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BPH VII SEMESTER

PUBLIC HEALTH RESEARCH

PUBLIC HEALTH RESEARCH COMPILED BY ANIL SHRESTHA


BIRAT HEALTH COLLEGE
UNIT 1: INTRODUCTION TO RESEARCH
1.1: Meaning, Definition, Purpose of research quality and importance of research in public
health.
Meaning:

 Research in common language refers to search for knowledge.


 In simple language, research means to search again.
 A detailed study of a subject, especially in order to discover (new) information or reach
a (new) understanding.
 Somebody defines research as journey from unknown to known while other defines it as
art of scientific investigation.
Definition:
• Research is a systematic investigation to find answer to a problem. (Burns 1994)
• Research is a systematic and organized effort to investigate a specific problem that needs
a solution (sekaran, 1992)
• Research defined as “systematized efforts to gain new knowledge.” (Redman and Mory).
• According to the American sociologist Earl Robert Babbie, “Research is a systematic
inquiry to describe, explain, predict and control the observed phenomenon. Research
involves inductive and deductive methods.”
• Inductive research methods are used to analyze the observed phenomenon whereas,
deductive methods are used to verify the observed phenomenon.
• Information gathering
• Exploratory: e.g., discovering, uncovering, exploring
• Descriptive: e.g., gathering info, describing, summarizing
• Theory testing
• Explanatory: e.g., testing and understanding causal relations
• Predictive: e.g., predicting what might happen in various scenarios

Characteristics of research:
• Empirical - based on observations and experimentation on theories.
• Systematic - follows orderly and sequential procedure.
• Controlled - all variables except those that are tested/experimented upon are kept
constant.
• Employs hypothesis - guides the investigation process
• Analytical – There is critical analysis of all data used so that there is no error in their
interpretation.
• Objective, unbiased, & Logical - all findings are logically based on empirical.

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• It establishes the relationship between cause and effect.
• It requires deep knowledge of the subject.
• Accuracy is one of the important character of research, the information that is obtained
while conducting the research should be accurate and true to its nature.
Important:
• Add to scientific knowledge
• Understanding the Cultural Perceptions of Disease & Healthcare through Research.
• Support managerial aspects of health development.
• Prevent the development or recurrence of disease and reduce the number of people who
become ill.
• Means to Understand Various Issues and Increase Public Awareness

1.2: Identification of research area and title finalizing process


Following factors may be considered for deciding the research area.
FINER
F= Feasible; the area should be feasible in terms of technical, financial and administrative
capabilities.
• It should be able to answer the following questions
• Can adequate number of subjects be available?
• Is there adequate expertise to do the work?
• Is the research is affordable?
• Can it be managed well
• Will the administrative support be available?
I= interesting; the selected problem area should be of interest to health policy manager and
researcher.
N=Novel; it should be able to fill the gap in existing knowledge and/ or able to solve the problem
in area.
E=Ethical; in applied research, most of the time human beings are involved and hence it is
necessary to fully observe ethical policies and procedures.
R=Relevant; selected problem should be relevant and have priority for that geographical area,
region and country

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Criteria for selecting a research topic:
• Relevance
• Avoidance of duplication
• Urgency of data needed
• Feasibility of study
• Applicability of result
• Ethical acceptability
• Political acceptability of the study

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UNIT 2: TYPES OF RESEARCH
2.1: Qualitative and Quantitative research approach

Quantitative Qualitative

A type of educational research in which the A type of educational research in which the
researcher decides what to study. researcher relies on the views of the participants.
Quantitative research looks at patterns in Qualitative research gathers information that is
numeric data. not in numerical form
Quantitative research gathers data in numerical Qualitative data is typically descriptive data
form which can be put into categories or
measured in units of measurement

This type of data can be used to construct graphs When you think of qualitative data, Think of the
and tables. word 'quality' – because in qualitative analysis we
are taking a deep quality look at a phenomenon

Quantitative Research Examples Qualitative Research Examples


• Application forms • Diary accounts
• Closed ended Questionnaires • Document review
• IQ Tests • Open ended Questionnaires
• Measurements • Unstructured interviews
• Unstructured observations

Purpose
 Qualitative: To understand & interpret social interactions.
 Quantitative: To test hypotheses, look at cause & effect, & make predictions.
Group Studied
 Qualitative: Smaller & not randomly selected.
 Quantitative: Larger & randomly selected.
Variables
 Qualitative: Study of the whole, not variables.
 Quantitative: Specific variables studied.
Type of Data Collected
 Qualitative: Words, images, or objects.
 Quantitative: Numbers and statistics.

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Forms of Data Collected
 Qualitative: Qualitative data such as open - ended responses, interviews, participant
observations, field notes, & reflections.
 Quantitative: Quantitative data based on precise measurements using structured &
validated data-collection instruments.
Role of the Researcher
 Qualitative: Researcher & their biases may be known to participants in the study, &
participant characteristics may be known to the researcher.
 Quantitative: Researcher & their biases are not known to participants in the study, &
participant characteristics are deliberately hidden from the researcher (double blind
studies).
Results
 Qualitative: Particular or specialized findings that is less generalizable.
 Quantitative: Generalizable findings that can be applied to other populations.
Final Report
 Qualitative: Narrative report with contextual description & direct quotations from
research participants.
 Quantitative: Statistical report with correlations, comparisons of means, & statistical
significance of findings.
What is to be observed?
 Qualitative: ¤ Qualities ¤ Behaviour ¤ Complexities
 Quantitative: ¤ Quantities ¤ Scales ¤ Trends
What are the type of questions asked?
 Qualitative: ¤ Why? ¤ How?
 Quantitative: ¤ How many? ¤ What?
How the results are interpreted (analysis)?
 Quali: ¤ Explore, explain, understand ¤ Narrative ¤ Particular ¤ Mainly inductive
reasoning: conclusions can be drawn from the evidence no matter how incomplete
 Quanti: ¤ Describe, measure, predict ¤ Statistical tables and chart ¤ Universal ¤ Mainly
deductive reasoning: everything is known before conclusions can be drawn

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Characteristics of each

Quantitative Research Qualitative Research

Ask specific narrow Qs Ask broad, general Qs.


Collects data from participants generally in Collects data consisting largely of words (text) or
numerical form. image (picture).
Analyses numbers using statistics Descriptions and analysis of words for themes.
Conducts the inquiry in unbiased, objective Conducts inquiry in subjective, biased manner.
manner

2.3: Applied Research

 It so called Professional Research


 Applied research is a methodology used to solve a specific, practical problem of an
individual or group.
 The study and research is used in business, medicine and education in order to find
solutions that may cure diseases, solve scientific problems or develop technology.
 Applied research is defined as a research which is used to answer a specific question,
determine why something failed or succeeded, solve a specific, pragmatic problem
related to product development, or to gain better understanding.
 Applied research “aims at finding a solution for an immediate problem facing a society,
or an industrial/business organisation.
 Applied research is designed to solve practical problems of the modern world, rather
than to acquire knowledge for knowledge's sake. The goal of applied research is to
improve the human condition.
 It focuses on analysis and solving social and real life problems.
 Research which studies the relationship and applicability of theories or principles to the
solution of a problem.
 It is designed to solve practical problems of the modern world, rather than to acquire
knowledge
Characteristics of Applied research:
• Phenomenon observed
• Question(s) asked
• Problem(s) established
• Draws upon larger research community
• Seeks to legitimize the field and profession
• Results yield new information/knowledge
• Should adhere to ethical standards
Formative research:

 Assessment tool to modify and improve products or programs during their planning,
development, implementation.

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• Proscriptive rather than descriptive.
• Assessment tool to modify and improve
• “… Research conducted during the development of a program to help decide on and
describe the target audience, understand the factors which influence their behaviour, and
determine the best ways to reach them. It looks at behaviours, attitudes and practices of
target groups, involves exploring behavioral determinants, and uses a myriad of methods
to collect data. Formative research may be used to complement existing epidemiological
and behavioral data to assist in program planning and design.”
• Entails asking:
- What methods worked well?
- What did not work well?
- How can implementation be improved?
- How can the theory informing the policy, and the policy itself, be improved?
When to Use Formative Research
1. Before (always):

 Critical – formulates the intervention

2. During:
• Monitoring and evaluation framework
• Quality of intervention delivery
• Intended effects
• Respond to concern
3. After:

 Program evaluation

Characteristics:
• Practical- informs decision making
• Designed to support change
• Improvement or reform of project
• Process-oriented
• Systematic

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Operational Research
Definition
• “Operational Research is the scientific study of operations for the purpose of making
better decisions.”
• WHO (2003) “The use of systematic research techniques for program decision making to
achieve a specific outcome.”
Objectives:
• Decision making and improve its quality.
• Identify optimum solution.
• Integrating the systems
• Improve the objectivity of analysis
• Minimize the cost and maximize the profit
• Improve the productivity.
• Success in competition and market leadership
• To develop more effective approaches to the programming.
Scope of operational research:
• National plans and budget.
• Health care services and National Health Programs.
• Government development and public sector unit.
• Industrial establishment and private sector unit.
• National defence services.
• Research and development in engineering.
• Public works department.
• Business management.
• Agriculture and irrigation projects.
• Education and training.
• Transport and communication
2.4: Basic Research
• Basic research is also known as pure research and fundamental research.
• The term basic research refers to study and research that is meant to increase our
scientific knowledge base.
• This type of research is often purely theoretical with the intent of increasing our
understanding of certain phenomena or behaviour but does not seek to

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• For example; basic science investigations probe for answers to questions such as:
• How did the universe begin?
• What are protons, neutrons, and electrons composed of?
• What is the specific genetic code of the fruit fly?
Features of Basic Research:
• Increases understanding of fundamental principles
• Builds new knowledge
• Often purely theoretical in nature
• Usually a source of new scientific ideas or new perspectives about the world
• Lays down the foundation of science
• Mainly academic in nature or carried out by universities
• Supports theories that explain how the world operates
• Increases man’s scientific knowledge base or understanding of phenomenon
• Does not seek to solve problems
• Outcome does not have potential, direct economic value
• No immediate practical use
• Generates new ideas, principles and theories or simply expand man’s knowledge.
• Expands knowledge about things
• It is not intended to create or invent something
Basic research steps:
• Define research problem
• Review of literature
• Formulate hypotheses
• Preparing the research design
• Data collection
• Data analysis
• Interpretation and report writing

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Basic Research process

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UNIT 3: RESEARCH PROBLEM
3.1: Introduction and Selection criteria of the problem
Introduction:
• One of the most difficult phases of any research project is the choice of suitable problem.
• The identification of a good research problem should be considered a discovery in itself,
it is a researcher’s perception or a recognition of problem that motivates research.
• The problem exists when we don't have enough information to answer a question.
Criteria of problem selection
1. Originality
• While selecting a problem originality should be maintained.
• The purpose of research is to fill the gaps in existing knowledge to discover new facts and
not to repeat already known facts.
• Appropriate knowledge about previous research to identify our own research problem
and to avoid duplication
2. Neither general nor specific
• If the problem is very general, it is usually too vague to be tested.
• If the problem is very specific, it is too narrow to important or consequential.
• At any rate some kind of compromise must be made between generality and specificity.
3. Significance
While selecting a problem for the study researchers should pose the following question:-

 Is the problem important one?

 Will client benefits out of study?

 Will the result lead to practical implication?


4. Feasibility
• The feasibility of a research problem needs to be pragmatically examined.
• Regardless of how significant or researchable a problem may be, pragmatic consideration
such as time , money, facilities and equipment, methodology, source of data, study design
etc

5. Suitability
• The suitability of the problem for a particular research worker is the matter of the
feasibility.
• He should possess the required competence, knowledge and understanding.

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• He should be skill full enough to develop, administer and interpret the necessary data
gathering devices and procedures.
• He should be competent enough to carry out all the steps of his project.
6. Facilities
• Research requires certain facilities such of the problem should make significant
contribution to the concerned body of knowledge or to the solution of some significant
practical problem must be considered.
7. Usefulness
• The study of the problem should be socially relevant. This consideration is particularly
important in the case of higher level academic research and sponsored research.
8. Researcher’s interest
• The problem should interest the researcher and be a challenge to him. Interest in a
problem depends upon the researcher’s educational background, experience, outlook and
sensitivity.
9. Researcher’s competence
• The researcher must be competent to plan and carry out a study of the problem. He must
have the capacity to deal with that problem.
10. Research ability
• The problem should be researchable, amenable for finding answers to the question
involved in it through scientific method.
11. Importance and urgency
• In selecting problems, their relative importance and significance should be considered.
An important and urgent problem should be given priority over an unimportant one.
12. Solvability
• The problem chosen for study should be solvable.
13. Interesting
• The problem should be interesting to investigator himself and other.
3.2: Sources of problem

 Reading
 Academic experience
 Daily experience
 Exposure to field situation
 Consultations
 Brain storming
 Research
 Intuition

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1. Reading
• When we critically read books and articles relating to the subject of our interest, various
question may arise in our mind. Similarly, areas of research may strike to our mind when
we read research report.
2. Academic experience
• Classroom lecture, class discussion, seminar discussion and out of class exchange of ideas
with fellow students and professor will suggest many stimulating problems to be studied.
3. Daily experience
• We learn different things daily in our life. If we are alert, inquisitive and sensitive to life
situations, we may hit upon questions worth of investigation.
4. Exposure to field situations
• Field visit, internship training and extension work provide exposure to practical problems
which call for study.
5. Consultations
• Researchers, administrators, field visit and business executives will help a researcher to
identify meaningful problems for research.
6. Brain storming
• Intensified discussion within a group of interested persons may often be a means of
identifying pertinent questions and of developing new ideas about problem.
7. Research

 Research on one problem may suggest problems for further research.


8. Intution

 Sometime new ideas may strike to one’s mind like a flash.


3.3: Examples of problem
• Weight gain from early to middle adulthood may increase risk of major chronic diseases.
• Prevalence of RTA in urban area
• Knowledge and perception about family planning among married couple.
• Prevalence of use of family planning methods in newly married couple.
• Knowledge attitude about contraceptive devices among secondary students.
• Knowledge of first aid among ambulance driver.
• Job satisfaction among nurses working at private hospital.

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UNIT 4: REVIEW OF THE LITERATURE
4.1: Process of search, documentation and reference style
Definition of literature review
It is a systematic identification, location, scrutinizing and presentation of summary of written
materials that contain information on the related research problems.
Review of literature is:

 The selection of available documents (published and unpublished) on the topic which
contains: information, ideas, data, methods and evidences.
 The systematic analysis of main variables and arguments (just not gathering information,
evidences)
 Critical evaluation formerly linked to justification and methodology
What is literature review?
A literature review is a way to:

 Compare studies and know “what’s out there” on a specific topic.


 Analytically examine existing body of research.
 Identify an article that documents a particular fact.
 Bring order to an abundance of information spread across too many places.

Goals of Literature review:

 Demonstrate familiarity with a body of knowledge and to establish credibility.


 Put your work in correct and know what work others have done.
 Discover ‘best practices’ and ‘worst nightmares’
 Fulfill intellectual and personal curiosities

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Types of review

 Self-study reviews
o Increases reader’s confidence in an area that is rarely published.
 Context Reviews
o Places project/research in the big picture
 Historical reviews
o Traces the development of an issues over time Theoretical Reviews Compare how
different theories address an issue.
 Methodological reviews
o Points out how methodologies vary by study
 Integrative reviews
o Summarizes what is known at a particular point in time.
Source of literature:

 Published information
 Unpublished information
 Experts, scientific societies and organizations
Possible source of literature review

 Primary sources – The articles published by person who conducted the research study.
Most of the articles, published in journals are the original reports and are considered as
primary source. It can be from individuals, groups or organizations
 Secondary sources – The articles written up on the basis of findings of other investigations
(not original) e.g. review articles.
Places where information article are available
Community and district level

 Clinic, hospital statistics (routine records) of treatments, observations, Local surveys,


personal reports, district of local publications
National level

 Articles in journals and documentations of national level like publications Nepal health
research council, MOH, Journals of different associations and centre.
International level

 IDRC, UNICEF, UNFPA, WHO etc

Function of literature review

 Provides a theoretical background


 Helps to establish links between your proposed study and what has already been studied.
 Enables that your findings contributes to existing knowledge base
4.2: Uses of literature in research/ Purpose / Importance
Why? (In general)

 To avoids unintentional duplication of the information.

