Standard for

Writing Study Proposal

Jarir At Thobari

Faculty of Medicine

Universitas Gadjah Mada

September - 2014

Block 3.1

In science, the credit goes to the man who

convinces the world, not to the man to

whom the idea first occurs

Sir Francis Darwin

Start

Registration of thesis preparation

Verification thesis title

Completing thesis administration

Submit thesis title (signed by supervisors) to secretariat study program

Proposal writing (guided by supervisors)

Changed title Proposal Seminar

Proposal seminar

Proposal revision

Submit proposal for ethical clearance to the Ethics Committee

Thesis manuscript & publication revision

Thesis examination

Final revision (thesis and manuscript publication) & endorsed by supervisor and examiner

Selesai

Submit thesis’s soft copy & manuscript publication to library FM UGM

Research conduct, data analysis, writing thesis and manuscript publication

FINISH

STRUCTURE OF STUDY

PROPOSAL (FOR UNDERGRADUATE STUDENTS)

Title

Accurately, completely, and

specifically identify the main

topics

Be unambiguous, Be

concise

Attract intended readers

Include independent and

dependent variables

Include setting and design

Title - cont

Avoid

Acronyms

Abbreviations

Noun clusters

Complement fixation laboratory technique for adult

rhesus monkey antigen isolation

Keep word order simple

Title... example

The Effect of Acetylator Status

on Serum Levels of Isoniazid and

Sputum Conversion

of Tuberculosis Patients in Yogyakarta:

A cross sectional study

Main Part (Chapter) (1) Introduction,

(2) Literature Review,

(3) Methods

(4) References

Chapter I – Introduction

(a) Study Background,

(b) Problem Formulation,

(c) Study Originality ,

(d) Study Benefit, and

(e) Objectives

Background

Brieftly and compact

Flow in systematic structure, logic and attractive

Indicate the burden of the existing problem

Indicate the strong reason why the study is needed to be

done.

Early paragraph main existing problem and indicate it

is important to be solve

Background – cont...

Include known, unknown and the question

The nature and scope of the problem

The gap or general problem

Previous findings, pertinent literature

General method statement (ex. animal study)

The hypothesis/research question-signal

Background – cont...

Use the present tense for what is currently true

Use the past tense for previous findings

Use past tense to state the question

Avoid using names or other investigators

Repeat key terms from the title

Make the gap obvious

Common errors: too much background, no gap, no question

Background

What is the Tuberculosis?

Burden of Tuberculosis worldwide

Burden of Tuberculosis national

Factors are contibuted for effectiveness of treatment (sputum

conversion) such as HIV co-infection, MDR-TB

MDR-TB is caused by inadequate TB management

TB management in general and isoniazid as first line antibiotic

and how it is metabolized in the body

Polymorphism cause difference on acetylator status of isoniazid

Study showed inconsistently on effect of acetylator status on

succesfull of treatment

Problem Formulation

An explanation of the reasons why the

issues raised in the proposed study are

considered interesting, important and need

to be investigated.

Describe the position of the study problem

in a wider range of problems.

Problem formulation

Is serum levels of Isoniazid in adult pulmonary

tuberculosis patients who received intensive therapy

influenced by acetylator status?

Does serum levels of Isoniazid affects the success and

failure of sputum conversion in adult pulmonary

tuberculosis patients?

Does acetylator status affect sputum conversion in adult

pulmonary tuberculosis patients?

Study Originality/authenticity

The authenticity of the research presented

to show that the problems encountered

have never been solved by previous

researchers.

Study originality

Research on polymorphism genotyping NAT2 in

Indonesian population ever conducted (Yuliwulandari et

al., 2007). This study shows that 65.4% is a rapid

acetylator and 35.6% were slow acetylator, but the study

does not explain the effect of genotype on levels of

Isoniazid and TB treatment success

Research on the relationship between acetylator status

on TB treatment success ever done (Weiner et al.,

2003). But 88% of the study subjects are racial or ethnic

whites, African Americans, and Hispanics.

Study Benefits

Explains the benefits can be expected from

the results of research to the development

of science and for healthy of patients,

population and for policy making

Study Benefits

The result is expected to provide scientific information on

the effect of acetylator status on levels of serum INH and

its influence on the success of TB treatment.

Results of this study will provide important scientific

information that can support the success of the

government's TB eradication program and STOP TB

programs that have been implemented

Study Objectives

Specify the purpose or goal to be

achieved.

Goals can be general purpose consisting

of some special purpose.

Study Objectives

General Purpose Determine the effect of acetylator status on the success of

therapy and serum levels of INH in adult pulmonary TB patients

in the city of Yogyakarta.

Special Purpose

1. Determine the effect of acetylator status on serum

levels of INH in adult pulmonary TB patients.

