Public Health Research

MPH Ist Year
Research Methodology
Prabesh Ghimire
Research Methodology MPH 19th
Batch
Table of Contents
UNIT 1: INTRODUCTION TO PUBLIC HEALTH RESEARCH ...................................................................................... 3
Definition of scientific methods in public health ....................................................................................................... 4
Problem Identification and Justification ................................................................................................................... 5
Research in Sensitive Issues ...................................................................................................................................... 6
Action Research......................................................................................................................................................... 9
Research Management ........................................................................................................................................... 10
Research Management ............................................................................................................................................ 10
Research Plan ........................................................................................................................................................... 11
UNIT 2: SELECTION OF A RESEARCH TOPIC ......................................................................................................... 13
UNIT 3: LITERATURE REVIEW ............................................................................................................................. 14
Need for Literature Review ..................................................................................................................................... 14
Different Search Strategies for Research Retrieval ................................................................................................. 15
UNIT 4: THEORY AND RESEARCH ....................................................................................................................... 16
UNIT 5: RESEARCH QUESTIONS AND HYPOTHESIS .............................................................................................. 17
Variables .................................................................................................................................................................. 17
Conceptual Framework ........................................................................................................................................... 17
UNIT 6: RESEARCH ETHICS ................................................................................................................................. 18
Brief History of Research Ethics .............................................................................................................................. 19
Ethical Issues during the Planning and Execution of Research ............................................................................... 21
UNIT 7: SELECTING STUDY PARTICIPANTS .......................................................................................................... 23
Determining Sample Size in Quantitative Studies ................................................................................................... 23
Determining Sample Size in Qualitative Studies ..................................................................................................... 24
Type I and Type II Error ........................................................................................................................................... 25
UNIT 8: INSTRUMENTATION .............................................................................................................................. 26
Developing Measurement Instrument .................................................................................................................... 26
UNIT 9: QUANTITATIVE RESEARCH METHODS EXPERIMENTAL ........................................................................ 29
Internal Validity ....................................................................................................................................................... 30
Threats to Internal Validity ..................................................................................................................................... 31
Controlling Threats to Internal Validity .................................................................................................................. 32
External Validity (Generalizability) .......................................................................................................................... 33
Threats to External Validity..................................................................................................................................... 33
Controlling Threats to External Validity ................................................................................................................. 34
Prabesh Ghimire Page | 2

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UNIT 10: DATA ENTRY ANALYSIS AND REPORT WRITING.................................................................................... 34

Process of Data Management (Data Entry- Data Analysis) ..................................................................................... 34
Regression analysis and other multivariate methods ............................................................................................. 36
Survival Analysis ...................................................................................................................................................... 37
Report Writing ......................................................................................................................................................... 38
UNIT 11: JOURNAL CLUBS AND DISSEMINATION OF RESEARCH FINDINGS, AND CRITIQUES ON PAPER ...............39
Concepts of Journal Clubs ....................................................................................................................................... 39
Manuscript Development ....................................................................................................................................... 39
Dissemination of Research Findings ........................................................................................................................ 41
Guidelines for Contributors (authors, co-authors and corresponding authors) ..................................................... 43
Publication Ethics .................................................................................................................................................... 43
Critiques on Published Paper Reporting a Quantitative Study................................................................................ 45
UNIT 12: INTRODUCTION TO QUALITATIVE RESEARCH ....................................................................................... 46
Concept of Qualitative Research ............................................................................................................................. 46
Similarities and Differences between Quantitative and Qualitative Research ....................................................... 52
UNIT 13: DESIGNING A TOPIC GUIDE AND INTERVIEW AND DISCUSSIONS .......................................................... 53
In-depth Interview................................................................................................................................................... 53
Study Design for a Qualitative Focus Group Discussion .......................................................................................... 55
UNIT 14: QUALITATIVE DATA ANALYSIS ............................................................................................................. 57
Principles of Qualitative Data Analysis .................................................................................................................... 57
Approaches to Qualitative Analysis......................................................................................................................... 58
UNIT 15: TRUSTWORTHINESS OF QUALITATIVE DATA ........................................................................................ 61
Strategies to Ensure Trustworthiness of Qualitative Data ...................................................................................... 62
Triangulation in Qualitative Research ..................................................................................................................... 63
UNIT 16: CRITIQUE A PUBLISHED PAPER REPORTING A QUALITATIVE STUDY ..................................................... 64
UNIT 17: MIXED METHODS IN HEALTH RESEARCH.............................................................................................. 65
Introduction to Mixed Method Study ..................................................................................................................... 65
Characteristics of Mixed Methods Research ........................................................................................................... 65
Mixed Method Designs ........................................................................................................................................... 66
Selecting a Type of Mixed Method Design .............................................................................................................. 67
Variations on the Mixed Method Design ................................................................................................................ 69
MISCELLANEOUS ............................................................................................................................................... 71

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UNIT 1: INTRODUCTION TO PUBLIC HEALTH RESEARCH

Definition of scientific methods in public health
Scientific method is the defining characteristics of scientific research. It is a set of research principles and
methods that help researchers obtain valid results from their research studies.
Because the scientific method deals with the general approach to research rather than the content of
specific research studies, it is used by researchers in all different scientific disciplines. The biggest benefit
of scientific method is that it provides a set of clear and agreed-upon guidelines for gathering, evaluating,
and reporting information in the context of a research study.
Although some disagreements exist regarding the exact characteristics of the scientific method, most
agree that it is characterized by the following elements:
i. Empirical approach
- The empirical approach is an evidence based approach that relies on direct observation and
experimentation in the acquisition of new knowledge.
- The empirical approach, with its emphasis on direct, systematic, and careful observation, is best
thought of as the guiding principle behind all research conducted in accordance with the scientific
method.
ii. Observations
- In the context of science, observation means more than just observing the world around us to get
ideas of research.
- Observation also refers to the process of making careful and accurate measurements, which is a
distinguishing feature of well-conducted scientific investigation.
- When making measurements in the context of research, scientists typically take a great precautions
to avoid making biased observations.
iii. Questions
- After getting a research idea, perhaps from making observation of the world around us, the next step
in the research process involves translating that research idea into an answerable question.
- In order to yield a important information, it is important to formulate a research question that can be
answered through available scientific methods and procedures.
iv. Hypotheses
- Hypotheses are the researchers attempt to explain the phenomenon being studied, and that
explanation should involve a prediction about the variables being studied.
- These predictions are then tested by gathering and analyzing data, and the hypotheses can either be
supported or refused on the basis of data.
v. Experiments
- After articulating the hypothesis, the next step involves actually conducting the experiments (or
research study).
- A key aspect of conducting a research study is measuring the phenomenon of interest in an accurate
and reliable manner.
vi. Analyses
- After conducting the study and gathering the data, the next step involves analyzing the data, which
generally calls for the use o statistical techniques.
- A key decision that researchers must make with the assistance of statistics is whether the null
hypothesis should be rejected.

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vii. Conclusions
- After analyzing the data and determining whether to reject the null hypothesis, the researcher is now
in a position to draw some conclusions about the results of the study.
- In scientific method, it is important that researchers make only those conclusions that can be
supported by the data analyses.
viii. Replication
- One of the most important elements of the scientific methods is replication,
- Replication essentially means conducting the same research study a second time with another group
of participants to see whether the same results are obtained.
- Replication serves several integral purposes, including establishing the reliability of the research
studys findings and determining whether the results of the original study are generalizable to other
groups of research participants.
The scientific method is based on certain basic postulates which can be stated as under:
- It relies on empirical evidence;
- It utilizes relevant concepts;
- It is committed to only objective considerations;
- It presupposes ethical neutrality, i.e., it aims at nothing but making only adequate and correct
statements about population objects;
- It results into probabilistic predictions;
- Its methodology is made known to all concerned for critical scrutiny are for use in testing the
conclusions through replication;
- It aims at formulating most general axioms or what can be termed as scientific theories.
Empirical research and data

Empirical research can be defined as the evidence based research based on experimentation or
observation (evidence).
- Such research is conducted to test hypothesis
- Empirical data refers to the data produced by observation or experimentation.
- The theme in scientific method is that all data must be empirical which means it is based on evidence.
- The empirical data fits to a scientific methods in the following ways:
observing a phenomenon
forming an idea about what was observed
testing an idea with an experiment
recording the results of experiment
analyzing the results to arrive at a conclusion
- The empirical data may be numbers or narrative depending on the types of research. Therefore,
empirical data can be gathered through two types of research methods: qualitative and quantitative
methods
Problem Identification and Justification
The first step and one of the most important requirements of the research process is to identify the
problem. Whether a problem situation requires research depends on the three conditions:
i. There should be a perceived difference or discrepancy between what exists and the ideal or planned
situation.

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ii. The reason(s) for difference should be unclear (so that it makes sense to develop research
questions); and
iii. There should be more than one possible answer to a question or more than one solution to the
problem.
The sources for generating appropriate research question/problems are numerous. These may be
personal experiences, literature sources, existing theories, and previous researches.
Following criteria may be considered for deciding the research problem: (FINER criteria)
i. Feasible to implement
- The selected research problem 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 affordable?
ii. Interesting
- The selected problem areas should be of interest to health policy managers and the researcher.
iii. Novel
- The research on identified problem should be able to fill the gap in existing knowledge and/or able to
solve the problem in an area.
iv. Ethical
- In applied research, most of the time human beings are involved and hence it is necessary to fully
observe ethical policies and procedures.
- Such problems should never be selected, the research on which may have a deleterious effect on
human beings.
v. Relevant
- Selected problem should be relevant and have priority for that geographical area, region and country.
Research in Sensitive Issues
Ranzetti and Lee define sensitive research topic as one that is intimate, discreditable or incriminating. It is
a type of research which potentially poses a substantial threat to those who are or have been involved in
it. Examples include research exploring death, cancer, sexual abuse, violence, drug abuse or
homelessness.
Although there are some topics that are more obviously sensitive, any topic could potentially be seen as
sensitive depending on the people being reached and their feelings about the topic.
For example, the level of sensitivity of the topic may vary according to culture, age, gender or a number of
other factors.
Areas in which research is likely to be sensitive
- where research intrudes into the private sphere or investigate into some deeply personal experience;
- where the study is concerned with deviance or social control;
- where the study intrudes on the vested interests of powerful persons or the exercise of coercion or
domination; or
- where the research deals with things that are sacred to those being studied that they do not wish
profaned.

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Importance of sensitive research

- Sensitive research addresses some of societys most pressing social issues and policy questions.
Methods of data collection in sensitive research

i. Randomized Response Techniques (RRT)
- It is a survey method especially developed to ensure the privacy of respondents when studying
sensitive issues.
- The crux of the randomized response method is that people answer one out of two questions,
selected by a randomized device. So the interviewee can never know what question is answered by
the respondent, guaranteeing respondents privacy.
- Warner (1964) proposed a randomization technique now known as the Related question method.
- Respondents have to choose with the aid of a randomizing device, one of these two statements:
o I have sensitive attribute A
o I do not have sensitive attribute A
- Without revealing to the interviewer which statement was selected the respondent answers according
to his status on attribute A.
ii. Normative Technique

- The normative technique (NT) is a variant of multiplicity sampling and was developed expressly to
investigate heroin use.
- This technique requires respondents to report on the deviant behavior of close friends.
- With correction for duplication, to account for multiple respondents reporting the same person,
number of people doing the deviant behavior can be estimated.
iii. Unmatched-count technique

- The unmatched count technique, also known as the item count technique has been used to ask about
sensitive topics such as sexual risk behaviours, racial prejudice, dangerous driving etc.
- Baseline groups receive a list of non-sensitive items while the treatment group members are shown
this same list with an additional sensitive item added to it.
- All respondents are asked to indicate how many, but not which items apply to them.
- Difference in the means between baseline and treatment groups is used to estimate the prevalence of
the sensitive behavior.
iv. Bean Method

- The bean method was recently developed to collect information on health risk behaviours.
- This method presents respondents with one large and one small jar of beans, both containing mixed-
up beans of different colours.
- The number of beans should be large enough so that addition or removal of a single bean from either
jar is not noticeable.
- Respondents are instructed to move a black bean from the smaller jar to the large jar if the answer to
a sensitive question is no and to move a bean of another specified colour from the small jar to the
large jar if the answer is yes.
- Respondents do this in private, without being watched.
- After multiple respondents have completed the exercise, changes in the bean composition in the jars
are used to estimate the prevalence of a sensitive behavior.
- This method is believed to produce similar or higher estimates of the sensitive behavior compared to
face to face direct questions.

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v. Other methods
- Micro-aggregation method
- Grouped answer method (2 or 3 card method)
- Crosswise, triangular, diagonal and hidden sensitivity models
- Survey with negative questions
Other Tools and techniques for sensitive research data collection

Techniques Tools
In-depth interview Interview schedule
Individual Survey Self-administered open-ended questionnaire
Mailed questionnaire
Telephone survey
Handling/ Analysis of Data in Sensitive Topics

During data analysis, it is very important to ensure confidentiality and anonymity of the subject. After
collecting data from individuals, there are few rules to consider when handling and analyzing their
responses:
i. Avoiding names and other directly identifiable attributes as far as possible.
ii. Limiting the role of analysis to as few researchers as possible, depending upon the volume of work.
iii. Keeping identifiable information in a locked place with access to researchers only.
iv. Bracketing: combining variable codes into broader categories. For example, rather than listing the
name of a place of residence for subjects, listing the district or zone.
v. Using pseudonyms in place of actual names
vi. De-identification and anonymization of data for protection from risk of disclosure
Prior to data archival, the researcher needs to remove any information that could allow subjects to be
identified. This can be done in two ways:
i. De-identification:
- De-identification of data refers to the process of removing or obscuring any personally identifiable
information in a way that minimizes the risk of unintended disclosure of the identity of individuals and
information about them.
- Some of the common methods of data de-identification includes
Data suppression
Randomization
Shuffling
Creating pseudonyms or surrogate
Sub-sampling
Aggregation/Generalization
Character masking
Masking
Encoding
Blurring
ii. Anonymization:
- Anonymization of data refers to the process of data de-identification that produces data where
individual record cannot be linked back to an original as they do not include the required translation
variables to do so.

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Action Research
Action research is an approach to change which incorporates action (i.e. the change process) with
research which informs and assesses the impact of the change.
It is a form of research which informs and assesses the impact of the change.
- Action research is particularly suited to identifying problems in public health practice and helping
develop potential solutions in order to improve practice.
- For this reason, action research is increasingly being used in health related settings.
It has been noted that two criteria are fundamental to action research:
- The cyclic process of action research, which involves some kind of action intervention
- The research partnership, in which the degree of involvement or participation of the researched may
range from cooperation, when the research participants work with outsiders to determine priorities but
responsibility remains with the outsiders to direct the process, to collective action.
Distinguishing characteristics of Action Research
Hart and Bond presented a typology of action research that identified seven distinguishing characteristics:
- It has an educative base
- It deals with individuals as members in groups
- It is problem focused
- It involves a change intervention
- I t aims at improvement and involvement
- It involves cyclic processes
- It is founded on collaboration
Types of action research
i. Experimental
- Educative base: re-education
- Group in research are selected by researcher for purposes of measurement/inferring relationship
between cause and effect.
- Problem focus: Problem relevant for social science/ management interests
- Change intervention: Problems to be solved in terms of research aims
ii. Organizational
- Educative base: re-education/ training
- Groups in research are work groups and/or mixed groups of managers and workers.
- Problem focus: Problem relevant for management/social science interest
- Change intervention: Problems to be solved in terms of management aims
iii. Professionalizing
- Educative base: reflective practice
- Groups in research are professionals and/or (interdisciplinary) professional group.
- Problem focus: Problem emerges from professional practice/experience
- Change intervention: Problems to be resolved in the interests of research-based practice and
professionalization.
iv. Empowering
- Educative base: consciousness-raising
- Groups in research are fluid groupings, self selecting or natural boundaries or open/closed by
negotiation.
- Problem focus: Problem emerges from members practice/experience
- Change intervention: Problems to be explored as a part of process of change, developing an
understanding of meanings of issues in terms of problem and solution.

