Research Methodology

Medical Affairs, Getz Pharma

August 13, 2025

Main Presenter

Prof. Awosan Kehinde Joseph (MBBS, MPH, FWACP)

Professor of Public Health and Community Medicine / Consultant Physician
Department of Community Health / Community Medicine,
Usmanu Danfodiyo University / Teaching Hospital, Sokoto, Nigeria
[Link]@[Link]
Co-Presenters

Shafqat S. KHANZADA Muhammad Hammad

Assistant Manager Clinical Research Clinical Research Services Associate
[Link]., (Biostatistics) Pharm. D, [Link]., [Link]. (Healthcare
M.B.A. (Business Management)
Management)
Learning objectives
By the end of this session, participants will be able to:
❑ Clearly define key concepts such as research, research methodology,
research methods, research design, and study designs.

❑ Describe the steps involved in the research process, from problem

identification to interpretation of results, and communicating the research
findings.

❑ Identify common study designs, outlining their steps, strengths, weaknesses,

and applications.

❑ Interpret the hierarchy of scientific evidence and its relevance in guiding

study design and evidence appraisal.

❑ Recognize potential biases in observational and experimental studies and

discuss strategies to minimize them.
Research
❑ Research is a systematic inquiry into a specific topic or
question to obtain new knowledge, expand existing
knowledge, or confirm and refine previous findings.

❑ Research is a rigorous and disciplined process involving

collecting, analyzing, and interpreting data to answer
specific questions or solve particular problems.
Research Methodology

6
 Research Methodology
❑ Research methodology refers to the overall approach and
framework used to guide the research process.

❑ It encompasses the following:

o Philosophical Underpinnings (Ontological
and Epistemological). Key Focus Areas:
▪ Why a particular method was
o Research Approach (Quantitative, Qualitative, chosen (i.e., the rationale)
and Mixed).
▪ How the research is conducted
o Research Design (Includes the Study Area, rigorously and systematically (to
ensure that the findings are valid
Study Design, Study Population, Sample Size and reliable)
Estimation, Sampling Techniques, Research
Methods (including Method and Instrument of ▪ The theoretical foundation behind
Data Collection, and Data Analysis Techniques), and the research approach
Reporting and Communicating Research Findings.
7
(Awosan, 2023)
Research Methods

❑ Research methods refer to the specific

techniques, tools, and procedures used to
Key Focus Areas:
collect and analyze data in a research study.
▪ What specific method was
❑ These are the practical steps taken to carry used
out the research. ▪ How data was collected
and analyzed
❑ These methods can include surveys,
interviews, focus group discussions,
observations, etc.

(Awosan, 2023) 8
Research Methodology Vs. Methods
❑ The key differences between research
methodology and research methods are
shown in Table 1.

❑ To sum up, research methodology is

the framework and rationale that
guides a study, while research methods
are the specific techniques, tools, and
procedures used to gather and
interpret data.

❑ Both are essential and interconnected, with the

9
methodology informing the choice of methods. (Awosan, 2023)
Research Design
❑ Research design is the overall plan or strategy Key Focus Areas:
that outlines the entire research process. It ▪ What type of study will be
provides a framework for conducting the study conducted, and when and
where it will take place
and achieving the research objectives.
▪ Who or what will be studied,
❑ It involves decisions about the type of research, the and whether variables will be
sampling strategy, data collection methods, and data controlled or manipulated
analysis, interpretation, and presentation. ▪ How participants will be
selected, and how data will be
❑ Designing and documenting research as a Research collected and analyzed
Proposal is one of the steps in the Research Process.

(Awosan, 2023) 10
Need For Research Design:

❑ Research design is needed because it

facilitates the smooth navigation of
various research operations, thereby
making research as efficient as possible
and ensuring the greatest amount of
information is obtained with minimal
Source: [Link]
expenditure of effort, time, and money.

11
The Research Process
❑ The research process is a dynamic and systematic
journey that transforms a curious inquiry into a
structured and meaningful exploration.

❑ It is a carefully orchestrated sequence of steps

designed to gather, analyze, and interpret data to
generate new knowledge or address specific
questions.

❑ Understanding the intricacies of this process is

Source: [Link]
essential for conducting rigorous and impactful
research.
12
(Awosan, 2023)
The Research Process contd.
❑ Research involves a structured and systematic
approach that typically follows seven key steps:

Step 1: Defining the research question and

drafting a suitable title for the study
Step 2: Conducting a literature review
Step 3: Designing the study and drafting
the research proposal
Step 4: Data collection
Step 5: Data analysis
Step 6: Concluding and interpreting
findings
Step 7: Documenting and communicating Figure 1: Steps in conducting research
13
the research Source: Awosan (2023)
The Research Process Contd.
Step 1: Defining the Research Question
❑ A research question is the question a study sets to
answer.

❑ The foundation of any research endeavour lies in

formulating a clear and focused research question
or hypothesis.

❑ The research process begins with a well-defined

research question.