2. Determine the effect of serum levels of INH in

patients with sputum conversion in adult pulmonary

TB patients

3. Determine the effect of acetylator status on sputum

conversion in adult pulmonary TB patients

Chapter II – Literature Review

(a) Literature review,

(b) Basic Theoretical,

(c) Conceptual Framework

(d)Hypothesis,

Literature Review

A systematic description of the results of studies that

have been conducted by previous researchers, and

nothing to do with the research that will be done.

It should be pointed out that the problems studied

unanswered or unresolved satisfactorily.

The facts are presented taken from the original source.

All sources used must be specified by stating the

author's name and year of publication (in the name of

the system), as listed in the bibliography.

Literature Review

Tuberculosis

Burden of disease

Tuberculosis treatment

Isoniazid

Polymorphism and Genetic Factor

Acetylator status

Sputum conversion

Basic Theory

Described the theoretical basis of a

literature review and compiled as a guide

to solve the problem and to formulate

research hypotheses.

Can form the theoretical basis of

qualitative description, mathematical

models, or equations are directly related

to the fields of science under study.

Basic Theory

Isoniazid (INH) is one of the major antituberculosis drugs and TB

treatment success is influenced by levels of INH. Several factors

influence the levels of INH such as drug and patients factors

(acetylator status)

Acetylator status is influenced by polymorphisms and it is known that

two thirds of the population of Indonesia is a fast acetylator group

In the group of rapid acetylator status, INH metabolism is faster so

that the lower levels of INH.

Evaluate the success of TB treatment success expressed by sputum

conversion.

Several factors can affect the success of sputum conversion such as

patient factors (age, nutritional status, smoking status, and co-

morbidities; treatment continuity as side effects of drug treatment and

medication oversight.

Conceptual Framework

Describes the research flow chart of the

process of research to be conducted in

accordance with the formulation of the problem

and the objectives to be achieved.

Conceptual Framework

Acetylator Status of

Patients with

Tuberculosis

Serum concentrations

of Isoniazid

Serum Conversion

Patient Factor

age, sex,

smoking, nutrition

Drugs Factor

type, dosage,

frequency, duration

Continuity of treatment

Side effects of drugs

and DOT

Others

Drug Resistance

and HIV infection

Hypothesis

A brief statement concluded from a literature or

theoretical basis and is a temporary answer to

the problem, and still have to be verified.

The hypothesis does not necessarily have to

exist in the proposed research

Hyphothesis

Adult pulmonary TB patients with rapid acetylator status had lower

levels of serum INH compare to slow acetylator status.

There are differences in the mean serum levels of INH between

success and failure on sputum conversion in adult pulmonary TB

patients

Adult pulmonary TB patients with rapid acetylator status have the

risk of failure on sputum conversion is greater than slow acetylator

status.

Chapter III – Study Methodology (a) Type and Study Design,

(b) Time and Study Settings,

(c) Study subjects,

(d) Sample size,

(e)Study Material and Tools,

(f)The course of study,

(g) Study Variables,

(h) Operational Definitions of variables

(i) Analysis of the results (statistics methods)

(j) Ethical Consideration

(k) Study schedule and costs

Type and Design Research

The type and design of the study

are used in the study (the study

design will be described in detail

elsewhere).

Example: The study is an observational

study design cross sectional method, to

assess the status of INH acetylator and

measured levels in serum and sputum

conversion in patients with smear-

positive pulmonary TB.

Time and study settings

Mention when the study will be

done, and where the study will be

conducted.

Example: The study will be conducted over 6

months period between January-June 2013. The

study will be conducted in the city of Yogyakarta

at the 4 primary health centers. Measurement of

serum levels of INH and determination of

acetylator status will be performed in the

Laboratory of Pharmacology and Fac. Medicine

UGM.

Study subjects

Who are the study subjects? What are elligibility

criteria? (Inclution and exclution criteria of the

subjects who will be included in the study)

Example: Subjects are adult pulmonary TB patients in the city of

Yogyakarta obtained from 4 Primary health centers, and taken in

sequence until sufficient number of samples. Subjects are included

if....., subjects are excluded from study if .......

Sample size

Number of subjects will be needed

to approve the hypothesis.

Formula is used to calculate

sample size

Error type I and error type II are

used to calculate sample size and

assumptions for the study results

Sample size calculation will be

described in detail elsewhere

Study materials and tools

(devices)

Materials specifications to be

determined.

Tools used to conduct the

research must be clearly

defined and, if necessary,

accompanied with pictures

and descriptions.

Course (procedure) of study

Clearly and detail describe how the each step

of the study will be performed

Example: how the acetylator status will be determined?;

how the serum level of isoniazid will be measured?; how

the sputum conversion will be determined?

Research variables

Mention research variables that will be

studied as

independent variables,

dependent variables,

confounding variables,

and others.

