Challenges to Providing Patient-Centered Care for Multidrug-Resistant Tuberculosis (MDR-TB) in South Africa

Purpose: 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.  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) examine the effect of each ADR on HRQOL, controlling for patient and clinical characteristics; 2) describe concordance between patient report and clinician documentation ADRs. 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 isiZulu 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, laboratory values, and clinician documentation of ADRs.  

Results: The majority of participants (n=121) were co-infected with HIV (75%), female (51%), and did not have enough food to eat everyday (51%). Aim 1) All but two participants reported at least one ADR (98%) with an average of 8.6 per person. 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 multivariable model: tinnitus, gastrointestinal symptoms: nausea/vomiting and diarrhea, and symptoms affecting movement: myalgia, arthralgia, and peripheral neuropathy. Aim 2) ADRs were reported much more frequently in the patient interviews (µ = 8.6) compared to medical records (µ = 1.4). Insomnia was most common (67 vs. 2%), followed by peripheral neuropathy (65 vs. 18%), and confusion (61 vs. 4%). Kappa scores were very low, with the highest degree of concordance found in hearing loss (kappa = 0.23), which was the only ADR not found to be significantly different between the two data sources (p = 0.34).

Conclusion: This study helps fill the knowledge gap on the effect of ADRs from MDR-TB treatment on HRQOL. The study also showed a lack of concordance between patient report and clinician documentation of ADRs. These findings indicate the need for improved documentation of ADRs to better reflect the patient experience during MDR-TB treatment. These data have important implications for country-level pharmacovigilance programs that rely on clinician documentation of ADRs for MDR-TB policy formation. For clinicians, findings reinforce the need to improve detection, documentation and management of ADRs to provide patient-centered care.  Further research is needed to determine effective ADR management techniques to improve HRQOL outcomes for patients on this lengthy and challenging treatment.