1
Table of ContentsA.Main Page..........................................................................................................................................4
1.Research title..................................................................................................................................4
2.Name of researcher........................................................................................................................4
3.Research Supervisor........................................................................................................................4
4.Keywords........................................................................................................................................4
5.Duration of research (Months).......................................................................................................4
6.Budget.............................................................................................................................................4
B.STATEMENT AND VERIFICATION........................................................................................................5
7.Researcher’s statement..................................................................................................................5
8.Verification from the responsible supervisor and the chairman of Research Module....................5
C.RESEARCH DESCRIPTION....................................................................................................................6
9.Background.....................................................................................................................................6
10.Problem Identification and Research Question(s).........................................................................7
Research problem :........................................................................................................................7
Research questions :.......................................................................................................................7
Hypothesis :....................................................................................................................................7
11.General Objective, Specific Objective and Research Benefit.........................................................7
General Objective:..........................................................................................................................7
Specific Objective(s):......................................................................................................................7
Research Benefit(s):.......................................................................................................................8
12. Literature Review and Conceptual Frame....................................................................................9
Tuberculosis...................................................................................................................................9
Introduction...................................................................................................................................9
Stop TB strategy in Indonesia.........................................................................................................9
DOTS program................................................................................................................................9
2
Medication of TB..........................................................................................................................10
Isoniazida......................................................................................................................................10
How does Isoniazida works?.........................................................................................................10
Clinical Uses..................................................................................................................................11
Compliance of the patient............................................................................................................11
Age Group....................................................................................................................................12
Theoritical Framework.....................................................................................................................13
Conceptual Framework....................................................................................................................14
13. Methods.....................................................................................................................................15
1.Design........................................................................................................................................15
2.Time and Place..........................................................................................................................15
3.Research Material.....................................................................................................................15
4.Research Procedure..................................................................................................................15
5.Population.................................................................................................................................16
6.Sample.......................................................................................................................................16
7.Inclusion and Exclusion criteria.................................................................................................17
8.Variable:....................................................................................................................................18
9. Operational Definition..............................................................................................................18
10.Methods for Data Collection...................................................................................................19
11.Data Analysis...........................................................................................................................20
12. Time Frame.............................................................................................................................21
14. Research Ethics..........................................................................................................................23
15. References.................................................................................................................................24
APPENDICES.....................................................................................................................................26
Appendices 1: Information for the prospective subject.............................................................26
Appendices 2:Informed Consent.................................................................................................26
3
Appendices 3: Booklet.................................................................................................................27
Identity Page................................................................................................................................28
Data Page.....................................................................................................................................29
Appendices 4 : Patient Medical Record (Form A1)......................................................................30
4
A.Main Page
1.Research titleDifference of TB drug compliance between elderly patient and non-elderly patient in a DOTS
environment
2.Name of researcherName: Aldo Ferly NPM: 0906550575
3.Research SupervisorName: Prof.Dr.dr. Rianto Setiabudy SpFK
Department: Pharmacology
4.KeywordsTubercolosis Directly Observed Treatment
Environment
Drug Consumption Compliance
Geriatric Medicine
5.Duration of research (Months)The research will be conducted in a total period of 6(six) months
6.BudgetRp2.836.685,00
5
B.STATEMENT AND VERIFICATION
7.Researcher’s statementWe herewith confirm that:
a. This research proposal with title stated in the main page is an original research, not a plagiarism
b. We agree to conduct the research with title stated in the main page
Researcher(s)
Aldo Ferly
Signature(s) Date
8.Verification from the responsible supervisor and the chairman of Research Module
Signature of Supervisor
(Name : ................................)
Signature of Chairman of Research Module
(Name : DR. dr. Saptawati Badarsono, MS)
C.RESEARCH DESCRIPTION
9.Background
6
Tubercolosis is a bacterial infection caused by the bacterial called Myobacterium
Tubercolosis infection.
