Basic Concepts of Research

and
Research Proposal

Elfatih M. Malik (MBBS, MD, FPH-UK)

Associate Professor
Fellow at Faculty of Medicine, UofK
Work for
a research career
not
a research project!
 Learning objectives
By the end of this workshop, the learner should be
able to:
1. Explain the need for research
2. Define the steps to conduct a research
3. Explain the components of research proposal
4. Select research topic and question/s
5. Search the literature, and write sound review
6. Avoid plagiarism
7. Cite and write references using software (Mendeley)
8. Write introduction, hypothesis and objectives
 On what basis people base their knowledge in day-to-day?

 Beliefs (intuition)  Systematic

observation
 Consensus
 Valid
 Authority's opinion explanations

 Casual observation
 Consistently
 Subjective applied logic
 Informal logics
 Unverifiable sources Scientific
methods
 Susceptible to errors
 What is research?

• Systematic collection, analysis and interpretation

of data to generate new knowledge and answer
a certain question or solve a problem …

• Research is an organized and systematic way of

finding answers to questions ….

• A scientific way of answering questions and

testing hypothesis …
Principles of scientific methods (research)
 Testable
The hypothesis can be supported or contradicted by observations
 Replicable
The hypothesis can be tested repeatedly
 Objective
The hypothesis can be tested independently by others
 Transparent
The hypothesis and results can be publicly shared so they can be
tested by anyone
 Falsifiable
Finding contradictory evidence is a possibility
 Logically consistent
The hypothesis is internally consistent and the conclusion to support or
reject it, is logically sound
 Types of research
• Basic research:
– Generate new knowledge and technologies
• Applied research (Health system research):
– Identify priority problems and to design and evaluate
policies and programs

• Quantitative:
– Objective observations and measurements
– How often or how many people behave in a certain way?
• Qualitative:
– Developing explanations of social phenomena
– Why and How people behave in a certain way?
Fundamental questions about research

• What it’s made of?

– The study protocol (Research proposal)
– The goal is to make the project feasible, efficient,
and cost-effective

• How it works?
– Valid inferences about:
• What happened in the study sample ? (internal validity)
• How these study findings generalize to general population
(external validity)
– The goal is to minimize the errors that threaten
conclusions
 Main components of a research

• Preparing a research proposal

Publication proposal
• Collecting data
– Fieldwork, desk analysis…

• Analysing data Reporting collection

• Submitting a research report Analysis

and

• Manuscript for publication

The Research Proposal (protocol)
• The written plan of the study

• The “blue print” of the study

• Why proposal?
– Proposals help the investigator organize the
research in a logical, focused, and efficient
way
– Proposals are devices for seeking grant funds
 Elements of the Study Proposal
1. What questions will 2. Why are these 3. How is the study
the study address? questions important? structured?

Background
Research
and Design
questions
significance

4. Who are the subjects and 5. What measurements will 6. How large is the study and
how will they be selected? be made? how will it be analysed?

Subjects
Statistical
and Variables
issues
sampling
1. The research question
• The objective of the study

• The uncertainty the investigator wants to resolve

• Started as general and narrowed down to a

concrete, researchable issue

• Good question should pass the “so what test”

• FINER criteria: feasible, interesting, novel, ethical,

and relevant
Characteristics of a Good Research Question

Adequate number of subjects

Adequate technical expertise
Feasible
Affordable in time and money
Manageable in scope
Getting the answer intrigues the
Interesting investigator and friends
FINER

Confirms, contradicts or extends

Novel previous findings
Provides new findings

Amenable to a study that IRB will

Ethical approve

To scientific knowledge
Relevant To clinical and health policy
To future research
13
“A question well-stated is a
question half-answered”
How to develop and assess your research question/s?
PICOT criteria (Riva et al, 2012)

P Population (patients) What specific population/ patients

you are interested in?
I Intervention (for What is your intervention?
intervention studies only)
C Comparison group What is the main alternative to
compare with the intervention?
O Outcome of interest What do you intend to accomplish,
measure, improve or affect?
T Time What is the appropriate follow-up
time to assess outcome?
Examples of research question
• Should people eat more vegetables?
– How often do Sudanese eat vegetables?
– Does eating vegetables lower the risk of
cancer?
– Is there a risk of insecticide toxicity from
increasing vegetables intake in older adults?
• ……
• ……
 Questions sometimes raised by WHO,
TDR, CDC, Governments ….
Operational research on the frontline to fight antimicrobial resistance
1. Is over-prescription of antibiotics happening in my
hospital?

