Impact of Tuberculosis on the Health-related Quality of Life of Tuberculosis Patients

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Tuberculosis

Background of the Study

Pulmonary tuberculosis is a disease caused by the bacteria, Mycobacterium tuberculosis. Acquisition of this bacterial disease is through inhalation of respiratory droplets which contains the tubercle bacilli

According to the World Health Organization, 9.6 million people worldwide became sick with Pulmonary TB disease. There were 1.5 million TB-related deaths worldwide. Over 95% of TB deaths are living in poor or remote communities are most at risk and evidence shows children are dying from these preventable diseases because effective interventions are not provided equitably across all communities. It is among the top 5 causes of death for women aged 15 to 44. In 2014, an estimated 1 million children became ill with TB and 140 000 children died of TB.1,5,7

According to the Philippine Department of Health, tuberculosis (TB) remains among the principal causes of morbidity and mortality in the nation. There remains an estimated three cases per one thousand people, despite measures of treatment and control from the government and various NGOs. An estimated 480,000 people have tuberculosis in the nation; a mortality rate of about 33%. An estimated 12,000 have multi-drug resistant TB and can possibly spread it to 10-20 people per year. As such, the Philippines has been categorized as among the top twenty-two countries plagued with tuberculosis by the World Health Organization, ranking number eight in the most recent listing. This is reflective of the economic status of the nation and its patients. Despite this, the country has made strides to combat the disease.2

In the Cebu Province, 12,032 cases were recorded in the year 2011. 1,881 tuberculosis cases were isolated from Cebu City. Tuberculosis is the seventh important cause of morbidity and mortality rate in the Central Visayas region of the country. Aside from proper education and information campaign on tuberculosis, the regional Department of Health has also joined with private doctors and institutions. The health centers in the Visayas region, and certain hospitals, prisons, government and private institutions and clinics are providing tuberculosis services, which include diagnosis from the samples submitted, proper treatment and support by counselling. There are 160 DOTS Facilities in the region, 162 TB Microscopy Labs; 1 Reference Lab, 2 MDR-TB Treatment Sit and 36 Jails providing DOTS services. 3,4

In 2015, the Philippine DOH reported that the Philippines was one of seven of the high-burden countries from the WHO’s list that had achieved its Millennium Development Goal in combating tuberculosis. As of 2013, causes and deaths due to tuberculosis had been reduced by over 50% from the 1990 baseline.6,7

Despite these recent successes, tuberculosis remains a top 10 leading cause of mortality and morbidity in the nation. Though much progress has been made, even more must continue to be done in order to remove the burden of the disease from the islands.

A patient with pulmonary tuberculosis is assessed through diagnostic, radiologic, and clinical assessments but does not consider any dimension of health. Here in the Philippines, the patient does not only face issues in physical symptoms, but also faces social and economic concerns. Hence, for a more exhaustive assessment of the patient’s status, it is essential to consider the other dimensions of health of the patient.

In healthcare, the quality of life is often regarded in terms of how a certain ailment or disease affects the total well being of the patient. In this study, the Quality of Life (QoL) will be measured through the WHO QoL (BREF) which has the four domains to assess the impact of PTB.

These triggered the minds of the researchers to conduct a study on the impact of the health-related quality of life of pulmonary tuberculosis patients at Vicente Sotto Memorial Medical Center.

Review of Related Literature

Tuberculosis has affected thousands of people dating thousands of years back. The absolute affirmation of the prevalence has been found in the spines of Egyptian mummies dating back from 5000 B.C. TB was written down on paper by Hippocrates and stated its cases as severely fatal as it almost killed everyone who was infected dating back from 460 B.C. It was called the white plague when it paved its way to Europe. It was featured in multiple writings, and since the population was oblivious about anything and everything about tuberculosis, death was accepted as inevitable. 8

Pulmonary Tuberculosis (PTB) is a transmissible, or infectious, disease that generally affects the lungs, but can also affect other parts of the body. Most cases of tuberculosis generally do not have symptoms. These cases are known as latent tuberculosis; however, 10% of latent infections can develop into the active form of the disease, which can be very lethal. The disease is spread through the air by infected individuals when they open their mouths to cough, speak, etc. and the disease is spread by the Mycobacterium tuberculosis (MTB) bacterium. It is worth noting that those with latent TB cannot spread the disease. 15

