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The Research Proposal

Bernardo M. Cuevas Jr., M.D.

Chair
Department of Clinical Epidemiology
UST-FMS
July 2010

work out your ideas for research in detail and

systemaHcally
clear research objec,ves
methods
ques,ons

enables you to communicate your ideas

Once approved, you may be expected to sHck

to what you said
Just wriHng a proposal may push you into a
more rigid, less open-ended research design
WriHng a good research proposal takes Hme

A scienHc invesHgaHon
An orderly system
A tool for growth
A problem-solving acHvity

The problem is coming up with a problem!

get you into the habit of wriHng (as opposed

to simply talking)
learn more about how to communicate
a structure to begin reviewing the relevant
literature
an indicaHon of where you started
essenHal if you are to seek funding

What does a research proposal look like?

Its an argument
A hierarchy of concepts
A recipe
(Punch, 2000 and Kumar, 1996)

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Example A
What do I want to nd out and how?
Who is it for?
What do I expect to happen?
(Punch, 2000 and Kumar, 1996)

IntroducHon

statement of the problem

research quesHons/hypotheses
theoreHcal perspecHve
deniHon of terms
delimitaHon and limitaHons of the study
signicance of the study

Review of the literature

Methods
research design
sample, populaHon and subjects
instruments and materials
variables in the study
data analysis

(Creswell, 1994)

Example B

Title and Htle page

Abstract
IntroducHon

DelimitaHons refers to dening the limits or

the boundaries of the study
limitaHons means the limiHng condiHons or
constraints that you anHcipate

area and topic

background and context
statement of purpose (or aims)

Research quesHons
general
specic

Conceptual framework, theory, hypotheses (if appropriate)

The Review of Literature
Methods
design strategy and framework
sample
data collecHon instruments and procedures
data analysis

Signicance
LimitaHons and delimitaHons (if appropriate)
Consent, access and parHcipants protecHon
References
Appendices
(Punch, 2000, p. 67)

Example C

The proposals can dier in the degree of detail

The research proposals can dier in structure

A statement of the objecHves of the study

A list of the hypotheses, if you are tesHng any
The study design you are proposing to use
The seang for your study
The research instruments you are planning to use
InformaHon on sample size and sampling design
InformaHon on data processing procedures
An outline of the proposed chapters for the report
The studys problems and limitaHons
A proposed Hme-frame (The GANTT Chart)

some researchers choosing to integrate the

literature they have read in every secHon, or
perhaps to have a much longer secHon on
research ethics if this is a major concern

(Kumar, 1996, p. 170)

The structure will be inuenced by your

research topic, your approach and your own
personality

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Topic of research either a RESEARCH

QUESTION or TITLE
Abstract
IntroducHon
- raHonale or biologic basis
- signicance
- relevance
-hypotheses
- objecHves

Bioethics & medico-legal concerns

- informed consent
- condenHality
- memoranda
- InsHtuHonal Review Board
GANTT CHART
budget

Should have a lot in common with the

research quesHon (PICO)
Hallmarks of a good Htle: accurate, complete,
specic
Fewest possible words that adequately
describe the contents of the paper
Not > 2 lines when typewriken
Best to decide amer the research study

Conceptual framework summary

Literature search summary
Materials & Methods
- sample size
- sampling
- conduct of research
- instruments & instrumentaHon
- biostaHsHcs (report & analysis)

FuncHons of the Title:

To idenHfy the main topic or the
main point of the paper
To akract readers

Undergraduate Clinical
Epidemiology Course
Improves Clinical Prac,ce

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signicance of the quesHon and the overall

topic
state the hypothesis
point out key preliminary data
synopsis of methodologies planned

Sample size: all medical school graduates batch 2000

to 2005 compared to all graduates batch 2010 to
2015
Study design: Before Amer study
StaHsHcs: comparison of two proporHons, 95%
condence interval, X2 test, signicant p < 0.05
Conclusions: If the dierences in the outcomes are
signicant then we can observe if the intervenHon is
benecial or detrimental to clinical pracHce

What is the problem?

Why is it important to do the study?
Present what is known and not known
Usually ends with a 1-sentence descripHon of
the research quesHon (objecHves)

2 Main Purposes:
1. To akract readers
2. To tell them what to expect
Must demonstrate to readers/reviewers
that they are reading the work of a
professional
Should be short 1-2 pages

Funnel structure

Start from something known

to something unknown (narrow)

to the quesHon the paper is

asking

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What the introducHon should NOT

contain
DeniHon of terms
ExplanaHon of makers

The background secHon provides an

opportunity to bring reviewers up to date on
current research in the area of the proposal
This secHon should summarize succinctly
studies from the literature and related work
published by the invesHgator

Answer the following quesHons:

Answer the following quesHons:

Why should your mentor let you select this

topic?
What do you hope to learn from it?
What will this new knowledge add to the eld
of knowledge that already exists on this topic?
What new perspec,ve will you bring to the
topic?

What use might your nal research paper

have for others in this eld or in the general
public?

To whom might you decide to share your
ndings with once the project is complete?

