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Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults.

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Accurate, rapid detection of tuberculosis (TB) and TB drug resistance is critical for improving patient care and decreasing TB transmission. Xpert® MTB/RIF assay is an automated test that can detect both TB and rifampicin resistance, generally within two hours after starting the test, with minimal hands-on technical time. The World Health Organization (WHO) issued initial recommendations on Xpert® MTB/RIF in early 2011. A Cochrane Review on the diagnostic accuracy of Xpert® MTB/RIF for pulmonary TB and rifampicin resistance was published January 2013. We performed this updated Cochrane Review as part of a WHO process to develop updated guidelines on the use of the test.
OBJECTIVES: To assess the diagnostic accuracy of Xpert® MTB/RIF for pulmonary TB (TB detection), where Xpert® MTB/RIF was used as both an initial test replacing microscopy and an add-on test following a negative smear microscopy result.To assess the diagnostic accuracy of Xpert® MTB/RIF for rifampicin resistance detection, where Xpert® MTB/RIF was used as the initial test replacing culture-based drug susceptibility testing (DST).The populations of interest were adults presumed to have pulmonary, rifampicin-resistant or multidrug-resistant TB (MDR-TB), with or without HIV infection. The settings of interest were intermediate- and peripheral-level laboratories. The latter may be associated with primary health care facilities.
SEARCH METHODS: We searched for publications in any language up to 7 February 2013 in the following databases: Cochrane Infectious Diseases Group Specialized Register; MEDLINE; EMBASE; ISI Web of Knowledge; MEDION; LILACS; BIOSIS; and SCOPUS. We also searched the metaRegister of Controlled Trials (mRCT) and the search portal of the WHO International Clinical Trials Registry Platform to identify ongoing trials.

SELECTION CRITERIA: We included randomized controlled trials, cross-sectional studies, and cohort studies using respiratory specimens that allowed for extraction of data evaluating Xpert® MTB/RIF against the reference standard. We excluded gastric fluid specimens. The reference standard for TB was culture and for rifampicin resistance was phenotypic culture-based DST.

DATA COLLECTION AND ANALYSIS: For each study, two review authors independently extracted data using a standardized form. When possible, we extracted data for subgroups by smear and HIV status. We assessed the quality of studies using QUADAS-2 and carried out meta-analyses to estimate pooled sensitivity and specificity of Xpert® MTB/RIF separately for TB detection and rifampicin resistance detection. For TB detection, we performed the majority of analyses using a bivariate random-effects model and compared the sensitivity of Xpert® MTB/RIF and smear microscopy against culture as reference standard. For rifampicin resistance detection, we undertook univariate meta-analyses for sensitivity and specificity separately to include studies in which no rifampicin resistance was detected.
MAIN RESULTS: We included 27 unique studies (integrating nine new studies) involving 9557 participants. Sixteen studies (59%) were performed in low- or middle-income countries. For all QUADAS-2 domains, most studies were at low risk of bias and low concern regarding applicability.As an initial test replacing smear microscopy, Xpert® MTB/RIF pooled sensitivity was 89% [95% Credible Interval (CrI) 85% to 92%] and pooled specificity 99% (95% CrI 98% to 99%), (22 studies, 8998 participants: 2953 confirmed TB, 6045 non-TB).As an add-on test following a negative smear microscopy result, Xpert®MTB/RIF pooled sensitivity was 67% (95% CrI 60% to 74%) and pooled specificity 99% (95% CrI 98% to 99%; 21 studies, 6950 participants).For smear-positive, culture-positive TB, Xpert® MTB/RIF pooled sensitivity was 98% (95% CrI 97% to 99%; 21 studies, 1936 participants).For people with HIV infection, Xpert® MTB/RIF pooled sensitivity was 79% (95% CrI 70% to 86%; 7 studies, 1789 participants), and for people without HIV infection, it was 86% (95% CrI 76% to 92%; 7 studies, 1470 participants). Comparison with smear microscopy In comparison with smear microscopy, Xpert® MTB/RIF increased TB detection among culture-confirmed cases by 23% (95% CrI 15% to 32%; 21 studies, 8880 participants).For TB detection, if pooled sensitivity estimates for Xpert® MTB/RIF and smear microscopy are applied to a hypothetical cohort of 1000 patients where 10% of those with symptoms have TB, Xpert® MTB/RIF will diagnose 88 cases and miss 12 cases, whereas sputum microscopy will diagnose 65 cases and miss 35 cases. Rifampicin resistanceFor rifampicin resistance detection, Xpert® MTB/RIF pooled sensitivity was 95% (95% CrI 90% to 97%; 17 studies, 555 rifampicin resistance positives) and pooled specificity was 98% (95% CrI 97% to 99%; 24 studies, 2411 rifampicin resistance negatives). Among 180 specimens with nontuberculous mycobacteria (NTM), Xpert® MTB/RIF was positive in only one specimen that grew NTM (14 studies, 2626 participants).For rifampicin resistance detection, if the pooled accuracy estimates for Xpert® MTB/RIF are applied to a hypothetical cohort of 1000 individuals where 15% of those with symptoms are rifampicin resistant, Xpert® MTB/RIF would correctly identify 143 individuals as rifampicin resistant and miss eight cases, and correctly identify 833 individuals as rifampicin susceptible and misclassify 17 individuals as resistant. Where 5% of those with symptoms are rifampicin resistant, Xpert® MTB/RIF would correctly identify 48 individuals as rifampicin resistant and miss three cases and correctly identify 931 individuals as rifampicin susceptible and misclassify 19 individuals as resistant.

