Metlit-06 Usulan Penelitian (A) - Prof. Dr. Sudigdo S, SpA (K)

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From

Proposal
to Report
Writing

Sudigdo Sastroasmoro

Prologue
Scientific knowledge is knowledge
obtained by scientific procedures
Professionals should always use
scientific knowledge to solve their
professional problems
Good professionals is obliged to
participate in scientific development by
doing (however small) research in their
relevant field

Science is made of facts


as a house is made of stones
But a bulk of facts
is not necessarily a science
as a mass of stones is not a house

Before you start.

Think very carefully


what you will do for
your
research

FINER
Feasible: Time, expertise / manpower,
material, money, study subjects
Interesting to the investigator

Novel: Original, replicative


Ethical: Research Ethics Committee
Relevant to patient care, health care,
scientific development

Questions about Relevance


Is the magnitude of the problem really
important?
Is the topic appropriate to answer the big
question?
Does literature study support the need for
investigation?
Can you develop one or more hypothesis?
Do you think your peer group has the same
perception about the topic?
Does the topic consist knowledge gap that is
appropriate to be answered by doing

Questions about Novelty


Cant find similar study home and abroad?
Are there similar studies but give controversial
results?
Are there similar studies but had a low
validity?
Have not been studied in Indonesia?
Have a prediction that different results may be
found?
Other aspects: see originality

Characteristics of high quality


research
Original
Independent
Substantial contribution
(Rigor)

Originality in research
The following studies are labeled to as
original research, original contribution, or
original article

Knipscheer HC, et al. Short-term efficacy and safety of


pravastatin in 72 children with familial
hypercholesterolemia. Pediatr Res. 1996;39:867 871.
de Jongh S, et al. Efficacy and safety of statin therapy in
children with familial hypercholesterolemia: a randomized,
double-blind, placebo-controlled trial with simvastatin.
Circulation. 2002;106:22312237.
Wiegman A, et al. Efficacy and safety of statin therapy in
children with familial hypercholesterolemia: a randomized
controlled trial. J Am Med Assoc. 2004;292:331337.

What is original research?


1.
2.
3.
4.
5.

6.
7.
8.
9.
10.
11.

12.

Never done before


Continuing others original study
Developing others original idea
Using new technique to find old data
Proposing / designing everything & ask investigators
/ technicians to perform the study under your
guidance
Finding new empirical data
Have not been done in Indonesia
Using old technique to explore new area
New evidence for old issue
Examining others idea with original technique
Multidisciplinary approach to solve old issue
Applying others findings in different populations

Questions about Interesting


Are you really interested?
Why? Give reasons
Have you done similar study before?
Should someone offer you other topic, do
you tend to change your topic or try your
best with your original topic?

Questions about Ethics


Can you perform the study in line with ethical
principles?
If you plan to use humans, especially patients,
have you considered carefully that appropriate
protection can be applied?
In the case that the subject would be
incompetent to give consent, have you
considered from whom the consent can be
obtained?
Have you considered the subjects response for
participating in the study?

Questions about Feasibility


Are you sure that the topic is within your area
of expertise?
Are there literature to be the basis for
developing sensible hypothesis?
What about the availability of
medical, laboratory, other facilities
expertise
drugs
study subjects (Lasagnas law)
time, money,
consultants, etc?

Study Protocol
Aims as guidance for the investigator in the
whole process of the planned research
Different formats or styles, depending on
institutions: should be followed rigidly
Followings are general requirements of
most research proposal

Anatomy & Physiology


I.

Introduction

II.
III.
IV.
V.

Literature review
Methodology
References
Appendices

I. Introduction
A. Background
B. Research question(s)

C. Hypotheses
D. Purpose

E. Significance

A. Background: Why do
research?
Most important part of research
proposal
Should be arranged as the following:

What is the problem?

What is known?

What is unknown? (knowledge gap)

What your study will add?

Background
Typically 4-8 pages
I personally recommend to make subtitles
for Background, so that the information
provided and the logical sequence are
better understood.
Six-page long background without subtitles
may result in to and fro information that
make the reader or even the writer get
confused.
Adequate and strong references

Single gene-mutation in familial


hypercholesterolemia in children of young
patients with myocardial infarction a
screening method and economic analysis
Increased incidence of young people with AMI
Factors associated with young AMI
Genetic studies in children of YAMI
Abroad
In Indonesia

Gene mutation as predictor for YAMI


Population-based vs. group-based screening
Knowledge gap to be filled with the proposed
study