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 To focus on the topic
 To better understand about subject area.
 To develop and to inform research approach
 To develop justification of the study
 To develop conceptual framework of the study
Why? (In specific)

 To focus on specific problem, issue and debate


 To relate to the problem, issues and debate in terms that show a balance between the
theoretical, methodological and practical aspects of the topic
 To include a clearly stated research methodology based on existing literature
 To provide an analytical and critically evaluative stance to the existing literature on the
topic
 It helps to generate or focus on a research problems
 It ascertains which is already known in relation to topic of interest
 It helps in understanding the insight necessary for the development of a broad conceptual
context.
 It seems to be function of providing a perspective on the problem in terms of interpreting
the result of the study
 It helps to be familiar with the research strategy and specific methods and procedure,
measuring, instrument and statistical analysis that could be used in the study
In your own thesis, it helps
1. To bring clarity and focus to your research problem
2. Improve your research methodology
3. Broaden your knowledge base in your research area.
4. Contextualize your findings.
Searching in the internet

 Using online version of the Journals


 Using database: Pubmed, Medline, Science Direct, CINAHL, Psychinfo, Cochrane
 Online magazines, e-books, etc.
 Use a search engine: Yahoo, Google….
 Use keywords, synonymous words of your topic
 Use journal+ keyword to find articles in the journal
 Use “keywords” to avoid unrelated materials
 Use keywords pdf to get PDF file only
 Use keywords ppt to get power point file only
 Joining chat groups, email group, professional association
 Searching bibliographies in encyclopedias such as
Searching in the library

 Developing working bibliography


 Using library’s electronic book catalog
 Examining the bibliography at the end of the book
 Examining the references at the end of the article
 Searching bibliographies in encyclopedias

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Searching outside the library

 Discuss with experts


 Contact with supervisors
 Discuss with local people, non-medical professional (to get different perspectives)
 Discuss and share with your friends
 Try to get many comments
Rules for good literature review

 Identify and discuss the relevant key study on the topic


 Include as much update material as possible
 Critically evaluate the material and show your analyses.
 Use illustrations and examples to justify your analyses and arguments
 Be analytical, evaluative and critical and show this in your review
 Make your review worth reading by making yourself clear, systematic, coherent
 Explain why the topic is interesting
 Don’t omit classic word without proper reference
 Don’t use jargon
 Don’t use the list of the materials
Steps/ Process in literature review
1. Establish research focus
2. Identify where to search
3. Select appropriate search terms
4. Use Operators and wildcards
5. Organize Research history
6. Determine the relevant Literature
7. Analyze, Synthesis and Summarize evidence into a report
Step 1: Establish research focus

 Keep your topic specific and focused


 Be prepared to revise it along the way based on what you discover in the literature
Step 2: Identify where to search

 Academic Literature
o Books, scholarly journal articles
o Dissertations
 Government documents
 Policy Reports
 Grey Literature
 Papers published by professional societies
o Internet search engines: Google.com or Yahoo.com
o Online databases: Psycho Info, social Services Abstracts, Medline, ERIC

Step 3: Select appropriate search terms

 A search term is a term used to find information on your topic


 Search terms can include

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o Key words-Example: For Literature review on “Adolescent problems” possible
key words- teenage, media, effects,
o Author
o Title
o Journal or Publication
o Other descriptors
Step 4: Use Operators and wildcards

 ‘Wildcards’ are symbols that expand the scope of your search


o Eg (*)patent#
 ‘Operators’ define the relationships between words or group of words.
Note:
Operators and wildcards vary by search engine, check each database’s Help section
Examples of operators
Sample operators:

 Use AND to narrow search and retrieve records containing all of the words it separates.
 Use OR to broaden search and retrieve records containing any of the words it separates.
 Use NOT to narrow search and retrieve records that do not contain the term following it.
 Use () to select a phrase or groups of words Phrase –(participatory action research)

Step 5: Organize Research history


Document your search process:

 Keep record of all materials examined


 Keep a record of all Web searches
 Set a bookmark of the Universal Resource Locator (URL) for commonly used websites
 Record key words used for electronic searches
 Print home pages of the websites
 Photocopy journal articles , book chapters and other materials

Step 6: Determine the relevant Literature


To determine what is relevant literature

 Check article abstracts for summaries of research design and findings of reading entire
article.
 Consider type of measurement and analysis
 Consider contribution of the article/research to the field
 Does it help you know what to do or what not to do in your study?

Step 7: Analyze, Synthesis and Summarize evidence into a report

 Briefly summarizes findings


 Synthesize literature by identifying common themes

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 Differentiate b/w what is “Known” and “not known”
 Identify topics of debate
 Evaluate and analyze findings
 Identify relevance of data to your research project
Remember:

 Reference all citations and create a reference list or bibliography

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UNIT 5: FORMULATION OF RESEARCH OBJECTIVES AND HYPOTHESIS
5.1: Meaning and types of research objectives.
Meaning
• A research objective is a clear, concise, declarative statement, which provides direction to
investigate the variables under the study.
• Research objectives focus on the ways to measure the variables, such as to identify or
describe the.
• The objectives of a research project summarize what is to be achieved by the study.
Importance of objective
• Research is an organized investigation of a problem where an investigator attempts to
gain solution to a problem.
• In order to get the right solution a clearly defined objectives are very important.
• A clearly defined objective directs a researcher in the right direction.
• A clearly defined objectives are important feature of a good research study.
• Without a clear objective a researcher is aimless and directionless in conducting the
study.
• Without focused objectives, no replicable scientific findings can be expected.
Characteristics
• Research objective is a concrete statement describing what the research is trying to
achieve.
• A well-known objective will be SMART
• S – SPECIFIC
• M – MEASURABLE.
• A – ATTAINABLE.
• R – REALISTIC.
• T – TIME BOUND
• Research objective should be RELEVANT, FEASIBLE, LOGICAL, OBSERVABLE,
UNEQUIVOCAL & MEASURABLE.
• Objective is a purpose that can be reasonably achieved within the expected timeframe and
with the available resources.
• The objective of research project summarizes what is to be achieved by the study.
• The research objectives are the specific accomplishments the researcher hopes to achieve
by the study.
• The objectives include obtaining answers to research questions or testing the research
hypotheses

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Need For Objectives
• The formulation of research objectives will help the researcher as follows
Focus
• A clearly defined research objective will help the researcher to focus on the study.
• The formulation of research objectives helps in narrowing down the study to its
essentials.
• It will avoid unnecessary findings, which otherwise lead to wastage of resources
Avoid unnecessary data
• The formulation of research objectives helps the researcher to avoid unnecessary
accumulation of data that is not needed for the chosen problem.

• For example when the researcher is interested in in identifying the presence or absence
of chosen variables but not in detailed description he can avoid collection of unwanted
information.
Organization
• The formulation of objectives organize the study into a clearly defined parts or phases.
• Thus the objectives help organize the study results in to main parts as per the preset
objectives.
Gives Direction
• A well formulated objective will facilitate the development of research methodology and
will help to orient the collection, analysis, interpretation & utilization of data.
Types of Research Objectives
• General objectives.
• Specific objectives.

General Objectives

 General objectives are broad goals to be achieved.


 The general objectives of the study states what the researcher expects to achieve by the
study in general terms.
Specific Objectives
• Specific objectives are short term and narrow in focus.
• General objectives are broken into small logically connected parts to form specific
objectives.
• The general objective is met through meeting the specific objectives stated.

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• Specific objectives clearly specify what the researcher will do in the study, where and for
what purpose the study is done.
Method of stating objective
• The following guideline must be taken into account while stating the objectives…
• The objective should be presented briefly and concisely.
• The objective should cover the different aspects of the problem and its
contributing factors in a coherent way and in a logical sequence.
• The objectives should be clearly phrased in operational terms, specifying exactly
what the researcher is going to do, where and for what purpose.
• The objectives are realistic considering the local conditions.
• The objectives use action verbs that are specific enough to be evaluated.

5.2: Definition of research hypothesis


• Hypothesis is considered as an intelligent guess or prediction that gives directional to the
researcher to answer the research question.
• Hypotheses are assumptions or theories that a researcher makes and tests.
• Hypotheses are predictions about the relationship among two or more variables or
groups based on a theory or previous research (Pittenger, 2003)
• “A hypothesis is a conjectural statement of the relation between two or more variables”.
(Kerlinger, 1956)
• “Hypothesis is a formal statement that presents the expected relationship between an
independent and dependent variable.”(Creswell, 1994)

5.3: Purpose and nature of research hypothesis


• The hypothesis is a clear statement of what is intended to be investigated. It should be
specified before research is conducted and openly stated in reporting the results. This
allows to:
o Identify the research objectives
o Identify the key abstract concepts involved in the research
o Identify its relationship to both the problem statement and the literature review

 A problem cannot be scientifically solved unless it is reduced to hypothesis form


 It is a powerful tool of advancement of knowledge, consistent with existing knowledge
and conducive to further enquiry
 It can be tested –verifiable or falsifiable
 Hypotheses are not moral or ethical questions
 It is neither too specific nor to general
 It is a prediction of consequences

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 It is considered valuable even if proven false
Importance of Hypothesis

 Direct our observations


• Identifies the variables examined and data to be collected

 Describe a relationship among variables


• Can state that as one variable increases, the other will decrease; as one
variables increases, the other will increase, and so on.

 Refer to populations
• Hypotheses help researchers infer that results of a sample will translate
to a population

Functions of Hypothesis
• Hypotheses can:
– Estimate Population Characteristics
– Correlate Variables
– Display differences among Two or more populations
– Show possible Cause and Effect
5.4: Types of hypothesis
• Null Hypotheses
o Designated by: H0 or HN
• Alternative Hypotheses
o Designated by: H1or HA

Null Hypothesis
• The null hypothesis represents a theory that has been put forward, either because it is
believed to be true or because it is to be used asa basis for argument, but has not been
proved. ƒHas serious outcome if incorrect decision is made!
Alternative Hypothesis
• The alternative hypothesis is a statement of what a hypothesis test is set up to establish.
• Opposite of Null Hypothesis.
• Only reached if H0is rejected.
• Frequently “alternative”is actual desired conclusion of the researcher
Other Types of hypothesis

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• Simple
• Complex
• Empirical
• Null
• Alternative
• Logical
• statistical
Simple Hypothesis
• Simple hypothesis is that one in which there exits relationship between two variables one
is called independent variable or cause and the other is dependent variable or effect.
• Ex. Smoking leads to cancer
• The higher ratio of unemployment leads to crimes.
Complex Hypothesis
• Complex hypothesis is that one in which as relationship among variables exists.
• In this type dependent and independent variables are more than two
• Ex. Smoking and other drugs leads to cancer, tension, and chest infections etc.
• The higher ration of unemployment poverty illiteracy leads to crimes like dacoit etc.
Empirical Hypothesis
• Empirical which means it is based on evidence.
• In scientific method the word "empirical" refers to the use of working hypothesis that can
be tested using observation and experiment.
• Empirical data is produced by experiment and observation.
Null Hypothesis
• Null the hypothesis that there is no significant difference between specified populations,
any observed difference being due to sampling or experimental error.
• It is denoted by H0
Alternate Hypothesis
• The alternative hypothesis, denoted by H1 or Ha,
• Is the hypothesis that sample observations are influenced by some non-random cause.
Statistical Hypothesis
• A hypothesis which can be verified statistically called statistical hypothesis.
• The statement would be logical or illogical but if statistic verifies it, it will be statistical
hypothesis

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Directional Hypothesis
• Directional Hypothesis predicts the direction of the relationship between the
independent and dependent variable.
• Example- High quality of nursing education will lead to high quality of nursing practice
skills.
• Girl's ability of learning moral science is better than boys.
Non- Directional Hypothesis
• Non -directional Hypothesis predicts the relationship between the independent variable
and the dependent variable but does not specific the directional of the relationship
• Example- teacher student relationship influence student’s learning.
• There is no significant difference between 9th class boys and girls abilities of learning
moral values.
Casual Hypothesis
• Causal Hypothesis predicts a cause and effects relationship or interaction between the
independent variable and dependent variable.
• This hypothesis predicts the effect of the independent variable on the dependent variable
Associative Hypothesis
• Associative Hypothesis predicts an associative relationship between the independent
variable and the dependent variable.
• When there is a change in any one of the variables, changes also occurs in the other
variable

5.5: Variables

 A characteristics of a person, object, phenomenon that can take of different values.

 Example: Eye Color, Sex, Food Types, and Religion preferences can be classified (kind),
Heart Rate, Height, Weight, Blood Pressure can be measured (valued).

 If Male and Female both appear in a research project then Sex becomes a variable.
Why variable needs to be taken into consideration?

 To present and analyze the data in convenient way

 Identification of variables helps in the presentation of data

 To achieve the objective of research

 To test hypotheses

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Types of Variables

 Qualitative: Usually unmeasurable. They are classified by some characteristics. People


are categorized as to sex (male, female), eye color (blue, brown, green, etc), Political
affiliation (democrat, communist, independent etc.), Antibiotic taken (Regular, Irregular)

 Quantitative: Measurable and can be expressed numerically such as birth weight, height,
age, parity, distance, monthly income, Consultation time etc.
Qualitative Variables

 Outcome of diseases: Recovery, Chronic illness, Death

 Status of Disease Infection: Positive, Negative

 Main type of staple food eaten: Maize, Rice, Wheat etc.

 Living: Rural, Urban

 Availability of drugs: Yes, No

 Birth weight: Low, High, Normal

 Socioeconomic status: Low, High

 Education status: Illiterate, Literate

 Age: Teenager, Adolescent, Old

 Knowledge: Poor, Medium, Good

 Field of study: Public Health, Sociology, Microbiology, Medicine, Nursing etc.


Since the values of these variables are expressed in categories, we call them categorical variables.
Quantitative Variables

 Age:

 Weight:

 Height:

 Distance:

 Temperature;

 Air pollution index:

 Income:

 Intelligence score or memory test:

 Parity:

 Blood Pressure:

 WBC or RBC count:

 Volume of water drinking:

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Because the values of all these variables are expressed in numbers, we call them numerical
variables.
Quantifiable Qualitative Variables

 Often categorical variables are disguised as quantitative variables.

 For example, one might record gender information coded as 1=Male, 2=Female. One
might record encounters with an antibiotic coded as 1=Yes, 2=No. (Data is generally
easier to manipulate in an analysis spreadsheet when it's coded quantitatively)

 Still--the variable is categorical; it is not naturally measured as a number.

 Qualitative variables can be coded to appear numeric but their numbers are meaningless,
as in male=1, female=2.

 You can see how any categorical variable may be coded to look like a quantitative variable
--simply by arbitrarily assigning numbers to categories.
Types of Qualitative Variables (Categorical Variable)

 Nominal Variable: Considered by name, referred as nominal variable.


o Two types: Dichotomous (e.g. Infection: +ve and –ve; Availability of drugs: yes,
no; Gender: Male and Female) and Polychotomous (e.g. Nationality: Nepali,
Indian, American, Pakistani; Eye Color: blue, brown, green)

 Ordinal Variable: Expressed in order, referred as ordinal variable. e.g. Income: Low,
Medium, High; Birth weight: Low, High, Normal; Knowledge: Poor, Medium, Good;
Seriousness of Disease: Severe, Moderate, Mild)
Types of Quantitative Variables (Numerical Variable)

 Discrete variable: Usually thought of as being a whole unit, one that cannot be
fractionated or divided up into smaller parts.
o Examples: Intelligence score, WBC or RBC count, Parity, Number of
microorganisms, and Number of Drugs etc.

 Continuous variable: Can be divided into fractional amounts in large or small degrees.
o Examples: Height, Weight, Blood Pressure, Age, Distance, Consultation Time etc.
Independent and Dependent Variables

 In research, particularly analytical and interventional study (research hypothesis testing


study), the term independent and dependent variable are used.

 The dependent variable is the one that is expected to change as a result of the treatment.
It is not under the control of the researcher.

 The independent variable is expected to cause some effect on the dependent variable.

 Dependent variable describes or measures the problem under study

 Independent variable describes or measures the factors assumed to cause or influence


the problem.

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 e.g. Smoking -----------------------  Lung Cancer
Pressure from peers to smoke ---- Smoking

 Hypothesis: A vegetarian diet produces stronger and healthier people than does a non-
vegetarian.

 Independent variable: Type of diet (qualitative, nominal)

 Dependent variable: Strength and health score (quantitative, discrete)


Confounding Variable

 A variable that is associated with the problem and with the possible cause of the
problem is a confounding variable.

 It must be associated with the exposure and independent of that exposure be a factor.

 It interacts with the dependent variable to make the independent variable extremely
effective or ineffective.

Cause (Independent Effect/Outcome


Variable) (dependent Variable)

Other Factors
(Confounding Variables)

Example:

Malnutrition
Mother’s Education

Family income

Background variables

 Universal variable

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o E.g. Age, sex, education, occupation, Socio Economic Status, religion, marital
Status.

 Often related to independent variable

 Influence the problem indirectly.

 Background variables should be measured if they are important.

5.6: Operational definition

 It is important to define all unusual terms that could be misinterpreted.


 This definition help to establish the frame of reference with which the researcher
approached the problem.
 The variables must be defined in operational terms.

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UNIT 6: RESEARCH DESIGN
6.1: Meaning of research design

 A research design is the arrangement of conditions for collection & analysis of data in a
manner that aims to combine relevance to the research purpose with economy in
procedure.

 A research design is a specific plan or protocol for conducting the study which allows the
investigator to translate the conceptual hypothesis into an operational one.

6.2: Need for research design


• It facilitates the smooth sailing of the various research operations
• Makes research as efficient as possible yielding maximal information with minimal
expenditure of effort, time & money.
• Helps in advance planning of methods to be adopted for collecting of relevant data & the
techniques to be used in the analysis.

6.3: Features of good research design


• A good design has words like efficient, flexible, economical, appropriate, and so on.
• The design with less experimental error is a best design.
• Thus, good design question is related to objective of their search problem and problems
nature.
• A single design is not an answer for all sorts of research problems.
• A research design should have following study considerations:

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o Way of gathering information
o The availability of staff
o Researcher skills
o The problem nature and
o The study of problem aim
o The time and money.

6.4: Types of research design


6.4.1: Case study
• Case study research excels at bringing us to an understanding of a complex issue or object
and can extend experience or add strength to what is already known through previous
research.
• Case studies emphasize detailed contextual analysis of a limited number of events or
conditions and their relationships.
• Researchers have used the case study research method for many years across a variety of
disciplines.
• Critics of the case study method believe that the study of a small number of cases can offer
no grounds for establishing reliability or generality of findings.
• Others feel that the intense exposure to study of the case biases the findings.
• Some dismiss case study research as useful only as an exploratory tool.
• Yet researchers continue to use the case study research method with success in carefully
planned and crafted studies of real-life situations, issues, and problems.
This introduction to case study research draws upon their work and proposes six steps that
should be used:
1. Determine and define the research questions
2. Select the cases and determine data gathering and analysis techniques
3. Prepare to collect the data
4. Collect data in the field
5. Evaluate and analyze the data
6. Prepare the report
6.4.2: Ecological study
• In an ecological study the unit of analysis is a group of individuals (such as counties, states,
cities, or census tracts).
• Yang et al. (1998) conducted an ecological study examining the association between
chlorinated drinking water and cancer mortality among 28 municipalities in Taiwan. The

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investigators found a positive association between the use of chlorinated drinking water
and mortality from rectal, lung, bladder, and kidney cancer.
• Ecological studies are relatively quick and inexpensive to perform and can provide clues
to possible associations between exposures and outcomes of interest.

6.4.3: Cross sectional study


• An “observational” design that surveys exposures and disease status at a single point in
time (a cross-section of the population)

Time

Study only exists at this point in time

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• Often used to study conditions that are relatively frequent with long duration of
expression (nonfatal, chronic conditions)
• It measures prevalence, not incidence of disease
• Example: community surveys
• Not suitable for studying rare or highly fatal diseases or a disease with short duration of
expression
Advantage of Cross Sectional studies

 Quick, Cheap

 Accurate disease assessment

 Accurate current exposure assessment

 Starting point in prospective cohort studies for screening out already existing conditions

 Allow a risk statement to be made, although this is not precise

Disadvantages

 Weakest observational design, (it measures prevalence, not incidence of disease).