As the disease general affects the lungs (90%, known as pulmonary tuberculosis or PTB), symptoms usually include prolonged coughing which produces sputum as well as chest pain. In some cases, individuals have been known to cough up blood, and in even rarer cases, the disease can spread to the pulmonary arteries, resulting in severe bleeding. It is worth noting that the disease usually affects the upper lung lobes more frequently, though the reasoning is not well understood as of yet. The disease can develop into a chronic illness and result in scarring in the aforementioned upper lobes of the lungs. The disease may also spread to other parts of the body (extra pulmonary TB) and result in a variety of symptoms depending on where in the body the disease settles. Generally, symptoms may include fatigue, night sweats, and weight loss. Complications also target specific parts of the body, depending on infection sites, which commonly include the central nervous system, lymphatic system, the bones, and others.15

Tuberculosis plagues the developing world and is widespread throughout the world, with an estimated one-third of the population thought to be infected with the disease according to the World Health Organization (WHO). TB is recognized as being the second deadliest infectious disease in the world, behind HIV/AIDS. In addition, it is the leading cause of mortality in people with HIV. As a result, it is an important public health problem, making effective intervention necessary.

Despite being widespread throughout the world, TB is a treatable disease; however, many strains are becoming increasingly drug-resistant to the conventional treatment methods, such as isoniazid and rifampin, which are considered the backbone of initial anti-TB treatment. Such strains are known as multidrug-resistant (MDR) TB. Additional strains, extensively drug-resistant (XDR) and totally drug-resistant TB pose a threat to global TB control. This makes the early detection and prevention of the disease of paramount importance, especially in areas where the disease can be endemic. Unfortunately, such areas are in the developing world (Africa, Asia, etc.) and these poorer countries usually lack the resources necessary to effectively combat the disease, especially in high-risk areas of the countries. Certain populations are at a higher risk of contracting the disease, especially children and those with weakened immune systems by other diseases such as HIV/AIDS (which is also endemic in the developing world). As a result, many countries have adopted directly observed treatment short course (DOTS) strategies to contain the TB endemic in their own countries. The methods are cost-effective, but the emergency of the aforementioned drug-resistant strains makes the treatment and containment of the disease increasingly difficult, though laboratories around the world are researching new methods of treating the disease in an attempt to more properly control it and halt its spread.

In the Philippines, TB still ranks as among the leading causes of morbidity and mortality in the countries, with an estimated three cases per 1000 people. As a high risk area and part of the developing world, the Philippine Government has recognized the threat TB faces to its country and implemented various programs to combat the disease. Among these is its own DOTS program. The DOTS program has been implemented since the 1990s and it, along with other national and international (as well as NGO) programs/initiatives, has seen the prevalence rate decrease from about 5 per 1000 population to 3 per 1000 population; however, the emergence of the aforementioned drug-resistant strains of the disease not only makes it more fatal, but difficult to control. Despite this, the past success and the dedication of the government to the control of the disease.     

Patient treatment and management initially start with detection. If a patient is suspected with tuberculosis, the patient undergoes a series of diagnostic procedures or a full work- up algorithm to fully determine if he/she is suffering from tuberculosis. A patient’s diagnosis is based on the National Tuberculosis Program’s (NTP) classification which are as follows: history of treatment, bacteriologic status (confirmed or clinically diagnosed), and based on anatomic site (pulmonary or extra pulmonary).

Patient treatment and management initially start with detection. If a patient is suspected with tuberculosis, the patient undergoes a series of diagnostic procedures or a full work- up algorithm to fully determine if he/she is suffering from tuberculosis. A patient’s diagnosis is based on the National Tuberculosis Program’s (NTP) classification which are as follows: history of treatment, bacteriologic status (confirmed or clinically diagnosed), and based on anatomic site (pulmonary or extra pulmonary).

A patient positive for pulmonary tuberculosis is diagnostically confirmed according to the following criteria: one (1) smear- positive for acid fast bacteria (AFB) sputum, with or without abnormalities consistent with active TB;  a sputum sample subjected under culture which yields a positive result for MTB complex, with or without radiographic abnormalities consistent with active TB; and a sputum sample which yields a positive result for MTB complex using rapid techniques such as Xpert MTB/RIF, with or without radiographic abnormalities consistent with active TB.9

A patient positive for pulmonary tuberculosis is clinically confirmed according to the following criteria: a patient who has been decided to take up a full course anti-TB therapy by the physician with two (2) sputum specimens negative for AFB or MTB but with radiographic abnormalities consistent with active TB.

