Research Methodology Lecture Notes
Research Methodology Lecture Notes
RESEARCH METHODOLOGY
FOR HEALTH AND CLINICAL SCIENCE STUDENTS
LECTURE NOTES
Frundi L. Fru
GENERAL OBJECTIVES
After going through this course, the student (or aspirant researcher) should be able to:
❖ Explain the basic concepts in clinical/medical research and the purpose for which research is
conducted and also explain the risks and benefits of research
❖ Explain the research process as it pertains to the various steps in the conduct of research.
❖ Appreciate the implications of ethics in research.
❖ Describe the role of research in health and social welfare.
❖ Identify the various types of research designs.
❖ Apply the principles of hypothesis formulation, data collection, analysis, and interpretation
of research findings.
EXPECTED OUTCOMES
At the end of this course, the student (aspirant researcher) is expected to be able to:
1. Identify researchable topics and source for necessary information to carryout research.
2. Plan, organize and conduct a small research.
3. Write a scientific (or term) paper either presenting a review or quantitative research findings.
4. Prepare and present both in written and oral format, research findings.
5. Plan and present posters, a seminar, scientific talk or conference.
In addition to the aforementioned objectives and expectations, the student after completing this
course should be able to answer the following questions:
❖ What is research and how is it different from problem solving?
❖ Describe the criteria for researchable topics in clinical/medical sciences.
❖ Why is literature review helpful in conducting research?
❖ Identify the purpose of hypothesis.
❖ Explain why research questions are necessary.
❖ Describe the characteristics of different variables.
❖ Identify major research designs.
❖ Describe the purpose of the pilot study.
❖ Distinguish the different study designs.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
GENERAL INTRODUCTION
The course Research Methods is designed to create consciousness of and the need for research by
all health practitioners for improvement of care. The course enables the student and young
researcher to acquire the basic skills and knowledge required of a researcher, and to conduct simple
research studies.
Whatever field of study one may belong to, it is an obligation to strive and extend the body of
knowledge and for health/clinical sciences, a lot can be gained through research. This course will
also equip you with information on the evolution of research in nursing, and further expose you to
the collaborative nature of research among nurses and other health care personnel for the benefit of
patient’s care.
Research Method as a course is essential for continued improvement in patient care. Health
practitioners are being increasingly required to utilize research – based practice (evidence – based
practice) to make decisions and take action in respect of patient care. They are accepting the need
to base their professional actions and decisions on evidence to show that the actions are clinically
appropriate, cost effective, and so more acceptable to the patients.
Research findings will help health practitioners eliminate actions that do not achieve the desired
results, and help them to identify those practices that can change outcomes. It is only through
research that clinicians can in the real sense improve their effectiveness, and enhance their
professional lives. With research, one could attend research presentations at conferences, be in
position to evaluate completed research work, and be able to discuss implications and relevance of
the findings. Nurses are also able to incorporate research results into nursing practice. Professionals
with research skills are better placed to make contributions to the profession and to the body of
scientific knowledge.
This lecture note on research methodology is primarily aimed at health science students. It is also
hoped to be useful for other individuals who would like to understand the basic principles and
undertake health research. There is a strong belief that it will serve as a guideline for undergraduate
health science students as they are required to identify the most important health problems and
carry out some research work.
In general, this lecture note tries to cover the three major components of a research process:
development of the research proposal, fieldwork (data collection) and write-up of the scientific
report. General learning objectives followed by introductory sections which are specific to each
chapter are placed at the beginning of most of the chapters. The lecture note also includes a number
of exercises for the students so that they can examine themselves whether they have understood the
topic under consideration. It is assumed that this lecture note on research methodology will be
given to health science students who have taken basic Epidemiology and Biostatistics courses. It is
also important to note that this lecture note focuses on quantitative research. When the point of
discussion refers to qualitative research, it would be clearly shown so as to avoid the confusion that
may arise. As we go through the concepts of research, we will look through the definition of
research as a systematic and scientific approach towards the solution of problems.
This course requires that the student spends some time to read. The course content available for this
course is quite vast and one needs to spend great time to study it. This explains why a great amount
of effort and time was put into the development of this course, to make it more understandable and
readable. It is advised that the student endeavour to attend all tutorial sessions where s/he would
have the opportunity to compare his/her knowledge with that of peers.
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CHAPTER ONE
INTRODUCTION TO RESEARCH
1. Order and Control: Scientific methods follow a systematic approach to problem solving. The
aspect of control concerns the effort made to reduce interference in the study situation. For
example, in a study to explore the relationship between diet and heart disease, the researcher must
take steps to control or exclude other possible causes of heart disease like stress, cigarette smoking,
as well as age and sex.
2. Empiricism: The scientific method searches for evidence (empirical – real) through
observations, verified through our sense organs – sight, taste, touch, smell, and hearing. E.g. the
colour of a patient’s eye; the presence or absence of skin inflammation etc.. Sometimes, our senses
may not record fully what is real and so, extensions of our senses are used to collect the empirical
evidence in the form of instruments, equipment, tools e.g. weighing scale, thermometer,
questionnaires, or other instruments that aid the senses to gather the necessary information.
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1.2.1 Definitions
1. Research: Research is a scientific inquiry aimed at learning new facts, testing ideas or theories.
It is the systematic collection, analysis and interpretation of data to generate new knowledge and
answer a certain question or solve a problem.
Generally, research can be defined as a methodical investigation into a subject in order to discover
facts, to establish or revise a theory, or to develop a plan of action based on discovered facts.
Research can also be defined as a systematic investigation; including development testing and
evaluation, designed to discover or contribute to the body of generalisable knowledge.
Generalisable knowledge consists of theories, principles or relationships, (or the accumulation of
data on which they may be used) that can be corroborated by accepted scientific observation and
inference.
The practice of medicine and behavioural therapy refers to the class of activities designed solely to
enhance the wellbeing of an individual patient or client. The purpose of practice is to provide
diagnosis, preventive and treatment therapy. These practices must be distinguished from research
although the two often occur together in the same place.
2. Researcher: In a broad sense a researcher is the individual who undertakes to study; a person
who conducts a carefully designed study especially to discover new facts or information. In
research terminology, the term “INVESTIGATOR” is more frequently used and is defined as: “A
person responsible for the conduct of a trial at a trial site”. If a trial is conducted by a team of
individuals at a trial site, the investigator is responsible for the team and may be called the principal
investigator.
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1.3.1 Basic (pure) research is necessary to generate new knowledge and technologies to deal
with major unresolved health problems. IT is investigation or study carried out to satisfy a desire to
increase the knowledge base in an area of interest. Basic or pure research provides the baseline
information in the area of knowledge which could be necessary to undertake further research in that
area. For example, a research to establish factors responsible for poor compliance to dietary
regimen by diabetic patients will result in a list of many factors. Those factors could form the basis
for more research in the future that could lead to certain important decisions in the care of diabetic
patients.
1.3.2 Applied research on the other hand is necessary to identify priority problems and to design
and evaluate policies and programs that will deliver the greatest health benefit, making optimal use
of available resources. It is the research whose findings could have immediate practical utility.
Qualitative research is concerned with finding the answers to questions which begin with: why?
How? In what way?
Quantitative research, on the other hand, is more concerned with questions about: how much? How
many? How often? To what extent? etc.
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Public health problems are complex, not only because of their multicausality but also as a result
of new and emerging domestic and international health problems. Social, economic, political,
ethnic, environmental, and genetic factors all are associated with today’s public health concerns.
Consequently, public health practitioners and researchers recognize the need for multiple
approaches to understanding problems and developing effective interventions that address
contemporary public health issues. Qualitative methods fill a gap in the public health toolbox; they
help us understand behaviors, attitudes, perceptions, and culture in a way that quantitative methods
alone cannot. For all these reasons, qualitative methods are getting renewed attention and gaining
new respect in public health. A thorough description of qualitative research is beyond the scope of
this lecture note. Students interested to know more about qualitative methods could consult other
books which are primarily written for that purpose. The main purpose of this lecture note is to give
a detailed account on the principles of quantitative research.
Essential health research: Consists of activities to define the health problems of a given country
or community, to measure their importance and to assure the quality of activities to deal with them.
Much of this research comes within the category of health service research but there will be
elements of clinical research and development of technology, depending on the situation. The
information, which may be obtained in a number of ways, is essential and specific to each country
for planning and monitoring health services. Some of the research conclusions, however, may be
generalized and applicable to other areas.
Clinical research: In its widest sense, this group of topics ranges from studies of the prevention
and diagnosis of diseases through new methods of treatment to problems of care and rehabilitation.
The sophistication will vary from problem to problem and there will be overlap with the fields of
essential and biomedical research. Some of the research will be mainly of local importance; much
will be useful for other individuals in other countries. Examples include clinical trials of disease
prevention and the design of new chemotherapeutic agents. Wherever clinical facilities exist, there
is a potential for clinical research.
Biomedical research: It is the most basic part of health research which demands more resources,
facilities and skilled investigators. The results of biomedical research are more often of universal
importance and thus of general significance. During the past two decades, concepts and research
approaches to support health development have evolved rapidly. Many of these have been
described by specific terms such as operations research, health services research, health manpower
research, policy and economic analysis and decision-linked research. Each of these has made
crucial contributions to the development of health research.
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Bearing in mind that HSR is undertaken primarily to provide information to support decision-
making at all levels that can improve the functioning of the health system, some of the essential
features are summarized as follows:
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N.B: The roles of health managers and the community should be identified in the various phases of
the research process.
The following seven steps outline a simple and effective strategy for finding information for a
research paper and documenting the sources you find. Depending on your topic and your
familiarity with the library, you may need to rearrange or recycle these steps. Adapt this outline to
your needs. We are ready to help you at every step in your research. There are many models
available and taught concerning how to conduct a research process. Therefore, the process
presented here is only one of many; however, it is a tried and proven process.
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❖ begin to browse the library's online catalog (OPAC) to find sources held by the library that
relate to your topic
❖ browse subject-based encyclopedias, handbooks and directories to begin to refine your topic
➢ review the footnotes, endnotes and bibliographies from the end of subject-based
encyclopedia and handbook articles to identify related sources
❖ also refer to bibliographies in course textbooks and reserve readings
❖ browse subject-related, indexed sources on the World Wide Web to find sources that relate to
your topic:
➢ use the Sawyer Library's Help and Research Guides
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Step 7: Communicate/present the research citing what you find using a standard format
❖ communicate your research in the format required by your professor
❖ properly use citations to avoid plagiarism
❖ Give credit where credit is due; cite your sources.
❖ Citing or documenting the sources used in your research serves two purposes, it gives proper
credit to the authors of the materials used, and it allows those who are reading your work to
duplicate your research and locate the sources that you have listed as references.
❖ Knowingly representing the work of others as your own is plagiarism. Use one of the styles
listed in the referencing section of this lecture note or another style approved by your instructor
or institution. This lecture gives details of the APA referencing style in the referencing section.
RESEARCH TIPS:
❖ Work from the general to the specific. Find background information first, and then use more
specific and recent sources.
❖ Record what you find and where you found it. Record the complete citation for each source;
you may need it again later.
❖ Translate your topic into the subject language of the indexes and catalogs you use. Check
your topic words against a thesaurus or subject heading list.
1.7 EXERCISES
❖ 1. The health of any community depends on the interaction and balance between the health
needs of the community, the health resources that are available, and the selection and
application of health and health related interventions. Discuss!
❖ 2. To invest in research is to invest for a better future. Does this statement sound true? Justify
your answer.
❖ 3. Describe the characteristics of HSR by giving your own examples.
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CHAPTER TWO
TOPIC SELECTION
2.2 INTRODUCTION
The development of a health project goes through a number of stages. Formulation of the research
proposal is the major task in the process of developing a research project. The proposal draws on all
the preparatory steps of the research process and pulls them together in a document describing the
rationale and the methodology proposed for research. The proposal is a basis for approval and
funding. After approval, the proposal is used as a blueprint during implementation of the project. It
should be noted that development of a research proposal is often a cyclical process. The process is
not always linear. It is a usual practice to go up and down on the developed proposal and make the
necessary revisions. Is there evidence to indicate that the research proposal focuses on a problem of
priority importance? Was the given health problem identified by relevant groups of the health
system? Was the problem adequately analyzed to include all possible contributory factors from
different sectors? Was it clearly stated? These questions should be clearly answered before trying to
develop the research proposal. The sections that follow are devoted to giving the guidelines useful
for identification, selection, analysis and statement of the given problem.
Example1:
Problem situation: In district “ Y “ a report showed that in the first month there were 500 children
under one year old who started immunization, but at the end of the year it was found out that there
were only 25 children who completed their vaccination.
Discrepancy: All the 500 children at district “Y “should have completed their vaccination but only
5% out of those who started vaccination has completed.
Problem (research) question: why only 5% of the children completed their vaccination?
Definite answer: Out of the 1 hospital, 2 health centers and 10 health stations found in district “Y”
only 2 health stations were functioning, the rest were closed due to insecurity in the area.
Decision: In the above example, assuming that all the given facts are true, there is no need of
undertaking a research, since definite answer is obtained to the problem situation.
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Example 2:
Problem situation: In district “Z” (population 150,000) there are 2 health centers, 1 hospital and 15
health stations and all of them function smoothly. However, at the end of the year it was found that
the EPI coverage was only 25%.
Discrepancy: Although district “Z” had 100% availability of health services and at least 80% of
the children should have had full vaccinations the EPI coverage was only 25% as seen above.
Problem question: What factors influence the low EPI coverage in district “Z”?
Possible answers:
❖ Mothers might have problems for not attending in the EPI sessions.
