is primarily a statistical analysis package, and as such is a weaker choice for
pure mathematical uses, with less ability to perform mathematical and numerical
analyses.

Importance of Software in Statistics:

- As quantitative research grows, application of statistical software (SS) becomes a more
crucial part of data analysis. Researchers are experiencing a transition from manual
analysis with paper to more efficient digital/electronic analysis with statistical software.
It identifies the prerequisites of producing world-class studies by using modern SS
solutions.

- SS allows researchers to avoid routine mathematical mistakes and produce accurate

figures in their research if they input all data correctly.

- SS allows researcher to write their own procedures which may be easily shared and
made available to all users depending on the used software.

- Teaching statistics at the university level is constantly changing due to the influence of
modern technology. The use of statistical software for computations and visual
representations, enable students’ active knowledge constructions by “doing” and
“seeing” statistics.