05/09/2019

Introduction to Research
Methodology
Public Health and Primary Care Unit
UWI-STA

At end of the session

• Define what 'Health Research' is

• Outline importance of research
• Recognise the benefits to students
• Describe the main steps of conducting a health research.
• Prioritise problems for research

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Research Defined

• A course of critical inquiry leading to the discovery of fact or

information which increases our understanding of human health
and disease

• A scientific inquiry aimed at learning new facts, testing ideas, etc.

• The systematic collection, analysis and interpretation of data to

generate new knowledge and answer a certain question or solve
a problem.

Importance to medicine and public health

• Knowledge obtained from sound research is transformed into clinical

practice, leading to medical practice that is evidence-based.

• Cornerstone for informed and effective decision-making

• Integral to efforts to improve the health of the population

• Integral to the effectiveness of health systems

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Benefits to Medical Students

• Promoting health research in general

• Preparation for postgraduate research involvement

• Enhances skills in
• Searching and critically appraising medical literature
• Apply evidence-base decisions to clinical situations

• Independent continued learning.

• Writing research papers – getting published

Prioritizing Problems

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Criteria for prioritizing problems for research

• Relevance
• How large/widespread is the problem? Who is affected? How severe is the
problem?
• Avoid Duplication
• Has the topic been researched? If yes, are there major questions that need
further investigation?
• Political acceptability
• Is it of interest to (supported by) the government/authorities?
• Facilitates smooth conduct of the research; increases the chance that the
results of the study will be implemented.

prioritizing problems cont’d

• Applicability of possible results and recommendations

• Urgency of data
• How urgently are results needed for decision making?
• Prioritise research – which to be done first and which later?

• Ethical acceptability
• Will we be inflicting harm on others?

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Scale for Rating Research Topics

Relevance Political acceptability
1 = Not relevant
1= Topic not acceptable
2 = Relevant
2 = Topic somewhat acceptable
3 = Very relevant
3 = Topic fully acceptable
Avoidance of duplication
Applicability
1 = Sufficient information already available
1 = No chance of recommendations being implemented
2 = Some information available but major issues not
covered 2 = Some chance of recommendations being implemented
3 = No sound information available on which to base 3 = Good chance of recommendations being implemented
problem-solving
Urgency
Feasibility
1 = Information not urgently needed
1 = Study not feasible considering available resources
2 = Information could be used but a delay of some months
2 = Study feasible considering available resources
would be acceptable
3 = Study very feasible considering available resource
3 = Data very urgently needed for decision-making

Scale for Rating Research Topics CONT’D

Ethical acceptability
1 = Major ethical problems
2 = Minor ethical problems
3= No ethical problems

Rating should be based on existing data NOT on mere assumptions.

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The Process Outline

The Protocol

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Basics of the Protocol

1. Title
2. Abstract
3. Introduction
• Statement of the research problem
• Significance of the proposed work
4. Objective of the study (Research Questions)
5. Methods (and Materials)
• Type of study (study design)
• Study population
• Type of data (defining each variable to collected)

Basics of the protocol cont’d

Methods and Material cont’d

• Inclusion/ exclusion criteria

• Sampling procedure to be used and sample size and power calculation.

• Data collection and management

• Data analysis

• Ethical considerations
• Pretest or pilot study:

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Basics of the protocol cont’d

6. Work plan (project management)

• Personnel, training
• Schedule (timetable)- provide actual dates for each activity
- Pilot phase
- Final study
• Onset/start, data collection, analysis, write-up
• Relevant facilities
• Cooperating organizations
7. Plan for utilization and dissemination of research results
8. Budget
9. References
10.Appendices

1.Title of Research

A good title should be short, accurate, and concise.

It should make the central objectives of the study clear

to the reader.

Important to specify what population will be

investigated, and where it will be conducted.

E.g. Face masks in the protection of healthcare workers

in resource poor settings of Kouvah

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2. Introduction

• Background information and Problem Statement

Convince the reader of the relevance of the study (magnitude,

severity of the problem).

Provide enough background data for reader to understand the

different aspects of the problem and the context in which it
occurs.

Review of available literature and reports to further illustrate

why the problem is important

The Problem Statement

• Gives basis for development of research proposal

(research objectives, methodology, work plan, etc)

• Allows easier identification of relevant studies/reports to guide

your own study design

• Should outline why proposed research on the problem should be

undertaken and what will be achieved with the study results.

