Adverse Drug Reactions and Resultant Health-Related Quality of Life During Multidrug-Resistant Tuberculosis Treatment in South Africa
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Background/Significance: The incidence of multidrug-resistant tuberculosis (MDR-TB) is on the rise globally. MDR-TB takes a minimum of 2 years to treat and the treatment regimen produces many adverse drug reactions (ADRs). The World Health Organization (WHO) has called for further research on the treatment of community- based MDR-TB patients as care is being decentralized to outpatient settings. In the WHO’s TB progress report for 2015, they note there is a dearth of literature about anti- TB drug-induced mortality, morbidity and loss in quality of life, particularly in low- resource settings.
Purpose: This study directly addresses this gap in knowledge by examining the effect of ADRs from MDR-TB treatment on heath-related quality of life (HRQOL) for patients in a low-resource, high HIV-burden population in South Africa.
Methods: A cross-sectional, observational study design was used to: 1) describe patient and clinical characteristics of community-based MDR-TB patients; 2) examine the relationship between Aim 1 characteristics and ADRs; and 3) examine the effect of each ADR on HRQOL, controlling for Aim 1 characteristics. MDR-TB patients in the initial intensive phase of treatment were recruited using convenience sampling from an outpatient MDR-TB clinic in South Africa. Patient interviews were conducted in English or isi Zulu and included questions on individual characteristics (age, sex, education, employment, relationship status, alcohol/smoking, stigma, and adherence) and environmental characteristics (housing status, food insecurity, social support and discrimination). ADRs and symptom bother over the past month of treatment were collected using a symptom checklist and HRQOL was collected using the EQ-5D. A medical chart data abstraction was conducted to capture MDR-TB treatment, HIV/AIDS status and treatment, co-morbidities, BMI, and laboratory values.
Results: Aim 1: The majority of participants (=121) were co-infected with HIV (75%), female (51%), and did not have enough food to eat everyday (51%). Aim 2: All but two participants reported at least one ADR (98%) with an average of 8.6 per person. In the multivariable analysis, being female and starting MDR-TB treatment with elevated liver enzymes were significantly related to an increase in total ADRs. There was no significant difference in ADRs by HIV status. Aim 3: An increase in total ADRs was significantly related to a decrease in HRQOL. Of the 18 ADRs assessed, six were associated with a decrease in HRQOL in the final model: tinnitus, gastrointestinal symptoms: nausea/vomiting and diarrhea, and symptoms affecting movement: myalgia, arthralgia, and peripheral neuropathy. Patient and clinical characteristics that remained significant were the loss of relationship and hospitalization during treatment, with past hospitalization associated with increased HRQOL.
Implications: This study helps fill the knowledge gap on the effect of ADRs from MDR-TB treatment on HRQOL. For clinicians, findings reinforce the need to improve detection, documentation and management of ADRs. Further research is needed to determine effective ADR management techniques to improve HRQOL outcomes for patients on this lengthy and challenging treatment.
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