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Background: Pirfenidone and Nintedanib have significantly improved the prognosis of patients with idiopathic pulmonary fibrosis (IPF), reducing mortality risk and exacerbations. This study aimed to analyze antifibrotic treatment utilization and its association with clinical outcomes (i.e., acute exacerbation or death) during 2014–2021 in newly diagnosed IPF patients, using Healthcare Utilization Databases of the Marche Region, Italy. Methods: The first 12-month adherence to antifibrotic was estimated using the Proportion of Days Covered (PDC), defining adherence as PDC ≥ 75%. State Sequence Analysis over the initial 52 weeks of treatment was used to identify adherence patterns. The role of adherence patterns on acute exacerbations/death, adjusted by demographic, clinical features, and monthly adherence after the 52-week period (time-dependent variable), was assessed with Cox regression. Results: Among 667 new IPF cases, 296 received antifibrotic prescriptions, with 62.8% being adherent in the first year. Three antifibrotic utilization patterns emerged—high adherence (37.2%), medium adherence (42.5%), and low adherence (20.3%)—with median PDCs of 95.3%, 79.5%, and 18.6%, respectively. These patterns did not directly influence three-year mortality/exacerbation probability, but sustained adherence reduced risk over time. Conclusions: Good adherence was observed in in this population-based study, emphasizing the importance of continuous antifibrotics therapy over time to mitigate adverse outcomes. [ABSTRACT FROM AUTHOR]

Aim: To explore family caregivers' experiences of contributing to self‐care of patients with chronic obstructive pulmonary disease (COPD). Design: A qualitative description study. Methods: Individual semi‐structured interviews were conducted face‐to face, by telephone or video calls in a purposive sample of 17 family caregivers of patients with COPD recruited in Italy, and analysed through content analysis. The consolidated criteria for reporting qualitative studies (COREQ) checklist was used for study reporting. Results: Ten subcategories were derived from 106 codes grouped into three main categories: family caregiver contributions to maintaining disease stable and ensuring a normal life for patients; family caregiver contributions to disease monitoring; and family caregiver contributions to coping with disease exacerbations. Family caregivers provided practical and emotional support, and their contribution was essential to improve treatment adherence, to enable the patient to continue living a normal life, and to have access to the healthcare services. Family caregivers were constantly vigilant and monitored patients daily to detect worsening conditions, and they managed exacerbations especially when patients were unable to do it due to their critical conditions. Conclusion: This study broadens knowledge of family caregivers' contributions to patients' self‐care in COPD, describing the different ways family members provide daily care to patients and the many responsibilities they take on. Impact: Family caregivers perform a variety of behaviours when supporting patients with COPD in self‐care, especially when patients are more dependent and the disease more severe. Nurses should acknowledge the various contributions provided by family caregivers and develop educational interventions aiming to support them in patient care and improve patient outcomes. Patient or Public Contribution: Researchers shared the draft study report with participants for validation and feedback. This helped to strengthen the study design and results. [ABSTRACT FROM AUTHOR]

Background: A new Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification has been proposed, based also on COPD Assessment Test (CAT). Objectives: The aim of this large, multicenter, retrospective study was to determine the impact of pulmonary rehabilitation (PR) on CAT items in individuals with COPD, GOLD group E, recovering from an exacerbation (ECOPD). As secondary aims, we evaluated whether gender, associated chronic respiratory failure (CRF), and age might influence results. Methods: Data of 2,213 individuals with available paired pre- and post-PR CAT were analyzed. Other common outcome measures were also assessed. Results: After PR, total CAT improved from 20.8 ± 7.8 to 12.4 ± 6.9 (p = 0.000), and 1,911 individuals (86.4%) reached the minimal clinically important difference (MCID). All CAT items improved significantly without any significant difference among them. However, item "confidence with disease" improved significantly more in males than in females (p = 0.009). Total CAT and six out of eight items improved significantly more in individuals with CRF than in those without (all p < 0.001). Total CAT and three items improved significantly more in younger than in older individuals (p = 0.023). Only presence of CRF was significantly associated with the probability of improving total CAT more than the MCID. Conclusion: In individuals with COPD, GOLD group E, recovering from ECOPD, PR improves all CAT items; however, gender, associated CRF and age may influence the effect size, suggesting the need to evaluate all items in addition to total CAT score. [ABSTRACT FROM AUTHOR]

