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Impact of alcohol consumption on tuberculosis treatment outcomes: a prospective longitudinal cohort study protocol.

ABSTRACT: BACKGROUND:An estimated 10% of tuberculosis (TB) deaths are attributable to problematic alcohol use globally, however the causal pathways through which problem alcohol use has an impact on TB treatment outcome is not clear. This study aims to improve understanding of these mechanisms. Specifically, we aim to 1) assess whether poor TB treatment outcomes, measured as delayed time-to-culture conversion, are associated with problem alcohol use after controlling for non-adherence to TB pharmacotherapy; and 2) to determine whether pharmacokinetic (PK) changes in those with problem alcohol use are associated with delayed culture conversion, higher treatment failure/relapse rates or with increased toxicity. METHODS:Our longitudinal, repeated measures, prospective cohort study aims to examine the associations between problem alcohol use and TB treatment outcomes and to evaluate the effect of alcohol on the PK and pharmacodynamics (PD) of TB drugs. We will recruit 438 microbiologically confirmed, pulmonary TB patients with evidence of rifampicin susceptibility in Worcester, South Africa with 200 HIV uninfected patients co-enrolled in the PK aim. Participants are followed for the six months of TB treatment and an additional 12 months thereafter, with sputum collected weekly for the first 12 weeks of treatment, alcohol consumption measures repeated monthly in concert with an alcohol biomarker (phosphatidylethanol) measurement at baseline, and in person directly observed therapy (DOT) using real-time mobile phone-based adherence monitoring. The primary outcome is based on time to culture conversion with the second objective to compare PK of first line TB therapy in those with and without problem alcohol use. DISCUSSION:Globally, an urgent need exists to identify modifiable drivers of poor TB treatment outcomes. There is a critical need for more effective TB treatment strategies for patients with a history of problem alcohol use. However, it is not known whether poor treatment outcomes in alcohol using patients are solely attributable to noncompliance. This study will attempt to answer this question and provide guidance for future TB intervention trials. TRIAL REGISTRATION:Clinicaltrials.gov Registration Number: NCT02840877 . Registered on 19 July 2016.

SUBMITTER: Myers B

PROVIDER: S-EPMC6162918 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Impact of alcohol consumption on tuberculosis treatment outcomes: a prospective longitudinal cohort study protocol.

Myers Bronwyn B Bouton Tara C TC Ragan Elizabeth J EJ White Laura F LF McIlleron Helen H Theron Danie D Parry Charles D H CDH Horsburgh C Robert CR Warren Robin M RM Jacobson Karen R KR

BMC infectious diseases 20180929 1

<h4>Background</h4>An estimated 10% of tuberculosis (TB) deaths are attributable to problematic alcohol use globally, however the causal pathways through which problem alcohol use has an impact on TB treatment outcome is not clear. This study aims to improve understanding of these mechanisms. Specifically, we aim to 1) assess whether poor TB treatment outcomes, measured as delayed time-to-culture conversion, are associated with problem alcohol use after controlling for non-adherence to TB pharma ...[more]

PMID: 30268101

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Project description:Objectives To investigate whether moderate alcohol consumption has a favourable or adverse association or no association with brain structure and function.Design Observational cohort study with weekly alcohol intake and cognitive performance measured repeatedly over 30 years (1985-2015). Multimodal magnetic resonance imaging (MRI) was performed at study endpoint (2012-15).Setting Community dwelling adults enrolled in the Whitehall II cohort based in the UK (the Whitehall II imaging substudy).Participants 550 men and women with mean age 43.0 (SD 5.4) at study baseline, none were "alcohol dependent" according to the CAGE screening questionnaire, and all safe to undergo MRI of the brain at follow-up. Twenty three were excluded because of incomplete or poor quality imaging data or gross structural abnormality (such as a brain cyst) or incomplete alcohol use, sociodemographic, health, or cognitive data.Main outcome measures Structural brain measures included hippocampal atrophy, grey matter density, and white matter microstructure. Functional measures included cognitive decline over the study and cross sectional cognitive performance at the time of scanning.Results Higher alcohol consumption over the 30 year follow-up was associated with increased odds of hippocampal atrophy in a dose dependent fashion. While those consuming over 30 units a week were at the highest risk compared with abstainers (odds ratio 5.8, 95% confidence interval 1.8 to 18.6; P?0.001), even those drinking moderately (14-21 units/week) had three times the odds of right sided hippocampal atrophy (3.4, 1.4 to 8.1; P=0.007). There was no protective effect of light drinking (1-<7 units/week) over abstinence. Higher alcohol use was also associated with differences in corpus callosum microstructure and faster decline in lexical fluency. No association was found with cross sectional cognitive performance or longitudinal changes in semantic fluency or word recall.Conclusions Alcohol consumption, even at moderate levels, is associated with adverse brain outcomes including hippocampal atrophy. These results support the recent reduction in alcohol guidance in the UK and question the current limits recommended in the US.

