Research question, criteria, formulation, and relation to research designs.

Research Question
Professor Tarek Tawfik Amin
Epidemiology and Public Health, Faculty of Medicine, Cairo University
Geneva Foundation for Medical Education and Training
Asian Pacific Organization for Cancer Prevention
amin55@myway.com dramin55@gmail.com
Basic Research Competency Program for Research Coordinators
August 2015, MEDC, Faculty Of Medicine, Cairo University, Cairo, Egypt.

Objectives
By the end of the day, research coordinators will be able to:
1- Recognize the components, functions and criteria of a good
research question.
2- Criticize research question against standard criteria.
3-Develop a research question fulfilling the FINER criteria.
4- Mastering searching the available bibliographic databases
through following sound search strategies.
5- Recognize the indications, types and how to write up a
research hypothesis.
5/7/2016 2Professor Tarek Tawfik Amin

Methodology
1- Interactive lecturing
2- Group and individual work
3- Internet and web-based sessions.
4- Assignments

Contents and plan
Session title Duration Methods Activities
Research: definition, types
elements, and cycle
9:00-9:30 Interactive session
Research idea and research
question
9:30-11:00 Interactive
Individual/group work
Activity I
Activity II
Break 1 11:00-11:30
Formulation of research
question
REACP : research question
11:30-12:30 Interactive
Activity III
Break 2 12:30-1:00
Searching the Bibliographic
databases
1:00: 1:30 Interactive
Hands-on
Activity IV
Break 3 1:30-1:45
Hypothesis 1:45-3:00 Interactive
Activity V
5/7/2016 Professor Tarek Tawfik Amin 4

Research
• Definitions
• Elements
• Cycle

Research?
More than a set of skills, it is a way of
thinking: examining critically the various
aspects of day to day professional work;
Understanding and formulating guiding
principles that govern a particular
procedures;
Developing and testing new theories for the
enhancement of your practice.
Thyer 1993

Research: Working Definition
• It is the habit of questioning with
systematic examination of the observed
information to find answers which may
results in more effective professional
services. Kumar R 2005.

Scientific Research Definition:
Research is a structured inquirythat utilizes
acceptable scientific methodologyto solve
problems and creates new knowledge that is
generally applicable. Grinnell 1993

Types of research
Application
Objectives Inquiry mode
Pure
research
Applied
research
Exploratory
research
Descriptive
research
Explanatory
research
Correlational
research
Quantitative
research
Qualitative
research

Research process “The 8 steps model”
Formulating
a research
question
Research
design
Instruments
for data
collection
Selecting
a sample
Research
protocol
writing
Data
collection
Data
processing
Research
report
FINER
Variables and
hypotheses: definition
and typology
Literature
review
Research design:
functions
Study designs
Methods and
tools of data
collection
Validity and
reliability of the
research tool
Field test
of the tools
Sampling theory
and designs
Contents of
research proposal
Editing
Code
book
Coding
Methods of data
Processing:
computing
and statistics
Principles of
Scientific writing
What How Conducting of the study
Kumar 2005
Dissemination
including publication

Research cycle

Trading between different designs
Treatment /
Intervention/
Program Study
population
Exploration
Causes/associations
Effect
Exploration
Outcome/
Impact/
Change
Experimental studies
Non-experimental studies
Randomization
Non
Experimental: starts from the cause to effect.
Non-experimental: starting from the effects to trace the cause.
Semi (Quasi) experimental: a mix of both.

Iodine deficiency disorders
(an example of research cycle)
• Observation and reporting of enlarged thyroid
among pre/school children and frequent cretins
in the New Valley.
• No clue about the size of the problem?
• Prevalence studies were carried out, more 40%
prevalence, morbidity among human and
animals.
• What are the causes of IDDs?
• Comparative ecological studies between the
costal and NV (including water, soil and
vegetables analysis). Concluding iodine5/7/2016 13Professor Tarek Tawfik Amin

Trading between different designs
Treatment /
Intervention/
Program Study
population
Exploration
Causes/associations
Effect
Exploration
Outcome/
Impact/
Change
Experimental studies
Non-experimental studies
Randomization
Non
Experimental: starts from the cause to effect.
Non-experimental: starting from the effects to trace the cause.
Semi (Quasi) experimental: a mix of both.