Background: Bronchodilator delivery via a high-flow nasal cannula (HFNC) has generated interest in recent years. The efficacy of in-line vibrating mesh nebulizers with an HFNC during COPD exacerbation is limited. The aim of this study was to evaluate the clinical response of subjects with COPD exacerbation who require bronchodilator therapy (anticholinergic and β-agonist) by using a vibrating mesh nebulizer in line with an HFNC. Methods: This was a prospective single-center study performed in a respiratory intermediate care unit that enrolled patients with a diagnosis of COPD exacerbation who required noninvasive ventilation on admission. All the subjects underwent noninvasive ventilation breaks with an HFNC. After clinical stability, pulmonary function tests were performed to assess changes in FEV1 and clinical parameters before and after bronchodilation by using a vibrating mesh nebulizer in line with an HFNC. Results: Forty-six patients with COPD exacerbation were admitted. Five patients who did not use noninvasive ventilation and 10 patients who did not receive bronchodilator treatment with a vibrating mesh nebulizer were excluded. Thirty-one were selected, but 1 subject was secondarily excluded due to loss of data. Finally, 30 subjects were included. The primary outcome was spirometric changes in FEV1. The mean ± SD FEV1 before receiving bronchodilator treatment by using a vibrating mesh nebulizer in line with an HFNC was 0.74 ± 0.10 L, and, after receiving treatment, the mean ± SD FEV1 changed to 0.88 ± 0.12 L (P < .001). Similarly, the mean ± SD FVC increased from 1.75 ± 0.54 L to 2.13 ± 0.63 L (P < .001). Considerable differences were observed in breathing frequency and heart rate after receiving bronchodilator treatment. No relevant changes were observed in the Borg scale or SpO2 after treatment. The mean clinical stability recorded was 4 d. Conclusions: In subjects with COPD exacerbation, bronchodilator treatment by using a vibrating mesh nebulizer in line with an HFNC showed a mild but significant improvement in FEV1 and FVC. In addition, a decrease in breathing frequency was observed, suggesting a reduction in dynamic hyperinflation. [ABSTRACT FROM AUTHOR]

Bronchial asthma has a high socio-economic impact in Western countries. Low adherence to prescribed inhalation treatments contributes to poor asthma control and the higher utilization of healthcare resources. Although adolescents usually do not comply with long-term inhaled treatments prescribed on a regular basis, the related economic consequences still are poorly investigated in Italy. Aim: A 12-month estimation of the economic impact of non-adherence to inhalation treatments in adolescents with mild-to-moderate atopic asthma. Methods: Non-smoking adolescents aged 12–19 years, without any significant comorbidity, prescribed with inhaled cortico-steroids (ICS) or ICS/long-acting beta(2)-adrenergics (LABA) via dry powder inhalers (DPIs) on a regular basis were automatically selected from the institutional database. Spirometric lung function, clinical outcomes, and pharmacological information were collected. The adolescents' adherence to their prescribed regimen was calculated monthly. Adolescents were divided in two sub-groups based on their adherence to prescriptions: ≤70% (not adherent) or >70% (adherent), and statistically compared (Wilcoxon test, assuming p < 0.05). Results: Overall, 155 adolescents fulfilled the inclusion criteria (males, 49.0%; mean age, 15.6 years ± 2.9 SD; mean BMI, 19.1 ± 1.3 SD). Mean values of lung function were: FEV1 = 84.9% pred. ± 14.8 SD, FEV1/FVC = 87.9 ± 12.5 SD; MMEF = 74.8% pred. ± 15.1 SD and V25 = 68.4% pred. ± 14.9 SD. ICS had been prescribed in 57.4% of subjects and ICS/LABA in 42.6%. Mean adherence to original prescriptions was 46.6% ± 9.2 SD in non-adherent and 80.3% ± 6.6 SD in adherent adolescents, respectively (p < 0.001). The mean rates of hospitalizations, exacerbations, and GP visits; the average duration of absenteeism; the frequency of systemic steroids and antibiotics courses needed over the study period were significantly and substantially lower in adolescents adherent to prescriptions (all p < 0.001). The mean total annual extra cost calculated in the two sub-groups was EUR 705.8 ± 420.9 SD in non-adherent adolescents and EUR 192.1 ± 68.1 SD in adherent adolescents, respectively (p < 0.001), which was 3.7 times higher than in non-adherent adolescents. Conclusions: In adolescents, the clinical control of mild-to-moderate atopic asthma is directly and strictly related to the degree of adherence to prescribed inhalation therapies. All clinical and economic outcomes prove dramatically poor when adherence is low, and treatable asthma can be frequently mistaken for refractory asthma in these cases. Adolescents' non-adherence impacts the burden of the disease quite substantially. Much more effective strategies centered specifically on adolescents' asthma are needed. [ABSTRACT FROM AUTHOR]