2. How well are my clinicians adhering to treatment

guidelines for infections?

3. Are there gaps in infection prevention and control at

health facilities under my supervision?

17
 2. The background and significance
Issues to be addressed? Researcher:
• Cites previous relevant researches
• What is known about • Indicates the problems with the prior
the topic at hand? research
• States uncertainties remain
• Specifies how the findings will help
• What is not known resolve these uncertainties
about the topic? • Indicates how findings will lead to new
scientific knowledge and
• States how findings will influence
• Why is the research guidelines or public health policy.
question important?

Often, work on the background and significance section may lead to modifications
in the research question…
 3. The design
• Descriptive/ observational/ experimental

• Which design?
– Research question
– Level of evidence
– Feasibility

• Typical sequences for studying a topic:

– Descriptive studies: explore the lay of the land
– Analytical studies: evaluate associations
– Experimental studies: establish the effects of an intervention
Typical sequences for studying a topic
• Descriptive:
– What is the average number of servings of fish per
week in the diet of Americans with a history of CHD?

• Analytical:
– Is there an association between fish intake and risk of
recurrent myocardial infarction in people with a history
of CHD?

• Experimental:
– Does treatment with fish oil capsules reduce total
mortality in people with CHD?
 4. Study Subjects

• State your study population

• Decide about:
– What are your inclusion and exclusion criteria?
– How to recruit enough subjects?
 5. Variables
• Decide about which variables to measure

• Researchers need to state clearly the:

– Predictor variables (Independent variables)
– Confounding variables
– Outcome variable/s (Dependent variable)
 6. Statistical Issues
• Develop plans for estimating sample size and for managing
and analysing the study data

• In case of analytical and intervention studies, specify a

hypothesis to:
– Provide the basis for testing the statistical significance of the findings
– Allow the investigator to calculate the sample size (prob. & power)

• In descriptive studies:
– No need for a hypothesis (do not involve tests of statistical significance)
– Take adequate sample to produce acceptably narrow confidence
intervals for means, proportions, or other descriptive statistics
 How research works?
• The goal of clinical research is to draw
inferences from findings in the study
about the population (Valid inferences)
Findings in
• Internal validity: the study
– The degree to which the investigator
draws the correct conclusions about
what actually happened in the study
…

• External validity: Truth in the

– The degree to which these
conclusions can be appropriately universe
applied to people and events outside
the study (generalizability) …
 The process of designing and implementing a research project
sets the stage for drawing conclusions from the findings

Truth in Infer Truth in the Infer Finding in

Drawing the  study
 the study
conclusion population

…………………… ..................... ……………………. ……………………… …………………… …………………….

Designing and Research  Study  Actual

implementing question Design plan Implement study

External Internal
validity validity
Research Concept Note
and Proposal
 Components of a research concept note
Title
Problem statement

Justification

Research question/s
Objectives
Study type
Study Population, sample
size and sampling
Data collection
Data analysis
Proposed period
References
 Writing a Research Proposal

1. Title (topic)
2. Introduction (background,
problem statement and
justification)
3. Research questions
4. Hypothesis (if any)
5. Objectives
6. Materials and methods
7. Timeframe
8. Budget
9. Dissemination of the results
10. References
11. Appendices
 Material and methods: the backbone of the research

Study design
Study area/ setting
Study population, sample size and
sampling
Data collection
Description of intervention (if any)
Data analysis and management
Ethical considerations
 1. Title
2. Introduction:
– Background,
– Problem statement
– Justification)
3. Research questions
4. Hypothesis (if any)
5. Objectives
– General objective
Research 6.
– Specific objectives
Materials and methods

proposal –
–
Study design
Study area/ setting
– Study population
– Sample size
– Sampling
– Data collection
– Description of intervention (if any)
– Data analysis
– Ethical considerations
7. Timeframe
8. Budget
9. Dissemination of the results
10. References
11. Appendices
 Criteria for Research Priorities
Prof Muna Ibrahim Abdelaziz

• Unknown: controversial and conflicting evidence

• Un-quantified: there is a need to quantify

• Unexplained: to generate hypotheses or test hypotheses

• Needed to inform action: policy, strategy, action

• Can be done: Feasible, ethical, ….

