Impact of Early Non-Invasive Ventilation in Amyotrophic Lateral Sclerosis: A multicenter Randomized Controlled Trial.

BACKGROUND AND OBJECTIVE: Forced vital capacity (FVC) less than 50% of predicted is one of the main parameters used for Non-Invasive Ventilation (NIV) initiation in Amyotrophic Lateral Sclerosis (ALS). Recent studies suggest that higher values of FVC could be considered as a threshold. The aim of this study is to evaluate whether early use of NIV improves the prognosis of ALS patients compared with standard initiation. METHODS: This is a randomized, parallel, multicenter, open-label, controlled clinical trial, with recruitment at the ALS outpatient multidisciplinary units of six Spanish hospitals. Patients were included when their FVC reached the 75% threshold and were randomized by computer, stratifying by center in an allocation ratio of 1:1 to Early NIV (FVC below 75%) or Standard NIV (FVC below 50%) initiation. The primary outcome was time to death or tracheostomy.Trial registration number ClinicalTrials.gov: NCT01641965. RESULTS: Between May 2012 and June 2014, 42 patients were randomized to two groups, 20 to Early NIV and 22 to Standard NIV initiation. We found differences in survival in favor of the intervention group: an incidence of mortality (2.68 [1.87-5.50] vs. 3.33 [1.34-4.80] person-months) and a median survival (25.2 vs. 19.4 months), although without reaching statistical significance (p = 0.267). CONCLUSIONS: This trial did not reach the primary endpoint of survival; nevertheless, it is the first Randomized Controlled Trial (RCT) to demonstrate the benefits of early NIV in slowing the decline of respiratory muscle strength and reducing adverse events. Although not all the results reached statistical significance, all the analyzed data favor early NIV. In addition, this study demonstrates good tolerance and compliance with early NIV without quality of sleep impairment. These data reinforce the early respiratory evaluation of ALS patients and NIV initiation with an FVC of around 75%.

Dissociation between physical capacity and daily physical activity in COPD patients. A population-based approach.

BADKGROUND: Physical capacity (PC) and daily physical activity (PA) are two crucial factors in the clinical course of COPD, although they do not always maintain a close relationship. The objectives were to evaluate the frequency of PC-PA dissociation in patients with COPD and subjects without airflow limitation (AL) and to identify its risk factors. METHODS: A sample of 319 COPD patients and 399 subjects without AL was consecutively obtained from a population-based sample of 9092 subjects evaluated in the EPISCAN II study. Baseline evaluation included clinical questionnaires, lung function testing, blood analysis and low-dose computed tomography (CT) scan with evaluation of lung density and airway wall thickness. A distance walked in 6 min > 70% predicted was considered an indicator of normal PC, while a Yale Physical Activity Survey summary index score <51 was used to identify with sedentary lifestyle. RESULTS: 166 COPD patients (52.0%) reported a sedentary lifestyle with evidence of preserved PC, while this phenomenon was present in 188 (47.1%) subjects without AL. In the COPD group, symptoms of chronic bronchitis, depression and elevated hematocrit and blood eosinophil count were identified as independent risk factors for PC-PA dissociation. In turn, in the subjects without AL, the risk factors for PC-PA dissociation were low fat-free mass, obesity and anxiety, as well as reduced levels of HDL-cholesterol and the absence of osteoporosis. CONCLUSIONS: Almost half of COPD patients and subjects without airflow limitation with preserved PC maintain a sedentary lifestyle, with different risk factors for sedentarism between both groups.

Stress in Emergency Healthcare Professionals: The Stress Factors and Manifestations Scale.

Background: Healthcare workers are continuously exposed to a high level of stress, especially emergency department professionals. In the present research, we aimed to determine the internal consistency and validity of the Stress Factors and Manifestations Scale for in-hospital and out-of-hospital emergency workers. Methods: A quantitative, prospective, cross-sectional, and observational study including 269 emergency service professionals. Results: The scale was composed of 21 items, with a Cronbach's α value of 0.908. The hospital workers (38.4 ± 10.8 vs. 35.1 ± 9.9, p = 0.014) and women (39.3 ± 11.4 vs. 34.2 ± 8.6, p < 0.001) had higher levels of stress. The sensitivity, specificity, and predictive values of the scale were adequate. Conclusion: In the present study, including in-hospital and out-of-hospital emergency workers, the Stress Factors and Manifestations Scale presented appropriate usefulness, internal consistency, and validity, with optimal predictive ability. Higher levels of anxiety, female gender, being less optimistic, and working in hospital emergency departments were related to increased stress levels. Further studies are warranted to validate our results and potentially extend the Stress Factors and Manifestations Scale to other contexts.

