Research Methods Lecture Note

Dr. Mitiku Bonsa (Ph.D, Assistant professor)

Email: [email protected]

Audiences: undergraduate students (Pharmacy).

Madda Walabu University, Goba Referral Hospital

School of Medicine,
Bale-Goba, Ethiopia.

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 Course Information

• Course Name: Research Methods

• Course code: Phar 4211
• Module Name: Pharmaceutical Research
• Module Code: Phar-M5211
• Course ECTS: 3

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 Course Description
 This course is intended to equip pharmacy students;
 with a basic working knowledge and skills in the proper
conduct of research in pharmacy practice and the
pharmaceutical sciences.
 It also gives the trainee an acquaintance with:
 research proposal writing,
 critical appraisal of scientific paper,
 application of common statistical packages.

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 Course objectives
After completion of this course students will be able to:
– Differentiate the major types of study designs
– Identify the main issues in the design, conduct and presentation
of a research
– Explain the major elements that need to be examined when
making a critical assessment of a research paper.
– Demonstrate how to deal with each of these elements with
reference to a published paper
– Demonstrate a basic understanding of common statistical
packages useful for data processing and analysis
– Explain the major components of research in the pharmaceutical
sciences

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Course Organization

Lecture 1: Introduction To Health Research

Lecture 2: Choosing And Developing Research Title
Lecture 3: Research Proposal Writing
Lecture 4: Epidemiological Study Designs
Lecture 5: Critical Appraisal Of Scientific Papers
Lecture 6: Ethics of Research Involving Human Subjects
Lecture 7: Research Report Writing Protocol

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Mode of Delivery and Evaluation

Mode of delivery Mode of evaluation

• Lecturing • Attendance (5%)

• Reading assignments • In class test (20%)

• Seminar presentation • Individual task(15%)

• Group work (10-20%)

• Discussion
– critical appraisal

– develop thesis proposal.

• Final examination (40%)

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 Lecture 1: Introduction to Health Research

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 Introduction health Research

At the end of this session the students able to:

– Define research.
– Describe categories of research.
– Understand health research triangle.

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 What Is Research?

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10
 Definition of Research….

 Scientific research;

– relies on the application of scientific methods based on scientific

paradigm.
 Improving health care for the future is focus of clinical research.
 Clinical research helps doctors and researchers learn about:
 human health and disease.
 better ways to prevent and treat diseases.

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 Research Process

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 Ultimate Purpose of Research

 Close the gaps in the literature's knowledge.

 Find the answers to the unanswered scientific questions.

 Undertaking high impact research that anticipate the

health issues of tomorrow while overcoming the
challenges of today is crucial.

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 Categories of research

 emphasizes the role of experience

and observation in the
development of clinical knowledge.

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 Brief summary of categories of research

Empirical research Theoretical research

 a way of gaining knowledge • It is research in which the

by means of:
goal is:
 direct & indirect
– to prove/disprove a
observation or experience.
hypothesized truth.
 empirical evidence can be
analyzed quantitatively or
qualitatively.
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Brief summary of categories of research…

Basic (fundamental ) research Applied research

 focuses on finding solutions to
• designed to extend the bases of
immediate health problems.
knowledge in a discipline, for  Necessary to:
the sake of understanding itself. – identify priority problems
– design programs and
• necessary to generate new policies
knowledge and technologies to • that will deliver greatest
health benefits,
deal with major unresolved
• optimal use of available
health problems. resources.

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Brief summary of categories of research…

Explanatory (causal ) research Exploratory research

 explores how and why  investigate health problem

something occurs when limited which is not clearly defined.
information is available.  conducted for better
 explained as a “cause & effect” understanding of research
model, investigating patterns problem,
and trends in existing data not  but will not provide
previously investigated. conclusive results.

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Brief summary of categories of research…

Quantitative research Qualitative research

 the process of collecting and  do not attempt to quantify

analyzing numerical data. results through statistical
 can be used to find patterns, make summary or analysis.
predictions, test causal effect, and  Often the goal is to look for
generalize results. meaning.
 employs statistical techniques.