• Any others?
 Rating sheet and scale
(1=low; 2=medium and 3=high)

Criteria Problems identified for research

Problem 1 Problem 2 Problem 3
Relevance
Avoidance of duplication

Urgency of data needed

Political acceptability
Feasibility
Applicability of findings
Ethical acceptability
Total
 Literature Review
• A comprehensive summary of the ideas, issues, approaches
and findings that have been published or unpublished on a
particular topic…

• It is not a simple description but it is critical synthesis

(or bringing together) what the researcher has read…

• What worked and what didn’t work in terms of

contents, methods, tools and what gaps, inconsistencies or
problems still need to be addressed in further research on
the topic.
Why researchers review the literature?

• It prevents you from duplicating work that has

been done before…

• It increases your knowledge on the problem you

want to study and this may assist you in refining your
“problem statement“…

• It gives you confidence why your particular research

project is needed…

• To be familiar with different research methods..

 Sources and resources of literature

• Published information • Internet:

(journals, books, etc.)
– PubMed
• Unpublished documents – Midline
(surveys, reports, raw data
etc.) – Websites: WHO
– Google scholar
• Organizations/ institutions – Google
reports and data…
• Libraries
• Opinions, beliefs of key • Key informants
persons …
• ..etc
• Others …
 How to Search?

• Start with at least some idea of the broad

subject area…

• List/ ask about possible sources …

• Collect publications/ documents for this

broad area…

• Start by reading the abstract. If it is

relevant then download and save …
What to do with the identified references?

References that are identified:

• Should first be skimmed or read…

• Then summaries of the important information

in each of the references may be recorded
(on separate index cards)…

• These should then be classified so that the

information can easily be retrieved…
 Annotated bibliography
No. Reference Summary Remarks
1 Ekman, B. The impact of health Generally, insurance is found to
insurance on outpatient utilization and increase the intensity of
expenditure: evidence from one utilization and reduce out-of-
middle-income country using national pocket spending, while no
household survey data. Health Res general insurance effect on the
Policy Sys 5, 6 (2007). probability of use is found
https://doi.org/10.1186/1478-4505-5-6
2 Matthew Jowett, Anil Deolalikar and The results indicate that,
Peter Martinsson. Health insurance and overall, insured patients are
treatment seeking behaviour: evidence more likely to use outpatient
from a low‐income country. Health facilities, and public providers,
Care Financing. an effect that is particularly
https://doi.org/10.1002/hec.862 strong at lower income levels.
3 Wang H, Liu Y, Zhu Y, Xue L, Dale M, et The evidence from this study
al. (2012) Health Insurance Benefit indicates that the design of
Design and Healthcare Utilization in health insurance benefits is an
 Beliefs and practice related to malaria treatment
References Summary Your comments Key words

Baraka, The majority of respondents Study not Knowledge

1999 identified: representative
• fever as an indication for
malaria
• Convulsion indicates severity
Adil et al, “no need to consult health The study was Attitude
2000 personnel when getting febrile conducted in a
during rainy season… this is remote area where
straightforward malaria” there is no facility
Malik et al, • >70% used CQ in injectable Use both qualitative Practice
2000 form in the event of malaria and quantitative Attitude
• Injectable drugs might cause methods
paralysis
Elmurdi & When there is cough with fever National malaria Practice
Omer, among children, mothers usually survey
2001 consult health personnel
Organizing your literature review
Topical Order:
• Organize by main topics or issues; emphasize the relationship of
the issues to the main “problem”

Chronological Order:
• Organize the literature by the dates of publications

Problem-Cause-Solution Order:
• Organize the review so that it moves from the problem to the
solution

General-to-Specific Order (funnel approach):

• Examine broad-based research first and then focus on specific
studies that relate to the topic

Specific-to-General Order:
• Discuss specific research studies so conclusions can be drawn
 Organizing your literature review