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Research Management
Research Management
Every steps of research must first be planned, then designed and developed, implemented and ultimately
evaluated. The Elements of research management are described below:
i. Research Planning
- Research planning should be conducted in stages of increasing detail and exactitude.
- At the preliminary or research proposal stage, only the most general notion of data requirements may
be known.
- Once a proposal has been formulated, it is important to determine whether a new research is needed.
- If it is decided that alternative data sources cannot meet the information needs, the team proceeds to
formulate statement of objectives, and to develop some appreciation of frame options, the general
sample size, precision requirements, data collection options, schedule and cost.
- A decision about feasibility of the research is usually made at this point.
- In later stages of the survey process, plans are revised, elaborated and refined and more detailed
aspects are examined.
ii. Design and development

- The overall objective of this phase is to find the set of methods and procedure that achieve an
appropriate balance of quality objectives and resource constraints.
- It is during this phase that any required pretests or pilot surveys are carried out to assess for
example, the adequacy of the questionnaire, suitability of the survey frame, operational procedures,
etc.
- All field materials are prepared for data collection stage.
- Sample selection and estimation procedures are finalized.
iii. Implementation
- Having ensured that all systems are in place, the research can now be implemented.
- Interviewers are trained, the sample is selected and information is collected, all in a manner
established during the development phase.
- Following these activities, data processing begins.
- The survey results are produced and analyzed. These results are then checked for confidentiality and
disseminated.
iv. Research evaluation

- Every step of the survey should be evaluated in terms of its efficiency, effectiveness and cost,
particularly in case of repeated surveys, so that improvements in their design and implementation can
be made over time.
- This involves assessments of the methods used, as well as evaluations of operational effectiveness
and cost performance.
v. Quality Assurance and Quality Control

- At every step, data quality should be measured and monitored to ensure the quality of data and
research process.

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Research Plan
The research plan is the main part of a grant application describing a principal investigator's proposed
research, stating its importance and how it will be conducted.
An essential tool to depict a research plan is research proposal.

A research proposal is a written document specifying what the investigator proposes to study, and is
therefore, written before the project has commenced.
Structure and content of the research plan/proposal

Contents Description
1 Research Title - Often titles are stated in terms of a functional relationship, because such titles
clearly indicate the independent and dependent variables
2 Abstract - It is a brief summary of approximately 300 words.
- It should include the main research question, the rationale for the study, the
hypothesis (if any) and the method.
- Descriptions of the method may include the design, procedures, the sample
and any instruments that will be used
3 Introduction - Its purpose is to establish a framework for the research, so that readers can
understand how it relates to other research.
- It should answer the question of why the research needs to be done and what
will be its relevance.
- The introduction typically begins with a statement of the research problem in
precise and clear terms.
4 Objectives - Research objectives are the goals to be achieved by conducting the research.
They may be stated as general and specific.
- The general objective of the research is what is to be accomplished by the
research project
- The specific objectives relate to the specific research questions the
investigator wants to answer through the proposed study
5 Variables - During the planning stage, it is necessary to identify the key variables of the
study and their method of measurement and unit of measurement must be
clearly indicated.
- Four types of variables are important in research: Independent, Dependent,
Confounding and Background Variables
6 Methodology
i. Research - The choice of the research design, whether descriptive, analytical,

Design experimental, operational or a combination of these depend on a number of
considerations, but this choice must be explained in relation to the study
objectives

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ii. Research - Depending on the type of the study, the following questions should be
participants answered
- What are the criteria for inclusion or selection?
- What are the criteria for exclusion?
- What is the sampling procedure to ensure representativeness and reliability?
- Will there be use of controls in the study?
iii. Sample size - The proposal should provide information and justification about sample size in
the methodology section
iv. Ethical - The proposal must describe the measures that will be undertaken to ensure
issues that proposal is carried out in accordance with ethical principles.
v. Research - The research setting includes all the pertinent facets of the study such as
settings population to be studied, the place and time of study.
vi. Study - Instruments by which the data are collected should be described.
instruments
vii. Collection of - A short description of the protocol of data collection is described
data
viii. Data - The description should include the design of the analysis form, plans for
analysis processing and coding the data and the choice of the statistical method to be
applied to each data.
7 Gantt Chart - An overview of tasks/proposed activities and a time frame is presented in a
Gantt Chart
8 Budget - A proposal budget with item wise/activity wise breakdown and justification for
the same is provided.
9 References - A proposal should end with relevant references on the subject
10 Appendixes - Appropriate appendixes such as questionnaires, interview protocols, consent
form, official letters, etc are included
Should Plan be Flexible? Give your ideas in support and against the flexible plan. (2070/3)
- Yes, plan should be unconditionally be flexible.
- Detailed planning is key to the smooth running of research. However, research takes place in an
unpredictable and uncertain world and even the most meticulously planned projects will encounter
unforeseen barriers.
- An experienced researcher knows that as a result of the unexpected circumstances, research
generally takes longer than originally projected and often costs more too.
- It is not feasible to plan for every eventuality and therefore practitioner researchers so have to be
prepared to be flexible.
- In some research designs, such as action research, flexibility may be an important component in the
process as each stage depends upon the outcome of the preceding stage.
Common unexpected reasons that may affect research plan

- The points below focus on the most common types of unexpected and unplanned reasons that are
likely to affect the research plan.
i. The changing landscape of the research setting
- External forces such as disasters and civil conflicts, policy changes, etc.
- Changes of role at work

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ii. Time
- Underestimated research time through inexperience
- The disappearing research participant
- Research governance and ethics: approval process
iii. Research life/balance
- Unforseen life events
Gantt Chart
- A Gantt chart is a type of bar chart, devised by Henry Gantt in the 1910s, that illustrates a project
schedule.
- Gantt chart provides an excellent overview of a research project and enables the researcher to
sequence research activities in the right order.
- Such chart shows activities as blocks or bars over time.
- It is an intuitive chart used to show resources and time allocation for key tasks, and it supports
monitoring of activities during the management phase.
- In Gantt Chart, the time taken by an activity is represented by a horizontal line, the length of which is
proportional to the duration of activity.
- As a rule, the time in the chart should flow from left to right and the activities be listed from top to
bottom.
Advantages
- It ensures that all activities are carefully and sequentially planned for and that the total duration or
activity times are considered.
- -The use of resource field helps isolate which person is responsible for the particular research tasks
and use of horizontal bars shows research activity over a timeline.
Limitations
- It does not show inter-dependencies between different activities, and thus impact of delay of one
activity over the other cannot be assessed.
- Analytical integration of time, work and resource is quite difficult.
- If the time schedule is changed, it is difficult to change the length or position of bars of a Gantt chart.
UNIT 2: SELECTION OF A RESEARCH TOPIC

One of the preliminary steps of research process is to select the topic. Each topic that is proposed for
research has to be judges according to certain guidelines or criteria.
The following guidelines or criteria may help in the selection and prioritization of research topic.
i. Relevance:
- It depends on the following: What is the magnitude of the problem? Who is affected? How severe is
the problem? Who perceives the problem?
- These problems should be discussed with all the concerned persons involved and topic should be
decided.
ii. Avoidance of duplication

- Researcher should make sure that the suggested topic has not been investigated before, either within
the proposed study area or in another area with similar conditions.
- If the topic has been researched, the results should be reviewed and analyzed to explore whether
major questions that deserve further investigation remain unanswered.

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iii. Urgency of data needed

- If there any timeline for the research to be done? Are results needed for making a decision or
developing health interventions?
- Depending on the urgency, researcher should decide the priority of the topics to be researched.
iv. Feasibility of the study

- It is important to find out the feasibility in terms of the following:
Affordability: i.e. whether resources are available or not
Geographical: i.e. difficult to reach or remote areas
Administrative and peer support, availability of study subjects, etc.
v. Applicability of results
- Is it likely that the recommendations from the study will be applied?
vi. Political acceptability of the study

- A research topic that has interest and support of the local/ national authorities may increase the
chances that the results of the study will be implemented.
UNIT 3: LITERATURE REVIEW
- The literature review is a process of gathering an analytical summary of research findings of a topic of
interest. It is a comprehensive compilation of what is known about the phenomenon.
- The literature review is guided by the researchers curiosity about a particular subject and gaps in the
knowledge about the subject area.
- The literature review is intended to assess the evidence regarding the research topic by identifying
and synthesizing studies that examine the subject of interest.
- The literature review provides the context within which the research is conducted.
Need for Literature Review
The main purpose of literature review is to identify what is known and unknown about an area that has
not been totally resolved in practice.
A second purpose is to determine how an issue can be resolved and managed based on research
evidence.
Specifically, a good literature review does the following:

- Identifies a research problem and indicates how it can be studied.
- Helps clarify and determine the importance of a research problem.
- Identifies what is known about a problem and identifies gaps (what is unknown) in a particular area of
knowledge.
- Provides evidence that a problem is of importance
- Identifies theoretical frameworks and conceptual models for organizing and conducting research
studies.
- Identifies research design and methodologies for conducting like studies.
- Provides a context for interpretation, comparison and critique of study findings.

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Stages of literature review

i. Problem formulation -- which topic or field is being examined and what are its component issues?
ii. Literature search -- finding materials relevant to the subject being explored.
iii. Data evaluation -- determining which literature makes a significant contribution to the understanding
of the topic.
iv. Analysis and interpretation -- discussing the findings and conclusions of pertinent literature.
Different Search Strategies for Research Retrieval
A search strategy is a structured organization of terms used to search a database for literature. Some of
the techniques that can be used to develop a search strategy includes:
i. Truncation and wildcards
a. Truncation
- Truncation is useful for finding singular and plural forms of words and variant endings.
- A keyword should be shortened to its 'stem' or 'trunk' and truncation symbol should be added.
- Many databases use an asterisk *as their truncation symbol.
- For example, typing therap* into a search box will find references containing any of these words:
therapy, therapies, therapist or therapists.
b. Wild cards
- A wildcard finds variant spellings of words. It is used to search for a single character, or no
character at all, anywhere in the keyword.
- Many databases use a question mark? as their wildcard symbol.
- Wildcards are useful for finding British and American spellings, for example, behavio?r will find
behaviour and also behavior.
ii. Searching for the exact phrase

- If we want words to appear in an exact phrase without other significant words appearing between, the
phrase must be enclosed in quotation marks.
- Phrase searching decreases the number of results and makes results more relevant.
iii. Adjacency search

- This is useful if we want to look for papers where words might appear near each other rather than
only right next to each other.
- Many data base use adjx where x is the maximum number of additional words you will allow
- For example, searching for physician ADJ3 relationship would retrieve papers like physician and
patient relationship, relationship of the physician to the patient and so on.
iv. Boolean Logic

- Boolean operators (AND, OR and NOT) allows to combine search terms in different combination.
a. OR
- OR increases the number of results retrieved and is usually used to combine synonyms to make
results more comprehensive.
- Searching for mental health OR eating disorders find articles that mention EITHER of these
topics.
b. AND

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- AND reduces the number of results retrieved and is usually used to combine different concepts to
make results more relevant
- Searching for mental health AND eating disorders finds articles that mention both of these topics.
c. NOT
- NOT reduces the number of results by excluding a search term.
- Searching for for mental health NOT eating disorders find articles that mentions mental health but
removes any articles that mention eating disorders.
v. Citation Searching
- Citation searching means that if we have found a relevant article, we can find a list of articles that cite
it.
- Citation searching helps to find more recent papers on the same or similar subject.
UNIT 4: THEORY AND RESEARCH
Theory of Verifiability
- The Verifiability theory of meaning was put forth in the early twentieth century by a group of logical
positivists.
- The verifiability theory was based upon the verifiability principle, which states: "A statement is literally
meaningful if and only if it is either analytic or empirically verifiable."
- If it failed that test, then it was held to be literally meaningless.
- Although the verifiability principle can be taken as a general principle of meaning, it also establishes
an important general criterion for scientific methodology and even the meaning of science itself.
- Since the verifiability principle can be interpreted as a general theory of meaning, it cannot act as a
sufficient condition for science. It however, does seem a necessary condition.
- That it seems a clear thesis of logical positivism that one cannot have science without the verifiability
principle as standard
Theory of Falsifiability
Sir Karl Popper (1902-1994), considered on of the most influential twentieth century philosophers of
science, asserted that for a theory to be science, a necessary condition is that the theory consist of
hypotheses that could be falsified.
- According to Popper, falsification is the best approach for testing scientific theories and contrasts
sharply with the verification approach.
- The theory must be organized in a way such that its assertions can be refuted. This necessity for a
scientific theory to be falsifiable is known as demarcation criteria.
- Advocating the use of falsifiability as a scientific method to test theories, Popper therefore rejected
inductivism, because falsification dictates that researcher must begin with falsifiable hypotheses
before observations are made.
- The data are collected to refute them not verify them.
- It is easier for the same set of fata to support or verify many different theories simultaneously. Thus,
falsification provides more rigor and confidence in the conclusions.

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UNIT 5: RESEARCH QUESTIONS AND HYPOTHESIS
Variables
A variable is a characteristic, event, or response that represents the elements of the research question in
a detectable way (Creswell, 2008). Variables are carefully described upfront to guide the design of
quantitative studies.
Four types of variables are important in health research:

- Independent variables:
- Variables that are manipulated or treated in a study in order to see what effect differences in them will
have on those variables proposed as being dependent on them.
- The different synonyms for the term independent variable which are used in literature are: cause,
input, predisposing factor, risk factor, determinant, antecedent, characteristics and attribute.
- Dependent variables:
- These re variables in which changes are results of the level or amount of the independent variable or
variables.
- Synonyms: effect, outcome, consequence, result, condition, disease.
- Confounding or intervening variables:

- These are variables that should be studied because they may influence or mix the effect of the
independent variables.
- For instance, in a study of the effect of measles (independent variable) on child mortality (dependent
variable), the nutritional status of the child may play an intervening (confounding) role.
- Background variables:
- These are variables that are so often of relevance in investigations of groups or populations that they
should be considered for possible inclusion in the study.
- For example sex, age, ethnic origin, education, marital status, social status etc.
Conceptual Framework
- Conceptual framework is the researchers understanding of how the particular variables in his study
connect with each other. Thus, it identifies the variables required in the research investigation. It is
the researchers map in pursuing the investigation.
- According to Miles and Huberman (1994), A conceptual framework explains, either graphically or in
narrative form [both are much preferred], the main things to be studied the key factors, constructs or
variables and the presumed relationships among them
- According to McGahie et al. (2001), conceptual framework sets the stage for the presentation of the
particular research question that drives the investigation being reported based on the problem
statement.
- Conceptual framework lies within a much broader framework called theoretical framework. The latter
draws support from time-tested theories that embody the findings of many researchers on why and
how a particular phenomenon occurs.