❑ This question serves as the guiding star, directing

the focus of the entire study. (Awosan, 2023)
The Research Process Contd.
Step 1: Defining the Research Question contd.
❑ The qualities and importance of well-defined research questions include:

Qualities Importance
o Clarity o Provides Clarity and Focus
o Specificity o Aids in Hypothesis Formulation
o Measurability o Guides Methodological Choices
o Feasibility o Facilitates Literature Review
o Relevance o Shapes the Research Design
o Inherent Interest and Significance o Guides Data Analysis and Interpretation

(Awosan, 2023)
The Research Process Contd.
Step 1: Defining the Research Question contd.
❑ The tasks involved in crafting well-defined research questions include:
o Identifying the research topic o Prioritizing and Refining Questions
o Identifying the Research Problem o Ensuring Alignment with Research
Paradigm
o Specifying the Research Objectives
o Collaborating and seeking feedback
o Formulating the Research Questions
The Research Process Contd.
Step 1: Defining the Research Question contd.
❑ Task A: Identifying the Research Topic
o A research topic is a broad subject or area of interest that the
researcher wants to explore. For example, “Internet use”.

❑ Task B: Identifying the Research Problem

o A research problem is a specific, focused, and articulated statement that
identifies the issue or gap in knowledge that the researcher intends to
investigate. It stems from the broader research topic. For example,
“Internet Addiction among undergraduate students”.
o The sources of research problems include:
o Literature Review o Interdisciplinary Perspectives
o Interviewing Practitioners o Deductions from Theory
o Observations and Experiences
(Awosan, 2023)
The Research Process Contd.
Step 1: Defining the Research Question contd.
❑ Task C: Specifying the Research Objectives
o State the study's objectives in plain terms. The aim of the study
should be specified. These well-defined objectives lay the foundation
for developing research questions that support the study’s goals.

❑ Task D: Formulating the Research Question

❑ The inquiries a research study aims to address are research
questions. Create a list of possible research questions by holding a
brainstorming session.
❑ Several criteria/frameworks have been developed for formulating
clear and specific research questions.

(Awosan, 2023)
The Research Process Contd.
Step 1: Defining the Research Question contd.
❑ Task D: Formulating the Research Question contd.
❑ In clinical research, the FINER criteria in compliance with the PICOT
framework are instrumental in preparing clear and specific research questions.
 Feasible (F)  Ethical (E)
Adequate number of subjects? Potential harm to subjects?
Adequate technical expertise? Potential breech of subject
Affordable in time and money? confidentiality?
Is it possible to measure or manipulate the  Relevant (R)
variables? To scientific
 Interesting (I) knowledge/theory?
To the investigator? To organizational, health or
social management and policy?
 Novel (N)
To individual welfare?
To the field?
The Research Process Contd.
Step 1: Defining the Research Question contd.
❑ Task D: Formulating the Research Question contd.
❑ In clinical research, the FINER criteria in compliance with the PICOT framework
are instrumental in preparing clear and specific research questions contd.
 Population (P)  Outcome (O)
Specific group of interest? Measurable changes or
Clear inclusion and exclusion criteria? effects?
 Intervention (I) Primary and secondary
outcomes specified?
Specific treatment, procedure, or exposure?
Clearly defined parameters?
 Time (T)
Duration of intervention or
 Comparison (C) follow-up?
Alternative intervention, placebo, or no Time frame for measuring
intervention? outcome?
Clearly distinguished from intervention?
The Research Process Contd.
Step 1: Defining the Research Question contd.
❑ Task E: Prioritizing and Refining Questions
❑ Evaluate and prioritize the potential questions based on their relevance,
specificity, and feasibility. Refine the questions to ensure they align with
the characteristics of clear and specific research questions.

❑ Task F: Ensuring Alignment with Research Paradigm

❑ Ensure the research questions align with the methodological and
philosophical presumptions of the selected research paradigm. The
alignment will make the study more coherent.

❑ Task G: Collaborating and Seeking Feedback

❑ Share your research questions with peers, mentors, or coworkers for
comments before finalizing them.
(Awosan, 2023)
 The Research Process Contd.
Step 2: Conducting a Thorough Literature Review
❑ This step involves exploring relevant studies, articles, and scholarly works that
pertain to the research question, and organizing it in a Key Findings Matrix.

❑ Conducting a thorough literature review helps

situate the research within the broader context,
identify gaps in the current body of knowledge,
and understand relevant theories and
methodologies.

Source: [Link]
❑ Search for relevant articles in the Electronic Databases using strings of
keywords (formed with Boolean operators), Medical Science Headings (MESH)
Source: Awosan (2023) vocabularies, etc. You can also use a reference manager (e.g., EndNote)
 The Research Process Contd.
Step 2: Conducting a Thorough Literature Review contd.
▪ Google Scholar
o Discipline covered: Multidisciplinary; covers a wide range of academic
disciplines.
o Access option: Generally free, but some full-text articles may require a
subscription or purchase.
o Provider: Google
o Link: [Link]

Source: Awosan (2023)

The Research Process Contd.
Step 2: Conducting a Thorough Literature Review contd.
▪ PubMED
o Discipline covered: Biomedical and life sciences, including
medicine, nursing, dentistry, and related fields.
o Access option: Free access to a significant portion of the database.
o Provider: National Library of Medicine.
o Link: [Link]
 The Research Process Contd.
Step 3: Designing the Study and Drafting the Research Proposal
❑ This phase involves selecting appropriate research methods, data collection
techniques, and sampling strategies. The research design outlines how data will
be collected and analyzed.

❑ It encompasses decisions regarding the

research approach (quantitative, qualitative, or
mixed methods), sampling strategies, data
collection methods, and data analysis
techniques.