Introduction to the lit review

 Content - what is covered
 Structure - how it is organized
 Boundaries - what is outside of its scope
Body of the Lit Review SECTION 2: ADDITIONAL
SECTION 1: The next most important SECTIONS
The most important topic or a key topic or a key concept  Follow the
concept  discussed and evaluated same pattern
 discussed and evaluated  summarized and related
 summarized and related to your to your research project
research project
Conclusion
From each of the section summaries,
 highlight the most relevant points
 relate these back to the need for research
 reiterate what these mean for the research design
 Pitfalls
• Review isn’t logically organized
• Review isn’t focused on most important aspects
of the study
• Review doesn’t relate literature to the study
• Too few references or outdated references cited
• Review isn’t written in author’s own words
• Review reads like a series of disjointed
summaries
• Review doesn’t argue a point
• Recent references are omitted
 Citing and referencing
 Citation or reference is a way of giving credit for someone's thinking,
writing or research …

 You mark the material when you use it (a citation) and give the full
identification at the end (a reference)….

 Why citation and referencing?

 Credit sources of information & ideas

 Reader can locate for further information

 Increase and spread knowledge

 Show depth, breadth & quality of your reading!

 A citation style or reference system is a standardised system

for referring to materials used in your writing….
Vancouver/ Harvard style
 Plagiarism
• Plagiarism means that a substantial scientific contribution is
presented as one's own by copying original text, concepts or
data of others without referring to the original source…

• The availability of text in digital form increases the possibility

of accidentally using someone else's material without
acknowledgement…

• By all means use quotes and paraphrased material but cite it

properly

• Plagiarism Checker - A Free Online Plagiarism Detector

• https://smallseotools.com/plagiarism-checker/
What if plagiarism detected?

• Intentional or unintentional plagiarism??

• Consequences:
• Receiving zero on the assignment

• Failing the course

• Suspension

• Expulsion
• SMSB
Your research title
• 30 words maximum,

• The title should be

comprehensive, covering the main
study objective (s), study area and
the period …

• Answer: what, where, when and

how questions …
 Introduction
• Consist of:
– Background (guided by the title)
• What we know about the topic?
– Problem statement (knowledge gap)
• What we do not know?
– Justification (need for data)
• Why this study?

• Refers always to previous studies, reports and

any other available information

• Do not exceed 2-3 pages.

 The background (re-presented)
• Issues to be addressed?
– What is known about the topic at hand?
– What is not known?
– Why is the research question important?
• Researcher:
– Cites previous research that is relevant
– Indicates the problems with the prior research
– States uncertainties remain
– Specifies how the findings will help resolve these uncertainties
– Indicates how findings will lead to new scientific knowledge and
– States how findings will influence guidelines or public health policy.

• Often, work on the background and significance section may lead to

modifications in the research question…
 The knowledge gap: research statement
Why is it important to state and define the research problem?

• Is the foundation for the research proposal…

• Makes search for published data easier …

• Enables the researcher to systematically point

out
– Why the proposed research on the problem
should be undertaken? and
– What you hope to achieve with the study
results?….
Comparison of lectures based on problems (LBP) with problem based
learning (PBL) in teaching of respiratory course for medical students in the
International University of Africa, Khartoum, Sudan (March 2020-July 2020)
Modified from Smah O. Mohager (EDC UofK)

• Evidence from literature showed difficulty implementing

PBL properly in low income countries (Amoako-Sakyi D 2015;
Carloye L 2017). Focused group discussion in our setting with
students revealed an overall dissatisfaction (Personal
communication).

• Alternative satisfactory and context suitable educational

method, probably LBP is required to substitute PBL.

• Reliable evidence of the efficacy and approval of the LBP

is needed.
 Ulrich RJ, Troxel AB, Carmody E, et al.
Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter,
Double-Blind Randomized Controlled Trial in Hospitalized Patients.
Open Forum Infect Dis. 2020 Sep 23;7(10)
Background: Effective therapies to combat coronavirus 2019 (COVID-19) are
urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity
against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the
clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled
trials are needed to determine the safety and efficacy of HCQ for the treatment
of hospitalized patients with COVID-19.
Methods: We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with
laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30
days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit
admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14.

Results: A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and
laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%)
subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but
this did not achieve statistical significance (P = .350). There were no significant differences in COVID-19 clinical scores,
number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated
with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of
stay.