Prevalent cases are survivors
 The temporal sequence of exposure and effect may be difficult or impossible to determine
 Usually don’t know when disease occurred
 Rare events a problem. Quickly emerging diseases a problem
Uses of cross sectional studies

 Provide a wealth of data for health systems research and Planning of Health services

 Describing distribution of a disease, disability, pathological condition, immunological


condition, nutritional status, fitness, or intelligence

 In health systems research to describe ‘prevalence’ by certain characteristics

 Finding out service utilization and compliance pattern

 Opinion surveys and KAP survey (knowledge, attitudes and practice)

 Common procedure used in family planning

6.4.4: Case control and nested


Introduction
• The case-control study is an analytic epidemiologic research design in which the study
population consists of groups who either have (cases) or do not have a particular health
problem or outcome (controls).
• The investigator looks back in time to measure exposure of the study subjects. The
exposure is then compared among cases and controls to determine if the exposure could
account for the health condition of the cases.

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• Hallmark of the case-control study is that it begins with people with the disease (cases)
and compares them to people without the disease (controls).
• Also called:- Case-Referent, Case-Compeer, Retrospective Study
• Determines the strength of the association between each predictor variable and the
presence or absence of disease.
• An alternative observational design to identify risk factors for a disease/outcome.
• Question:
• How do diseased cases differ from non-diseased (controls) with respect to prior
exposure history?
• Compare frequency of exposure among cases and controls
• Effect cause.
• Cannot calculate disease incidence rates because the CCS does not follow a disease
free- population over time

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Characteristics
• Observational/Non-experimental
• Occasionally Exploratory
• Explanatory (Analytical)
• Retrospective
• Effect to Cause
• Both Exposure & Disease have already occurred
• Uses Comparison Group
Steps of Case Control Study
1. Selection of Cases and Controls
2. Matching
3. Measurement of Exposure
4. Analysis and interpretation

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1. Selection of Cases
A] Definition of Case:-
i) Diagnostic Criteria: Must be specified before the study is undertaken.
ii) Eligibility Criteria: Incident cases are eligible than prevalent cases. (severity and
duration)
B] Sources of Cases:-
i) Hospital patients, patients in physician's practices, or clinic patients.
ii) General Population
iii) Industrial Population
1. Selection of Controls

 Controls must be similar to the cases as possible, except for the absence of the disease
under study.
 Sources of Controls:- Should come from population at risk of disease.
• Population of defined area
• Hospital patients
• Probability sample of total population
• Neighbors
• Friends or associates of cases
• Siblings, spouses or other relatives

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Qualities of Control
• Comparability is more important than representativeness in the selection of controls
• The control must be at risk of getting the disease.
• Controls should emerge from the same study base, except that they are not cases. For
example, if cases are selected exclusively from hospitalized patients, controls must also
be selected from hospitalized patients.
• Obtain power by matching more than one (generally < 4) control per case.
2. Matching
• Process of selecting the controls so that they are similar to the cases in certain
characteristics (not all aspects), such as age, race, sex, socioeconomic status, and
occupation.
• An Optimal Matching involves only those variables which improve statistical efficiency or
eliminate bias from the effect of interest.
• Any variable that is matched in study cannot be evaluated as a risk factor in that
investigation.
Matching Variables: e.g. age
Matching Criteria: e.g. control must be within the same 5 year age group must be set up in
advance.
Confounding Factor:
Associated both with exposure and disease, and is distributed unequally in the study and control
groups (study effect is mixed with another effect).
Purpose: To reduce possibility of confounding or mixing of effect of interest with effects of other
risk factor.

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Misconception: The goal of Matching is to make the case and control groups similar in all
respects, except for disease status.

3. Measurement of Exposure
• Information about exposure may be obtained by interviews, by questionnaires or by
studying past records of cases such as hospitals records, employment records etc.
• Information should be obtained in precisely the same manner for cases and controls.
• Exposure rate
• Exposure Rate among Cases = a/ a+c
• Exposure Rate among Control = b/ b+d
4. Analysis
Estimation of disease risk associated with exposure (Odds Ratio):-
• The ratio of the ratio of exposure in Cases compared to the ratio of exposure in Control.
• Measures the strength of the association between risk factor and outcome.
Cases Controls

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Exposed a b
Unexposed c d
OR = ad/bc

Odds Ratio (OR) = ad/bc


= (38 x 15) / (2 x 35)
= 8.14

Interpretation: - Smokers showed the risk of having lung cancer 8.14 times that of nonsmokers.
Bias in Case Control Study
Bias is the Systematic error in the determination of the association between the exposure and
disease.

 Bias due to Confounding:


o This bias can be removed by matching

 Memory or Recall Bias:


o Cases may be more likely to recall the existence of certain events than the controls

 Selection Bias:
oCases and controls are not representative of general population. The bias can be
controlled by prevention
 Berkesonian Bias:
o Arises due to different rates of admission to hospitals for people with different
diseases (i.e. hospital cases and control)
 Interviewer’s Bias:
o The bias occurs if the interviewer knows the hypothesis and also knows the who
cases are. The prior information lead him to question the case more thoroughly
than the controls regarding the positive history of suspected risk factor.

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Advantages
• Relatively easy to carry out
• Rapid and Cheap compare to cohort
• Require relatively small number of subjects
• Good for rare outcomes/ disease: Cancer
• Can examine many exposures/ etiological factors
• No risk to subjects
• No attrition problems, do not require follow up of individual into the future
• Ethical problems minimal
Weakness
• Cannot measure: Incidence, Prevalence and Relative Risk
• Can only study one outcome
• Limitations in recall and recall bias
• Problem of selection of appropriate control groups
• Other possible effects of exposure cannot be studied
• Representativeness of cases and control may be difficult
Applications
• Evaluating Vaccine Effectiveness
• Evaluations of Treatment & Program Efficacy
• Evaluation of Screening
• Outbreak Investigations
• Genetic Epidemiology
• Occupational Health Research

Nested Case Control Study


• A case-control study design in which cases and controls are from the subjects in an
ongoing cohort study.
• This is hybrids of retrospective and prospective analyses because they start by identifying
a population, then collect baseline data and follow the population for the next several
years.
• An efficient method for studying case-control relationships among a cohort once a
number of cases have emerged.

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Advantages of Nested Case Control study
• Possibility of recall bias is eliminated, since data on exposure are obtained before disease
develops.
• Exposure data are more likely to represent the pre-illness state since they are obtained
years before clinical illness is diagnosed.
• Costs are reduced compared to those of a prospective study, since laboratory tests need
to be done only on specimens from subjects who are later chosen as cases or as controls.
Limitation of Nested Case Control study

 The drawback of nested case-control studies is non-diseased persons from whom the
controls are selected may not be fully representative of the original cohort, due to death
or failure to follow-up cases.

Case Cohort Study


• A case-control study design in which cases are develop an ongoing cohort study but
controls are randomly chosen from the defined cohort.
• controls are not individually matched to each case
• Cases and controls are not matched on calendar time and length of follow up
• It is possible to study different diseases (different set of cases) in the same case cohort
study using the same cohort for controls.

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6.4.5: Cohort study
Introduction

 Cohort study is type of analytical study which is undertaken to support the existence of
association between suspected cause and disease.

 Cohort study is known by variety of name:


o Prospective studies
o longitudinal
o Forward looking study
o Incidence study

 The most widely used term however is Cohort study


Distinguishing features of cohort study
a. The cohort are identified prior to the appearance of the disease under investigation.
b. The study groups so defined, are observed over a period of time to determine the
frequency of disease among them.
c. The study proceeds forward from cause to effect.
What is cohort?

 Ancient Roman military unit, a band of warriors.

 Persons banded together.

 Group of persons with a common statistical characteristic. [Latin]


o E.g. age, birth date,

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Concept of cohort

 Cohort is a group of people who share a common characteristics or experience within a


defined time period or study duration.

 In Epidemiological study a cohort is a well-defined group of people having common


experience or exposure, are followed up for the incidence of diseases occurrence (new
diseases) or events
Example:

 For examples a group of person born on the same day or in the same period of time is
Birth Cohort,

 Persons exposed to a common drug, vaccine or infection within a defined period of time
constitutes exposure cohort.

 All employees in an office building

 Everyone who attended a football game

 All the residents of a neighborhood

 Army personal who are recruited in the same date

 Patients regularly taking anti tubercular drug (i.e DOTS) in a health center
Indication:

 When there is good evidence of exposure and disease.

 When exposure is rare but incidence of disease is higher among exposed

 When follow-up is easy, cohort is stable

 When ample funds are available

General consideration while selection of cohorts


• Both the cohorts are free of the disease.
• Both the groups should equally susceptible to disease
• Both the groups should be comparable
• Diagnostic and eligibility criteria for the disease should be defined well in advance.

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Types of cohort study
I. Prospective cohort study
II. Retrospective (historical) cohort study
III. Combination of Retrospective and Prospective cohort study.
Elements of cohort study
1. Selection of study subjects
2. Obtaining data on exposure
3. Selection of comparison group
4. Follow up
5. Analysis

1. Selection of study subjects

 General population
o Whole population in an area
o A representative sample

 Special group of population


o Select group
 occupation group / professional group

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o Exposure groups
 Person having exposure to some physical, chemical or biological agent

 e.g. X-ray exposure to radiologists


2. Obtaining data on exposure

 Personal interviews / mailed questionnaire


 Reviews of records
o Dose of drug, radiation, type of surgery etc
 Medical examination or special test
o Blood pressure, serum cholesterol
 Environmental survey
 By obtaining the data of exposure we can classify cohorts as
o Exposed and non-exposed and
o By degree exposure we can sub classify cohorts
3. Selection of comparison group

 Internal comparison
o Only one cohort involved in study
o Sub classified and internal comparison done

 External comparison
o More than one cohort in the study for the purpose of comparison
o e.g. Cohort of radiologist compared with ophthalmologists

 Comparison with general population rates


o If no comparison group is available we can compare the rates of study cohort with
general population.
o Cancer rate of uranium miners with cancer in general population
4. Follow up

 To obtain data about outcome to be determined (morbidity or death)


o Mailed questionnaire, telephone calls, personal interviews
o Periodic medical examination
o Reviewing records
o Surveillance of death records
o Follow up is the most critical part of the study

 Some loss to follow up is inevitable due to death change of address, migration, change of
occupation.

 Loss to follow-up is one of the draw-back of the cohort study.

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5. Analysis

 Calculation of incidence rates among exposed and non-exposed groups

 Estimation of risk
o Relative risk
o Attributable risk
o Population- attributable risk

Incidence rate

 Incidence among exposed = a


a+b

 Incidence among non-exposed = c


c+d

Estimation of risk
Relative Risk
Incidence of disease among exposed
RR = Incidence of disease among non-exposed
a/a+b
= _________
c/c+d

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Attributable Risk
Incidence of disease among exposed – incidence of disease among non-exposed
AR = Incidence of disease among exposed
a/a+b – c/c+d
AR = a/a+b

Problem:

Smoking Lung cancer Total

YES NO

YES 70 6930 7000

NO 3 2997 3000

73 9927 10000

Find out Incidence rate, RR and AR for above data


1. Incidence of lung cancer among smokers
70/7000 = 10 per 1000
2. Incidence of lung cancer among non-smokers
3/3000 = 1 per thousand
3. RR = 10 / 1 = 10
(Lung cancer is 10 times more common among smokers than nonsmokers)
4. AR = 10 – 1 / 10 X 100
= 90 %
(90% of the cases of lung cancer among smokers are attributed to their habit of smoking)

Strengths

 We can find out incidence rate and risk

 More than one disease related to single exposure

 Can establish cause - effect

 Good when exposure is rare

 Minimizes selection and information bias

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Weaknesses

 losses to follow-up

 Often requires large sample

 Ineffective for rare diseases

 long time to complete

 Expensive

 Ethical issues

6.4.6: Interventional research


• More specifically, a research design refers to the type of study that will be conducted,
whether it will be pre-experimental, quasi-experimental, or true experimental.
Pre-experimental designs include:-
o case study design
o one group pre-test/post-test design
o static group comparison design (cross-sectional study)
Quasi-experimental designs include

 nonequivalent control group (comparison group) design

 Counter balanced design

 time series design (may include panel design)

 equivalent time samples design

 equivalent materials design separate sample pre-test/post-test design

 separate sample pre-test/post-test control group design

 multiple time-series design

 recurrent institutional cycle design

 regression/discontinuity analysis

True experimental designs include:

 pre-test/post-test control group design

 Solomon four-group design

 post-test only control group design

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Experimental Studies
• In observational studies (eg. Descriptive, case-control and cohort) no action is taken . The
epidemiologist observe only the natural course of event.
• The Experimental studies are similar to cohort studies except they involve some action,
intervention, or manipulation
Aims of Experimental studies
1. To provide scientific proof of etiological (or risk) factor which may permit modification
or control.
2. To provide the method of measuring the effectiveness and efficiency of health services for
prevention, control and treatment of disease and improve the health of the community.
Types of Experimental studies
1. Randomized Controlled Trials
2. Non- Randomized or “Non- Experiment” trials (those departing from strict randomization
for practical purposes )

Randomized Controlled Trials


”An epidemiological experiment in which subjects in a population are randomly allocated into
groups, usually called study and control groups to receive and not receive an experimental
preventive or therapeutic procedure, maneuver, or intervention”
John M. Last, 2001

Design

Why RCT
• GOLD STANDARD of study design
• Makes group comparable
• Controls for confounding (known and unknown)
• Prevents selection bias

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Basic Steps

Basic Steps
1. The protocol
2. Selecting reference and experimental populations
3. Randomization
4. Intervention
5. Follow up
6. Assessment
1. The protocol
• RCT is conducted under a strict protocol
• The protocol should include
• aims and objectives of the study
• selection criteria of study and control group
• detailed procedure
• The protocol should be followed throughout the study
2. Selecting Reference and Experimental Populations
a. Reference or target population

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• It is the population in which finding of trials, if successful, are applied.(eg drug,
vaccine)
• Reference population may be board or limited specifically by geography, age, sex,
occupation, social group etc.
b. Experimental or study population
• Actual population that participates in the experimental study
• The study population is derived from the reference population to generalize the
study findings to the target population.
Participants must fulfill the following criteria:
• They must give informed consent
• They should be representative of the population
• They should be qualified for the trail
• The participants are randomly assigned into study and control group.
• Study group is the group of individuals who are offered the new treatment,
preventive agent or any type of intervention under investigation.
• Control group is the group of individuals who are not offered the measure and
receive the usual accepted treatment or placebo.
3. Randomization
• Randomization is a process which gives the every subject equal chances to be selected for
the study.
• It is an attempt to eliminate bias and allow for comparability.
• Randomization is the heart of RCT.
• It works best when sample is large.
4. Manipulation / Intervention
• It is the intervention stage, which is performed after the selection of study and control
group.
Types of interventions
• Interventions
• Pharmaceutical (Therapeutic or Preventive)
• Device
• Procedure
• Behavior modification
5. Follow Up
• It is essential till final assessment of outcome.

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• During follow up, there may be attrition problem due to death, migration, and loss of
interest.
6. Assessment
• The final step is assessment of the outcome in terms of positive and negative results.
• Bias during assessment may be due to subject variation, observer bias and bias in
evaluation.
• Blinding is done to reduce bias in outcome assessment.
• In single blind trial, the participant is not aware whether belongs to the study
group or control group.
• In double blind trial, both the doctor or study team member and participants do
not know the group allocation and treatment received.
• In triple blind trial, the participants, investigator and analyzer are all blind.

Types of RCT
1. Clinical Trial
• Concerned with evaluating therapeutic agent, mainly drugs
• Eg. Evaluation of beta-blockers in reducing cardiovascular mortality
• Not all clinical trials are susceptible to being blinded
2. Preventive Trials:
• Trial of primary preventive measures
• Eg. Vaccines
• Analysis of preventive trials must result in clear statement about benefits to
community, risk involved and cost to health
3. Risk Factor Trials:
• Investigator intervenes to interrupt the usual sequence in the development of
disease for those individuals who have risk factor for developing the disease.
• Primary prevention of CHD using clofibrate to lower serum cholesterol

4. Cessation Experiment:
• An attempt is made to evaluate the termination of a habit which is considered to
be causally related to disease
• Cigarette smoking and lung cancer
5. Trials of Etiological Agents:
• To confirm or refute an etiological hypothesis

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6. Evaluation of Health Services:
• DOTS for PTB

1. Clinical Trials- Diagnostic, Therapeutic, Prophylactic, Devices, Procedures, Regimens,


Protocols streptomycin for treating TB
2. Preventive Trials- pertussis vaccine
3. Risk factor Trials- Multiple Risk Factor Intervention Trial (MRFIT)
4. Cessation Experiments- E.g. smoking
5. Trial of etiological agents- eg. Retrolental fibroplasia(Retinopathy of prematurity)
6. Evaluation of health services- DOTS
3Cs issues in designing RCT
a) Compliance: The extent to which the patient’s behaviour changes coincides with clinical
prescription. The non-compliance may be due to followings:
• The patient may misunderstand which drugs and dose are intended.
• Run out of prescription medications
• Confuse various preparations of the same drug
• Have no money or insurance to pay for drugs
• Compliance is particularly important in medical care outside hospital
b) Co-intervention: The application of additional diagnostic or therapeutic procedures to
members of either or both the experimental and the control groups. After randomization, patients
may receive a variety of interventions other than the ones being studied.
c) Contamination: The inadvertent application of the experimental procedure to members of the
control group, or inadvertent failure to apply the procedure to members of the experimental
group. For example, exchange of study treatment regimens among study participants.
Advantages
1. Demonstrate causality
2. Randomization: eliminate the influence of confounding variables
3. Blinding : decreases bias
Disadvantages
1. Expensive
2. Compliance
3. Selective population
4. Ethical issue

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6.4.7: Time series
• The defining feature of time series research designs is that each participant or sample is
observed multiple times, and its performance is compared to its own prior performance.
• In other words, each participant or population serves as its own control.
• The outcome—depression or smoking rates, for example—is measured repeatedly for
the same subject or population during one or more baseline and treatment conditions.
• When the researcher studies only one or a few individuals, these are called Single Subject
Research Designs (SSRD).
• They are particularly useful when:
o Few participants are available—problems with low incidence rates, for example
o Participants are relatively heterogeneous
o Participants demonstrate variability from day to day
o When the researcher studies an entire population, such as a community, city, or health
care delivery system, these are interrupted time series designs (ITSD).
o They are particularly useful when you want to evaluate the effects of a law, policy or
public health campaign that has been implemented in a community.

