AN ASSESSMENT OF HEALTH-RELATED QUALITY OF LIFE AND ITS DETERMINANTS, AMONG ADULTS DIAGNOSED WITH PULMONARYTUBERCULOSIS ATTENDING DOTS FACILITIES IN LAGOS STATE

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AN ASSESSMENT OF HEALTH-RELATED QUALITY OF LIFE AND ITS DETERMINANTS, AMONG ADULTS DIAGNOSED WITH PULMONARYTUBERCULOSIS ATTENDING DOTS FACILITIES IN LAGOS STATE

CHAPTER ONE

INTRODUCTION

 

        1.1       Background

Tuberculosis (TB) is a chronic multi-systemic disease that results from infection with Mycobacterium tuberculosis and other species of the Mycobacterium tuberculosis complex (M tuberculosis, M bovis, M africanum, M microtii, M. canetti).1 Tuberculosis is usually typified by the pulmonary disease which accounts for about 80% of cases of TB.2 However, it can affect other parts of the body, collectively termed as extra-pulmonary tuberculosis. Extra-pulmonary sites of infection are common in the spine (Potts disease); central nervous system, where it can cause meningitis, tuberculoma, abscesses and cerebritis; gastro-intestinal system, with ileocecal involvement in 80-90% of such cases. Other common sites of involvement are the genitourinary system and the lymphatic system (e.g. cervical lymphadenopathy).3

The World Health Organization declared tuberculosis as a global public health emergency in 1993.4  This unprecedented step was as a result of the global resurgence in tuberculosis cases, largely fuelled by the Acquired Immune Deficiency Syndrome (AIDS) pandemic. While improvements in global control have been implemented, tuberculosis continues to be a leading cause of death in many countries.2 In 2015, an estimated 10.4 million people developed TB and out of whom, about 1.2 million were HIV-positive. In the same year, 1.4 million died from tuberculosis, including 400,000 deaths among those with HIV co-infection. Although Asia has the highest burden of tuberculosis, Africa has the highest ratio of cases and deaths per capita, and about 75% of cases of tuberculosis among people living with HIV&AIDS.2 The annual risk of infection in Nigeria was reported as 2% from a WHO survey in 1998 but recent studies suggest an annual risk of infection as high as 6.2%.5

In Nigeria, tuberculosis remains a major public health problem. The results from the first-ever survey of the national prevalence of TB disease in Nigeria led to an upward revision of global estimates of TB burden.6 Following this survey, TB mortality in the African Region in 2013 was estimated to be 44% higher than previously reported. The global burden of new TB also rose by

400,000 to nine million new cases. Compared with the previous estimates, the new estimates for Nigeria were 200% higher for incidence, 100% higher for prevalence and 400% higher for mortality.7 By 2015, Nigeria, along with five other countries accounted for 60% of new cases worldwide and it is currently one of the fourteen countries on the three high-burden country lists – High TB-burden, high MDR-TB burden and high TB-HIV burden countries.2 Nigeria has the fourth largest number of incident cases of TB worldwide (586,000), after India, Indonesia and China; and a TB mortality rate of 99/100,000 population.2 The TB treatment gap, that is the gap between cases detected and those started on treatment, has also become the highest, accounting for 15 per cent of the global gap.8

Furthermore, the dual epidemic of TB and HIV has threatened gains made in tuberculosis control. HIV prevalence among TB patients has increased over tenfold, from 2.2 % in 1991 to 27% in 2008, with a slight fall to about 23% in 2012 .9 There are also peculiar diagnostic and therapeutic challenges associated with TB and HIV co-infection and it contributes a significant burden on an already weakened health system.10  Immune reconstitution syndrome (IRIS), for example, could occur. This is a transient worsening of respiratory signs and symptoms and/or radiological deterioration, despite reduction in viral load. It may develop in TB-HIV co-infected patients who are treated with anti-TB medications concomitantly with Highly Active Anti-retroviral therapy  (HAART). There are also potential drug interactions between selected protease inhibitors and