Research idea and research
question

Define the Research Problems (the 4Ps):
Sourcesof researchideas/questions
Aspect of study about Study of
Study
population
People Individuals,
organizations, groups,
communities
Provide you with
required
information or you
collect
information from
them
Subject areas Problem
Program
Phenomenon
Issues, situations,
associations, needs,
profiles etc.,
Content structure,
outcomes, attributes,
etc.,
Cause-effect,
relationships, etc.,
Information that
you need to collect
to find answers to
your research
question

Research idea vs. question
Idea Question
Less specific
Very broad
Clearly defined
Predictor/outcome/specified
population
Less operational
Low practicality
Simple, Measurable
Objective
I wonder if Determine the design
Discipline bounded Not but the hardest part in
the research process
I wonder if Egyptians have
different patterns of osteoporotic
fractures!!!
What are the risk factors for major
osteoporotic fractures in Egyptian
women aged <60 years ?

Statement Question Idea
1. What predictors affecting survival of Egyptian children with brain tumors ?
2. What are the possible barriers to cervical cancer screening among Egyptian
women?
3. What are the risk factors for osteoporotic hip fractures among Egyptian
women aged ≥60 years?
4. Does the length of time from diagnosis to treatment of colo-rectal cancer
predict survival?
5. What are the possible correlates of hypovitaminosis D in obese Egyptian
adults?
6. Is there a relationship between smoking and depression?
7. How stress is contributing to cardiovascular diseases and cancer?
8. Do breast cancer genes responsible for the development of breast cancer in
Egyptian women?
9. What is the effect of patients’ education using simulation on prevention of
diabetic foot ulcer?
10. Do adolescents receive equal health care services in Egypt?
•State whether the following is research question or research idea:

Conceiving the Research Question.
The research question is the
uncertainty about something in the
population that the investigator
wants to resolve by making
measurements on his study
subjects.
No shortage of questionsas one leadsto another.
Tamoxifen and breast cancer

What Is A Research Question And What Is Its Purpose?
• A research question is a question that a
study is designed to answer.
1- ‘a question that you propose to answer
through data collection’. Hennink 2011.
2- Guides all subsequent tasks in the
research process.
3- Keep you focused during the research
project.

Research question functions
Silverman (2010) suggests the question’s
purpose includes :
• Organizing the study and giving it direction
and coherence
• Delimiting the study, showing its
boundaries
• Keeping the researcher focused
• Providing a framework when you write up
your research

Before formulating your research question, remember:
o Study that cannot contribute to generalizable
knowledge is not ethical.
o Puts patients at risk of harm (even from minor
inconvenience) is not acceptable.
o Scientific validity is not a “nice to have” but a
requirement of all research
o Validity = ability of study to correctly answer
research question posed [latter]

The research question is the
primary objective of your study!!!
Remember:

Components of research question
- Exposure (factors-predictors-correlates-
determinants)
- Outcome (disease, morbidity, harm, benefit,
burden)
- Relation (if any)
- Specified population

The research question should specify !
Smoking
Cancer lung
Exposure
DiseaseOutcome
Predictor
Confounders Confounders Occupational hazards

Types of research questions
• Hypothesis generating e.g. What factors predict
mortality following traumatic brain injury?
• Hypothesis testing –e.g. Is X procedure associated
with lower mortality than Y procedure for acute T disease.
• Parameter estimation –e.g. What is the prevalence of
depression among older (>60 years) cancer patients?
• Confirmatory study –e.g. Does test A have the same
diagnostic accuracy in our population mimicking population
Z?

Research question: opportunity to
collaboration and consultation.
Your ideal question might be to determine the full
pharmacokinetics of a new treatment for visceral
leishmaniasisin very young children. Such a rich
pharmacokinetic study would need venous blood collected
from each participant at regular time interval s .
Do you need consultation for the feasibility of
such procedure?
Whom and why?

Consultation and collaboration
Consultation with medical staff and community leaders
would highlight this as being unfeasible both in terms of
acceptability and clinical practice.
So what?

Key message:
Collaboration and Consultation
To ensure that the question is turned
into an ethical , safe and accurate
study which is conducted in a
manner that produces a valid and
reliable answer obtained in an
acceptable manner.

Research question:
Basic element: the scope
The question’s scope is neither too broad nor too
narrow.
Too broad scope may result in you gathering
far more information than you need or can
reasonably handle, e.g. planning to carry out a
survey on the perception of physicians towards clinical
research in India.

Too narrow scope
• You risk ending up with insufficient data to
make your study valid and representative
e.g.
interested in how to improve national
health care for sufferers of HIV, but only
look at participants from one select
community, too small data set that is too
small to be truly representative nationally
(potentially biased).

