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RAJIV GANDHI UNIVERSITY OF HELATH SCIENCES
BANGALORE-560041
Proforma for Registration of Subjects for Dissertation
MR. ANOOP MASIH SANDHU
1ST YEAR M.SC. (NURSING
NAME OF THE CANDIDATE AND VIVEKANANDA
COLLEGE
OF
1
ADDRESS
NURSING
CHITRADURGA – 577501
KARNATAKA –INDIA
VIVEKANANDA
2
COLLEGE
OF
NAME OF THE INSTITUTE
NURSING CHITRADURGA-57501.
M.SC. NURSING 1ST YEAR
3
COURSE STUDY AND SUBJECT
MEDICAL SURGICAL NURSING.
4
DATE OF ADMISSION TO COURSE
11-06-2009
A
STUDY
TO
ASSESS
THE
AWARENESS OF DOTS THERAPY
AMONG TUBERCULOSIS PATIENTS
5
TITLE OF THE TOPIC
AT
SELECTED
HOSPITALS
CHITRADURGA, KARNATAKA.
1
AT
1. BRIEF RESUME OF INTENDED WORK
a. INTRODUCTION
DOTS means that a trained health worker or other designated individual (excluding a
family member) provides the prescribed Tb drugs and watch the patient swallow every dose.
Studies shown that 85-90% of patients receiving DOT complete therapy compared to 61% for
those on self administered therapy. DOTS help patient’s finished TB therapy as quickly as
possible without unnecessary gaps.1
With the introduction of DOTS, the qualities of diagnosis and treatment outcome in
Tuberculosis have improved considerably. Still treatment compliance may be a problem due to
the social stigma and or deficient knowledge of the disease and its treatment 1.
The world health organization declared tuberculosis as a global emergency in 1993. To
intensify the efforts to control TB, the government of India gradually replaced the National
Tuberculosis Programme by The Directly Observed Short Course Therapy (DOTS) Programme
which is now known as The Revised National Tuberculosis Programme (11). Tuberculosis is a
disease caused by bacteria called Mycobacterium Tuberculosis causes nearly two million deaths
worldwide each year 3.
In developing world there is crucially important to develop an effective TB vaccine,
shortening the amount of time required to ascertain drug sensitivity, improving the diagnosis of
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TB and creating a new high effective anti TB medications. Without support for such efforts, we
run the risk of loosing the battle against TB 4.
DOT therapy is used in a residential clinic environment and is designed to be cost
effective. When used properly, a course of DOTS therapy cures over 80% of patients, striking a
significant blow against tuberculosis worldwide. DOTS therapy has five elements beginning with
political commitment which must be accompanied by sustained, improve the case detection,
standardized treatment, reliable drug supply system, periodic evaluation and measurement5.
Treatment with properly implemented DOTS has a success rate exceed 95% and
prevent the emergence of further multi drug resistance strains of tuberculosis3.
The WHO advices that all TB patients should have at least the first two months of their
therapy observed ; this means an independent observer watching tuberculosis patients swallow
their anti TB therapy(4). Treatment with properly implemented DOTS has a success rate
exceeding 95% and prevents the emergence of further multi drug resistant strains of TB.
Administering DOTS decreases the possibilities of TB from recurring, resulting in a reduction in
unsuccessful treatment. This is in part due to the fact that areas without the DOTS strategies
generally provide lower standards of care 3.
WHO estimates that eight million people get TB every year, of whom 95% live in
developing countries. An estimated three million people die from TB every year, around 4,
00,000 of them in India alone 5.
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b. Need for the Study
WHO report 2008; tuberculosis is a major cause of illness and death worldwide especially
in Asia and Africa. Globally 9.2 million new cases and 1.7 million deaths from Tb occurred in
2007 of which 0.7 million cases and 0.2 million deaths were in HIV positive people 6.
The Global rate of Tuberculosis is growing at approximately 1.1% per year. India ranks
first in the estimated number of tuberculosis cases and approximate 1761 (thousands) cases per
10, 49,549 population at the rate of 168 cases per 1, 00,000 population 2. WHO estimates that
eight million people get TB every Year, of whom 95% live in developing countries. An estimate
of 3 million people dies from TB every year 6.