Indonesia is the third largest Tubercolosis-infected country in 2008, according to the
latest survey by WHO Regional Office for South East Asia, TB incidence is 228 per 100,000
population, TB prevalence is 244 per 100,000 population and mortality is 39 per 100,000
population
One of the main problem of eradicating TB is low drug compliance among TB patient,
drug compliance is important because if the medication period of 9 months is not finished
completely, TB will relapse and a new more violent strain of TB will appear which immune to
previous medication. American Journal of Respiratory Care and critical care medicine
recorded that up to 77% of TB case is in fact recurring TBi
In order to fight the compliance problem Ministry of Health of Indonesia with World Health
Organization made a program which is called WHO-Indonesia Joint Evaluation that
recommends the changing of the strategy in handling the problem of Tubercolosis in
Indonesia. Since the year of 1995, Indonesia impliments new program to fight the
tubercolosis bacteria which is called the DOTS(Directly Observed Treatment Shortcource
Chemotherapy) program. By previous research it is proven that DOTS program is effective in
increasing the compliance of the patient.ii
According to Gerakan Terpadu Penanggulangan Tuberkolosis, even thought that most
cases of TB happened between the age of 15 to 55 years old, which is the productive age
but from year to year, there are large increase of incidence rate moves into the older
generation with it’s peak between the age of 55 to 64. This high incidence rate poses serious
treat because it might increase the prevalence rate of elderly with TB. Considering the
condition of the elderly people, the effectiveness of TB therapy might be different from adult
patient.iii
7
10.Problem Identification and Research Question(s)
Research problem :The research problem that we are going to address here is the effectiveness of DOTS program
especially in elderly people that can be measured by drug compliance.
Research questions :According to the research problem and background information above, We can make the
following research questions:
1. Is there any difference of TB drug compliance between elderly patient and non-elderly
patient in a DOTS environment?
Hypothesis :There are difference of TB drug compliance between elderly patient and non-elderly patient in a
DOTS environment
11.General Objective, Specific Objective and Research Benefit
General Objective:1. To find out whether there are difference of TB drug compliance between elderly patient
and non-elderly patient in a DOTS environment
Specific Objective(s):1. To identify the age group of the patient, whether they belong to elderly patient or non-
elderly patient
2. Measure the number of medication that they consumed in a month and categorize
wheter they are compliant or not
3. Find out if there are any difference of compliance between the elderly and non-elderly
patient
Research Benefit(s):Benefit(s) for the researcher:
To pass the necessary requirement of the first stage of research module of Faculty of
Medicine University of Indonesia
8
To prepare our research practice that will be conducted from the second to the sixth
semester
To improve the researcher’s skills both in theory and application of making a good
research
To gain knowledge of TB and understanding the effect of age group to TB drug
consumption compliance
Benefit(s) for the Institution:
To fulfill Tri Darma Perguruan Tinggi with its vision of conducting education, research,
and dedicative service to the community
To realize the vision of Faculty of Medicine University of Indonesia 2010
Benefit(s) for the government:
Increase government care for the elderly
To Evaluate the effectiveness of the ongoing DOTS program
To be used to develop the enhanced DOTS program
Benefit(s) for the Society:
To educate the society of the effect of different age group in drug consumption
compliance
12. Literature Review and Conceptual Frame
Tuberculosis
IntroductionTuberculosis is an infectious disease which cause the highest mortality in the world. The
World Health Organization predicts that 2 billion people have latent TB, 3 million people die of
this disease annually.iv
Stop TB strategy in IndonesiaMinistry of Health in the book Kerangka Kerja Strategi Pengendalian TBC di Indonesia
tahun 2006-2010 made a strategic plan to control TB which consists of:
9
Expansion of TB control:Error: Reference source not found
1. Pursue quality DOTS expansion and enhancement
2. Address TB/HIV, MDR-TB and other challenges
3. Involve all care provider
4. Engage TB patients and affected communities
Supported by health system strengthening
1. Strengthened policy and ownership
2. Strengthened health system and TB control management
3. Research
For this research, we will focus more on the first step of Expansion of TB control which is to
pursue quality DOTS expansion and enhancement
DOTS programIn 1994, Indonesian government make a collaboration with the World Health
Organization(WHO), making a committee on evaluation of TBC which is called WHO-
Indonesian Joint Evaluation, this committee makes the recommendation of the need to make
substantive change in the strategy to eradicate TB from Indonesia which is called “DOTS
Strategy” from that moment DOTS strategy was born. v
DOTS itself is an acronym for Directly Observed Treatment Shortcourse which mean a
direct consumption of medication in the presence of Drug Consumption Observer (DCO)
The primary aims of this program are to have a high recovery rate of TB patient, to
prevent TB patient to stop the medication before fully cured and to prevent any side effect of the
medication and any resistance of the medication.