Relationship between sleep habits and academic performance in university Nursing students.

BACKGROUND: Sleep disorders are composed of a group of diseases of increasing prevalence and with social-health implications to be considered a public health problem. Sleep habits and specific sleep behaviors have an influence on the academic success of students. However, the characteristics of sleep and sleep habits of university students as predictors of poor academic performance have been scarcely analyzed. In the present study, we aimed to investigate sleep habits and their influence on academic performance in a cohort of Nursing Degree students. METHODS: This was a cross-sectional and observational study. An anonymous and self-administered questionnaire was used, including different scales such as the 'Morningness and Eveningness scale', an author-generated sleep habit questionnaire, and certain variables aimed at studying the socio-familial and academic aspects of the Nursing students. The association of sleep habits and other variables with poor academic performance was investigated by logistic regression. The internal consistency and homogeneity of the 'sleep habits questionnaire' was assessed with the Cronbach's alpha test. RESULTS: Overall, 401 students (mean age of 22.1 ± 4.9 years, 74.8 % females) from the Nursing Degree were included. The homogeneity of the 'sleep habits questionnaire' was appropriate (Cronbach's alpha = 0.710). Nursing students were characterized by an evening chronotype (20.2 %) and a short sleep pattern. 30.4 % of the Nursing students had bad sleep habits. Regarding the academic performance, 47.9 % of the students showed a poor one. On multivariate logistic regression analysis, a short sleep pattern (adjusted OR = 1.53, 95 % CI 1.01-2.34), bad sleep habits (aOR = 1.76, 95 % CI 1.11-2.79), and age < 25 years (aOR = 2.27, 95 % CI 1.30-3.98) were independently associated with a higher probability of poor academic performance. CONCLUSIONS: Almost 1/3 of the Nursing students were identified as having bad sleep habits, and these students were characterized by an evening chronotype and a short sleep pattern. A short sleep pattern, bad sleep habits, and age < 25 years, were independently associated with a higher risk of poor academic performance. This requires multifactorial approaches and the involvement of all the associated actors: teachers, academic institutions, health institutions, and the people in charge in university residences, among others.

Degree of control of patients with chronic obstructive pulmonary disease in Spain: SINCON study.

BACKGROUND: Disease control is an important objective of COPD management. The SINCON study evaluated the level of control in terms of respiratory symptoms and exacerbations in Spanish patients with COPD for ≥2 years. METHODS: SINCON was a descriptive, cross-sectional, multicenter study that assessed degree of control using a combined index comprising COPD assessment test (CAT), modified Medical Research Council dyspnea scale (mMRC), and number of moderate/severe exacerbations in the last year. Based on this score, patients were categorized as "well controlled" or "poorly controlled". Degree of control was also assessed relative to patient phenotype, setting (primary care [PC] vs respiratory care [RC]), and impact of treatment on morning symptoms. RESULTS: Of the 481 patients (PC: 307, RC: 174) analyzed, COPD was poorly controlled in 63.2%. Some differences were found between clinical settings: PC patients were more poorly controlled (PC: 66.4% vs RC: 57.5%; P = 0.06) and had higher CAT score (PC: 17.9 vs RC: 15.5; P < 0.05), and higher rate of moderate/severe exacerbations during previous year (PC: 1.5 vs RC: 1.1; P < 0.05), while dyspnea degree was similar in both settings. Regarding phenotypes, non-exacerbators demonstrated better control vs exacerbators. Morning symptoms score improved between waking and 3 h after bronchodilator treatment (P < 0.05), with greater improvements in PC patients (PC: - 6.5 vs RC: - 5.0 points; P < 0.05). CONCLUSIONS: Most COPD patients were poorly controlled with some differences observed between PC and RC settings and between patient phenotypes. Our index may be easily used in PC settings to optimize COPD treatment.