❑ The research design must align with the research question and objectives.
A well-designed study is crucial for generating reliable and valid results.
Source: Awosan (2023)
 The Research Process Contd.
Step 3: Designing the Study and Drafting the Research Proposal contd.
❑ There are 2 sections in a research proposal, namely, the preliminary
section and the body of the proposal.

❑ The Preliminary Section: The format essentially depends on the

institution concerned. The format of the preliminary section of a
Postgraduate Medical College is shown below:
o Title of research, Name and address of o Certification page (by the
candidate, College involved, and Degree supervisors);
in view o Approval by the Head of
Department;
o Name, address and qualifications of
supervisors; o Table of Contents;
o List of Abbreviations; and
o Declaration page (by the candidate);
o Abstract or Summary
Source: Awosan (2023)
 The Research Process Contd.
Step 3: Designing the Study and Drafting the Research Proposal contd.
❑ The Body of the Proposal: The format essentially depends on the
institution concerned. The format of the body of the proposal of a
Postgraduate Medical College is shown below:
o Chapter One: Introduction
The sections in this chapter often include:
▪ 1.1 Background Information ▪ 1.6 Research Hypothesis
▪ 1.2 Problem Statement ➢ 1.6.1 Null hypothesis
▪ 1.3 Justification of the Study ➢ 1.6.2 Alternative hypothesis
▪ 1.4 Research Questions ▪ 1.7 Scope of the Study
▪ 1.5 General and Specific ➢ 1.7.1 Geographical scope
Objectives ➢ 1.7.2 Conceptual scope
➢ 1.5.1 General Objective ➢ 1.7.3 Temporal scope
➢ 1.5.2 Specific objectives
▪ 1.8 Definition of Terms
Source: Awosan (2023)
 The Research Process Contd.
Step 3: Designing the Study and Drafting the Research Proposal contd.
❑ The Body of the Proposal contd.: The format of the body of the
proposal of a Postgraduate Medical College is shown below contd.:
o Chapter Two: Literature Review
The sections in this chapter often include:
▪ 2.1 Introduction or Overview ▪ 2.4 Conceptual Framework
▪ 2.2 Theoretical Framework ▪ 2.5 Gaps in the Literature
▪ 2.3 Empirical Review
➢ 2.3.1 Prevalence of Excessive
Internet Use
➢ 2.3.2 Factors Associated with
Excessive Internet Use
➢ 2.3.3 Adverse Effects of Excessive
Internet Use

Source: Awosan (2023)

 The Research Process Contd.
Step 3: Designing the Study and Drafting the Research Proposal contd.
❑ The Body of the Proposal contd.: The format of the body of the
proposal of a Postgraduate Medical College is shown below contd.:
o Chapter Three: Materials and Methods
The sections in this chapter often include:
▪ 3.1 Study Area ▪ 3.7 Personnel and Pretesting
▪ 3.2 Study Design ▪ 3.8 Data Collection
▪ 3.3 Study Population ▪ 3.9 Data Management
➢ 3.3.1 Inclusion criteria ▪ 3.9.1 Measurement of Research Variables
➢ 3.3.2 Exclusion criteria ▪ 3.9.1 Data Cleaning, Test of Normality, and
Statistical Analysis
▪ 3.4 Sample Size Determination
▪ 3.10 Ethical Consideration
▪ 3.5 Sampling Technique
▪ 3.6 Data Collection Method and ▪ 3.11 Anticipated Limitations
Instrument (including Validity and ▪ 3.12 Budget
Reliability of Data Collection Instrument)
Source: Awosan (2023) ▪ 3.13 Timeline (Gantt chart)
o References o Appendices
 The Research Process Contd.
Step 4: Data Collection
❑ This step involves gathering relevant data using chosen methods, ranging from
surveys and experiments to interviews, observations, or analysis of existing
datasets. A mobile phone-based (i.e., electronic) data collection using the
Open Data Kit (ODK) is preferred to a paper-based data collection.

❑ Rigorous attention to detail is crucial to ensure that data is accurate, reliable,

and relevant to the research objectives.

Source: Awosan (2023)

 The Research Process Contd.
Step 5: Data Analysis
❑ Once the data is gathered, it undergoes a systematic process of analysis. The
choice of analysis method depends on the research question, study design,
and type of data collected.

❑ Quantitative research involves statistical

analysis to identify patterns, correlations, and
significant findings. Qualitative research
involves coding, categorizing, and interpreting
textual or visual data.
Source: [Link]

❑ Both approaches aim to derive meaningful insights from the collected

information.
Source: Awosan (2023)
 The Research Process Contd.
Step 6: Concluding and Interpreting Findings
❑ This stage involves presenting the results of the study and concluding based on
the analysis.

❑ The results and conclusions should be presented clearly and should be based on
the research question and the research hypothesis.

Source: Awosan (2023)

 The Research Process Contd.
Step 7: Documenting and Communicating Research
❑ This stage involves presenting the research findings in a written report, journal
article, or conference presentation.

❑ The reporting should be clear, concise, and should follow the guidelines of the
relevant academic or professional community.

Source: Awosan (2023)

Study Design

❑ Study design refers to the specific plan or blueprint for a particular research
investigation within the broader research design. It is a focused set of decisions
about how a specific study will be conducted.

❑ Whereas research design focuses on the overall research

process and framework (e.g., observational design and
experimental design); study design focuses on the specific
details and procedures of an individual study (e.g., cross-
sectional study design, case-control study design, and
randomized controlled trial (RCT) design).