Before the first treatment commence, DOTS must be explained to the patient both the
mechanism and also the benefits. One DCO must be chosen and present in the polyclinic. DCO
must be a person who wants to help the patient until he or she fully recover(at least 6 months)
usually DCO is a family member which is trusted by the patient.
Medication of TB
10
The medication of TB is four drugs which are: Isoniazida, Rifampisin, Pirazinamida,
Streptomisin and Etambutol. These drugs are given in combination. These drugs are now
combined into one tablet which is called four in one.vi
In medication of TB the main problem is that many doctor does not follow the standard
protocol from the ministry of health and prescribe the 4 drugs separately, this will make the
patient confused and decrease the compliance of the patient.
In the following passage, we will discuss briefly about the type of TB medication used in this
study
Isoniazidavii
Isoniazid is the most active drug for the treatment of tuberculosis caused by susceptible
strains. The size of Isoniazida structure is small and can be easily solubled in water.
How does Isoniazida works?Inside the bacteria body, This drug inhibits most tubercle bacilli in a concentration of 0.2
mcg/mL or less and is bactericidal for actively growing tubercle bacilli. It is less effective against
atypical mycobacterial species. Isoniazid penetrates into macrophages and is active against
both extracellular and intracellular organisms
Clinical UsesThe usual dosage of isoniazid is 5 mg/kg/d; a typical adult dose is 300 mg given once
daily. Up to 10 mg/kg/d may be used for serious infections or if malabsorption is a problem. A
15 mg/kg dose, or 900 mg, may be used in a twice-weekly dosing regimen in combination with a
second antituberculous agent (eg, rifampin 600 mg). Pyridoxine, 25–50 mg/d, is recommended
for those with conditions predisposing to neuropathy, an adverse effect of isoniazid. Isoniazid is
usually given by mouth but can be given parenterally in the same dosage.
Isoniazid as a single agent is also indicated for treatment of latent tuberculosis. The
dosage is 300 mg/d (5 mg/kg/d) or 900 mg twice weekly for 9 months.
Compliance of the patientThe compliance of the patient is one of the main concern of TB medication. TB
medication must be taken for 6 to 8 months. The length of the medication usually makes the
patient bored and stopped in the middle of the medicationviii
11
Usually, after taking medication for 2 months, patient feel healthy and stop the
medication. Actually, the wellness feeling of the patient does not mean that TB germs are fully
eradicated. It is generally accepted that a TB medication can only stop after 6 to 8 months of
treatment.
The lack of compliance in taking medication is one of the largest problem in eradicating
TB. If the patient is not compliance, TB germs will be resistant to the medication and in turn will
be much more ferocious. If that condition happened, the medication will be much more
complicated, the drugs will be much more limited, the time of the medication will be much more
longer and also the medication will be much more costly. Moreover, the patient will be a source
of future spreading of the “improved” disease toward the society
This is a very serious problem. In the DOTS strategy, this problem is solved by using
“Increased surveilence”. Every TB patient have their own Drug Consumption Observer who
have the obligation to remind the patient to take their own medication. DCO is trained to ensure
that the patient really take the medication in the limited time constraint. DCO must ensure and
observe that the patient really take the medication.Error: Reference source not found
According to WHO, the definition of compliance is taking 85% of the medication. In this
study we use this definition to term compliance.ix
Age Group In this research we divide the age into several categories according to age cycle, life
cycle grouping which are: below 65 and above 65 these 2 categories represents. According to
the classification according to life cycle grouping, age above 65 is considered as elderly.
There are several factors which enables that the elderly age group has different drug
compliance with the non-elderly. The three factors are: memories, activity and other diseases
beside TB
Elderly memories are different with the adults memory, elderly people are more prone to
many memory-related disease such as Alzheimer disease that can decrease the memory. The
decrease of the memory might lead to low compliance because the subject does not remember
taking the medication
12
Activity means that elderly people has different set of activity with younger person. For
example, the elderly must spent time more in sleeping than the younger person. This might
affect the compliance of the medication in older people
Other disease beside TB means that older people usually have more than 1 disease so,
the medication will be much more complicated than younger people.