Acute hypothyroidism in children


undergoing open heart surgery Prevalence
and role of oral thyroxin
Kemajuan tata laksana PJB
Luar biasa namuan ada beberapa kendala
Salah satunya hipotiroidisme akut
Peran hormon tiroid
Sudah dinilai pada orang dewasa dgn tiroid IV
Hasil kontroversial
Peran tiroid pada anak
Belum diteliti, khususnya oral
Hasil yang diharapkan
utama
tambahan

b. Research question(s)
Formulation of background in interrogative
sentence(s) which are:

brief and direct

clear

not multi-interpretable

Research question(s): examples


Is additional of drug A associated with better
prognosis in patients with diabetic neuropathy
compared with standard regimen?
Is neonatal asphyxia a risk factor for delayed
motoric development at 2 years of age?
Does administration of injectable contraceptive
result in undernutrition of infants who are
exclusively breast-fed at the age of 6 months?
Does passive smoking cause chronic and
recurrent cough in underfive children?

c. Hypothesis
A tentative answer for research question that
should be validated empirically
Hypothesis should not be judged as correct or
incorrect, but valid or not valid
Not all studies need hypothesis; surveys and
other descriptive studies do not need hypothesis
Any research questions containing the words:
associated with, related to, correlated to,
different from, larger, smaller, better, worse,
more, cause, risk factor(s), etc need one or
more hypothesis.

Characteristics of good hypothesis


Written in a positive sentence
Based on good scientific reasoning
Can be validated empirically
Simple:
describe the association of one or more
independent variables and one dependent
variable
can be tested separately with hypothesis testing
(cf. complex hypothesis)
Formulated a priori (cf. a posteriori, data dredging,
fishing expedition)

d. Purpose of the study


General: wider aspect of prospective nature
To reduce mortality associated with DSS
Specific: What exactly will be measured
To determine demographic and clinical factors
associated with the development of DSS in
adults
To determine the effectiveness of Crystalloid A
as compared with RL in managing pts with DSS
For analytic studies, in general, specific purposes
are in-line with hypotheses

e. Significance
Academic
Clinical
Health policy
Further research
Note: quick vs. non-quick yielding
researches

II. Literature review


Detailed, but only aspects relevant to the
substance of the research; no need to review
all aspects of the disease or problem under
investigation
Requirement: good literature search and
appraisal - Original articles, reviews,
quantitative reviews, meta-analyses
Most recent publications (use internet!); older
ones for historical perspectives
Repeated revisions, including language:
words, sentences, paragraphs, literature
citations, etc.

Theoretical & Conceptual


frameworks
Theoretical framework: Summary of literature
review related directly to planned study
Not needed for grant application (included in
Background)
Followed by conceptual framework in the
form of diagram showing inter-relationships
amongst variables

III. Methods

All must be elaborated explicitly in great details!!


Design(s): one study may have more than
1 designs
Time and place
Population: target, source
Criteria for inclusion and exclusion
Sample: sampling techniques
Sample size

III. Methods (cont.)


Procedures, equipment, drugs,
randomization, blinding, measurements,
interventions, follow-up, etc
Variable identification: independents,
dependents, confounders, extraneous, etc
Definitions
Ethics Committee approval
Plan of analyses: types of tests, computer
programs used (appropriate, please!!), p
value, confidence intervals, etc

IV. References
Consistent style; FMUI: Vancouver style
Follow rigidly every aspects {Number of authors
included, editor(s), abbreviations of journals, first
& last pages, etc}, incl. punctuation (comma,
colon, semicolon, full-stop, etc)
Important: fit the citation numbers in text and
numbers in the reference list!
Electronic materials not published in printed
format should be considered as unpublished
materials, as are theses, dissertations, personal
communications (use them if no comparable
published sources exist)

V. Appendices
Investigator(s), incl. curriculum vitae and research
tract records / previous publications
Sponsors
Time table
Plan of budget
Formulae (sample size), specific procedures, etc
Dummy tables
Ethical clearance
Informed consent form
Other relevant materials or information

Concluding remarks
Research proposal (protocol)
development is the very first step in
research activities
Needs exercises by reading & reviewing
other proposals; much better: learning by
doing
Arrangement of Title, Introduction, and
Methods must be in logical sequences,
reflecting scientific exercise
Badly written proposal will eventually
result in bad study conclusion(s)

Be prepared for
Lasagnas law
Dissertation blue
Writers block
Technical, financial, procedural, bureaucratic
aspects
Unwritten rules in PhD research:

Supervisors
Examiners
Department and related institutions
Family
Yourself

Its okay, but the show must go on

After the study is


completed.

Report
To examiners (for thesis / dissertation)
To academic society (medical journal)
To layman
Different approach

To medical journal
Usual format: IMRAD
Always look Instructions to Authors
In-house style: specific for that
journal
A continuum from proposal to report
writing

To medical journal
PROPOSAL

REPORT

Introduction
Literature review
Methods
References

- Introduction
- None
- Methods
- Results
- Discussion
- Conflict of interest
- References

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