standard for writing study proposal
DESCRIPTION
Jarir at Thobari-2014TRANSCRIPT
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