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Accuracy of diabetes screening methods used for people with tuberculosis, Indonesia, Peru, Romania, South Africa.

ABSTRACT: Objective:To evaluate the performance of diagnostic tools for diabetes mellitus, including laboratory methods and clinical risk scores, in newly-diagnosed pulmonary tuberculosis patients from four middle-income countries. Methods:In a multicentre, prospective study, we recruited 2185 patients with pulmonary tuberculosis from sites in Indonesia, Peru, Romania and South Africa from January 2014 to September 2016. Using laboratory-measured glycated haemoglobin (HbA1c) as the gold standard, we measured the diagnostic accuracy of random plasma glucose, point-of-care HbA1c, fasting blood glucose, urine dipstick, published and newly derived diabetes mellitus risk scores and anthropometric measurements. We also analysed combinations of tests, including a two-step test using point-of-care HbA1cwhen initial random plasma glucose was ≥ 6.1 mmol/L. Findings:The overall crude prevalence of diabetes mellitus among newly diagnosed tuberculosis patients was 283/2185 (13.0%; 95% confidence interval, CI: 11.6-14.4). The marker with the best diagnostic accuracy was point-of-care HbA1c (area under receiver operating characteristic curve: 0.81; 95% CI: 0.75-0.86). A risk score derived using age, point-of-care HbA1c and random plasma glucose had the best overall diagnostic accuracy (area under curve: 0.85; 95% CI: 0.81-0.90). There was substantial heterogeneity between sites for all markers, but the two-step combination test performed well in Indonesia and Peru. Conclusion:Random plasma glucose followed by point-of-care HbA1c testing can accurately diagnose diabetes in tuberculosis patients, particularly those with substantial hyperglycaemia, while reducing the need for more expensive point-of-care HbA1c testing. Risk scores with or without biochemical data may be useful but require validation.

SUBMITTER: Grint D

PROVIDER: S-EPMC6239004 | biostudies-other | 2018 Nov

REPOSITORIES: biostudies-other

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Accuracy of diabetes screening methods used for people with tuberculosis, Indonesia, Peru, Romania, South Africa.

Grint Daniel D Alisjhabana Bachti B Ugarte-Gil Cesar C Riza Anca-Leila AL Walzl Gerhard G Pearson Fiona F Ruslami Rovina R Moore David A J DAJ Ioana Mihai M McAllister Susan S Ronacher Katharina K Koeseomadinata Raspati C RC Kerry-Barnard Sarah R SR Coronel Jorge J Malherbe Stephanus T ST Dockrell Hazel M HM Hill Philip C PC Van Crevel Reinout R Critchley Julia A JA

Bulletin of the World Health Organization 20180827 11

<h4>Objective</h4>To evaluate the performance of diagnostic tools for diabetes mellitus, including laboratory methods and clinical risk scores, in newly-diagnosed pulmonary tuberculosis patients from four middle-income countries.<h4>Methods</h4>In a multicentre, prospective study, we recruited 2185 patients with pulmonary tuberculosis from sites in Indonesia, Peru, Romania and South Africa from January 2014 to September 2016. Using laboratory-measured glycated haemoglobin (HbA1c) as the gold sta ...[more]