❖ The MCH, EPI, OPD, etc… programmes might not have been integrated; hence children
might have missed opportunities in getting immunization.
❖ The follow up of defaulting children might not be effective and other reasons.
Decision: Thus, the above problem situation is researchable.
3. Feasibility: Consider the complexity of the problem and the resources you will require to carry
out the study.
Thought should be given first to personnel, time, equipment and money that are locally available.
In situations where the local resources necessary to carry out the project are not sufficient, you
might consider sources available at the national level.
4. Political acceptability: It is advisable to research a topic that has the interest and support of the
authorities. This will facilitate the smooth conduct of the research and increases the chance that the
results of the study will be implemented.
6. Urgency of data needed: How urgently are the results needed for making a decision? Which
research should be done first and which can be done late?
7. Ethical acceptability: We should always consider the possibility that we may inflict harm on
others while carrying out research. Therefore, it will be useful to review the proposed study.
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EXERCISES
1. In a certain district (population, 150,000), sanitary conditions are very poor (only 5% of
households have latrines) and diseases connected with poor sanitation, such as, gastroenteritis and
worms are very common. The Ministry of Health has initiated a sanitation project that aims at
increasing the number of households with latrines by 20% each year. The project provides
materials and the population should provide labour. Two years later, less than half of the target has
been reached. State the discrepancy, research question and the possible answers. Is this problem
situation researchable?
2. Go to the nearby health institution and identify three health problems. Discuss about these health
problems and rate them based on the selection criteria. When rating these problems based on the
criteria, use the rating sheet indicated at the bottom of the table (you can also refer to the "Scales
for rating research topics” presented in section 2.4.2). You can do the exercise in small groups.
Which topic do you select for research? Defend your first choice in a plenary session.
Rating Sheet
Criteria for selecting a research topic Proposed topics
Problem I Problem II Problem III
Relevance
Avoidance of duplication
Feasibility
Political acceptability
Applicability
Urgency of data needed
Ethical acceptability
Total
Rating scale: low = 1; moderate = 2; High = 3
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CHAPTER THREE
ANALYSIS AND STATEMENT OF THE PROBLEM
3.2 INTRODUCTION
Was the problem adequately analyzed to include all possible contributory factors from different
sectors? Was it clearly stated? These questions should be clearly answered before trying to develop
the research proposal. The sections that follow are devoted to giving the principles useful for the
analysis and statement of the given problem.
b) Points that need to be considered for justifying the selected research problem
A health problem selected to be studied has to be justified in terms of its:
❖ Being a current and existing problem which needs solution
❖ Being a widely spread problem affecting a target population
❖ Effects on the health service programmes
❖ Being a problem which concerns the planners, policy makers and the communities at large.
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❖ An analysis of the major factors that may influence the problem and a convincing argument
that available knowledge is insufficient to answer a certain question and to update the
previous knowledge.
❖ A brief description of any solutions that have been tried in the past, how well they have
worked, and why further research is needed.
❖ A description of the type of information expected to result from the project and how this
information will be used to help solve the problem
❖ If necessary, a short list of definitions of crucial concepts used in the statement of the
problem.
A list of abbreviations may be annexed to the proposal, but each abbreviation also has to be written
out in full when introduced in the text the first time.
3.5 EXERCISES
1. Why do we need to analyze the research problem?
2. What are the points required to justify the selected research problem?
3. What information should be included in the statement of a problem?
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CHAPTER FOUR
LITERATURE REVIEW
4.2 INTRODUCTION
At the outset of his/her study the investigator should be acquainted with the relevant literature. It is
of minimal use to wait until a report is written.
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Overall, the literature review should be adequate, relevant and critical. In addition to this,
appropriate referencing procedures should always be followed in research proposals as well as in
research reports. While reviewing a literature give emphasis to both positive and negative findings
and avoid any distortion of information to suit your own study objectives.
Finally, after an exhaustive literature review, summarize the findings and write a coherent
discussion by indicating the research gap which supports the undertaking of your study.
4.6 EXERCISES
1. Why is literature review important when preparing a proposal?
2. The presentation of research results or scientific publications from other writers without quoting
the author is not appropriate. Does this statement sound true? Justify your answer.
3. Mention some of the sources of information in your area and describe how such information
could be summarized on index cards.
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CHAPTER FIVE
RESEARCH OBJECTIVES
5.2 INTRODUCTION
Having decided what to study, and knowing why s/he wants to study it, the investigator can now
formulate his study objectives. Objectives should be closely related to the statement of the problem.
For example, if the problem identified is low utilization of health stations in a rural district, the
general objective of the study could be to assess the reasons for this low utilization. If we break
down this general objective into smaller and logically connected parts, then we get specific
objectives.
5.3 DEFINITIONS
Specific objectives: measurable statements on the specific questions to be answered. Unlike the
general objectives, the specific objectives are more specific and are related to the research problem
situation. They indicate the variable to be examined and measured.
Example: In the study of missed opportunity for EPI in Yaoundé the specific objectives could be:
❖ To find out the magnitude of missed opportunities for children who attend OPD, MCH, etc. in
Yaoundé,
❖ To examine the reasons for children not being immunized while attending the OPD, MCH,
etc. services.
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Examples of action verbs are: Avoid the use of vague non-action verbs such
❖ to determine as;
❖ to compare ➢ to appreciate
❖ to verify ➢ to understand
❖ to estimate ➢ to study
❖ to describe ➢ to believe
❖ to find out
❖ to establish
A hypothesis is a prediction of a relationship between one or more variables and the problem under
study. That is, it specifies the relationship among variables. These variables are to be statistically
tested at a later stage. In order to measure the relationship among variables to be studied the
dependent and independent variables need to be identified. A few examples are given below:
1. The health of children living in rural ‘villagization’ projects is better than those living in
traditional rural communities.
2. To examine whether there is any significant difference between district “A” and district “B”
with respect to their malaria prevalence rates
3. An increase in the frequency of face washing is followed by a reduction in trachoma
prevalence.
One of the most important problems usually observed among students is the tendency of stating too
many study objectives which are not appropriately addressed (or sometimes will be forgotten) in
the sections that follow. It should be noted that it is on the bases of these specific objectives that the
methods, results and discussion sections will be presented. For example, sample size calculations
for each stated objective and identifying (selecting) the most appropriate sample size that will
answer the required research questions is not covered in the development of most research
proposals. This is also true during the write up of the completed research work. It is not uncommon
to come across a situation in which some of the specific objectives are not addressed in the results
section at all. It is therefore advisable to limit the number of specific objectives. In most practical
situations, the number of specific objectives should not exceed three.
In a nutshell, your objectives should be SMART (i.e. Specific, Measurable, Attainable, Realistic
and Time-bound).
5.5 EXERCISES
1. Define general objectives, specific objectives and hypotheses by giving your own examples.
2. The objectives of a study should be written after the statement of the research problem and
before the methods section. Does this statement sound true? Justify your answer.
3. List the characteristics of research objectives.
4. Comment on the statement: “A question well-stated is a question half-answered”.
5. Mention some of the problems that may arise as a result of having too many objectives.
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CHAPTER SIX
RESEARCH METHODS
6.2 INTRODUCTION
In the previous chapters we have dealt with the identification, selection, analysis and statement of
the problem. The importance of literature review and formulation of study objectives were also
emphasized. Now we must decide exactly how we are going to achieve our stated objectives. That
is, what new data do we need to shed light on the problem we have selected and how we are going
to collect and process these data? The major issues that constitute the "methods section" of a
research proposal will be dealt in the sections that follow.
1. Non-intervention (Observational) studies in which the researcher just observes and analyses
researchable objects or situations but does not intervene; and
2. Intervention studies in which the researcher manipulates objects or situations and measures the
outcome of his manipulations (e.g., by implementing intensive health education and measuring the
improvement in immunization rates.)
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I. Exploratory study
An exploratory study is a small-scale study of relatively short duration, which is carried out when
little is known about a situation or a problem. It may include description as well as comparison.
For example: A national AIDS Control Programme wishes to establish counseling services for
HIV positive and AIDS patients, but lacks information on specific needs patients have for support.
To explore these needs, a number of in-depth interviews are held with various categories of patients
(males, females, married and single) and with some counselors working on a programme that is
already under way. When doing exploratory studies we describe the needs of various categories of
patients and the possibilities for action. We may want to go further and try to explain the
differences we observe (e.g., in the needs of male and female AIDS patients) or to identify causes
of problems. Then we will need to compare groups.
If the problem and its contributing factors are not well defined it is always advisable to do an
exploratory study before embarking on a large-scale descriptive or comparative study.
b. Routine-data-based studies
These are the type of studies in which the data are derived from routine data-collection systems
(e.g., cancer registration or death certification). They may be carried out at an individual level if
information on the exposure(s) and outcome(s) of interest is available for each of the study subjects
or at an aggregated level (ecological studies) if the group rather than the individual is the unit of
study. Once the data from a particular study have been collected, the association between the
exposure and the outcome of interest can be quantified by calculating an appropriate measure of
effect. This may be expressed as either the ratio of the measure of disease occurrence in the exposed
relative to that in the unexposed (relative measure) or as the difference between the two (absolute
measure). The first type of measure is particularly important when assessing etiology, whereas the
second type is more useful for evaluations of the public health impact of the association.
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In ecological studies data from entire populations are used to compare disease frequencies between
different groups during the same period of time or in the same population at different points in
time. Example: Countries with low cigarette consumption have lower lung cancer rates than those
countries with high cigarette consumption.
❖ Ecological studies are usually quick and easy to do and can be done with already available
information.
❖ Since ecological studies refer to whole populations rather than to individuals, it is not possible
to link an exposure to occurrence of disease in the same person.
1. Observational studies
❖ No human intervention involved in assigning study groups; simply observe the relationship
between exposure and disease.
❖ Subject to many potential biases, but by careful design and analysis, many of these biases can
be minimized.
❖ Examples of observational studies: comparative cross-sectional, cohort and case-control
studies.
b) Cohort studies: Study groups identified by exposure status prior to ascertainment of their
disease status and both exposed and unexposed groups followed in identical manner until they
develop the disease under study, they die, the study ends, or they are lost to follow-up.
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c) Case-control studies: Group of subjects with the disease (cases) and group of subjects without
the disease (controls) are identified. Information, about previous exposures is obtained for cases
and controls, and frequency of exposure compared for the two groups.
2. Intervention studies
In intervention studies, the researcher manipulates a situation and measures the effects of this
manipulation. Usually (but not always) two groups are compared, one group in which the
intervention takes place (e.g. treatment with a certain drug) and another group that remains
‘untouched’ (e.g. treatment with a placebo). The two categories of intervention studies are:
❖ experimental studies and
❖ quasi-experimental studies
a. Experimental studies
An experimental design is a study design that gives the most reliable proof for causation. In an
experimental study, individuals are randomly allocated to at least two groups. One group is subject
to an intervention, or experiment, while the other group(s) is not. The outcome of the intervention
(effect of the intervention on the dependent variable/problem) is obtained by comparing the two
groups. A number of experimental study designs have been developed. These are widely used in
laboratory settings and in clinical settings. For ethical reasons, the opportunities for experiments
involving human subjects are restricted. However, randomized control trials of new drugs are
common. At community level, where health research is frequently undertaken, we experience not
only ethical but also practical problems in carrying out experimental studies. In real life settings, it
is often impossible to assign persons at random to two groups, or to maintain a control group.
Therefore, experimental research designs may have to be replaced by quasi-experimental designs.
Therapeutic trials are conducted among patients with a particular disease to determine the ability
of an agent or procedure to diminish symptoms, prevent recurrence, or decrease risk of death from
that disease.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
A preventive trial (community trial) involves the evaluation of whether an agent or procedure
reduces the risk of developing disease among those free from that condition at enrolment. Thus,
preventive trials can be conducted among individuals at usual risk (e.g. vaccine trials)
b. Quasi-experimental studies
In a quasi-experimental study, one characteristic of a true experiment is missing, either
randomization or the use of a separate control group. A quasi-experimental study, however, always
includes the manipulation of an independent variable which is the intervention. One of the most
common quasi-experimental designs uses two (or more) groups, one of which serves as a control
group in which no intervention takes place. Both groups are observed before as well as after the
intervention, to test if the intervention has made any difference. (This quasi-experimental design is
called the ‘non-equivalent control group design’ because the subjects in the two groups (study and
control groups) have not been randomly assigned by the Investigator.
Another type of design that is often chosen because it is quite easy to set up uses only one group in
which an intervention is carried out is called a ‘BEFORE-AFTER’ study. The situation is analyzed
before and after the intervention to test if there is any difference in the observed problem. This
design is considered a ‘pre-experimental’ design rather than a ‘quasi-experimental’ design because
it involves neither randomization nor the use of a control group.
A particular research question may be addressed using different approaches. The choice of study
design for investigation is influenced by:
❖ Particular features of the exposure and disease.
❖ Logistic considerations of available resources.
❖ Results from previous studies and gaps in knowledge that remain to be filled.
❖ Ingenuity and creativity of the researcher
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a) Volunteer populations: Persons who volunteer to enter a study may differ in many respects
from those who do not so volunteer, and therefore the findings in a volunteer population do not
necessarily apply to the population at large.
b) Hospital or clinic populations: Persons receiving medical care are obviously not representative
of the general population from which they have come from. That is, persons treated in hospital for a
certain disease may differ from those patients with the same disease but not receiving care for it.
Definition:
A variable is an entity, event a characteristic of a person or object that can take on different values.