AUTHORS' CONCLUSIONS: In adults thought to have TB, with or without HIV infection, Xpert® MTB/RIF is sensitive and specific. Compared with smear microscopy, Xpert® MTB/RIF substantially increases TB detection among culture-confirmed cases. Xpert® MTB/RIF has higher sensitivity for TB detection in smear-positive than smear-negative patients. Nonetheless, this test may be valuable as an add-on test following smear microscopy in patients previously found to be smear-negative. For rifampicin resistance detection, Xpert® MTB/RIF provides accurate results and can allow rapid initiation of MDR-TB treatment, pending results from conventional culture and DST. The tests are expensive, so current research evaluating the use of Xpert® MTB/RIF in TB programmes in high TB burden settings will help evaluate how this investment may help start treatment promptly and improve outcomes.

Interferon Gene Expression in Sputum Cells Correlates with the Asthma Index Score During Virus-Induced Exacerbations.

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The majority of asthma exacerbations are related to viral respiratory infections. Some, but not all, previous studies have reported that low interferon responses in patients with asthma increase the risk for virus-induced exacerbations.

OBJECTIVE: We sought to determine the relationship between lower airway inflammatory biomarkers, specifically interferon gene expression, and the severity or presence of an exacerbation in asthmatics experiencing a naturally occurring viral infection.

METHODS: Sputum samples were analyzed from subjects in an asthma exacerbation study who experienced a confirmed viral infection. Subjects were monitored for daily symptoms, medication use, and peak expiratory flow rate until baseline. Sputum samples were assessed for cell counts and gene expression.

RESULTS: IFN-γ expression was significantly greater in patients with asthma exacerbations compared to non-exacerbating patients (p=0.002). IFN-α1, IFN-β1, and IFN-γ mRNA levels correlated with the peak Asthma Index (r=0.58, p<0.001; r=0.57, p=0.001; and r=0.51, p=0.004, respectively). Additionally, IL-13, IL-10 and eosinophil major basic protein mRNA levels were greater in patients with asthma exacerbations compared to non-exacerbating patients (p=0.03, p=0.06, and p=0.02, respectively), and IL-13 mRNA correlated with the peak Asthma Index (p=0.006).

CONCLUSIONS: Our findings indicate that asthma exacerbations are associated with increased rather than decreased expression of interferons early in the course of infection. These findings raise the possibility that excessive virus-induced interferon production during acute infections can contribute to airway inflammation and exacerbations of asthma. This article is protected by copyright. All rights reserved.

The COPD assessment test (CAT) assists prediction of COPD exacerbations in high-risk patients.

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We evaluated the predictive value of the COPD assessment test (CAT™) for exacerbation in the following six months or time to first exacerbation among COPD patients with previous exacerbations. COPD outpatients with a history of exacerbation from 19 hospitals completed the CAT questionnaire and spirometry over six months. Exacerbation events were prospectively collected using a structured questionnaire.

