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Conceiving a Research
Question

Noel R. Juban, MD, MSc Epidemiology

Department of Clinical Epidemiology

UP College of Medicine

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What is Research?

Research is the systematic

collection,
analysis, and
interpretation of data

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to answer a certain question or

to solve a problem

People Interested in Research

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Investigator

Evaluators of research

Prioritizing authorities

Consumers of research

Reasons for Doing Research

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Pure interest
Pre-requisite for promotion,
graduation, recognition

Origins of a Research Question

Medical

articles and conferences

Critical thinking about clinical practices and problems
Discussions with colleagues
Applying new concepts or methods to old issues
Ideas that emerge from teaching
Top 10 causes of morbidity and mortality

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A sample research question

Is fexofenadine (FEX) as effective
as desloratidine (DL) in the relief of
nasal symptoms and increasing the
peak nasal inspiratory flow (PNIF)
among patients with seasonal allergic
rhinitis?

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P: adults with seasonal rhinitis

I: FEX
C: DL
O: nasal symptoms
M:

Feasible

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Adequate number of subjects

Adequate technical expertise
Affordable in time and money
Manageable in scope

Interesting

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To the investigator

Novel

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Confirms or refutes previous

findings
Extends previous findings
Provides new findings

Ethical

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Apply for institutional review

board approval

Relevant

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To scientific knowledge
To clinical and health policy
To future research directions

FINER Criteria for a Good Research

Question

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Feasible
Interesting
Novel
Ethical
Relevant

The Research Question Format

Biologic/ theoretical
rationale
Study population
Maneuver or exposure
under study
Primary outcome
Comparative maneuver
or exposure
Study design

5/28/14

A Research Question

Is fexofenadine (FEX) as effective as

desloratidine (DL) in the relief of
nasal symptoms and increasing the
peak nasal inspiratory flow (PNIF)
among patients with seasonal allergic
rhinitis?

9/3/2005

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P -population

I / E intervention/exposure

C comparison/control

O outcome measures

M methods (study design)

SOME EXAMPLES

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Example 1
P middle-aged woman
A 40 year old woman
hospitalized with severe
is hospitalized with
depression
severe depression. I Group psychotherapy

Might the addition of

group psychotherapy
C Usual care
improve her
(pharmacotherapy)
outcomes?

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O improve symptoms
and shorten hospital stay

Research question 1

Among middle-aged women with

severe depression admitted at MMC,
will group psychotherapy improve
clinical symptoms (???) and decrease
length of hospital day as compared to
pharmacotherapy (usual care)?

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Example 2

A 30 year old man has been taking Zoloft for mild

depression for 6 months with good results. Hes
concerned, however about the sexual side effects
of the drug. Are phosphodiesterase inhibitors (e.g.
sildenafil=Viagra) effective in treating sexual
dysfunction associated with SSRIs?

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P male with mild depression on

Zoloft
I viagra
C no viagra /placebo
O improved sexual functions

Research question 2

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Example 3

A 9 year old boy is referred by his

school for symptoms of hyperactivity
and inattention. You confirm a
diagnosis of ADHD without co-morbid
conditions. Would treatment with
stimulants alone be as effective as
combined medication and
psychosocial intervention?

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Example 4

What is the percentage of patients

with ruptured appendicitis who
developed complications after an
exploratory lap?

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Example 5

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The Research Question and Study Plan:

Problems and Solutions

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The research question is not FINER

! Not feasible

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Too broad

Specify a smaller set of variables

Narrow the question

Not enough subjects

Expand inclusion criteria

Modify exclusion criteria
Add other sources
Lengthen the time frame

Methods beyond the

skills of investigator

Collaborate with colleagues

Consult experts / review literature
Learn the skills

Too expensive

Modify study design

The research question is not FINER

! Not interesting, novel, or relevant
Consult with mentor
Modify the research question
! Uncertain ethical suitability
Consult with the IRB
Modify the research question

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The study plan is vague

! Write the research question at an early stage
! Get specific in the 1-2 page study plan
How the subjects will be sampled
How the variables will be measured

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Where is your research question falling

into the research loop?

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BURDEN OF ILLNESS
How grave is the burden
of illness?
REASSESSMENT
Did the mortality rate
decrease significantly?

MONITORING
PROGRAM
Is implementation
operating well in the
field?
SYNTHESIS AND
IMPLEMENTATION
How will the program be
implemented?

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ETIOLOGY OR CAUSATION

MEASUREMENT
ITERATIVE LOOP

What are the causes

or risk factors/
predictors of the
disease?
COMMUNITY
EFFECTIVENESS
,
Is the treatment
effective in reducing
the problem?

EFFICIENCY
What procedure is more cost
effective?

Summary

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All studies should start with a research

question that addresses what the
investigator would like to know.
Goal: Find an important one that can be
developed into a feasible and valid study plan
Key ingredients: scholarship and
experience
Sources of research questions
FINER criteria of a good research question
Develop the research question into a brief
written study plan

Summary

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Developing the research question and

study plan is an iterative process
that includes consultations, familiarity
with the literature, pilot studies.
Qualities needed: judgment,
tenacity, creativity
Focus on a single primary question

Next Steps . . .
Start writing the protocol outline

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Outline of the Study Protocol

!
!
!
!

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Research Question
Significance (Background)
General and specific objectives
Methodology
! Study Design - time frame
epidemiologic approach
! Subjects - selection criteria
sampling design
! Variables - predictor variables
outcome variables
!Statistical issues hypothesis
sample size
analytic approach
! Ethical considerations and issues

Formulation of Research Objectives

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General Objectives
Specific Objectives

Why should research objectives be

developed?

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Focus the study

Avoid collection of
unnecessary data
Organize the study
Facilitate development of
the research methodology

How should objectives be stated?

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Cover the different aspects of the

problem in a coherent and logical
sequence
Clearly phrased in operational terms
Realistic
Use action verbs e.g. to determine,
to compare, to validate

SMART - Guide for Assessing

Objectives
S simple and specific
M measurable
A - attainable
R - realistic
T time bound
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