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UNIT 7: SAMPLING DESIGN AND PROCEDURES
7.1: Population

 Refers to the entire group of individuals or items of interest who have one or more similar
characteristics.
 Is an aggregate of objects, living or nonliving under study? The population may be finite or
infinite.
 A population is the totality of objects under study.
 A group of individuals’ persons, objects or items from which samples are taken for
measurement is a population. Example: a population of HIV/AIDS patients, doctors, nurses,
TB patients etc.

Types
1. Finite population:

 Individuals of the population are countable is finite population. Example: number of NMC
registered doctors, number of students in certain college etc.
2. Infinite population:

 Individuals of the population are uncountable is infinite population. Example: number of


bacteria in the pond, number of fishes in the sea etc.
Target and study population
Target population:

 It is the study population from which sample is drawn.


 Specific pool of cases sample that researchers wants to study.
Study/sampling population:

 The population of interest in which do research.


7.1: Census
Definition
 The procedure of collecting information for entire population is known as census.
 Complete enumeration of population is said to be census

Characteristics of a Good Population Census

 It must be conducted by the Government of the state or country where the census is
taking place.
 It must be conducted at the same time (simultaneously) throughout the country.
 It must involve regular counting at specific time intervals e.g. Nigeria’s population taken
in 1953, 1963, 1973 etc. i.e. at an interval of 10 years.
 It must reveal the population of a country at a specific period of time, e.g. Nigeria’s
population census as of 1963.
 It must involve the physical counting of people rather than by proxy.

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Types of Population Census
There are two types of population census. They are:

1. Defacto Population Census


2. De jure Population Census

Defacto Population Census: This is the type of population census which involves the counting
of only those who are present physically during census. In this group, only those that are
present physically are seen and counted.

De jure Population Census: This is the type of population census which involves the counting
of people who have been permanent residents of a specific area. It does not matter whether the
person is present or not. This is the population census commonly referred to as counting by
proxy.

The Importance or Reasons for Population Census

1. Population Size: Population census helps the Government to know the number of people
living in the country and the structure of the population.
2. Revenue Estimates: It also helps in the determination of taxable adults so as to know the
amount of revenue expected from that sector.
3. Forecasts Future Economic Needs: It enables the country to forecast future her future
economic needs e.g. housing, food etc.
4. Determines the Level of Unemployment: Population Census provides Government with
statistics to determine the level of unemployment in the country.
5. Number of Immigrants: The number of immigrants can be known through the statistics
gotten from population census.
6. Distribution of Resources: It can assist the government in the distribution of resources e.g.
areas of high population like Lagos and Kano will get more resources than areas of low
population.
7. Provision of Social Amenities: Population Census gives the Government an idea of the
different population in various parts of the country and this will help it in the provision of social
amenities like housing, water, electricity, roads, schools, and hospitals e.t.c.
8. Determination of Population Density: Population Census helps the Government to know areas
in the country where population per land area is low.
9. Reveals Level of Manpower: It helps to reveal the total number of people who are working.
When the level of manpower is high, the economic development of the country is assured.
10. Giving of Aids: It assists the international agencies and Governments in giving aids and other
assistance to countries.
11. Investment Decisions: Population Census can influence a country’s investment decision
making process. Many investors like to invest in Nigeria because of its high population.

7.2: Sample

 A finite subset of statistical individuals in a population is called a sample and the number
of individuals in a sample is called the sample size.
 For the purpose of determining population characteristic instead of enumerating entire
population, the individuals in the sample only are observed.
 Then the sample characteristics are utilized to approximately determine the population.

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 It consists of subsets or the small unit of the population, which represents the
characteristics of whole population.
Sampling technique

 It is the process of selecting a portion of population, which represents whole population.

Some examples of sample drawn from the population

 Blood test, stool test, urine test etc.


 A few drops of water are tested whether it is drinkable or not.
 Medicine is tested to the some people to find the efficiency of medicine.
 A few grains of rice are picked up to test whether the rice is cooked or not.
Sampling

 It is a process of systematically selecting cases for inclusion in a research project.


 It involves the selection of a number of study units from a defined study population.
Objectives of Sampling

 Estimation of population parameters (mean, proportion etc.) from the sample statistics.
 To test the hypothesis about the population from which the sample or samples are drawn
Importance

 It entails at lower cost.


 It takes shorter time.
 Better quality of information can be collected.
 More comprehensive data can be collected
Two main characteristics of a representative sample

 Precision which implies the size of the sample


 Unbiased Character
Sampling Concept and Terminologies
Population: It is the entire group of people that is under investigation
Sample: It may be defined as a sub set or small unit which represents the characteristics of whole
population.
Sampling unit: It refers to the units, which are chosen in selecting the sample
Sampling frame: The listing of the population from which we draw the sample is called the
sampling frame.
Sampling Design: It is the technique and procedure the researcher adapts in selecting a sample.
Element: It is the unit about which information is collected and it provides the basis of analysis.
Estimation: It is the process of making inferences about population from sample data.
Parameter: It is characteristic of defined population. It is the summary description of a given
variable in a population such as mean (μ), standard deviation (σ) etc.

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Statistics: It is characteristic of a sample. It is the summary description of a given variable in a
sample such as mean (¯x), standard deviation (s), Proportion (p) etc.
Criteria of Good Sampling:

 Sample should be representative of Population


 Sample size should be adequate to produce reliable results
 Sampling procedures should be practical and feasible.
 Sampling design should be economic and efficient
Process of Sampling
The sampling process comprises following stages:
a. Defining the population of concern
b. Specifying a sampling frame, a set of items or events possible to measure
c. Specifying a sampling method for selecting items or events from the frame
d. Determining the sample size
e. Implementing the sampling plan
f. Sampling and data collecting
g. Reviewing the sampling process

Types of Sampling
There are mainly 2 types of Sampling
1. Probability sampling
2. Non probability sampling

1. Probability Sampling:

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 In this design, the rules and procedure for selecting the sample and estimating the
parameters is explicitly and rigidly defined.
 Each and every Item of the population has equal chance of being selected in sample
Types of Probability Sampling
Probability Sampling includes following techniques:
a. Simple Random Sampling
b. Systematic Sampling
c. Stratified Sampling
d. Cluster Sampling
e. Multistage Sampling
a. Simple Random Sample:

 The method is applicable when the population is small, homogeneous and readily
available.
 The principle is that every unit of the population has an equal chance of being selected.
 It can be done by Lottery method and using a table of random numbers or a computer
random number generator
Using Random Number Method
1. Obtain a complete sampling frame
2. Give each case a unique number, starting at one
3. Decide on the required sample size
4. Select that many numbers from a table of random numbers or using computer
Table of random numbers (usually found at back of statistics textbooks) e.g.
92941 04999 77422 25992 27372
94157 43252 83266 47196 94045
48135 34237 46293 46178 50110
78907 37586 50940 88094 28209
By Using Lottery Method (Mechanical Device)

 Obtain a complete sampling frame


 Print off the list of population & tear then into separate strips
 Mix them up real good,
 Pull out the unit as per required.
 Can be done with replacement or without replacement

b. Systematic Sampling:
In this design, first of all, sampling interval “K” is determined. K is the ratio of N/n where N is the
sampling units in the population and n is the sample size required. After determining K, one
number between 1 and K will be drawn at random. Then every K item is included in the sample.
This type of sampling is used when sampling frame are not available.

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Advantages of Systematic Sampling

 Applied to field studies where a population is large


 Easy and precise
 The time and labor involved in the collection of sample is relatively small.
 If the population is sufficiently large, homogeneous and each unit is numbered, this
method can yield accurate results.
Disadvantages:

 Effect of periodicity (bias caused by particular characteristics arising in the sampling


frame at regular units).

c. Stratified Random Sampling


The population is divided into non-overlapping group called strata. A random sample is then
selected from each stratum. This has been to ensure the sample adequately represented. This
design will give more precise estimates. This is applied when there are heterogeneity or variation
between strata but are homogenous within stratum.
Merits of Stratified Random Sampling

 Proportionate representative sample from each strata is secured.


 It gives greater accuracy

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d. Cluster Random Sampling:

 In this type of Sampling, Population is divided into groups, usually geographic or


organizational. Then, some of the groups are randomly chosen and every element found
in each sampling unit will be included in the study.
 For e.g. to study the practice of ICU nurses; this sampling method is used such as the initial
stage might be divided the Hospital of Nepal into geographic region obtain a list of hospital
in each region. Then select the specific hospitals randomly, then select ICU nurses from
this hospital randomly.

 It is most often used to evaluate vaccination coverage in Expanded Programme of


Immunization (EPI) and Universal Immunization Programme (UIP), where only 210
children, taking 7 from each cluster in the age group 12-23 months are to be examined

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e. Multistage Sampling

 In this method, the sampling procedure is carried in several stages. The population is first
divided into large groups called first stage units. These first stage units are then divided
into smaller groups called second stage units, and first stage units are divided into third
stage units and so on until we get desired sample size.
 For e.g. in a T.B. survey, physical examination or Mantoux test may be done in all cases of
sample in the first stage, in the second stage, X-ray of chest may be done in positive cases;
while sputum may be examined in X-ray positive cases in the third stage
Merits of Multistage Sampling

 It introduces the flexibility in sampling


 It enables the use of existing division and subdivision which saves extra labour.
 It is less costly and laborious, more efficient and purposeful
2. Non Probability Sampling

 In this sampling, the samples are selected according to purpose of the study.
 Types of Non Probability Sampling:
a. Convenience (Accidental) Sampling
b. Purposive (Judgement) Sampling
c. Quota Sampling
d. Snowball Sampling
a. Convenience Sampling

 In this sampling, subjects are selected according to convenience of the investigator. The
convenience may be in respect of availability of source list, accessibility of the units, etc.

 The method is to be used when


o The population is not clearly defined
o Sampling units are not clear
o A complete source list is not available

 For e.g. the selection of names from telephone directory


b. Purposive Samples

 In this sampling, Subjects are selected for a good reason tied to purposes of research. The
choice of selection is supreme and nothing is left to chance. It is not highly recommended
approach as generalization of the findings are limited. But it is more practical in relation
to economy of time and effort to be made sample selection.
c. Quota Sampling

 Quota Sampling is named from the procedure of establishing quota, from the various
strata of population. In this sampling, Quota is given according to specific characteristics
e.g. gender, age, education, race, religion, etc. and Pre-plan number of subjects are taken
in specified categories. (e.g. 100 men, 100 women)
 There are two types of quota sampling:

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 Proportional
 Non proportional
Proportional quota sampling

 In proportional quota sampling , we represent the major characteristics of the population


by sampling a proportional amount of each
 E.g. 40% of women and 60% of men in a population of 100, sample needed 40 women and
60 men.
Non Proportional Quota Sampling

 It is a bit less restrictive. In this method, we specify the minimum number of sampled units
that we want in each category.
 Not concerned with having numbers that match the proportions in the population.
d. Snowball Sampling

 The snowball sampling is used intensively in the sociological studies where a specific
behavior or characteristic is present in few individuals who are used to locate others with
same specific behaviors or similar characteristics. Because people of same characteristics
tend to be associated with other both at personal and professional basis
o It is used when the desired sample characteristic is very rare.
o It relies on referrals from initial subjects to generate additional subjects.
o This technique can dramatically lower search costs, but it comes at the expense of
introducing bias

7.3: Sampling frame

 The listing of the population from which we draw the sample is called the sampling frame.
7.4: Reference, Target and study population

 See terminology
7.5: Determination of sample size
A general rule is that the larger the sample, the better the representation. However, a relatively
small sample properly selected may be much reliable than the large sample poorly selected. If
population is homogenous with respect to the characteristics under study. A small sample can
provide reasonably good estimate. So the sample size should not be too large neither too small
but optimum.
The following factors should be considered while determining sample size.

 Size of population
 Availability of resources
 Degree of precision required
 Homogeneity or heterogeneity of population
 Nature of study
 Method of sampling adopted
 Nature of respondents

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Formulas for sample size determination
For quantitative data,
Sample size (n) = 4σ2/L2
Where σ is standard deviation of population (from past experiences) and L is the desired
allowable error
For qualitative data
Sample size (n) = 4pq/L2
Where p is probability of happening and and q is 1-p
Bias

 Bias is a term which refers to how far the average statistic lies from the parameter.
 Bias and Error in Sampling
o A sample is expected to mirror the population from which it comes
o There is no guarantee that any sample will be precisely representative of the
population from which it comes.
Sampling error
There are two basic causes for sampling error.

 One is chance: Unusual units in a population do exist and there is always a possibility that
an abnormally large number of them will be chosen.
 The second cause of sampling error is sampling bias. Sampling bias is a tendency to favour
the selection of units that have particular characteristics.
Non sampling error

 It is an error that results solely from the manner in which the observations are made.
 May either be produced by participants in the statistical study or by product of the
sampling plans and procedures?
 Inaccurate measurements due to malfunctioning instruments or poor procedures.

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Numerical examples
Q.1.Mean pulse rate of a population is supposed 70 per minute with standard deviation 8 beats.
Calculate minimum sample size required to verify it if allowable error L= +/-1beat at 5% risk.
Here σ = 8, L= 1
Then, sample size (n)=4σ2/L2
=4.8.8/1.1 =4.64/1 =256
Q.2 mean systolic blood pressure of students in one college was found to be 120 with SD 10.
calculate minimum sample size required to verify it if allowable error L= +/-2 at 5% risk.
Here σ = 10, L= 2
Then, sample size (n)=4σ2/L2 =4.10.10/2.2 =400/4= 100
3. Incidence rate in lat epidemic was found to be 50/1000(5%) of the population exposed.
calculate minimum sample size required to find incidence if allowable error is 10% and 20%.
Here p =5%, then q =100-5=95%
If, L= 10% of p, then L =5.10/100=0.5
Then, sample size (n) =4pq/L2
=4.5.95/(0.5)2=1900/0.25=7600
If, L= 20% of p, then L =5.20/100 =1
Then, sample size (n) =4pq/L2 = 4.5.95/1.1 =1900

7.6: Sampling techniques


See type of sampling

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UNIT 8: INSTRUMENTATION
8.1: Measurement of statistical data

 See chapter 5
8.2: Estimation and testing of hypothesis

 See Chapter 5
8.3: Qualitative and Quantitative approach of instrumentation
8.4.1: FGD, IDI, KII, PRA/PLA, Observation
Focus Group Discussion (FGD)
A qualitative research technique in which a skilled moderator leads a small group of participants
in an unstructured discussion about a particular topic.

Requirements for Effective FGD Implementation

 6 to 12 participants
 Careful screening of participants
 Homogeneous participants in terms of characteristic under study
 Relaxed atmosphere
 Room with one-way mirror and audio- and video-recording capabilities
 Session duration between one and two hours
 Trained moderator
 Compensation for participation
Use of Focus Group Discussion

 Generate information for questionnaires

 Assess needs

 Find what community consider when making decisions

 Assess local resources


Key Steps in Conducting a FGD
Step 1: Plan the entire FGD study
Step 2: Decide what types of groups are needed
Step 3: Select moderator and field team
Step 4: Develop facilitator's guide and format for recording responses
Step 5: Train field team and pretest instruments
Step 6: Prepare for individual FGDs
Step 7: Conduct FGDs
Step 8: Analyze and interpret FGD results

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In Depth Interview (IDI)
Interview

 A systematic procedure with scientific purpose where verbal information is produced by


posing specific questions to the subject of interest.
 Interviews take time but are one of the researcher’s best sources of information. Crucial
when goal is to help others learn more about themselves or how well they are performing
Best method to use when

 some of the questions may require clarification

 when answers may require clarification, or

 When the researcher does not know all of the issues and wishes to pursue them as they
arise.
Where to interview?

 Private

 Quiet

 Comfortable

 No distractions
Recording methods:

 Written notes

 Tape recording

 Checklist or survey form


Personal Interview
Advantages

 Flexible

 Abundance of information

 Exceed original questions

 High data control

 Relatively high response rate


Involves face-to-face communication between an interviewer and a respondent

Disadvantages

 Expensive

 Slow data collection

 Narrow geographical coverage

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 Biased interviewer
The Interview Process

 Determine information needed.


 Identify people to interview.
 Call and set up appointments.
 Send interviewee a set of questions you will ask.
 Verify appointment a day before actual interview.
 Show up on time.
 Conduct the interview.
 Summarize results immediately.
 Send interviewee a summary of results.
 Follow-up as needed.
Key Informant Interviews (KII)
There are formal and informal leaders in your community that may be able to provide you with
background information about nutritional problem. Interview
What are key informant interviews?

 In depth interviews with 15-35 people

 Interview is focused on a topic with which the interviewee has firsthand knowledge

 Primary goal is to obtain qualitative description of perceptions or experiences, rather


than measuring aspects of the experience.
KII Can Provide

 Qualitative, descriptive data for decision-making

 Understanding of motivation, behavior and perspectives of participants

 Examples of successes or shortcomings of the study

 Preliminary info for designing a quantitative study


Steps of KII
Step 1: Identify the Information You Want to Know
Step 2: Identify the Key Informants
Step 3: Meet with the Key Informant
Step 4: Share Information with Other Planning Members

Advantages Disadvantages

Provide information from knowledgeable Doesn’t work for quantitative data


People

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Opportunity to explore unanticipated ideas Vulnerable to informant or interviewer
bias

Easy and inexpensive Difficult to prove validity of findings

Participatory rural appraisal (PRA):


PRA hypothesis: PRA enables development agents to effectively elicit community participation
in identifying problems, needs, resources, solutions and priorities, mapping community action
plans and implementation of project in order to bring about sustainable development.
PRA definition: PRA is a community development approach that attempts to empower whole
communities to define their own strategies and action within the limits of their skills, strengths
and resources in order to realize sustainable development. PRA has been advocated as a
sustainable community development approach since the mid-eighties.
Realistic and true development entails the continuous and sustained improvement of the
standard of living of the majority of people.

 PRA has evolved as a promising approach towards true and sustainable community
development.
 It emphasizes true and sustainable development that is community initiated.
 PRA facilitates community organization towards community development plans and
actions.
 It upholds community needs and priorities.
 PRA attempted to harmonize community development efforts.
 PRA encourages interactions between development agents and community members.
 PRA encourages continuous follow-up and assessment of project progress.
 PRA provides basis for transparency and accountability.