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Steps of constructing conceptual framework

i. Choosing a topic
- Identifying a research problem and deciding on a research topic.
ii. Conducting literature review

- Reviewing relevant and updated research articles on selected research theme.
- Preferring more reliable sources such as peer-reviewed and well known scientific journals.
iii. Isolating important variables

- Identifying the specific variables (dependent, independent, etc) described in the literature and figuring
out how these are related.
- Some abstract contain the variables and the salient findings thus may serve the purpose.
- If these are not available, finding the research papers summary.
- If the variables are not explicit in the summary, identifying the variables of the study by reviewing the
methodology or the results and discussion section,
iv. Generating the conceptual framework

- Building the conceptual framework using the mix of identified variables.
- Point out dependent and intervening variables and show the direction of the study.
- Problem statement should serve as a reference in constructing the conceptual framework.
UNIT 6: RESEARCH ETHICS

Ethical Principles
The ethical principles which guide the health research and care are:
i. Principle I: Respect for the Autonomy of the Participant
- This principle is based on the premise that an individual when informed of all aspects of an activity
can decide for her/himself a correct course of action.
- This requires specific attention to the following:
An individuals right to decide what is best for her/him cannot be overruled by any consideration
of person.
Researchers must actively safeguard the interests of the persons with impaired or diminished
autonomy and ensure that the vulnerable people are afforded security against harm, abuse or
exploitation

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No researches should take precedence over respect for human rights, fundamental freedom and
human dignity, and practices contrary to human dignity should be prohibited.
ii. Principle II: Beneficence and Non-Malfeasance
- The principle of beneficence requires that the research activity should benefit the participants directly
or indirectly.
- If benefits are not obvious, the researcher should ensure that the participation in research does not
lead any harm.
- All attempts to maximize benefits and minimize the risks should be taken by the researcher.
- The principle of non malfeasance proscribes those researches which are likely to cause deliberate
harm to the participants.
iii. Principle III: Justice
- Justice requires that persons in similar circumstances be treated alike and that differences between
persons due to circumstances be acknowledged and addressed.
- In the context of health research, justice requires that persons having similar health complaints or
threats be treated equally.
- Justice also requires the equitable distribution of the burdens and benefits of research.
iv. Principle IV: Protection of Environment

- This fundamental principle is re-enforced by WMA Declaration of Helsinki, which stresses that special
precautions must be exercised for the protection of the environment in the conduct of research.
- Every researcher is responsible for a moral engagement to protect the social, cultural and natural
heritage of communities and societies.
- This responsibility includes commitment to the following:
To ensure the proper and safe disposal of biologically hazardous waste from laboratory, clinical
and filed research.
To safeguard the c cultural, linguist and religious heritage of communities and individuals.
To treat biologic and genetic heritage of the people with respect and caution. This requires
respecting the principles of informed consent and confidentiality of genetic data.
Brief History of Research Ethics
- Code of medical ethics dates back as far as Babylon with Hammurabis Code of Law (1790 BC),
Charaka Samhita (800-400 BC) and the Hippocratic Oath (600 BC).
- Concept of just moral propriety in medicine was propounded by Thomas Hobbes in 1651 AD.
- Thomas Percival came up with the concept of bio-ethics and legislative aspects of ethics related
behavior.
- Ethics related to health and biomedical research is a more recent phenomenon. The first document
on this subject is the Nuremberg Code in 1947.
- This was followed by a series of international declarations, conventions and convenants related to
ethics in health, health care and research.
- The most prominent of these documents are the World Medical Association (WMA)s Declaration of
Helsinki, the council of International Organization of Medical Sciences (CIOMS)s International Ethical
Guidelines for Biomedical Research Involving Human Participants and the WHO and ICH Guidelines
for Good Clinical Practice.

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Helsinki Declaration
The Declaration of Helsinki was adopted in the 18th General Assembly (June 1964) of World Medical
Association as a statement of ethical principles to provide guidance to physicians and other participants in
medical research involving human participants.
The declaration highlights that it is the duty of physicians to promote and safeguard the health of the
people. In medical research on human participants, consideration related to well-being of the human
participants should take precedence over the interests of science and society.
Some of the major principles for medical research highlighted in the declaration are summarized below:
i. It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the
human participants.
ii. Medical research involving human participants should be conducted only by scientifically qualified
persons and under the supervision of a clinically competent medical person.
iii. Every medical research project involving human participants should be preceded by careful
assessment of predictable risks and burdens in comparison with foreseeable benefits to the
participants or to others.
iv. Medical research involving human participants should only be conducted if the importance of the
objective outweighs the inherent risks and burdens to the participants.
v. The participants must be volunteers and informed participants in the research project.
vi. The right of research participants to safeguard their integrity must always be respected. Every
precaution should be taken to respect the privacy of the participants, the confidentiality of the
patients information and to minimize the impact of the study on the participants physical and mental
integrity and on the personality of the participant
vii. In any research on human beings, each potential participant must be adequately informed of the
aims, methods and institutional affiliations of the researcher, the anticipated benefits and potential
risks. The participant should be informed of the right to abstain from participation in the study or to
withdraw consent to participate at any time without reprisal. After ensuring that the participant has
understood the information, the physician should then obtain the participants freely-given informed
consent.
viii. For a research participant who is legally incompetent, physically or mentally incapable of giving
consent or is a legally incompetent minor, the investigator must obtain informed consent from the
legally authorized representative.
ix. Both authors and publishers have ethical obligations. In publication of the results of research, the
investigators are obliged to preserve the accuracy of the results. Negative as well as positive results
should be published or otherwise made publicly available.
Apart from basic principles, the declaration also highlights on the additional principle for medical research
combined with medical care. Some of them are listed below:
i. When medical research is combined with medical care, additional standards should apply to protect
the patients who are research participants.
ii. The benefits, risks, burdens and effectiveness of a new method should be tested against those of the
best current prophylactic, diagnostic, and therapeutic methods.
iii. At the conclusion of the study, every patient entered into the study should be assured of access to the
best proven prophylactic, diagnostic and therapeutic methods identified by the study.
iv. The physician should fully inform the patient which aspects of the care are related to the research.

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Ethical Issues during the Planning and Execution of Research
According to the National Ethical Guidelines 2011, all health research conducted in Nepal must have the
approval of the Ethical Review Board (ERB) of the NHRC or a similar body authorized by NHRC.
The following ethical guidelines are proposed for any research involving human subjects:
i. 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.
ii. Voluntary participation

- The human participation in research must be ensured voluntarily
- The voluntary participation should be secured through process of providing information to participants
and comprehension by participants regarding research aims, risks and benefits and understanding
that the participation is with their consent.
iii. Children in health research

- No research which could be done in adults should be carried out in children.
- Research that are of relevance to children should be carried only after taking informed consent from
parent or guardian of the child.
iv. 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.
v. 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.
vi. Potential benefit

- 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.
vii. Harm and risks

- The participation in a research activity should not in any way harm the research participant.
- If there are any risks involved in the research, it should be of minimal nature.
viii. Compensation
- The research participants should make provisions for compensating the research participants or
community for the harms incurred in the research process.
- Also, the researcher should make provisions to compensate the efforts and time of the participants for
the purpose of the research.
ix. Qualifications and competence for the research

- Principal investigator of any research must have relevant qualifications and competence to conduct
research.

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x. Confidentiality
- 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.
xi. Transfer of biological samples outside Nepal

- If the health research involves the transfer of biological samples to other countries, the researcher
should provide convincing reasons for the same.
Roles of Nepal Health Research Council in Setting and Ensuring Ethical Standards
One of the roles of NHRC is to review all health research proposals to be conducted in Nepal for the
scientific quality and ethical propriety and take necessary steps to approve or disapprove such research
proposals.
NHRC has set a National Ethical Guidelines for Health Research and constituted an Ethical Review
Board (ERB) to safeguard the dignity, rights and well being of research participants and to promote
ethical health research in Nepal.
The roles of ethical review board under NHRC are
i. Review research proposals according to the National Ethical Guidelines for Health Research in Nepal
with a view to approve, amend or reject the proposal.
ii. Supervise or monitor the implementation of health research projects approved by ethical review
board.
iii. Resolve ethical issues arising out of reviewing, approving, supervising and disseminating of research
findings.
iv. Conduct training programmes for members and reviewers of ERB and Institutional Review
Committees on the ethical review process.

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UNIT 7: SELECTING STUDY PARTICIPANTS
Determining Sample Size in Quantitative Studies
Calculation of exact sample size is an important part of research design. It is very important to understand
that different study design need different method of sample size calculation and one formula cannot be
used in all designs.
i. Sample size calculation for cross-sectional surveys

- Cross sectional studies or cross sectional survey are done to estimate a population parameter like
prevalence of some disease in a community or finding the average value of some quantitative
variable in a population.
- Sample size formula for qualitative variable and quantities variable are different.
a. For qualitative variable

- Suppose a researcher wants to know proportion of children who are stunted in a population, then this
formula should be used as proportion is a qualitative variable.
2
(1/2) (1 )
=
2
Where, Z (1-/2) is standard normal variate (at 5% Type I error, it is 1.96)

p = expected proportion in population based on previous studies or pilot studies
d = absolute error or precision (has to be decided by researcher)
For quantitative variable

- Suppose the same researcher is interested in knowing average systolic blood pressure of children of
the same city.
- Below mentioned formula should be used as blood pressure is a quantitative variable
2
(1/2) 2
=
2
Where, Z (1-/2) is standard normal variate as mentioned above

SD = Standard deviation of variable. Value of standard deviation can be taken from previously done
study or through pilot study.
d = absolute error or precision (has to be decided by researcher)
ii. Sample size calculation for case-control studies

a. Formula for sample size calculation for comparison between two groups when endpoint is quantitative
data
( + 1) 2 (/2 )2
=
2
Where,
SD = Standard deviation of variable. (from previously done study or through pilot study.)
Z /2 is standard normal variate
Z is power of study (0.842 at 80% power)
d is the effect size (difference between mean values)
r is the ratio of control to cases

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b. Formula for sample size calculation for comparison between two groups when endpoint is qualitative
( + 1) (/2 )2 (1 )
=
(1 2) 2
Where,
p 1 - p 2 is the difference in proportion of events in two groups
p = pooled prevalence
iii. Sample size calculation for testing hypothesis (intervention studies)

- Complex formula is used for this type of studies and it is usually advised to use statistical software
(example G power) for calculation of exact sample size.
- The procedure for calculation of sample size in intervention studies involving two groups is mentioned
here.
a. Formula for sample size calculation for comparison between two groups when endpoint is quantitative
data
- When the variable is quantitative data like blood pressure, weight, height, etc., then the following
formula can be used for calculation of sample size for comparison between two groups.
2 2 (/2 )2
=
2
Where,
SD = Standard deviation of variable. (from previously done study or through pilot study.)
Z (1-/2) is standard normal variate
Z is power of study (0.842 at 80% power)
d = effect size (difference between mean values)
b. Formula for sample size calculation for comparison between two groups when endpoint is qualitative
- When the endpoint of a clinical intervention study is qualitative, then the following formula can be
used for sample size calculation for comparison between two groups.
2 (/2 )2 (1 )
=
(1 2) 2
Where,
p 1 - p 2 is the difference in proportion of events in two groups
p = pooled prevalence
Determining Sample Size in Qualitative Studies
- In qualitative studies, sample size is rarely predetermined.

- The standard for sample size in a qualitative study is the achievement of saturation.
- Saturation has been achieved when the researcher concluded that responses are repetitive, and no
new information is being generated.
- Determining when an adequate sample has been achieved is the responsibility of the researcher.
- Documenting saturation is one of the ways that qualitative researchers can improve the
trustworthiness of a study, and it may be achieved with as few as six or eight subjects or may require
much larger numbers.
- As the complexity of the phenomenon under study increases, it will be more likely that a large number
of subjects will be required to achieve saturation

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Type I and Type II Error
There are usually two types of errors a researcher can make, Type I error and Type II error.
Type I error
- A type I error is characterized by the rejection of the null hypothesis when it is true and is referred by
alpha () level.
- Alpha level or the level of the significance of a test is the probability researchers are willing to take in
the making of a type I error.
- In public health research, alpha level is usually set at a level of 0.05 or 0.01.
- Type I error can be minimized by increasing the sample size.
Type II error
- Type II error is the failure to reject false null hypothesis.
- The probability of making a type II error is called beta (), and the probability of avoiding type II error
is called power (1- ).
It is important to point out that both Type I and Type II errors are always going to be there in the decision
making process.
The situation is further complicated by the fact that a reduction in probability of committing a type I error
increases the risk of committing a type II error and vice versa. Thus, researchers have to find a balanced
type I and type II errors they are willing to allow for.
H 0 True H 0 false
Reject H 0 Type I error Correct Decision
Do not reject
Correct decision Type II error
H0

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UNIT 8: INSTRUMENTATION
Developing Measurement Instrument
Instrumentation
Instrumentation is the process of developing, testing and using the measurement tools (questionnaire,
checklist, etc.) for a research purpose.
Questionnaire
A questionnaire is a research instrument consisting of a series of questions and other prompts for the
purpose of gathering information from respondents.
Qualities of a good questionnaire

Following are some of the desired qualities of a good questionnaire:
i. Limited Number of Questions
The number of question in a questionnaire should be as limited as possible. Questions should be only
relating to the purpose of enquiry.
ii. Simplicity
Language of the questions should be simple, lucid and clear. Questions should be short, not long or
complex. Mathematical questions should be avoided.
iii. Proper order of the questions

Questions must be properly sequenced to avoid confusions. The arrangements should be logical and
divided into groups and sub-groups for easy understanding.
iv. No undesirable questions

Undesirable questions or personal questions must be avoided. The questions should not offend the
informants.
Leading, double-barreled or suggestive questions should be avoided.
v. Non-controversial
Questions should be such that it can be answered impartially. No controversial questions should be
asked.
vi. Instructions
A questionnaire must show clear instructions for filling in the form.
Steps in developing a questionnaire

There are number of steps required to develop a questionnaire to ensure that the end product is rigorous
and meets the needs of research.
i. Identifying the research aims
One of the first step in developing a questionnaire is to clearly identify the aims of the research.
Once these have been identified, one can then move on to developing a series of well defined
questions that are likely to elicit the kinds of information that will contribute to answering research
question.