Operational definition

Mainly with the operational definitions of

study variables such as how to clear

measurement and units of measurement

used. Example: Serum levels of INH is INH concentration measured

in the serum of patients from venous blood samples of the

subjects are taken two hours after taken INH patients on day

56 of treatment or during the intensive phase is completed.

INH concentrations are measured by HPLC method and is

expressed in units of µg/ml.

Schedule of Research and costs

In a study schedule is shown the stages of

research, details of activities at each stage, the

time required to carry out each stage. Schedule

research can be presented in matrix form or

description. Schedule research can be

presented in tabular form or description.

In the proposed thesis research students are

asked to plan the costs for thesis research.

Ethical Consideration

Informed consent or compliance with animal welfare regulations

Approval for Ethical Committee

“Before the study start, the protocol will be approved by Medical

and Health Research Ethics Committee (MHREC) Faculty of Medicine, Universitas Gadjah Mada. Informed consent is to be obtained directly from each subject. Once the informed consent document has been signed, subjects are considered enrolled in the study”

Methods – cont...

LAST PART

(a) References

(b) Appendix

Reference – harvard style

Article from Scientific Journal

You, C.H., Lee, K.Y., Chey, R.Y., Menguy, R., 1980.

Electrogastrographic study of patients with unexplained nausea,

bloating and vomiting. Gastroenterology 79(2):311-4.

Goate, A.M., Haynes, A.R., Owen, M.J., Farral, M., James, L.A.,

Lai, L.Y., et al., 1989. Predisposing locus for Alzheimer's

disease on chromosome 21. Lancet 1:352-5.

The Royal Marsden Hospital Bone-marrow Transplantation

Team, 1977. Failure of syngeneic bone-marrow graft without

preconditioning in post-hepatitis marrow aplasia. Lancet 2:742-4.

Reference – harvard style

Article from scientific journal with volume from supplements

Magni, F., Rossoni, G., Berti, F., 1988. BN-52021 protects guinea-pig

from heart anaphylaxis. Pharmacol. Res. Commun. 20 Suppl 5:75-8.

Gardos, G., Cole, J.O., Haskell, D., Marby, D., Paine, S.S., Moore, P.,

1988. The natural history of tardive dyskinesia. J. Clin.

Psychopharmacol. 8(4 Suppl):31S-37S.

Article from scientific journal without volume

Baumeister, A.A., 1978. Origins and control of stereotyped movements.

Monogr. Am. Assoc. Ment. Defic. (3):353-84.

Article from scientific journal with comments

Piccoli, A., Bossatti, A., 1989. Early steroid therapy in IgA neuropathy: still open

question [comment]. Nephron 51:289-91.

Reference – harvard style

Author is single author

Colson, J.H., 1986. Sports Injuries And Their Treatment. 2nd rev. ed. S. Paul,

London.

author is an editor

Diener, H.C., Wilkinson, M. (Eds.), 1988. Drug-Induced Headache. Springer-

Verlag, New York.

Author is an organization

Virginia Law Foundation, 1987. The Medical And Legal Implications Of AIDS. The

Foundation, Charlottesville.

Article from books chapter

Winstein, L., Swartz, M.N., 1974. Pathologic properties of invading

microorganisms. In: W.A., Sodeman Jr, W.A. Sodeman (Ed.): Pathologic

Physiology, Mechanisms of Disease, pp: 457-72. Saunders, Philadelphia.

Reference – harvard style

Proceedings from conference/seminar

Vivian, V.L. (Ed.), 1985. Child abuse and neglect: a medical community response.

Proceedings of the First AMA National Conference or Child Abuse and Neglect;

1984 Ma 30-31; Chicago: American Medical Association, Chicago.

Manuscript from scientific meeting

Harley, N.H., 1985. Comparing radon daughter dosimetric and risk models.

In:Gammage RB, Kaye SV, editors. Indoor air and human health. Proceedings of

the Seventh Life Sciences Symposium; 1984 Oct 29-31; Knoxville (TN), pp:69-

78. Lewis, Chelsea (MI).

Technical or scientific report

Akutsu, T., 1974. Total heart replacement device. National Institutes of Health,

Bethesda (MD). National Heart and Lung Institute; Report No.:NIH-NIHI-69-

2185-4.

Reference – harvard style

Thesis

Youssef, N.M., 1988. School adjustment of children with congenital heart disease

[dissertation]. Univ. of Pittsburg, Pittsburg (PA).

Electronic manuscript

Morse, S.S., 1995. Factors in the emergence of infectious diseases. Emerg Infect

Dis [serial online] [cited 1996 Jun 5];1(1):[24 screens]. Available from: URL:

http://www.cdc.gov/ncidod/EID/eid.htm

Monograph in electronic format

CDI, clinical dermatology illustrated [monograph on CD-ROM]. Reeves JRT,

Maibach H. CMEA Multimedia Group, producers. 2nd ed. Version 2.0 San Diego:

CMEA; 1995.

Thank You