Rifampicin, cumulative toxicity and risk of non-compliance due to pill burden.11

There has been a worrying spread of multidrug-resistant TB (MDR-TB) and extensively drugresistant TB (XDR-TB) globally. These forms of TB are difficult to treat and associated with high  levels of mortality.12 There were about 480 000 new cases of multidrug-resistant TB (MDR-TB) and an additional 100 000 people with rifampicin-resistant TB (RR-TB) in 2015. Treatment for rifampicin-resistant TB (RR-TB) and multidrug-resistant TB (MDR-TB) typically require more toxic drugs. The period for treatment was 20 months up till early 2016, when it was reduced to 9 to 12 months.2 A systematic review of Nigerian MDR-TB prevalence studies showed that 32.0% of newly diagnosed cases and 53.0% of previously-treated TB patients from different settings in Nigeria were resistant to at least one anti-TB medication. In addition, MDR-TB occurred in 6.0% of new and 32.0% of previously-treated TB patients. However, the burden varied across different regions, depending on the drug susceptibility testing method used.13

Thus, tuberculosis remains an ongoing challenge for Nigeria. Although potentially curable, it is associated with significant morbidity and mortality.14,15  Lagos State in particular, has the highest notification rates in Nigeria, with 8,410 TB cases notified in 2014, while Kano with the 2nd highest burden had 5,590 cases.16 Lagos has been responsible for about eleven percent of the TB cases registered in Nigeria annually. The state has some peculiarities which make it easier for tuberculosis to spread. These include an extremely high population density, rapid urbanisation with growth of residential areas around busy and often congested road networks, high industrialization and air pollution.17 All these factors tend to favour overcrowding and poor housing, well-known risk factors for transmission of tuberculosis.

Major progress has been made in tuberculosis control globally with the introduction of the Directly- Observed Treatment, Short course (DOTS) strategy in 1994.18 Global TB control was further boosted by increased political commitment as demonstrated in the Amsterdam declaration (2000)19 and the Washington Commitment to Stop TB (2001).20 Since 1995, over 40 million patients have been treated in DOTS programmes worldwide.21 The Stop TB Strategy introduced in 2001, built on the successes of DOTS, with a view to rapidly scaling-up of prevention and treatment. It also incorporated the targets set by the Millennium Development Goal (MDG 6,

Target 15) which was to halt and begin to reverse the   incidence of TB by 2015 by ensuring all

TB patients benefit from universal access to high-quality diagnosis and patient-centred treatment.21 Traditionally, outcome measures for TB include measures of disease burden, morbidity and mortality. However, these fail to capture the impact of the illness on a person’s daily living and functioning, which is a growing concern among healthcare providers.22 It is recognized that chronic and sub-acute conditions and their treatment alter people’s perception of their health and well-being and that the social and emotional burden of a disease can equal and even exceed the  physical impact of illness.23 For healthcare to be comprehensive in a true sense, it should monitor not only the indicators of changes in frequency and severity of disease but also those that are  an estimate of well-being.

Quality of life (QOL) is a vital measure in the assessment of population well-being and health status24 and is becoming an important outcome by itself and  a supplement to traditional biological outcomes.25  The World Health Organization (WHO) defines quality of life as “an individual’s perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns”.26 Health is   one of the domains in quality of life and the concept of  health-related quality of life (HRQOL) is a multidimensional construct that broadly describes how well individuals function in their daily lives and their own perception of well-being in physical, psychological, and social aspects, thus encompassing those aspects of overall quality of life that directly affect health.27 The importance of quality of life research has gained momentum worldwide in recent years.  It has been employed both in cross-sectional and analytic studies and is increasingly being used as an endpoint in clinical trials, particularly as it relates to chronic health-related conditions.28–30 Patients with pulmonary tuberculosis commonly present with physical symptoms such as cough, fever, fatigue and night sweats among others.31–33 However, beyond the diagnosis of the physical disease, the impact of a chronic illness like tuberculosis on an individual patient is often far-reaching, affecting not only his/her physical health but also psychological, economic and social components of health.34,35 All these dimensions have a great impact on the functional and overall wellbeing of the patient and can  consequently impair the quality of life of the patient suffering from tuberculosis and consequently impact negatively on treatment outcomes .36

1.2 Statement of the Problem

Studies that have examined the HRQOL of people with TB have found that they report poorer HRQOL indices compared with the general population.37 A study in Canada found that those with active TB reported lower health-related quality of life than subjects treated for latent tuberculosis and healthy controls.38  A study in Ethiopia found that patients with TB-HIV co-infection are more likely to have poorer scores compared with tuberculosis or HIV alone.39 Multi-drug resistant TB also adversely affects HRQOL. Studies suggest that patients with multi-drug resistant TB (MDR-