A joint monitoring mission conducted by WHO and Govt of India in September 2003
founded that under the NTBP, each day more than 10,000 symptomatic patients are examined,
more than 40,000 sputum slides are checked, more than 2500 patients are placed on treatment
and nearly 5000 lives are saved 5
The 2001 revised national Tuberculosis Control programme status report of Govt of India
estimated that the direct and indirect cost of TB to the country amounted to $ 3 billion per year 5.
In 2004, there were an estimated 8.9 million new Tb cases world wide. But in 1985 and 2992,
cases of TB in United State increase by 20 % 3.
4
A prospective observational study was conducted at Udupi Manipal, Karnataka to
evaluate the safety of DOTS therapy by monitoring adverse drug reactions (ADRs) among 94 TB
patients admitted at the DOTS centre Kasturba Hospital, Manipal and at DOTS centre Udupi for
eight months. The study revealed that on evaluation of the causality of ADRs, a majority of them
were found to be possible” by both WHO and Naranjo’s Scales. The severity assessment of
ADRs showed that 31 (51%) reactions were “moderate” and 30 (49%) was of the “mild” nature.
The study concluded that DOTS therapy to be safer 2.
A study was conducted in DTC Kottayam among 100 randomly selected patients to
assess the awareness of Tb and attitude towards DOTS. The data was collected by using a field
tested questionnaire and interview .The study revealed that the ware ness about Tb was found to
be Excellent (91%); 40% were also knowledgeable its treatment but none knew about DOTS.
The study concluded that 91% were satisfied with DOTS, 6% were unhappy and rest had no
opinion 7.
A retrospective study was conducted at rural TB unit, south India to identify risk factors
for non adherence among TB patients. The data was collected by interview schedule. The study
revealed that out of 1666 patients, 1108(67%) adhered and 55 (33%) did not adhere to DOT. The
risk factors associated with non-adherence were illiteracy (39%), difficulty in accessing health
facility and non government DOT centre (43%). The study concluded that patients should be
educated about tuberculosis and importance and DOTS 8.
5
According to the reports global rate of tuberculosis is growing at approximately 1.1% per year.
India ranks first in the estimated number of tuberculosis patients so cases of tuberculosis are
growing day by day in our country. WHO estimated that 8 million people get Tuberculosis
every year of whom 95% in developing countries. An estimate of 3 million people dies due to
Tuberculosis every year. Government has revised Tuberculosis control programme in 2001 and
spend about 3 billion per year. But a survey report confirm 8 million new TB cases world wide.
And this report also confirms TB cases in developed countries.
So awareness of DOTS therapy among Tuberculosis patients is very less as revealed in
studies. So there is desperate need regarding the awareness of DOTS programme among the
Tuberculosis patients. As I had posted in Government hospital Chitradurga in Tuberculosis
ward patients were unaware of Tuberculosis control programme ( DOTS THERAPY). So I felt a
need to study the awareness of DOTS programme among hospitalized Tuberculosis patients.
6.3. REVIEW OF LITERATURE
A time series cross sectional study was conducted at Boston to evaluate the DOTS
strategies in improving the case finding and treatment success by using empirical data. The study
estimate the impact of DOTS expansion on case detection using reported case notification data;
secondly the study estimated the effect of DOTS expansion on treatment success. The study
revealed that DOTS programme variables had no statistically significant impact on case
detection in a wide range of models and specification. DOTS population coverage had a
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significant effect on overall treatment success rate i.e. at least 18% increase in treatment success
(95 CI 5-31%). The study concluded that the DOTS technical package improve overall treatment
success 11.
A cohort study was conducted in Tiruvallur District of Tamil Nadu to evaluate the impact
of improved treatment outcome during 1999-2003.the successful treatment outcome was
compared to the prevalence of TB in the subsequent cohort. The study revealed that the
proportion of patients who completed treatment successfully was 75.3% in first cohort period
which is the higher proportion of treatment success among patients under DOTS. Second cohort
study resulted in a lower prevalence of smear positive cases during 1991-2001. The study
concluded that the higher proportion of successful completion of treatment after DOTS
implementation was associated with a substantial decline in the prevalence of TB 12.