A simple example of a variable is a person's age. The variable can take on different values, such as,
20 years old, 30 years old, and so on. Other examples of variables are:
a) Temperature in oC h) Health status
b) Weight in kilograms i) Marital status (single, married, divorced and widowed)
c) Height in centimeters j) Job satisfaction index (1 to 5)
d) Monthly income in Franc k) Occupation (civil servant, farmer, student, et.)
e) Educational attainment l) Disease condition (presence or absence of a disease)
f) Weather m) The pieces of information gathered in the course of a
g) Economic status research study.
The first four variables (a - to - d) are numerical variables because they are expressed in numbers
(metric data). Since the values of the remaining three variables (e to l) are expressed in categories,
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
we call them categorical variables. Because in the health research we often look for associations, it
is important to make a distinction between “dependent” and “independent” variables. Both the
dependent and independent variables together with their operational definitions (when necessary)
should be stated.
The IV is the antecedent, whereas the DV is the consequent. In experiments, the IV is the variable
that is controlled and manipulated by the experimenter; whereas the DV is not manipulated, instead
the DV is observed or measured for variation as a presumed result of the variation in the IV. “In
nonexperimental research, where there is no experimental manipulation, the IV is the variable that
‘logically’ has some effect on a DV. For example, in the research on cigarette-smoking and lung
cancer, cigarette-smoking, which has already been done by many subjects, is the independent
variable” (Kerlinger, 1986, p.32).
In an experiment, the independent variable is the variable that is varied or manipulated by the
researcher, and the dependent variable is the response that is measured. Sometimes, researchers
are not able to actually control and manipulate an IV, this particular type of IV is technically
referred to as a status variable (e.g., gender, ethnicity, etc.). Even though researchers do not
actually control or manipulate status variables, researchers can, and often do, treat them as IVs
(Heppner, Kivlighan & Wampold, 1999).
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Background variables - In almost every study involving human subjects, background variables,
such as, age, sex, educational status, monthly family income, marital status and religion will be
included. These background variables are often related to a number of independent variables, so
that they influence the problem indirectly. Hence they are called background variables or
background characteristics.
Confounding variable - A variable that is associated with the problem and with a possible cause of
the problem is a potential confounding variable. This type of variable may either strengthen or
weaken the apparent relationship between the problem and a possible cause.
Composite variable - A variable based on two or more other variables may be termed a composite
variable. Incidence and prevalence rates, sex ratios, and other rates and ratios are composite
variables, since they are based on separate numerator and denominator information.
For example:
1. In a study on VCT acceptance, you want to determine the level of knowledge concerning HIV in
order to find out to what extent the factor ‘poor knowledge’ influences willingness to be tested for
HIV. The variable ‘level of knowledge’ cannot be measured as such. You would need to develop a
series of questions to assess a person’s knowledge, for example on modes of transmission of HIV
and its prevention methods. The answers to these questions form an indicator of someone’s
knowledge on this issue, which can then be categorized. If 10 questions were asked, you might
decide that the knowledge of those with:
❖ 0 to 3 correct answers is poor,
❖ 4 to 6 correct answers is reasonable, and
❖ 7 to 10 correct answers is good.
When defining variables on the basis of the problem analysis diagram, it is important to realize
which variables are measurable as such and which ones need indicators. Once appropriate
indicators have been identified we know exactly what information we are looking for. This makes
the collection of data as well as the analysis more focused and efficient.
2. Nutritional status of under-5 year olds is another example of a variable that cannot be measured
directly and for which you would need to choose appropriate indicators. Widely used indicators for
nutritional status include weight-for-age, weight-for-height, height-for-age, and upper-arm
circumference. For the classification of nutritional status, internationally accepted categories
already exist, which are based on standard growth curves. For the indicator weight/age, for
example, children are:
❖ Well nourished if they are above 80% of the standard
❖ Moderately malnourished if they are between 60% and 80%
❖ Severely malnourished if they are below 60%
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
For certain variables, it may not be possible to adequately define the variable or the indicator
immediately because further information may be needed for this purpose. The researcher may need
to review the literature to find out what definitions have been used by other researchers, so that he
can standardize his definitions and thus be able later to easily compare his findings with those of
the other studies. In some cases the opinions of “experts” or of community members of health care
providers may be needed in order to define the variable or indicator. The variables to be studied are
selected on the basis of their relevance to the objectives of the investigation.
❖ The initial list is usually too long
❖ It has to be pruned to facilitate the collection and processing of the data.
Once the variables are selected, each of them should be clarified. There are two aspects to be
considered.
❖ Clear definition of variables in terms of objectively measurable facts (i.e., operational
definition) - this was repeatedly mentioned (addressed) in the above examples
❖ The scale of measurement to be used in data collection.
Unless the variables are clearly and explicitly defined, there can be no assurance that, if the study is
performed by a different investigator, or repeated by the same investigator, similar findings would
be obtained. The following example shows the different definitions (two different definitions)
given to "obesity". The two kinds of definitions are: conceptual and operational. The conceptual
definition is often akin to a dictionary definition.
Scales of Measurement:
As part of the process of clarifying each of the variables to be studied, its scale of measurement
should be specified. There are four types of scales of measurement: Nominal, Ordinal, Interval
and Ratio. They are listed in ascending order of power and preference.
1. Nominal Scale: This consists of two or more named categories (classes) which are qualitatively
different from each other.
E.g. Sex: male (1); Female (2)
Marital status: 1. Married 2. Single 3. Divorced 4. Widowed
2. Ordinal scale: This has the additional quality that the categories are ranked and have implied
order. However, the intervals between classes are not necessarily equal.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Example 1: Severity of a disease: Severe (grade III); moderate (grade II); mild (grade I); absent
(grade 0).
Example 2: Educational status: 0; 1-6; 7-8; 9 -12; more than 12.
3. Interval scale: This has the additional quality that the intervals between classes are equal.
Example: Temperature (in Celsius)
Equal differences between any pair of numbers in the scale indicate equal differences in the
attribute being measured. The difference in temperature between 20oC and 25oC is the same as the
difference between 30oC and 35oC. The ratio between numbers in the scale is not, however,
necessarily the same as that between the amounts of the attribute. That is, a room at 30oC is not
'twice as hot' as one at 15oC. This is because the zero on the scale does not indicate absence of the
attribute.
4. Ratio scale: This has the additional quality that zero indicates absence of the attribute. As a
result, the ratio between numbers in the scale is the same as that between the amounts of the
attribute being measured.
Example: Weight measured in kilograms, height in cm, etc.
6.6 SAMPLING
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DEFINITIONS
❖ Target population (reference or theoretical population): Is that population about which an
investigator wishes to draw a conclusion.
❖ Study population (population sampled): Population from which the sample actually was
drawn and about which a conclusion can be made. For Practical reasons the study population
is often more limited than the target population. In some instances, the target population and
the population sampled are identical.
❖ A sample: This is “a smaller (but hopefully representative) collection of units from a
population used to determine truths about that population” (Field, 2005)
❖ Sampling unit: The unit of selection in the sampling process; For example, in a sample of
districts, the sampling unit is a district; in a sample of persons, a person, etc.
❖ Study unit: The unit on which the observations will be collected; for example, persons in a
study of disease prevalence, or households, in a study of family size.
❖ N.B: The sampling unit is not necessarily the same as the study unit.
❖ Sample design: The scheme for selecting the sampling units from the study population.
❖ The sampling frame is the list from which the potential respondents (sample) are
drawn/selected e.g. Registrar’s office, Class rosters. The existence of an adequate and up-to-
date sampling frame often defines the study population. You must assess sampling frame
errors. Possible Sampling frame errors (from frame above) may include: University versus
personal email addresses; changing class rosters; are all students in your population of interest
represented?
Two Questions:
1. What is your population of interest? That is to whom do you want to generalize your results?
Probable answers could be to: All doctors; School children; Cameroonians; Women aged 15-45
years; any other group of individuals.
Three (3) factors that influence sample representativeness: 1. Sampling procedure. 2. Sample
size. 3. Participation (response)
When might you sample the entire population? 1. When your population is very small. 2. When
you have extensive resources. 3. When you don’t expect a very high response
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An important issue influencing the choice of the most appropriate sampling method is whether a
sampling frame is available, that is, a listing of all the units that compose the study population.
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2. Quota sampling: is a method that insures that a certain number of sample units from different
categories with specific characteristics appear in the sample so that all these characteristics are
represented. In this method the investigator interviews as many people in each category of study
unit as he can find until he has filled his quota. This method of sampling is often used by market
researchers. The population is first segmented into mutually exclusive sub-groups, just as in
stratified sampling. Then judgment used to select subjects or units from each segment based on a
specified proportion; interviewers are given a quota of subjects of a specified type to attempt to
recruit. For example, an interviewer might be told to go out and select 20 adult men and 20 adult
women, 10 teenage girls and 10 teenage boys so that they could interview them about their
television viewing. It is this second step which makes the technique one of non-probability
sampling. In quota sampling the selection of the sample is non-random. For example interviewers
might be tempted to interview those who look most helpful. The problem is that these samples may
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
be biased because not everyone gets a chance of selection. This random element is its greatest
weakness and quota versus probability has been a matter of controversy for many years. There are
several flaws with the method, but most importantly it is not truly random.
3. Purposeful/Judgmental sampling (for qualitative studies): The researcher chooses the sample
based on who they think would be appropriate for the study. This is used primarily when there are a
limited number of people that have expertise in the area being researched. Qualitative research
methods are typically used when focusing on a limited number of informants, whom we select
strategically so that their in-depth information will give optimal insight into an issue about which
little, is known. This is called purposeful sampling.
The above sampling methods do not claim to be representative of the entire population.
Random sampling strategies to collect quantitative data: If the aim of a study is to measure
variables distributed in a population (e.g., diseases) or to test hypotheses about which factors are
contributing significantly to a certain problem, we have to be sure that we can generalize the
findings obtained from a sample to the total study population. Then, purposeful sampling methods
are inadequate, and probability or random sampling methods have to be used.
1. Simple random sampling: This is the most basic scheme of random sampling. In this case each
individual is chosen entirely by chance and each member of the population (i.e. all subsets of the
frame) is given an equal chance, or probability, of being selected.
One way of obtaining a random sample is to give each individual in a population a number or make
a numbered list of all the units in the population from which you want to draw a sample. Each unit
on the list should be numbered in sequence from 1 to N (Where N is the Size of the population).
Decide on the size of the sample. Then select the required number of sampling units use a table of
random numbers or “lottery” to decide/determine which individuals to include. It is applicable
when population is small, homogeneous & readily available. Estimates are easy to calculate.
Simple random sampling is always an EPS design, but not all EPS designs are simple random
sampling.
2. Systematic Sampling: Individuals are selected at regular intervals from a list of the whole
population (the sampling frame). The intervals are chosen to ensure an adequate sample size. For
example, every 10th member of the population is included. Systematic sampling relies on arranging
the target population according to some ordering scheme and then selecting elements at regular
intervals through that ordered list. Systematic sampling involves a random start and then proceeds
with the selection of every kth element from then onwards. In this case, k = population size divided
by sample size. It is important that the starting point is not automatically the first in the list; ideally
we randomly select a number from within the first to the kth element in the list to tell us where to
start selecting individuals from the list. For example, a systematic sample is to be selected from
1000 students of a school. The sample size is decided to be 100. The sampling fraction is: 100/1000
= 1/10. The number of the first student to be included in the sample is chosen randomly by picking
one out of the first ten pieces of paper, numbered 1 to 10, also referred to as 'sampling with a skip
of 10'. . If number 5 is picked, every tenth student will be included in the sample, starting with
student number 5, until 100 students are selected. Students with the following numbers will be
included in the sample: 5, 15, 25, 35, 45, . . . , 985, 995. This method is often convenient and easy
to use, although it may also lead to bias for reasons outlined below.
Systematic sampling is an EPS method, because all elements have the same probability of selection
(in the example given, one in ten). It is NOT 'simple random sampling' because different subsets of
the same size have different selection probabilities - e.g. the set {4, 14, 24... 994} has a one-in-ten
probability of selection, but the set {4, 13, 24, 34...} has zero probability of selection.
Advantages: 1. Sample easy to select 2. Systematic Sampling is usually less time consuming and
easier to perform than SRS. 3. Suitable sampling frame can be identified easily, and unlike SRS,
systematic sampling can be conducted without a sampling frame (useful in some situations where a
sampling frame is not readily available). 4. Sample evenly spread over entire reference population.
5. It provides a good approximation to SRS.
Disadvantages: 1. It should not be used if there is any sort of cyclic pattern in the ordering of the
subjects on the list, as sample may be biased if hidden periodicity in population coincides with that
of selection. 2. Difficult to assess precision of estimate from one survey.
3. Stratified sampling: It is used when we might reasonably expect the measurement of interest to
vary between the different sub-groups. If it is important that the sample includes representative
groups of study units with specific characteristics (for example, residents from urban and rural
areas), the sampling frame must be divided into groups, or strata, according to these characteristics.
Gender or smoking habits would be examples of strata. In stratified sampling, the population is first
divided into sub-groups (or strata) who all share a similar characteristic. The study sample of a
predetermined size is then obtained by taking samples from each stratum (group) by simple random
or systematic sampling. In a stratified sample, the probability of an individual being included varies
according to known characteristics, such as gender, and the aim is to ensure that all sub-groups of
the population that might be of relevance to the study are adequately represented. Thus in a
nutshell, where population embraces a number of distinct categories, the frame can be organized
into separate "strata." Each stratum is then sampled as an independent sub-population, out of which
individual elements can be randomly selected. Every unit in a stratum has same chance of being
selected. Using same sampling fraction for all strata ensures proportionate representation in the
sample. Adequate representation of minority subgroups of interest can be ensured by stratification
& varying sampling fraction between strata as required. Finally, since each stratum is treated as an
independent population, different sampling approaches can be applied to different strata. The fact
that the sample was stratified should be taken into account at the analysis stage.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Oversampling: Choice-based sampling is one of the stratified sampling strategies. In this, data are
stratified on the target and a sample is taken from each stratum so that the rare target class will be
more represented in the sample. The model is then built on this biased sample. The effects of the
input variables on the target are often estimated with more precision with the choice-based sample
even when a smaller overall sample size is taken compared to a random sample. The results usually
must be adjusted to correct for the oversampling.