PRA limitations:
1. Multidisciplinary and collaboration is hard to achieve.
2. PRA team preparedness – rarely fully prepared and equipped with the PRA
philosophy, principles, tools and process.
3. Financial support – PRA can be an expensive exercise financially.
4. Time frame: PRA is mostly limited by time.
5. Community barrier: language and cultural differences can be a major constraints.
6. Community, socio-economics/education greatly influence the outcome of PRA
process.
7. General insecurity: hard to work with.

PRA focuses on:

 community development
 community participation
 community responsibility
 community organization
 community resource base
 community sustainability

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 community empowerment
Principles of PRA:
1. multidisciplinary
2. reversal of learning
3. rapid and progressive learning
4. offsetting bias
5. optimal ignorance and optimal information is collected
6. seeking diversity
7. triangulating
8. facilitating- “ they can do it”
9. self-critical awareness and responsibility
10. sharing information
11. flexibility and informality
12. optimizing cost

PRA tools:

1. visualized analysis
2. interviewing and sampling
3. group and team dynamics

PRA process:
a. Site selection: by leaders and/or politicians, change agents and project predetermined.
b. setting PRA objectives
c. Review of secondary data- reports, books, management plans, key informants, profect
plans, maps etc.
d. preliminary visits
e. forming the PRA team
f. PRA training for the team
g. Data, information generation
h. Report writing
i. follow up

Observation
• Observation refers a systematically selecting, watching and recording overt behaviour
and characteristics of living beings, objects and phenomena.
• Observation is done with help of checklist.
• Observation relies on the researchers’ ability to gather data though their senses and
allows researchers to document actual behaviour rather than responses related to
behaviour
Why?
• To define current work practices (tasks, methods, working conditions)
• To look for improper practices (ergonomics, safety, inefficiencies)
• To develop a basis for comparing with standards

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How?
• In person watching
• Photographing
• Videotaping
What to observe?
• Job specifications / job description
• Standards
• Manuals and procedures
Who do you observe?
• Random sample of workers
• Representative sample
• Best and worst
• Men and women, young and old, etc…
Steps in observation:
• Define behaviors you want to see
• Determine critical behaviors
• Define the work cycle
• Rate behaviors on importance
• Use of checklists to organize information, ease of recording, ease of analysis
Types of Observation
• Participatory: In this type of observation, the observer takes part in the situation and
asks questions to the concerned respondent whenever needed.
• Non-participatory: Here the observer simply watches the situation, openly or concealed.
Advantages
• It gives more accurate information on the behaviours and activities in comparison to
those methods where events can only be reported i.e. questionnaires and interviews
• It provides data in the situations where in subjects can't read questionnaire or are
unwilling to take part in interview
• The participatory observation allows the researcher to gain experience and learn the
situation through the interactions.
• It is also helps to verify the reliability of responses to questionnaire and interviews
Disadvantages
• The investigators' own biases i.e. prejudices, desires, cultural influences may distort the
observation.

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• The participatory observation may change the true study findings due to presence and
interaction of investigator (his position and relation with others) with the respondents.
• The ethical problems may arise if the observation process conducted without informing
the respondents.
8.4.2: Questionnaire schedule

 A questionnaire is a format containing a list of questions sequentially ordered to obtain


information relevant to the objectives of the study.
 Respondents can give full and correct answers to these questions only of each question is
itself carefully designed and clearly worded.
Develop Questionnaire
1. Determine the contents of the questionnaire.
2. Formulate the questions.
3. Order the questions.
4. Arrange the questionnaire.
5. Translate the questionnaire (if necessary).
1. Determine Contents of the Questionnaire

 Outline the most important objectives of the study.


 List under each objective the types of information directly relevant and necessary in
meeting these objectives.
 Rearrange and organize the lists into separate sub-themes or sections of the
questionnaire.
 Decide how the questionnaire will be administered; i.e., whether it will be filled in by
respondents themselves or by an interviewer (which is more common in developing
countries).
2. Formulate the Question

 Each question must be clear, simple, and specific.


o "Where do you normally seek treatment when your child falls ill?"
o “Has your child been ill with cough within the past two weeks?”
o “Did you visit anyone for advice or treatment?”
 Each question must measure one thing at a time.
o "How do you and your staff normally treat children who present with cough?"
 Questions should not be biased.
o "When a child presents with ARI, do you prescribe an antibiotic?"
o "What do you do when a child presents with ARI? “
 Questions must be free from ambiguity.
o "Do you think ampicillin and tetracycline are effective for treating ARI?"
o “Which antibiotics do you think as most effective for treatment of ARI?”
3. Order the Question

 Ensure a logical order of topics, and of questions within a topic. Ideas should flow
smoothly from one question to another, moving from more general questions to more
specific ones within each topic.

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 Begin with relatively non-controversial and interesting questions, e.g. how many years
have you worked at this health post?

 Any instructions for skipping one or more questions should be clearly indicated and, if
possible, written in a different font or typeface.
4. Arrange the Questionnaire

 Provide necessary headings and spaces for labeling and identifying all questionnaires, ie.,
identifying information for respondent, date and place of interview, as well as name of
interviewer.

 Provide necessary instructions at the start of each section of the questionnaire. Give
guidance and reminders at relevant sections to the interviewers.

 Provide sufficient space between questions.

 Be consistent with codes or boxes for pre categorized answers.

 Provide enough space for writing down answers to open-ended questions.


5. Translate the Questionnaire

 To ensure consistency in the use of words and meanings, questionnaires must be


thoroughly translated before the field work begins.

 One effective way of checking the accuracy of translations is to have a different translator
do a back translation into the original language in which the questionnaire was
written. The two versions can then be compared to iron out any differences.
Useful consideration must be given to the following:

 Type of questions structure: Whether to be open/close

 Phrasing and wording of questions: is the question clear and easily understood?

 Layout of the questions: paper-space, margin etc.

 Aids to the respondent: consideration of factors affecting the respondents ability to


answer

 Aids and instructions to the interviewer: to remind her/him of what he/she has to do at
different stages of the interview.
Question Structure

 Can be closed, open and combination of both

 Open ended: Permit free response not given answers to choose


o Example: we are interested in what you had for your main meal yesterday, please
list the food you ate yesterday’s main meal.

 Close Questions: offer a list of options, from which the respondents must chose.
o Example: what is your marital status?
1. Single 

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2. Married 
3. Separated/ Divorced 
To express their opinion by choosing rating points.
Example: How useful was the workshop?
1. Extremely useful
2. Very useful
3. Useful
4. Not very useful
5. Not useful at all
Combination of open and close question
Example: How did you become a member of VDC?
1. Volunteered
2. Elected at Community meeting
3. Nominated by community leaders
4. Nominated by the health staff
5. Other (specify)
Advantages of the open questions

 He/ She is less influenced by the interviewer, so may lead to more truthful answers.

 Respondents get more opportunity to talk freely about their own feelings

 Chances of unexpected answer (new ans.) is ↑


Disadvantages of the open questions

 Can become long & tiring to record

 The respondents may talk unwanted things

 The respondents may not remember or cannot know the answer

 Needs skilled interviewer

 Difficult to analyze & takes more time to analyze


Advantages of the close questions

 Answers can be record quickly

 Analysis is easy

 To remember the answer is easy by the options

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Disadvantages of the close questions

 The question may not fit for suit the respondent

 Respondents may choose options they would not have thoughts of themselves

 Important information may be missed if it is not asked

 May lose interest after a number of close question


Phrasing and wording of questions
The following rules will help to make questions clear and unambiguous:
1. ask short, specific questions
2. use simple everyday words
3. ask one question at a time
Example: How many children do you have and how many are going to school?
The above question can be rephrased as follows:
1. How many children do you have?
2. How many of your children go to school?
Now these two questions can be answered separately without any confusion.
Filter (jump):
A filter instruction is an instruction to the interviewer not to ask certain questions, if they are not
applicable to the respondent
Example:
Q 1. How many children do you have?
(Filter) → If ‘None’ then go to Q. 3.
Q 2. How many of your children go to school?
Q 3. Are you using any contraceptive?
Do not ask too general question.
Example: “Are most people you know satisfied with the medical care given at your health
center?”
“Most people you know” is a very general phrase.

Memory and recall


Is helping the respondents to remember.
Respondents can be helped to remember past events and conditions in 3 ways
1. Prompts: Giving choices as closed questions

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2. Probes: Ask additional questions which help to clarify answer giving to the original
question.
Example: Original, How many weeks pregnant were you, when he/she was born?
i. <38 weeks
ii. 34 > 38 weeks
iii. 38> 41 weeks
iv. > 41 weeks
Probe: was he/she early or late? how early or late was he/she?
3. Preliminary questions: to put a sequence of short questions, each of which leads to the
important question.
Pre – test of the questionnaire
The draft questions must be tested during the interview

 Amongst friends and colleagues

 Under field conditions in a pilot study.

8.5: Pre- testing and its importance


Testing materials before they are used in live examinations allows us to make certain our exams
are accurate, fair and reliable.
The draft questions must be tested during the interview

 Amongst friends and colleagues

 Under field conditions in a pilot study.


Pretesting assesses:
 Recognition: have the materials been understood?
 Acceptability: is there anything offensive/unacceptable in the materials?
 Familiarity and relevance: is the problem known and relevant to the target audience?
Importance of pre testing
 Save money
 Avoid big mistakes
 Reach people with useful information and education – which they can understand, accept,
and act on
8.6: Reliability and validity
Criteria for measurement:

 Reliability :- Consistency of measurement

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 Validity :- Confidence in measurement
Reliability

 Reliability refers to the consistency, stability or dependability of the data.

 Degree to which scores are free of “measurement error”

 Consistency of measurement
(It focused on measurement)

 hen measurement procedure yields consistent scores when the phenomenon being
measured is not changing.

 A reliable measurement is one that if repeated a second time will give the same result as
it did the first time.
Validity

 The extent to which measures indicate what they are intended to measure.

 Validity is the extent to which a measurement does what it is supposed to do.

 Validity refers to data that are not only reliable but also true and accurate.

 The match between the conceptual definition and the operational definition.

 If a measurement is valid it is also reliable. But if it is reliable, it may or may not be valid.
Reliability & Validity

Summary

 The real difference between reliability and validity is mostly a matter of definition.

 Reliability estimates the consistency of measurement, or more simply the degree to which
an instrument measures the same way each time it is used in under the same conditions
with the same subjects.

 Validity, on the other hand, involves the degree of measuring what is supposed to
measured, more simply, the accuracy of your measurement.

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 Validity is more important than reliability because if an instrument does not accurately
measure what it is supposed to, there is no reason to use it even if it measures consistently
(reliably).

8.7: Pilot study


Pilot studies are small-scale, preliminary studies which aim to investigate whether crucial
components of a main study – usually a randomized controlled trial (RCT) – will be feasible. For
example, they may be used in attempt to predict an appropriate sample size for the full-scale
project and/or to improve upon various aspects of the study design. Often RCTs require a lot of
time and money to be carried out, so it is crucial that the researchers have confidence in the key
steps they will take when conducting this type of study to avoid wasting time and resources.

Thus, a pilot study must answer a simple question: “Can the full-scale study be conducted in
the way that has been planned or should

What are the main reasons to conduct a pilot study?


Pilot studies are conducted to evaluate the feasibility of some crucial component(s) of the full-
scale study. Typically, these can be divided into 4 main aspects:

 Process: where the feasibility of the key steps in the main study is assessed (e.g. recruitment
rate; retention levels and eligibility criteria)
 Resources: assessing problems with time and resources that may occur during the main
study (e.g. how much time the main study will take to be completed; whether use of some
equipment will be feasible or whether the form(s) of evaluation selected for the main study
are as good as possible)
 Management: problems with data management and with the team involved in the study
(e.g. whether there were problems with collecting all the data needed for future analysis;
whether the collected data are highly variable and whether data from different institutions
can be analyzed together).

Reasons for not conducting a pilot study


 A study should not simply be labelled a ‘pilot study’ by researchers hoping to justify a
small sample size. Pilot studies should always have their objectives linked with
feasibility and should inform researchers about the best way to conduct the future, full-
scale project.

How to interpret a pilot study


Readers must interpret pilot studies carefully. Below are some key things to consider when
assessing a pilot study:

 The objectives of pilot studies must always be linked with feasibility and the crucial
component that will be tested must always be stated.
 The method section must present the criteria for success. For example: “the main study
will be feasible if the retention rate of the pilot study exceeds 90%”. Sample size may vary
in pilot studies (different articles present different sample size calculations) but the pilot
study population, from which the sample is formed, must be the same as the main study.
However, the participants in the pilot study should not be entered into the full-scale study.
This is because participants may change their later behavior if they had previously been
involved in the research.

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 The pilot study may or may not be a randomized trial (depending on the nature of the
study). If the researchers do randomize the sample in the pilot study, it is important that
the process for randomization is kept the same in the full-scale project. If the authors
decide to test the randomization feasibility through a pilot study, different kinds of
randomization procedures could be used.
 As well as the method section, the results of the pilot studies should be read carefully.
Although pilot studies often present results related to the effectiveness of the
interventions, these results should be interpreted as “potential effectiveness”. The focus
in the results of pilot studies should always be on feasibility, rather than statistical
significance. However, results of the pilot studies should nonetheless be provided with
measures of variability (such as confidence intervals), particularly as the sample size of
these studies is usually relatively small, and this might produce biased results.

8.8: Data collection process


8.8.1: Primary method of data collection: Interview, mailed questionnaire, observation
and objectives test
See above
8.8.2: Secondary methods of data collection: Data from office records of institutions,
journals, bulletins
This is secondary data collection method. Sources are
1. Census data
2. Geographical information from local unit of government.
3. public places from local people
4. Health facilities- DoHS, DHO/DPHO, NGO, HPs/SHPs etc.
5. vital event registration office from district/ region/central level
6. surveys conducted in past
These types of data from different possible sources can be collected by reviewing the relevant
documents of the related institutions

 The tools are-note cards, note books, checklist and data compilation forms
 Important for community based survey or study.

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UNIT 9: DATA PROCESSING
9.1: Quantitative approach
9.1.1: Coding and decoding, editing and feeding
Data Processing
Data and Information
What is data?

 Set of value of a variable


What is information?

 Processed form of data, that gives meaningful impression for rational decision making

How data are converted into information?

 Data are converted into information to describe, explain, predict and/or


monitor/evaluate a program and its results

 How?
o Selection
o Comparison
o Interpretation
o Analysis
Data Processing/ Methods of Data Processing

 It is the means of systematic collection of data and then analyzing, summarizing &
reporting of the collected data systematically.

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 It is the process of making with meaningful use of raw data.
Techniques/Method

 Editing

 Coding

 Tabulating

 Interpretation

 Analysis

 Preparing Report

 Presentation

Editing
• Irrespective of the method of data collection, the information collected is called raw data
or simply data. The first step in processing your data is to ensure that the data is ‘clean’ –
that is, free from inconsistencies and incompleteness. This process of ‘cleaning’ is called
editing.
• Editing consists of scrutinizing the completed research instruments to identify and
minimize, as far as possible, errors, incompleteness, misclassification and gaps in the
information obtained from the respondents.
• Sometimes even the best investigators can:
• forget to ask a question
• forget to record a response
• wrongly classify a response
• write only half a response
• write illegibly
• In the case of a questionnaire, similar problems can crop up. These problems to a great
extent can be reduced simply by
• Checking the contents for completeness and
• Checking the responses for internal consistency.

There are several ways of minimizing such problems


• By inference – Certain questions in a research instrument may be related to one
another and it might be possible to find out the answer to one question from the answer
to another. Of course, you must be careful about making such inferences or you may
introduce new errors into the data.

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• By recall – If the data is collected by means of interviews, sometimes it might be
possible for the interviewer to recall a respondent’s answers. Again, you must be
extremely careful.
• By going back to the respondent – If the data has been collected by means of
interviews or the questionnaires contain some identifying information, it is possible to
visit or phone a respondent to confirm or ascertain an answer. This is, of course,
expensive and time consuming.
Ways of editing the data:
I. Examine all the answers to one question or variable at a time
II. Examine all the responses given to all the questions by one respondent at a time.

Coding
• Coding is the process of organizing and sorting your data.
• Codes serve as a way to label, compile and organize data.
• Use numbers to represent response categories. For example,

On a scale of attitudes about work,


5=Very satisfied
4=Satisfied
3=Neutral
2=Dissatisfied
1=Very Dissatisfied
On a survey of college majors,
Business=1
Education=2
Engineering=3
Health=4
Liberal Arts=5
Science=6
Steps of coding
• Step I Developing a code book
• Step II Pre-testing the code book
• Step III coding the data
• Step IV verifying the coded data.
Step I: Developing a code book
• A code book provides a set of rules for assigning numerical values to answers obtained
from respondents.

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• The questions selected should be sufficient to serve as a prototype for developing a code
book, as they cover the various issues involved in the process.
Step II: Pre-testing the code book
• Once a code book is designed, it is important to pre-test it for any problems before you
code your data.
• A pre-test involves selecting a few questionnaires/interview schedules and actually
coding the responses to ascertain any problems in coding.
• It is possible that you may not have provided for some responses and therefore will be
unable to code them.
• Change your code book, if you need to, in light of the pre-test.
Step III: Coding the data
• Once your code book is finalized, the next step is to code the raw data. There are three
ways of doing this:
• Coding on the questionnaires/interview schedule itself, if space for coding was
provided at the time of constructing the research instrument
• Coding on separate code sheets that are available
• Coding directly into the computer using a program such as SPSS.
Step IV: Verifying the coded data
• Once the data is coded, select a few research instruments at random and record the
responses to identify any discrepancies in coding.
• Continue to verify coding until you are sure that there are no discrepancies.
• If there are discrepancies, re-examine the coding.
Decoding

 Decoding is the process of converting code into plain text or any format that is useful for
subsequent processes. Decoding is the reverse of encoding. It converts encoded data
communication transmissions and files to their original states.
9.1.2: Data cleaning
• After the data have been entered into a computer file, the researcher should check them
over thoroughly for errors.
• Detecting and resolving errors in coding and in transmitting the data to the computer is
referred to as data cleaning.
• Researchers who have invested a great deal of time and energy in collecting their data do
not want their work undermined by avoidable mistakes made at the stage of data
processing because, unlike sampling error and certain kinds of measurement error, data
processing errors are avoidable.
• The way to avoid them is to be exceedingly careful about entering the data and to use
every possible method of checking for mistakes.

