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Plenary 4
BIOSTAT 206 GROUP 1
Adrianne C. Ablola
Bernadette C. Bautista
Renz Annika B. Daquioag
Ivy P. Roxas
Faye C. Rubico
Chapter I: Introduction Background of the Research Question Pulmonary Tuberculosis (PTB)
caused by Mycobacterium tuberculosis
easily spread from person to person via sneezing, coughing, and talking second to HIV/AIDS as the greatest killer worldwide due to a single infectious agent (WHO)
TB Burden: Worldwide
TB Burden: Philippine Mortality
TB Burden: Philippine Morbidity
What is DOTS? Directly Observed Treatment Short-Course (DOTS)
Efforts by the Philippine Government to control TB started in 1996 contribute significantly on the increase in case detection and cure rate of PTB in the country
locally implemented in health centers by medical staff composed of physicians, nurses, medical technologists, and barangay health workers
Research Objectives
General Objective: To determine the different factors associated with adherence of TB patients to DOTS treatment in health facilities of Paranaque City from the year 2008 to 2010
Research Objectives Specific Objectives: 1. To identify socio economic factors, clinical status, health system
related factors, behavioral and other external factors that contributed to TB DOTS treatment non-adherence
2. To determine socio economic factors, clinical status, health system related factors, behavioral and other external factors that promoted adherence with TB DOTS treatment
3. To compare the factors affecting adherence and non-adherence among TB DOTS patients
Significance of the Study Provide an evidence of the factors that associates with adherence of TB patients in the DOTS facilities in city of Paranaque Gathered data may be used to improve and develop the service delivery of the DOTS Program Prevention of non-ahherence to treatment may eliminate or decrease prolifiretion of MDR-TB cases
Chapter II. Theoretical Background
Figure 1: Conceptual Framework
Operational Definition Variable Operational
Definition
Categories of
Variable
Method of Data
Collection
Source of
Data
Potential error in
measuring the variable
Type of Adherence The completion to
the whole duration
of treatment
regardless of the
factors
a. adherent
b. non-adherent
Review of
records or
documents
Secondary Faulty procedure
adopted by the observer
Age Length of time from
birth measured in
months or age in
years at last
birthday during
treatment
Code as is Face-to-face
Interview
Primary Recall bias of respondent
and personal error of
faulty procedure adopted
by the observer
Gender Biological sex of the
participant
a. male
b. female
Face-to-face
Interview
Primary Personal error of faulty
procedure adopted by
the observer
Variable Operational
Definition
Categories of
Variable
Method of Data
Collection
Source of
Data
Potential error in
measuring the
variable
Employment
During Treatment
The kind of work
that the subject had
when he/ she was
on treatment
a. Employed
b. Unemployed
c. Self-Employed
Face-to-face
Interview
Primary Response bias to
please interviewer
and personal error
of faulty
procedure
adopted by the
observer
Monthly income
during treatment
Monthly salary of
the family of the
subject
Code as is Face-to-face
Interview
Primary Response bias to
please interviewer
and personal error
of faulty
procedure
adopted by the
observer
Operational Definition
Variable Operational
Definition
Categories of Variable Method of Data
Collection
Source of
Data
Potential error in
measuring the
variable
Level of Education The highest
educational
attainment by the
subject.
a. Never Went to School
b. Elementary
c. High School
d. Vocational
e. College
f. Post-Graduate
Face-to-face
Interview
Primary Response bias to
please interviewer
and personal error
of faulty
procedure
adopted by the
observer
Operational Definition
Variable Operational
Definition
Categories of Variable Method of Data
Collection
Source of
Data
Potential error in
measuring the
variable
Smoking Self-reported
smoking status of the
participant which is
based on the number
of cigarette sticks
consumed per day
which will be
computed based on
pack years in the
analysis.
Non-Smoker: No history
of smoking.