4. Cluster sampling: When a list of groupings of study units is available (e.g. villages, etc.) or can
be easily compiled, a number of these groupings can be randomly selected. In a clustered sample,
sub-groups of the population are used as the sampling unit, rather than individuals. Clusters are
often geographic units (e.g. districts, villages) or organizational units (e.g. clinics). The population
is divided into sub-groups, known as clusters, and a selection of these are randomly selected to be
included in the study. All members of the cluster are then included in the study. Clustering should
be taken into account in the analysis. The General Household survey, which is undertaken annually
in some countries, is a good example of a cluster sample. All members of the selected
households/clusters are included in the survey.
a) Cluster sampling is an example of 'two-stage sampling'.
b) First stage a sample of areas is chosen;
c) Second stage a sample of respondents within those areas is selected.
d) Population divided into clusters of homogeneous units, usually based on geographical
contiguity.
e) Sampling units are groups rather than individuals.
f) A sample of such clusters is then selected.
g) All units from the selected clusters are studied.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Advantages: 1. Cuts down on the cost of preparing a sampling frame. 2. This can reduce travel and
other administrative costs.
Disadvantages: 1. Sampling error is higher for a simple random sample of same size.
Often used to evaluate vaccination coverage in EPI
Identification of clusters: List all cities, towns, villages & wards of cities with their population
falling in target area under study; Calculate cumulative population & divide by 30, this gives
sampling interval; Select a random number. less than or equal to sampling interval having same no.
of digits. This forms 1st cluster;
❖ Random no.+ sampling interval = population of 2nd cluster.
❖ Second cluster + sampling interval = 4th cluster.
❖ Last or 30th cluster = 29th cluster + sampling interval
5. Multi-Stage Sampling: This is a complex form of cluster sampling in which two or more levels
of units are embedded one in the other. This method is appropriate when the population is large and
widely scattered. The number of stages of sampling is the number of times a sampling procedure is
carried out. First stage, random number of districts chosen in all states; Followed by random
number of talukas (districts or Hamlets), villages; Then third stage units will be houses. All
ultimate units (houses, for instance) selected at last step are surveyed.
❖ The primary sampling unit (PSU) is the sampling unit (or unit of selection in the sampling
procedure) in the first sampling stage;
❖ The secondary sampling unit (SSU) is the sampling unit in the second sampling stage, etc. e.g.
After selection of a sample of clusters (e.g. household), further sampling of individuals may be
carried out within each household selected. This constitutes two stage sampling, with the PSU
being households and the SSU being individuals.
Advantages: less costly, we only need to draw up a list of individuals in the clusters actually
selected, and we can do that when we arrive there.
Disadvantage: less precise than SRS.
6. Multiphase Sampling: Part of the information collected from whole sample & part from
subsample. In Tb survey MT in all cases – Phase I. X –Ray chest in MT +ve cases – Phase II.
Sputum examination in X – Ray +ve cases - Phase III; Survey by such procedure is less costly, less
laborious & more purposeful.
9. Event Sampling: Event Sampling Methodology (ESM) is a new form of sampling method that
allows researchers to study ongoing experiences and events that vary across and within days in its
naturally-occurring environment. Because of the frequent sampling of events inherent in ESM, it
enables researchers to measure the typology of activity and detect the temporal and dynamic
fluctuations of work experiences. Popularity of ESM as a new form of research design increased
over the recent years because it addresses the shortcomings of cross-sectional research, where once
unable to, researchers can now detect intra-individual variances across time. In ESM, participants
are asked to record their experiences and perceptions in a paper or electronic diary. There are three
types of ESM: # Signal contingent – random beeping notifies participants to record data. The
advantage of this type of ESM is minimization of recall bias.
❖ Event contingent – records data when certain events occur
❖ Event contingent – records data when certain events occur
❖ Interval contingent – records data according to the passing of a certain period of time
ESM has several disadvantages. One of the disadvantages of ESM is it can sometimes be perceived
as invasive and intrusive by participants. ESM also leads to possible self-selection bias. It may be
that only certain types of individuals are willing to participate in this type of study creating a non-
random sample. Another concern is related to participant cooperation. Participants may not be
actually fill out their diaries at the specified times. Furthermore, ESM may substantively change the
phenomenon being studied. Reactivity or priming effects may occur, such that repeated
measurement may cause changes in the participants' experiences. This method of sampling data is
also highly vulnerable to common method variance. Further, it is important to think about whether
or not an appropriate dependent variable is being used in an ESM design. For example, it might be
logical to use ESM in order to answer research questions which involve dependent variables with a
great deal of variation throughout the day. Thus, variables such as change in mood, change in stress
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
level, or the immediate impact of particular events may be best studied using ESM methodology.
However, it is not likely that utilizing ESM will yield meaningful predictions when measuring
someone performing a repetitive task throughout the day or when dependent variables are long-
term in nature (coronary heart problems).
When we take a sample, our results will not exactly equal the correct results for the whole
population. That is, our results will be subject to errors. This error has two components: sampling
and non-sampling errors.
Reliability (or precision): This refers to the repeatability of a measure, i.e., the degree of closeness
between repeated measurements of the same value. Reliability addresses the question, if the same
thing is measured several times, how close are the measurements to each other?
Intra-observer variation: differences in measuring the same observation by the same observer on
different occasions.
Validity: This refers to the degree of closeness between a measurement and the true value of what
is being measured. Validity addresses the question, how close is the measured value to the true
value? To be accurate, a measuring device must be both valid and reliable. However, if one cannot
have both, validity is more important in situations when we are interested in the absolute value of
what is being measured. Reliability on the other hand is more important when it is not essential to
know the absolute value, but rather we are interested in finding out if there is a trend, or to rank
values.
Bias in sampling
There are five important potential sources of bias that should be considered when selecting a
sample, by whatever method:
1. Any changes from the pre-agreed sampling rules can introduce bias
2. Bias is introduced if people in hard to reach groups are omitted (accessibility bias)
3. Replacing selected individuals with others, for example if they are difficult to contact, also
introduces bias
1. It is important to try and maximize the response rate to a survey; low response rates can
introduce bias. Non-response bias refers to failure to obtain information on some of the
subjects included in the sample to be studied. It results in significant bias when the
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
following two situations are both fulfilled: (i) when non-respondents constitute a significant
proportion of the sample, (ii) when non-respondents differ significantly from respondents, it
4. If an out of date list is used as the sample frame, it may also introduce bias, for example if it
excludes people who have recently moved to an area. Bias resulting from incompleteness of
the sampling frame could be accessibility bias, seasonability bias, self-reporting bias,
volunteer bias, non-response bias etc.
The issue of non-response should be considered during the planning stage of the study:
In order to calculate the required sample size, you need to know the following facts:
a) The reasonable estimate of the key proportion to be studied. If you cannot guess the
proportion, take it as 50%.
b) The degree of accuracy required. That is, the allowed deviation from the true proportion in the
population as a whole. It can be within 1% or 5%, etc.
c) The confidence level required, usually specified as 95%.
d) The size of the population that the sample is to represent. If it is more than 10,000 the precise
magnitude is not likely to be very important; but if the population is less than 10,000 then a
smaller sample size may be required.
e) The difference between the two sub-groups and the value of the likelihood or the power that
helps in finding a statistically significant difference.
➢ Note that ‘e’ is required when there are two population groups and the interest is to
compare between two means or proportions.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Estimating a proportion
❖ Estimate how big the proportion might be (P)
❖ Choose the margin of error you will allow in the estimate of the proportion (say ± w)
❖ Choose the level of confidence that the proportion in the whole population is indeed between
(p-w) and (p+w). We can never be 100% sure. Do you want to be 95% sure?
❖ The minimum sample size required, for a very large population (N>10,000) is:
no = Z2 p (1-p) / w2
no = (1.96)2 (.26 × .74) / (.03)2 = 821.25 ≈ 822; Thus, the study should include at least 822
subjects.
b) If the above sample is to be taken from a relatively small population (say N = 3000), the required
minimum sample will be obtained from the above estimate by making some adjustment.
n = noN/{(no+(N-1)} = 821.25 / (1+ (821.25/3000)) = 644.7 ≈ 645 subjects
Example 2
A hospital administrator wishes to know what proportion of discharged patients is unhappy with the
care received during hospitalization. If 95% Confidence interval is desired to estimate the
proportion within 5%, how large a sample should be drawn?
N.B. If you don’t have any information about P, take it as 50% and get the maximum value of PQ
which is 1/4 (i.e., 25%).
Estimating a mean
The same approach is used but with SE = σ / √n = Standard error.
The required (minimum) sample size for a very large population is given by: no = Z2 σ2 / w2
Example: A health officer wishes to estimate the mean serum cholesterol in a population of men.
From previous similar studies a standard deviation of 40 mg/100ml was reported. If he is willing to
tolerate a marginal error of up to 5 mg/100ml in his estimate, how many subjects should be
included in his study?
(α =5%, two sided)
a) If the population size is assumed to be very large, the required sample size would be:
no = (1.96)2 (40)2 / (5)2 = 245.86 ≈ 246 persons
- If the population size is, say, 2000, the required sample size would be 220 persons.
b) If the investigator anticipates that 15% of the subjects will fail to comply with the intended
study, the sample size required will be: n = (1/(1-0.15)) x 246 = 290 men
NB: σ2 can be estimated from previous similar studies or could be obtained by conducting a small
pilot study.
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E.g. The proportion of nurses leaving the health service is compared between two regions. In one
region 30% of nurses is estimated to leave the service within 3 years of graduation. In other region
it is probably 15%.
Solution: The required sample to show, with 90% likelihood (power), that the percentage of nurses
is different in these two regions would be: (assume a confidence level of 95%)
N.B. Sample size calculation using the STATCALC calculator of the Epi Info program is
given in chapter 8.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
HOW LONG will it take to collect the data for each component of the study?
Step 1: Consider:
❖ The time required to reach the study area(s);
❖ The time required to locate the study units (persons, groups, records). If you have to search
for specific informants (e.g., users or defaulters of a specific service) it might take more time
to locate informants than to interview them.
❖ The number of visits required per study unit. For some studies it may be necessary to visit
informants a number of times, for example if the information needed is sensitive and can only
be collected after informants are comfortable with the investigator or if observations have to
be made more than once (for example, follow-up of pregnant mothers or malnourished
children). Time needed for follow-up of non-respondents should also be considered.
Step 2: Calculate the number of interviews that can be carried out per person per day
Step 3: Calculate the number of days needed to carry out the interviews. For example:
❖ You need to do 200 interviews,
❖ Your research team of 5 people can do 5 x 4 = 20 interviews per day,
❖ You will need 200÷20 = 10 days for the interviews.
Step 4: Calculate the time needed for the other parts of the study, (for example, 10 days)
Step 5: Determine how much time you can devote to the study.
If the team has fewer days for fieldwork than the required, they would need additional research
assistants to help complete this part of the study.
Note: It is always advisable to slightly overestimate the period needed for data collection to allow
for unforeseen delays.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Accuracy and “practicability” are often inversely correlated. A method providing more satisfactory
information will often be a more expensive or inconvenient one. Therefore, accuracy must be
balanced against practical considerations (resources and other practical limitations)
Advantages:
❖ Documents can provide readymade information relatively easily
❖ The best means of studying past events.
Disadvantages:
❖ Problems of reliability and validity (because the information is collected by a number of
different persons who may have used different definitions or methods of obtaining data).
❖ There is a possibility that errors may occur when the information is extracted from the
records. (This may be an important source of unreliability if handwritings are difficult to
read.
❖ Since the records are maintained not for research purposes, but for clinical, administrative or
other ends, the information required may not be recorded at all, or only partly recorded.
Self-administered questionnaire: the respondent reads the questions and fills in the answers by
himself (sometimes in the presence of an interviewer who “stands by” to give assistance if
necessary. The use of self-administered questionnaires is simpler and cheaper, such questionnaires
can be administered to many persons simultaneously.
Example:
❖ to students of a school
❖ they can also be sent by post unlike interviews.
However, they demand a certain level of education on the part of the respondent.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
In general, apart from their expense, interviews are preferable to self-administered questionnaires
provided that they are conducted by skilled interviewers. While interviewing, a precaution should
be taken not to influence the responses; the interviewer should ask his questions in a neutral
manner. He should not show agreement, disagreement, or surprise, and should record the
respondent’s precise answers without shifting or interpreting them.
Questionnaire Design
Questions may take two general forms: they may be “Open ended” questions, which the subject
answers in his own words, or “closed” questions, which are answered by choosing from a number
of fixed alternative responses.
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The main methods of collecting qualitative data are: individual interviews, focus groups and
observation
Qualitative Interviews
Qualitative interviews are semi structured or unstructured. If the interview schedule is too tightly
structured this may not enable the phenomena under investigation to be explored in terms of either
breadth or depth. Semi structured interviews tend to work well when the interviewer has already
identified a number of aspects he wants to be sure of addressing. The interviewer can decide in
advance what areas to cover but is open and receptive to unexpected information from the
interviewee. This can be particularly important if a limited time is available for each interview and
the interviewer wants to be sure that the "key issues" will be covered.
