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FromProposal
to Report
Writing
Sudigdo Sastroasmoro
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Prologue
Scientific knowledge is knowledge
obtained by scientific procedures
Professionals should always usescientific knowledge to solve their
professional problems
Good professionals is obliged toparticipate in scientific development by
doing (however small) research in their
relevant field
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Science is made of facts
as a house is made of stonesBut a bulk of facts
is not necessarily a science
as a mass of stones is not a house
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Before you start.
Think very carefullywhat you will do for
yourresearch
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FINER
Feasible: Time, expertise / manpower,
material, money, study subjects
Interesting to the investigatorNovel: Original, replicative
Ethical: Research Ethics Committee
Relevant to patient care, health care,
scientific development
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Questions about Relevance
Is the magnitude of the problem reallyimportant?
Is the topic appropriate to answer the big
question?Does literature study support the need forinvestigation?
Can you develop one or more hypothesis?Do you think your peer group has the sameperception about the topic?
Does the topic consist knowledge gap that is
appropriate to be answered by doing
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Questions about Novelty
Cant find similar study home and abroad?
Are there similar studies but give controversialresults?
Are there similar studies but had a lowvalidity?
Have not been studied in Indonesia?
Have a prediction that different results may befound?
Other aspects: see originality
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Characteristics of high quality
research
Original
Independent
Substantial contribution
(Rigor)
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Originality in research
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.
The following studies are labeled to asoriginal research, original contribution, ororiginal article
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What is original research?1. Never done before
2. Continuing others original study3. Developing others original idea
4. Using new technique to find old data
5. Proposing / designing everything & ask investigators
/ technicians to perform the study under yourguidance
6. Finding new empirical data
7. Have not been done in Indonesia
8. Using old technique to explore new area9. New evidence for old issue
10. Examining others idea with original technique
11. Multidisciplinary approach to solve old issue
12. Applying others findings in different populations
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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?
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Questions about Ethics
Can you perform the study in line with ethicalprinciples?
If you plan to use humans, especially patients,
have you considered carefully that appropriateprotection can be applied?
In the case that the subject would be
incompetent to give consent, have youconsidered from whom the consent can be
obtained?
Have you considered the subjects response for
participating in the study?
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Questions about Feasibility
Are you sure that the topic is within your areaof expertise?
Are there literature to be the basis fordeveloping sensible hypothesis?
What about the availability ofmedical, laboratory, other facilities
expertise
drugs
study subjects (Lasagnas law)
time, money,
consultants, etc?
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Study Protocol
Aims as guidance for the investigator in the
whole process of the planned research
Different formats or styles, depending oninstitutions: should be followed rigidly
Followings are general requirements of
most research proposal
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Anatomy & PhysiologyI. Introduction
II. Literature review
III. Methodology
IV. ReferencesV. Appendices
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I. Introduction
A. Background
B. Research question(s)
C. Hypotheses
D. PurposeE. Significance
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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?
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Background
Typically 4-8 pages
I personally recommend to make subtitles
forBackground, so that the informationprovided and the logical sequence arebetter understood.
Six-page long background without subtitlesmay result in to and fro information thatmake the reader or even the writer getconfused.
Adequate and strong references
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Increased incidence of young people with AMI
Factors associated with young AMIGenetic 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
Single gene-mutation in familial
hypercholesterolemia in children of young
patients with myocardial infarction a
screening method and economic analysis
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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
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Formulation of background in interrogative
sentence(s) which are:
brief and direct
clear
not multi-interpretable
b. Research question(s)
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Is additional of drug A associated with betterprognosis in patients with diabetic neuropathy
compared with standard regimen?
Is neonatal asphyxia a risk factor for delayedmotoric 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?
Research question(s): examples
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A tentative answerfor research question thatshould be validated empirically
Hypothesis should not be judged as correct or
incorrect, but valid or not validNot 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.
c. Hypothesis
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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)
Characteristics of good hypothesis
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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 Aas compared with RL in managing pts with DSS
For analytic studies, in general, specific purposes
are in-line with hypotheses
d. Purpose of the study
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Academic
Clinical
Health policy
Further research
Note: quick vs. non-quick yielding
researches
e. Significance
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Detailed, but only aspects relevant to thesubstance of the research; no need to reviewall aspects of the disease or problem underinvestigation
Requirement: good literature search andappraisal - Original articles, reviews,quantitative reviews, meta-analyses
Most recent publications (use internet!); olderones for historical perspectives
Repeated revisions, including language:words, sentences, paragraphs, literature
citations, etc.
II. Literature review
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Theoretical framework: Summary of literature
review related directly to planned study
Not needed for grant application (included in
Background)
Followed by conceptual framework in theform of diagram showing inter-relationships
amongst variables
Theoretical & Conceptual
frameworks
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Design(s): one study may have more than
1 designsTime and place
Population: target, source
Criteria for inclusion and exclusionSample: sampling techniques
Sample size
III. Methods
All must be elaborated explicitly in great details!
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Procedures, equipment, drugs,
randomization, blinding, measurements,
interventions, follow-up, etc
Variable identification: independents,dependents, confounders, extraneous, etc
Definitions
Ethics Committee approvalPlan of analyses: types of tests, computer
programs used (appropriate, please!!),p
value, confidence intervals, etc
III. Methods (cont.)
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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 printedformat should be considered as unpublished
materials, as are theses, dissertations, personal
communications (use them if no comparable
published sources exist)
IV. References
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Investigator(s), incl. curriculum vitae and researchtract records / previous publications
Sponsors
Time tablePlan of budget
Formulae (sample size), specific procedures, etc
Dummy tables
Ethical clearance
Informed consent form
Other relevant materials or information
V. Appendices
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Research proposal (protocol)development is the very first step inresearch activities
Needs exercises by reading & reviewingother proposals; much better: learning bydoing
Arrangement of Title, Introduction, andMethods must be in logical sequences,reflecting scientific exercise
Badly written proposal will eventually
result in bad study conclusion(s)
Concluding remarks
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Be prepared forLasagnas law
Dissertation blue
Writers block
Technical, financial, procedural, bureaucraticaspects
Unwritten rules in PhD research: Supervisors
Examiners
Department and related institutions
Family Yourself
Its okay, but the show must go on
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After the study is
completed.
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Report
To examiners (for thesis / dissertation)
To academic society (medical journal)
To layman
Different approach
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To medical journal
Usual format: IMRAD
Always look Instructions to AuthorsIn-house style: specific for that
journal
A continuum from proposal to reportwriting
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To medical journal
PROPOSAL REPORT
Introduction - Introduction
Literature review - None
Methods - Methods- - Results
- - Discussion
- - Conflict of interestReferences - References