Importance:

Importance:
Shows that research idea has a sound scienHc or
biologic raHonale

To see if available scienHc literature

with similar research ideas have already
provided answers
Avoid duplicaHon
CriHcal appraisal if researches are valid
Research can be redone

Gives idea on how to go about the study regarding

research methodology, standard procedures,
deniHons, incidence, & sample size
To give input on the feasibility, pracHcality, & worth

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Internet search (Medline/Pubmed, Ovid)

HERDIN (Health Research and Devt Info. Network by
the PCHRD or Phil. Council for Health Research &
Devt)
Grey literature (publicaHons which are not published
or distributed through usual channels, e.g. thesis,
research reports, scienHc proceedings)
CDs
Ancestry
Friends, relaHves, pharmaceuHcal/med. reps.

Common errors in conducHng research include

lack of conrmaHon of drug concentraHons
inadequate reproducibility of nal results
lack of standardizaHon of procedures
inadequate follow-up
incomplete data recording
overall lack of organizaHon

The methods secHon should include

a descripHon of the design, conduct, and analysis

of each study being proposed

Common errors in design include

lack of specicaHon of primary outcome

lack of randomizaHon or blinding in clinical trials
inadequate jusHcaHon of sample size
failure to adjust the total study number for expected
dropouts/failed experiments or paHent refusal
use of single drug doses or concentraHons rather than
development of doseresponse or concentraHon
response relaHons

Inadequate or inappropriate staHsHcal methods

can be a major weakness of a grant proposal

Many invesHgators feel condent with all aspects of

their methods except the staHsHcal secHon. Because
staHsHcal issues underlie the design and analysis
strategy for every study, the input of a biostaHsHcian is
essenHal in planning the research and wriHng the grant
applicaHon

StaHsHcal consideraHons include specicaHon of

the primary end points that drive power
calculaHons

Common staHsHcal errors in research proposals

include

lack of sample size/power calculaHons

treaHng conHnuous variables as dichotomous
repeated t -tests when a more comprehensive
modeling approach should be taken
applicaHon of staHsHcal tests that assume normality
without verifying assumpHons
failure to consider covariate eects
failure to disHnguish between inter-individual & intra-
individual variability

At least one full paragraph (and someHmes an

enHre page) of the research proposal should be
devoted to staHsHcal analysis
Omen several smaller staHsHcs secHons are
appropriately included amer each method is
presented

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Even the best methods have potenHal

problems and weaknesses

1. Bibliography
2. Informed Consent Form
3. Case Report Form or Data CollecHon
Form
4. Flowchart of AcHviHes
5. QuesHonnaire
6. Dummy Tables

It is criHcal that the methods secHon discuss

potenHal problems that may be encountered
during the study and state how the
invesHgator proposes to deal with these
problems creaHvely

The Research Design

Most research designs can be constructed from
six basic elements:

Qualitative

Quantitative
Analytic

Descriptive

Observational
Crosssectional

Cohort

Retrospective

Casecontrol

Prospective

Interventional

Natural
experiment

RCT

Quasiexperiment

Purpose: QuanHtaHve or QualitaHve

Time: Cross-secHonal, RetrospecHve, ProspecHve or
AmbispecHve
Program(s) or Treatment(s): Single or ComparaHve Treatment
Observa;on(s) or Measure(s): Point measures or Repeated
Measures
Groups or Individuals: N-of-1 or cohort
Assignments of Subjects: Randomized or Non-randomized

Diagnosis: prospecHve cohort study with

good quality validaHon against gold
standard
Prognosis: prospecHve cohort study
Therapy or preven;on: prospecHve,
randomized controlled clinical trial (RCT)
Harm / E;ology: RCT, cohort or case-control
study (probably retrospecHve)
Economic: analysis of sensible costs against
evidence-based outcomes

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Cross-sectal

Case- control

Cohort

Classification
of population

Population w/ & Cases w/

w/o exposure, w/ diseases, controls
& w/o disease
w/o disease

Population free
from disease

Rare condition

N/A

Best

N/A

To determine a
precise risk

Gives relative
prevalence

Only estimate
possible

BEST

Sample
represented

Survivors at
point in time

Uncertain

Non-diseased

N/A

BEST

Temporal
sequence

Retrospective,
relship revealed
at point in time

Retrospective

Prospective or
retrospective

To determine whether N/A

exposure preceded
disease
For administrative
purposes

N/A

N/A

Function

Describes assn
bet. exp & dis
simultaneously

Compares
prevalence of exp.
in cases & control

Compares
incidence in
exposed & unexp.

If attrition is a serious May have

problem
occurred
before

Attrition
usually
minimal

N/A

Evidence of
causality

Only suggestive

Needs more
careful analysis

STRONG

Time & Money

LEAST
EXPENSIVE

MOST
EXPENSIVE

Bias

May be difficult
to manage

Needs more effort

to manage

EASY TO
MANAGE

Cross-sectal

Case- control

Cohort

Cross-sectal

Case- control

Cohort

Time relationship

ED

ED

ED

Data collection

Slice of time

Retrospective

Forward

Subject
recruitment

Exposed &
unexposed,
look at old &
new cases at
the same time

Cases & noncases separately

& look backward
for diff. of
exposure

Exposed &
unexposed &
prospective
surveillance of
new cases

Uses

Reliability &
validity,
epidemics,
prevalence
studies

Rare diseases &

outcomes, long
duration diseases

Rare exposures,
short duration
diseases,
incidence
studies

Levels of bias

++

+++

++

+++

Strength of results +

BEST

In between