Semi structured interviews (sometimes referred to as focused interviews) involve a series of open
ended questions based on the topic areas the researcher wants to cover. The open ended nature of
the question defines the topic under investigation but provides opportunities for both interviewer
and interviewee to discuss some topics in more detail. If the interviewee has difficulty answering a
question or provides only a brief response, the interviewer can use cues or prompts to encourage
the interviewee to consider the question further. In a semi structured interview the interviewer also
has the freedom to probe the interviewee to elaborate on the original response or to follow a line of
inquiry introduced by the interviewee.
Unstructured interviews (referred to as "depth" or "in depth" interviews) have very little structure
at all. The interviewer goes into the interview with the aim of discussing a limited number of
topics, sometimes as few as one or two, and frames the questions on the basis of the interviewee's
previous response. Although only one or two topics are discussed they are covered in great detail.
Subsequent questions would depend on how the interviewee responded. Unstructured interviews
are exactly what they sound like - interviews where the interviewer wants to find out about a
specific topic but has no structure or preconceived plan or expectation as to how they will deal with
the topic. The difference with semi structured interviews is that in a semi structured interview the
interviewer has a set of broad questions to ask and may also have some prompts to help the
interviewee but the interviewer has the time and space to respond to the interviewees’ responses.
Qualitative interviews should be fairly informal. Interviewees should feel as though they are
participating in a conversation or discussion rather than in a formal question and answer situation.
However, achieving this informal style is dependent on careful planning and on skill in conducting
the interview.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Physical arrangements: Communication and interaction during the FGD should be encouraged in
every possible way. Arrange the chairs in a circle. Make sure the area will be quiet, adequately
lighted, etc., and that there will be no disturbances.
During the discussion: One of the members of the research team should act as a "facilitator" for
the focus group. One should serve as "recorder."
Report writing in focus group discussions: Start with a description of the selection and
composition of the groups of participants and a commentary on the group process, so the reader can
assess the validity of the reported findings. Present your findings, following your list of topics and
guided by the objective(s) of your FGD. Include questions whenever possible, particularly for key
statements.
The method of data collection chosen for a study should be appropriate for the type of information
required. Whether the required information is quantitative or qualitative in nature is the major
consideration. It would be time wasting to use unstructured interviews for essentially quantitative
studies where information could be more efficiently collected through structured interviews or
questionnaires. Conversely, self completed questionnaires are generally unsuited to qualitative
research: even when there is space for comments or for respondents to express ideas the space is
limited and requires respondents to have skills in articulation and literacy.
Observation
Not all qualitative data collection approaches require direct interaction with people. It is a technique
that can be used when data collected through other means can be of limited value or is difficult to
validate. For example, in interviews participants may be asked about how they behave in certain
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situations but there is no guarantee that they actually do what they say they do. Observing them in
those situations is more reliable: it is possible to see how they actually behave. Observation can
also serve as a technique for verifying or nullifying information provided in face to face encounters.
In some research observation of people is not required but observation of the environment. This can
provide valuable background information about the environment where a research project is being
undertaken. For example, an action research project involving an institution may be enhanced by
some description of the physical features of the building.
These sources of bias can be prevented by carefully planning the data collection process and by
pre-testing the data collection tools.
2. Observer bias:
Observer bias can easily occur when conducting observations or utilizing loosely structured group-
or individual interviews. There is a risk that the data collector will only see or hear things in which
(s)he is interested or will miss information that is critical to the research. Observation protocols and
guidelines for conducting loosely structured interviews should be prepared, and training and
practice should be provided to data collectors in using both these tools. Moreover it is highly
recommended that data collectors work in pairs when using flexible research techniques and
discuss and interpret the data immediately after collecting it. Another possibility - commonly used
by anthropologists - is using a tape recorder and transcribing the tape word by word.
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4. Information bias:
Sometimes the information itself has weaknesses. Medical records may have many blanks or be
unreadable. This tells something about the quality of the data and has to be recorded. For example,
in a TB defaulter study the percentage of defaulters with an incomplete or missing address should
be calculated. Another common information bias is due to gaps in people’s memory; this is called
memory or recall bias. A mother may not remember all details of her child’s last diarrhoea episode
and of the treatment she gave two or three months afterwards. For such common diseases it is
advisable to limit the period of recall, asking, for example, ‘Has your child had diarrhoea over the
past two weeks?’
Confidentiality of information
❖ Should be stated right on the top of the first page of the questionnaire
❖ If possible, use code numbers instead of names
❖ The purpose of the study should be explained at the beginning
❖ The respondent has the right not to be interviewed
The plan for data processing and analysis must be made after careful consideration of the objectives
of the study as well as of the tools developed to meet the objectives. The procedures for the
analysis of data collected through qualitative and quantitative techniques are quite different.
❖ For quantitative data the starting point in analysis is usually a description of the data for
each variable for all the study units included in the sample. Processing of data may take place
during data collection or when all data has been collected; description and analysis are usually
carried out after the fieldwork has been completed.
❖ For qualitative data it is more a matter of describing, summarizing and interpreting the data
obtained for each study unit (or for each group of study units). Here the researcher starts
analyzing while collecting the data so that questions that remain unanswered (or new
questions which come up) can be addressed before data collection is over.
Preparation of a plan for data processing and analysis will provide you with better insight into the
feasibility of the analysis to be performed as well as the resources that are required. It also provides
an important review of the appropriateness of the data collection tools for collecting the data you
need. That is why you have to plan for data analysis before the pretest. When you process and
analyze the data you collect during the pre-test you will spot gaps and overlaps which require
changes in the data collection tools before it is too late!
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Sorting data
An appropriate system for sorting the data is important for facilitating subsequent processing and
analysis. If you have different study populations (for example village health workers, village health
committees and the general population), you obviously would number the questionnaires
separately.
In a comparative study it is best to sort the data right after collection into the two or three groups
that you will be comparing during data analysis.
For example, in a study concerning the reasons for low acceptance of family planning services,
users and non-users would be basic categories;
In a case control study obviously the cases are to be compared with the controls. It is useful to
number the questionnaires belonging to each of these categories separately right after they are
sorted.
For example, the questionnaires administered to users of family planning services could be
numbered U1, U2, U3, etc., and those for the non-users N1, N2, N3, etc.
For computer data analysis, quality control checks of data must also include a verification of how
the data has been transformed into codes and subsequently entered into the computer. The same
applies if data are entered into master sheets.
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1. Categorizing
Decisions have to be made concerning how to categorize responses. For categorical variables that
are investigated through closed questions or observation, the categories have been decided upon
beforehand. In interviews the answers to open-ended questions (for example, ‘why do you visit the
health centre?’) can be pre-categorized to a certain extent, depending on the knowledge of possible
answers that may be given. However, there should always be a category called ‘Others, specify . . .’
which can only be categorized afterwards. These responses should be listed and placed in
categories that are a logical continuation of the categories you already have. Answers that are
difficult or impossible to categorize may be put in a separate residual category called ‘others’, but
this category should not contain more than 5% of the answers obtained.
For numerical variables, the data are often better collected without any pre-categorization. If you
do not exactly know the range and the dispersion of the different values of these variables when
you collect your sample (e.g., home-clinic distance for out-patients, or income), decisions
concerning how to categorize and code the data at the time you develop your tools may be
premature. If you notice during data analysis that your categories had been wrongly chosen you
cannot reclassify the data anymore.
2. Coding
If the data will be entered in a computer for subsequent processing and analysis, it is essential to
develop a CODING SYSTEM. For computer analysis, each category of a variable can be coded
with a letter, group of letters or word, or be given a number. For example, the answer ‘yes’ may be
coded as ‘Y’ or 1; ‘no’ as ‘N’ or 2 and ‘no response’ or ‘unknown’ as ‘U’ or 9. The codes should
be entered on the questionnaires (or checklists) themselves. When finalizing your questionnaire, for
each question you should insert a box for the code in the right margin of the page. These boxes
should not be used by the interviewer. They are only filled in afterwards during data processing.
Take care that you have as many boxes as the number of digits in each code.
Coding conventions
Common responses should have the same code in each question, as this minimizes mistakes by
coders.
For Example:
Yes (Positive response Code - Y or 1
No (negative response) Code - N or 2
Don’t know Code - D or 8
No response/unknown Code - U or 9
Codes for open-ended questions (in questionnaires) can be done only after examining a sample of
(say 20) questionnaires. You may group similar types of responses into single categories, so as to
limit their number to at most 6 or 7. If there are too many categories it is difficult to analyze the
data.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
For example, the straightforward answers of the smoking questionnaire for male smokers could be
processed as follows:
Note that for age and number of cigarettes smoked both the raw data and the categories have been
entered. This makes it easier to control for coding mistakes and allows for calculating averages.
There are 31 male smokers; if there are less than 31 answers, there must be some non-responders
(NR), as happened in Q9, or a mistake was made.
If you work with two persons; one reading and the other writing, the risk of mistakes will be
reduced, as you can discuss the answers and control for mistakes while filling in the data.
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1. If only one person is doing the compilation use manual sorting. If a team of 2 persons work
together use either manual sorting or tally counting.
When you need to sort out subjects who have a certain combination of variables (e.g. females who
used each type of health facility) sort the questionnaires into piles according to the first question
(gender), then subdivide the piles according to the response to the other question (use of health
facility).
4. After doing either manual or tally counting, check the total number of subjects/responses in each
question to make sure that there has been no omission or double count.
Note: One can tally in two ways: using strokes or squares (illustrate here). The latter way is
preferable as it reduces the possibility of error.
It should be noted that hand tallying is often used in combination with master sheet analysis when
the relationship between two or three variables needs to be established, or details analyzed.
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The identification of an appropriate statistical package is the first step in using a computer. Some
examples of packages commonly used are: Epi Info, SPSS, STATA, etc.
iii. Verification
During data entry, mistakes will definitely creep in. The computer can print out the data exactly as
it has been entered, so the printout can be checked visually for obvious errors, (e.g., exceptionally
long or short lines, blanks that should not be there, alphabetic codes where numbers are expected,
obviously wrong codes).
Example:
❖ Codes 3-8 in the column for sex where only 1(F) and 2 (M) are possible
❖ Codes above 250 when you had only 250 subjects
If possible, computer verification should be built in. This involves giving the appropriate
commands to identify errors.
Example: The computer can be instructed to identify and print out all subjects where the ‘sex’
column has a code different from 1 (F) or 2 (M).
iv. Programming
A certain amount of basic knowledge of computer programming is needed to give the appropriate
commands.
v. Computer outputs
The computer can do most of the analysis and the results can be printed. It is important to decide
whether each of the tables, graphs, and statistical tests that can be produced makes sense and should
be used in your report. That is why we PLAN the data analysis BEFOREHAND!
1. Frequency counts
From the data master sheets, simple tables can be made with frequency counts for each variable. A
frequency count is an enumeration of how often a certain measurement or a certain answer to a
specific question occurs.
For example, Smokers 51; Non-smokers 93; Total 144
If numbers are large enough it is better to calculate the frequency distribution in percentages
(relative frequencies): 51/144 x 100 = 35% are smokers and 93/144 x 100 = 65% nonsmokers.
This makes it easier to compare groups than when only absolute numbers are given. In other words,
percentages standardize the data.
It is usually necessary to summarise the data from numerical variables by dividing them into
categories. This process may include the following steps:
(1) Inspect all the figures: What is their range? (The range is the difference between the largest and
the smallest measurement.)
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
(2) Divide the range into three to five categories. You can either aim at having a reasonable number
in each category (e.g. 0-2 km, 3-4 km, 5-9 km, 10+ km for home-clinic distance) or you can define
the categories in such a way that they are each equal in size (e.g., 20-29 years, 30-39 years, 40-49
years, etc.). Sometimes one looks actively for a ‘critical’ value, when making different categories.
For example, in a study relating family income to prevalence of diarrhoea over a certain period,
there appeared to be no statistical relation when income was arbitrarily subdivided into four
categories. When the average income was calculated, however, this appeared to be a critical value.
The children in families with an income above average had had significantly less diarrhoea than the
children in families with an income below average.
(3) Construct a table indicating how data are grouped and count the number of observations in each
group.
2. Cross-tabulations
Further analysis of the data usually requires the combination of information on two or more
variables in order to describe the problem or to arrive at possible explanations for it. For this
purpose it is necessary to design CROSS-TABULATIONS.
Depending on the objectives and the type of study, two major kinds of cross-tabulations may be
required:
❖ Descriptive cross-tabulations that aim at describing the problem under study.
❖ Analytic cross-tabulations in which groups are compared in order to determine differences, or
which focus on exploring relationships between variables.
When the plan for data analysis is being developed, the data, of course, are not yet available.
However, in order to visualize how the data can be organized and summarized it is useful at this
stage to construct so-called DUMMY cross-tabulations.
A DUMMY TABLE contains all elements of a real table, except that the cells are still empty. In a
research proposal dummy tables should be prepared to describe the study population in order to
show the crucial relationships between variables.
To further analyse and interpret the data, certain calculations or statistical procedures must usually
be completed. Especially in large cross-sectional surveys and in comparative studies, statistical
procedures are necessary if the data are to be adequately interpreted. Statistical tests should, for
example, indicate whether differences are true differences or due to chance. When conducting such
studies it is advisable to consult a person with statistical knowledge from the start in order that:
❖ correct sampling methods are used and an appropriate sample size is selected;
❖ decisions on coding are made that will facilitate data processing and analysis; and
❖ a clear understanding is reached concerning plans for data processing, analysis and
interpretation, including agreement concerning which variables need to be cross-tabulated.
Processing and analysis of qualitative data
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Step 1: Take a sample of (say 20) questionnaires and list all answers for a particular question. Take
care to include the source of each answer you list (in the case of questionnaires you can use the
questionnaire number), so that you can place each answer in its original context, if required.