Project description:BackgroundDespite intense investigation, the temporal sequence between alcohol consumption and mental health remains unclear. This study explored the relationship between alcohol consumption and mental health over multiple occasions, and compared a series of competing theoretical models to determine which best reflected the association between the two.MethodsData from phases 5 (1997 to 1999), 7 (2002 to 2004), and 9 (2007 to 2009) of the Whitehall II prospective cohort study were used, providing approximately 10 years of follow-up for 6,330 participants (73% men; mean ± SD age 55.8 ± 6.0 years). Mental health was assessed using the Short Form (SF)-36 mental health component score. Alcohol consumption was defined as the number of UK units of alcohol drunk per week. Four dynamic latent change score models were compared: 1) a baseline model in which alcohol consumption and mental health trajectories did not influence each other, 2) and model in which alcohol consumption influenced changes in mental health but mental health exerted no effect on changes in drinking and 3) vice versa, and (4) a reciprocal model in which both variables influenced changes in each other.ResultsThe third model, in which mental health influenced changes in alcohol consumption but not vice versa, was the best fit. In this model, the effect of previous mental health on upcoming change in alcohol consumption was negative (? = -0.31, 95% CI -0.52 to -0.10), meaning that those with better mental health tended to make greater reductions (or shallower increases) in their drinking between occasions.ConclusionsMental health appears to be the leading indicator of change in the dynamic longitudinal relationship between mental health and weekly alcohol consumption in this sample of middle-aged adults. In addition to fuelling increases in alcohol consumption among low-level consumers, poor mental health may also be a maintaining factor for heavy alcohol consumption. Future work should seek to examine whether there are critical levels of alcohol intake at which different dynamic relationships begin to emerge between alcohol-related measures and mental health.

Project description:BackgroundWhile the health, social, and economic impacts of opioid addiction on adults and their communities are well known, the impact of maternal opioid use on the fetus exposed in utero is less well understood.MethodsThis paper presents the protocol of the ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study, a multi-site prospective longitudinal cohort study of infants with antenatal opioid exposure and unexposed controls. Study objectives are to determine the impact of antenatal opioid exposure on brain development and neurodevelopmental outcomes over the first 2 years of life and explore whether family, home, and community factors modify developmental trajectories during this critical time period.ResultsPrimary outcomes related to brain development include cortical volumes, deep cerebral gray matter volumes, resting-state functional connectivity measures, and structural connectivity measures using diffusion tensor imaging. Primary neurodevelopmental outcomes include visual abnormalities, cognitive, language, and motor skills measured using the Bayley Scales of Infant Development and social-emotional and behavioral problems and competence measured by the Brief Infant-Toddler Social and Emotional Assessment.ConclusionsThe OBOE study has been designed to overcome challenges of previous studies and will help further understanding of the effects of antenatal opioid exposure on early infant development.ImpactThis study will integrate MRI findings and comprehensive neurodevelopmental assessments to provide early insights into the functional topography of the brain in this high-risk population and assess MRI as a potential biomarker. Rather than conducting neuroimaging at a single time point, the study will include serial MRI assessments from birth to 2 years, allowing for the examination of trajectories throughout this period of rapid brain development. While previous studies often have had limited information on exposures, this study will use umbilical cord assays to accurately measure amounts of opioids and other substances from 20 weeks of gestation to birth.

Project description:BackgroundTuberculosis (TB) still represents a major public health problem in Latin America, with low success and high default rates. Poor adherence represents a major threat for TB control and promotes emergence of drug-resistant TB. Expanding social protection programs could have a substantial effect on the global burden of TB; however, there is little evidence to evaluate the outcomes of socioeconomic support interventions. This study evaluated the effect of a conditional cash transfer (CCT) policy on treatment success and default rates in a prospective cohort of socioeconomically disadvantaged patients.Methods and findingsData were collected on adult patients with first diagnosis of pulmonary TB starting treatment in public healthcare facilities (HCFs) from 16 health departments with high TB burden in Buenos Aires who were followed until treatment completion or abandonment. The main exposure of interest was the registration to receive the CCT. Other covariates, such as sociodemographic and clinical variables and HCFs' characteristics usually associated with treatment adherence and outcomes, were also considered in the analysis. We used hierarchical models, propensity score (PS) matching, and inverse probability weighting (IPW) to estimate treatment effects, adjusting for individual and health system confounders. Of 941 patients with known CCT status, 377 registered for the program showed significantly higher success rates (82% versus 69%) and lower default rates (11% versus 20%). After controlling for individual and system characteristics and modality of treatment, odds ratio (OR) for success was 2.9 (95% CI 2, 4.3, P < 0.001) and default was 0.36 (95% CI 0.23, 0.57, P < 0.001). As this is an observational study evaluating an intervention not randomly assigned, there might be some unmeasured residual confounding. Although it is possible that a small number of patients was not registered into the program because they were deemed not eligible, the majority of patients fulfilled the requirements and were not registered because of different reasons. Since the information on the CCT was collected at the end of the study, we do not know the exact timing for when each patient was registered for the program.ConclusionsThe CCT appears to be a valuable health policy intervention to improve TB treatment outcomes. Incorporating these interventions as established policies may have a considerable effect on the control of TB in similar high-burden areas.

Dataset Information

Impact of alcohol consumption on tuberculosis treatment outcomes: a prospective longitudinal cohort study protocol.

Publications

Impact of alcohol consumption on tuberculosis treatment outcomes: a prospective longitudinal cohort study protocol.

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