  1. TB) had significantly lower mean “quality of life” scores than PTB patients and high rates of psychological co-morbidity.40,41 A patient with tuberculosis may encounter physiological, psychological, financial and social problems that potentially, can impair the quality of life.42 Several factors associated with poor quality of life of these patients include prolonged hospitalization, stigma, difficulties in maintaining family life and consequent loss of social networks.43

Psychological distress has been found commonly in people with tuberculosis. A study in South

Africa found an 82% prevalence of psychological distress among those being treated for PTB, with 25% classified as having severe psychological distress.44  Depressive states have also been reported in those with tuberculosis.45 People with TB have often reported negative emotions such as anxiety and fear from the concerns about rejection by their families and their communities.46 Individuals with tuberculosis often suffer from health-related stigma and the social burden of illness. They are often perceived by others as ‘sources of infection’.47  They in turn describe feelings of guilt and isolation,  as they are afraid of transmitting the disease to others. As awareness increases about the strong link between TB and HIV, individuals with tuberculosis may be perceived as a high-risk group for HIV infection or vice-versa. Thus the stigma linked to HIV ⁄ AIDS could also compound the stigma of tuberculosis.48,49

Tuberculosis has also been perceived as a disease which can adversely affect social relationships.50 Studies that explored perceptions of TB patients to the disease found that they believed that TB led to diminished marriage prospects for them and even family members. There were also cases of divorce and broken engagements attributed to TB particularly among female patients.5152 All these issues described can impair the psycho-social and mental well-being of people with TB. Tuberculosis commonly affects those in the productive age-groups and as such has also been found to limit work roles, hamper productivity and income-earning activities.53 TB results in lost income and there have been reports of TB patients losing their jobs as a result of  the disease. 54,55

There are also aspects of treatment which could potentially affect a patient’s quality of life. Treatment requires prolonged therapy and the use of a combination of several drugs, some of which are associated with severe side-effects. A study of over four thousand TB patients in China found that 15%  of them showed at least one adverse drug reaction (ADR).56 In the case of patients with HIV co-infection, there is the additional possibility of undesirable drug interactions.57 Patients also have to present at the health facility frequently to obtain medication, which may be seen as punitive by patients.58 In addition, the attitudes of health workers to patients may have an effect on their psychological well-being and their attitude to medication adherence.59

Follow-up studies carried out on individuals who completed tuberculosis treatment suggest that the clinical burden of the disease often extends beyond the duration of treatment.60 A study conducted in China found that there was a significant increase in quality of life over the course of treatment. However, TB patients still scored significantly lower in mental health, vitality, and physical domains of quality of life at the end of treatment, compared with controls.61 This may be attributable to residual anatomic changes and varying degrees of functional damage, despite achieving a “microbiological cure”. 62

Tuberculosis control programmes appear to focus around achieving successful treatment outcomes in terms of traditional clinical indicators such as achieving a microbiological cure or completing therapy as prescribed. Issues relating to the impact of tuberculosis on general health status have not been optimally captured by the current design of the many tuberculosis control programmes.60  It has been argued that current measures of disease burden are likely to underestimate the true impact of disease as clinical measures may correlate poorly with daily well-being and function in spheres of life that matter most to the patient.63 A study of HRQOL may aid in elucidating those factors that may influence potential long-term consequences of the disease and which may be important points of intervention.

        1.3 Justification for the Study

There has been a shift in paradigm to define disease outcomes beyond morbidity and mortality measures. The inclusion of patient-reported outcomes (PROs) forms an important aspect of the management of diseases and their outcome.63 The concepts of ‘quality of life (QOL)’ and ‘healthrelated quality of life (HRQOL)’, which are examples of PROs, are increasingly being used to describe health status and overall well-being of patients.64

Measures of quality of life provide additional information on a patient’s health status that cannot be provided from conventional clinical and laboratory measurements. A comprehensive assessment of patients treated for tuberculosis should include other domains beyond the routine bacteriological, clinical and radiological assessments in order to assess “improvement”. The incorporation of the measurement of HRQOL of TB patients will further lead to an in-depth understanding of the effect of disease on various dimensions of health. HRQOL can be a predictor of treatment success, and hence pre-treatment assessment of HRQOL may have prognostic value. This is vital to clinical practice because it can improve patient-provider communication, track functional changes over time and adherence to medication.65 This enriches results obtained from conventional physical and laboratory investigations when evaluating illness impact as well as the effectiveness of a treatment. Also, HRQOL measures are used in economic evaluations to help inform policy-making decisions. This is applied by combining life expectancy and quality of life to generate the quality-adjusted life-year (QALY), a method of valuing benefits for use in economic evaluation; and so can be used to assess cost-effectiveness of various permutations of treatment.66