Theoritical Framework
13
Conceptual Framework
14
13. Methods
15
Compliance of
TB Medication
1.DesignThis research use cross sectional design to try to find out association between the age
group and the compliance of drug consumption in TB patient.
2.Time and PlaceThis research will take place in puskesmas cawang from November 1st 2009 to June 1st
2010
3.Research MaterialMaterials needed for this research are:
Isoniazida
Booklets to record everyday TB consumption
Form to record the medication that the patient returned in the end of the month
4.Research ProcedureThe procedure of this research is as following
1. In the 1st of March 2010, participants of this research will be given medication of TB
according to their usual TB medication, participants are asked to take the medication
normally and record any drug consumption on the booklets provided. The researcher
must tell the patient to bring the medication that he/she has not finished consumed after
a month but do not tell them that the medication will be counted
a. Rules concerning the consumption of medication are in line with DOTS program
guidelines including the presence of Drug Consumption Observer
2. In the end of the month, 31st of March 2010, participants are asked to return the
medication that they have not yet finished consume in the one month period. Some
medication are expected to be returned by each of the research participant.
3. The researcher count the medication returned by the patient and fill form A1(see
appendices) which objective is to record the name of the patient, their Drug
Consumption Observer and the medication returned.
4. Make sure the number returned are according to the booklets that records daily TB
consumption
5.Population
16
Target PopulationIn this research, the target population is pulmonary TB patient taking medication in DOTS environment
Accessible populationAccessible population for this research is the patient of pulmonary TB patient currently taking medication of TB in puskesmas cawang in the period of march-april 2009
6.SampleSample choosing method:
In this research, we choose the sample based in systematic sampling method.
simple illustration of systematic sampling method:
Suggest that in puskesmas Cawang we want to choose 20 patient out of 200 patients
using the method of systematic sampling, so, it is needed 20/200 or in other words 10 out of 100
patients, so, every 10 patient will be chosen by the researcher. In the beginning of the research
every subject was given number from 1 to 200. Every 10th patient will be chosen as sample. The
determinant of the first number should be done randomly for example by using pencil tip. If, for
example, the first number is 3 than patient number 3,13,23,33,43,53 … will be chosen as
research subject.
Sample Sizex
The number of the sample used in this study will follow the minimum sample size formula for
cross-sectional study. The formula used for this study is:
The definition of each symbols are:
n = sample size
P = proportion of the condition that we are going to find out
q = 1-P
d = different between proportion of the sample and population
17
= Value of normal curve according to which is the confidence level
In this section, we are going to determine each of the value above
P
From the literature, we found out that TB prevalence in Indonesia is 0.00224 therefore the value
of P is 0.00224
q
The value of q is 1-0.00224 which is 0.99776
d
We want that the relative accuracy of this study is 1% therefore, the value of d is 0.01
In this study, we want to minimize the type 1 error to 5% so, the value of according to
normal curve value is 1.96
So, from the explanation above, we will calculate the sample size needed:
= 85
However, we must add 10% of the population to safeguard against dropout sample:
85+(10% x 85) = 85+8.5 = 94
The final sample size needed is 94 people
7.Inclusion and Exclusion criteria
Inclusion criteria:1. Patient of pulmonary TB in the period of January-October 2010
2. Patient participate in DOTS program in eradicating TB done by the ministry of health
3. Patient has taken TB medication for 2 to 5 months
18
4. Both genders are eligible
Exclusion criteria:1. Patient have conditions and/or disease that could disturb interpretation of the result
2. Patient does not have any close relative/person that act as Drug Consumption Observer
3. Patient refuse to participate
Drop out criteria:1. Patients failed to record the daily drug taking activity in the book provided by the
researcher
2. Patients failed to return the drug in the end of the month
3. Researcher Lose contact with the patient
4. Patient lose contact with their DCO during the medication period
8.Variable:In this study, the independent variable is the age of the subject with the possible value
as 2 categorial data which are: below the age of 65 or above the age of 65
The dependent variable is the compliance of the subject to the medication give
according to the DOTS guideline, the compliance of the medication is categorized into
compliant, if the patient consumed more than 85% of the medication or non-compliant if the
patient consumed less than 85% of the medication.