The challenge
The challenge in searching for a research
question is not a shortage of
uncertainties ; it is the difficulty of
finding an important one that can be
transformed into a feasible and valid
study plan‘ Grinner 1993

Research question: THE GIGO
“Garbage In- Garbage Out”
Research question is the input into the study
which influence the quality of your research
(output).
Problem formulation will govern the design,
sampling, instruments used, and analysis plan.

Characteristics of a good research question
“FINER Criteria”.
- Adequate number of subjects.
- Adequate technical expertise
-Affordable in time and money
-- Manageable in scope
To the investigator
- Confirms or refuses previous findings
- Extends previous findings
- Provides new findings
- To scientific knowledge
- To clinical and health policy
- To future research directions
Feasible
Interesting
Novel
Ethical
Relevant

Feasibility
What kinds of information do you need to answer the
question?
What kinds of information are available?
What resources are needed to obtain data needed?
Is there access to resources needed?
Feasibility does NOT mean using invalid methods
because that is “the best that can be done”

Novelty of research question
the ‘who cares?’ test
the ‘so what?’ test.
“Novelty or new information means new answers to the
potential questions representing a user’s request or
information need.”
Novelty in publication: The dilemma

Examples from the
literature
Criticize these
research questions

Factors Impacting The Type
Of Research Question.
1- Time limits and the length of time the study will take
2-Experience of the researchers
3- Scope of the problem to be solved
4- Cooperation of others e.g. collaborators , participating sites
, etc.
5- Ethical concerns e.g. would the research be of merit,
acceptable to the community,
6- Funding availability and budget requirements
7- Facility and equipment requirements and availability
8- Time required to enroll participants e.g. enough incidence
of condition.
9- If an intervention is involved, is it safe for use in the target
population and is there enough data to support this safety.

Research question: Knowledge generated
and relation to research design
A- To gain detailed knowledge about a topic on which not a great deal is known e.g.
Rocio viral encephalitis , and this type of question would be said to be gathering
‘descriptive/exploratory ’ knowledge.
[Qualitative descriptive design]
B- Explaining the relationship between areas of a given topic e.g. examining a
community’s use of malaria nets and reduction of malaria cases . seeking
‘explanatory’ knowledge.
[Quantitative designs like surveys].
C-Aiming to establish predictive knowledge. examines ‘cause and effect’
relationships e.g. ‘Would initiatives to reduce neonatal mortality result in decreased
birth rates ?
[Quantitative analytical design ]

Research question is a predictor to research design
In other words: the research design is dependent
on the formulated research question.

Functionality of research question
Research question
Research design
Primary objective
Simple, clear and in prioriSecondary research questions
Secondary objectives
Primary end point
Calculation of the sample
Protocol development
Standard operating procedures
Running study
Statistical analysis

Question Design
1- What is the current health status of Egyptian adults aged 50 or more?
2. What are the commonly occurring malignancies among residence of Cairo year
2014?
3. What is the standard value for leucocytes countries among health Egyptian
adults?
4. Does the survival rate of cancer patients correlated with sex, age, tumor type,
and stage of disease ?
5. What would be the difference in lifestyle patterns between Cancer patients and
non-cancer patients when compared?
6. Duration of smoking and the development of lung cancer, does time matter?
7. Do patients with lung cancer differ from patients admitted to the hospital of
general surgery regards the previous smoking habits?
8. Does new drug B which improve the survival compared to the traditional
chemotherapy X with low overall survival and severe side effects in patients
with prostate cancer ?
For the following research question, suggest a researc

Origins of a research question.
 For established investigator:
The best research questions usually emerge from findings
and problems faced and observed in prior studies, and in
those of other workers in the field “Major Players”.
 For new and other investigators:
☼ Mastering of the literature.
☼ Being alert to new ideas and techniques.
☼ Keeping the imagination roaming.
☼ Attending seminar, workshops and conferences.

Review of literature:
its role in research question formulation.
Hulley et al . (2007) suggest that ‘carrying out a
systematic review is a great first step in developing
and establishing expertise in a research area and the
underlying literature review can serve as
background for grant proposals and research
reports ’.

1- It is possible that the data your research
question is designed to generate already
exists . A literature review will help to
establish if this is the case and therefore
whether the study you are considering is
necessary. Novelty of your research
question?
2- Another reason for a literature review is
that examining the evidence already
available may influence the type of
research question that you set.