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 Health Research Triangle

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 Health Research Triangle…..

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 Classification of Health Research

– Biomedical Research
– Clinical Research
– Epidemiological Research Public health
research
– Health System Research

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 Biomedical Research
 Biomedical research:

– Advances in biomedical research as well as technology innovations

offer new hopes and transformative opportunities for improved
healthcare.
– The success of biomedical research in the early 50s of polio
vaccination, antibiotics, antipsychotic drugs, and equally dramatic
success in the applications of:
 Cardiopulmonary bypass,

 Dialysis,

 Organ transplantations.

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 Clinical Research

 Definition of clinical research might appear to be self-

evident;
– however, some researchers have narrowly defined
clinical research to refer to clinical trials (i.e.,
intervention studies in human patients),
– while others have broadly defined it as any research
design that studies humans (patients or subjects) or any
materials taken from humans.

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 Health System Research

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 Health System Research……

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 Lecture 2: Research Topic Selection

 At the end of this session students able to:

– source of research idea.

– steps of topic selection.
– criteria for prioritizing problems for research.

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 Research Topic Selection,,,,,,,

 The ability to develop a good research topic is an

important skill.
 The question of what research to do is not faced by
researchers only.
 Policy-makers and funders;
 have to make decisions on what research to encourage &
support.

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 Steps of Topic Selection

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 Criteria For Prioritizing Problems For
Research

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 Criteria For Prioritizing …

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 Criteria For Prioritizing …

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 Criteria For Prioritizing …

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 Criteria For Prioritizing …

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 Criteria For Prioritizing …

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 Criteria For Prioritizing …

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 Criteria For Prioritizing …

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 Criteria For Prioritizing …

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 Criteria For Prioritizing …

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 the Scales for Rating Research Topics

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 Criteria For Selecting A Research Topic ..

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Criteria For Selecting A Research Topic ..

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 Criteria For Selecting A Research Topic ..
Rating scale: 1-Low, 2-Medium, 3- High
Criteria selecting a research Topic Proposed Topic
Health Health Health
Problem 1 Problem 2 Problem 3
1. Relevance 2 3 3
2. Novelty 1 1 2
3. Feasibility 2 1 3
4. Political acceptability 3 3 3
5. Applicability 1 1 2
6. Urgency of Data Needed 2 1 3
7. Ethical acceptability 2 1 3
8. Interest 2 3 3
Total 15 14 22
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 Lecture 3:Thesis Proposal Development

By the end of this session: you will able to,

 define the research proposal,
 elaborate on the components of a research proposal,
 develop a thesis proposal.
Individual versus group (optional)

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 What Is Research Proposal?

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 Major Components of A Research Proposal

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 I). Formulation of Title of the Study

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 Title of the Study…..

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 II). Summary/Abstract
 The summary;

– speaks for the proposal when it is separated from it.

– provides reader with a first impression of proposed research.
– It should consists: Introduction, objective, methods, budget
 This is called structured format.

– do not put references, figures and/or tables .

– Keep to about 150-300 words with one page.

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 III). Table of Content

 Provides the reader a quick overview of the

major sections of research proposal, with
page references page refer
List of Tables And Figures
 If you have many tables and/or figures it is
helpful to list these with page numbers.

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 IV). List of Abbreviations/Acronyms

 If abbreviations,
 a shortened form of a word used in place of the full word.
 Acronyms,
 a word formed from the first letters of each of the words in a
phrase or name
 these should be stated in full text the first time they are
mentioned
 If many, should be listed in ascending alphabetical order

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1. Introduction section

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 1. Introduction section….

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 1. Introduction …
Introduction

Problem Rationale of Significance of

the study the study
statement

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 1.1. Statement of the Problem

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 Statement of the Problem…

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 Statement of the Problem…

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 1.2. Rationale of the study

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 1.3. Significance of the study

 What expected from this section:

– explaining the potential value of the study findings,

– identifies the target beneficiaries.
– elaborate on how the results will benefit them.
– justification of the ways the study;
• will add to the scholarly knowledge,
• how it improve the practice or policy.