Current Smoker:
- Light Smoker: 15 or
less cigarette
sticks/day
- Moderate Smoker: 16-
24 cigarette
sticks/day
- Heavy Smoker: 25 or
more cigarette
sticks/day
Reference:
JAMA Sept 16,1988_Vol
260, No. 11
Face-to-face
Interview
Primary Response bias to
please interviewer
and personal error
of faulty procedure
adopted by the
observer
Operational Definition
Variable Operational
Definition
Categories of Variable Method of Data
Collection
Source of
Data
Potential error in
measuring the
variable
Alcohol Intake Self-reported alcohol-
drinking status of the
participant which is
based on the number
of units of alcohol
consumed per day.
a. Yes
b. No
Face-to-face
Interview
Primary Response bias to
please interviewer
and personal error
of faulty
procedure
adopted by the
observer
Drug Abuse Self-reported if the
subject is taking
prohibited drugs
a. Yes
b. No
Face-to-face
Interview
Primary Response bias to
please interviewer
and personal error
of faulty
procedure
adopted by the
observer
Operational Definition
Variable Operational
Definition
Categories of
Variable
Method of Data
Collection
Source of
Data
Potential error
in measuring
the variable
Relief of
Symptoms
During treatment in
which the subject
feel relief of
symptoms
a. Yes
b. No
Face-to-face
Interview
Primary Subjective
bias which
involves
evaluation
based on
personal,
poorly
measurable,
and
unverifiable
data or feelings
Operational Definition
Variable Operational
Definition
Categories of
Variable
Method of Data
Collection
Source of
Data
Potential error
in measuring
the variable
Side effects A peripheral or
secondary effect,
especially an
undesirable
secondary effect of
a drug or therapy
a. Yes
b. No
Review of records
or documents
Secondary Personal bias
and faulty
procedure
adopted by the
observer
Operational Definition
Variable Operational
Definition
Categories of Variable Method of Data
Collection
Source of
Data
Potential error in
measuring the
variable
Availability of
drugs and
supplies
Adequacy of
supplies and drugs
and other logistics
in the DOTS facility
at the time of study
a. Poor
b. Satisfactory
c. Good
d. Excellent
Review of records
or documents
Secondary Faulty procedure
adopted by the
observer
Co-morbidities Is the presence of
one or more
additional disorders
(or diseases) co-
occurring with PTB
or the effect of such
additional disorders
or diseases at the
time of study
a. Diabetes
b. HCVD
c. Other pulmonary
disease
d. Arthritis
e. Cancer
f. HIV
g. Other diease
Review of records
or documents
Secondary Faulty procedure
adopted by the
observer
Operational Definition
Variable Operational
Definition
Categories of Variable Method of Data
Collection
Source of
Data
Potential error in
measuring the
variable
Category of
Treatment
A class of treatment
in which the subject
belonged during
treatment.
a. Category I
b. Category II
c. Category III
Review of records
or documents
Secondary Personal error of
faulty procedure
adopted by the
observer
Types of TB
patient
Categorization of
TB patient
according to history
of TB disease of the
subject
a. New
b. Relapse
c. Treatment failure-
d.Transfer-in
e.Return-after-default
f. Others
Review of records
or documents
Secondary Personal error of
faulty procedure
adopted by the
observer
Operational Definition
Variable Operational
Definition
Categories of Variable Method of Data
Collection
Source of
Data
Potential error in
measuring the
variable
Level of
knowledge of
DOT provider
Trainings and
seminars acquired
by the DOT staff.
a. Poor
b. Satisfactory
c. Good
d. Excellent
Review of records
or documents
Secondary Faulty procedure
adopted by the
observer
Stigma Disgrace felt which
is associated with
having a disease of
TB
a. no stigma- the
subject did not
feel the stigma
b. with stigma - the
subject did feel
the stigma
Face-to-face
Interview
Primary Response bias to
please
interviewer and
personal error of
faulty procedure
adopted by the
observer
Operational Definition
Variable Operational
Definition
Categories of Variable Method of Data
Collection
Source of
Data
Potential error in
measuring the
variable
Family support The emotional,
psychological and
monetary support
that was given to
the subject by their
family during
treatment
a. With family support
b. No family support
Face-to-face
Interview
Primary Response bias to
please
interviewer and
personal error of
faulty procedure
adopted by the
observer
History of anti-
TB drug intake
Previous anti-TB
drug intake of the
subject before
he/she started
treatment in the
DOTS facility
a. no history
b. one history of
drug intake
c. two or more
history of drug
intake
Review of records
or documents
Secondary Faulty procedure
adopted by the
observer
Operational Definition
Chapter III. Methodology Research Design Case Control Study Study Population TB Patients seeking treatment in the DOTS Facility of Paranaque City. Target population will include patients seeking treatment in the DOTS Facility of Paranaque City in the year 2008-2010 with treatment outcome of default, cured and treatment completed
Inclusion Criteria A. Subject
Subjects who were enrolled and included in the TB register in the year of 2008 to 2010 in the DOTS Facility of Paranaque City
Subjects with traceable address and contact number
Subjects who are still living in Paranaque City
Subjects who have ability to comprehend the true nature of the study
Inclusion Criteria
B. Facility
DOTS facility that have available record of the patients such as TB Register, treatment card, medical abstract and inventory of medicines DOTS Facility nurse and midwife who were supervising TB patients in the DOTS facility at the time of treatment
Exclusion Criteria
A. Subject
Subjects who have recurrent TB at the time of study
Patients with MDR-TB at the time of study
Subjects with neurologic and psychiatric disorder
Patients who have treatment outcome other than default, cured and treatment completed.
