Health-related quality of life and its association with medication adherence in active pulmonary tuberculosis in South Africa - an integrated patient-centered outcomes approach

Introduction: Tuberculosis (TB) is a leading cause of morbidity and mortality in South Africa. Whilst clinical parameters are important objective outcomes in TB, they are often not directly correlated with the subjective well-being of the patient which can be assessed using patient- reported outcome (PRO) measures. Health-related quality of life (HRQOL) is a specific PRO of multi-dimensional nature, which includes physical, mental and social health domains. Furthermore, HRQOL may be associated with medication adherence. The thesis evaluates HRQOL and its association with medication adherence in TB in South Africa. Methods: A systematic review on HRQOL and adherence in TB was conducted. Based on the findings, a conceptual framework for HRQOL in TB was developed as a basis for identifying PRO measures, and to generate an endpoint model. The two generic measures SF-12 and EQ-5D-5L, the respiratory-specific measure St. George´s Respiratory Questionnaire (SGRQ), the condition-specific measure Hospital Anxiety and Depression Scale (HADS) for HRQOL and well-being assessment and the Morisky Medication Adherence Scale (MMAS) for adherence assessment were finally selected. All these measures were applied in an observational, longitudinal, multicentre study at five data collection time points during the six- month standard TB treatment. Eligible patients were older than 18 years, new TB cases and were diagnosed without HIV co-infection. Change over time in the Physical Component Score (PCS-12) of SF-12 was defined as primary endpoint. Sample size estimation based thereupon has led to a recruitment target of 96 patients. Statistical analysis included significance testing, correlations, univariable and multivariable analysis, and repeated measures ANOVA. Results: A total of 131 patients participated in the study. Whilst HRQOL was impaired in all physical, mental and psycho-social health domains at the start of standard TB treatment, it improved significantly, and in a clinically meaningful manner, during the course of treatment. The greatest improvement in average mean score from baseline to six-month treatment (+95%) was observed in mental health. Younger patients with higher education and in employment reported a better HRQOL. Adherence mean scores stayed constant with participants attaining a medium average level throughout the treatment course. Associations between HRQOL and adherence were mainly weak, and included a positive relationship with improvements in anxiety and depression, pain and discomfort, and psycho-social health aspects after six months of treatment. Discussion: This was the first longitudinal study in South Africa which evaluated HRQOL and its association with medication adherence in TB following a patient-centred and integrative approach. The study demonstrated the need for an integrative understanding of TB with HRQOL as one of the core elements to inform gaps in current TB management. In addition to an adequate drug treatment, the management of TB should also include services that focus on mental and psycho-social needs of the patient. Conclusion: An understanding about patient-reported HRQOL in TB treatment should support the identification of sustainable health innovations in TB, help determining the value of new products, and support decision making with regard to health policy and pricing. In addition, an integrative patient-centred approach can contribute towards supporting the Sustainability Development Goal 3 target and the End TB strategy of the World Health Organization

Health-related quality of life and its association with medication adherence in active pulmonary tuberculosis– a systematic review of global literature with focus on South Africa

IntroductionTuberculosis (TB) is a leading cause of morbidity and mortality in South Africa. Clinical parameters are important objective outcomes in TB; however they often are not directly correlated with subjective well-being of the patient, but can be assessed using patient-reported outcome (PRO) measures. Health-related quality of life (HRQOL) is a specific PRO generally multi-dimensional in nature and includes physical, mental and social health domains. The inclusion of HRQOL PROs in trials and clinical practice can provide additional information beyondclinical and microbiological parameters. Furthermore, HRQOL may be associated with medication adherence. This review focuses on patient-reported HRQOL and its association with medication adherence in TB patients in South Africa.MethodsA comprehensive search strategy was developed focusing on the impact of TB on patient-reported HRQOL,the existence of a conceptual framework of TB-specific HRQOL, determinants of medication adherence and the association of HRQOL with medication adherence. Data were extracted from all identified articles and additionaldata extraction was performed by two independent reviewers with special focus on longitudinal studies in order to understand changes of HRQOL and adherence over time. Research gaps were identified with regard to patient-reported HRQOL and medication adherence.ResultsA total of 66 articles met the eligibility criteria. Ten HRQOL studies and one adherence study used a longitudinal design, none of these in South Africa. A variety of different generic and disease-specific HRQOL measures were identified in the articles. In South Africa four HRQOL and five adherence studies (non-longitudinal) were published. Similar factors (socio-demographic, socio-economic, disease-related, therapy-related and psycho-social aspects) affect HRQOL and adherence. Although standard TB treatment improved all health domains, psychological well-being and social functioning remained impaired in microbiologically cured patients after treatment.ConclusionWhile evidence of TB impact on HRQOL and medication adherence and their association exists, it is verylimited for the South African situation. No valid and reliable TB-specific HRQOL measures were identified in this systematicreview. An assessment of HRQOL in TB patients in South Africa is required as this may assist with improving current disease management programmes, medication adherence and national treatment guidelines.Electronic supplementary materialThe online version of this article (doi:10.1186/s12955-016-0442-6) contains supplementary material, which is available to authorized users