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 Research problem
 A research problem:
– area of concern that needs for further investigation.
 Defining a research problem allows for formulation of;
 research question to be answered,
 research hypothesis to be tested.
 Try to persuade the reader:

– the research question not be answered adequately.

– the answer would contribute to science or society.

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 Research problem …
Example:
– Ideally we expect that all mothers should breastfeed their
infants for full two years or even longer.
– But actually few mothers do. So i.e. there is a discrepancy in
the actual the expected behavior of mothers.
– Therefore, we can say that problem exists.
• This problem raises several questions.

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 2. Research question and Hypothesis

 A research question is:

 a concise question which expresses what the
research project will aims to address.
 the question the researcher wishes to answer
directly through the analysis of data.
 associated with the problem statement.

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 Research Hypothesis

 Research hypotheses;

– a statement of prediction that will be tested by research.

– before formulating your research hypothesis, read about the topic
of interest to you.
– Key feature of all research hypotheses is that they must make
prediction.
 These predictions are tested by gathering,& analyzing data.

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 Research Hypothesis…

 In short, hypotheses are typically phrased as “if-then ”statements.

Example 1,
– a researcher may hypothesize that “if people exercise for 30
minutes per day at least three days per week, then their
cholesterol levels will be reduced.”
 This hypothesis makes a prediction about;

– the effects of exercising on levels of cholesterol,

• the prediction can be tested.

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2. What is Literature reviews (LR)?

 Literature review is the critical description or synthesis of

relevant literature.
– to identify the knowledge gap
• indicating the needs of the present or future
research

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 The purpose of Literature Review

 To show that your research will fill the gap.

 It serves to answer the questions:

• What research has already been done?

• What do you think is missing?
• How has previous research not explained questions that your
study seeks to address?
• Allows you to show that your work is original & innovative.

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How to carry out LR

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 3. A conceptual framework in research

 A conceptual frameworks:

– illustrates the expected relationship between your variables.

– defines the relevant objectives for your research process,

• maps out how they come together to draw coherent

conclusions.
– You should construct your conceptual framework before you begin
collecting your data.
– often represented in a visual format and illustrate cause-and-effect
relationships.
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 3. A conceptual framework in research…

Distal Distal independent

independent variable (B)
variable (A)

Outcome variable
(E)
Distal Distal
independent independent
variable (C) variable (D)

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 3. Formulation of Research Objectives
Research objectives;

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Formulation Research Objectives….

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How should objectives be stated?

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 4. Research Methods and Materials

 Method

– the specific tools used to gather and analyzing data, such as

questionnaires and open ended interviews we use;
• to gain fuller understanding of phenomena.

– What methods to use for a research project will depend on the design of
that project and the researcher’s theoretical mindset.
 Methodology: the grand architectural design of the entire project.

• Failure to appreciate the differences between these two terms may result in
the researcher placing undue emphasis on the tools used.

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 4. Research Methods & Material….

 It should contain sufficient detail for readers to

replicate the work done & obtain similar results.
 This provides a description of the exact
(specific) actions, plan, or strategy to be
used to answer the research questions.

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 Methods…………

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Methods…..

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 4.1. Study Area And Period

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 4.2. Clinical Study Designs
Criteria to Select Study Design

 Selection of a design is dependent on multiple situations including:

 Availability of data,
 Nature of exposure and outcome under study,

 Character of the target population,

 Research hypothesis,

 Ethical issues,

 Duration of the natural history of a disease,

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4.2. Study Design…

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 4.2. Study Designs…

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 4.3. Population under instigation

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 4.4. Eligibility Criteria
 Inclusion and exclusion criteria determine which members of the
target population can or can’t participate in a research study.
 Collectively, they’re known as eligibility criteria, and establishing
them is critical when seeking study participants for clinical trials.

