Date Published: April 20, 2017
Publisher: Public Library of Science
Author(s): Tanja Kastien-Hilka, Bernd Rosenkranz, Edina Sinanovic, Bryan Bennett, Matthias Schwenkglenks, Ashutosh Nath Aggarwal.
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.
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.
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.
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.
At the beginning of 2016, the United Nations (UN) introduced the Sustainable Development Goals (SDGs) to replace the Millennium Development Goals (MDGs) established in 2000 . The third goal of the SDGs (SGD3) aims to ensure healthy lives and promote well-being at all ages . One target of SGD3 focuses on universal health coverage, including access to safe, effective, high quality and affordable essential medicines . Access to medicines requires sponsors to demonstrate that the medicine is safe, effective and affordable. The evidence of the real benefit of a treatment is usually evaluated based on clinical trials and real world data evidence. Only after this evidence has been provided, can medicines be made accessible through healthcare organizations. The World Health Organization (WHO) claims that patient involvement in their healthcare is a social, economic and technical necessity . The evaluation of a patient-reported perspective of a disease and treatment contributes to a comprehensive understanding of the benefit and risk associated with that disease. This is important as some concepts cannot be measured objectively. One specific patient-reported outcome (PRO) is health-related quality of life (HRQOL). HRQOL is a PRO which refers to the multi-dimensional nature of health, and usually includes physical, mental and social health domains .
A detailed description of the study design and methodology has been published previously (Kastien-Hilka et al 2016). Briefly, the study followed an observational longitudinal design including prospective, repeated measures of HRQOL per study participant.
In total, 131 eligible patients were recruited and agreed to participate in the study. Overall, 444 interviews were conducted over the duration of the study with questionnaires completed for data analysis.
The increasing prevalence of non-communicable diseases (NCDs) and communicable diseases such as TB in South Africa leads to an increased pressure on healthcare resources. More importantly, from the patient perspective it also has an impact on the general well-being and HRQOL of patients.
TB negatively impacts the HRQOL of patients, with specific impairment reported in physical, mental and psycho-social health aspects, however with treatment HRQOL improves significantly. Different aspects of health (HRQOL domains) are impacted differently and it would appear that the rate of improvement in each domain may also be different. HRQOL reveals different outcomes depending on the type of measure applied and depending on the cultural background and the study setting, making comparison of HRQOL outcomes difficult. Generic HRQOL PROs may not adequately capture all relevant aspects of TB, and thus a disease-specific HRQOL measure is required. This study also 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 UN SDG3 target and will support the End TB strategy of the WHO.