❑ Study design is an important aspect of research methodology, as it

determines the types of data that will be collected, the sampling methods,
and the statistical analyses that will be performed.
34
(Awosan, 2023)
 Research Using Primary Data
❑ These studies utilize primary data.
o They include:
• Observational studies (in which
the researchers observe without
intervening). They can be
descriptive or analytical.

• Experimental studies (in which the

researchers assign or manipulate
the exposure/intervention).

Figure 2: Study designs 35

Source: Awosan (2023)
 Research Using Primary Data contd.

❑ Descriptive Observational studies:

o Descriptive observational studies aim to
describe disease distribution by person,
place and time.
o The types include:
➢ Case Report
➢ Case Series
➢ Cross-sectional Study
➢ Longitudinal Study (Panel, Trend, and Cohort)
➢ Ecological Study
36
Source: Awosan (2023)
 Research Using Primary Data contd.
❑ Analytical Observational studies:
o Analytical observational studies aim to test
hypotheses and investigate associations or
causes.
o The types include:
➢ Comparative Cross-sectional Study
➢ Case-Control Study
➢ Cohort Study (Prospective, Historical
and Ambidirectional)
➢ Nested Case-Control Study
➢ Case-Cohort Study
37
Source: Awosan (2023)
 Research Using Primary Data contd.
❑ Experimental Studies:
o Experimental studies establish cause and effect
relationship between an exposure/intervention
and an outcome. They are analytical by default.
o The types include:
➢ Pre-Experimental Designs (One-Shot Case Study
design, One-Group Pretest-Posttest Design, Static
Group Comparison Design)

➢ True-Experimental Designs (Randomized Control

Trials [RCTs], Clinical Trials, Field [or Community-Based]
Trials)

➢ Quasi-Experimental Designs (Non-equivalent

Control Group Design; One-Group Posttest Only
Design, Interrupted Time –Series Design) Source: Awosan (2023) 38
 Research Using Primary Data contd.
❑ Validation Studies:
o These evaluate tools, measures, or instruments
used in health research.
o They include:
• Instrument Validation Studies: The tests
done include:
➢ Validity (Construct, Content, Criterion, etc.)
➢ Reliability (Test-Retest, Interrater, etc.)

• Diagnostic Accuracy Studies: The designs

include:
➢ Single Gate Design
➢ Two-Gate Design
➢ Two-Arm Randomized Design 39
Source: Awosan (2023)
 Descriptive Observational Studies
❑ Case Reports
o A Case Report is a detailed report of the
diagnosis, treatment, response to treatment,
and follow-up after treatment of an individual
patient.
o Steps in Conducting a Case Report
➢ Step 1: Case Selection ➢ Step 4: Discussion with Experts

➢ Step 2: Data Collection ➢ Step 5: Write a Structured Report

Case reports are structured according to the
➢ Step 3: Literature Review CARE (CAse REports) Guidelines. It is
available at:
[Link]
(Awosan, 2023) 40
 Descriptive Observational Studies contd.
❑ Case Reports contd.
Strengths Limitations
o Novel Discoveries o Lack of Generalizability
o Hypothesis Generation o No Control Group
o Improving Patient Care o Potential for Bias

Applications
o Medical and Educational Learning o Patient Safety and Drug Monitoring
o Early Identification of New Syndromes
or Diseases

(Awosan, 2023) 41
 Descriptive Observational Studies contd.
❑ Case Series
o A case series is a descriptive study that tracks
patients with a known condition or treatment over
time. It involves a group of individuals, often with
the same disease or undergoing the same
treatment.

o Steps in Conducting a Case Series

➢ Step 1: Case Selection ➢ Step 4: Literature Review
➢ Step 2: Data Collection ➢ Step 5: Write a Structured Case
➢ Step 3: Data Analysis Series Description
Case reports are structured according to the
CARE (CAse REports) Guidelines. It is
available at:
(Awosan, 2023) [Link] 42
 Descriptive Observational Studies contd.
❑ Case Series contd.

Strengths Limitations
o Detailed Exploration of Rare o Limited Generalizability
Conditions
o No Control Group
o Early Identification of Treatment
o Confounding Factors
Efficacy or Adverse Effects
o Educational Value
Applications
o Documenting Rare Diseases o Highlighting Uncommon
o Identifying Disease Progression and Complications
Variability
(Awosan, 2023) 43
 Descriptive Observational Studies contd.
❑ Cross-sectional Studies
o Cross-sectional studies examine data from a
population at a single point in time. They measure
both the exposure and outcome simultaneously. A
representative sample of the population is selected,
and data on both exposure (e.g., risk factors) and
outcome (e.g., health status) are collected.

o Steps in Conducting a Cross-sectional Study

➢ Step 1: Define the Research ➢ Step 5: Data Collection
Question
➢ Step 6: Data Analysis and Interpretation
➢ Step 2: Identify the Population
➢ Step 7: Write a Structured Report
➢ Step 3: Select the Sample The STROBE (STrengthening the Reporting of
OBservational Studies in Epidemiology) Guidelines provide
➢ Step 4: Develop or Select Data a checklist for reporting observational studies. It is available
Collection Instrument at: [Link]
44
(Awosan, 2023)
 Descriptive Observational Studies contd.
❑ Cross-sectional Studies contd.