Literature reviews have their limitations .
1- Effective reviews can be time consuming,
2- Require skill in identifying and analyzing
appropriate material , and
3- Examining past evidence which may not
reflect current states or thinking.

Formulation of research question

Steps in formulation of a research question
Indentify
broad field or
subject area
of your
interest
Dissect the
broad area
into sub-
areas
Select what
is of most
interest to
you
Raise the
research
question
Formulate
the
objectives
Assess your
objectives
and double
check for
sufficient
interest
Testfornovelty
FINER
Review of literature

Steps in formulation of a research problem
Physical
activity (PA)
Prevalence
Barriers
Profile/Patterns
Genders
Sedenatrism
Disease
prevention
The role of
PA in cancer
prevention
What is the size of
population with
PA meeting the
recommendations
for cancer
prevention?
Objective:
Determine the size
of the population
with enough PA to
prevent certain
types of cancers
namely CRC and
post M. BC
Am I
interested in
doing that?
Tools,?
Sample?
Resources?
etc.,
Reviewof
literature at
all steps
Reviewof
literature at
all steps

Group work
• FINER?
• Designs?
• Components?

Assuring novelty
• Searching the bibliographic databases.

Research question: RECAP

References
1. Bhattarai A, Al i A, Kachur S, Martens s on A, Abbas A, Khati b R, Al -mafazy A, Rams an M, Rotl l ant G, Gers tenmai er J, Mol
teni F, Abdul l a S, Montgomery S, Kaneko A, Bj orkman A. Impact of Artemi s i ni n-Bas ed Combi nati on Therapy and Ins
ecti ci de-Treated Nets on Mal ari a Burden i n Z anz i bar: Pl os Medi ci ne 2007; 4(11): 309.
2. Bowl i ng A. Res earch Methods i n Heal th: Inves ti gati ng Heal th and Heal th Servi ces 3rd ed. 2009. Open Uni vers i ty Pres s
, Berks hi re.
3. Fi tzpatri ck S. The Ins ti tute of Cl i ni cal Res earch ‘Cl i ni cal Tri al Protocol ’ handbook (2006), Bucki nghams hi re:ICR Publ i s
hi ng.
4. Henni nk M, Hutter I, Bai l ey A. Qual i tati ve Res earch Methods 2011.Sage Publ i cati ons , London.
5. Hul l ey SB, Cummi ngs SR, Browner W S, Grady DG, Newman TB. Des i gni ng Cl i ni cal Res earch 3 rd Ed. 2007, Li ppi ncott W i
l l i ams & W i l ki ns , Phi l adel phi a.
6. Gai l l ard P, Fowl er M, Francoi s D, Coovadi a H, van der Hors t C, van Rompay, K, Ruff A, Taha T, Thomas T, de Vi ncenz i I,
Newel l M, Ghent IAS W orki ng Group on HIV i n W omen and Chi l dren. Us e of Anti retrovi ral Drugs to Prevent HIV-1
Transmi s s i on Through Breas t-feedi ng: From Ani mal Studi es to Randomi zed Cl i ni cal Tri al s : Epi demi ol ogy and Soci
al Sci ence 2004; 35 (2): 178-187.
7. Kent D, McGrath D, Loanni di s J, Benni s h M. Sui tabl e Moni tori ngApproaches to Anti retrovi ral Therapy i n Res ource-Poor
Setti ngs :Setti ng the Res earch Agenda: Cl i ni cal Infecti ous Di s eas es 2003; 37(Suppl 1):S13–24
8. Mi s ra U, Ti n Tan C, Kal i ta J. Vi ral encephal i ti s and epi l eps y: Epi l eps i a 2008; 49(Suppl . 6):13–18.
9. Si l verman D. Doi ng Qual i tati ve Res earch 3rd Ed. 2010. Sage Publ i cati ons , London.
10. W HO/IVR Ethi cs Meeti ng. Ethi cal cons i derati ons ari s i ng from vacci ne tri al s conducted i n paedi atri c popul ati ons
wi th hi gh di s eas e burden i n devel opi ng countri es . Nov 2002, Ghana.
11. Xu D, Lv J, Dong Y, W ang S, Su T, Z hou F, Z ou W , Z hao M, Z hang H. Renal i nvol vement i n al arge cohort of Chi nes e pati
ents wi th Cas tl eman di s eas e: Nephrol . Di al . Trans pl ant 2011; 0: 1-7.

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