Step 2: To establish your categories, you first read carefully through the whole list of answers.
Then you start giving codes (A, B, C, for example or key words) for the answers that you think
belong together in one category, and write these codes in the left margin. Use a pencil so that it is
easy to change the categories if you change your mind.
Step 3: List the answers again, grouping those with the same code together.
Step 4: Then interpret each category of answers and try to give it a label that covers the content of
all answers. In the case of data on opinions, for example, there may be only a limited number of
possibilities, which may range from (very) positive, neutral, to (very) negative.
Data on reasons may require different categories depending on the topic and the purpose of your
question. After some shuffling you usually end up with 5 to 7 categories.
Step 5: Now try a next batch of 20 questionnaires and check if the labels work. Adjust the
categories and labels, if necessary.
Step 6: Make a final list of labels for each category and give each label a code (keyword, letter or
number).
Step 7: Code all your data, including what you have already coded, and enter these codes in your
master sheet or in the computer.
Note again that you may include a category ‘others’, but that it should be as small as possible,
preferably used for less than 5% of the total answers. If you categories your responses to open-
ended questions in this way you can:
❖ Analyze the content of each answer given in particular categories, for example, in order to
plan what actions should be taken (e.g., for health education). Gaining insight in a problem, or
in possible interventions for a problem, is the most important function of qualitative data.
❖ Report the number and percentage of respondents that fall into each category; so that you gain
insight in the relative weight of different opinions or reasons.
Questions that ask for descriptions of procedures, practices, or beliefs usually do not provide
quantifiable answers (though you may quantify certain aspects of them). The answers rather form
part of a jigsaw puzzle that you have to put together in order to obtain insight in your problem/topic
under study.
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IN CONCLUSION, a plan for the processing and analysis of data may include:
❖ a decision on whether all or some parts of the data should be processed by hand or computer;
❖ dummy tables for the description of the problem, the comparison of groups (if applicable)
and/or the establishment of relationships between variables, guided by the objectives of the
study;
❖ a decision on the sequence in which tables or data from different study populations should be
analyzed;
❖ a decision on how qualitative data should be analyzed;
❖ an estimate of the total time needed for analysis and how long particular parts of the analysis
will take;
❖ a decision concerning whether additional staff will be required for the analysis; and
❖ an estimate of the total cost of the analysis.
Why do we need ethical approval? Before you embark on research with human subjects, you are
likely to require ethical approval. You may wonder why all this bureaucracy is needed. But history
shows us that prior to the development of ethical and human rights over the last 40 years, patients’
rights were often ignored and many individuals were seriously harmed by medical experimentation.
❖ Atrocities committed during World War II in the Nazi Germany which led to the 1947
Nuremberg Code of Practice and in turn the 1964 Declaration of Helsinki
❖ Tuskegee Syphilis Study in USA (1932-1970s) to study the long-term effects of untreated
syphilis- 400 men out of the 600 participants were never told about the infection and were
never treated despite the fact that treatment became available
❖ A study to examine the natural progression of cervical carcinoma in New Zealand (1980s)-
conventional treatment was withheld from women in trial and women were not asked for their
consent.
Ethical decisions are based on three main approaches: duty, rights and goal-based. The goal-based
approach assumes that we should try to produce the greatest possible balance of value over
disvalue. Discomfort to one individual may be justified by the consequences for the society as a
whole. According to the duty-based approach, your duty as a researcher is founded on your own
moral principles. As a researcher, you will have a duty to yourself and to the individual who is
participating in the research. So even if the outcome of the proposed research is for a good cause, if
it involves the researcher lying or deceiving his subjects in some way, then this would be regarded
as unethical. In the rights-based approach, the rights of the individual are assumed to be all-
important, thus a subject’s right to refuse must be upheld whatever the consequences for the
research. Research studies should be judged ethically on three sets of criteria, namely: ethical
principles, ethical rules, and also scientific criteria. The latter is often neglected but is important
since if a study is poor or the sample size insufficient then the study is not capable of demonstrating
anything and consequently could be regarded as unethical.
Ethical principles
Non-Malfeasance- we ought not to inflict evil or harm: This principle states that we may not
inflict harm on or expose people to unnecessary risk as a result of our research project. This is
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particularly important if our subjects may not be competent in some way, such as, the ability to
give informed consent.
Beneficence – we ought to further others’ legitimate interests: This is the principle that obliges us
to take positive steps to help others pursue their interests.
These interests clearly have to be legitimate.
Justice-we ought to ensure fair entitlement to resources: This principle is concerned with people
receiving their due. This means people should be treated equally in every way since not all people
are equally competent or equally healthy.
Ethical rules
The ethical rules of research, like principles, are not absolute in that one may override another
although clearly this must be justified. These rules are essential for the development of trust
between researchers and study participants. Like the ethical principles on which the rules are based,
there are four:
Veracity (truthfulness): All subjects in any research project should always be told the truth. There
is no justification for lying, but this is not the same non-disclosure of information should it, in
particular, invalidate the research.
Privacy: When subjects enroll in a research study, they grant access to themselves, but this is not
unlimited access. Access is a broad term and generally includes viewing, touch or having
information about them.
Confidentiality: Although someone may grant limited access to him or herself, they may not
relinquish control over any information obtained. Certainly, no information obtained with the
patient’s or subject’s permission from their medical records should be disclosed to any third person
without that individual’s consent. This applies to conversations too.
Fidelity: Fidelity means keeping our promises and avoiding negligence with information. If we
agree for example, to send a summary of our research findings to participants in a study we should
do so.
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❖ A pilot study is the process of carrying out a preliminary study, going through the entire
research procedure with a small sample.
Pretesting is: Simpler; less time consuming; and less costly than conducting an entire pilot study.
Therefore, pretesting is recommended as an essential step in the development of the research
projects. It is useful in examining the practicability, reliability and suitability of the method. The
comments of the respondents will help in improving the sequence and layout of the questionnaire. It
is also important to know the time taken by the interview. In a community study, cooperation can
be enhanced by suitable public relations and preparatory educational work in the community. The
best results are provided by contacts with key individuals and organizations in the community.
6.9 EXERCISES
1. Identify the most appropriate study design for the research proposal you are planning to
develop.
2. Describe the various data collection techniques and state their uses and limitations.
3. State the differences between quantitative and qualitative research methods by giving
appropriate examples.
4. A nutritionist wants to determine the prevalence of malnutrition among children under 5 in
the Southwest region. If a sample of 3000 children is required, what is the sampling technique
he should use to select the required subjects? Write a short note on the procedures (steps) he
should follow in selecting these subjects.
5. In a school there are about 1800 students and the investigator wants to determine the
prevalence of a certain character (eg. KAP on HIV/AIDS) by taking 450 students). The
following table gives the distribution of students by grade and number of sections.
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CHAPTER SEVEN
WORK PLAN AND BUDGET
Work plan could be presented in different forms, such as work schedule and GANTT chart
(developed in the Early 20th century. After the U.S. engineer H. L. Gantt (1861-1919)), but we will
demonstrate the GANTT chart here. A GANTT chart is a planning tool that depicts graphically the
order in which various tasks must be completed and the duration of each activity. The length of
each task is shown by a bar that extends over the number of days, weeks or months the task is
expected to take.
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7.2 BUDGET
Why do we need to design a budget? A detailed budget will help you to identify which resources
are already locally available and which additional resources may be required. The process of budget
design will encourage you to consider aspects of the work plan you have not thought about before
and will serve as a useful reminder of activities planned, as your research gets underway.
How should a budget be prepared? It is necessary to use the work plan as a starting point.
Specify, for each activity in the work plan, what resources are required. Determine for each
resource needed the unit cost and the total cost. The budget for the fieldwork component of the
work plan will include funds for personnel, transport and supplies. Note that UNIT COST (e.g., per
diem or cost of petrol per km), the MULTIPLYING FACTOR (number of days), and TOTAL
COST are required for all budget categories.
Budget justification: It is not sufficient to present a budget without explanation. The budget
justification follows the budget as an explanatory note justifying briefly, in the context of the
proposal, why the various items in the budget are required. Make sure you give clear explanations
concerning why items that may seem questionable or that are particularly costly are needed and
discuss how complicated expenses have been calculated. If a strong budget justification has been
prepared, it is less likely that essential items will be cut during proposal review.
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CHAPTER EIGHT
MAJOR COMPONENTS AND OUTLINE OF THE DIFFERENT PHASES IN A
RESEARCH PROCESS
Title and cover page: The cover page should contain the title, the names of the authors with their
titles and positions, the institution (e.g., MAFLEKUMEN Higher Institute/School of Health
Sciences) and the month and year of submission of the proposal. The title could consist of a
challenging statement or question, followed by an informative subtitle covering the content of the
study and indicating the area where the study will be undertaken.
Table of contents: A table of contents is essential. It provides the reader a quick overview of the
major sections of your research proposal, with page references, so that (s)he can go through the
proposal in a different order or skip certain sections
I) Introduction
Statement of the research problem
❖ Background and definition of the problem of the study
❖ Why the proposed study is important, i.e., general statement on rationale behind the research
project.
State of knowledge: knowledge pertinent to subject under study
❖ Local data/knowledge
❖ Literature review
Significance of the proposed work
Specific statements on the significance of the results of the study should be given. Where to use the
results; who to make us of the results; what the result would be used for; and other details related
with the usefulness of the end results of the study.
The objectives should meet the purpose of the study. They should be phrased clearly,
unambiguously and very specifically. Also, they should be phrased in measurable terms.
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What characteristics will be measured? How will the variables be defined? What scales of
measurement will be used etc.
❖ Inclusion/ exclusion criteria
❖ Sampling procedure to be used and sample size and power calculation.
❖ Data collection and management
➢ Data collection and coding forms should be appended to protocol
➢ Training and quality control, bias control, data entry and storage, data clean-up and
correction of deficiencies
❖ Data analysis
➢ Management of dropouts
➢ Frequencies, rates, other parameters
➢ Statistical programs and tests to be used
➢ Data presentation (dummy tables to be appended)
❖ Ethical considerations: rights and welfare of the subjects and method of obtaining their
informed consent
❖ Pretest or pilot study: (allows us to identify potential problems in the proposed study)
V) Budget (itemize all direct costs in Francs CFA) Personnel, material/supplies, travel, analysis,
contingency, etc.
VI) References: List only those cited in text using the appropriate format like the Havard-APA
(American Psychology Association') Style for citation and Bibliographic referencing.
VII) Appendices: -
❖ Glossaries
❖ Data collection and coding forms
❖ Dummy tables for data presentation
❖ Letters of support (cooperation)
EXERCISE: Develop a research proposal of your own topic. Take account of all the chapters
covered so far and write your final proposal in line with the guideline given above.
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7. Conducting pretest in the research location (nearby area) and revising data collection tools
❖ The pretest should assess the validity of the data-collection instruments and procedures, as
well as the sampling procedures
❖ It should identify scientific as well as logistical problems and constraints
❖ Revise the data-collection tools and other procedures after the pretest
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8. Data collection
After getting permission for the conduct of the study, obtained the necessary resources, trained the
required personnel, made pretests and modified data-collection tools and procedures, the required
data collection can be carried out.
9. Processing data
After collecting and sorting the data, all questionnaires and records should be checked for errors.
This should be done before leaving the area where data collection is done. If there is any error to be
corrected regarding a particular questionnaire, it would be easy for the data collector or supervisor
to make the changes by visiting the respondent from which the information was obtained. During
this stage, answers given for open-ended questions may be converted into quantifiable numerical
form for processing by computer or other means.
Abstract (Summary)
The summary should be brief and informative. A reader who has been attracted by the title will
usually look at the summary to decide whether the report is worth reading. The summary should be
written only after the first or even the second draft of the report has been completed. It should
contain:
❖ a very brief description of the problem (WHY this study was needed)
❖ the main objectives (WHAT has been studied)
❖ the place of study (WHERE)
❖ the type of study and methods used (HOW)
❖ major findings and conclusions, followed by
❖ The major (or all) recommendations.
The summary will be the first (and for busy health decision makers most likely the only) part of
your study that will be read. Therefore, its writing demands thorough reflection and is time
consuming. Several drafts may have to be made, each discussed by the research team as a whole.
Dedication
Acknowledgements
It is good practice to thank those who supported you technically or financially in the design and
implementation of your study. Also your employer who has allowed you to invest time in the study
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and the respondents may be acknowledged. Acknowledgements are usually placed right after the
title page or at the end of the report, before the references.
Table of contents
A table of contents is essential. It provides the reader a quick overview of the major sections of
your report, with page references, so that (s)he can go through the report in a different order or skip
certain sections.
II) Objectives
The general and specific objectives should be included as stated in the proposal. If necessary, you
can adjust them slightly for style and sequence. However, you should not change their basic nature.
If you have not been able to meet some of the objectives this should be stated in the methodology
section and in the discussion of the findings. The objectives form the HEART of your study. They
determined the methodology you chose and will determine how you structure the reporting of your
findings.
III) Methods
The methodology you followed for the collection of your data should be described in detail.
The methodology section should include a description of:
❖ the study type;
❖ major study themes or variables (a more detailed list of variables on which data were
collected may be annexed);
❖ the study population(s), sampling method(s) and the size of the sample(s);
❖ data-collection techniques used for the different study populations;
❖ how the data were collected and by whom;
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❖ procedures used for data analysis, including statistical tests (if applicable).
If you have deviated from the original study design presented in your research proposal, you should
explain to what extent you did so and why. The consequences of this deviation for meeting certain
objectives of your study should be indicated. If the quality of some of the data is weak, resulting in
possible biases, this should be described as well under the heading ‘limitations of the study’.