9. Operational DefinitionTo avoid misinterpretation and misguidance, important terms in this research are defined as
follow:
The term compliance in this procedure refers to number of medication. The patient is
said to comply if he/she takes 85% of the medication
The term non-compliance in this procedure if a patient failed to take 85% of the
medication
Tuberculosis in this program refers to the bacteria Mycobacterium tubercolosis that
affect lung
DOTS program is a program in eradicating TB outlined in Indonesian-WHO joint
evaluation(1994)
Age is a period from the delivery shown by the date of birth in the identity card until now
19
DCO(Drug Consumption Observer) is a person assigned to observe the drug
consumption of the patient
10.Methods for Data CollectionFirst, the patient must understand the procedure for the experiment, the aim and
purpose of the experiment and sign the informed consent paper that will have been prepared by
the research team in 1st of March 2010.
In the 1st of March 2010, patient and his/her DCO will be given the medication needed
monthly medication. The amount of the drug is according to their usual monthly TB medication +
10% buffer size. For example: if the person usual monthly medication is 60 tablets, then the
medication that is given is 60+(10% x 60) = 66 tablets.
The patient and their DCO are asked to fill the booklet prepared by the researcher team
throughout the 1 month medication period.
In 1st of April 2010, research team will collect the booklets and the medication that the
subject has not finished during the 1 month period. The data collection will be in the puskesmas
Cawang. After the samples are collected, the following steps must be taken by the researcher:
Calculate the medication returned by the test subject. The number returned by
the patient will determine the drug compliance of the patient
Analyze the booklet to determine if the number of medications returned are
caused by compliance or other factor (misplaced drug etc.)
11.Data AnalysisAfter the results have been collected, the researcher will use the data to determine these
four outcomes:
Subject with age higher than 65 with high drug compliance
Subject with age higher than 65 with low drug compliance
Subject with age lower than 65 with high drug compliance
Subject with age lower than 65 with low drug compliance
20
Then, We fill the group to this table
Subject with age
lower than 65
Subject with age
higher than 65
Total
Subject with low drug
compliance
a B a+b
Subject with high drug
compliance
c D c+d
Total a+c b+d a+b+c+d
Then, we move to the next part which is Inferential Statistics
Inferential Statistics
The first step that we should do in doing statistical analysis is determine the null hypothesis
Null hypothesis
There are no correlation between age group on drug consumption compliance of a pulmonary
tubercolosis patient in a directly observed treatment environment
Alternative hypothesis
There are correlation between age group on drug consumption compliance of a pulmonary
tubercolosis patient in a directly observed treatment environment
Stastical Analysis
21
The data analysis will be done with SPSS 16.0 software which is available in the Faculty
of Medicine University of Indonesia computer lab.
Because the data is between two categorical data which are age group and consumption
compliance, we will use the chi-square test to determine if the result of this study is statistically
significant or not. In doing the chi-square test, we must remember that there are 2 conditions
that must be fulfilled so the test can be done:xi
1. No cells in the crosstable are empty
2. No cells have expected count less than 5
If the condition cannot be fulfilled then we should use another test called fisher test. The
significant result of both the chi-square test or the fisher test then is used to found out is the
result. if the result <0.05 then the result is considered statistically significant and we reject the
null hypothesis.
12. Time FrameNov
09
Dec
09
Jan 10 Feb 10 Mar 10 Apr 10 May 10 Jun 10
Make research
proposal
X
Proposal
submission
X
Proposal
evaluation
X
Booklet
printing
X X
Preparation of
Medication
X
22
Data collection X
Data analysis
and
interpretation
X X
Report writting X
14. Research Ethics.
This study uses human as it’s subject, but the discomfortnes of the subject of this study will be
minimal since the medication that the patient use are the same as what they received every
other month.