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ii. Identifying methods and relevant questions

The next step is to consider what kind of data is going to best serve the information needs of the
research.
In quantitative method, survey questionnaire typically includes:
Basic quantity, information or categorical questions
Forced choice yes/no questions
Multiple choice questions
A scale
Ranking
In qualitative method, open-ended questions are included.
iii. Presentation of Questionnaire

a. Sequencing of questions
A questionnaire needs to be shaped into a logical sequence that provides some order and is
likely to make sense to participants.
A general rule is to work from the broadest to narrowest questions and from least sensitive to
more sensitive questions.
Filter or skipping questions can be used as applicable.
b. Questionnaire length
When developing a questionnaire it is wise to keep the length to a minimum in terms of the time it
is likely to take for participants to respond.
If it is necessary to construct a relatively long questionnaire, headings and transition statements
can be inserted to explain to the participant what the next group of questions is about.
c. Language and phrasing

A key issue in developing a questionnaire is to use language appropriate to the group/s targeted
and to pitch the wordings of questions in a culturally appropriate way.
Some key points regarding wording include:
Avoiding wordings that is ambiguous or imprecise
Avoiding double barreled questions
Avoiding leading questions
Using small precise questions
Phrasing questions in the positive way wherever appropriate or mixing of positive and
negative questions throughout the questionnaire
d. Presentation and Layout

The way a questionnaire is presented and laid out has an impact in appealing the audiences and
maximizing the response rate.
Some key points regarding presentation and layout of questionnaire include:
Clear headings
Clearly separated questions and answers
Making the form of response required constant (e.g. tick or circle)
Sufficiently spacing
Formal fonts

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iv. Predetermine coding

Questionnaires should be precoded to facilitate data analysis.
v. Pretest and revise the questionnaire

Questionnaire should ne pretested before it is administered.
A questionnaire may be too long, ambiguous, incomplete, unclear, or biased in some way.
Pretest not only helps overcome these problems but also helps to refine procedural problems such as
improper skip patterns.
Based on the pretest and a thorough review of all previous steps, the questionnaire should be
revised.

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UNIT 9: QUANTITATIVE RESEARCH METHODS EXPERIMENTAL
Randomized Controlled Trial (RCT)

- A randomized controlled trial is an epidemiological experiment designed to study the effects of a
particular intervention, usually a treatment for a specific disease (clinical trial).
- Participants in the study population are randomly allocated to intervention and control groups, and the
results are assessed by comparing outcomes.
- To ensure that the groups being compared are equivalent, patients are allocated to them randomly,
i.e. by chance. If the initial selection and randomization is done properly, the control and treatment
groups will be comparable at the start of the investigation; any differences between groups are
chance occurrences unaffected by the conscious or unconscious biases of the investigators.
Design of RCT
The basic steps in conducting a RCT include the following
i. Writing the protocol
- One of the essential features of a randomized controlled trial is that the study is conducted under a
strict protocol.
- The protocol specifies the aims and objectives of the study, questions to be answered, criteria for the
selection of study and control groups, size of the sample, procedures for allocation of subjects and
controls, treatment to be applied, etc.
- The protocol aims at preventing bias and to reduce the sources of error in the study.
ii. Selecting a reference and experimental population

a. Reference population
- It is the population to which the findings of the trial are expected to be applied.
- Reference population depends upon the nature of the study and may be geographically limited or
limited to persons in specific age, sex or social groups.
b. Experimental or study population

- The study population is derived from the reference population.
- It is the actual population that participates in the experimental study.
- Ideally, it should be randomly chosen from the reference population, so that it has the same
characteristics as the reference population.
iii. Randomization
- Randomization is the heart of the randomized controlled trial.
- It is the statistical procedure by which the participants are allocated into groups usually called study
and control groups, to receive or not to receive an intervention.
- Randomization is an attempt to eliminate bias and allow for comparability by matching both known
and unknown confounders.
- By randomization, every individual gets an equal chance of being allocated to either groups.
iv. Follow up
- This implies examination of the experimental and control group subjects at pre set conditions till the
final assessment of the outcome.
- The duration of follow up usually depends upon the study undertaken.
- Efforts should be made to minimize the losses to follow-up.

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v. Assessment
- The final step is the assessment of the outcome of the trial in terms of positive and negative results.
- The incidence of positive/negative results is rigorously compared in both the groups and the
differences, if any are tested for statistical significance.
Figure: Design of Randomized Controlled Trial (RCT)
Strengths
- Excellent internal validity
- Provides precise measures of eifficacy and acute toxicity of new therapies under ideal conditions.
- Because of randomization, measurement of effect size is less prone to bias
Weakness
- Limited external validity
- Patients with co-morbidity are under-represented in RCTs.
- Have limited ability to detect rare and chronic toxicities, especially those that occur in patients
completion of the trial.
Internal Validity

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Internal Validity is the degree to which the results of a study are correct for the sample of patients
being studied.
Internal validity of an experimental design concerns the degree to which changes in the dependent
variable (effect) can be attributed to the independent variable (cause).
It is internal because it applies to the conditions of a particular group of persons being studied and not
necessarily to others outside the study population.
The internal validity of a health research is determined by how well the design, data collection, and
analyses are carried out, and it is threatened by all the biases and random variation.
Therefore, the concerns of internal validity revolve around whether the design is randomized, whether
the outcomes are appropriate, whether there are confounding effects and so on.
Example of internal validity, measurements of blood haemoglobin must distinguish accurately
participants with anaemia as defined in the study. Analysis of the blood in a different laboratory may
produce different results because of systematic error, but the evaluation of associations with
anaemia, as measured by one laboratory, may still be internally valid.
Threats to Internal Validity
i. Maturation
The term maturation refers to changes (biological pr psychological) that may occur within the subjects
simply as a function of the passage of time.
These changes threaten internal validity because they may produce effects that could be mistakenly
be attributed to the experimental treatment.
Subjects may perform differently on the dependent variable measure simply because they are older,
wiser, hungrier or more fatigued than they were at the time of first measurement.
ii. History
Specific events or conditions, other than the experimental treatment may occur between the
beginning of the treatment and the posttest measurement and may produce changes in the
dependent variable.
iii. Testing effect

Testing a test once may affect the subjects performance when the test is taken again, regardless of
any treatment.
In designs using a pretest, subjects may do better on the posttest because they have learned subject
matter from a pretest, have become familiar with the format of the test and testing environment or are
less anxious the second time.
iv. Instrument accuracy

The instrumentation threat to internal validity is a result of a change in the instruments used during
the study.
The change may involve the type of instruments, the difficulty level, the scorers, the way the tests are
administered, using different observers for pre-and post measures, etc.
v. Statistical regression
Statistical regression occurs when an extreme performance on a test is followed by a less extreme
performance.

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vi. Selection bias

Selection is a threat when there are important differences between the experimental and control
groups even before the experiment begins.
If the groups are not equivalent before the study, we cannot know whether any difference observed
later is due to the treatment.
vii. Experimental mortality (attrition)

The experimental mortality threat occurs when there is differential loss of participants from the
comparison groups.
This differential loss may result in differences on the outcome measure even in the absence of
treatment.
viii. Selection-maturation interaction

Selection and maturation may interact in such a way that the combination results in an effect on the
dependent variable that is mistakenly attributed to the effect of the experimental treatment.
Such interaction may occur on a quasi-experimental design.
Controlling Threats to Internal Validity
Many threats to internal validity are minimized through use of randomization and a control group.
i. Randomization
Randomization allows the assumption that the group do not differ at the beginning of the experiment.
The randomization process controls for history upto the point of the experiment; that is the researcher
can assume that past events are equally distributed among groups.
Randomization also controls for maturation because the passage of time is equivalent in all groups.
Statistical regression, selection biases and selection-maturation interaction are also controlled
because they occur only when groups are not randomly formed.
ii. Using Control Group

Some types of research design are based on a comparison between the effects of a treatment and no
treatment. The group that is used to measure the effects of no treatment is called control group.
The control group has the characteristics similar to those of the treatment group except it doesnt
receive independent variable.
Theoritically, the subjects in the control group and subjects in the experimental group are equally
likely to be exposed or to demonstrate the effects of maturation, history and testing. Son, any effects
that these factors may exert may be assessed in the control group.
iii. Other control methods

Another way of reducing threats to internal validity is ensuring the accuracy of the measuring
instruments. It is imperative that the instrument be thoughtfully selected, calibrated and used properly
by the investigator, since no research design or other method can minimize measurement error.
Experimental mortality is typically beyond the control of the researcher. Sometimes a researcher may
provide incentives or plead with a subject to complete the study, but they are violating subjects
ethical rights.

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Primary threats to internal validity and control measures

Threats Controlling measures
Maturation Randomization, control group
History Randomization, control group
Testing Randomization, control group, no pre-test
Instrument accuracy Researchers action
Statistical regression Randomization
Selection bias Randomization
Experimental mortality Researcher hopes subjects stay in study (beyond
direct control of researcher)
Selection maturation interaction Randomization
External Validity (Generalizability)
External validity refers to the extent to which the findings of a study can be generalized to other
subjects, settings and treatments.
It is the degree to which the results of a study hold true in other settings.
Generalizability expresses the validity of assuming that participants in a study are similar to other
population.
Threats to External Validity
i. Selection-treatment interaction (non representativeness)

A major threat to external validity of experiments is the possibility of interaction between subject
characteristics and treatment so that results found for certain kinds of subjects may not hold for
different subjects.
This interaction occurs when the subjects in a study are not representative of the larger population to
which one may want to generalize.
ii. Setting-treatment interaction (artificiality)

Artificiality in the setting may limit the generalizability of the results.
The findings of a contrived lab study of motivation may not be the same as one would obtain in a
study conducted in a public school setting.
iii. Reactive effects of pre-testing

Using a pre-test may increase or decrease the experimental subjects sensitivity or responsiveness to
the experimental variable and thus make the results obtained from this pretested population
unrepresentative of effects of the experimental variable on the unpretested population from which the
experimental subjects are selected.
iv. Multiple treatment interference

When a researcher is interested in studying more than one experimental variable on the same
subjects, there is a risk of the treatments interfering with or facilitating one another. The performance
of one task may inhibit or enhance the performance of a different task.

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v. Subject effects
Attitudes and feelings of the participants that develop during a study may influence the
generalizability of the findings to other settings.
This threat is called the reactive effect because subjects are reacting to the experience of
participating in an experiment.
Controlling Threats to External Validity
i. Randomization
Randomization is the key to controlling most threats to external validity.
Randomization increases the experiment's external validity by controlling for selection-treatment
interaction.
ii. Having a representative sample

External validity is generally controlled by selecting the participants, treatments, experimental
situation, and tests to represent some large population.
This is the best way to ensure that the sample is a good representation of this group, which increases
the ability to accurately generalize the study results.
iii. Use of control group

The reactive effects of pretesting can be assessed through the use of control group.
In the one group would receive the pre-test only, another would receive the treatment only, and a
third would receive the pre-test and the treatment.
A comparison would be made across the groups to measure the influence of each of the conditions.
Primary threats to external validity and control measures

Threats Control measures
Reactive effects of pre-testing Control group or randomization
Selection-treatment interaction Matching, Randomization, control group
Setting-treatment interaction No much researchers control
Multiple treatment interference Randomization of treatments, design or researcher
appraisal
Overall Have a representative sample
UNIT 10: DATA ENTRY ANALYSIS AND REPORT WRITING
Process of Data Management (Data Entry- Data Analysis)
Data management falls under the rubric of research project management. Data management involves
preparatory, data collection, data organization and data analysis/dissemination stages. Each stage is
equally important for study outcomes.
Objectives of data management

To acquire data and prepare them for analysis
To maintain quality control and data security
Support inquiries, review, reconstruction and archiving

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i. Data collection procedures

The quality of data collected is foundation to the validity of study findings. Written standardized
procedures facilitate consistency in data collection across study participants and data collectors.
The quality of data collection requires a systematic approach and includes; i) training data collectors
and 2) monitoring completeness and accuracy of raw data.
Several strategies will assure quality data collection in face to face interviews, particularly when
multiple data collectors are used.
Interviewers training must focus on consistency in how questions are asked and how participants
responses are needed.
Consistency can be facilitated by scripting the interview so that all directions for participants are
written and are read to participants.
The completeness and accuracy for the recorded responses are also monitored.
Data collectors are instructed to check all items to see if every item has a recorded response before
completing the interview.
A second line of quality assurance is having other research team members review data collection
instruments for completeness and accuracy.
After all checks of raw data are completed, the data collection instruments are ready for data entry.
ii. Instrument coding

During the preparatory stage of data management, data collection instruments and individual data
items are assigned codes for ease of data entry and management.
Coding is a good opportunity to review each data form for any irregularity that can be easily detected,
including verbal information written on the questionnaire.
Correction of irregularities (multiple responses to an item, inconsistent values, missing reponses, etc.)
generally requires access to the data form, so it is easier to take care of the problem at the coding
stage rather than when the forms have been filed and the computerized dataset is in use.
iii. Data entry, cleaning and editing

After coding, data forms are entered especially by using data entry software.
Data entry needs to be performed by well-trained and responsible personnel.
Consistency in data entry is best achieved by one rather than multiple individuals, and as the number
of person involved in data entry increases, the chance for error also increases.
Checks are implemented to validate that files were merged properly.
After the data entry is accomplished, cleaning and editing needs to be performed to check the quality
of data.
Data cleaning and editing basically involves detecting missing values and extreme values and
correcting them as applicable.
iv. Data analysis

With the availability of computer statistical packages, it is easy to compute and analyze many
statistics.
The first stage of data analysis should be emphasize obtaining a feel for the data.
Many of the methods of analyzing a dataset includes examination of:
Univariate distribution analysis (frequency distribution, summary statistics, graphs or other)
Cross-tabulation (frequency distribution across important groupings such as sex, ethnicity,
exposure, disease, etc.)
Scatter plots, showing pairs of continuous variables

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Correlation matrices
Hypothesis testings (t-test, chi-square test, ANOVA)
Multivariate /logistics regression analysis
It is often helpful to prepare summary tables of basic information from the above examination that can
be used for reference purposes during later stages of analysis and writing.
Graphical representation of data is extremely useful throughout the examination of the data.
v. Report writing
All research members need to play a role in planning, developing and submitting manuscripts.
Multiple reviews are essential to the development of quality manuscripts/ report.
vi. Documentation and data archiving

Documentation is also critical during the data analysis and dissemination stage
All data analysis activities must be documented to create an analysis history.
A written summary of each analysis is useful for preventing unnecessary duplication of analyses.
Archived data included all raw data, the database stored in statistical programs and analysis outputs.
Hard copies and computer folders are secured and kept for ongoing analysis.
Regression analysis and other multivariate methods
Multivariate analysis (MVA) is based on the statistical principle of multivariate statistics, which involves
observation and analysis of more than one statistical outcome variable at a time.
Statistically speaking, multivariate analysis refers to statistical models that have 2 or more dependent
or outcome variables.
A simple linear regression model has a continuous outcome and one predictor, whereas a multiple or
multivariable linear regression model has a continuous outcome and multiple predictors (continuous
or categorical).
The specific advantage of multivariate analysis methods are as follows:

i. They resemble closely how the researcher thinks about the data
ii. More data can be analyzed simultaneously, thereby providing greater statistical power.
iii. Regression models can give more insights into relationship between variables.
iv. The focus is on relationship among variables rather than on isolated individual factors.
The main methods of multivariate analysis are summarized in the table below:
Methods Type of dependent Type of independent Purpose
variable variable
1 Multiple Continuous (numerical) Mostly continuous but To describe the extent,

Regression in practice categorical direction, and strength of the
Analysis can be used relationship between several
independent variables and a
continuous dependent variable
2 Logistic Categorical dichotomous Continuous and To describe how many times
Regression categorical more likely is the event in one
Analysis group compared to the other