Strengths Limitations
o Quick and Cost-Effective o Cannot Establish Causality
o Prevalence Estimation o Potential for Bias
o Hypothesis Generation o Confounding Variables

Applications
o Public Health Research o Health Services Research
o Healthcare Planning

(Awosan, 2023) 45
 Analytical Observational Studies
❑ Comparative Cross-sectional Studies
o Comparative cross-sectional studies are a type of
observational study that compares two or more
groups at a single point in time. They are used to
explore differences between these groups in terms
of specific characteristics, behaviors, or outcomes.
Population A Population B

o Steps in Conducting a Comparative Cross-sectional Study

➢ Step 1: Define the Research ➢ Step 5: Data Collection
Question and Hypothesis
➢ Step 6: Data Analysis and Interpretation
➢ Step 2: Define the Study Population
and Comparison Groups ➢ Step 7: Write a Structured Report
The STROBE (STrengthening the Reporting of
➢ Step 3: Select the Samples OBservational Studies in Epidemiology) Guidelines provide
a checklist for reporting observational studies. It is available
➢ Step 4: Develop or Select Data at: [Link]
Collection Instruments 46
(Awosan, 2023)
 Analytical Descriptive Observational Studies contd.
❑ Comparative Cross-sectional Studies contd.

Strengths Limitations
o Quick and Cost-Effective o No Temporal Relationship
o Useful for Describing Prevalence o Risk of Confounding
o Good for Hypothesis Generation o Selection Bias

Applications
o Public Health Research o Social Science and Behavioral
o Health Disparities Research Research

(Awosan, 2023)
47
 Analytical Observational Studies contd.
❑ Case-control Studies
o Case-control studies compare individuals with a specific outcome (cases) to those
without the outcome (controls) to identify potential risk factors. Retrospective data
is collected on exposures and risk factors, and the two groups are compared to
identify differences.

Figure 3: Case-Control Study 48

Source: Awosan (2023)
 Analytical Observational Studies contd.
❑ Case-control Studies contd.
o Steps in Conducting a Case-Control Study
➢ Step 1: Define the Research Question ➢ Step 5: Measurement of Exposure
➢ Step 6: Analysis and Interpretation
➢ Step 2: Selection of Cases
of Data
➢ Step 3: Selection of Controls ▪ Compute the Odds Ratio (OR)
OR =1 The exposure is not related to the disease

➢ Step 4: Matching OR > 1 The exposure is positively related to the disease

▪ Individual (Pair) Matching OR < 1 The exposure is negatively related to the disease

▪ Frequency (Group) Matching ➢ Step 7: Write a Structured Report

▪ Caliper (Distance) Matching The STROBE (STrengthening the Reporting
of OBservational Studies in Epidemiology)
Guidelines provide a checklist for reporting
observational studies. It is available at:
(Awosan, 2023) [Link] 49
 Analytical Descriptive Observational Studies contd.
❑ Case-control Studies contd.

Strengths Limitations
o Efficient for Rare Diseases o Recall Bias
o Cost-Effective and Time-Efficient o Difficulties in Matching Controls
o Good for Outbreak Investigations o Not Ideal for Studying Rare Exposures

Applications
o Epidemiological Research o Public Health Investigations
o Genetic and Environmental
Risk Factors
(Awosan, 2023)
50
 Analytical Observational Studies contd.
❑ Prospectively Cohort Studies
o Cohort studies are a type of observational study design in which a group of individuals
(cohort) who share a common characteristic or exposure is followed over time to assess the
incidence of outcomes (e.g., diseases, behaviors). Depending on when the data is collected
relative to the outcome, cohort studies can be prospective (Figure 4), retrospective (or
historical), or ambidirectional.

Figure 4: Prospective Cohort Study 51

Source: Awosan (2023)
 Analytical Observational Studies contd.
❑ Prospective Cohort Studies contd.
o Steps in Conducting a Prospective Cohort Study
➢ Step 1: Formulate the Research ➢ Step 6: Analysis and Interpretation
Question of Data
▪ Compute the Relative Risk (RR)
➢ Step 2: Selection the Study Population RR =1 The exposure is not related to the disease

RR > 1 The exposure is positively related to the disease

➢ Step 3: Define Exposure and Outcome RR < 1 The exposure is negatively related to the disease

➢ Step 4: Divide the Cohort Based on

➢ Step 7: Write a Structured Report
the Exposure Status The STROBE (STrengthening the Reporting
of OBservational Studies in Epidemiology)
➢ Step 5: Follow up Guidelines provide a checklist for reporting
observational studies. It is available at:
[Link]
(Awosan, 2023) 52
 Analytical Descriptive Observational Studies contd.
❑ Prospective Cohort Studies contd.

Strengths Limitations
o Ability to Establish Temporality o Expensive and Time-Consuming
o Direct Measurement of Incidence o Loss to Follow-Up
o Good for Studying Rare Exposures o Inefficient for Studying Rare Diseases

Applications
o Risk Factor Identification o Evaluation of Interventions
o Prognostic Studies

(Awosan, 2023)
53
 Analytical Observational Studies contd.
❑ Historical Cohort Studies
o Historical cohort studies (also known as retrospective cohort studies) are a type of
observational study in which data is collected from past records to identify individuals who
were exposed and those who were not. These individuals are then followed forward in time
based on historical data up to the present time to assess the occurrence of outcomes
(Figure 5)