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• This is an essential process that may also identify respondent-related errors.

9.1.3: Preparation of master table/ Dummy table


Introduction
• Tables are one of the best ways to show the answer to your research question.
• It is important to consider what information you will need to collect before finalizing the
data collection tools, and generation of Dummy tables will inform this process.
• Dummy tables outline how the results of the trial will be reported.
• In addition, the process of creating dummy tables will make sure that you have what you
need on your data collection form.
• After you have collected and analyzed your data, you will fill in the tables to complete your
project.

9.2: Qualitative approach


9.2.1: Sorting, Narrative, Triangulation
Sorting
• Sorting – "arranging items in some sequence and/or in different sets. “
• Sorting is the process of arranging data into meaningful order so that you can analyze it
more effectively.
• Sort text data into alphabetical order
• Sort numeric data into numerical order
• Group sort data to many levels,
"About sorting on table worksheets

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About sorting on crosstab worksheets

Narrative
• Narrative research is a term that subsumes a group of approaches that in turn rely on the
written or spoken words or visual representation of individuals.
• These approaches typically focus on the lives of individuals as told through their own
stories.
• The emphasis in such approaches is on the story, typically both what and how is narrated.
• Narrative research can be considered both a research method in itself but also the
phenomenon under study.
• Narrative methods can be considered “real world measures” that are appropriate when
“real life problems” are investigated.
• It is a useful part of the social science investigation, but may not always stand alone for
evidence and support for the conclusions of a report.
Procedures for Conducting Narrative Research
1. Determine if the research problem or question best fits narrative research.
2. Select one or more individuals who have stories or life experiences to tell, and spend
considerable time with them gathering their stories through multiples types of
information.
3. Collect information about the context of these stories.
4. Analyze the participants’ stories, and then “restory” them into a framework that makes
sense.
5. Collaborate with participants by actively involving them in the research

Triangulations
• Triangulation refers to the use of multiple methods or data sources in qualitative research
to develop a comprehensive understanding of phenomena (Patton, 1999).

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• Triangulation also has been viewed as a qualitative research strategy to test validity
through the convergence of information from different sources. Denzin (1978) and Patton
(1999)
• Triangulation means using more than one method to collect data on the same topic.
• This is a way of assuring the validity of research through the use of a variety of methods
to collect data on the same topic, which involves different types of samples as well as
methods of data collection
• However, the purpose of triangulation is not necessarily to cross-validate data but rather
to capture different dimensions of the same phenomenon.
Purpose
• The purpose of triangulation in qualitative research is to increase the credibility and
validity of the results.
• Triangulation "gives a more detailed and balanced picture of the situation
• Method of cross-checking data from multiple sources
• “Triangulation also crosschecks information to produce accurate results for certainty in
data collection.”
Types
Denzin (1978) identified four basic types of triangulation
• Data triangulation: involves time, space, and persons
• Investigator triangulation: involves multiple researchers in an investigation
• Theory triangulation: involves using more than one theoretical scheme in the
interpretation of the phenomenon
• Methodological triangulation: involves using more than one method to gather data, such
as interviews, observations, questionnaires, and documents

9.2.2: Content analysis, Meta-analysis


Content analysis
• Content analysis is a method of analysing written, verbal or visual communication
messages (Cole 1988).
• Content analysis as a research method is a systematic and objective means of describing
and quantifying phenomena (Krippendorff 1980, Downe-Wamboldt 1992, Sandelowski
1995).
• Content analysis is a research method for studying communication artifacts.
• Social scientists use content analysis to quantify patterns in communication.
• More generally, content analysis is research using the categorization and classification of
speech, written text, interviews, images, or other forms of communication.

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According to Klaus Krippendorff, six questions must be addressed in every content
analysis
• Which data are analyzed?
• How is the data defined?
• From what population are data drawn?
• What is the relevant context?
• What are the boundaries of the analysis?
• What is to be measured?
Reliability
• Robert Weber notes: "To make valid inferences from the text, it is important that the
classification procedure be reliable in the sense of being consistent: Different people
should code the same text in the same way”
Kinds of Text
There are five types of texts in content analysis:
• Written text: such as books and papers
• Oral text: such as speech and theatrical performance
• Iconic text: such as drawings, paintings, and icons
• Audio-visual text: such as TV programs, movies, and videos
• Hypertexts: which are texts found on the Internet

Meta-Analysis
• A meta-analysis is a statistical analysis that combines the results of multiple scientific
studies.
• Meta-analysis is a quantitative, formal, epidemiological study design used to
systematically assess previous research studies to derive conclusions about that body of
research
• Conceptually, a meta-analysis uses a statistical approach to combine the results from
multiple studies
• In an effort to increase power (over individual studies)
• A meta-analysis is a statistical overview of the results from one or more systematic
review.
Advantages
• Results can be generalized to a larger population.
• The precision and accuracy of estimates can be improved as more data is used. This, in
turn, may increase the statistical power to detect an effect.

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• Inconsistency of results across studies can be quantified and analyzed.
• Hypothesis testing can be applied on summary estimates.
• Moderators can be included to explain variation between studies
• The presence of publication bias can be investigated
• Created by panels of experts
• Based on professional published literature
• Considered an evidence-based resource
Disadvantages
• Slow to change or be updated
• Not always available, especially for controversial topics
• Expensive and time-consuming to produce
• Recommendations might be affected by the type of organization creating the guideline

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UNIT 10: ANALYSIS OF DATA AND FINDINGS
10.1: Selection on appropriate statistical techniques
• Selection of appropriate statistical test is very important for analysis of research data.
• Use of wrong or inappropriate statistical test is a common phenomenon observed in
articles published
• Wrong statistical tests can be seen in many conditions like use of paired test for unpaired
data or use of parametric statistical tests for the data which does not follow the normal
distribution or incompatibility of statistical tests with the type of data, etc.
Selection of appropriate statistical tests depends on the following three things:
• What kind of data we are dealing with?
• Whether our data follow the normal distribution or not?
• What is the aim of the study?

10.2: Descriptive and analytical statistical Method


Means
• The common average of many individual values of observation obtained arithmetically is
referred to as arithmetic mean.
• It is number obtained by dividing the sum of values of all the items in a series by the total
number of items of the series
• The arithmetic mean (or mean or average) is the most commonly used and readily
understood measure of central tendency.
• In statistics, the term average refers to any of the measures of central tendency.
• The arithmetic mean is defined as being equal to the sum of the numerical values of each
and every observation divided by the total number of observations
Merits:
• It is determined for almost every kind of data.
• It is finite and not indefinite.
• It is readily put to algebraic treatment.
• It is least affected by fluctuations of sampling.
• It is balances the value on either site
• It is based on all the observation in a series
• It is best measure for comparing two or more series of data
Demerits:
• The arithmetic mean is highly affected by extreme values.

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• It is not an appropriate average for highly skewed distributions.
• It cannot be computed accurately if any item is missing.
• Misleading conclusions
Standard Deviation
• Standard Deviation of the series is the positive square root the arithmetic mean of the
squares of deviations of the various items from the arithmetic mean of series.
• Standard Deviation is also called root mean square deviation.
• Standard Deviation is a statistical term used to measure the amount of variability or
dispersion around an average.
• Dispersion is the difference between the actual and the average value.
• The larger this dispersion or variability is, the higher is the standard deviation.
• Its symbol is σ (the greek letter sigma)
Merits
• It summarizes in one figure the deviation of large distribution from mean.
• It indicate whether the variation of difference of an individual from the mean is real or by
chance.
• It helps in finding the suitable size of sample for valid conclusions
• It helps in calculating the stander error
Demerits:
• It gives more weightage to extreme values.
• The process of squaring deviations and taking square root involves lengthy calculation

Probability
• The probability or chance that an event will occur can define as the number of times in
which that event occurs in a very large number of trials.
• It is define as the ratio of number of times a particular event occurs to the total number of
trails during the event could have happened.
• P(A)= Frequency of occurrences/ Number of trials

Basic law of probability


• If the probability occurrence of an event is 1, the event will occur certainly.
• If the probability occurrence of an event is 0, the event will never occur.
• The probability of any event must assume a value between 0 and 1

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• The sum of probabilities of all the sample events in a sample space must be equal to 1. It
can also said that probability of the sample space in any experiment is always one.
• Closer the probability is to 1, the more likely it is that event will occur.
• Closer the probability is to 0, the less likely it is that event will occur
Normal Distribution
• In probability theory, the normal (or Gaussian) distribution is a very common continuous
probability 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
• Normal Distribution represents the probability distributions of frequency of continuous
variables whose frequency are concentrated around the center and gradually fall onwards
two ends.
• The Normal Distribution of a variables is usually represent by a graph which appears as a
symmetrical bell shaped curve.

Properties of Normal distribution curve


• The normal distribution represent the common probability distribution of frequencies of
a random continuous variable.
• The graph representing normal distribution of a continuous variable is called normal
distribution curve. It is perfectly symmetrical and continuous.

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• The normal distribution curve is bell shaped and extends indefinitely on both the sides.
The sides tend to approaches the base line of the curve but never meet the base line
• The normal distribution curve is unimodal (ie it has only one peak)
• For normal distribution all measure of central tendency are equal.
• The observation are clustered around the mean and there are relatively few observation
at the extremes
• The total area covered by the normal curve is equal to unity or 1 because normal
distribution is a continuous probability distribution and always equal to 1.
• The normal distribution can be fully determine and normal curve can be fully specified if
its mean and standard deviation are known.
Parametric Test
• Statistical test that are carried out for estimating and testing a hypothesis about one or
more population parameters are called Parametric test.
• Parametric statistical test is one that makes assumptions about the parameters (defining
properties) of the population distribution(s) from which one's data are drawn.
• It includes:
• t-test or student t-test
• F-test
• Z-test
t-test
The t-test is applied under following assumptions
• Sample are drawn from normal populations and are random
• For testing the equality of two populations means the populations variance are equal
• SD may not be known
• In case of two samples some adjustments in degree of freedom for t test are made
Non-Parametric test
• Nonparametric tests are those statistical procedure that do not require sample data and
don not follow any probability distributions.
• Nonparametric tests are sometimes called distribution-free tests because they are based
on fewer assumptions (e.g., they do not assume that the outcome is approximately
normally distributed).
• It includes:
• Sign test
• Wilcoxon signed rank test.
• Wilcoxon rank sum test

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• Mann-Whitney test
• Kolmogorov-smirnov test
• Spearman’s rank correlation coefficient.
Situations for the use of nonparametric tests
• When quick data analysis is required to have a rough idea about how the things are
working with data.
• When only comparative rather than the absolute magnitudes are available as in case of
clinical data. For eg pt can be categorized as better ,unchanged or worse
• When data available is nonparametric or distributions free in nature and the sample
drawn are from populations with identical distribution.
• When data does not satisfy the assumption of a parametric procedure
Chi-square test
• Chi-square test is used as a test of significance when the data is expressed in frequencies
or in terms of percentages
Characteristics of chi-square Distribution
• Chi-square is always positively skewed. i.e x2 value is always positive
• Chi-square value increase with the increase with degree of freedom
• The S.D of X2 distributions is equal to ∫2n where n is degree of freedom
• The mean of distributions is the number of degree of freedom
• The value of x2 lies between 0 and infinity
• For different degree of freedom, the shape of curve will be different
• Chi-square is a statistic hypothesis and not a parameter
Inference
• Statistical inference: Drawing conclusions about the whole population on the basis of a
sample
• Precondition for statistical inference: A sample is randomly selected from the population
(=probability sample)
Correlation Analysis:
• The correlation analysis and regression analysis are related in a sense as both are dealing
with the relationships among the variables.
• The coefficient of correlation is a measure of linear relationship between two variables,
for example: price of a security and an indicator.
• The values of the correlation coefficient always lie between -1 and +1.
• Correlation indicates the degree of relationship between two variables

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Measures of Correlation
• Scatter diagram method
• Karl pearson’s correlation coefficient
• Spearman’s rank correlation coefficient

Regression Analysis:
• Regression analysis involves the identification of the relationship that exist between a
dependent variable and either one or more independent variables.
• Regression analysis is mainly used for forecasting and predicting.
• It is also used in understanding as which of the independent variables are related to the
dependent variable and also in exploring the types of these existing relationships.
Types
• Simple regression- study only two variable
• Multiple regression- study more than two variable

10.3: Presentation of Data

 This refers to the organization of data into tables, graphs or charts, so that logical and
statistical conclusions can be derived from the collected measurements.
Tabular presentation of Data
• Tabular presentation of data is an orderly arrangement of data into series of row and
columns where data can be read in to two dimensions.
• Statistical data are arranged in forms of tables designed to provide information that are
easily understood.
• These tables are called frequency tables.
• They may be :
• One way frequency tables
• Two ways frequency tables
Objectives of tabulation
• To simplify the complex data in a systematic and concise form.
• To facilitate easy comparison.
• To facilitate analysis of data through central tendency and measures of dispersion.
• To detect errors if any in a data.
Parts of table
• Table number – for proper identification and reference

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• Table title –to show the nature of data it includes.
• Stubs- to describe the heading of horizontal rows
• Captions- for heading of vertical rows
• Body- include numerical information in a table
• Footnote-placed at the bottom of the table to clarify specific items
Survey results of the ages of students in the Adult Basic Education maths classes are shown in this
frequency table.

Age Interval(yrs) Frequency

15-19 13

20-24 15

25-29 20

30-34 10

35-39 8

40-44 4

Graphic presentation of data


• Graphic presentation is a method of presenting statistical data in forms of curves on a
graph paper.
• A graph is a visual portrayal of a collection of numerical data or statistical data

A graph consist of two lines


• 1 Abscissa- horizontal line called X-axis
• 2 Ordinate- vertical line called Y-axis
Types of graphs
1. Line frequency graph
2. Histogram
3. Frequency polygon
4. Kite diagrame
5. Stem and leaf display or plot
6. Frequency curves
7. Cumulative Frequency curves or ogive
8. Scatter and Dot Diagram

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1. Line Frequency Graph
• These form the simplest way of diagrammatic representation of data.
• On the X-=axis of the graph is plotted the discrete variable and Y-axis the frequency
2. Histogram
• A histogram is a graphic representation of frequency of a continuous quantitative data.
• The frequency are representation in forms of bar.
• Histogram is two dimensional, in which both length and breadth of rectangle are
considered
3. Frequency polygon
• Frequency polygon is an alternative to the histogram for representing frequency
distribution graphically.
• For drawing a polygon, data value are placed on the horizontal axis and frequencies on
the vertical axis
4. Kite Diagram
• This is a special type of bar graph which provide an extremely clear visual display of a
change in frequency of non-numerical variables that are distributed with in the given
area.
• For constructing kite diagram frequency of each variables are plotted as line
symmetrically placed astride the X-axis
5. Stem and leaf display or plot
• A Stem and leaf plot is a data that uses part values a the stem to form groups or classes
and part of data values as a leaf
• Construct the stem and leaf plot from flowing values 96,98,107,110,112

Data stems leaves

96 9 6

98 9 8

107 10 7

110 11 0

112 11 2

6. Frequency curves

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• When number of observation is very large and the class intervals are small widths, the
frequency polygon tends to lose its angulations. It produces a smooth graph . This is
known as frequency curve
• This provide a continuous graph
Types
• Symmetrical curves
• Moderately Symmetrical or Skewed curves
• Extremely asymmetrical or j-shaped curves
• U-shaped curves
• Bimodal curves
• Mixed curves
7. Cumulative Frequency curves or ogive
• Ogive is a graphic representation of a cumulative frequency distribution. On the vertical
axis cumulative frequency are represent and the horizontal axis it market of the class
boundaries

8. Scatter and Dot Diagram


• It is prepared in cases in which frequencies at least two variables have been cross
classified.
• One of them variable is independent and other is dependent
Diagrammatic Presentation of Data
1. Bar Diagram

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2. Pie Chart
3. Pictogram
4. Cartogram or map diagram
1 Bar Diagram
• Bar diagram consists of equally vertical rectangular bars of equal width placed on a
common horizontal base line.
• The heights of the rectangles are proportional to the frequencies.
• The bar diagram is used with discrete or discontinuous qualitative variables
Types
Simple Bar Diagram
• It is used to compare two or more items related to a variable.
• The bars are usually arrange according to relative magnitude of items.
• The length of bars is determine by the value of amount or the variable

0 Series 1
Category Category Category Category
1 2 3 4

Multiple or Grouped Bar Diagram


• A multiple bar diagram is used when a number of items are to be compared in respect of
two, three or more values.
• They can prepare either by changing the width of a bar or by using different colours or
different patterns of representation for each character.

600
400 science
200 arts
0 commerce
2003-04 2004-05 2005-06 2006-07

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Divided or component bar diagram
• A divided or component bar diagram can be formed by dividing a single bar in to several
component parts with the help of different colours or designs.
• A single bar represent the aggregate value whereas the components parts represent the
component values of the aggregate value

2000 commerce
1000
0 science
arts

2. Pie chart or pie Diagram


• It is used for percentage distribution.
• Different components are represented by means of sectors of a circle.
• The angle of sectors are proportion to the respective values or measurements of different
values
• The pie chart is also know as circular chart or sector chart.
• Pie chart is mainly used to depict categorical or qualitative data. But it can be used for
qualitative data also.

9%
10%
1st Qtr
2nd Qtr
23% 58% 3rd Qtr
4th Qtr

3. Pictogram
• When statistical data is represented by pictures.
• They give a more attractive presentation.
• In this method of presentation each picture is assigned some numerical value which can
be expressed either by denoting it or writing it on the edge of each picture

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4. Cartogram or map diagram
• When numerical facts are shown in form of maps they are termed as cartograms.
• It is most suitable for geographical data.
• Different values can be represent by different colors, varying degree of shading or cross-
hatching by dots of similar size with different density of number.

10.4: Conclusion, summary and recommendations


Conclusion
• Communicating the findings of research to others is the usual link in the research process.
If the report is so well done, the research worker refines his/her thinking and detailed
records facilities the critical testing of the work done. If he/she is interested in
communicating his/her work to others, the report must be well written in order to fulfill
that purpose effectively. The researcher must indicate what his contribution has been to
his field of study. Negative as well as positive result should find a place in conclusion.
Summary and recommendation
• The summary includes brief restatement of the problem, description of procedures used,
major findings, conclusion and recommendations for the future.
• After a brief re-statement of the problem and a description of the procedures used in the
investigation, conclusions are presented.
• The final unit of the report usually contains the major findings of the study and conclusion.
• Recommendation should be included.