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3 Analysis of Continuous All nominal To describe the relationship

variance between a continuous
dependent variable and one or
more nominal independent
variables.
4 Discriminant Nomina (polychotomous) Commonly all To determine how one or more

analysis continuous, but in independent variables can be
practice a mixture of used to discriminate among
various types can be different categories of a nominal
used as long as some dependent variable
are continuous
5 Factor Commonly continuous, Commonly To define one or more new

analysis but in practice may be of continuous, but in composite variables called
any type. The variables practice may be of factors
are not initially identified any type. The
as dependent or variables are not
independent, but the initially identified as
resulting factors may be independent or
used as dependent or dependent, but the
independent variables in resulting factors may
a later analysis be used as
independent or
dependent variables
in a later analysis
Survival Analysis
Survival analysis is a collection of statistical procedures for data analysis for which the outcome variable
of interest is time until an event occurs. It is concerned with measuring the risk of occurrence of an
outcome event as a function of time. The time could be measured in days, weeks, months or years from
the beginning of observed follow-up on a subject. The event could be death, disease, incidence or
relapse or recovery.
In general, survival analysis allows for the proper treatment of incomplete data particularly due to subjects
dropping out of the study. This is known as censored data. There are generally three reasons why
censoring may occur:
i. A person does not experience the event before the study ends
ii. A person withdraws from the study before an event occurs (lost to follow-up)
iii. An intervening event occurs prohibiting further observation (e.g. adverse drug reaction)
Survival analysis attempts to answer questions such as:

What is the proportion of a population which will survive past a certain time?
Of those that survive, at what rate will they die or fail?
Can multiple causes of death or failure be taken into account?
How do particular circumstances or characteristics increase or decrease the probability of survival

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Methods of Several Analysis

Survival analysis is done in several ways:
- To describe the survival times of members of a group
Life tables
Kaplan-Meier curves
Survival function
Hazard function
- To compare the survival times of two or more groups
Long-rank test
- To describe the effect of categorical or quantitative variables on survival
Cox proportional hazard regression
Parametric survival models
Survival trees
Report Writing
The table below summarizes a general framework that must be considered in writing a research report.
Sections of the Key points to be considered
report
1 Title Page Title of the research/report
Name of the researcher
Date of Submission
2 Table of contents Table of contents shows the sections of the report
3 Executive summary This section gives a summary of the whole report
or abstract Outlines-purpose, research method, findings, main conclusions and
recommendations.
Mainly written in past tense
4 Introduction This sections outlines context, background and purposes

Defines terms and sets limit of the research
Should be written such that readers can easily identify what, how and why
research was conducted
5 Methodology Explanation is made on how research was done and outline of how sampling
was performed, how data was collected, etc. is presented.
6 Results/Findings Findings of the research are presented in this section
Only facts are presented with no interpretations
Graphic forms (tables and graphs) are used to present quantitative findings
7 Discussion Interpretation and evaluation of the results are done
It analyses results; draws together different aspects of the findings, findings
of other studies and refers to literature.
8 Conclusion Brief statements of major findings pertinent to research question are
presented
9 Recommendations Suitable changes/ solutions are suggested
10 Appendix Additional information are attached (e.g surveys, questionnaires, glossary,
raw data, etc)
11 References All references used are listed out

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UNIT 11: JOURNAL CLUBS AND DISSEMINATION OF RESEARCH FINDINGS, AND CRITIQUES ON
PAPER
Concepts of Journal Clubs
A journal club is a group of individuals who meet regularly to critically evaluate recent articles in the
academic literature.
The purpose of a journal club is to review specific research studies and to discuss the implications on
public health. Journal clubs provide a forum for a collective effort to keep up with scientific literature.
Benefits of journal clubs

There are many benefits to participating in a journal club, including
Keeping abreast of the latest and best public health research,
Promoting awareness of current health research findings,
Encouraging research utilization.
Journal clubs also encourage interaction and dialogue among health professionals and promote team
building.
It can promote a better understanding of the research process and an improved ability to critically
appraise research
Process of Journal Club

The American Journal of Critical Care describes the process of journal club as:
Posting and distributing copies of the research article and the journal club discussion questions prior
to each meeting.
Setting up a convenient meeting time and location.
Identifying a facilitator for the meeting (Initially, this could be a public health educator, specialist,
public health manager, or senior staff member, with journal club members then taking turns to lead
subsequent journal club sessions.)
Encouraging active participation of those attending by using the discussion questions.
Evaluating the journal club. At the end of the session, gathering feedback from participants.
Manuscript Development
According to the guidelines by International Committee of Medical Journal Editors (ICMJE), the general
requirements in development of manuscript include the following:
i. Title Page
General information about an article and its authors is presented on a manuscript title page and
usually includes
a. Article title
The title provides a distilled description of the complete article and should include information that
will make electronic retrieval of the article sensitive and specific.
Some journals require a short title, usually no more than 40 characters (including letters and
spaces) on the title page.
b. Author information:
Each author's highest academic degrees should be listed, although some journals do not publish
these.

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The name of the department(s) and institution(s) or organizations where the work should be
attributed should be specified.
c. Disclaimers
An example of a disclaimer is an author's statement that the views expressed in the submitted
article are his or her own and not an official position of the institution or funder.
d. Source(s) of support
These include grants, equipment, drugs, and/or other support that facilitated conduct of the work
described in the article or the writing of the article itself
ii. Abstract
Original research, systematic reviews, and meta-analyses require structured abstracts.
The abstract should provide the context or background for the study and should state the study's
purpose, basic procedures (selection of study participants, settings, measurements, and analytical
methods), main findings and principal conclusions.
It should emphasize new and important aspects of the study or observations, note important
limitations, and not over interpret findings.
iii. Introduction
Introduction should provide a context or background for the study (that is, the nature of the problem
and its significance).
The specific purpose or research objective of, or hypothesis tested by, the study or observation
should be stated.
iv. Methods
Methods section should aim to be sufficiently detailed such that others with access to the data would
be able to reproduce the results.
The Methods section should include a statement indicating that the research was approved or
exempted by the responsible review committee.
a. Technical Information
Specify the study's main and secondary objectives
Identify methods and procedures in sufficient detail to allow others to reproduce the results.
b. Statistics
Describe statistical methods with enough detail.
When possible, quantify findings and present them with appropriate indicators of measurement
error or uncertainty (such as confidence intervals).
Specify the statistical software package(s) and versions used.
v. Results
Results should be in logical sequence in the text, tables, and figures, giving the main or most
important findings first.
All the data in the tables or figures should not be repeated in the text; only the most important
observations should be emphasize or summarized.

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Restrict tables and figures to those needed to explain the argument of the paper and to assess
supporting data.
vi. Discussion
It is useful to begin the discussion by briefly summarizing the main findings, and explore possible
mechanisms or explanations for these findings.
Emphasize the new and important aspects of the study and putting the findings in the context of the
totality of the relevant evidence.
Link the conclusions with the goals of the study.
vii. References
Direct references should be provided to original research sources whenever possible.
References should be numbered consecutively in the order in which they are first mentioned in the
text.
viii. Abbreviations and symbols

Only standard abbreviations should be used; use of nonstandard abbreviations can be confusing to
readers.
Abbreviations in the title of the manuscript should be avoided.
Dissemination of Research Findings
Various Approaches of disseminating research findings

i. Scientific Publications
- For many researchers, publication in a scientific per-reviewed journal is a peak achievement.
- It signals acceptance of the work within the community and a visible contribution to the field.
- The big limitation of peer-reviewed publications is that key audiences tend not to read them
extensively.
- Although the structure of peer-reviewed papers can be very similar to a research report, its audiences
differ.
- Every scientific journals have specific requirements and formats for submitted articles and particular
guidelines to be followed by all authors.
ii. Conference Presentations

- Conference are an ideal forum for disseminating the research findings to experts in related field and
discussing research design, methodology, findings, future directions and discussions.
- Participating in conference usually involves three steps: call for papers, abstract submission and
acceptance for presentation.
- Many conferences allow the dissemination of research findings either in the form of oral presentation
or a poster.
iii. Policy briefs

- Policy briefs are short documents that present findings and recommendations of a research project to
a non-specialized audience.
- It is single alone document, focused on a single topic and no more than 2-4 pages.

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- Because policy makers are constrained by time and overwhelmed by various sources of information,
they are likely to make quick decision by selecting the evidence most appropriate to their political
leanings.
iv. Press-release
- The media is a crucial audience for research findings because it is both a target for and dissemination
of research evidence.
- The media can reach stakeholders that research teams cannot.
- They can popularize findings, pres government for change and highlight inequities or programmes
that are not working.
- However researchers must be aware that the media can be too sensational with chances of reporting
twisted facts. For these reasons, one of the best way to reach media is through a press-release.
- In general press release can be prepared in no longer than one page summarizing in several lines
major findings, justifying why the research findings deserve publication.
v. Other approaches
- Scientific seminars
- Community presentations
- Dissemination workshops
- Websites
- Mass media
Deciding target population for research dissemination

Determining the primary and secondary audiences for the information being disseminated is a critical
aspect of the dissemination strategy. The research team must understand who the audience is, how they
absorb research evidence. This will greatly increase the likelihood that the dissemination approach will
meet its objectives.
One tested way to decide target audience is to classify them into primary and secondary audiences.
- Primary audiences are those who need to make a decision or a change.
- Secondary audiences are those in a position to influence the decisions or actions of the primary
audience.
The level of audience (primary or secondary) is determined by the dissemination objectives.
An easy way to decide the target audiences is on the basis on dissemination objectives as follows:
Target Audiences Dissemination objectives Approach of
dissemination
1 Policy Makers - To provide policy options Policy briefs
2 Research community - Provide knowledge base to scientific Scientific publication
community in related field Conferences/seminars
3 Ethical review committee - To ensure compliance to ethical Research report
guidelines Scientific publication
Conferences/seminars

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4 Implementing team - To describe programmatic gaps and Dissemination

other considerations workshops
Research Report
Scientific publication
Conferences/seminars
5 Funder - To ensure compliance to grant Research report

agreement
6 Community - Information and general awareness Press release
- Validate findings Community meetings
Guidelines for Contributors (authors, co-authors and corresponding authors)
According to the guidelines for authorship established by the International Committee of Medical Journal
Editors (ICMJE), all persons designated as authors should qualify for authorship, and all those who
qualify should be listed.
Three basic criteria must collectively be met to be credited as an author:

- Substantial contribution to the study conception and design, data acquisition, analysis, and
interpretation.
- Drafting or revising the article for intellectual content.
- Approval of the final version.
The following are some general guidelines, which may vary from field to field
- The order of authorship should be a joint decision of the coauthors.
- Individuals who are involved in a study but dont satisfy the journals criteria for authorship, should be
listed as contributors or acknowledged individuals. Examples include: assisting the research by
providing advice, providing research space, departmental oversight and obtaining financial support.
- For large multi-center trials, the list of clinicians and centers is typically published, along with a
statement of the individual contributions made. Some groupd list authors alphabetically, sometimes
with a note to explain that all authors made equal contributions to the study and publication.
Publication Ethics
Some of the ethical issues to be considered in research publication includes:

i. Authorship
- Naming authors on a scientific paper ensures that the appropriate individuals get credit, and are
accountable, for the research.
- Deliberately misinterpreting a scientists relationship to their work is considered to be unethical and
undermines confidence in the publication of work itself.
- Ghost authorship, gift authorship and guest authorship are strictly considered unacceptable.
ii. Plagiarism
- One of the most common types of publication misconduct is plagiarism
- Plagiarism occurs when one author deliberately uses anothers work without permission, credit, or
acknowledgement.

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- Plagiarism takes different forms, from literal copying to paraphrasing someone elses work and can
include data, words and phrases or ideas and concepts.
- When it comes to publication, it is essential to credit the work of others as a critical part of the
research process.
iii. Simultaneous submissions

- Simultaneous submission occurs when a person submits a paper to different publications at the same
time, which can result in more than one journal publishing that paper.
- Authors have an obligation to make sure their paper is based on original (never before published)
research.
- Intentionally submitting or re-submitting work for duplicate publication is considered a breach of
publication ethics.
iv. Research fraud

- Research fraud is publishing data or conclusions that were not generated by experiments or
observations, but by invention or data manipulation.
- There are two kinds of fraud in research and scientific publishing:
a. Fabrication: making up research data and results and recording or reporting them
b. Falsification: changing or omitting data or results in such a way that research is not accurately
represented.
- Both type of fraud are serious misconduct because they result in publication of unscientific results.
v. Salami Slicing
- Unlike duplicate publication, which involves reporting the exact same data in two or more
publications, salami slicing involves breaking up or segmenting a large study into two or more
publications.
- As a general rule, as long as the slices of a broken up study share the same hypotheses, population
and methods, the slices are not acceptable for publication more than once.
Plagiarism
- Plagiarism occurs when one author deliberately uses anothers work without permission, credit, or
acknowledgement.
- Plagiarism takes different forms, from literal copying to paraphrasing someone elses work and can
include data, words and phrases or ideas and concepts.
- Plagiarism has varying different levels of severity such as:
a. How much of someones work was taken- a few lines, paragraphs, pages, the full article?
b. What was copied- results, methods or introduction section?
- Providing credit for the work of others is a critical part of the research process.
Forms of plagiarism
Forms of plagiarism What is it? Key notes
Literal Copying Reproducing someones work word for Literal copying is only acceptable if
word, in whole or in part, without the source is referenced and
permission and acknowledgment of the quotation marks are put around the
original source. copied text.

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Substantial Copying This can include research materials, "Substantial" can be defined as both
processes, tables, or equipment quantity and quality of what was
copied. If the research work captures
the essence of another's work, it
should be cited.
Paraphrasing Reproducing someone Paraphrasing is only acceptable if the

else's ideas while not copying word for source is properly referenced without
word, without permission and changing the meaning intended by
acknowledgment of the original source the source.
Text-recycling Reproducing portions of an author's

own work in a paper, and resubmitting it
for publication as an entirely new paper.
Preventing plagiarism
- Keeping track of sources used while researching and using it in a paper.
- Fully acknowledging and properly citing the original source in the paper.
- Using quotation marks around word for word text and referencing properly.
- Comparing the paraphrasing with the source to make sure the intended meaning is retained.
Critiques on Published Paper Reporting a Quantitative Study
The overall goal of a research critique is to formulate a general evaluation of the merits of a study and to
evaluate its applicability to public health practice. A research critique goes beyond a review or summary
of a study and carefully appraises a studys strengths and limitations. The critique should reflect an
objective assessment of a studys validity and significance. A research study can be evaluated by its
component parts, and a thorough research critique examines all aspects of a research study. Some
common questions used to guide a research critique include:
Elements of critique Common questions that needs to be reviewed

1 Position of Author - Does the researchers qualifications/position indicate a degree of
knowledge in the field of study?
2 Study Title Is the title clear and unambiguous?
3 Description of the - What was the purpose of the research?
Study - Does the problem have significance to nursing?
- Why is the problem significant/important?
- Identify the research questions, objectives, or hypothesis(es)
4 Literature Review - Does the literature review seem thorough?
- Does the review include recent literature?
- Does the content of the review relate directly to the research problem?
- Evaluate the research cited in the literature review and the argument
developed to support the need for this study.
5 Conceptual Framework - Does the research report use a theoretical or conceptual model for the
study?
- Does the model guide the research and seem appropriate?
- How did it contribute to the design and execution of the study?
- Are the findings linked back to the model or framework?

