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The cost-effectiveness of domiciliary non-invasive ventilation in patients with end-stage chronic obstructive pulmonary disease: a systematic review and economic evaluation.

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The cost-effectiveness of domiciliary non-invasive ventilation in patients with end-stage chronic obstructive pulmonary disease: a systematic review and economic evaluation.

Health Technol Assess. 2015 Oct;19(81):1-246

Authors: Dretzke J, Blissett D, Dave C, Mukherjee R, Price M, Bayliss S, Wu X, Jordan R, Jowett S, Turner AM, Moore D

Abstract
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a chronic progressive lung disease characterised by non-reversible airflow obstruction. Exacerbations are a key cause of morbidity and mortality and place a considerable burden on health-care systems. While there is evidence that patients benefit from non-invasive ventilation (NIV) in hospital during an acute exacerbation, evidence supporting home use for more stable COPD patients is limited. In the UK, domiciliary NIV is considered on health economic grounds in patients after three hospital admissions for acute hypercapnic respiratory failure.
OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of domiciliary NIV by systematic review and economic evaluation.
DATA SOURCES: Bibliographic databases, conference proceedings and ongoing trial registries up to September 2014.
METHODS: Standard systematic review methods were used for identifying relevant clinical effectiveness and cost-effectiveness studies assessing NIV compared with usual care or comparing different types of NIV. Risk of bias was assessed using Cochrane guidelines and relevant economic checklists. Results for primary effectiveness outcomes (mortality, hospitalisations, exacerbations and quality of life) were presented, where possible, in forest plots. A speculative Markov decision model was developed to compare the cost-effectiveness of domiciliary NIV with usual care from a UK perspective for post-hospital and more stable populations separately.
RESULTS: Thirty-one controlled effectiveness studies were identified, which report a variety of outcomes. For stable patients, a modest volume of evidence found no benefit from domiciliary NIV for survival and some non-significant beneficial trends for hospitalisations and quality of life. For post-hospital patients, no benefit from NIV could be shown in terms of survival (from randomised controlled trials) and findings for hospital admissions were inconsistent and based on limited evidence. No conclusions could be drawn regarding potential benefit from different types of NIV. No cost-effectiveness studies of domiciliary NIV were identified. Economic modelling suggested that NIV may be cost-effective in a stable population at a threshold of £30,000 per quality-adjusted life-year (QALY) gained (incremental cost-effectiveness ratio £28,162), but this is associated with uncertainty. In the case of the post-hospital population, results for three separate base cases ranged from usual care dominating to NIV being cost-effective, with an incremental cost-effectiveness ratio of less than £10,000 per QALY gained. All estimates were sensitive to effectiveness estimates, length of benefit from NIV (currently unknown) and some costs. Modelling suggested that reductions in the rate of hospital admissions per patient per year of 24% and 15% in the stable and post-hospital populations, respectively, are required for NIV to be cost-effective.
LIMITATIONS: Evidence on key clinical outcomes remains limited, particularly quality-of-life and long-term (> 2 years) effects. Economic modelling should be viewed as speculative because of uncertainty around effect estimates, baseline risks, length of benefit of NIV and limited quality-of-life/utility data.
CONCLUSIONS: The cost-effectiveness of domiciliary NIV remains uncertain and the findings in this report are sensitive to emergent data. Further evidence is required to identify patients most likely to benefit from domiciliary NIV and to establish optimum time points for starting NIV and equipment settings.
FUTURE WORK RECOMMENDATIONS: The results from this report will need to be re-examined in the light of any new trial results, particularly in terms of reducing the uncertainty in the economic model. Any new randomised controlled trials should consider including a sham non-invasive ventilation arm and/or a higher- and lower-pressure arm. Individual participant data analyses may help to determine whether or not there are any patient characteristics or equipment settings that are predictive of a benefit of NIV and to establish optimum time points for starting (and potentially discounting) NIV.
STUDY REGISTRATION: This study is registered as PROSPERO CRD42012003286.
FUNDING: The National Institute for Health Research Health Technology Assessment programme.

PMID: 26470875 [PubMed - in process]

The Gut-Liver-Lung Axis: Modulation of the Innate Immune Response and its Possible Role in COPD.

Evidence from epidemiological studies suggest that a diet high in fiber is associated with better lung function and reduced risk of chronic obstructive pulmonary disease (COPD). The mechanism for this benefit remains unknown, but as fiber is not absorbed by the gut this finding suggests the gut may play an active role in pathogenic pathways underlying COPD.