The baseline CAT score categorised into four groups (0-9, 10-19, 20-29, and 30-40) showed strong prediction for time to first exacerbation and modest prediction for any exacerbation or moderate-severe exacerbation (AUC 0.83, 0.64, and 0.63 respectively). In multivariate analyses, the categorised CAT score independently predicted all three outcomes (p = 0.001 or p < 0.001). Compared with the lowest CAT score category, the higher categories were associated with significantly shorter time to first exacerbation and higher exacerbation risks. The corresponding adjusted median time was >24, 14, 9, and 5 weeks and the adjusted RR was 1.00, 1.30, 1.37, and 1.50 in the category of 0-9, 10-19, 20-29, and 30-40 respectively. Exacerbation history (≥2 vs. 1 event in the past year) was related to time to first exacerbation (adjusted HR 1.35; p = 0.023) and any exacerbation during the study period (adjusted RR 1.15; p = 0.016).

The results of this study support the use of the CAT as a simple tool to assist in the identification of patients at increased risk of exacerbations. This could facilitate timely and cost-effective implementation of preventive interventions, and improve health resource allocation.

Non-communicable diseases in the Arab world.

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Non-communicable diseases in the Arab world.

Lancet. 2014 Jan 17;

Authors: Rahim HF, Sibai A, Khader Y, Hwalla N, Fadhil I, Alsiyabi H, Mataria A, Mendis S, Mokdad AH, Husseini A

Abstract
According to the results of the Global Burden of Disease Study 2010, the burden of non-communicable diseases (cardiovascular disease, cancer, chronic lung diseases, and diabetes) in the Arab world has increased, with variations between countries of different income levels. Behavioural risk factors, including tobacco use, unhealthy diets, and physical inactivity are prevalent, and obesity in adults and children has reached an alarming level. Despite epidemiological evidence, the policy response to non-communicable diseases has been weak. So far, Arab governments have not placed a sufficiently high priority on addressing the high prevalence of non-communicable diseases, with variations in policies between countries and overall weak implementation. Cost-effective and evidence-based prevention and treatment interventions have already been identified. The implementation of these interventions, beginning with immediate action on salt reduction and stricter implementation of tobacco control measures, will address the rise in major risk factors. Implementation of an effective response to the non-communicable-disease crisis will need political commitment, multisectoral action, strengthened health systems, and continuous monitoring and assessment of progress. Arab governments should be held accountable for their UN commitments to address the crisis. Engagement in the global monitoring framework for non-communicable diseases should promote accountability for effective action. The human and economic burden leaves no room for inaction.

PMID: 24452044 [PubMed - as supplied by publisher]

Survival Benefit of CPAP Favors Hypercapnic Patients with the Overlap Syndrome.

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Survival Benefit of CPAP Favors Hypercapnic Patients with the Overlap Syndrome.

Lung. 2014 Jan 23;

Authors: Jaoude P, Kufel T, El-Solh AA

Abstract
BACKGROUND: Patients with the combination of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), known as the "overlap syndrome," have a substantially greater risk of morbidity and mortality compared to those with either COPD or OSA alone. The study's objective was to report on the long-term outcome of hypercapnic (PaCO2 ≥ 45 mmHg) and normocapnic patients with the overlap syndrome treated with continuous positive airway pressure (CPAP).
METHODS: A nonconcurrent cohort of consecutive patients with the overlap syndrome was followed for a median duration of 71 months (range 1-100) at a VA sleep center. All patients were managed according to the prevailing recommendations of both diseases. The end point of the study was all-cause mortality.
RESULTS: Of the 271 patients identified, 104 were hypercapnic (PaCO2 = 51.6 ± 4.3 mmHg). Both normocapnic and hypercapnic patients had comparable apnea-hypopnea indexes (AHI) (29.2 ± 23.8 and 35.2 ± 29.2/h, respectively; p = 0.07) and similar adherence rates to CPAP (43 and 42 %, respectively, p = 0.9). Survival analysis revealed that hypercapnic patients who were adherent to CPAP had reduced mortality compared to nonadherent hypercapnic patients (p = 0.04). In contrast, the cumulative mortality rate for normocapnic patients was not significantly different between the adherent and the nonadherent group (p = 0.42). In multivariate analysis, the comorbidity index was the only independent predictor of mortality in normocapnic patients with the overlap syndrome [hazard ratio (HR) 1.68; p < 0.001] while CPAP adherence was associated with improved survival (HR 0.65; p = 0.04).
CONCLUSIONS: CPAP mitigates the excess risk of mortality in hypercapnic patients but not in normocapnic patients with the overlap syndrome.

PMID: 24452812 [PubMed - as supplied by publisher]

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