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6 Sampling - Are the size and key characteristics of the sample described?
- Is the sampling method appropriate?
- Were the participants suitable for informing research?
- How representative is the sample?
7 Methods and Design - Are the study methods described?
- How were the data collected?
- Are the data collection instruments clearly described?
- Were the instruments appropriate measures of the variables under
study?
- Describe and evaluate the validity and reliability of the instruments
8 Analysis - How were the data analyzed?
- Do the selected statistical tests appear appropriate?
- Is a rationale provided for the use of selected statistical tests?
9 Results - What were the findings of the research?
- Are the results presented in a clear and understandable way?
- Discuss the interpretations of the study by the authors
- Are the interpretations consistent with the results?
- Are study limitations addressed?
10 Conclusions and - Were the conclusions accurate and relevant to the problem the
recommendations authors identified?
- Were the authors recommendations appropriate?
11 Public Health - How does the study contribute to the body of knowledge?
Significance and - Discuss implications related to practice/education/research
Applications - What additional questions does the study raise?
UNIT 12: INTRODUCTION TO QUALITATIVE RESEARCH
Concept of Qualitative Research
Qualitative research is a type of formative research that offers specialized techniques for obtaining in-
depth responses about what people think and how they feel. It enables the program management to gain
insight into attitudes, believes, motives and behaviours of the target population.
Importance of qualitative research in public health

Many researchers wish to investigate a problem or major issue in public health practice or education for
practice that cannot be answered by qualitative research. There are some major reasons for using
qualitative research:
- Qualitative research can be important tool in understanding emotions, perceptions and actions of
people who suffer from a public health condition.
- The meanings that health professionals give to their work will only be uncovered if researchers
observe their interaction with clients and ask them about their experiences. This also applies to
students destined for the health care field.
- Qualitative research is person-centered and holistic perspective. The approach helps develop an
understanding of human experiences, which is important professionals who focus on caring,
communication and interaction.
- The reason for particular types of health related behavior can only be understood when it is observed
and people are asked about it. Therefore health promotion and education policies can be developed
through this type of research; policies for changing health behavior can only be effective if the
reasons for this behavior are clearly understood.

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Uses and applications

i. Studying Quality of Care
- The concept of quality in health care is multidimensional and multifaceted and some of the questions
asked related to quality of care or services may not be acquiescent to quantitative methods.
- Qualitative research offers a variety methods to be used for identifying what is really important to both
patients and carers
ii. Identifying obstacle for change

- Qualitative methods can also used to identify and detect obstacles to change and the reasons why
improvement does not occur.
- It is therefore an important component of health services research because it enables us to reach
areas not amenable to quantitative research, for example lay and professional health beliefs.
iii. Studying health provider- user interaction

- Qualitative methods in health research are widely used to study issues related to health provider-user
interaction.
- Studies concerning provider versus consumer agendas in public health practice and health
professionals perceptions of effective health care are examples.
iv. Understanding users perceptions

- Recently there have been more studies concentrating on users own perceptions and views regarding
their health and health care services.

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- For example: a study on womens views and experiences on the mental health effect of unsafe
abortion following an unplanned pregnancy.
- Another example is the study on womens experience of delivery at home.
v. Identifying social determinants of health

- Qualitative methods have also been used in identifying socio-cultural factors that affect health care
positively or negatively.
- Such information can be helpful in improving service delivery.
vi. Other applications

- Understanding patient satisfaction
- Evaluation of new technology used in health care
- Developing communication strategies, concepts and treatments
- Understanding trends in behavior or attitude shifts
- Identifying information needs of potential target segments
Paradigms of Qualitative Research

A valid research is based upon some assumptions which relate to underlying epistemology which guides
the research. Following are the paradigms for qualitative research
According to Guba and Lincoln According to Orlikowski and Baroudi
Positivism Positivism
Post-Positivism Interpretive
Critical Theory Critical
Constructivism
i. Positivism:
- It is based on the natural sciences.
- Theories and hypotheses are tested and verified or falsified.
- Neutrality and objectivity are characteristics of this approach where personal biases are intended to
be avoided.
- Positivist research usually employs quantitative statistical methods and claims to provide objective
scientific knowledge.
- Interpretivist researchers criticize this approach, as it is lacking in everyday subjective interpretations
or context.
ii. Post-positivism
- This paradigm accepts that society is really imperfect and that absolutes are difficult to establish, but
it still strives for objectivity.
- Post positivist research often combines qualitative (non-numerical) and quantitative (numerical)
approaches to data collection and analysis.
- Post-positivists recognize that all knowledge is fallible, but nevertheless insist that it is possible to
identify some knowledge claims as more likely to be true than others.
iii. Critical theory

- Critical theory takes the view that human beings are able to critically assess and change society and
become emancipated.
- Objective reality is criticized.
- It is strongly influenced by values, judgments and interests of humankind.

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- The feminist standpoint, action research and phenomenology are influenced to some extent by critical
theory.
iv. Constructivism
- The basic assumption guiding the constructivism paradigm is that knowledge is socially constructed
by people active in the research process, and that researchers should attempt to understand the
complex world of lived experience from the point of view of those who live it.
- The constuctivist paradigm emphasizes that research is a product of the values of researchers and
cannot be independent of them
Paradigm Positivism Postpositivism Critical Theory Constructivism

Nature of reality Assumes that Reality exists but is Reality exists but Reality is multiple
(Ontology) there is an difficult to is difficult to and constructed by
objective reality apprehend apprehend people who
observe it
Nature of - People can - Knowledge is - Knowledge is - Knowledge is

Knowledge know about the approximation of mediated by constructed by
(Epistemology) reality and reality values and the researcher
uses symbol to - Emphasis on ideologies and the subject
describe this objectivity - Emphasis on - Subjectivity is
objective subjectivity greatly valued
reality.
- Emphasis on
objectivity
Nature of Quantitative Preferably Both quantitative Preferably

Methods methods quantitative and qualitative qualitative methods
(Methodology) methods methods
Approaches/Strategies/Designs of Qualitative Research

i. Phenomenology
- Phenomenology examines human experience through the descriptions provided by the people
involved. These experiences are called lived experiences.
- The goal of phenomenological studies is to describe the meaning that experiences hold for each
subject.
- This type of research is used to study areas in which there is little knowledge.
- In phenomenological research, respondents are asked to describe their experiences as they perceive
them. They may write about their experiences, but information is generally obtained through
interviews.
- In this process, the researchers put aside their own feelings and beliefs about the phenomena under
consideration to keep from biasing their observations. This is called bracketing
- Phenomenology could be difficult to understand, particularly if a person has a limited background in
philosophy. This method is rigorous, critical and systematic.
ii. Ethnography
- Ethnography involves the collection and analysis of data about cultural groups. The end purpose of
ethnography is the development of cultural theories.
- In ethnographic research, the researcher frequently lives with the people and becomes a part of their
culture.

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- The researcher explores with the people their rituals and customs.
- An entire cultural group may be studies or a subgroup in the culture.
- Ethnographers interview people who are most knowledgeable about the culture. These people are
called key informants.
- Data are generally collected through participant observation and interviews.
iii. Grounded Theory

- Grounded theory is a study in which data are collected and analyzed and then a theory is developed
that is grounded in the data.
- What differentiates grounded theory from other types of qualitative research is its focus on building
theory.
- Grounded theory is more concerned with the generation rather than testing of hypotheses.
- The theory that is generated is self-correcting, which means that as data are gathered, adjustments
are made to the theory to allow for the interpretation of new data that are obtained.
- Grounded theory is particularly useful for addressing questions about process, that is, how something
changes over time.
- Data in grounded theory can come from interviews, observations, and a wide variety of documentary
materials.
iv. Case-Studies
- Case studies are in-depth examinations of people or groups of people.
- A case study can also examine an institution, such as hospice care for the dying.
- In public health, case studies have frequently been concerned with a particular disease or health
related states and events.
- For a case study to be considered as a qualitative study, the researcher must be interested in the
meaning of experiences to the subjects themselves, rather than in generalizing results to other
groups of people.
- Data may be collected in case studies through various means such as questionnaires, interviews,
observation or written accounts by the subjects. Content analysis is used in evaluating the data from
case studies.
Approaches Field of Origin Aim

1 Phenomenology Psychology and philosophy Understand a phenomenon and how it
is experienced by people
2 Ethnography Anthropology and Sociology Describe the shared culture of a group
of individuals
3 Grounded Theory Sociology Generate a theory (of a social
process, an action) grounded in data
from the field
4 Case Study Human and social sciences Study an issue through an in-depth
description of a case

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ETIC and EMIC Perspectives

In the study of cognition in organizations, and in social science more broadly there are two long-standing
approaches to understanding the role of culture.
i. The inside perspective of ethnographers, who strive to describe a particular culture in its own terms
ii. The outside perspective of researchers, who attempt to describe differences across cultures in terms
of a general, external standard.
Pike (1967) designates these approaches as the emic and etic perspectives respectively.
Some of the assumptions and associated methods of emic and etic perspectives have been summarized
in the table below:
Features Emic/Insider Perspective Etic/Outsider Perspective
Defining Behaviour is described as seen from the Behaviour described from a vantage external
assumptions perspective of cultural insiders to the culture.
and goals
Describe the cultural system as a Describe the ways in which cultural variables
working whole fit into general causal model of a particular
behavior
Typical Observations recorded in a rich Focus on external, measurable features that
features and qualitative term that avoid imposition of can be assessed by parallel procedures at
methods the researchers constructs different cultural sites.
Long-standing wide-ranging observation Brief, narrow observation of more than one
of one setting or a few setting setting, often a large number of settings
Examples of Ethnographic fieldwork; participant Multisetting survey; cross-sectional
typical study observation along with interviews. comparison of responses to instruments
types measuring health perceptions and related
variables.
Content analysis of texts providing a Comparative experiment treating culture as a

window into indigenous thinking about quasi experimental manipulation to assess
health whether the impact of particular factors varies
across cultures.
Strengths of qualitative research

- Issues can be examined in detail and depth.
- The researcher is not restricted to specific questions or lists. Interviews are in-depth discussions
guided by the researcher to yield relevant information.
- The research framework and direction can be quickly revised as new information emerges.
- Methods are adaptable for use with a wide range of subjects. For example, visual representation and
mapping exercises can be done with people with low levels of literacy.
- Data collection can be more informal, relaxed and fun, which encourages subjects to participate in the
research.
Limitations
- Data is collected from a few cases or individual, which means that findings cannot be generalized to
the larger population.
- Research quality is heavily dependent on the individual skills of the researcher.
- Rigour is more difficult to maintain, assess and demonstrate.
- The volume of data makes analysis and interpretation time consuming.
- It is not well understood as quantitative research. It is therefore often more difficult to convince others
of the importance of its contribution.

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Similarities and Differences between Quantitative and Qualitative Research
Similarities between quantitative and qualitative research approaches

- Both research traditions are rigorous in their methods (although each may use different criteria for
validity and reliability).
- Both demand the highest ethical standards with respect to the treatment of people in the study.
- Both methods involve the use of observations to address research questions.
- Although the nature of the research questions is typically different, both approaches are
fundamentally concerned with answering research questions about the nature of social reality.
Differences between quantitative and qualitative research approaches

Basis of Quantitative Qualitative
differences
General Seeks to confirm hypotheses about Seeks to explore phenomena
Framework phenomena
Instruments use more rigid style of Instruments use more flexible, iterative style
eliciting and categorizing responses to of eliciting and categorizing responses to
questions questions
Uses highly structured methods such Uses semi-structures methods such as in-
as questionnaires, surveys, and depth interviews, focus groups, and
structured observation participant observation.
Largely inductive reasoning (infers Largely deductive reasoning
general ideas from observations)
Analytical To quantify variation To describe variation
objectives To predict causal relationships To describe and explain relationships
To describe characteristics To describe individual experiences and
group norms
Question format Closed-ended Open-ended
Data format Numerical obtained by assigning Textual (obtained from audiotapes,
numerical values to responses videotapes and field notes)
Flexibility in Study design is stable from beginning Some aspects of the study are flexible (for
study design to end example, the addition, exclusion, or wording
of particular interview questions)
Participant responses do not influence Participant responses affect how and which
or determine how and which questions questions researchers ask next
researchers ask next
Study design is subject to statistical Study design is iterative, that is, data
assumptions and conditions collection and research questions are
adjusted according to what is learned,
Methods Research can take place even without Research generally takes place in the field
direct contact with the participant, as in and involves face to face encounters with the
the case of telephone or mailed survey participant.
Results and Results tend to summarize patterns of Results are in-depth explanations for
analysis similarities, variability, size, direction patterns of behavior
and/or significance of any differences
between specific groups

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UNIT 13: DESIGNING A TOPIC GUIDE AND INTERVIEW AND DISCUSSIONS
In-depth Interview
The in-depth interview is a technique designed to elicit a vivid picture of the participants perspective on
the research topic.
During in-depth interview, researchers engage with participants by posing questions in a neutral manner,
listening attentively to participants responses and asking follow up questions and probes based on those
responses.
They do not lead participants according to any preconceived notions, nor do they encourage participants
to provide particular answers by expressing approval or disapproval of what they say.
In-depth interviews are usually conducted face-to face and involve one interviewer and one participant.
When to use in-depth interview?

i. Complex subject matter and knowledgeable respondents: For example, a study among health
providers on their attitudes and practices regarding the treatment of a particular disease.
ii. Higher sensitive subject matter: A study among women who have had an abortion regarding their
feeling about family planning
iii. Geographically dispersed respondents
iv. Peer pressure: Example, a study of male teenagers to explore their attitudes about sexually
responsible behavior.
Salient Features of In-depth Interview

There are a number of core features of the in-depth interview
i. Combining structure with flexibility
- In-depth interviews combine structure with flexibility. So, even the most unstructured interview will be
initiated with at least some sense of the themes that will be explored.
ii. Interactive:
- The material is generated by the interaction between the researcher and participant in the sense that
what the researcher asks about, and the way they frame questions, is driven to a large degree by
what the participant says.
iii. Getting below the surface:

- The researcher uses a range of questioning techniques (such as probes and follow up questions) to
achieve depth of exploration and explanation. The initial response is often at a fairly surface level; the
interviewer will listen and probe to obtain a deeper and full understanding of the participants
experiences and the meaning they hold for that individual.
iv. Generative
- The in-depth interview is generative in the sense that new knowledge or thoughts are likely to be
created. The interview may also be generative in the sense that participants put forward ideas and
suggestions on a particular topic and propose solutions for problems raised during the interview.
v. Importance of language
- In-depth interview focuses on how participants express themselves. The language used by
participants is explored because it holds and elucidates meaning. To capture this as effectively as
possible, interviews as generally audio-recorded.