There is a growing awareness that aberrant activity of the innate immune system, characterised by increased neutrophil and macrophage activation, may contribute to the development or progression of COPD. Innate immunity is modulated in large part by the liver where hepatic cells function in immune-surveillance of the portal circulation as well as providing a rich source of systemic inflammatory cytokines and immune mediators (notably interleukin-6 and C-reactive protein). We believe that the beneficial effect of dietary fiber on lung function is through modulation of innate immunity, and subsequent attenuation of the pulmonary response to an inflammatory stimuli, most apparent in current or former smokers.

We propose that the "Gut-Liver-Lung axis" may play a modifying role in the pathogenesis of COPD. In this review, we summarise lines of evidence that include animal models, large prospective observational studies and clinical trials, supporting the hypothesis that the Gut-Liver-Lung axis plays an integral part in the pathogenic mechanisms underlying the pathogenesis of COPD.

An evaluation of comparative treatment effects with high and low dose fluticasone propionate/formoterol combination in asthma.

Despite extensive use of inhaled corticosteroid/long-acting β2-agonist combinations in asthma, limited data evaluating dose-response for this combination class are available. The benefits of dose escalation and nature of patient subgroups likely to benefit are thus ill-defined.

METHOD: In this randomised, double-blind, 8-week study the effects of two dose levels (100/10 and 500/20 μg b.i.d.) of a fixed combination of fluticasone/formoterol (flutiform®) were compared in 309 patients. Treatment effects upon spirometric and symptom-based endpoints were examined in the overall population and in two subgroups defined a priori by % predicted FEV1 at baseline (≥40-≤60% ["severe" airways obstruction] and >60-≤80% ["moderate" airways obstruction]).

RESULTS: No dose-response was evident for spirometric outcomes (FEV1, FEV1 AUC0-12, PEFR) either overall or in either subgroup. At variance with the spirometric data, statistically significant dose-dependent differences were seen for nocturnal outcomes and consistent numerical differences were found across multiple symptom-based outcomes (symptom scores, sleep scores, rescue medication use, asthma control days, AQLQ scores, exacerbations); greater effects were noted with the higher dose of fluticasone/formoterol. Between-group differences for the overall population were driven by treatment effect differences in the "severe" subgroup.

CONCLUSION: In this exploratory comparison a high dose of fluticasone/formoterol in asthmatic patients appears to provide additional improvement in symptom-based rather than spirometric outcomes. Additional benefits from high versus low dose treatment are most likely in patients with severe airway obstruction, although the doses at which ceiling effects are attained may vary between individuals.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00734318; EudraCT number: 2007-001633-34.

Using EMR to improve compliance with clinical practice guidelines for management of stable COPD.

Clinical practice guidelines are underutilized in the outpatient management of chronic obstructive pulmonary disease (COPD). We hypothesize that a structured approach using the electronic medical record (EMR) will improve compliance with clinical practice guidelines for the evaluation and management of patients with stable COPD.

METHODS: Clinical records were evaluated in a pre- and post-intervention analysis of patients with COPD seen in our pulmonary clinics at a single tertiary care academic setting. Patient charts were retrospectively screened for the diagnosis of COPD and individually assessed for a diagnosis of COPD by spirometry. We then developed and implemented a COPD Flowsheet based on clinical practice guidelines into each outpatient clinic encounter for COPD with repeat chart review of clinic patients. Improvement in the pre- to post-intervention quality metrics were compared using t-test and Chi squared as indicated. A p-value of <0.05 was considered significant.

RESULTS: A total of 200 patients were screened in the pre-intervention period and 347 in the post-intervention period. Of these, 144 (72%) and 267 (77%) met criteria for COPD based on FEV1/FVC < 0.70, respectively. There was a significant increase in the use of severity assessment by BODE index (13.2% vs 32.2%, p-value < 0.001), inhaler technique teaching (35.4% vs 65.2%, p-value < 0.001), osteoporosis screening (20.8% vs 44.9%, p-value < 0.001) and influenza vaccination (74.3% vs 83.5%, p-value = 0.03) in post intervention period.

CONCLUSIONS: Implementation of a standardized COPD Flowsheet developed from clinical practice guidelines improves advanced assessment of patients with COPD and other quality of care measures.

Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia

Between 27 September and 1 October 2015, the National IHR Focal Point for the Kingdom of Saudi Arabia notified WHO of 1 additional case of Middle East respiratory syndrome coronavirus (MERS-CoV) infection. A 38-year-old, non-national male from Riyadh city developed symptoms on 21 September and, on 28 September, was admitted to hospital. The patient, who has no comorbidities, tested positive for MERS-CoV on 30 September. Currently, he is in stable condition in a negative pressure isolation room on a ward. Investigation of history of exposure to the known risk factors in the 14 days prior to the onset of symptoms is ongoing. Contact tracing of household and healthcare contacts is ongoing. (Source: WHO Disease Outbreaks)

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