Clinically diagnosed criteria are characterized by as follows: a patient with two (2) sputum specimens negative for AFB or MTB or with smear not done due to specified conditions but with radiographic abnormalities consistent with active TB; and there has been no response to a course of antibiotics and/or symptomatic medications; and who has been decided by either the TBDC and/or the physician to have TB disease activity requiring a full course of anti-TB therapy. Second, a child who fulfils three (3) of the five (5) criteria suggestive for TB activity, namely: a positive tuberculin test, signs and symptoms indicative of TB, exposure to a person/environment with an active TB case, an abnormal chest radiographic suggestive of TB, and other laboratory findings suggestive of tuberculosis and who has been decided by the physician to have TB disease requiring a full course of anti-TB chemotherapy but with two (2) sputum specimens negative for AFB or with smear not done. Lastly, a patient who is clinically diagnosed with HIV/AIDS with two (2) sputum specimens negative for AFB or MTB but nevertheless, has been decided by the physician to have the activity of the diseases requiring a full course of anti-TB chemotherapy. 9

The treatment given to patients shall be patterned with the NTP policies and guidelines. At least four (4) drugs (rifampin, pyrazinamide, ethambutol, and isoniazid) in fixed dose combination shall be given to patients under supervision by the approved health partner.

Patients who are bacteriologically confirmed, seriously-ill clinically confirmed, those that will be registered in the TB clinic, and those patients who will be required a longer hospitalization will be given access to the abovementioned drugs. Patients who are initially treated at the hospital will be properly endorsed and referred and shall be given at least one-week supply of anti- TB drugs upon discharge. All patients will be registered to the TB register and be given an NTP ID card.

A medical partner, may it be a nurse or a supervised health worker delivers the prescribed medication to the patient’s household. The partner watches the patient swallow the medication and documents every visit and checks for side effects. The prescribing physician or the medical partner explains and supports the patients by giving continuous patient education using a patient- centered management approach.

The patient has his/her sputum analyzed weekly for the presence of AFB until sputum conversion takes place.

The Quality of Life (QoL) is defined as the individuals’ perception of their physical and mental health in their daily lives which cover physical, psychological, economic, spiritual, and social functioning. 11 The presence of a disease affects the daily living of the patient. A TB diagnosis may lead to fear, frustration, and disappointment which may lead to depression or anxiety. Knowledge on a patient’s QoL plays an essential factor for an improved response to treatment among PTB patients, which may lead to better outcome in patients’ mental health, infection surveillance and prevention programs. 12,14

The assessment of a patient’s QoL is necessary for patients with a chronic disease like pulmonary tuberculosis whose social and mental well being might be affected by the disease and the long term treatment as well as the social stigma attached to it.

Healthcare-related QoL used to refer to the assessment of physical abilities using an external evaluation tool. Today, healthcare-related QoL acknowledges the actual situation of the subjects in relation to their personal experience which varies over time and can be influenced by external factors such as length and severity of illness, family support, etc. Health-related QoL is now usually evaluated by the use of a patient questionnaire which usually covers the physical, social, emotional, cognitive, work- or role- related, and spiritual dimensions and comes across other aspects such as disease related symptoms, therapy induced side effects, and even the financial impact of the medical condition.

In 1991, the World Health Organization founded the World Health Organization Quality of Life (WHOQOL) which aims to develop and assessment instrument that is to be used across different cultures to assess the quality of life. The instrument is used to assess the individual’s perception and the domains of health.

It comprises of 26 items which measure the following domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF, a shorter version of the original instrument is found to be more convenient for studies with a large population.

Domain facets measured using the instrument are as follows:  (1) Physical health which includes activities of daily living, dependence on medicinal substances and medical aids, energy and fatigue, mobility, pain and discomfort, sleep and rest, and work capacity; (2) Psychological which includes bodily image and appearance, negative feelings, positive feelings, self-esteem, spirituality / religion / personal beliefs,  thinking, learning, memory and concentration; (3) Social relationships which includes personal relationships, social support, and sexual activity; and lastly the Environment domain which includes financial resources, freedom, physical safety and security, health and social care like accessibility and quality, home environment, opportunities for acquiring new information and skills, and  Participation in and opportunities for recreation / leisure activities, and the Physical environment (pollution / noise / traffic / climate). 13

Significance of the Study

This study will benefit the following:

PTB Patients. The study of pulmonary tuberculosis can be a learning paradigm for the patients in terms of enhancing the patient’s knowledge, awareness and outlook towards pulmonary tuberculosis. The goal of the study is to create self awareness among the patients to improve their quality of life.

Vicente Sotto Memorial Medical Center.  This study will enable the system of Vicente Sotto Medical Center to improve their program and create relevant interventions to improve the quality of life of the patients.