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Literature Review

• Become acquainted with the relevant literature

• Prevents duplication; allows refinement of ‘problem statement’
• Increases familiarity with different research methods
• Sources
• PubMed, Medline, Cochrane
• Books, journals
Institutions, experts,
• Annual reports, guidelines
• Conferences

4. Objectives (of the Study)

• Should be closely related to ‘problem statement’

• A general objective can be split/broken smaller and connected
specific objectives.
• General objectives : aim of the study in general terms
• E.g. To assess low EPI coverage in Kouvah
• Specific objectives: measurable statements related to the
research problem situation.
• E.g. To establish the reasons for the lack of immunization among children at
the health services in Kouvah.

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SMART Objectives

• Research objectives must be: S-M-A-R-T

• Specific
• Measurable
• Attainable
• Relevant
• Time-bound

Purpose of Objectives

• To focus the study

• To avoid collection of unnecessary data
• To organize the study in clearly defined parts or phases
• Properly formulated, specific and SMART objectives facilitates
development of the research methodology and will help to
orient the collection, analysis, interpretation and utilization of
data.
• Action terms for Objectives
• To determine; to compare; - to verify
• To calculate; to describe; to establish

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Research Question

Problem researchable if
1. There should be a perceived difference or discrepancy between
what it is and what it should be;

2. The reason(s) for this difference should be unclear (so that it

makes sense to develop a research question);

3. There should be more than one possible and plausible answer to

the question (or solution to the problem).

Research Question e.g.

Situation: Kouvah has 2 health centers, 1 hospital all of which functions smoothly.
However, at the end of the 2016 it was detected that the immunization coverage
was only 40%.

Discrepancy: Even with good (100%) access to health services, 60% of the Kouvah
child population were not receiving their full vaccinations (PI coverage was 40%)
Research question: What factors influence the low vaccination coverage among
children in Kouvah?
Possible answers: Mothers might have problems attending EPI sessions; MCH, MOE
and EPI programmes might not be integrated resulting on children having missed
opportunities for immunization; Follow up of defaulting children might not be
effective and other reasons.
• The above problem situation is researchable

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FEASIBLE

INTERESTING
Criteria for
Developing NOVEL
Research Question
ETHICAL

RELEVANT
Nothing FINER than a good research question

Good research question?

• Feasible • Ethical
• Subjects • Social or scientific value
• Resources • Safe
• Manageable
• Data available? • Relevant
• Advance scientific knowledge?
• Interesting
• Influence clinical practice?
• Novel • Impact health policy?
• In relation to previous findings
• Guide future research?
• Confirm or refute?
• New setting, new population

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A Research Question Must Identify

1. The variables under study

2. The population being studied

5. Research Methods

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Study Design

• The guide researchers use to collect, analyze and

interpret observations; a logical model
• Observational (non-intervention) studies
• researcher observes and analyses situations but does not
intervene
• Intervention studies
• researcher manipulates the situation and measure the outcome
of the manipulations

• Two primary arms: Descriptive and Analytical

Types of Studies

• Descriptive studies
• describe occurrence of outcome

• Analytic studies
• describe association between exposure and outcome

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Descriptive Analytic

Case report Cohort study

RCT

Case series Case-Control

study
Descriptive
Epidemiology Case-Crossover
study

Cross-sectional
study

Before-After
study

Ecologic study

Hypothesis formation

Descriptive
Case reports Case series
epidemiology
Study Design FLOW

Analytic Animal Lab

epidemiology study study
Clinical
trials Hypothesis testing

Cohort Case- Cross-

control sectional
Source: Dr Songer, PittEdu

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Descriptive Studies Develop hypothesis

Investigate it’s
Case-control Studies relationship to outcomes

Define it’s
Cohort Studies meaning with exposures

Test the link

Clinical trials experimentally

Descriptive Studies

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A Case report

• Description of one interesting and unusual clinical case

• This is anecdotal and may form the basis for further study
• Hypothesis generating

• Good way to report on something very rare

• e.g. previous undescribed disease
• e.g. unexpected link between diseases

Case series

• Description of several cases in which no attempt is made to answer

specific hypotheses or compare results with another group of cases.
• illustrate a new finding,
• emphasize a clinical principle, or
• generate new hypotheses