Association between Health-Related Quality of Life and Medication Adherence in Pulmonary Tuberculosis in South Africa

Background: Health-related quality of life (HRQOL) and adherence to treatment are two often inter-related concepts that have implications for patient management and care. Tuberculosis (TB) and its treatment present a major public health concern in South Africa. The study aimed to evaluate the association between HRQOL and adherence in TB patients in South Africa.Methods: Four self-reported HRQOL and one self-reported adherence measures were used in an observational longitudinal multicentre study during 6-month standard TB treatment. These included the generic Short-Form 12 items (SF-12) and European Quality of Life 5 dimensions 5 levels (EQ-5D-5L), the disease-specific St. George's Respiratory Questionnaire (SGRQ) and the condition-specific Hospital Anxiety and Depression Scale (HADS) for HRQOL. Adherence was measured by the Morisky Medication Adherence Scale 8 items (MMAS-8). The relationship between both concepts was examined in 131 patients using Spearman's rho correlations, and linear regression models.Results: HRQOL improved over 6-month TB treatment, whereas adherence mean scores stayed constant with participants attaining a medium average level. Around 76% of patients reported to be high adherers and 24% were reporting a medium or low adherence. Associations between HRQOL and adherence were mainly weak. High adherence at treatment start was positively related to improvements in anxiety and depression after 6-month treatment. The overall improvement in pain and discomfort, and psychosocial health aspects over treatment time was positively, but weakly associated with adherence at 6 months of treatment.Conclusion: A positive relationship exists between adherence and HRQOL in TB in a South African setting, but this relationship was very weak, most likely because HRQOL is affected by a number of different factors and not limited to effects of adherence. Therefore, management of TB patients should, besides adequate drug treatment, address the specific mental and psychosocial needs

Health-related quality of life in South African patients with pulmonary tuberculosis

BACKGROUND: The evaluation of patient-reported health-related quality of life (HRQOL) in pulmonary tuberculosis (TB) contributes to a comprehensive understanding of the burden associated with this disease. The aim of this study was to assess the overall impact of TB on the health status and on single health domains identified in the WHO definition of health, including physical, mental and social health aspects. METHODS: Four instruments for HRQOL evaluation were applied in a longitudinal multicentre study during six-month standard TB treatment in South Africa. These included the generic SF-12 and EQ-5D-5L, the disease-specific St. George´s Respiratory Questionnaire (SGRQ) and the condition-specific Hospital Anxiety and Depression Scale (HADS). Statistical analysis included significance testing, univariable and multivariable analysis, and repeated measures ANOVA. Change over time in the physical component score (PCS) of SF-12 was defined as primary endpoint. A target sample size of 96 patients was estimated. RESULTS: HRQOL of the study participants was impaired in all physical, mental and psycho-social health domains at treatment start. HRQOL improved significantly and in a clinically meaningful manner during the course of standard TB treatment, over the period of the study. The greatest improvement (95%) was observed in mental health. Younger patients with higher education and who were employed had a better HRQOL. DISCUSSION: This study demonstrates the need for an integrative understanding of TB with HRQOL as core element to inform gaps in current TB management. Improvements in the management of TB following an integrative patient-centred approach will contribute towards meeting the United Nations Sustainable Development Goal 3 (SDG3) target and will support the End TB strategy of the WHO

How to evaluate health-related quality of life and its association with medication adherence in pulmonary tuberculosis – designing a prospective observational study in South Africa