Health Care Professionals. Health care professionals will be guided on what should be emphasized in the health promotion process to the patients and through the data and valuable information gathered in the study. The study will give them key awareness on what areas could they possibly improve on in taking action and management to pulmonary tuberculosis patients towards the improvement of the quality of life of these patients.

The Community. The findings of this study will benefit the community considering that more updated knowledge on the health status and outlook of pulmonary tuberculosis would be made available to the public and to the patients and their families. The study would be an eye opener or serve as an awareness to help empower the community itself.

Future Researchers. This study can be of additional heap of information and possible resource for future researches in health care management on the pulmonary tuberculosis disease in general.

General Objective

This study aims to determine the impact of tuberculosis on the Health-related quality of life of Tuberculosis Patients at Vicente Sotto Memorial Medical Center.

Specifically, this study aims to:

  1. To determine the available health services for patients with tuberculosis of Vicente Sotto Memorial Medical Center through key informant interviews as to:

1.1 DOTS

1.1.1 Diagnostic

1.1.2 Therapeutic

1.2 Ward

1.3 Centers for Multi-Drug Resistant Tuberculosis (MDR-TB)

  1. To determine the socio-demographic characteristics of tuberculosis patients at Vicente Sotto Memorial Medical Center as to:

2.1 Age

2.2 Civil Status

2.3 Address

2.4 Gender

2.5 Education

2.6 Occupation

  1. To determine the impact of tuberculosis on the quality of life through questionnaire-guided interviews of patients as to:

3.1 Physical Health

3.2 Psychological Health

3.3 Social Relationship

3.4 Environment

 

Scope and Limitations

The main focus of this study is to review patients diagnosed for pulmonary tuberculosis in Vicente Sotto Memorial Medical Center based on the four dimensions of health which are physical health, psychological health, social relationship, and the environment. The said study is limited only in obtaining information from key informants from the 1) DOTS Section, 2) Pulmonary Section, 3) DOH Communicable Diseases Section, 4) Family Medicine Department, 5) Centers for MDR-TB ( Multi-Drug Resistant- Tuberculosis) and 6) the Communicable Disease Ward. Admitted patients with final diagnosis of pulmonary tuberculosis and those who registered at the TB-DOTS center in VSMMC between (date) to (date) are to be interviewed for this study. The researchers were limited in gathering the necessary data thru the use of the World Health Organization Quality of Life (WHOQOL)- BREF.  Patients who had known respiratory co-morbidity other than PTB or any known and diagnosed chronic illness which may affect the QoL were excluded from the study.

Accuracy of the results and findings will be dependent upon the sole accuracy of the data obtained in Vicente Sotto Memorial Medical Center only.

Definition of Terms

Tuberculosis (PTB). Refers to an infectious disease caused by the bacteria, Mycobacterium tuberculosis that directly affects the lungs.

Quality of Life. Refers to how PTB affects the total well-being of the patient based on the four domains which are physical health, psychological health, social relationship, and the environment.

Diagnostic services. Refers to all activities and facilities that are used in relation to pulmonary tuberculosis concerned to its identification and cause.

Rehabilitative services. Refers to all activities and facilities that are used in relation to pulmonary tuberculosis concerned to restoring the health of the patient.

Key informant interview. Interview that is qualitative in nature with people who have first-hand knowledge about the current situation, activities, and facilities.

Physical Health. Refers to the freedom of disease or abnormality, and the condition of optimal well- being.

Psychological Health. Refers to the patient’s capacity to function at a satisfactory level of emotional and behavioural adjustment.

Social Relationship. Refers to the patient’s ability to interact and develop meaningful relationships with others and oneself.

Materials and Methods

Research Design

This study utilizes a Descriptive Cross Sectional study design that uses a standardized questionnaire acquired from the WHO (World Health Organization).

Research Locale

This study is to be conducted in Vicente Sotto Memorial Medical Center which is a general tertiary teaching/training hospital under the Philippine Government, located at B. Rodriguez St., Cebu City. The hospital offers Emergency Room Services, Out-Patient Services, Clinical Specialty Services, In-patient Services-Pay (Medicare (PHIC) and Service Wards), Operating Room Services, Organ Transplant Unit, Critical Care Unit Services, Cardiac Catheterization, Hemodialysis Unit, Peritoneal Dialysis Unit, Laboratory and Diagnostic Services, Veterans In-patient & Out-patient Clinical Services, Women and Children Protection Unit Services, Reproductive Tract Infection Clinic, Psychological & Counseling Services, Dietary Counseling Services, Blood Transfusion Services, Lying-In Birthing Center.