• E.g. experience of a group of patients with a similar diagnosis

• Cases may be identified from a single or multiple sources

• Cannot study cause and effect relationships

• Cannot assess disease frequency

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Case Report One case of

Unusual/rare findings

Case Series Multiple cases of

findings
Descriptive
Population-based
Epidemiology Study cases with denominator

Analytical Studies

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Analytical Studies

Experimental Studies Observational Studies

• Randomized controlled • Group data

clinical trials • Ecologic

• Community trials • Individual data

• Cross-sectional
• Cohort
• Case-control
• Case-crossover

Cross sectional study

Survey of the frequency of disease, risk factors or other

characteristics in a defined population at one particular point in
time.

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Cohort study

• An observational study of a group of people with a specific

characteristic or disease who are followed over a period of time to
detect change (Retrospective or Prospective)

Case-control study

• Observational study where characteristics of people with a disease

(cases) are compared with selected people without the disease
(controls)

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Controlled Trials

• Experimental study in which an intervention is applied to one

group and the outcome compared with that in a similar group
(controls) not receiving the intervention

Study Population and sample

• The study population should be clearly identified

• Study sample
• must be representative
• large enough size to ensure sufficient power
• Variables
• Identify the variables that will be involved
• Four types of variable are important in research:
• Independent (predisposing/risk factors),
• Dependent (outcome/condition/disease),
• Confounding, and Background variables.
• Specify whether variables are:
• Numerical (continuous/discrete), or
• Categorical (ordinal/nominal).

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Study Population and sample

Inclusion criteria
• Those characteristics that subjects being recruited must have to
be included in the study

Exclusion criteria
• Those characteristics that should disqualify subjects from being
included in the study.

7. Dissemination Plan for research results

• Outline how research findings will be disseminated

Consider
Progress reports
Final report
Publications
Seminars, workshops, and conferences
Discussion with policymakers and program managers

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9. References

• References in your text should be numbered in the

sequence in which they appear I
• Different referencing styles exist e.g. Vancouver system

10. Annexes

These may include:

• Interview schedule/ questionnaires (and/or other data collection tools)
• Informed consent form
• Institutional/Ethical approval for the study

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Tips for your Protocol

The Protocol

• Write out introduction and methodology in detail

• Give it to people to read to check for major flaws

• Get help at this stage

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The study

• Assign roles
• Projected time to completion
• Get ethical approval
• Get all equipment before start
• Accurate testing and measurements
• Stick to your protocol
• Stick to your sample size and sampling plan

Authorship

• Should be directly involved at the every stage

• Idea stage
• Protocol development
• Actual performance of the study
• Interpretation of results
• Writing up

• All authors must take full responsibility for the study

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EXTRA MATERIAL

• NOTE BELOW WAS NOT COVERED IN THE LECTURE BUT PROVIDED

IF STUDENTS CONSIDER QUALITATIVE STUDIES

Overview of Qualitative Research

Methodologies

• Qualitative Research
• Ethnography, Case Study, Grounded Theory, Participatory
Action Research, Phenomenology (each grounded in a specific
discipline and philosophical assumptions)
• Researchers study things in their natural settings
• attempt to make sense of (or interpret) some phenomenon

• Looks at the meanings people bring to whats under observation

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Research Questions

• State research questions, not objectives (i.e. specific goals for the
research) or hypotheses (i.e. predictions that involve variables and
statistical tests).

• Example: How do students use use PBL as a study tools?

Characteristics of Qualitative Research

• Takes place in the natural setting

• Uses multiple methods that are interpretive

• Fundamentally interpretive (role of researcher as interpreter)

• Researcher views social phenomena holistically

• Researcher systematically reflects on who he or she is in the inquiry and

is sensitive to his or her personal biography and how it shapes the study

• Researcher uses complex reasoning that is multifaceted, iterative, and

simultaneous

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Research Methods

• Interviews
• Focusgroups
• Participant observation (field notes)
• Video
• Text and Image analysis (documents, media data)

Data Analysis

• Organize and prepare the data for analysis

• Read all data, get a sense of the whole

• Begin detailed analysis with coding process

• Generate a description of the setting/people as well as categories

or themes for analysis

• Represent themes (writing, visual, etc.)

• Interpret and make meaning out of data

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