Conclusions: In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or
improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized
controlled trials or pooled analyses are needed.
 Problem statement …
The problem:
Measles is a common problem in Sudan. The main
intervention to eliminate measles is vaccination.
Desired:
having at least 95% of children under 5 years vaccinated
Existing:
Only 60% of the target group vaccinated
The gap:
35% of children is not vaccinated and we do not know the
reasons for that
 Justification ….
Briefly provide an answer to
questions such as: WHO
Why you plan to conduct the recommends
study? adding low dose
 Nobody conduct such research of PQ to ACTs to
before… reduce malaria
 Nobody conduct such research transmission.
before in Sudan… WHO stated the
 No recent data… need for RCTs.
 Many researches have been
conducted but limited to…
(WHO, 2015)
 Raised by a respectable
institution or organization …
Yaro, J.B., Ouedraogo, A., Diarra, A. et al. Risk factors for Plasmodium falciparum
infection in pregnant women in Burkina Faso: a community-based cross-sectional
survey. Malar J 20, 362 (2021). https://doi.org/10.1186/s12936-021-03896-8

• There have been many studies of risk factors for malaria in

pregnancy in sub-Saharan Africa, where increased risk was
reported to be associated with younger age in pregnancy,
primigravidae, first trimester of pregnancy, non-use of ITNs,
lack of education and HIV co-infection [15, 16, 18, 19].
• Few, however, have evaluated socioeconomic and
environmental risk factors for malaria in pregnancy. For
example, recently a number of studies have shown that
malaria in children is associated with poor housing [9, 20, 21],
but it is not known whether this is also true for pregnant
women.
• Identifying risk factors for malaria in pregnancy could assist in
developing interventions to reduce malaria burden in
pregnancy in Burkina Faso and other countries in sub-Saharan
 Research Hypothesis
• A specific version of the research question that
summarizes the main elements of the study
– The sample,
– The predictor and outcome variables

• Do we need hypothesis?
– Hypotheses are not needed in descriptive studies,
– Hypothesis are needed in analytical and experimental
studies

• Why?
– It establishes the basis for tests of statistical significance.
55
• If any of the following terms appear in the
research question, then the study is not
simply descriptive, and a hypothesis should
be formulated:
– greater than,
– less than,
– causes,
– leads to,
– compared with,
– more likely than,
– associated with,
– related to,
– similar to,
– correlated with.
56
 Characteristics of a Good Hypothesis:
Simple versus Complex
• Simple: Contains one predictor and one outcome variable:
– A sedentary lifestyle is associated with an increased risk of
proteinuria in patients with diabetes

• Complex: Contains more than one predictor and/ or more

than one outcome variables:
– A sedentary lifestyle and alcohol consumption are
associated with an increased risk of proteinuria in patients
with diabetes
– Alcohol consumption is associated with an increased risk
of proteinuria and of neuropathy in patients with diabetes
57
 Research objectives
The formulation of objectives will help us to:
1. Focus the study (narrowing it down to essentials)

2. Avoid collection of data that are not strictly

necessary for understanding and solving the
identified problem

3. Organize the study in clearly defined parts

 How you state your research objectives?

We have to make sure that our objectives:

• Are SMART
• Cover the different aspects of the problem and its
contributing factors in a coherent way and in a
logical sequence
• Are clearly expressed in measurable terms
• Meet the purpose of the study
• Use action verbs that are specific enough to be
measured
 Action verbs
Examples of action • Examples of vague
verbs are: non-action verbs such
• To determine as:
• To compare • To appreciate
• To verify • To understand
• To calculate
• To establish
• To estimate
• To believe
• To identify
 General and Specific Objectives

General objective/s:
• Is the aim of the study in general terms (similar to title)

Specific objectives:
• Measurable statements on the specific questions to be
answered (SMART)
• Are more specific and are related to the research problem
• They indicate the variable to be examined and
measured
 Title:
Objectives Determinants of use of LLINs by
pregnant mothers in Sudan,
Remember: 2019
Action verbs
General objective:
To assess the determinants of
SMART utilization of LLINs by pregnant
mothers in Sudan
Related to the
title, problem, Specific objectives:
question and 1. To estimate the use of LLINs
by pregnant mothers
hypothesis
2. To identify factors affecting
Are they good the use of LLINs
objectives?
Work for
a research career
not
a research project!