Research Respondents/Subjects

​Inclusion Criteria

The researchers will interview key informants in VSMMC as to: 1) DOTS Section, 2) Pulmonary Section, 3) DOH Communicable Disease Section, 4) Family Medicine Department, 5) Centers for MDR-TB ( Multi-Drug Resistant- Tuberculosis) and 6) the Communicable Disease Ward in VSMMC.

Patients given a final diagnosis of pulmonary tuberculosis category I, II, and III aged 20-65 years admitted and registered at the TB-DOTS center of Vicente Sotto Memorial Medical Center  will be included in the study.

Exclusion Criteria

Admitted patients in the Communicable Disease Ward in VSMMC who had not been medically diagnosed with PTB and patients who had known respiratory co-morbidity other than PTB or any known and diagnosed chronic illness which may affect the QoL were excluded from the study.

Data Collection

Research Process

A transmittal letter was submitted to the Dean of the College of Medicine asking permission to conduct the study outside the school premises. Another letter is to be submitted to the Medical Director of Vicente Sotto Memorial Medical Center requesting permission to interview key informants in as to: 1) DOTS Section, 2) Pulmonary Section, 3) DOH Communicable Diseases Section, 4) Family Medicine Department, 5) Centers for MDR-TB ( Multi-Drug Resistant- Tuberculosis) and 6) the Communicable Disease Ward in VSMMC including the admitted patients with final diagnosis of Pulmonary Tuberculosis.

 

Gathering of Data

​A standardized questionnaire, the World Health Organization Quality of Life (WHOQOL)- BREF, will be utilized by the researchers in interviewing admitted patients with final diagnosis of Pulmonary Tuberculosis. An interview with key informants in as to: 1) DOTS Section, 2) Pulmonary Section, 3) DOH Communicable Diseases Section, 4) Family Medicine Department, 5) Centers for MDR-TB ( Multi-Drug Resistant- Tuberculosis) and 6) the Communicable Disease Ward will also be conducted to know the current diagnostic and rehabilitative services, activities, and facilities in relation to pulmonary tuberculosis in VSMMC. The data that will be obtained from the respondents will be treated with utmost discretion and confidentiality.

The data to be recorded include the available health services for patients with PTB  at VSMMC, the patient’s socio-demographic data, the impact of tuberculosis on the health-related quality of life of PTB Patients as to: 1) physical health, 2) psychological health, 3) social relationship, 4) environment.

 

Data Processing and Analysis

  • The results of this study will be processed using _______________ and will be presented through Microsoft Excel 2007. The main variables of the study will include the socio-demographic profile and the impact of tuberculosis on the health-related quality of life of PTB Patients as to: 1) physical health, 2) psychological health, 3) social relationship, 4) environment.
  • The scoring will based on the scoring guidelines provide by WHO found on Appendix A.
  •  ​For the demographic profile, the age in years of each patient will be divided into brackets (less than 14 years old, 15-29 years old, 30-44 years old, 45-59 years old and 60 years old and above). The frequency of patient in each bracket will then be presented in a line graph.
  • The frequency of male and female patients will be presented through a line graph.
  • The frequency of patients as to: 1) civil status, 2)educational attainment, 3) occupation will also be presented through a line graph.

For the impact of tuberculosis on the health-related quality of life of PTB Patients as to: 1) physical health, 2) psychological health, 3) social relationship, 4) environment will be tallied and will be presented in a frequency distribution table.

The obtained information on the available health services for patients with PTB at VSMMC will be described in detail as to the delivery of health service and patient management.

 

ETHICAL CONSIDERATIONS

​The study will consider that the researchers, with the informed consent of the patients, in accordance with the Geneva Convention and the Nuremburg Trials. However, extreme anonymity will be imposed upon the gathering of data; strict protocols including the guidelines of the Ethical Review Committee will be imposed and executed with regards to the treatment of the information. The study will consider the patient’s right to confidentiality and thus the data that will be gathered will be viewed strictly by the researchers only.

​                The researchers will ask for consent to interview key informants in the different sectors of VSMMC and the admitted patients with final diagnosis of PTB for academic purposes, from the hospital Department heads and the medical director of the institution.

​                The study will be screened by the Ethics Committee of CDU before the initiation of Data Gathering, which will ensure that the objectives mentioned above will be met, the Ethics Committee also will receive the right to terminate the study if ever any of the rules to be imposed are violated.

 

REFERENCES

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