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UNIT 11: PREPARATION OF REPORT
11.1: Concept, Meaning, Objective, importance of report
Concept

 A document containing information organized in a narrative, graphic, or tabular form,


prepared on periodic, recurring, regular, or as required basis. Reports may refer to
specific periods, events, occurrences, or subjects, and may be communicated or presented
in oral or written form.
 An account or statement describing in detail an event, situation, or the like, usually as
the result of observation, inquiry, etc.
 A report is an informational work made with the specific intention of relaying
information or recounting certain events in a widely presentable and scrutinized form.
Reports are often conveyed in writing, speech, television, or film.
Meaning

 Give a spoken or written account of something that one has observed, heard, done, or
investigated
 An account given of a particular matter, especially in the form of an official document,
after thorough investigation or consideration by an appointed person or body.
 Apiece of information that is unsupported by firm evidence.
Objective

 Taking prospective decisions.

 Providing information about the position, performance and changes.

 Presenting and disclosing information

 Compare actual results.

 For keeping track of information.


Importance
Decision Making Tool:

 A Reports provide the required information a large number of important decisions in


business or any other area are taken on the basis of information presented in the reports.
 This is one of the great importance of report.
Investigation:

 Whenever there is any problem, a committee or commission or study group investigates


the problem to find out the reason behind the problem and present the findings with or
without the recommendation in the form of a report.

Evaluation:

 Large scale organizations are engaged in multidimensional activities. It is not possible for
a single top executive to keep personal watch on what others are doing. So, the executive
depends on reports to evaluate the performance of various departments or units.

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Development of skill:

 Report writing skill develops the power of designing, organization coordination,


judgment and communication.
Neutral presentation of facts:

 Facts are required to be presented in a neutral way; such presentation is ensured through
a report as it investigates, explains and evaluates any fact independently.
Professional Advancement:

 Report also plays a major role in professional achievement. For promotion to the rank and
file position, satisfactory job performance is enough to help a person. But for promotion
to high level position, intellectual ability is highly required. Such ability can be expressed
through the report submitted to higher authority
Proper Control:

 Whether activities are happening according to plan or not is expressed through a report.
So, controlling activities are implemented based on the information of a report.
A managerial Tool:

 Various reports make activities easy for the managers. For planning, organizing,
coordinating, motivating and controlling, manager needs help from a report which acts as
a source of information.
Encountering Advance and Complex Situation:

 In a large business organization, there is always some sort of labor problems which may
bring complex situations. To tackle that situation, managers take the help of a report.
11.2: Layout of research report

 Anybody, who is reading the research report, must necessarily be conveyed enough about
the study so that he can place it in its general scientific context, judge the adequacy of its
methods and thus form an opinion of how seriously the findings are to be taken. For this
purpose there is the need of proper layout of the report. The layout of the report means
as to what the research report should contain.

 A comprehensive layout of the research report should comprise


a. Preliminary pages
b. The main text
c. The end matter.
a. Preliminary Pages
• In its preliminary pages the report should carry a title and date, followed by
acknowledgements.
• Then there should be a table of contents followed by list of tables and illustrations so that
the decision-maker or anybody interested in reading the report can easily locate the
required information in the report.

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b. Main Text
• The main text provides the complete outline of the research report along with all details.
• Title of the research study is repeated at the top of the first page of the main text and then
follows the other details on pages numbered consecutively, beginning with the second
page.
• The main text of the report should have the following sections:
• Introduction
• Statement of findings and recommendation
• The results
• The implications drawn from the result
• The summary.
Introduction
• The purpose of introduction is to introduce the research project to the readers.
• It should contain a clear statement of the objectives of research
• A brief summary of other relevant research may also be stated so that the present study
can be seen in that context.
• The hypotheses of study, if any, and the definitions of the major concepts employed in the
study should be explicitly stated in the introduction of the report.
• The methodology adopted in conducting the study must be fully explain
• The statistical analysis adopted must also be clearly stated.
• In addition to all this, the scope of the study should be stated and the boundary lines be
demarcated.
• The various limitations, under which the research project was completed, must also be
narrated
Statement of findings and recommendations
• After introduction, the research report must contain a statement of findings and
recommendations in non-technical language so that it can be easily understood by all
concerned.
• If the findings happen to be extensive, at this point they should be put in the summarized
form.
Results
• A detailed presentation of the findings of the study, with supporting data in the form of
tables and charts together with a validation of results, is the next step in writing the main
text of the report.
• This generally comprises the main body of the report, extending over several chapters.

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• The result section of the report should contain statistical summaries and reductions of
the data rather than the raw data.
Implications of the results
• Toward the end of the main text, the researcher should again put down the results of his
research clearly and precisely.
• He should, state the implications that flow from the results of the study, for the general
reader is interested in the implications for understanding the human behavior. Such
implications may have three aspects as stated below:
• A statement of the inferences drawn from the present study which may be expected to
apply in similar circumstances.
• The conditions of the present study which may limit the extent of legitimate
generalizations of the inferences drawn from the study.
• The relevant questions that still remain unanswered or new questions raised by the study
along with suggestions for the kind of research that would provide answers for them.
Summary
• It has become customary to conclude the research report with a very brief summary,
resting in brief the research problem, the methodology, the major findings and the major
conclusions drawn from the research results.
c. End Matter
• At the end of the report, appendices should be enlisted in respect of all technical data such
as questionnaires, sample information, mathematical derivations and the like ones.
• Bibliography of sources consulted should also be given.
• The value of index lies in the fact that it works as a guide to the reader for the contents in
the report.

11.3: Difference between Research Report and Research Paper


Research Report
• A research report is a paper reporting research that has already been conducted. As such,
it is used primarily in the sciences to tell other scientists (or your instructor) about the
process, findings and significance of your experiment.
• According to a guide prepared by the American Chemical Society, a good research report
of any kind should be organized in a way that parallels the method of scientific reasoning.
The usual parts of this report are Title, Abstract, Introduction, Experimental Details or
Theoretical Analysis, Results, Discussion, Conclusions and Summary, then References
Research Paper
• A research paper, on the other hand, is the research itself. In other words, a research
paper typically presents quotes or information from books or scholarly papers or even
movies, then analyzes them to reach some sort of conclusion. It does not report on an
objective, reproducible experiment done elsewhere but instead focuses on establishing

PUBLIC HEALTH RESEARCH COMPILED BY ANIL SHRESTHA 104


the author's thesis and arguing in favor of it. Research papers are usually used in the
humanities. The format for a good research paper includes an introductory paragraph,
two or three body paragraphs and a conclusion.

Research paper Research report

A research paper is a paper that requires you to A report paper is when you talk about a topic that
do research and have sources such as a book, may not require research.
internet source, encyclopdia, or magazine.

A research paper is which requires you to do A Research report is a normal report in which, a
research - theoretical / experimental. Basically, person reports his/her job, whatever has been
to find a solution for a defined problem. That is done in an already existing problem which has a
what is published as a research paper. particular solution and which is not mean to be
published

Purpose: To convince Purpose: To inform

Question- Based Topic- based

Has a clear, arguable thesis General discussion

You use data and ideas as evidence to support Summarize information gathered
your position

You analyze and interpret information Present analysis and interpretation of others

Your unique perspective and conclusion Does not result in new knowledge

11.4: Scientific Report writing, Manuscript and abstract


Scientific Report Writing
• A scientific report is a document that describes the process, progress, and or results of
technical or scientific research or the state of a technical or scientific research problem. It
might also include recommendations and conclusion of the research.
• Unlike an essay, a report has a formalised structure.
• Although seeking to answer the same questions such as:
• What did you do? And what did you find?
The sections of a scientific report are:
• Title
• Abstract
• Introduction

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• Method
• Results
• Discussion
• Reference List
• Appendices
Element/body of report
• Title Page
• Table of Content
• Abstract
• Introduction
• Materials and Methods (Experimental)
• Results
• Discussion
• Conclusion
• References
Title page
• The title page will include the following:
• Title of the report:
– Usually 4-12 words in length.
– Should be short, specific and descriptive, containing the keywords of the report.
• Authorship:
– Always publish under the same name.
– Include author addresses.
– Indicate the corresponding author and their contact details.
• Date:
– The date when the paper was submitted.
Table of Contents
• A Table of Contents is only required for length reports
Abstract
• The Abstract is a self-contained synopsis of the report - an informative summary of what
you did and what you found out. The Abstract should include the following:
• Objectives (as outlined in the Introduction) and scope of the investigation.

PUBLIC HEALTH RESEARCH COMPILED BY ANIL SHRESTHA 106


• A brief reference to the Materials and Methods.
• A summary of the results and conclusions - a brief but thorough statement of the
outcome/s of the experiment.
• If there is a hypothesis, you may state what it is and whether it was supported or
refuted.
The following should not be included in the Abstract:
• Literature citations.
• Formulae and abbreviations, references to tables.
• Although the Abstract comes first in a report, it is best to write it last, after you have the
results and conclusions.
Introduction
• This provides a summary of the analysis to be undertaken. The purpose of the
Introduction is to put the reader in the picture and place the research/experiment within
a context.
The following may be included in the Introduction:
• Background about the analysis to be carried out.
• A brief review of previous research (relevant literature) to give a background
• Reason/s why the research was undertaken.
• Statement of the hypothesis if there is one.
• An explanation of the different techniques and why they are used.
• A statement of the objective/s - what you hope to achieve.
The Introduction is the and why of the experiment, and should answer the following
questions:
• What was the purpose or objective of the experiment/research?
• Why was the experiment/research conducted in a particular manner?
• Why was it important in a broader context?
Materials and Methods
• The Materials and Methods, sometimes called Experimental, is a description of the
materials and procedures used - what was done and how
Results
The following will be included in your Results:
• Pictures and spectra.
• Tables and graphs whenever practical.

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• Brief statements of the results in the text (without repeating the data in the graphs and
tables). When writing about each picture, graph or table, refer to it parenthetically e.g.
(Figure 1).
• If possible give a section of related results and then comment on them rather than
presenting many pages of unrelated results and then discussing them at the end.
• Subheadings can be used to divide this section so that it is easier to understand.
Discussion
• State your interpretation of your findings, perhaps comparing or contrasting them with
the literature. Reflect on your actual data and observations.
• Explain or rationalize errant data or describe possible sources of error and how they may
have affected the outcome.
• The Discussion must answer the question "What do the results mean?" It is an argument
based on the results.
Conclusion
• This is the summing up of your argument or experiment/research, and should relate back
to the Introduction.
• The Conclusion should only consist of a few sentences, and should reiterate the findings
of your experiment/research.
• If appropriate, suggest how to improve the procedure, and what additional experiments
or research would be helpful.
References
• Cite any references that you have used, ensuring that each item in the reference list has
an in-text citation, and every in-text citation has a full reference in the reference list at the
end of your paper.
• Ensure that the references are formatted according to the style required by the journal
11.5: Element/ body of report

1. Title Page
2. Table of Contents
3. Abstract
4. Introduction
5. Materials and Methods
6. Results
7. Discussion
8. Conclusion
9. References

Title page

The title page will include the following:

 Title of the report:


o Usually 4-12 words in length.

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o Should be short, specific and descriptive, containing the keywords of the report.
 Authorship:
o Always publish under the same name.
o Include author addresses.
o Indicate the corresponding author and their contact details.
 Date:
o The date when the paper was submitted.

Table of Contents

A Table of Contents is only required for length reports.

Abstract

The Abstract is a self-contained synopsis of the report - an informative summary of what you
did and what you found out.

The Abstract should include the following:

 Objectives (as outlined in the Introduction) and scope of the investigation.


 A brief reference to the Materials and Methods.
 A summary of the results and conclusions - a brief but thorough statement of the
outcome/s of the experiment.

If there is a hypothesis, you may state what it is and whether it was supported or refuted.

The following should not be included in the Abstract:

 Literature citations.
 Formulae and abbreviations, references to tables.

Although the Abstract comes first in a report, it is best to write it last, after you have the results
and conclusions.

Introduction

This provides a summary of the analysis to be undertaken. The purpose of the Introduction is to
put the reader in the picture and place the research/experiment within a context.

The following may be included in the Introduction:

 Background about the analysis to be carried out.


 A brief review of previous research (relevant literature) to give a background -
paraphrase relevant facts from the scientific literature, citing the sources to support
each statement.
 Reason/s why the research was undertaken.
 Statement of the hypothesis (an idea or concept that can be tested by experimentation)
if there is one.
 An explanation of the different techniques and why they are used.
 A statement of the objective/s - what you hope to achieve.

The Introduction is the and why of the experiment, and should answer the following questions:

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 What was the purpose or objective of the experiment/research?
 Why was the experiment/research conducted in a particular manner?
 Why was it important in a broader context?

The Introduction should not include any results or conclusions.

Materials and Methods

The Materials and Methods, sometimes called Experimental, is a description of the materials
and procedures used - what was done and how. Describe the process of preparation of the
sample, specifications of the instruments used and techniques employed.

The Method should include such things as sample size, apparatus or equipment used,
experimental conditions, concentrations, times, controls etc.

While the Method does not need to include minute details (e.g. if you followed a set of written
instructions, you may not need to write out the full procedure - state briefly what was done and
cite the manual), there needs to be enough detail so that someone could repeat the work.

Do not keep using the word "then" - the reader will understand that the steps were carried out
in the order in which they are written.

The Method must be written in the past tense and the passive voice.

Results

This section states what you found.

The following will be included in your Results:

 Pictures and spectra.


 Tables and graphs whenever practical.
 Brief statements of the results in the text (without repeating the data in the graphs and
tables). When writing about each picture, graph or table, refer to it parenthetically e.g.
(Figure 1).
 If possible give a section of related results and then comment on them rather than
presenting many pages of unrelated results and then discussing them at the end.
Subheadings can be used to divide this section so that it is easier to understand.

Massive quantities of data or raw data (not refined statistically) can be presented in appendices.

Include only your own observed results in this section.

The following should not be included in your results:

 What you expected to find or what you were supposed to have observed.
 References to other works (published data or statements of theory).

Use the Discussion section of the report for these.

The Results section should be written in the past tense and passive voice, avoiding the use of "I"
and "we".

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Discussion

State your interpretation of your findings, perhaps comparing or contrasting them with the
literature. Reflect on your actual data and observations.

Explain or rationalise errant data or describe possible sources of error and how they may have
affected the outcome.

The Discussion must answer the question "What do the results mean?" It is an argument based
on the results.

Conclusion

This is the summing up of your argument or experiment/research, and should relate back to the
Introduction.

The Conclusion should only consist of a few sentences, and should reiterate the findings of your
experiment/research.

If appropriate, suggest how to improve the procedure, and what additional experiments or
research would be helpful.

References

Cite any references that you have used, ensuring that each item in the reference list has an in-
text citation, and every in-text citation has a full reference in the reference list at the end of your
paper. Ensure that the references are formatted according to the style required by the journal
(or your lecturer/supervisor), and be careful with spelling (the author whose name you
misspell may be asked to review the paper)

11.6: Qualities of good report

A lot of reports are written daily. Some of them are intended to document the progress of some
activities, feasibility reports, investigation reports, some of the reports are for monitoring
purposes, some are evaluation reports but it is clear that all the reports have some objective and
purpose behind it. That objective and purpose can only be achieved if a report has the following
qualities and characteristics:

1. It should be factual: Every report should be based on facts, verified information and valid
proofs.
2. Clear and Easily understandable: Explained below
3. Free from errors and duplication
4. Should facilitate the decision makers in making the right decision:
5. Result focused and result oriented
6. Well organized and structured
7. Ethical reporting style

Reader-Friendly

Readers are various stakeholders who receive reports generated by M&E. If reports are reader-
friendly, they are likely to be read, remembered and acted upon. Following decisions need to be
made by CSOs to make their reports reader-friendly:

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 What do they need to know?
 When do they need to know?
 How do they like to know?

Easy, Simple Language

M&E reports are meant to inform not impress. Using easy, simple language, be it Urdu or English
makes the report friendly on reader. To do this, here are some useful tips:

 Write only what is necessary


 Avoid repetition and redundancy
 Give interesting and relevant information
 Avoid preaching or lecturing
 Compose short and correct sentences

Purposeful Presentation

Each report has some objective(s) to meet. The “objective” comes from analyzing the needs of the
reader. A CSO is working for a project that has several donors, and is channeled through an agency
that needs to be informed about some specific things going on in the field. CSOs reports are the
main pathways or channels of information to the people who decide to fund this and other such
projects. Similarly, field reports are the amin vehicles for the management of the CSOs to make
decision regarding the project itself. A good report presents facts and arguments in a manner that
supports the purpose of the report.

Organized and Well-Structured

Each CSO comes up with a format of internal reporting to suit its requirements. Reporting to
donors is done on their prescribed formats. The M&E system should be able to generate
information that can be organized using different formats. In the annex, this manual provides
some useful formats that can be customized by a CSO.

Result-Focused

In general, all readers are interested in the RESULTS. Therefore, one over-riding principle that
CSOs should aim for in all report writing is to report on the results of their activities. This requires
some analysis on their part that goes beyond a mere description of their activities. Result-focused
means that description of activities is liked with the project objectives. This aspect must be
addressed especially in the project progress reports. According to Phil Bartle, “A good progress
report is not merely a descriptive activity report, but must analyze the results of those reported
activities. The analysis should answer the question, "How far have the project objectives been
reached?"

Timely Prepared and Dispatched

M&E generate “Information Products”, a customized set of information according to needs to a


defined group of users. M&E’s information products are time-bound for both internal and
external stakeholders. Reports, in suitable formats, need to be timely produced and made
available to the readers. It is useful to develop an Information Product Matrix (IPM) like the one
described below:

Straightforward

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A good report is straight forward, honest description. It contains no lies, no deception, no fluff. It
is neat, readable and to-the-point. It is well spaced, has titles and subtitles and is free of language
errors.

Manuscript

A manuscript is a handwritten or typed document, especially a writer's first version of a book or


research before it is published.