Figure 5: Historical Cohort Study 54

Source: Awosan (2023)
 Analytical Observational Studies contd.
❑ Historical Cohort Studies contd.
o Steps in Conducting a Historical Cohort Study
➢ Step 1: Formulate the Research ➢ Step 6: Establish Follow-Up Period
Question ➢ Analysis and Interpretation of
➢ Step 2: Identify and Access Historical Data
▪ Compute the Relative Risk (RR)
Data Sources
RR =1 The exposure is not related to the disease

➢ Step 3: Define the Study Population RR > 1 The exposure is positively related to the disease

RR < 1 The exposure is negatively related to the disease

➢ Step 4: Measure Exposure

➢ Step 7: Write a Structured Report
The STROBE (STrengthening the Reporting
➢ Step 5: Determine Outcome
of OBservational Studies in Epidemiology)
Guidelines provide a checklist for reporting
observational studies. It is available at:
(Awosan, 2023) [Link] 55
 Analytical Descriptive Observational Studies contd.
❑ Historical Cohort Studies contd.

Strengths Limitations
o Efficiency o Incomplete or Inaccurate Data
o Use of Existing Data o Selection bias
o Multiple Outcomes can be Studied o Confounding

Applications
o Public Health Research o Occupational and
o Pharmacoepidemiology Environmental Epidemiology

(Awosan, 2023)
56
 Experimental Studies
❑ Randomized Controlled Trials
o Randomized Controlled Trials (RCTs) are the gold standard for testing
interventions' efficacy and effectiveness.

o To conduct an RCT, researchers typically define inclusion and exclusion

criteria, randomly assign participants to the treatment or control group, and
then monitor and collect data on outcomes of interest over a specified
period of time.

o The study is often conducted in a double-blind manner, meaning that

neither the participants nor the researchers who interact with them know
which group they are in, to further minimize bias.

o RCTs are classified into several subtypes based on the design and the aim of
conducting them. 57
 Experimental Studies contd.
❑ Randomized Controlled Trials (RCT)s contd.
The types of randomized controlled trials include:
▪ Parallel RCT Designs: ▪ Cluster Randomized Controlled Trial
• Two-Group Randomized Subjects Design: In which entire groups or clusters are
Pretest-Posttest Design randomized rather than individuals.
• Two-Group Randomized Subjects
Posttest-Only Design ▪ Clinical Trials: In which the safety, efficacy, or
• The Solomon Four Group Design effectiveness of a new intervention is compared
with a gold standard. The sub-types in Phase 3 of
▪ Cross-Over Designs: the trial include:
• Planned Cross-Over Design • Superiority RCT Design
• Unplanned Cross-Over Design • Non-Inferiority RCT Design
• Equivalence RCT Design
▪ Factorial Designs:
▪ Field Trials (or Community Based
The 2x2 Factorial Design
•
Trials): In which the effectiveness of an
• The 3x3 Factorial Design intervention is evaluated under natural conditions
58
• The 2x2x2 Factorial design (Awosan, 2023) (i.e., in real-world settings).
 Experimental Studies contd.
❑ Randomized Controlled Trials (RCT)s contd.
o Steps in Conducting a Randomized Controlled Trial
➢ Step 1: Define the Research Question ➢ Step 7: Administration of the
Intervention
➢ Step 2: Design the Study Protocol
➢ Step 8: Monitoring and Follow Up
➢ Step 3: Obtain an ethical approval
➢ Step 9: Data Collection (Post-Intervention)
➢ Step 4: Recruitment of Participants ➢ Step 10: Data Analysis and
➢ Step 5: Randomization Interpretation
▪ Simple Randomization ▪ Intention-To-Treat (ITT) Analysis
▪ Block Randomization ▪ Per-Protocol (PP) Analysis
▪ Stratified Randomization
➢ Step 11: Write a Structured Report
➢ Step 6: Blinding (if applicable) The CONSORT (CONsolidated Standards Of
Reporting Trials) 2010 Checklist provides a
▪ Single Blinding framework for reporting parallel group randomized
▪ Double Blinding trials. It is available at: [Link]
▪ Triple Blinding (Awosan, 2023) [Link]/reporting-guidelines/consort/ 59
 Experimental Studies contd.
❑ Randomized Controlled Trials (RCT)s contd.
▪ Types of Blinding
 Experimental Studies contd.
❑ Randomized Controlled Trials (RCT)s contd.
▪ Types of Blinding contd.
 Experimental Studies contd.
❑ Randomized Controlled Trials (RCT)s contd.
▪ Types of Blinding contd.
TRIPLE BLIND STUDY
 Experimental Studies contd.
❑ Randomized Controlled Trials (RCT)s contd.

Strengths Limitations
o Minimization of Bias o Expensive and Time-Consuming
o Establishment of Causality o Complexity of Design
o Standardization of Interventions o Ethical Constraints

Applications
o Clinical Research o Evaluation of Interventions
o Public Health Interventions
(Awosan, 2023)
63
 Experimental Studies contd.
❑ Quasi-Experimental Studies
o The term quasi- (pronounced kwahz-eye) means almost, near, partial,
pseudo, or somewhat. Quasi-experiments are similar to true
experiments in that they involve an intervention, but they lack random
assignment.
o These studies are particularly useful when random assignment is not
feasible due to ethical, logistical, or practical constraints.
o They are based on the same structure as experimental designs but lacks
randomization, control, or both. The common types include:
• Non-equivalent Control Group Design • One Group Pretest-Posttest
• Two Group Non-randomized Pretest- Design
Posttest Design • One Group Posttest Only Design
• Two Group Non-randomized Posttest • Interrupted Time Series Design
Only design
64
(Awosan, 2023)
 Experimental Studies contd.
❑ Quasi-Experimental Studies contd.
o Steps in Conducting a Quasi-Experimental Study
➢ Step 1: Define the Research Question ➢ Step 6: Implement the Intervention

