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
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 as original research, original contribution, or original article

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. II. III. IV. V. Introduction 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 Introduction Literature review Methods References REPORT - Introduction - None - Methods - Results - Discussion - Conflict of interest - References