In Nigeria, several studies on HRQOL have been done in relation to HIV & AIDS, ageing as well as other chronic illnesses like hypertension and diabetes mellitus.   A few studies have also looked at the impact of TB/HIV co-infection against a background of HIV infection.67–70  A few studies have been done on quality of life of patients with TB but none examined changes in HRQOL over the course of treatment.36,71 There is a need to explore, more deeply, the quality of life of tuberculosis patients in Nigeria and how it affects disease and treatment outcomes. The impact of chronic health conditions like TB on the HRQOL of patients in sub-Saharan Africa with limited resources to ameliorate disability may be different from that of the other parts of world where similar studies were conducted.

A review by Bauer et al listed about 60 studies done on quality of life in people with tuberculosis.37 However about 75% of these studies were cross-sectional in design thus limiting the inferences that could be drawn. Diminished HRQOL scores among the patients, even at their treatment completion, are a pointer to the importance of collecting patient-reported outcomes data at various stages of the treatment as this strategy will enable the clinicians to take timely actions for addressing physical and/or mental well-being of the patients.

This study will assess HRQOL of patients with pulmonary tuberculosis, at repeated intervals through the course of treatment.  It will also consider changes in quality of life scores between patients with tuberculosis alone and those with TB-HIV co-infection, as well as identify key determinants of HRQOL.  This study will also attempt to define any association between healthrelated quality of life and treatment outcome.

With the findings from this study, it is envisaged that health care providers and clinicians will have a broader picture of the functioning and well-being of TB patients so that individual patientspecific needs are addressed. It is also envisaged that HRQOL could be considered as an adjunct outcome measure for TB patients treated through the Lagos State TB programme. This will help attain the best clinical or treatment outcome, and thus increasing the likelihood of adequate case management in TB programmes.  The findings from this study are likely to foster a holistic approach to managing tuberculosis patients, encourage patient-centred services that would empower individuals, families and communities affected by tuberculosis and consequently improve the quality of the DOTS programme in Lagos State.

 1.4 Research questions

  1. Are there differences in health-related quality of life of patients diagnosed with tuberculosis and those without TB from the same communities when matched for age, gender and socio-economic level?
  2. Is there a significant change in HRQOL of PTB patients measured at the baseline, two months and after six months when treatment is completed?
  3. Is there any correlation between the WHOQOL-BREF, a generic HRQOL scale and the

DR-12 scale which is specific for TB?

  1. What determinants are associated with HRQOL in patients with TB with particular regards to co-morbidities such as HIV, socio-economic, socio-demographic, disease/treatment related factors?
  2. What is the relationship between HRQOL and other outcomes in patients treated for TB

 

1.6 General and Specific Objectives

 

 1.6.1 General Objective

To measure and assess changes in the health-related quality of life in adult patients with tuberculosis over the course of DOTS-based treatment and evaluate the association with key determinants and treatment outcome

1.6.2 Specific Objectives

  1. To measure the health-related quality of life of patients with pulmonary tuberculosis using the WHOQOL-BREF and DR-12 at first contact (baseline), at 2 months and at 6 months of treatment
  2. To compare the health-related quality of life of patients with pulmonary tuberculosis and community controls at first contact using the WHOQOL-BREF
  3. To assess the correlation between the WHOQOL-BREF and the DR-12 in measuring Health-related quality of life of respondents with Pulmonary tuberculosis
  4. To determine factors associated with health-related quality of life among patients with tuberculosis
  5. To describe the association between health-related quality of life and treatment outcome at the sixth month of treatment

 

1.5 Hypothesis 

 

Null hypothesis (Level of significance α = 0.05)

  1. There is no statistically significant difference in health-related quality of life as measured by the WHOQOL-BREF in respondents with tuberculosis and controls without TB
  2. There is no statistically significant difference in magnitude of the score for health-related quality of life in patients at commencement of TB therapy, by two months and after completing the six months of therapy
  3. There is no statistically significant correlation between the WHOQOL-BREF and the DR-

12 instruments for measuring health-related quality of life

  1. Health-related quality of life is not significantly affected by socio-demographic, socioeconomic, HIV status, or other disease/treatment-related variables
  2. There is no statistically significant relationship between health-related quality of life and treatment outcomes in patients with TB

 

 

 

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