IV) Results
❖ Findings should be presented
❖ Tables and graphs could be used (should be well titled and captioned)
❖ The tables should be well constructed, and without anomalies such as percentages which do
not add up to 100 percent
❖ Avoid too many decimal places
❖ Graphs should clarify and not complicate, and care should be taken that they do not mislead
❖ If appropriate statistical tests are used, the results should be included. P-values alone are not
very helpful. Confidence intervals and the type of tests used should be indicated.
The conclusions and recommendations should follow logically from the discussion of the findings.
Conclusions can be short, as they have already been elaborately discussed in chapter 5. As the
discussion will follow the sequence in which the findings have been Research methodology
presented (which in turn depends on your objectives) the conclusions should logically follow the
same order. It makes easy reading for an outsider if the recommendations are again placed in
roughly the same sequence as the conclusions. However, the recommendations may at the same
time be summarised according to the groups towards which they are directed, for example:
❖ policy-makers,
❖ health and health-related managers at district or lower level,
❖ health and health-related staff who could implement the activities,
❖ potential clients, and
❖ The community at large.
Remember that action-oriented groups are most interested in this section. In making
recommendations, use not only the findings of your study, but also supportive information from
other sources. The recommendations should take into consideration the local characteristics of the
health system, constraints, feasibility and usefulness of the proposed solutions. They should be
discussed with all concerned before they are finalized.
VII) References
The references in your text can be numbered in the sequence in which they appear in the report and
then listed in this order in the list of references (Vancouver system). Another possibility is the
Harvard system of listing in brackets the author’s name(s) in the text followed by the date of the
publication (and page number in case you are quoting) for example: (Shan, 2000). In the list of
references, the publications are then arranged in alphabetical order by the principal author’s last
name. You can choose either system as long as you use it consistently throughout the report.
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Can I print my drafts and/or final project double-sided? No! It is recommended that the final
projects should be printed on one side.
PLAGIARISM: Academic research can be defined as the act of examining and referring to the
thoughts and writings of others. Plagiarism is when an individual submits or presents the work of
another person as his or her own. Therefore, when excerpts are used in paragraphs or essays, or
when one paraphrases someone else’s idea, the author must be acknowledged using the right
approach. The overall guiding principle for references is: it should be possible for the reader to
know exactly and fully, as to any part of the text, which sources the writer has used.
According to the Merriam-Webster Online Dictionary, to “plagiarize” means:
1. To steal and pass off (the ideas or words of another) as one’s own without proper recognition of
their origins (as for “ideas”, it is debatable).
2. To directly or indirectly use (another’s production) without crediting the source.
3. To commit literary theft.
4. To present as new and original an idea or product derived from an existing source.
In other words, plagiarism is an act of fraud. It involves both stealing someone else’s work and
lying about it afterward. Plagiarism is academic misconduct and will produce serious consequences
from dismissal from university for 6 months to expulsion.
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❖ Make sure you write down the source details you need on any photocopies you make.
❖ Remember to print or save details of any website you want to refer to (your tutor may ask to
see this) and record the date when you accessed the information.
❖ Make sure you are following the referencing system used in your department.
WRITING STYLE:
Students are expected to employ correct spelling, punctuation, and sentence and paragraph
structure. All papers should be proofread for spelling, grammatical, and typographical errors. If
unsure about these matters, students should consult a style guide or a dictionary. Students should
choose either the British, American or Canadian convention of English spelling and follow it
consistently. It is certainly acceptable to use spell check and grammar check, but they are no
substitute for careful proofreading. While a thesaurus can help a writer to vary word choices, it
should be used in conjunction with a dictionary, substituting words without knowing their precise
meaning can lead to embarrassing mistakes.
Example 2: Thailand was one of the Asian countries affected by the large outflow of capital funds
in 1997/1998. The Asian economic crisis was described as the “most severe economic contraction
in recent Thai history” (Warr, 2005: 115).
The full reference list will be: Warr, P. (2005). Poverty, Inequality, and Economic Growth: The
Case of Thailand. In A. B. Deolalikar (Ed.) Poverty, Growth, and Safety Nets: A Comparative
Regional Perspective. Toronto: De Sitter Publications.
Example 3: Despite enjoying rapid economic growth, illiteracy remains a great cause of concern in
India. According to Tharoor (2007: 137), “thirty-seven percent of all Indian primary school
children drop out before reaching fifth grade” and the number of the illiterate population of India
“exceeds the total combined population of the North American continent and Japan”.
The full reference list will be: Tharoor, S. (2007). The elephant, the tiger, and the cell phone.
New York: Arcade Publishing.
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If part of the quotation is omitted then this can be indicated using three dots:-
Example 1: Weir and Kendrick (1995) state that "networking is no longer solely within the male
domain . . ."(p.88).
Example 2: The complexity of the “double movement” in market society as a given structure is
spelt out by Polanyi himself: Our thesis is that the idea of a self-adjusting market implied a stark
utopia.
Such an institution could not exist for any length of time without annihilating the human and
natural substance of society; it would have physically destroyed man and transformed his
surroundings into a wilderness. Inevitably, society took measures to protect itself, but whatever
measures it took impaired the selfregulation of the market, disorganized industrial life, and thus
endangered society in yet another way. (Polanyi, 1957: 3, italic added)
Example 3: The complexity of the “double movement” in market society as a given structure is
spelt out by Polanyi himself: “Our thesis is that …. Inevitably, society took measures to protect
itself [the second movement], but whatever measures it took impaired the self-regulation of the
market, disorganized industrial life, and thus endangered society in yet another way” (Polanyi,
1957: 3).
Do I need to comment after a quotation? Absolutely! Some commentary should analyze the
quotation- the reader should not be responsible to interpret its meaning. As a rule, quotations
should be grammatically integrated into the essay writer's prose; they should not stand alone as
independent sentences.
Do I need to interpret after data insertion? Absolutely! Data sources (a map, a diagram, or a
table of statistics) must be correctly given. In addition, they should be explained and interpreted
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accordingly in line with the author’s purpose. It is the responsibility of the author, not the reader, to
have the inserted data clarified reflecting the author’s purpose of applying these data.
III: PARAPHRASING AN IDEA: You can paraphrase the sentences and/or ideas of others and
document the sources appropriately.
Example: The Five Forces Model, as popularized by Michael Porter, is a widely used approach to
assist managers in developing strategies in many industries (Porter, 1980).
The full reference list will be: Porter, M. (1980). Competitive strategy: techniques for analyzing
industries and competitors. New York: Free Press.
2. Figure.
Figure 1: Fishbone analysis - of an underperforming business
V. DOCUMENTING SOURCES
Primary Sources/Secondary Sources: Primary sources are the original words of a writer - novel,
speech, eyewitness account, letter, autobiography, interview, or results of original research.
Secondary sources are works about the primary sources and about the authors who produce
primary material, i.e. about someone or about someone’s accomplishments.
Terminology
Citing means formally recognizing, within your text, the sources from which you have obtained
information;
Bibliography is the list of sources you have used;
Reference is the detailed description of the source from which you have obtained your information.
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Single author:-
In a study by Seedhouse (1997) coping with illness was investigated ....
In a study (Seedhouse,1997) coping with illness was investigated ....
More than one citation Where more than one citation is used, arrange them by year first, then
alphabetically, and separate authors by semicolons.
(Steven 1975; James 1976; Bookchin 1980; George 1980; Francome and Marks, 1996). OR less
formally: There are indications that passive smoking is potentially threatening to the
health................ (Stevens, 1975; James, 1976; George, 1980; Francome and Marks, 1996)
Several citations by one author: Where several citations are by one author, they are listed together
under the first date. Separate years by commas and authors by semicolons.
(Steven 1975, 1978, 1992; Wood 1995, 1999).
Same author with several citations to same year: Several citations by one author in one year are
listed as a, b, c, and use commas to separate letters and years and semicolons to separate authors.
There is no space between the year and first letter. Ensure that the sequence is correct
(alphabetically) in reference list before adding letter.
(Xing 1995a, b, c)
-A book with two authors: (Marx and Engels, 1970). OR less formally: In the book by Marx and
Engels (1970) .....
-For three or more authors: Use et al. for all citations including the first. (Muchie et al., 1990).
OR less formally: Munchie et al. (1990) conclude that ....
Corporate or group authors: For corporate or group authors, use an acronym or abbreviation.
(UNDP 1992; World Bank 1995)
Citing and page numbers: Where direct quotations or indirect quotations with concrete references
are cited, specific pages must be referred to use either a comma then p. or pp. then the specific
page/pages; or a colon then the specific page/pages
Ex. (Hersh 1975, p. 172–184) or (Hersh 1975: 172- 184)
Citing another author's figure or table: Where a figure or table is cited from another author's
work, and this also applies in text. (Jackson 1999, p.13, fig. 2) or Jackson figure 2 (1999: 13)
*Quotation within someone else’s work (Citing within citing): To cite material not taken from the
original source but obtained through an intermediate source the reference must be made according
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to the reference style being used (see Styles of Citation). Where a quotation is cited within the
citing, the correct way is:
(Marx as quoted by Petras, 1999, p. 32) or (Marx in Petras, 1999: 32)
Please note that whilst many Institutions require page numbers to be included in all in-text
citations after the date, others require only direct quotations to include a page number
otherwise only dates. Please check with your supervisors for the policy in your institution.
a) References are made within the body of your essay to the full details of the work in the reference
list/bibliography in the following manner:
Stevenson (2003, p. 116) argues that …
…concerns about individual viewer responses (Stevenson, 2003, p. 118) …
Whoever is reading your essay can now turn to the reference list/bibliography and look for an entry
by Stevenson written in 2003.
b) When an author, or group of authors, has more than one publication in the same year a lower
case letter is added to the date. For example:
In two recent studies (Harding, 1986a, p. 80; Harding, 1986b, p. 138) it was suggested that ...
In two recent works Harding (1986a, p. 80; 1986b, p. 138) has suggested that ...
d) Organisations as authors
Where you have a document produced by an organisation and the organisation is commonly
referred to by an abbreviation/acronym, in the in-text reference you should write out the name of
the organisation in full the first time and give the abbreviation in square brackets. For example:
...clearly stated policy (Food and Agriculture Organization of the United Nations [FAO], 2005,
p. 24) then subsequent in-text references can just use the abbreviation. For example: ... measures to
improve food supplies (FAO, 2005, p. 36)
In the reference list/bibliography spell out the name of the organisation in full. For example: Food
and Agriculture Organization of the United Nations. (2005). title of doc etc.
e) When a source has no author, cite the first two or three words of the title followed by
the year. For example:
... in the recent book (Encyclopedia of psychology, 1991, p. 62)...... in this article (“Individual
differences,” 1993, p. 12)... – follow this example for web pages where no author is given
The key point is that your in-text reference matches the start of the reference in your
reference list/bibliography. However, if the author is designated as Anonymous, cite the word
‘Anonymous’ in your text.
For example: (Anonymous, 1993, p. 116).
Note: Underline when handwritten or italicize when typed the title of a journal or book and use
double quotation marks around the title of an article or chapter.
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f) When using quotations in your text observe the following examples: He stated, “The relative
importance of the systems may nevertheless remain in approximately the same proportion”
(Gardner, 1973, p. 41)
Smith (1991) found that “...there is no evidence that chimpanzees can produce a drawing and
discern the object represented in it...” (p. 84)
g) If you cite a work that you discovered in another work, follow these examples: -i- Smith (1970,
p. 27) cites Brown (1967) as finding ...; -ii- Brown (1967), cited by Smith (1970, p. 27), found ...; -
iii- It was found (Brown, 1967, cited by Smith, 1970, p. 27) that...
In your reference list/bibliography only list the author whose work you have seen. In these
examples you include Smith, but not Brown, the author whose work you have not seen.
h) Acts of Parliament should be cited in your text with the full title, including year of enactment.
For example: According to section 2 of the Criminal Justice Act 2003...
Format of the Bibliography: The bibliography should begin on a new page following the last
page of your paper (or, if you are using endnotes, following the notes page). For instance, if your
paper itself is a thirty-five and a half pages long, using half of page thirty-six, the bibliography
should begin on page thirty-seven. This page should also be numbered (page 37) just like the rest of
your paper. However, most advisors do not count the bibliography in the required pages but
nonetheless it should be numbered.
Page Format: The title of the page should be centered 3cm from the top of the page. In lengthy
bibliographies, entries are often (but not necessarily) placed in categories according to type or
subject of source, for the convenience of the reader.
Entry Format: All entries should be single-spaced. Entries themselves should be formatted in the
following way: The first line of an entry is set flush with the left margin. The second line (if one
exists) and all subsequent lines are indented one inch from the left margin. The entries are listed in
alphabetical order by author's last name, and are not numbered.
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❖ The APA format requires book and journal titles etc. to be italicized when typed; although in
a handwritten list you can underline instead.
❖ Arrange in year sequence (oldest to most recent) where an author has more than one
publication.
NUMBER OF AUTHORS:
- Single Author of Both a One-Author Work and a Multiple Author Work: When one person
serves as both the sole author of a one-author work and the first author listed on a multiple author
work, list the one-author entry first.
- More Than One Author, but Fewer Than Four: If there is more than one author but fewer than
four, use all the authors' names by listing the first name on the book/article according to the last
name first rule. All others follow in the normal order of first name, space, and last name.
- When There Are More Than Three Authors: When there are more than three authors, it is
IDEAL to list ALL authors in the bibliographic entry, then to refer to it in the notes by using only
the first author's name, followed by “et al.,” --- a Latin term meaning “and others.”