 Failure to properly define inclusion and exclusion criteria can

undermine your confidence that causal relationships exist between
treatment and control groups, affecting the internal validity and
external validity of your findings.

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 4.4. Eligibility Criteria
 Inclusion criteria:

– comprise the characteristics or attributes that prospective research

participants must have in order to be included in the study.

Example:
 You are running a clinical trial for a new treatment for individuals with
chronic heart failure. The following inclusion criteria apply:
– 18 to 80 years of age

– diagnosis of chronic heart failure at least 6 months before trial

– on stable doses of heart failure therapies

– willing to return for required follow-up (posttest) visits

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 4.4. Eligibility Criteria….
 Exclusion criteria:

– comprise characteristics used to identify potential research participants

who should not be included in a study.

Example:
 In the clinical trial for individuals with chronic heart failure, the

following exclusion criteria apply:

– The patient requires valve or other cardiac surgery

– The patient had a stroke within three months prior to enrollment

– The patient refuses to give informed consent

– The patient is a candidate for coronary bypass surgery

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 4.5. Study Variables
• variables are any characteristics that can take on different values.
• Researchers often manipulate or measure independent and dependent
variables in studies to test cause-and-effect relationships.

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 4.5. Study Variables

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Dependent Versus Independent Variables

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 Discussion Questions
Identify which variables are dependent and independent:

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 4.6. Operational Definition

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 Operational Definition….

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 Operational Definition….

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 4.7. Sample size calculation

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 Sample Size:
required for estimating proportions

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 Sample Size:
required for estimating proportions..

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 Sample Size:
required for estimating proportions..

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 Specific formula: case-control design

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 Sample size estimation for:
Cohort and RCT study design

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 Specific Formula:
Cohort and Intervention study design

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4. 8. Sampling techniques and procedure

 Definition of sampling:
• Procedure by which some members of the
population are selected as representatives.

• A sample is a collection of individuals selected from

a larger population.

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4. 8. Sampling techniques and procedure…

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 Sampling techniques and procedure….

• Basic conditions:
– the sample must be representative.
– the sample must be sufficiently large:
• minimizes sampling variation.
– there must be adequate coverage of the sample:
• information should be obtained form almost all:
high response rate.

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 Why sampling?

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 Errors in Sampling

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 Major Sampling Techniques

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 A). Non-probability Sampling

Non-probability sampling:
– every item has unknown chance of being selected.
– fast, easy and inexpensive way of obtaining data.
– used when it is practically impossible to use
probability sampling strategies.

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 Non-probability Sampling….
 The most common types of non-probability sampling:

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 1. Convenience Sampling

 Sometimes called haphazard or accidental sampling.

 For convenience,

 the study units that are available are selected.

 The sample is not representative; because sample units

are only selected if they can be accessed easily conveniently.

 Many clinic-based studies.

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 2. Quota Sampling

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 3. Purposive Sampling

 Purposive sampling;

 also known as judgment, selective or subjective sampling.

 non-randomized technique that selects sampling units based on

certain criteria.
 participants are chosen “on purpose,” not randomly.

 people who are assumed to provide rich information are selected

 used in qualitative research.

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 4. Snowball Sampling
 Snowball Sampling:

 some times called chain referral (network).

 people who are enrolled in the study are asked to name others;
 using their networks and contacts.
 useful for identifying hard-to-find individuals;
 example: those with illegal behavior, homeless.

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 B). Probability Sampling

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 1. Simple Random Sampling (SRS)

 Involves random selection

– Each member of a population has an equal chance.

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 Simple Random Sampling: Assumptions

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 Simple Random Sampling…

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2. Systematic Sampling: interval sampling
 Systematic sampling;

– we chooses elements from a target population by selecting a

random starting point and selecting sample members after a fixed
‘sampling interval.’
– we calculate the sampling interval by dividing the entire
population size by the desired sample size determination.
– Then, each group member is selected regularly to form a sample.

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 2. Systematic Sampling….

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 2. Systematic Sampling….