Factor that will possibly cause discomfort in the patient is the obligation for the patient to come
to the puskesmas the day the research began in the 1st of March 2010 to receive the drug
consumption booklet and 1st of April 2010 to collect the booklet and the medication that has not
yet been consumed. Our effort to minimize the discomfort is to increase the number of our
researcher collecting the data and giving the booklet so, the waiting time will be minimalized
23
To compensate with the discomfortness that the patient may experience in this research,
researcher will pay for the drug in the month of the research.
This research will upheld ethical value highly especially the value of autonomy, beneficence,
non-malefience and justice.
In this study, we believe that patient autonomy must be held with highest appreciation in order
to achieve that we must make sure that the patient really understand the research and the
subject will be given informed consent, which gives their approval about their participation in this
study. Patient who refuse to participate in the study must be excluded from the study
The principle of beneficence and non-maleficence is shown by ensuring that every medication
given to the patient valid and does not expired
The principle of justice is shown by treating every patient with the same manner regardless of
the background.
This proposal will be reviewed by the ethical commission of the FKUI in order to have ethical
clearance to do the research.
15. References1Badan Pusat Statistik. TB in Indonesia [pamphlet]. Jakarta:Penerbit Departemen Kesehatan;
20082 Moulding, TS. Medication Monitors to Treat Tuberculosis. American Journal of Respiratory and
Critical Care Medicine 1999;159:989-991
3 Burman WJ. Effectiveness of Time and Cost of DOTS program against SAT in Denver.
DenverMed 19944 Supari SF. Kerangka Kerja Penanggulangan TB 2006 – 2010. Jakarta: Departemen
Kesehatan;2006
24
5 Reddy TB, Riley R, Wymore F, Montgomery P, Decaprio D, Engels R, Gellesch M, Hubble J,
Jen D, Jin H, Koehrsen M, Larson L, Mao M, Nitzberg M, Sisk P, Stolte C, Weiner B, White J,
Zachariah ZK, Sherlock G, Galagan JE, Ball CA, Schoolnik GK. TB database: an integrated
platform for tuberculosis research. Nucleic Acids Res doi: 10.1093/nar/gkn6526 Permatasari A. Pemberantasan Penyakit TB Paru dan Strategi DOTS.e-USU repository 2005
7 Obat Anti Tuberkulosis (OAT) Program TBC. [Online]. 2009 [cited 2009 Nov 17]; Available
from: URL: http://www.tbindonesia.or.id/tbnew/obat/article/61/0003/48 Katzung BG., Basic and Clinical Pharmacology. 10th ed. San Fransisco(CA):Mcgraw Hill;2006.
9Senewe FP. Faktor-Faktor yang Mempengaruhi Kepatuhan Berobat Penderita Tuberulosis
Paru di Puskesmas Depok.BulPenelKesehatan 2002; 30:31-38
10Tuberculosis. [Online]. 2009[cited 2009 Nov 18]; Available from: URL:
http://www.who.int/topics11Age Categories, Life Cycle Groupings. [Online]. 2008 [cited 2009 Nov 18]; Available from:
URL: http://www.statcan.gc.ca/concepts/definitions/age2-eng.htm12Sastroasmoro S. Ismael S., Dasar-dasar Metodologi Penelitian Klinis. 3rd ed. Jakarta:Sagung
Seto;200713Muhlisi LA. Pengaruh Gender Terhadap Kepatuhan Minum Obat Penderita Tuberkulosis
Dengan Menggunakan Program DOTS di Kabupaten Purworejo.UGM repository 2004
16.Detail of BudgetType of Cost Subtype Information Amount
Transportation Rp 150.000,00
Photocopy
Booklet 95x10x100 Rp 95.000,00
Consent 95x100 Rp 9500,00
Souvenir
Patient 95x4000 Rp 380.000,00
Drug Cost
25
Puskesmas 29x67.045 Rp1.944.305,00
Sub total Rp2.578.805,00
Unpredicted cost 10% from sub total Rp 257.880,5
Rp2.836.685,00
i Moulding, TS. Medication Monitors to Treat Tuberculosis. American Journal of Respiratory and Critical Care Medicine 1999;159:989-991
ii Burman WJ. Effectiveness of Time and Cost of DOTS program against SAT in Denver. DenverMed 1994iii Supari SF. Kerangka Kerja Penanggulangan TB 2006 – 2010. Jakarta: Departemen Kesehatan;2006iv Reddy TB, Riley R, Wymore F, Montgomery P, Decaprio D, Engels R, Gellesch M, Hubble J, Jen D, Jin H, Koehrsen M, Larson L, Mao M, Nitzberg M, Sisk P, Stolte C, Weiner B, White J, Zachariah ZK, Sherlock G, Galagan JE, Ball CA, Schoolnik GK. TB database: an integrated platform for tuberculosis research. Nucleic Acids Res doi: 10.1093/nar/gkn652v Permatasari A. Pemberantasan Penyakit TB Paru dan Strategi DOTS.e-USU repository 2005
vi Obat Anti Tuberkulosis (OAT) Program TBC. [Online]. 2009 [cited 2009 Nov 17]; Available from: URL: http://www.tbindonesia.or.id/tbnew/obat/article/61/0003/4vii Katzung BG., Basic and Clinical Pharmacology. 10th ed. San Fransisco(CA):Mcgraw Hill;2006.