Exclusion Criteria B. Facility
Facilities which have had history of destruction or calamity destruction such as flood and fire that caused loss of patient files
Facilities which are under construction
Pretesting
constructed questionnaire was tested in one of the DOTS facility within Paranaque City
participants were selected to answer the questionnaire (SRS)
Cases -patients that were registered in the TB registry during the 2008 to 2010 with the treatment outcome of default
Controls - are those patients having a treatment outcome of cured and treatment
List of TB patients who were enrolled and included in TB Register in the year 2008-2010 with treatment outcome of default, cured and treatment completed
TB patients who were enrolled and included in TB Register in the year 2008-2010 with treatment outcome of default, cured and treatment completed
Adherent
Non-Adherent
Factors Associated with
Adherent to TB Treatment
Factors Associated with Non-
Adherent to TB Treatment
Research Study
Past Present (2008 2010)
Selection of Subjects
Figure 2. Selection of Subjects for determining the Factors Associated with Adherence to TB DOTS Treatment in the Health Facilities of Paraaque City from the year 2008 to 2010
Sample Size
Figure 3. Sample Size determination using EpiInfo to determine the factors associated with adherence to TB DOTS Treatment in the Health Facilities of Paraaque City from the year 2008 to 2010.
Data Collection Tools
Data Collection Tools
Data Collection Tools
16 DOTS Facility
Pool subjects from TB Register in the year of 2008-2010:
Note inclusion/exclusion criteria.
Review of medical history
Note address and contact number
Informed Consent
Self-administered questionnaire
Data collection
DATA ANALYSIS
Informed Consent
Assess the DOTS facility
Note inclusion/exclusion criteria.
Review inventory of medicine in the time of treatment
Assess knowledge on DOT staff (Nurse and midwife)
Knowledge assessment exam on DOT staff
Figure 2. Flowchart on the Process of Data Collection
Plan for Data Analysis Variable Type of Variable Descriptive Statistics Inferential Statistics
Age Ratio Mean, Standard Deviation Multiple Logistic Regression
Gender Nominal Frequency, Relative Frequency Multiple Logistic Regression
Employment Nominal Frequency, Relative Frequency Multiple Logistic Regression
Family Monthly Income Ratio Mean, Standard Deviation Multiple Logistic Regression
Level of Education Nominal Frequency, Relative Frequency
Multiple Logistic Regression
Mode of transportation Nominal Frequency, Relative Frequency
Multiple Logistic Regression
Smoking Nominal Frequency, Relative Frequency
Multiple Logistic Regression
Alcohol Intake Nominal Frequency, Relative Frequency
Multiple Logistic Regression
Drug Abuse Nominal Frequency, Relative Frequency
Multiple Logistic Regression
Side effects Nominal Frequency, Relative Frequency
Multiple Logistic Regression
Relief of Symptoms Nominal Frequency, Relative Frequency
Multiple Logistic Regression
Plan for Data Analysis Variable Type of Variable Descriptive Statistics
Inferential Statistics
Co-morbidities Nominal Relative Frequency
Multiple Logistic Regression
Types of TB patient Nominal Relative Frequency
Multiple Logistic Regression
History of anti-TB drug
intake
Nominal Relative Frequency
Multiple Logistic Regression
Category of Treatment Nominal Relative Frequency
Multiple Logistic Regression
Availability of drugs and
supplies
Ordinal Median, Mode Hierarchical Logistic
Regression
Knowledge of DOT
provider
Ordinal Median, Mode Hierarchical Logistic
Regression
Family Support Nominal Relative Frequency
Hierarchical Logistic
Regression
Attitude of DOT Provider Nominal Frequency, Relative Frequency Hierarchical Logistic Regression
The End