CITATION: Kastien-Hilka, T., et al. 2016. How to evaluate health-related quality of life and its association with medication adherence in pulmonary tuberculosis – designing a prospective observational study in South Africa. Frontiers in Pharmacology, 7:125, doi:10.3389/fphar.2016.00125.The original publication is available at http://journal.frontiersin.orgIntroduction: Health-related quality of life (HRQOL) has become an important measure to identify and shape effective and patient-relevant healthcare interventions innovations through outcomes. Adherence to tuberculosis (TB) treatment is a public health concern. The main objective of this research is to develop a study design for evaluation of HRQOL and its association with medication adherence in TB in South Africa. Methodology: A conceptual framework for HRQOL in TB has been developed to identify Patient-Reported Outcomes and Quality of Life Database (PROQOLID), (n.d.) measures for HRQOL and adherence and to generate an endpoint model. Two generic (SF-12 and EQ-5D-5L), one disease-specific (St. George’s Respiratory Questionnaire) and one condition-specific (Hospital Anxiety and Depression Scale) measure for HRQOL and Morisky Medication Adherence Scale for adherence assessment were identified. All measures are applied in a longitudinal multi-center study at five data collection time points during standard TB treatment. Statistical analysis includes multivariable analysis. Change over time in the physical component score of SF-12 is defined as primary endpoint. Sample size estimation based thereupon has led to a recruitment target of 96 patients. This study is on-going. Discussion: This is the first longitudinal study in South Africa which evaluates HRQOL and its association with medication adherence in TB in a comprehensive manner. Results will help to improve current treatment programs and medication adherence and will support the identification of sustainable health innovations in TB, determining the value of new products, and supporting decision making with regard to health policy and pricing.http://journal.frontiersin.org/article/10.3389/fphar.2016.00125/fullPublisher's versio

Association between health-related quality of life and medication adherence in pulmonary tuberculosis in South Africa

CITATION: Kastien-Hilka, T., et al. 2017. Association between health-related quality of life and medication adherence in pulmonary tuberculosis in South Africa. Frontiers in Pharmacology, 8:919, doi:10.3389/fphar.2017.00919.The original publication is available at https://www.frontiersin.orgBackground: Health-related quality of life (HRQOL) and adherence to treatment are two often inter-related concepts that have implications for patient management and care. Tuberculosis (TB) and its treatment present a major public health concern in South Africa. The study aimed to evaluate the association between HRQOL and adherence in TB patients in South Africa. Methods: Four self-reported HRQOL and one self-reported adherence measures were used in an observational longitudinal multicentre study during 6-month standard TB treatment. These included the generic Short-Form 12 items (SF-12) and European Quality of Life 5 dimensions 5 levels (EQ-5D-5L), the disease-specific St. George's Respiratory Questionnaire (SGRQ) and the condition-specific Hospital Anxiety and Depression Scale (HADS) for HRQOL. Adherence was measured by the Morisky Medication Adherence Scale 8 items (MMAS-8). The relationship between both concepts was examined in 131 patients using Spearman's rho correlations, and linear regression models. Results: HRQOL improved over 6-month TB treatment, whereas adherence mean scores stayed constant with participants attaining a medium average level. Around 76% of patients reported to be high adherers and 24% were reporting a medium or low adherence. Associations between HRQOL and adherence were mainly weak. High adherence at treatment start was positively related to improvements in anxiety and depression after 6-month treatment. The overall improvement in pain and discomfort, and psychosocial health aspects over treatment time was positively, but weakly associated with adherence at 6 months of treatment. Conclusion: A positive relationship exists between adherence and HRQOL in TB in a South African setting, but this relationship was very weak, most likely because HRQOL is affected by a number of different factors and not limited to effects of adherence. Therefore, management of TB patients should, besides adequate drug treatment, address the specific mental and psychosocial needs.https://www.frontiersin.org/articles/10.3389/fphar.2017.00919/fullPublisher's versio

Associations between HRQOL and socio-demographic factors at baseline.

<p>Associations between HRQOL and socio-demographic factors at baseline.</p

Baseline impairment of HRQOL in TB patients at treatment start.

<p>Baseline impairment of HRQOL in TB patients at treatment start.</p

Change in HRQOL over six-month treatment.

<p>Change in HRQOL over six-month treatment.</p