Book with One Author: Hicks, G. (1935) Proletarian Literature in the United States, International
Publishers: New York.
Book with Two or More Authors: Hicks, G., North, J. and Calmer, A. (1935) Proletarian
Literature in the United States, New York: International Publishers. or Not commonly used or
accepted you may use: Hicks, G., et al. (1935) Proletarian Literature in the United States, New
York: International Publishers.
Two or more books by the same author: Arrange alphabetically by the book's title.
Postman, N. (1985). Amusing ourselves to death: Public discourse in the age of show business.
New York: Viking.
Postman, N. (1979). Teaching as a conserving activity. New York: Delacorte Press.
Works by the same author that are published in the same year: Arrange them alphabetically by
title and add a letter after the year as indicated below.
McLuhan, M. (1970a). Culture is our business. New York: McGraw-Hill.
McLuhan, M. (1970b). From cliche to archetype. New York: Viking Press.
Book with only Editor/Translator: Buffington, N., Diogenes, M., and Moneyhun, C. (Eds.) (1997)
Living Languages: Contexts for Reading and Writing, Upper Saddle River, NJ: Prentice Hall.
Book with Editor/Translator in combination with Author (name of ed/trans. after title)
Ortiz, Simon (1997) “The Language We Know.” In Living Languages: Contexts for Reading and
Writing, edited by Nancy Buffington, Marvin Diogenes, and Clyde Moneyhun, 40-47. Upper
Saddle River, NJ: Prentice Hall.
Chapter in a Book: Shiva, V. (1993) “The Greening of the Global Reach,” in Wolfgang Sachs (ed.)
Global Ecology: A New Arena of Political Conflict, London: Zed Books.
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Newspaper article: -Caffeine linked to mental illness. (1991, July 13). New York Times, pp. B13,
B15.
-Young, H. (1996, July 25). Battle of snakes and ladders. The Guardian, p. 15.
Weekly Magazines: Axthelm, P. (1989) “Up Front: America's First Poet Laureate, Robert Penn
Warren, Was a Wise and Eloquent Son of the South,” People Weekly, 2 Oct., p.46.
Monthly Magazines: Lemley, B. (1995) “The Underground Architect,” New Age, Jan.-Feb.
Magazines which Include Volume or Issue Numbers (example: article with no author)
“A Passing Race,” (1989) Canadian Magazine, 71, p.34.
Article in a journal (Academic journal) - for articles retrieved online Academic Journal with
both Volume and Issue Numbers: Name of journals should be written in full and italicized.
Exapmle 1: Mellers, B. A. (2000). Choice and the relative pleasure of consequences. Psychological
Bulletin, 126, 910-924.
Note: List only the volume number if the periodical uses continuous pagination throughout a
particular volume. If each issue begins with page 1, then list the issue number as well.
Exapmle 2: Klimoski, R., and Palmer, S. (1993). The ADA and the hiring process in organizations.
Consulting Psychology Journal: Practice and Research, 45(2), 10-36.
Music- The basic pattern for a piece of music is: Writer, Initials. (Date of copyright). Title of
song etc. On title of album [medium of recording]. Location: Label. (Recording date if different
from copyright date.)
E.g.: Puccini, G. (1990). Nessun dorma. On Carreras Domingo Pavarotti in concert [CD]. London:
Decca.
Films- The basic pattern for a reference to a film is: Name of primary contributor – the director
or producer, or both, Initials. (Role of primary contributor). (year film released). Title of film
[Motion picture]. Country of origin – where the film was primarily made and released: Name of
studio.
E.g.: Spielberg, S. (Director). (1993). Jurassic Park [Motion picture]. United States: Universal
Pictures/Amblin Entertainment.
If the film doesn’t appear on the Library Catalogue, the Internet Movie Database www.imdb.com is
a good place to check all the details needed for a film reference (follow the Company credits link to
find details about the film studio/s involved). Alternatively, check Film and Video Guide at the
appropriate Subject Reference Collection in a city or University Library.
Review of a film: Kinder, M. (2002). Moulin Rouge [Review of the motion picture Moulin Rouge].
Film Quarterly, 55(3), 52–59.
E.g.: Malausa, V. (2001). Beauté du mensonge [Review of the motion picture The Tailor of
Panama]. Cahiers du Cinéma, 558, 82–83.
If the review is untitled, put everything in square brackets e.g. [Review of the motion picture
Moulin Rouge] in the normal title position.http://referencing.port.ac.uk 9
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Television programmes: Collinson-Jones, C. (Producer), & Dobson, E. (Director). (2003, July 14).
Casualties of peace [Television broadcast]. London: Channel 4.
Single episode from a television series: Fraser, R. (Writer), & Geoghegan, S. (Director). (2003).
Eyes wide open [Television series episode]. In P. Goodman (Producer), Holby City. London:
BBC1.
This example shows the most complete information possible for a television episode. If details of
the writer are unavailable, begin your reference with the name of the director.
Radio programmes: Portenier, G. (Producer). (2003, July 17). Crossing continents [Radio
broadcast]. London: BBC Radio 4.
Published Interviews: Bullard, R. (1998) “Dr. Robert Bullard: Some People Don't Have the
Complexion for...” in EMagazine, ed. by Jim Motavelli. July/August, p.10- 13.
Corporate Authors: World Bank (1993) “The East Asian Miracle: Economic Growth and Public
Policy.” New York: Oxford University Press.
Conference Proceedings:
Published conference proceedings with author or editor(s): Banks, S. et al (1998) Networked
Lifelong Learning: innovative approaches to education and training through the Internet:
Proceedings of the 1998 International Conference held at the University of Sheffield. Sheffield,
University of Sheffield.
Paper from published conference proceedings with author or editor(s): Proctor, P. (1998) The
tutorial: combining asynchronous and synchronous learning. In: Banks, S. et al. Networked
Lifelong Learning: innovative approaches to education and training through the Internet:
Proceedings of the 1998 International Conference held at the University of Sheffield. Sheffield,
University of Sheffield. p.3.1 - 3.7.
If no author or editor is given on the title page the name of the conference is cited first either in
italics or underlined.
Unpublished Papers
Xing, L. (1999) “A Critical Analysis of the Market Approach to Modernization”, conference paper
presented at the International Workshop: The Impact of Globalization on China, Russia and
Eastern Europe, organized by the Institute of East European, Russia and Central Asian Studies,
Chinese Academy of Social Sciences in cooperation with Research Center on Development and
International Relations at Aalborg University held on September 28, Beijing, China.
Dissertation: Hardman, J. P. (1999). Rainer Werner Fassbinder’s BRD trilogy: a manifesto for
social and political reform. Unpublished undergraduate dissertation, University of Portsmouth,
Portsmouth.
No author: If a work is signed Anonymous, your reference must begin with the word Anonymous,
followed by date etc. as normal.
If no author is shown, put the title in the normal author position.
Government publications
In broad terms White Papers contain statements of Government policy while Green Papers put
forward proposals for consideration and public discussion. They are cited in the same way.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Government Documents (white paper): (alphabetize by name of largest entity, followed by lesser
entities)
U.S. Federal Energy Regulatory Commission. (1977/78) Annual Report of the U.S.Federal Energy
Regulatory Commission, Washington, D.C., GPO.
An Act of Parliament: Great Britain (1990) National Health Service and Community Care Act
1990. Chapter 19. London, HMSO.
❖ Note on page numbers: Use pp. for page range only for encyclopedia entries, multi-page
newspaper articles and chapters or articles in edited books. For articles in journals or
magazines use the numbers alone separated from the volume/Issue number by a comma.
The followings are the minimum requirements for proper reference usage.
Web documents generally do not have fixed page numbers or any kind of section numbering. For a
document on the Web, the page numbers of a printout should normally not be cited, because the
pagination may vary in different printouts. An exception is PDF files, which appear with the same
pagination on all systems.
When citing in the text, if your source lacks page numbering, you must omit numbers from your
parenthetical references but instead provide the paragraph number. Whenever page numbers are
available on an electronic document, they must be cited otherwise the paragraph number.
The details shown below have been compiled according to the guidelines available on the APA
website (www.apastyle.org) Check this website and the recent edition of The Publication Manual
of the American Psychological Association for further guidance.
The basic pattern for a reference to an electronic source is: Author, Initials. (year when site was
produced or when document was published). Title. Retrieved month day, year, from internet
address. E.g.: Banks, I. (n.d.). The NHS Direct healthcare guide. Retrieved August 29, 2001, from
http://www.healthcareguide.nhsdirect.nhs.uk
If no date is shown on the document, use n.d.; If the author is not given, begin your reference with
the title of the document; If a document is part of a large site such as that for a university or
government department, give the name of the parent organization and the relevant department
before the web address: E.g. 1: Alexander, J., & Tate, M. A. (2001). Evaluating web resources.
Retrieved August 21, 2001, from Widener University, Wolfgram Memorial Library website:
http://www2.widener.edu/Wolfgram-Memorial-Library/webevaluation/webeval.htm
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E.g. 2: Deciding your future. (2000). Retrieved September 5, 2001, from University of Portsmouth,
Careers Service website: http://www.port.ac.uk/departments/careers/plancareer/deciding-your-
future.htm
NB: Never write the web address (URL) in the text of your essay. Use the author of the
website if your reference has one; otherwise use the first few words of the website title.
The following are examples of the Harvard style of web sources, as they would appear in the
bibliography.
Online Book: Use the same format as for a printed book, but add ‘Electronic version’ in square
brackets after the title. E.g.: Bryant, P.J. (1999) “The Age of Mammals” in Biodiversity and
Conservation [Online book] April < http://darwin.bio.uci.edu/~sustain/bio65/index.html> [11 May
1999].
In Text it will be: (Bryant 1998, p32) *Online books will have proper pagination*
Electronic Journal: Use the same reference format as for a printed journal article, but add
‘Electronic version’ in square brackets after the article title. E.g.: Foster, J.B. (2000) “Marx’s
Ecological Value Analysis” in Monthly Review [Online database] 52(4) Available
from:<http://www.umi.com/pqdauto/ > [Accessed 21 October 2001].
In Text it will be: (Foster 2000, p.2) *PDF with pagination* OR (Foster 2000, para.14) *without
pagination*
If you are referencing an online article where the format differs from the printed version or which
includes additional data or commentaries, you should add the date you retrieved the document and
the web address (URL) as in the following example (N.B. May 18 appears in the bracket next to
Wintour, P. because this is a newspaper article):
E.g.: Wintour, P. (2005, May 18). Blair believes his agenda is a moral certainty [Electronic
version]. The Guardian. Retrieved May 18, 2005, from Guardian Unlimited website:
http://politics.guardian.co.uk/queensspeech2005 /story/0,16013,1486296,00.html
Articles retrieved from a database: Use the format appropriate to the type of work retrieved and
add a retrieval date, plus the name of the database (you do not need to give the URL of the
database):
E.g. 1: Shahrani, A. M. (2002). War, factionalism, and the state in Afghanistan, American
Anthropologist,
104(3), 715–722. Retrieved June 16, 2010, from the JSTOR database.
E.g. 2: Traynor, I. (2004, July 13). US in talks over biggest missile defense site in Europe. The
Guardian, p. 2. Retrieved July 19, 2008, from the Nexis UK database.
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Frundi L. Fru, B.Sc., M.Sc. (PhD Candidate) Microbiology, LPN, HRE&GCP-AMANET
Report retrieved from the internet: Harris, J., & Grace, S. (1999). A question of evidence?
Investigating and prosecuting rape in the 1990s (Home Office Research Study 196). Retrieved July
19, 2004, from the UK Home Office website: http://www.homeoffice.gov.uk/rds/pdfs/hors196.pdf
Intranet document: The basic pattern for an intranet document (e.g. education, health or police
documents which cannot be accessed by anyone outside the institution) is: Author, Initials. or
Organisation if no named author. (year, plus month and day if given). Document title
(policy/report/circular number if given). Unpublished intranet document, Organisation (if not listed
first). E.g.: Bonar, I. (2003, October). Library policies and decision making. Unpublished intranet
document, University of Portsmouth.
REFERENCE TEXTS
1. Corlien M. Varkevisser, Indra Pathmanathan, and Ann Brownlee. Designing and conducting
health systems research projects: Volume 1 Proposal development and fieldwork. KIT/IDRC. 2003
2. Degu G, Tessema F. Biostatistics for Health Science Students: lecture note series. The Carter
Center 9EPHTI), Addis Ababa; January 2005.
3. Abramson JH. Survey methods in community medicine. 2nd ed. Eidenburgh: Churchill
Livingstone, 1979.
4. Altman DG. Practical Statistics for Medical Research. London: Chapman and Hall, 1991.
5. Colton T. Statistics in Medicine. Boston: Little, Brown and Company 9INC.), November 19974.
6. Mathers, Nigel; Howe, Amanda; and Hunn Amanda. Trent focus for research and development
in primary health care. Ethical considerations in research. Trent focus, 1998
7. ESTC-EPHA/CDC PROJECT. Training modules on health research. 2004.
8. Department of Community Health ,Jimma Institute of Health Sciences. Manual for student
research project. Jimma, April 1996.
9. Department of Community Health, Gondar College of Medical Sciences. Manual for field
training. Gondar, 1995.
10. Department of Community Health, Faculty of Medicine. Handout for Rural Community Health
Training Programme. January 2002.
11. Fletcher M. Principles and Practice of Epidemiology. Department of Community Health,
Faculty of medicine, Addis Ababa University. August 1992.
12. Getu Degu Tegbar Yigzaw. Research Methodology lecture note series. The Carter Center
9EPHTI), Addis Ababa; January 2006.
13. William M.K. Trochim. Social Research Methods E-Book 2006
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