A survey was conducted in Tiruvallur District in Tamil Nadu to assess the
epidemiological impact of the DOTS strategies on the prevalence of pulmonary tuberculosis
before 2.5 and 5 years after the implementation of DOTS strategy among 90000 patients. The
prevalence of PTB (smear positive /culture positive) was estimated. The study revealed that TB
prevalence decline by above 50% in 5 year from 609 to311 per 100000 population for culture
positive TB and from 326-169 /10000 for smear positive TB. The annual rate of decline was
126% in culture positive Tb and 12.3 % for smear positive TB. The decline was similar at all
ages and for both success. The study concluded that the case detection programme and DOTD
strategy are essential to reduce the burden of TB in the community 13.
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A cross sectional study has been carried out in two TB units in Anand District Gujarat
during 2002 to study the various aspects of compliance to DOTS for the treatment of TB among
292 registered tuberculosis patients. The study revealed that 93% of patients were compliant to
the DOT. the study concluded that the compliance of DOT was significantly high among those
who have good knowledge about various aspects of disease 14.
A pilot DOT strategy project was implemented in Drnod, Aimak, during a six weeks
period among the individuals with chronic cough of more than or equal to three weeks to
establish a TB control programme consistent with recommendations made by WHO and
International Union Against TB and Lungs Disease. This project reveled that the Screening of
1241 symptomatic individuals identified 169 smear positive TB cases (14%) most of them (92%)
were cured. The project concluded that DOTS strategy was successfully and may serve as an
example for countries with a health care tradition similar to that 15.
A retrospective study was conducted in Tiruvallur District South India among TB
patients registered during May 1999 to dec 2004 from a rural Tb Unit to estimate survival
probability for identifying risk factors for death of Tb patients treated under DOTS. Data was
collected by using the Life table and Cox’s regression Method. The study revealed that higher
death rates were independently associated with patient’s age, previous history of treatment
alcoholism and initial body weight. The study concluded that the survival probability was found
to be similar in all patients irrespective of categorization necessary actions need to be initiated 16.
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A descriptive study to assess the proportion of patients re-registered after default, failure
or successful treatment, completion and evaluate their treatment outcome among TB patients
under the treatment DOTS in rural area South India. Patients registered during 1999-2004
identified from the TB registered were considered for analysis. The study states that among 273
Category I patients “defaulted”, 23% and among 112 failure” cases, 68 % were registered. After
successful treatment completion of 1796 cases, 6.5 % were reregistered as “relapse”. The study
concluded that the finding emphasized the need for communicating and motivation and prompt
defaulted, retrieval action to reduce the default at all stages of treatment. Defaulters need to be
contact so that they can be started on treatment DOTS without delay 17.
A study was conducted in combodia to describe the implementation of DOTS
programme. The WHO recommended strategy was implemented in a phase manner throughout
the country. The study revealed that two and a half year after the start of the programme DOTS
was implemented in 85% of all the public hospitals and case detection rate has reached 127
smear positive cases and 149 PTB all forms per 100000. 90%patients received DOTS. 89% were
cured or completed treatment, 5% defaulted. The study concluded that DOTS strategy was
successful in treatment of patients 18.
An evaluative was conducted in Uganda to measure the effectiveness and acceptability of
community based TB care using DOTS strategy for TB control among TB patients. The data was
collected by using knowledge, attitude and belief questionnaire. The study revealed that 540
cases were registered in the control period before the implementation, 450 were registered in
intervention period, following the implementation of community based DOTS, the treatment
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success among new smear positive PTB increases from 56% to 74% and treatment interruption
decreases from 23% to 1%. The study concluded that community based DOTS were effective 19.
6.4 STATEMENT OF THE PROBLEM
A STUDY TO ASSESS THE AWARENESS OF DOTS THERAPY AMONG
TUBERCULOSIS PATIENTS AT SELECTED HOSPITALS AT CHITRADURGA,
KARNATAKA.