PMID: 30455529

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Project description:Rationale: Recent tuberculosis treatment trials failed to show that some 4-month (4m) regimens were noninferior to conventional 6-month (6m) regimens for a composite clinical outcome. Novel shortened regimens may still have important clinical and economic benefits in populations with high loss to follow-up (LTFU) and in subgroups such as people with human immunodeficiency virus.Objectives: To identify scenarios in which a novel 4m regimen would be preferred to a conventional 6m regimen for treatment of drug-susceptible tuberculosis in people with human immunodeficiency virus in South Africa, in terms of short-term and long-term clinical and economic outcomes.Methods: We used the Cost-Effectiveness of Preventing AIDS Complications-International microsimulation model to project outcomes modeled on participants in the OFLOTUB trial. For calibration purposes, we did a base case analysis by applying trial-informed parameters for the 4m/6m regimens, including monthly LTFU during treatment (0.68%/0.83%), average monthly tuberculosis recurrence (0.65%/0.31%), and monthly drug costs (U.S. dollars [USD]25.90/3.70). We then evaluated different scenarios and 4m regimen characteristics, varying key parameters, including LTFU (informed by observational cohort data), recurrence, and cost. We projected outcomes, including 2-year mortality and life expectancy. We conducted a cost-effectiveness analysis, evaluating the incremental cost-effectiveness ratio of a 4m versus 6m regimen.Results: In the base case model analysis, risk of the composite unfavorable outcome in the 4m/6m groups was 19.8%/15.9%, similar to the trial; projected life expectancies were 22.1/22.3 years. In analyses of alternative scenarios and 4m regimen characteristics, a 4m regimen yielded lower risk of the composite unfavorable outcome than the conventional 6m regimen if LTFU increased to greater than 3.5%/mo or if average recurrence after a 4m regimen decreased to less than 0.45%/mo, and it yielded higher life expectancy if LTFU was greater than 3.5%/mo or if recurrence was less than 0.5%/mo. A 4m regimen was not cost-effective in the base case but became cost-effective (incremental cost-effectiveness ratio <USD940/yr of life saved) in two-way sensitivity analysis; for example, if LTFU was greater than or equal to 5.3%/mo and either average recurrence was less than or equal to 0.5%/mo or drug cost was less than or equal to USD15/mo.Conclusions: A novel shortened tuberculosis treatment regimen could improve outcomes such as survival despite conferring a higher recurrence risk, particularly in settings where LTFU is higher than that seen in recent trials.

Project description:BackgroundThere is little evidence of patient acceptability for drug-resistant tuberculosis (DRTB) care in the context of new treatment regimens and HIV co-infection. We aim to describe experiences of DRTB-HIV care among patients in KwaZulu-Natal province, South Africa.MethodsIn this qualitative study using Bury's framework for chronic illness, we conducted 13 focus groups at a tertiary hospital with 55 patients co-infected with DRTB and HIV (28 women, 27 men) who were receiving new bedaquiline-based treatment for DRTB, concurrent with antiretroviral therapy. Eligible patients were consenting adults (aged >18 years) with confirmed DRTB and HIV who were enrolled into the PRAXIS study within 2 weeks of initiating bedaquiline-based treatment for DRTB. Participants were recruited from the PRAXIS cohort to participate in a focus group based on their time in DRTB treatment: early (2-6 weeks after treatment initiation), middle (2-6 months after discharge or treatment initiation if never hospitalised), and late (>6 months after treatment initiation). Focus groups were carried out in isiZulu language, audio recorded, and translated to English within 4 weeks. Participants were asked about their experiences of DRTB and HIV care and treatment, and qualitative data were coded and thematically analysed.FindingsFrom March, 2017, to June, 2018, distinctive patient challenges were identified at four critical stages of DRTB care: diagnosis, marked by centralised hospitalisation, renunciation from routine life, systemic stigmatisation and, for patients with longstanding HIV, renewed destabilisation; treatment initiation, marked by side-effects, isolation, and social disconnectedness; discharge, marked by brief respite and resurgent therapeutic and social disruption; and continuity, marked by deepening socioeconomic challenges despite clinical recovery. The periods of diagnosis and discharge into the community were particularly difficult. Treatment information and agency in decision making was a persistent gap. Sources of stigmatisation shifted with movement between the hospital and community. Resilience was built by connecting to peers, self-isolating, financial and material security, and a focus on recovery.InterpretationPeople with DRTB and HIV undergo disruptive, life-altering experiences. The lack of information, agency, and social protections in DRTB care and treatment causes wider-reaching challenges for patients compared with HIV. Decentralised, community, peer-support, and differentiated care models for DRTB might be ameliorative and help to maximise the promise of new regimens.FundingUS National Institutes of Health.TranslationFor the isiZulu translation of the abstract see Supplementary Materials section.