viii Senewe FP. Faktor-Faktor yang Mempengaruhi Kepatuhan Berobat Penderita Tuberulosis Paru di Puskesmas Depok.BulPenelKesehatan 2002; 30:31-38
ix Tuberculosis. [Online]. 2009[cited 2009 Nov 18]; Available from: URL: http://www.who.int/topics
x Sastroasmoro S. Ismael S., Dasar-dasar Metodologi Penelitian Klinis. 3rd ed. Jakarta:Sagung Seto;2007xi Muhlisi LA. Pengaruh Gender Terhadap Kepatuhan Minum Obat Penderita Tuberkulosis Dengan Menggunakan Program DOTS di Kabupaten Purworejo.UGM repository 2004
26
APPENDICES
Appendices 1: Information for the prospective subjectThe recovery rate of TB in Indonesia is very low, one of the reason why this happens is because
of the low drug compliance of TB patient. Compliance in consuming medication especially in TB cases is
very important because TB will relapse if the patient does not finish the medication. In this study,
researche try to find out if there are any correlation between age and drug medication compliance of
TB patient.
This research is very important as previously in the DOTS program, the methods to handle
patient are same regardless of age. If there is difference of compliance between the age, ministry of
health should make new guideline to differentiate TB patient with higher age and also lower age
All patient data will be confidential and only be used for research purpose, If there is anything
that you do not understand please kindly ask the researcher.
Appendices 2:Informed ConsentInformed Concent
I have read and understand the experiment and agree to help the researcher in his research about Correlation of Age Group on Drug Consumption Compliance of a Pulmonary TB patient in a Directly Observed Treatment Environment.
By signing this form, I agree to participate in this study.
Jakarta, March 2010
Signature
(Full Name: ........................................................)
27
Appendices 3: BookletTitle Page
TB Medication Booklet
For
Correlation of Age Group on Drug Consumption Compliance of a Pulmonary Tubercolosis Patient in a Directly Observed Treatment Environment
Research Purpose
28
Identity PagePatient
Name : ………………………………………..
Age : ………………………………………..
Weight : ………………………………………..
Address : ………………………………………..
Contact Number : ……………………………………….
DCO
Name : ……………………………………….
Age : ……………………………………….
Address : ……………………………………….
Contact Number : ………………………………………
Relation to patient : ………………………………………
29
Data PageDate/Time : …………………/…………………..
Type of Medication : ………………………………………
Quantity : ………………………………………
DCO Sign
Date/Time : …………………/…………………..
Type of Medication : ………………………………………
Quantity : ………………………………………
DCO Sign
Appendices 4 : Patient Medical Record (Form A1)Patient
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Name : ………………………………………..
Age : ………………………………………..
Weight : ………………………………………..
Address : ………………………………………..
Contact Number : ……………………………………….
DCO
Name : ……………………………………….
Age : ……………………………………….
Address : ……………………………………….
Contact Number : ………………………………………
Relation to patient : ………………………………………
Drug
Drug given in the beginning of a month : …………………………..
Drug expected to be taken in a month : …………………………..
Drug returned in the end of the month : …………………………..
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