6.5 OBECTIVES OF THE STUDY
1.
To assess the level of the awareness of DOTS therapy among tuberculosis patients at
selected hospitals at Chitradurga.
2.
To associate the relationship between the level of awareness of DOTS therapy in relation
to different socio- demographic variables.
3.
To provide guidelines regarding the prevention and management of tuberculosis among
hospitalized tuberculosis patients.
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6.6 OPERATIONAL DEFINITION
1. ASSESS : It is an activity to estimate the awareness regarding DOTS Therapy among
Tuberculosis patients.
2. AWARENESS: It is the ability to know the things “ Self Knowledge “
3. DOTS THERAPY: DOTS is a strategy used to reduce the number of Tuberculosis
(TB) cases.
6.7 INCLUSION & EXCLUSION CRITERIA
1. Inclusion criteria:
 Patients, those who are admitted in the hospital.
 Age: patients who belong to age group of 20 – 55 years.
 Sex: both male and female.
2. Exclusion criteria:
1. Those who are not willing to participate in the study.
2. Patients, who cannot understand, read or write Kannada or English.
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6.8 ASSUMPTION
 Many hospitalized tuberculosis patients will not have adequate awareness regarding the
DOTS therapy.
 There will be association between the level of awareness and socio-demographic
variables of adults.
6.9 HYPOTHESIS
: There will be significantly poor knowledge regarding DOTS
therapy among Tuberculosis patients.
6.10 Delimitation
The study will be delimited for
Tuberculosis patients admitted in selected hospitals at Chitradurga only.
7. MATERIALS AND METHODS
7.1 Source of Data
The data will be collected from the tuberculosis patients admitted in the selected
hospitals of Chitradurga district.
7.1.2 Research design: Non experimental, Descriptive survey design.
7.1.3 Setting : selected hospitals of Chitradurga district.
7.1.4 Population: patients admitted in the selected hospitals of Chitradurga district.
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7.2 Methods of Data Collection
Data will be collected from the adult patients individually through structured knowledge
questionnaire by visiting them personally in the wards.
7.2.1 Sampling Technique: convenient Sampling
7.2.2 Sample Size :
50
7.2.3 Inclusion criteria for Sampling:
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Patients, those who are admitted in the hospital.
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Age: patients who belong to age group of 20 – 55 years.
3. Sex: both male and female
7.2.4 Exclusion criteria for Sampling :
1. Those who are not willing to participate in the study.
2. Adults who cannot understand, read or write Kannada or English.
7.2.5 Method of data analysis and interpretation:
Appropriate statistical method will be used to analyze the collected data after the
collected.

Duration of the study : One month.
7.3 Variables :
Study Variable : awareness regarding DOTS therapy.
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it is
Attributable variable: - In this study are age, religion, level of education, occupation and
previous experience of hospitalization.
7.4 PROJECTED OUTCOME
The study will enhance the awareness among hospitalized patients regarding DOTS therapy.
7.5 FOLLOW UP: NO.
7.6 INSTRUMENTS:
Tools
Section (a) demographic variables.
Section (b) structured knowledge questions.
7.7 DATA COLLECTION PROCEDURE
Data will be collected from the tuberculosis patients individually through structured
knowledge questionnaire by visiting them personally in the wards.
7.8 does the study require any investigation or intervention to be conducted on patients or
other humans or animals?
NO.
7.9 have ethical clearance from your institution?
The investigator has planned to obtain the permission from concerned medical officer to
conduct the study in selected hospitals before the data is collected.
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REFERENCES
 Minnesota Department of Health for Heath, “Directly Observed Therapy (DOT) for the
treatment of Tuberculosis”; Jan 2006.
 Tak DK, Acharya L D,Gourinath K,Rao padma, Subish P, “Safety Evaluation of Anti
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 Reported Tuberculosis in the United States 2005
 Mathew Sarrel; “The Recent TB Epidemic”;
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http://www.stammerinstitute.com.
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