Project description:BackgroundDrug-resistant tuberculosis threatens recent gains in the treatment of tuberculosis and human immunodeficiency virus (HIV) infection worldwide. A widespread epidemic of extensively drug-resistant (XDR) tuberculosis is occurring in South Africa, where cases have increased substantially since 2002. The factors driving this rapid increase have not been fully elucidated, but such knowledge is needed to guide public health interventions.MethodsWe conducted a prospective study involving 404 participants in KwaZulu-Natal Province, South Africa, with a diagnosis of XDR tuberculosis between 2011 and 2014. Interviews and medical-record reviews were used to elicit information on the participants' history of tuberculosis and HIV infection, hospitalizations, and social networks. Mycobacterium tuberculosis isolates underwent insertion sequence (IS)6110 restriction-fragment-length polymorphism analysis, targeted gene sequencing, and whole-genome sequencing. We used clinical and genotypic case definitions to calculate the proportion of cases of XDR tuberculosis that were due to inadequate treatment of multidrug-resistant (MDR) tuberculosis (i.e., acquired resistance) versus those that were due to transmission (i.e., transmitted resistance). We used social-network analysis to identify community and hospital locations of transmission.ResultsOf the 404 participants, 311 (77%) had HIV infection; the median CD4+ count was 340 cells per cubic millimeter (interquartile range, 117 to 431). A total of 280 participants (69%) had never received treatment for MDR tuberculosis. Genotypic analysis in 386 participants revealed that 323 (84%) belonged to 1 of 31 clusters. Clusters ranged from 2 to 14 participants, except for 1 large cluster of 212 participants (55%) with a LAM4/KZN strain. Person-to-person or hospital-based epidemiologic links were identified in 123 of 404 participants (30%).ConclusionsThe majority of cases of XDR tuberculosis in KwaZulu-Natal, South Africa, an area with a high tuberculosis burden, were probably due to transmission rather than to inadequate treatment of MDR tuberculosis. These data suggest that control of the epidemic of drug-resistant tuberculosis requires an increased focus on interrupting transmission. (Funded by the National Institute of Allergy and Infectious Diseases and others.).

Project description:BackgroundSouth Africa's tuberculosis burden is the third highest globally and is closely associated with the country's devastating HIV epidemic. The separation of HIV and TB services in primary healthcare services in South Africa hampers TB case finding in patients who are co-infected with HIV and TB. This operational proof of concept study assessed an approach to improving tuberculosis detection and treatment by integrating tuberculosis management into HIV care.MethodsThe intervention involved workforce re-engineering accompanied by changes to the physical environment in three primary healthcare facilities in Gert Sibande district, Mpumalanga Province, that allowed HIV providers to test their HIV patients for TB and initiate and monitor TB treatment when indicated. To assess the proof of concept we compared the management of TB patients by HIV and TB providers, by reviewing the records of all facility patients who tested positive for tuberculosis between July 2015 and February 2016. We also considered the perceptions of healthcare providers and facility managers about the intervention through structured interviews.ResultsApproximately 30% of the 1855 patients with presumed TB in the three clinics had been identified by HIV providers. The percentage of patients consecutively tested for TB was 81.0% and 85.0% (p = 0.0551) for HIV and TB providers, respectively. Of the patients identified with TB by HIV and TB providers, 75.4% and 79.2% (p = 0.2876), respectively, were initiated on treatment. The defaulter rate was higher among HIV, compared to TB, providers (12.8% versus 4.2%). Overall, healthcare providers and facility managers had positive views of the intervention but raised concerns regarding potential increase in workload and administrative issues, as well as infection control.ConclusionsThe results of this proof-of-concept study indicate that the full spectrum of TB services can be easily and effectively integrated into existing HIV care programs. However, a possible shift in the service providers' workload, including administrative tasks, must be tackled and effective infection control must be ensured. Further research is needed to assess the impact of TB service integration into the scope of HIV care (or other chronic care programs) on patient outcomes, including analysis of routine data.

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Accuracy of diabetes screening methods used for people with tuberculosis, Indonesia, Peru, Romania, South Africa.

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Accuracy of diabetes screening methods used for people with tuberculosis, Indonesia, Peru, Romania, South Africa.

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