Determinants of medical prescriptions for COPD care: an analysis of the EPOCONSUL clinical audit.

Purpose: Current COPD management recommendations indicate that pharmacological treatment can be stepped up or down, but there are no recommendations on how to make this adjustment. We aimed to describe pharmacological prescriptions during a routine clinical visit for COPD and study the determinants of changing therapy. Methods: EPOCONSUL is a Spanish nationwide observational cross-sectional clinical audit with prospective case recruitment including 4,508 COPD patients from outpatient respiratory clinics for a period of 12 months (May 2014-May 2015). Prescription patterns were examined in 4,448 cases and changes analyzed in stepwise backward, binomial, multivariate, logistic regression models. Results: Patterns of prescription of inhaled therapy groups were no treatment prescribed, 124 (2.8%) cases; one or two long-acting bronchodilators (LABDs) alone, 1,502 (34.6%) cases; LABD with inhaled corticosteroids (ICSs), 389 (8.6%) cases; and triple therapy cases, 2,428 (53.9%) cases. Incorrect prescriptions of inhaled therapies were observed in 261 (5.9%) cases. After the clinical visit was audited, 3,494 (77.5%) cases did not modify their therapeutic prescription, 307 (6.8%) cases had a step up, 238 (5.3%) cases had a change for a similar scheme, 182 (4.1%) cases had a step down, and 227 (5.1%) cases had other nonspecified change. Stepping-up strategies were associated with clinical presentation (chronic bronchitis, asthma-like symptoms, and exacerbations), a positive bronchodilator test, and specific inhaled medication groups. Stepping down was associated with lung function impairment, ICS containing regimens, and nonexacerbator phenotype. Conclusion: The EPOCONSUL study shows a comprehensive evaluation of pharmacological treatments in COPD care, highlighting strengths and weaknesses, to help us understand how physicians use available drugs.

The evaluation of a remote support program on quality of life and evolution of disease in COPD patients with frequent exacerbations.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) patients often present considerable individual medical burden in their symptoms, limitations, and well-being that complicate medical treatment. To improve their overall health status, while reducing the number of exacerbations, a multidisciplinary approach including different elements of care is needed. The aim of this study was to evaluate the effects of a remote support program on COPD patients at high risk of experiencing worsening of their disease and other health-related outcomes. METHODS: An observational, multicenter, prospective study aimed at evaluating the impact of a 7-month remote support program on COPD patients in exacerbations control and changes in health status measured with the COPD assessment test (CAT). Factors associated with a clinically relevant decrease in CAT were assessed using a logistic regression analysis. RESULTS: A total of 114 subjects started the program. The majority of the study population were males (81.6 %), retired (70.2 %), without academic qualifications or with a low level of education (68.4 %), and ex-smokers (79.8 %). The mean ± SD age was 69.6 ± 9.1 years and the BMI was 27.8 ± 5.5 Kg/m2. Overall, 41.9 % (95 % CI 31.9-52.0) patients, significantly improved health status (CAT decrease ≥ 2 points). Univariate analysis showed that significant improvement in CAT was associated with baseline CAT scores [high CAT score 19.2 (±7.5) vs. low CAT score 12.4 (±6.4); OR = 1.15, 95 % CI: 1.07-1.24; p < 0.001] and with being non-compliant [62.5 % (15/24) of non-compliant vs 34.7 % (24/69) of compliant patients significantly improved CAT scores; OR = 3.13, 95 % CI: 1.19-8.19; p = 0.021). After controlling for the effect of all variables in a multivariable logistic regression model, the only factor that remained significant was baseline CAT score. The proportion of smokers in the total population remained constant during the study. There was a significant reduction in the number of exacerbations after entering this remote support program with median -1 (IQR: -2, 0), (p < 0.001). The Morisky-Green questionnaire showed an increase of treatment compliance, namely at baseline, 25.8 % (24/93) of patients were noncompliant while in the end 66.7 % (16/24) of them became compliant) (p = 0.053). CONCLUSIONS: A remote support program for high-risk COPD patients results in an improvement of the patients' health status, particularly in those with initially poor health status, and it helps to reduce COPD exacerbations.