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Protocol for a systematic review and economic evaluation of the clinical and cost-effectiveness of non-hospital-based non-invasive ventilation (NIV) in patients with stable end-stage COPD with hypercapnic respiratory failure.

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Chronic obstructive pulmonary disease (COPD) remains a significant public health burden. Non-invasive ventilation (NIV) is a method of supported breathing used as standard care for acutely unwell patients in hospital with COPD, but there is uncertainty around the potential benefits of using NIV in the treatment of stable patients in a non-hospital setting. This is a protocol for systematic reviews of the clinical and cost-effectiveness of NIV in this context, being undertaken in support of a model based economic evaluation.

METHODS/DESIGN: Standard systematic review methods aimed at minimising bias will be employed for study identification, selection and data extraction for both the clinical and economic systematic reviews. Bibliographic databases (for example MEDLINE, EMBASE) and ongoing trials registers will be searched from 1980 onwards. The search strategy will combine terms for the population with those for the intervention. Studies will be selected for review if the population includes adult patients with COPD and hypercapnic respiratory failure, however defined. Systematic reviews, randomised controlled trials and observational studies (with n >1) will be included, and quality assessment will be tailored to the different study designs. The primary outcome measures of interest are survival, quality of life, and healthcare utilisations (hospitalisation and Accident and Emergency attendances). Meta-analyses will be undertaken where clinical and methodological homogeneity exists, supported by predefined subgroup analyses where appropriate. A systematic review of the evidence on the cost-effectiveness of non-hospital NIV will be completed, and a model-based cost-utility analysis undertaken to determine the cost-effectiveness of non-hospital-based NIV compared with standard care. DISCUSSION: These reviews will attempt to clarify the clinical effectiveness of non-hospital NIV in COPD patients as well as the cost-effectiveness. The findings may indicate whether NIV in a non-hospital setting should be considered more routinely in this patient group, and what the likely cost implications will be.

The use of high-flow nasal oxygen therapy in the management of hypercarbic respiratory failure.

Hypercarbic respiratory failure, occurring secondary to chronic lung disease, is a frequently encountered problem. These patients present a significant challenge to respiratory and critical care services, as many are unsuitable for mechanical ventilation and most have multiple comorbidities. Recently, noninvasive ventilation (NIV) has become established as the primary modality for respiratory support in this group of patients. Several factors limit patient compliance with NIV, not least comfort and tolerability. A recent innovation in adult critical care is the use of high-flow nasal oxygen (HFNO) devices. These systems are capable of delivering high gas flows via nasal cannulae, with the ability to blend air and oxygen to give a controlled FiO2. Few clinical studies have been conducted in adults, although several are planned. To date the majority of available evidence addresses the use of HFNO in hypoxemic respiratory failure. Here we present a case in which a HFNO system was used to successfully manage hypercarbic respiratory failure in a patient unable to tolerate conventional NIV.

Mortality in patients with COPD exacerbations attending emergency departments.

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Limited information is available about predictors of short-term outcomes in patients with exacerbations of chronic obstructive pulmonary disease (eCOPD) attending an emergency department (ED). Such information could help stratify these patients and guide medical decision making. The aim of this study was to develop a clinical prediction rule for short-term mortality during hospital admission or within a week after the index ED visit.

METHODS: Prospective cohort study of eCOPD patients attending the EDs of 16 participating hospitals. Recruitment started in June 2008 and ended in September 2010. Information on possible predictor variables was recorded during the time the patient was evaluated in the ED, at the time a decision was made to admit the patient to the hospital or discharge home, and during follow-up. Main short-term outcomes were death during hospital admission or within one week of discharge to home from the ED, as well as at death within one month of the index ED visit. Multivariate logistic regression models were developed in a derivation sample and validated in a validation sample. The score was compared with other published prediction rules for COPD stable patients. RESULTS: 2,487 patients were included in the study. Predictors of death during hospital admission, or within one week of discharge to home from the ED were patient age, baseline dyspnea, previous need for long-term home oxygen therapy or noninvasive mechanical ventilation, altered mental status, and use of inspiratory accessory muscles or paradoxical breathing upon ED arrival (AUC: 0.85). Addition of arterial blood gas parameters (PO2, pH and PCO2) did not improve the model. The same variables were predictors of death at one month (AUC: 0.85). Compared with other commonly used tools for predicting the severity of COPD in stable patients, our rule was significant better. CONCLUSIONS: Five clinical predictors easily available in the ED-and also in the primary care setting-can be used to create a simple and easy-to-obtain score that allows clinicians to stratify patients with eCOPD upon ED arrival and guide the medical decision making process.