➢ Step 2: Design the Study and Draft the ➢ Step 7: Collect Post-Intervention Data
Proposal
➢ Step 8: Data Analysis and Interpretation
➢ Step 3: Obtain an ethical approval
➢ Step 9: Write a Structures Report
➢ Step 4: Recruitment of Participants
The STROBE (Strengthening the Reporting of
Observational Studies in Epidemiology) Checklist. Available
➢ Step 5: Establish Baseline Data at: [Link] and, TREND
(Transparent Reporting of Evaluations with
Nonrandomized Designs) Statement Checklist. Available at:
[Link]
ent_trend_checklist.pdf), are used in reporting quasi-
experimental studies, particularly those that do not involve
clinical trials.
(Awosan, 2023) 65
 Experimental Studies contd.
❑ Quasi-Experimental Studies contd.

Strengths Limitations
o Practicality o Selection Bias
o Applicability o Weaker Causal Inference
o Useful for Program Evaluation o Complex Analysis

Applications
o Public Health and Epidemiology o Behavioral and Psychological
o Social Sciences Research

(Awosan, 2023)
66
 Diagnostic Accuracy Studies
❑ Single Gate Design (or Single Cohort Design)
o A single-gate design involves selecting a single cohort of ▪ Plot the ROC Curve
participants from a defined population without prior knowledge of
their disease status. All participants then undergo both the
screening test and the reference (gold standard) test.
o The screening test results are then compared to the gold standard to
▪ Plot the Coordinates of
determine the test’s diagnostic accuracy indices, such as sensitivity, the ROC Curve
specificity, positive predictive value (PPV), negative predictive value
(NPV), etc.

❑ Steps in Conducting a Single Gate Design

➢ Step 1: Select the Study Participants
➢ Step 2: Perform the Screening Test
➢ Step 3: Perform the Gold Standard Test
➢ Step 4: Construct a 2 x 2 Table and Compute the
Diagnostic Accuracy Indices
▪ Compute the following:
- Sensitivity - Negative Predictive Value
- Specificity - Diagnostic Accuracy 67
- Positive Predictive Value Source: Awosan (2023)
 Diagnostic Accuracy Studies contd.

❑ Single Gate Design (or Single Cohort Design) contd.

Strengths Limitations
o Minimizes Selection Bias o Expensive and Time-consuming
o More Representative of Real- o Not Suitable for Rare Diseases
World Screening Scenarios
o Potential Verification Bias
o Reduces Spectrum Bias

Applications
o Screening Test Evaluation o Public Health Research
o Diagnostic Accuracy Studies

(Awosan, 2023)
68
 Hierarchy of Scientific Evidence
❑ The hierarchy of evidence is a ranked
framework that organizes study Secondary
designs according to their strength in Studies
minimizing bias and producing reliable
results.

❑ Importance of Hierarchy of Evidence

o It helps clinicians and researchers Primary
prioritize stronger evidence for decision- Studies
making.
o It guides evidence-based guidelines (e.g.,
WHO and CDC recommendations).
o It prevents reliance on anecdotal or biased
information.
 Bias in Observational Studies
❑ Bias in research is a systematic error in the design, conduct, analysis, or reporting of a study
that results in incorrect or misleading conclusions by consistently distorting the true
relationship between variables. The types of bias in observational studies include:

S/N Type of Bias Key Subtypes S/N Type of Bias

1 Selection Bias - Sampling bias 3 Confounding
- Non-response bias 4 Observer Bias
- Attrition bias (Loss to follow-up) 5 Lead-Time Bias
- Healthy worker effect
6 Length-Time Bias
- Berkson’s bias
7 Immortal-Time Bias
2 Information - Recall bias
(Measurement) 9 Publication Bias
- Interviewer bias
Bias - Misclassification bias (Differential and
Non-differential) Observational studies are more
prone to selection bias, recall bias,
- Surveillance (detection) bias
and confounding, because
- Reporting bias exposure assignment is not
controlled.
(Awosan, 2023; Porta, 2014)
 Bias in Experimental Studies
❑ The types of bias in experimental studies include:
S/N Type of Bias
S/N Type of Bias Key Subtypes
5 Additional Biases Specific to
1 Selection Bias - Inadequate randomization Experimental Studies
- Allocation concealment bias
i Hawthorne effect
2 Performance - Lack of blinding (participants) ii Contamination
Bias - Lack of blinding (researchers)
iii Co-intervention bias

3 Detection Bias - Outcome assessor bias iv Compliance bias

- Instrument bias v Placebo effect / Nocebo
effect
4 Reporting Bias - Selective outcome reporting
Experimental studies are more prone to
- Spin bias allocation-related bias, performance bias, and
- Publication bias blinding issues due to intervention management.

❑ Both observational and experimental studies share vulnerabilities like attrition bias,
interviewer bias, detection bias, and reporting bias. Good design, rigorous data collection,
and transparent reporting help minimize these biases.
 Conclusion

❑ In conclusion, research is a systematic effort to investigate a problem,

guided by clear questions and objectives. Research methodology outlines
the strategy, research methods are the tools, and research design is the
blueprint for their use. The research process, from problem identification
to data analysis, ensures credible findings, with primary data collection
remaining vital for original insights.