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Process of conducting in-depth interview

i. Greeting and introducing with the patient in a friendly manner and establishing positive rapport.
ii. Briefly describing the steps of the interview process (informed consent, question and answer, their
questions)
iii. Obtaining informed consent
iv. Turning on the tape recorder and verifying that it is working
v. Verifying informed consent orally with the tape recorder on
vi. Conducting the interviewing according to the interview guide. Using follow up questions and probes
as required.
vii. Giving the participant the opportunity to ask questions.
viii. Turning off the tape recorder and thanking the participant
ix. Clarifying any factual errors expressed by participants during the interview
Key skills for in-depth interviewing

Skills Includes
Rapport building The ability to quickly create interviewer/ participant dynamics that are
positive, relaxed and mutually respectful
Emphasizing the Treating the participant as the expert
participants perspectives Keeping the participant from interviewing researcher
Balancing deference to the participant with control over the interview
Demonstrating a neutral attitude
E.g. deflecting the question if a participant asks researcher what

he/she thinks by letting participant understand that researcher
considers his/her of view more important
Adapting to different Researcher being able to quickly adjust his/her style to suit each
personalities and individual participant
emotional states
E.g. knowing how to tone down heightened emotions, such as when a
participant starts crying or becomes belligerent
Strengths
- Elicits in-depth response, with nuances and contradictions
- Gets at interpretative perspective i.e, the connections and relationships a person sees between
particular events, phenomena, and beliefs.
Limitations of in-depth interview

- In-depth interviews generally take place in a wide range of settings; this limits the interviewers control
over the environment. Interviews conducted in a hospital or at a store may have to contend with many
disruptions, all of which inhibit the acquisition of information and limit the comparability of interviews.
- In-depth interviews are often conducted with knowledgeable respondents (such as physicians);
interviewers may not be completely familiar with the pertinent social or cultural context. Therefore,
some responses may not be correctly understood or reported.
- In the case of elite respondent, the respondent may have a desire to speak beyond the limits imposed
by the interviewer and to seek more interaction with the interviewer, widening the knowledge gap
even further.
- The potential for management observation and feedback is limited.

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Study Design for a Qualitative Focus Group Discussion
Focus group discussion is a unique method of qualitative research that involves discussing a specific set
of issues with a pre-determined group of people.
When to use a focus group discussion?

- To identify a range of views and experience
- To provoke discussion and explanation of issues
- To identify new issues and generate hypotheses
- To seek broad information about a community
- For less sensitive topics
- To understand group interaction and decision making
Salient Features of Focus Group Discussion

The ideal characteristics for a focus group are as follows:
- The group consists of eight to twelve members.
- Focus groups are generally conducted among homogenous target populations with similar social
status (e.g. consisting of all women, or all adolescents, etc.) but are likely to have a range of different
views.
- Discussion generally lasts for 90 minutes to two hours.
- The moderator has experience of the issues being discussed.
- Conversation should be videoed and/or audio-taped, or notes taken.
- Emphasis is on the interaction between the group members, rather than their individual perspectives.
- The goal is not for everyone to reach agreement; instead, the aim is for the participants to reflect on
the discussion topics, present their opinions, and respond to the comments of other group members.
Process of focus group discussion

i. Introduction: Moderators opening
- Welcoming and introducing to the participants
- Explaining the general purpose of the group
- Encouraging conflicting opinions
- Establishing openness: no right or wrong answers
- Establishing group rules
- Starting rapport building with respondents for smooth transition to next phase
ii. Phase I: Warm up

- Obtaining necessary background information of the participants
- Begin stimulating group interaction
- Providing all respondents opportunity to speak
- Probing respondents for clarity and understanding
iii. Phase II: Body of the discussion

- Moving from general to specific questions
- Obtaining a depth of response to key issues
- Obtaining members true feelings about topics
iv. Phase III: Closing

- Summarizing and recapping the identified themes of the group.

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- Discussing strengths of attitudes expressed

- Pointing out key differences between the group members and clarifying these distinctions
- Pointing out any remaining inconsistencies in respondent statements and seeking clarification.
- Acknowledging participation by respondents.
Group Facilitation Skills (Moderator Skills)

Facilitating the group is complex and requires a high order of skills. Some key facilitation skills include
i. Questioning skills
- A good facilitator uses open-ended and unbiased questions to permit respondents honest feelings to
emerge.
- Avoiding double-barreled and leading questions is also an important trait of a group facilitator.
ii. In-depth probing

- This skill is required to clarify and illuminate responses given by a group member. Some of the
examples of probing skills include:
Remaining silent- allowing the respondents to amplify what he/she said
Using the mirror techniques- restating what the respondent has just said
Repeating the respondents words as a question- its good?
Confronting the respond to clarify a position. Im confused. Earlier you said X, now youre
saying Y.
iii. Reweaving skills

- Reweaving information provided at an earlier stage of the group into the current discussion is an
important facilitation skill.
- Often a respondent will make a comment critical to the ultimate purpose of the group at a premature
stage of the discussion. The facilitator may let the comment drop until the appropriate point in the flow
of the group and then ask the respondent to expand upon the comment that was made earlier.
iv. Handling special problems

- Facilitators should be able to handle special problems that often occur in focus groups, such as
conflicts between respondents or a general lack of enthusiasm on the part of the group as a whole.
v. Identifying and handling respondent problems
- A group may have a variety of respondents such as dominating, timid or negative respondents which
may affect the focus group. The facilitator/moderator should identify such respondents and take
strategies to handle such problems.

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UNIT 14: QUALITATIVE DATA ANALYSIS
Principles of Qualitative Data Analysis
Following are the five principles that guide qualitative data analysis
i. People differ in their experiences and understandings of reality:
- The participants often have different understandings of reality, and that their perspectives may differ
substantially from the researchers assumptions.
- In analysis, researcher should take account of the following:
Be aware of own perspectives and take account of them in field notes and bracket them in
transcripts.
Return to participants to validate what has been understood
Note what is thought as emerging explanations and check them against raw data
Work closely with key informants during analysis
ii. Theory both guides qualitative research and results from it

- Qualitative analysis can be informed by theory, or it can generate theory.
- If the study is grounded in a theoretical framework, the plan for analysis should begin with the
concepts and categories that have guided the research design.
- In other study designs, researchers avoid imposing a theoritical framework letting theory emerge from
the data analysis.
iii. Exceptional cases may yield insight into a problem or new leads for further inquiry
- Although analysis may seek common ground or consensus across different individuals or groups, it is
equally important to understand how and why individuals or groups differ with respect to issues under
study.
- Identifying and tracking exceptions may yield important insights and lead to a better understanding of
the research problem.
iv. Understanding of human behavior emerges slowly and nonlinearly

- As in design and implementation, qualitative analysis typically follows an iterative path.
- A flexible and integrated approach is therefore essential if the researcher is to understand complex
issues from the participants perspectives.
- It may require numerous rounds of questioning, reflecting, rephrasing, analyzing, theorizing, and
verifying.
- Qualitative analysis should begin in the field continuing through (and beyond) the data collection
period.
v. A social phenomena cannot be understood outside its own context

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Approaches to Qualitative Analysis
There are several broad ways of analyzing qualitative data. Some of the important approaches to public
health practice are discussed below:
i. Content analysis
- Content analysis refers to a general set of techniques useful for analysing and understanding certain
words or concepts within texts or sets of texts.
- Researchers quantify and analyze the presence, meanings and relationships of such words and
concepts, then make inferences about the messages within the texts, the writer(s), the audience, and
even the culture and time of which these are a part.
- Mayring proposes two different approaches for qualitative content analysis according to researchers
approaches.
a. Inductive category development
b. Deductive category development
Figure: Procedure for a deductive approach to qualitative content analysis
Figure: Procedure for an inductive approach to qualitative content analysis

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Types of content analysis

Types of content Study starts with Timing of defining codes Sources of codes or
analysis or keywords keywords
Conventional content Observation Codes are identified Codes are derived from
analysis during data analysis data
Directed content Theory Codes are defined Codes are derived from
analysis during data analysis theory or relevant
research findings
Summative content Keywords Keywords are identified Keywords are derived
analysis before and during data from interest of
analysis researchers or review of
literature
ii. Thematic Analysis

Thematic analysis focuses primarily on the content of texts, assuming there is relationship between
representations and the social reality beyond the text.
Process of thematic analysis

According to Braun and Clarke, a thematic analysis can be performed in seven stages
SN Stages Description
1 Transcription Turning audio data into written texts (or transcripts) by writing down what
was said and how it was said so the data can be systematically coded and
analyzed
2 Reading and Reading and re-reading the data to become intimately familiar with the
familiarization content (i.e. immersion); analysis begins by noticing things of interest that
might be relevant to the research questions
3 Coding (Selective Identifying aspects of the data that relate to the research questions; can
and complete) involve selective coding where only material of interest is coded or
complete coding where the entire dataset is coded
4 Searching for Identifying salient features that capture something important about the data
themes in relation to the research question; may represent some level of patterned
response or meaning within the dataset
5 Reviewing themes Determining whether candidate themes fit well with the coded data; themes
should tell a story that rings true with the data.
6 Defining and naming Defining themes by stating what is unique and specific about each one; this
themes stage is useful because it forces researchers to define the focus and
boundaries of the themes by distilling to a few short sentences what each
theme is about
7 Writing the Report Writing the report by selecting compelling and vivid examples of data
extracts, and relating them back to the research question
iii. Grounded theory approach

Data analysis in grounded theory was originally introduced as a method of constant comparative analysis;
which consist of explicit coding and analytic procedures.
The key aspects in a grounded theory approach to analysis includes
c. Theoritical sampling: This is the process of data collection for generating theory whereby the
researcher jointly collects, codes and analyses the data and decides what data are to collect next in
order to develop the emerging theory.
d. Coding: This is the stage where data are broken into component parts and names are given to the
parts. Corbin and Strauss suggested three stages of coding: open coding, axial coding and selective
coding:

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Open coding: It is the initial step that includes comparison of incident with other incidents in terms
of similarity and differences, giving conceptual labels to incidents, and grouping those concepts
together into categories.
Axial coding: In axial coding, researchers relate categories with their sub-categories, test the
relationships against data and test the hypothesis.
Selective coding: It refers to the process by which researchers select one or more categories
intended to generate a story that connects the categories.
e. Theoritical Saturation: This refers to the point when no further coding is necessary because no new
instances are required to confirm a category, and/or when no new data collection is required as there
is sufficient confidence about the nature of the emerging concepts.
f. Constant comparison: This is the process whereby the data and the subsequent conceptualizations
from it are compared to ensure that there is a good fit. This happens throughout data analysis.
Figure: Data analysis procedure of grounded theory method
iv. Framework analysis

The five key stages of data analysis in the framework approach are
a. Familiarization- Immersion in the data (listening to tapes, reading transcripts, studying notes etc.) to
get an initial feel for the key ideas and recurrent themes.
b. Identifying a thematic framework- Identifying key issue, concepts and themes and the setting up of an
index framework.
c. Indexing- Systematically applying the index framework to the text form of the data, by annotating the
text with codes in the margin.
d. Charting- Data are lifted from their original context and rearranged according to themes in chart form.
There may be separate charts for each major subject or theme and they will contain data from several
different respondents. The process involves considerable synthesis and abstraction.
e. Mapping and interpretation- The charts are used to define concepts, map the range and nature of
phenomena, create typologies and find association between themes in order to provide explanations
for the findings. This process is guided by the original research questions as well as themes and
relationships emerging from the data.

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UNIT 15: TRUSTWORTHINESS OF QUALITATIVE DATA
According to Lincoln and Guba (1985), trustworthiness basically means how an inquirer can persuade his
or her audiences that the findings of an inquiry are worth paying attention to.
The qualitative research outlines four primary criteria in order to determine the trustworthiness of research
data. This consists of credibility, transferability, dependability and conformability.
i. Credibility:
- In qualitative research, credibility and authenticity refer to internal validity. Credibility is often linked to
the concept of truth value.
- The researcher asks: Are the findings credible to the people under study? And Do I have an
authentic portrait of what I am looking for?
- A studys credibility is said to be confirmed when the reader recognizes the situation described by a
research study as closely related to their own experiences.
ii. Transferability:
- Transferability and/or fittingness in a qualitative research refer as the degree to which the results of a
study can be generalized to other settings or samples.
- The researcher asks: Are the conclusions of the study transferrable to other contexts? Do they fit?
- S/he helps to provide a detailed database and thick description so that someone else can determine
whether the findings of the study are applicable to another context or setting
iii. Dependability:
- Dependability is another criterion to ensure the trustworthiness of the study. It roughly corresponds to
the concept of relaibaility in quantitative research.
- This requires an inquiry audit. The enquiry auditor generally a peer follows the process and a
procedure used by the researcher in the study and determines whether they are acceptable, that is
dependable.
iv. Confirmability:
- Confirmability captures the traditional concept of objectivity.
- Confirmability guarantees that the findings, conclusions and recommendation are supported by the
data and that there is internal agreement between the investigators interpretation and the actual
evidence. This is accomplished by incorporating and audit procedure.
Corresponding terms describing trustworthiness

SN Quantitative Research Qualitative Research All-embracing term
1 Validity Credibility Veracity
2 Relaibility Dependability Consistency
3 Objectivity Conformability Neutrality
4 Generalizability Tranferability Applicability

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Strategies to Ensure Trustworthiness of Qualitative Data
i. Audit trail
- The audit trail provides a mechanism for subsequent reviews by other researchers and has been
identified as the single most important trustworthiness techniques.
- It established both dependability and credibility.
- An audit trail is systematically maintained documentation system that consists of raw data, products
of data analysis, including coding procedures, products of data reconstruction and synthesis and
process notes.
- Because it explicates the research process, it can be reviewed by other researchers to attest to the
trustworthiness of the research.
ii. Field Notes
- Maintaining field notes entails the recording of comprehensive and detailed information, sometimes
referred to as thick descriptions.
- The use of field notes ensures that important information from the researchers personal experiences
in the study are incorporated into the process of analysis.
iii. Memos
- Memos are used throughout the qualitative research process to record personal biases, assumptions
and feelings.
- This approach serves to record the researchers thoughts, perspectives, intuitions and preliminary
ideas regarding the ongoing investigation and also safeguards the loss of important ideas.
iv. Triangulation
- Triangulation is defined as the researchers effort to collect information from a diverse range of
individuals and settings, using a variety of methods in order to construct appropriate explanations of
the phenomena being studied.
- Information collected from a variety of sources is compared and contrasted and serves to protect the
accuracy of data interpretation.
- It minimizes the possibility of arriving at erroneous interpretations and conclusions.
v. Member checking/ Validation

- Member checking is done by researcher by summarizing, repeating or paraphrasing the participants
words or by talking about their understanding of the participants words or actions. Then they ask
whether the participants feel that the interpretation is true and a fair representation of their
perspective.
- This procedure will help avoid misinterpretation or misunderstanding of the participants words or
actions.
vi. Peer debriefing

- Peer debriefing means that colleagues who are competent in qualitative research procedures might
re-analyse the data and provide a fresh perspective and point out questions, anomalies, weak or
missing evidence, or other gaps in the work.
- S/he can also provide valuable confirmation that the analysis and interpretation seem feasible as well.
vii. Other approaches

- Searching for negative case and alternative explanations
- Prolonged engagement and persistent observation
- Reflexivity

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Triangulation in Qualitative Research
Triangulation refers to the use of multiple methods or data sources in qualitative research to develop a
comprehensive understanding of phenomena (Patton, 1999).
Triangulation also has been viewed as a qualitative research strategy to test validity through the
convergence of information from different sources.
Types of triangulation
Denzin (1978) and Patton (1999) identified four types of triangulation:
i. Method triangulation:
- Method triangulation involves the use of multiple methods of data collection about the same
phenomenon.
- This type of triangulation, frequently used in qualitative studies, may include interviews, observation,
and field notes.
ii. Investigator triangulation

- Investigator triangulation involves the participation of two or more researchers in the same study to
provide multiple observations and conclusions.
- This type of triangulation can bring both confirmation of findings and different perspectives, adding
breadth to the phenomenon of interest
iii. Theory triangulation

- Theory triangulation uses different theories to analyze and interpret data.
- With this type of triangulation, different theories or hypotheses can assist the researcher in supporting
or refuting findings.
iv. Data source triangulation

- Data source triangulation involves the collection of data from different types of people, including
individuals, groups, families, and communities, to gain multiple perspectives and validation of data.