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 Systematic Sampling…

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 Example:
Systematic Random Sampling….

 Out of a total of 600 patients waiting, we want to randomly select 60

of them which there is no frame(list) before.
1. List population from 1 to 600
2. Get the fraction k= 600/60=10
3. Select a random number between 1 and 10 using lottery
method: e.g.. 8
4. Then, the first individual to be included in the sample will be 8 th
patient

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 3. Stratified Random Sampling

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 Stratified Random Sampling…

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 Stratified Random Sampling…

• Method of allocating sample size from each stratum:

a) Proportional allocation
• For method of sampling that involves the division of a population
into smaller subgroups known as strata.

a) Non proportional allocation (equal allocation )

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 Stratified Random Sampling…

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 Stratified Random Sampling…

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 4. Cluster Sampling

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 4. Cluster Sampling…

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 Steps In Cluster Sampling

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 Steps In Cluster Sampling…

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 5. Multi-stage Sampling
 Multi-stage sampling:
 divides the population into groups (or clusters).
 first, clusters are randomly selected and,
 second, sample units within the selected clusters randomly
selected.
 Similar to the cluster sampling, except that it involves
picking a sample from within each chosen cluster, rather
than including all units in the cluster.
 This type of sampling requires at least two stages.

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 Multi-stage Sampling….

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 Multi-stage Sampling

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 Multi-stage Sampling…

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 Multi-stage Sampling….

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 4.7. Data Collection tools & techniques

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 Data Collection Techniques and Tools..

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 Data Quality Control Measures…

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 Pretesting

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 4.9. Data Management And Analysis

Data
manag
ement

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 Data Management & Analysis…

 Data analysis:
Attention to:
1. Linear
– Identification of staff regression
needed.
2. Binary logistic regression
3. Ordinary
– Identification of analysis logistic
tasks to beregression
completed: (descriptive,
4. Multinomial logistic regression
inferential test).

– Analytic model and outcome measures will be used

– Model fitness, and multicollinearity issues

– Identification of statistical software to be used.

– Work plan for analysis of data.

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 Data Management & Analysis…

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 Bias
• Bias is a systematic distortion of a result due to a factor not
allowed for in the design of the study.
• For example,
• if the investigator, when studying the incidence of upper
respiratory tract infections (URI) in doctors and ancillary
staff in a hospital, failed to take into account their smoking
histories. It is likely that there would be a significant
difference in this regard between the two groups.
• Therefore, it becomes impossible to distinguish the effects
of occupation from the effects of smoking on the incidence
of URI.

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 4.10. Ethical Consideration

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 4.11. Plan For Dissemination of Findings

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 5. Work plan:

 Work plan is a schedule, chart or graph that

summarizes the different components of a research
proposal
 Ways of presenting a work plan
 Work schedule
 GANNT chart
 PERT chart.

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 The GANTT chart

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 The GANTT chart….

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 6. Cost of the Project (Budgeting)

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 How should a budget be prepared?.

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 Budget…..

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 Budget….. Direct

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 Budget…..

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 7. Reference Writing
Methods of citations in preparing literature review:
A) Vancouver system
– This system have been adopted as standard by over 300
biomedical journals
– For an article the following information should be noted:
Author(s)’ Surname followed by initials. Title of article.
Name of Journal. Year, Volume(number): page numbers of
article.
– Example: Louria DB. Emerging & re-emerging infections: The
societal variables. International Journal of Infectious Disease.
1996, 1(2):59-62.

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 7. Reference Writing
B) the Harvard System:
– In other journals & books it is common to put the year, between
brackets, straight after the name of the author(s).
– This is called the Harvard system.
• Name of the author(s) (year). Title. Place of Publication:
Publisher
Ex- Abramson JH (1990), 4th ed. Survey methods in
community medicine. Edinburgh: Churchill Livingstone.
• There are more systems in use for referencing to literature.
• Always carefully look what system is used in the journal
you are submitting an article to and follow it systematically.

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 Referencing – Why Is It So Important?

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