❑ Knowing the strengths, weaknesses, and place of common study designs

in the evidence hierarchy helps in choosing reliable approaches, while
awareness of biases in observational and experimental studies prevents
distortion. Ultimately, sound methodology is the key to producing valid,
high-quality evidence that advances knowledge and practice.
 References

Awosan, K.J. (2023). Essentials of Research Methodology for Students and

Professionals. Somerest Ventures. Retrieved from:
[Link] [Last accessed 2025 August 9].

Porta, M. (Ed.). (2014). A dictionary of epidemiology (6th ed.). Oxford

University Press. Retrieved from:
[Link]
%D8%B9%D8%A7%D9%85%D8%A9/Miquel-Porta-A-Dictionary-of-
[Link] [Last accessed 2025
August 9].

The references for the sources cited in this presentation are

provided above. You may access either the preview or the full
version through the accompanying link for further exploration.
Brainstorming

74
Brainstorming…

❑ Which study design involves following a group of individuals over a

period of time to identify potential risk factors and outcomes?

o a) Cross-sectional study

o b) Case-control study

o c) Cohort study

o d) Randomized controlled trial

Answer: c) Cohort study

75
Brainstorming…

❑ Which study design is an observational study that compares individuals

with a particular condition or disease (cases) to individuals without the
condition or disease (controls) to identify potential risk factors?

o a) Cross-sectional study

o b) Case-control study

o c) Cohort study

o d) Randomized controlled trial

Answer: b) Case-control study

76
Brainstorming…

❑ Which study design randomly assigns participants to a treatment group

or a control group to test the efficacy of a particular intervention?

o a) Cross-sectional study

o b) Case-control study

o c) Cohort study

o d) Randomized controlled trial

Answer: d) Randomized controlled trial

77
Brainstorming…

❑ Which study design is a study that includes some elements of an RCT, but
lacks full randomization or blinding?

o a) Cross-sectional study

o b) Case-control study

o c) Cohort study

o d) Quasi-experimental study

Answer: d) Quasi-experimental study

78
Brainstorming…

❑ Which of the following is a term used to describe when participants are

unaware of which intervention they are receiving in a research study?

o a) Blinding

o b) Masking

o c) Randomization

o d) Double blinding

Answer: a) Blinding
Brainstorming…

❑ In a randomized controlled trial, which of the following is an advantage of

blinding?

o a) It reduces bias in the allocation of treatments

o b) It allows the researchers to manipulate the variables more easily

o c) It eliminates the need for a control group

o d) It increases the generalizability of the study

Answer: a) It reduces bias in the allocation of treatments

 Brainstorming…

❑ Which of the following is an example of single blinding in a clinical trial?

o a) The participants do not know which treatment they are receiving

o b) The researchers do not know which treatment each participant is receiving

o c) Both the participants and the researchers do not know which treatment is
being given

o d) None of the above

Answer: a) The participants do not know which treatment they are

receiving
Brainstorming…
❑ Which of the following is an example of double blinding in a clinical trial?

o a) The participants do not know which treatment they are receiving, but the
researchers do

o b) The researchers do not know which treatment each participant is receiving,

but the participants do

o c) Both the participants and the researchers do not know which treatment is
being given

o d) None of the above

Answer: Both the participants and the researchers do not know which
treatment is being given
Brainstorming…

❑ In which of the following types of studies is blinding applicable?

o a) Cross-sectional studies

o b) Cohort studies

o c) Case-control studies

o d) Randomized controlled trials

Answer: d) Randomized controlled trials

Brainstorming…

❑ Which of the following is a disadvantage of blinding in a research study?

o a) It can be difficult to implement in some studies

o b) It can increase the risk of bias in the allocation of treatments

o c) It can reduce the generalizability of the study

o d) It can decrease the power of the study

Answer: a) It can be difficult to implement in some studies

 Guidelines Related to Clinical and
Applied Research Recommended by
ICMJE
 Reporting Guidelines For Main
Study Types

Study Type Acronym Description

Systematic Review & Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
PRISMA
Meta-Analyses The PRISMA checklist consists of 27 items
Consolidated Standards of Reporting Trials
Randomized Trials CONSORT
The CONSORT Statement comprises a 25-item checklist
Observational Studies STROBE Strengthening the Reporting of Observational Studies in Epidemiology
The STROBE checklist consists of 22 items
Diagnostic Accuracy STARD Standards for the Reporting of Diagnostic Accuracy Studies
Study The STROBE checklist consists of 30 items.
Case Reports CARE CAse REport
The CARE checklist consists of 13 items.
Animal Pre-Clinical ARRIVE Animal Research: Reporting of In Vivo Experiments
Research The ARRIVE checklist consists of 10 items.
Statistical methods and SAMPL Statistical Analyses and Methods in the Published Literature
analyses
Clinical Research Services Offering

Clinical Research Services SIGMA Workshop Modules

❖ Data analysis ❖ Synopsis Writing

❖ Sample size calculation ❖ Literature Search
❖ Synopsis Technical Review ❖ Research Methodology
❖ Manuscript Technical Review ❖ SPSS hands-on
❖ Paper writing & Publication ❖ Medical Paper Writing

For further details email us at: sigma@[Link]

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 Appendix: Supplementary Materials
Section A Books: Available at [Link]

Section B Videos:Available at [Link]

96