Significance

Writing a manuscript for publication is as difficult of a task as it is rewarding. It is a chance for


researchers to be able to finally share their novel ideas with the general public. This, however, is
a privilege and not an end result of years of work that goes into a study. It is important for
scientists to keep this in mind when designing their experiment and publishing their work. A
study should be ethically and methodologically just. The published manuscript should be accurate
and thorough. Falsifying or concealing data, intentionally or unintentionally, is immoral because,
scientific manuscripts have a broad impact and the clinical implications can have a detrimental
outcome if the science behind the research is fraudulent. A good scientist recognizes this
responsibility and is aware of the importance of publishing. Publishing is a great way to improve
the practice of science and medicine, get feedback, and provide a venue to develop and debate
new ideas.

Content

Title

Provide the audience with a title that is short, but detailed enough to give them an idea about the
investigation and the outcome. Do not be vague.

Abstract

The abstract should be a one to two sentence summary of the rest of the components of the
manuscript. It should also be structured in the same order as the overall paper.

Introduction

What is the purpose of the study? Why are you conducting the study? The introduction must state
the goals of the research being conducted. It must include a rationale for the study along with a
hypothesis. An important part of the introduction is a brief background that is based on a
thorough literature search so that the readers know what the study is based on; give a general
idea on what has been done already, and in what ways your study is different.

Material/Methods

An important aspect of all scientific research is that it be repeatable. This gives validity to the
conclusions. The materials and methods section of a manuscript allow other interested
researchers to be able to conduct the experience to expand on what was learned and further
develop the ideas. It is for this reason that this section of the paper be specific. It must include a
step-by-step protocol along with detailed information about all reagents, devices, and subjects
used for the study. How the data was collected and interpreted should also be outlined in detail,
including information on all statistical tests used.

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Results

For the results section of the paper, it is a good idea to rely on charts, graphs, and table to present
the information. This way the author is not tempted to discuss any conclusions deprived from the
study. The charts, graphs, and table should be clearly labeled and should include captions that
outline the results without drawing any conclusions. A description of statistical tests as it relates
to the results should be included.

Conclusion

Summarize the results in words rather than numbers and elaborate on the extent to which the
objectives of the study were met. Do not include information from a literature search. Instead,
focus on the primary conclusions of the study. Interpret the results for the audience; do not leave
any results unexplained. Scientific writing cannot be left open for interpretation. Be sure to avoid
over-interpreting the results and make general conclusions that cannot be justifiably derived
from the parameters of the study. Discuss any clinical implications and limitations of the study as
well as to what extent the conclusions are in concert with other scientists.

References

All references used for the study should be cited in accordance with guidelines set by the journal
in which the author wishes to be published in.

11.7: Process of report

• Use past tense for chapter I to III. For IV use past or present tense appropriately. e.g. “data
were analyzed”.
• Use approved abbreviations only. “E.g., i.e.”
• Do not begin a sentence with a number.
• Any no less than ten is written in words.
• Write short sentences, avoid compound sentences.
• Double space is ideal, 1.5 or 1.25 can be used.
Page number:
• Preliminary pages: roman small.
• Text: from chapter-I, arabic 1, 2, 3 e.t.c till last.
• Table no: 1, 2(table 1) with title just below and centre.
• Appendix is placed at last after reference.
Font size: Times New Roman

• Title:16
• Other title and main heading:14
• Body of text:12
• Read Vancouver, APA or guideline for writing
Reference:

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 Only relevant and cited sources.
UNIT 12: RESEARCH ETHICS AND PUBLICATION
12.1: Basic concepts on Research ethics and its principles

 Is the branch of philosophy that examines the question of what actions are morally right
or wrong and why?
 When most people think of ethics (or morals), they think of rules for distinguishing
between right and wrong, such as the Golden Rule ("Do unto others as you would have
them do unto you"), a code of professional conduct like the Hippocratic Oath ("First of all,
do no harm"), a religious creed like the Ten Commandments ("Thou Shalt not kill..."), or a
wise aphorisms like the sayings of Confucius. This is the most common way of defining
"ethics": norms for conduct that distinguish between acceptable and unacceptable
behavior.
 The fundamental concept of the word ethics is basically derived from the Greek word
“ethos”, which means character, or a fundamental outlook influencing behavior related to
customs and moral values of the people.
 Ethics deals with the process of determining correctness of an activity.
 It is a way of characterizing actions with regard to human dignity. It draws direction from
the moral values existing in society. It is guided by the concept of human rights, social and
professional responsibility.
 Ethics in the research context is concerned primarily with safeguarding the interests of
research participants and aims to safeguard their dignity and rights.
Objectives in research ethics.
• To protect human participants.
• To ensure that research is conducted in a way that serves interests of individuals, groups
and/or society as a whole.
• To examine specific research activities and projects for their ethical soundness, looking
at issues such as the management of risk, protection of confidentiality and the process of
informed consent.
Basic principles of research ethics:
1. Respect for persons (treating individuals as autonomous agents and protecting persons
with diminished autonomy).
2. Beneficence (minimizing harms and maximizing benefits)
3. Justice (fairness in the distribution of the benefits and burdens of research

12.2: Milestones of Research ethics in Nepal, and National Ethical Guidelines of a Health
research.
1982
• Nepal Health Research Committee was established under the Ministry of Health and was
chaired by the Secretary of Health.
1991 - 1995
• Nepal Health Research Council Act was authenticated and published on 12 April 1991.

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• Nepal Health Research Council was established as a salutatory and autonomous body on
12 April 1991 as promulgated by the Nepal Health Research Council Act No. 29 of the year
1991.
• Prof. Dr. Mrigendra Raj Pandey was nominated by GoN as the Emeritus Chairman of NHRC
on 29 April 1991, along with other board members.
• Minister of Health and Labor, Honorable Mr. Padama Ratna Tuladhar inaugurated NHRC
building on 24 February 1995.
• Health System Research Promotion and Development Project of NHRC was initiated in
collaboration with the World Health Organization. The project contributed to
encouraging young researchers in health research through training and research grant
1996 – 1999
• NHRC launched National effort to register health research conducted within the country
under the chairmanship of Prof. Dr. Mathura Prasad Shrestha.
• The high-level consultative meeting was organized to identify national health research
priority of Nepal. NHRC initiate publication of research findings through NHRC Bulletin,
NHRC Brochure and NHRC Journal called "Khoj-bin."
2000 – 2003
• NHRC in developing its ethical guideline.
• National Ethical Guideline for Health Research in Nepal was published for the first time
in 2001.
• Environment Health Unit was established in 2001. The Unit conducted several
Environment Health researches which led to the development of environment and health
policy such as Health Care Waste Management Guidelines, Indoor Air Quality Guideline
etc.
• South Asian Forum for Health Research was established in 2003 with the initiation from
the NHRC. The forum was set to network with Research Councils in South Asia.
• Nepal Health Research Policy was polished in 2003
2004-2006
• NHRC started carrying out national level studies on air pollution, arsenicosis, tobacco
taxation, essential health care services, etc
• National Guidelines for the use of Animal in Scientific Research in Nepal was developed
and published.
2007 – 2009
• NHRC conducted epidemiological studies including outbreak investigation and
assessment of burden of disease in Nepal.
• NHRC issued National Environmental Health Research Priority Area of Nepal in 2007.
• NHRC held first National Workshop on Climate Change and Human Health Impact on
2007.

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2010 – 2013
• NHRC updated National Ethical Guidelines and Standard Operating Procedures in 2011.
Similarly, National Health Research Priority was reviewed in 2013.
2014 Onwards
• NHRC organized First National Summit of Health and Population Scientist in 2015 and
NHRC is continuing the tradition science then.
• NHRC started tri-annual publication of the Journal of NHRC since 2014.
• NHRC began conducting research into emerging areas such as Mental Health, Non-
Communicable Diseases, and intervention studies. NHRC is doing research on Chronic
Kidney Disease and is planning for National Mental Health Survey. Non-Communicable
Disease intervention study is being implemented at Ilam district of Nepal since 2015. The
study is first of its kind in the history of NHRC.
National Ethical Guidelines of Health Research
1. Essential Research
• Research involving human participants should have been considered essential for the
understanding of a problem or disease process, or to identify a better diagnostic,
therapeutic or preventive approach to a disease.
2. Voluntary Participation
• The human participation in research must have been ensured voluntarily.
• The voluntary participation should be secured through a process of providing
information to the participants, comprehension by participants of the aims, objectives of
research; risks and benefits involved and an understanding that the participation is with
their consent, voluntary and with a provision that the participant can withdraw any time
without any negative consequences.
3. Children in Health Research
• No research which could be done in adults should be carried out in children.
• Only those researches which are of relevance to children should be carried out on
children.
• Research involving children should be carried out only after taking informed consent
from the parents or legal guardian of the child.
4. Pregnant Women in Health Research
• Research involving pregnant women and lactating mothers should not be carried out
unless the study is related to pregnancy and lactation.
5. Other Vulnerable People in Health Research
• Special attention should be given while recruiting participants from vulnerable groups of
people such as prisoners, students or military personnel or adults who are mentally
challenged or in an unconscious state.
6. Potential Benefit

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• The participation in a research activity should be of potential benefit to the participant or
to his or her community or the population in general.
7. Harm and Risks
• The participation in a research activity should not in any way harm the research
participant. If there are risks involved in participating in the research, it should be of
minimal nature.
• The risks/benefit ratio must be in favor of benefits and the researcher must demonstrate
that all efforts have been made to minimize the risks and maximize the benefits.
8. Compensation
• The researcher should have made provisions for compensating the research participants
or if relevant to the community for the harms incurred in the research process.
• In addition, the researcher should have made provisions to compensate the efforts and
time of the participants for the purpose of research.
• The information related to the provision for compensation should have been
communicated to the research participant.
9. Qualifications and Competence for the Research
• Principal investigator of any research must have relevant qualifications and competence
to conduct research.
10. Equal Distribution
• The selection of research participants should be such that there is equal distribution of
the burden and benefits of participation among population groups of different
geographical regions or ethnicity or socioeconomic status as far as possible.
11. Dissemination of Research Findings
• The research findings and their application or any further research emanating from such
research should be brought into the public domain through scientific and other
publications.
• The research findings should be shared with the local stakeholders preferably through
publication in local scientific journals.
• In case the researcher plans to publish the scientific paper in an internationally acclaimed
indexed journal, a summary from such a publication must be published in the local
scientific publication.
• Publications resulting from the research should be subject to such rights as are available
to the researcher and her/his associates as determined by the law(s) in force at that time.
12. Institutional Research Arrangements
• The research activity should be carried out only after making necessary institutional
arrangements required to conduct the research.
• Such institutional arrangements should include involvement of competent researchers
and support staff, organizational set up conducive to research, ensuring safety and
confidentiality of data and disseminating the research findings.

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• Institutional arrangements for preservation and archiving of research materials, data and
reports also must be in place.
• The research conducted in any institution should have received approval from the
institutional chief and other related authorities.
13. Confidentiality and Disclosure
• The research activity is carried out in such a way that the identity and data related to
human participants are kept confidential as far as possible.
• However, under compelling scientific and legal situations, such disclosures could be
made without informed consent of the participant
• Recommendations of Data Safety Monitoring Board or a similar body will constitute the
scientific reason and order from a court of law will be considered as compelling legal
reason.
14. Professional, Legal and Moral Responsibility
• Researchers and his/ her team, institution where the research is conducted, sponsors and
agencies funding the research should take professional, legal and moral responsibility to
abide by the principles, guidelines and directives of the Ethical Review Board or
Institutional Review Committee.
15. Transparency and Conflict of Interest
• The researchers and their associates will conduct the research with fairness, honesty,
impartiality and transparency. All involved in the research activity will fully disclose their
interest in different aspects of study and their conflicts of interest, if any.
• Failure to disclose relevant information can lead to suspension of the approval of research
activity or penalty determined by law.
• In case of suspension of the research, researcher should have ample occasion to lodge a
complaint against such a decision to a body constituted by the Ethical Review Board of
Nepal Health Research Council.
16. Research and the Environment
• Researchers will respect the environment while conducting any health research. Respect
for the environment is demonstrated through research being undertaken within a context
of social, cultural and natural heritage of a society.
• Health research proposals will have to ensure proper and safe disposal of all kinds of
hazardous waste from a laboratory, clinical or field research and also safeguard the
cultural, linguistic and religious heritage of individuals and communities.
17. International and/or Externally Sponsored Research
• Research conducted in collaboration with international or external sponsorship can be
conducted only if it is of relevance to the Nepalese people and/ or which can‟t be
conducted in the sponsoring country alone.
• Externally sponsored research should demonstrate provisions for capacity building and
strengthening that field of research.

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• It is mandatory that such research have one co-investigator from Nepal.
18. Transfer of Biological Samples Outside of Nepal
• If the health research involves the transfer of biological samples to other countries, the
researcher(s) will provide convincing reasons for the same.
• Such transfers will be permitted only for the reasons originally stated in the research
proposal.
• Such research must be sensitive to the need and existing culture and social norms of the
communities where it will be carried out.
19. Approval Required for all Health Research in Nepal
• All health research conducted in Nepal will have to receive approval from Ethical Review
Board of Nepal Health Research Council or of the Institutional Review Committees
approved by NHRC.
• Researchers conducting health research without such approval are liable to penalty
determined by law.

12.3: Concept of IRB


• An institutional review board (IRB), also known as an independent ethics committee
(IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee
used in research that has been formally designated to approve, monitor, and review
biomedical and behavioral research involving humans.
• They often conduct some form of risk-benefit analysis in an attempt to determine whether
or not research should be completed.
• Institutional Review Board (IRB) reviews and approves all research involving human
subjects to ensure that it is conducted in accordance with all institutional and ethical
guidelines.
• The purpose of the IRB is to assure that appropriate steps are taken to protect the rights
and welfare of humans participating as subjects in a research.
IRB Review Types
1 Exempt
A research activity may be declared exempt if it is considered low-risk and the only involvement
of human subjects will be in the categories outlined in federal law. Briefly described, these
categories are:
• Research conducted in established or commonly accepted educational settings, involving
normal educational practices.
• Research using anonymous or no-risk tests, surveys, interviews, or observations. (Note
that anonymous is not the same as confidential.
• Research involving the collection or study of existing data if it is publically available or if
subjects cannot be identified.

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• Research examining public benefit or service programs.
• Taste and food quality evaluation and consumer acceptance studies.
2. Expedited
• A research design plan may qualify for expedited review if it is judged to involve only
minimal risk, does not include intentional deception, does not employ sensitive
populations or topics, and includes appropriate informed consent procedures.
• The most common types of studies considered for expedited review include the following:
• Collection of data from voice, video, digital, or image recordings made for research
purposes.
• Research on individual or group characteristics or behavior or research employing
survey, interview, oral history, focus group, program evaluation, human factors
evaluation, or quality assurance methodologies.
• The collection of physical data through non-invasive procedures such as height and
weight; MRI, ECG, ultrasound; moderate exercise; collection of blood samples by heel stick
or finger stick.
3. Full Board
• Research that is judged to involve more than minimal risk, or involves protected
populations such as children, prisoners, or disabled individuals, must undergo a full board
review.
• Individuals intending to conduct research that requires a full board review should allow
some time to complete the review process as this review type may take longer than the
prior review processes.
• The following categories of research require full IRB approval:
• Projects for which the level of risk is determined by the IRB Chair to be greater than
minimal.
• Projects that involve the intentional deception of subjects, such that misleading or
untruthful information will be provided to participants.
• Projects that involve sensitive or protected populations (such as children or cognitively
disabled individuals).
• Projects that plan to use procedures that are personally intrusive, stressful, or potentially
traumatic (stress can be physical, psychological, social, financial, or legal)

12.4: Function of ERB of NHRC


ERB
• NHRC developed the National Ethical Guidelines for Health Research in Nepal and
constituted an Ethical Review Board (ERB) in accordance with the provisions made in the
Guidelines.

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• In order to facilitate the work of ERB, a Standard Operating Procedure (SOP) has been
developed.
• This SOP will guide the ERB to carry out its responsibilities in a consistent and smooth
manner. The purpose of this SOP is to safeguard the dignity, rights, safety and well being
of research participants and promote scientific and ethical health research in Nepal.
Functions:
• To safeguard the dignity, rights, safety and well-being of all actual or potential research
participants and ensure that animals, if used for research, are treated humanely.
• To review research proposals according to the National Ethical Guidelines for Health
Research in Nepal with a view to approve, amend or reject the proposal
• To supervise or monitor the implementation of health research projects approved by ERB
20
• To conduct training programmes for members and reviewers of ERB and Institutional
Review Committees (IRCs) on the ethical review process
• To resolve ethical issues arising out of reviewing, approving , supervising and
disseminating the research findings
• To promote research in the process of review, implementation , supervision of research
and dissemination of research findings
• To accredit IRC‟s and oversee their functions and guide them periodically

12.5: Concept and importance of publication in professional career


• The definition of "publication" as "distribution of copies to the general public with the
consent of the author“.
• There are different types of publication but as in professional career generally there are
two types of publications.

 Academic publications

 Electronic publications
• In academic publishing, a paper is an academic work that is usually published in
an academic journal.
• It contains original research results or reviews existing results. Such a paper, also called
an article, will only be considered valid if it undergoes a process of peer review by one or
more referees (who are academics in the same field) who check that the content of the
paper is suitable for publication in the journal.
• Some journals, particularly newer ones, are now published in electronic form only.
• Paper journals are now generally made available in electronic form as well, both to
individual subscribers, and to libraries.

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• Almost always these electronic versions are available to subscribers immediately upon
publication of the paper version, or even before; sometimes they are also made available
to non-subscribers, either immediately (by open access journals)

12.6: Introduction and types of Journal, List the index journal publish in Nepal
Introduction
• A daily newspaper —usually used in titles The Wall Street Journal
• A periodical dealing especially with matters of current interest an academic journal —
often used in titles The Journal of the American Medical Association
• A record of experiences, ideas, or reflections kept regularly for private use: diary.
• A record of current transactions; especially: a book of original entry in double-entry
bookkeeping; an account of day-to-day events; a record of transactions kept by a
deliberative or legislative body.
Types of Journals
There are various types of journals including:
• Academic/scholarly journals
• Trade journals
• Current affairs/opinion magazines
• Popular magazines
• Newspapers
Medical journals published in Nepal
• Asian Journal of Medical Sciences
• Journal of College of Medical Sciences-Nepal
• Journal of Institute of Medicine
• Journal of Nepal Pediatric Society
• Kathmandu University Medical Journal
• Nepal Journal of Obstetrics and Gynecology
• SAARC Journal of Tuberculosis, Lung Diseases and HIV/AIDS
• Medical Journal of Shree Birendra Hospital

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