Efficacy of a multifactorial intervention on therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): a randomized controlled trial.

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Therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is poor. This study evaluated the effectiveness of a multifactorial intervention on improving the therapeutic adherence in chronic obstructive pulmonary disease (COPD) patients with scheduled inhalation therapy. METHODS: The study design consisted of a randomised controlled trial in a primary care setting. 146 patients diagnosed with COPD were randomly allocated into two groups using the block randomisation technique. One-year follow-ups with three visits were performed. The intervention consisted of motivational aspects related to adherence (beliefs and behaviour) in the form of group and individual interviews, cognitive aspects in the form of information about the illness and skills in the form of training in inhalation techniques. Cognitive-emotional aspects and training in inhalation techniques were reinforced during all visits of the intervention group. The main outcome measure was adherence to the medication regimen. Therapeutic adherence was determined by the percentage of patients classified as good adherent as evaluated by dose or pill count. RESULTS: Of the 146 participants (mean age 69.8 years, 91.8% males), 41.1% reported adherence (41.9% of the control group and 40.3% of the intervention group). When multifactorial intervention was applied, the reported adherence was 32.4% for the control group and 48.6% for the intervention group, which showed a statistically significant difference (p = 0.046). Number needed to treat is 6.37. In the intervention group, cognitive aspects increased by 23.7% and skilled performance of inhalation techniques increased by 66.4%. The factors related to adherence when multifactorial intervention was applied were the number of exacerbations (OR = 0.66), visits to health centre (OR = 0.93) and devices (OR = 2.4); illness severity (OR = 0.67), beta-2-adrenergic (OR = 0.16) and xantine (OR = 0.19) treatment; activity (OR = 1.03) and impact (OR = 1.03) scales of the Saint George Respiratory Questionnaire. CONCLUSION: Application of the multifactorial intervention designed for this study (COPD information, dose reminders, audio-visual material, motivational aspects and training in inhalation techniques) resulted in an improvement in therapeutic adherence in COPD patients with scheduled inhalation therapy.Trial registration: Current Controlled Trials ISRCTN18841601.

The association of weight with the detection of airflow obstruction and inhaled treatment among patients with a clinical diagnosis of COPD.

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Most patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) have not had spirometry to confirm airflow obstruction (AFO). Overweight and obese patients report more dyspnea than normal weight patients, which may be falsely attributed to AFO. We sought to determine whether overweight/obese patients clinically diagnosed with COPD were more likely to be "misdiagnosed" (lack AFO on spirometry) and subsequently treated with inhaled medications. METHODS: Cohort: U. S. Veterans with a clinical diagnosis of COPD (ICD-9 code and/or inhaled medication use) and spirometry at one of three Pacific Northwest VA Medical Centers. Exposures: overweight and obesity (defined by Body Mass Index (BMI) categories). Outcomes: 1) Airflow obstruction on spirometry. 2) Escalation or de-escalation of inhaled therapies from 3 months before spirometry to 9-12 months after. We used multivariable logistic regression with calculation of adjusted proportions for all analyses. RESULTS: 52% of 5,493 Veterans clinically diagnosed with COPD had AFO. The adjusted proportion of patients with AFO decreased as BMI increased (p-value test of trend <0.01). Among patients without AFO, overweight and obese patients were less likely to remain off medications/have therapy de-escalated (adjusted proportions for normal weight, overweight, obese: 0.69 [95% CI 0.64 - 0.73], 0.62 [95% CI 0.58 - 0.65, p=0.014], 0.60 [95% CI 0.57 - 0.63. p=0.001]). CONCLUSIONS: Overweight and obese patients are more likely "misdiagnosed" with COPD and lack de-escalation of inhaled medications after spirometry demonstrated no AFO. Providers may be missing potential opportunities to recognize and treat other causes of dyspnea in these patients.

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