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

Apr 14, 2018

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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