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UNIT 16: CRITIQUE A PUBLISHED PAPER REPORTING A QUALITATIVE STUDY
Following are the criteria to consider in critiquing a qualitative research study

Elements of critique Criteria to consider for critiques
1 Relevance of Study - Is the research question interesting?
Question - Is the research question relevant to clinical practice, public health or
policy?
- Are the questions clear and unambiguous
2 Appropriateness of - Is qualitative methodology the best approach for the study aims?
Qualitative Method - Are study design described and justified?
3 Transparency of
Procedures
3.1 Sampling - Has the criteria for selecting the study sample been justified and
explained?
- Are the selected participants appropriate to provide access to the type
of knowledge sought by the study?
- Is the sampling strategy appropriate?
3.2 Recruitment - Was recruitment conducted using appropriate methods?
- Could there be selection bias in recruitment?
3.3 Data Collection - Was the collection of data systematic and comprehensive?
- Are the characteristics of the study group and setting clear?
- Why and when the data collection was stopped and is this
reasonable?
3.4 Ethics - Was informed consent sought and granted?
- Were participants anonymity and confidentiality ensured?
- Was approval from an appropriate ethics committee received?
4 Soundness of
interpretative
approach
4.1 Analysis - Is the type of analysis appropriate for the type of study?
- Are the interpretations clearly presented and adequately supported by
evidence?
- Was trustworthiness/reliability of the data and interpretations
checked?
4.2 Discussion and - Are findings sufficiently grounded in a theoretical or conceptual
presentation framework?
- Is adequate account taken of previous knowledge and how the
findings add up.
- Are limitations thoughtfully considered?
- Are red flags present? (jargon, over interpretation, anecdotal, doctor-
researcher, etc.)

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UNIT 17: MIXED METHODS IN HEALTH RESEARCH
Introduction to Mixed Method Study
Mixed methods research is a research design with philosophical assumptions as well as methods of
inquiry. As a methodology, it involves philosophical assumptions that guide the direction of the collection
and analysis and the mixture of qualitative and quantitative approaches in many phases of the research
process. As a method, it focuses on collecting, analyzing, and mixing both quantitative and qualitative
data in a single study or series of studies. Its central premise is that the use of quantitative and qualitative
approaches, in combination, provides a better understanding of research problems than either approach
alone.
Advantages of mixed method research

- Mixed methods approaches are useful when the researchers know very little about the group of
people they are investigating. In these circumstances, they can use a qualitative approach in order to
identify variables and use more quantitative approach to explore the questions.
- The combination of quantitative and qualitative approaches means that researchers can draw upon
strengths of one approach to compensate for the weakness of other approach.
- Mixed method research enhances the validity of the findings of a research project.
- This method allows the researcher to address the questions that cannot be answered by a
quantitative or qualitative approach alone.
Disadvantages
- This method can be both time consuming and expensive to conduct
- In some cases, researchers may find the quantitative and qualitative data either contradict each other
or in some other way call for additional explanation.
Characteristics of Mixed Methods Research
Creswell and Plano Clark (2011) identified six core characteristics of mixed methods research:
- Mixed methods research collects and analyzes rigorously both qualitative and quantitative data in
response to research questions.
- It mixes (or integrates or links) the two forms of data concurrently by combining them (or merging
them), sequentially by having one build on the other, or embedding one within the other.
- Mixed method research gives priority to one or both forms of data (in terms of what the research
emphasizes)
- Mixed methods research procedures are used in a single study or in multiple phases of a program of
study.
- The research procedures are framed within philosophical worldviews and theoretical foundation.
- Procedures into are combined into specific research designs that directs the plan for conducting the
study.

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Mixed Method Designs
The four basic mixed method designs are the convergent parallel design, the explanatory sequential
design, the exploratory sequential design and the embedded design.
i. The convergent parallel design (triangulation design)

- The convergent parallel design occurs when the researcher uses concurrent timing to implement the
quantitative and qualitative strands during the same phase of the research process, prioritizes the
methods equally, and keeps the strands independent during analysis and then mixes the results
during the overall interpretation.
- This design is used when a researcher wants to directly compare and contrast quantitative statistical
results with qualitative findings or to validate or expand quantitative results with qualitative data.
Example for understanding convergent design

The researcher might use a convergent design to develop a complete understanding of high school
students attitudes about tobacco use. During one semester, the researcher surveys the students about
their attitudes and also conducts focus group interviews on the topic with students. The researcher
analyzes the survey data quantitatively and the focus group data qualitatively and then merges the two
sets of results to assess in what ways the results about adolescent attitudes converge and diverge.
ii. Explanatory Sequential Design

- The explanatory design occurs in two distinct interactive phases. This design starts with the collection
and analysis of quantitative data, which has the priority for addressing the studys questions.
- The first phase is followed by the subsequent collection and analysis of qualitative data.
- The second, qualitative phase of the study is designed so that it follows from the results of the first,
quantitative phase.
- The researcher interprets how the qualitative results help to explain the initial quantitative results
Example for understanding explanatory design

The researcher collects and analyzes quantitative data to identify significant predictors of adolescent
tobacco use. Finding a surprising association between participation in extracurricular activities and
tobacco use, the researcher conducts qualitative interviews with adolescents who are actively involved in
extracurricular activities to attempt to explain the unexpected result

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iii. Exploratory Sequential Design

- In contrast to explanatory design, the exploratory design begins with and prioritizes the collection and
analysis of qualitative data in the first phase.
- Building from the exploratory results, the researcher conducts a second, quantitative phase to test or
generalize the initial findings.
- The researcher then interprets how the quantitative results build on the initial qualitative results.
Example for understanding exploratory design

The researcher collects qualitative stories about adolescents attempts to quit smoking and analyzes the
stories to identify the condition, contexts, strategies and consequences of adolescent quit attempts.
Considering the resulting categories as variables, the researcher develops a quantitative instrument and
uses it to assess the overall prevalence of these variables for a large number of adolescent smokers.
iv. Embedded design
- The embedded design occurs when the researcher collects and analyzes both quantitative and
qualitative data within a traditional quantitative or qualitative design.
- In an embedded design, the researcher may add a qualitative strand within a quantitative design,
such as experiment, or add a quantitative strand within a qualitative design, such as case study.
Example for understanding embedded design

The researcher may want to develop a peer intervention to help adolescents develop strategies for
resisting peer pressure to smoke. The researcher begins by conducting a few focus groups with
adolescents to learn when pressure is felt and how some adolescents resist. Using these results, the
researcher develops a relevant intervention and tests it with a quantitative experimental design involving
students at different schools.
Selecting a Type of Mixed Method Design
The choice of mixed method design is related to three decisions:

i. The timing of the use of collected data (i.e. the order in which the data are unsed in a study)
ii. The relative weight of the quantitative and qualitative approaches (i.e. emphasis given to each)
iii. The approach to mixing the two data sets (i.e. how the two data sets will be related or connected)
A decision tree can help identify choices for each of these three decisions

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The Major Mixed Methods Design Types

Design type Variants Timing Weighting Mixing
Convergent - Parallel databases Concurrent: Usually equal Merge the data
- Data transformation quantitative and during the
variant qualitative at same interpretation or
- Data validation variant time analysis
Explanatory - Follow-up explanations Sequential: Usually Connect the data
- Participant selection Quantitative followed quantitative between the two
by qualitative phases
Exploratory - Instrument development Sequential: Usually Connect the data
- Taxonomy development Qualitative followed qualitative between tow
by quantitative phases
Embedded - Embedded experimental Concurrent or Unequal Embed one type of
- Embedded correlational sequential data within a larger
design using the
other type of data.
Variations on the Mixed Method Design
i. Variants of convergent design

a. The parallel databases variant:
- It is the common approach where two parallel strands are conducted independently and are only
brought together during the interpretation.
- The researcher uses the two types of data to examine facets of a phenomenon and the two sets
of independent results are then synthesized or compared during the discussion.
b. The data-transformation variant

- It occurs when researchers implement the convergent design using an unequal priority, placing
greater emphasis on the quantitative strand, and use a merging process of data transformation.
c. The data validation variant

- It is used when the researcher includes both open and closed ended questions on a
questionnaire and the results from the open ended questions are used to confirm or validate the
results from the closed ended questions.

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ii. Variants of explanatory design

a. Follow-up explanations variant
- It is the most common approach for using the explanatory design.
- The researcher places the priority on the initial, quantitative phase and uses the subsequent
qualitative phase to help explain the quantitative results.
b. Participant selection variant

- This variant arises when the researcher places priority on the second, qualitative phase instead of
the initial quantitative phase.
- This variant is used when the researcher is focused on qualitatively examining a phenomenon but
needs initial quantitative results to identify and purposefully select the best participants.
iii. Variants of exploratory design

a. Theory-development variant
- In this variant, the researcher places the priority on the initial qualitative phase with the
quantitative phase playing a secondary role to expand on the initial results.
- The qualitative strand is conducted to develop an emergent theory or a taxonomy or classification
system, and the researcher examines the prevalence of the findings and/or tests the theory with a
larger sample.
b. Instrument-development variant
- In the instrument development variant, the initial qualitative phase plays a secondary role, often
for the purpose of gathering information to build a quantitative instrument that is needed for the
prioritized quantitative phase.

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iv. Variants of embedded design

a. Embedded experiment variant
- It occurs when the researcher embeds qualitative data within an experimental trial.
- The priority of this model is established by the quantitative, experimental methodology and the
qualitative dataset is subservient within that methodology.
b. Embedded correlational variant

- In this variant, qualitative data are embedded within a quantitative design.
- In this design, researchers collect qualitative data as part of their correlational study to help
explain how the mechanisms work in the correlational model.
MISCELLANEOUS
Health System Research

WHO defined health systems research (HSR) as the purposeful generation of knowledge that enables
societies to organize themselves to improve health outcomes and health services (WHO 2009).
Mills et al. (2008) define Health Systems Research as research concerned with how health services are
financed, delivered and organised and how these functions are linked within an overall health system with
its associated policies and institutions.
The objective of health system research is ultimately to promote the coverage, quality, efficiency and
equity of health systems.
Health systems research focus primarily upon health policies, organization and programs, but does not
address clinical management of patients or basic scientific research. The prime focus of health system
research is not a specific disease or service, but rather the health system as a whole.

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Table: Defining research to improve health systems

Research Domain Focus of the research Users for the research Utility of research output
output
Operational Operational issues of Health care providers Local
specific health programme managers
programmes
Implementation Implementation Programme managers, Local/borad
strategies for specific R&D managers
products or services
Health System Issues affecting some or Health system Broad
all of the building blocks managers, policy
of a health system makers
Methods commonly used in health systems research

i. Household surveys to identify determinants of care seeking behavious
ii. Stakeholder analysis
iii. Cost analysis
iv. Intervention or operational research
Applications of Health System Research for health policy and system with examples
i. Formative researches in health systems, might for example, address how clients perceive their
interactions with the health system and how health services could be made more responsive to them.
Such research is unlikely to feed directly into a particular policy decision but can help shape policy
responses.
ii. Health systems research can contribute to the development of evidence-based policy and practices in
many different ways at the national and sub-national level.
iii. Sometimes policy makers will commission specific pieces of research to enable them to develop
policy ideas into full blown proposals. For example in the process of developing the Thai universal
coverage scheme, research was commissioned to help the government plan how to implement the
policy. This included research to help estimate the cost of implementing the new scheme, and how
best to organize the scheme.
iv. Health system research can also play a role in monitoring a evaluating existing interventions. For
example, the Global HIV/AIDS Initiative Network, research in twelve different countries were
proceeded, in order to assess the impact of global HIV/AIDS initiatives on health systems.
v. The Commission on Macro-economic and Health did a little primary research, but it synthesized the
findings of a large number of studies on the links between health and economic development, and as
a consequence highlighted the importance of investment in health for economic development.
vi. Health systems research can contribute to the development of evidence-based policy and practices in
many different ways at the national and sub-national level.
Critical challenges in Health System Research

- Lack of clarity regarding the scope and nature of field
- Perceived lack of rigour in terms of the methods employed.
- Challenges in generalizing from one country context to another.

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Quality Assurance in Research
Quality Assurance in research includes all activities that are aimed at ensuring the quality.
Quality assurance in research takes place in overall process of the research cycle.
i. Quality assurance measures prior to data collection
- Recruiting technically qualified and competent persons to undertake research task
- Selecting standardized instruments and calibration to check the precision and bias
- Developing and maintaining standard definitions, classifications, frameworks and methodological
tools.
- Training of investigators
ii. Quality assurance during data collection

- Taking multiple measurements, observations or samples
- Checking the validity of the record with an expert
- Using standardized methods and tools for capturing observations
- Recording forms with clear instructions
- Independent assessment and monitoring of technical performance of data collector/researcher
iii. Quality assurance during digitization and data entry

When data are digitized, transcribed, entered in a database, or coded, quality is assured by standardized
and consistent procedures for data entry. This may include
- Setting up validation rules or input masks in data entry software
- Using data entry screens/ checks
- Detailed labeling of variable and record names to avoid confusion
- Accompanying notes and documentation about the data
iv. Quality Assurance before, during and after data analysis

- Re- checking coding of observations or responses and out of range values
- Checking data completeness
- Verifying random samples of the digital data against the original data
- Correcting errors made during transcription
- Peer review
- Triangulation
- Member checking
- Use of audit trails

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MPH Ist Year

Prabesh Ghimire Page | 2

UNIT 10: DATA ENTRY ANALYSIS AND REPORT WRITING.................................................................................... 34

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UNIT 1: INTRODUCTION TO PUBLIC HEALTH RESEARCH

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Empirical research and data

Problem Identification and Justification

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Research in Sensitive Issues

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Importance of sensitive research

Methods of data collection in sensitive research

ii. Normative Technique

iii. Unmatched-count technique

iv. Bean Method

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Other Tools and techniques for sensitive research data collection

Handling/ Analysis of Data in Sensitive Topics

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ii. Design and development

iv. Research evaluation

v. Quality Assurance and Quality Control

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An essential tool to depict a research plan is research proposal.

Structure and content of the research plan/proposal

i. Research - The choice of the research design, whether descriptive, analytical,

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Common unexpected reasons that may affect research plan

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UNIT 2: SELECTION OF A RESEARCH TOPIC

ii. Avoidance of duplication

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iii. Urgency of data needed

iv. Feasibility of the study

vi. Political acceptability of the study

UNIT 3: LITERATURE REVIEW

Need for Literature Review

Specifically, a good literature review does the following:

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Stages of literature review

Different Search Strategies for Research Retrieval

ii. Searching for the exact phrase

iii. Adjacency search

iv. Boolean Logic

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UNIT 4: THEORY AND RESEARCH

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UNIT 5: RESEARCH QUESTIONS AND HYPOTHESIS

Four types of variables are important in health research:

- Confounding or intervening variables:

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Steps of constructing conceptual framework

ii. Conducting literature review

iii. Isolating important variables

iv. Generating the conceptual framework

UNIT 6: RESEARCH ETHICS

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iv. Principle IV: Protection of Environment

Brief History of Research Ethics

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Ethical Issues during the Planning and Execution of Research

ii. Voluntary participation

iii. Children in health research

iv. Pregnant women in health research