Background: Idiopathic pulmonary fibrosis (IPF) primarily affects old patients. Old age is a predictor of mortality. Nintedanib, the only antifibrotic drug approved in Italy for patients aged >80 years, can slow the progression of IPF by reducing the rate of decline in forced vital capacity (FVC) and the risk of exacerbations. Objectives: The primary aim of the study was to compare the decline of FVC after 12 months of nintedanib in patients aged >80 years versus younger patients. Differences related to other functional data, safety, tolerability, hospitalizations, exacerbations, and mortality were evaluated. Methods: An observational, retrospective, multicenter study was carried out in Italy. Results: 159 (122 [76.7%] males) patients were recruited: 106 (66.7%) aged ≤80 years and 53 (33.3%) aged >80 years. FVC decline after 12 months of therapy was not significantly different (−45 mL [−170; 75] vs. −20 mL [−138; 110] mL; p: 0.51). No differences were found for other functional data. Diarrhea was the most frequent adverse event (AE). Rate and type of any AEs, permanent/temporary dose reduction, or drug discontinuation were not significantly different between patients aged ≤80 vs. >80 years. Furthermore, acute exacerbations, hospitalization, and mortality were not significantly different. Conclusions: Nintedanib is effective and safe in patients with IPF aged >80 years, and no significant differences were found when clinical outcomes were compared with those of younger patients. Thus, older age should not be a barrier for the early prescription of antifibrotic treatment in IPF patients. [ABSTRACT FROM AUTHOR]

Objective To describe the Family and Community Physiotherapist model, which aims to incorporate rehabilitation services within primary health care in Tuscany, Italy. Methods The Department of Health Professions of the Central Tuscany local health authority designed the model during 2020-2021. We describe the four phases of the organizational case study implementation of the model, namely: (i) analysis of the political and organizational framework, as well as determination of changing health-care needs; (ii) model co-design and training of multiprofessional health-care workers (local general practitioners, physiatrists and geriatricians); (iii) delivery and surveillance of rehabilitation services; and (iv) evaluation. Findings During the initial roll-out of the project in April-December 2021, general practitioners referred 165 patients with a mean age of 83.7 years (standard deviation: 11.1) to the Family and Community Physiotherapist. Interventions were mainly activated for patients with comorbidities (64/165; 38.8%), followed by those with long-term immobilization issues (36/165; 21.8%). The most commonly provided intervention was counselling, contributing to the achievement of objectives for 127 patients (77.0%). A full rehabilitation path was proposed for only 10 patients (6.1%). No additional costs were incurred by the health authority during the implementation of the model. Conclusion Our model facilitated the provision of rehabilitative care in the community, preventing the exacerbation of chronic conditions and meeting the population health needs in non-hospital environments. The model overcame the typical lack of integration within health-care services with flexibility, promoting care proximity solutions to cope with health challenges such as an ageing population and the coronavirus disease. [ABSTRACT FROM AUTHOR]

In patients with cystic fibrosis (CF), multidrug-resistant (MDR) bacteria can predispose to exacerbations, limit the effectiveness of antibiotic treatments and promote the progression of lung disease. The aim of this retrospective study was to compare pulmonary exacerbations (Pex), hospitalizations, lung function and nutritional status in a group of children and adolescents with CF colonized by MDR bacteria and in a noncolonized control group. Overall, 7/54 pediatric patients (12.9%) were colonized by MDR bacteria and enrolled (3 with Achromobacter xyloxidans, 3 with Stenotrophomonas maltophilia and 1 with Burkholderia cepacia). The control group included 14 sex- and age-matched CF patients (8/14 colonized by Staphylococcus aureus, 2/14 by Pseudomonas aeruginosa, 2/14 by both microorganisms and 2/14 germ free). At the time of enrollment and 12 months before the first detection of the MDR microorganism, children colonized by MDR bacteria showed lower body mass index (BMI) and lower FEV1/FVC compared to the control group. Over the previous year before the first detection, children colonized with MDR had more Pex compared to control group; those colonized by S. maltophilia experienced the highest number of Pex. In the 12 months following the first detection of MDR bacteria, all seven patients colonized by MDR had at least one Pex and patients colonized by S. maltophilia had the highest number (mean ± SD: 6 ± 2.6 vs. 1.7 ± 2.3). Our study suggests that CF pediatric patients infected by MDR bacteria have lower BMI, more obstructive disease and experience more exacerbations than patients without MDR bacteria. These differences are present even before being infected, suggesting that children and adolescents with more severe disease are predisposed to be colonized by MDR bacteria. S. maltophilia appeared to be the most aggressive pathogen. Further studies and the implementation of antimicrobial stewardship programs are necessary to clarify when and how to treat patients with CF and MDR bacteria in order to avoid the improper use of antibiotics and the development of antibiotic resistance. [ABSTRACT FROM AUTHOR]

Background: Chronic obstructive pulmonary disease (COPD) represents an important health challenge, despite being preventable and manageable thanks to up-to-date recommendations. In Italy, the pharmaceutical care of COPD patients is still ill-timed and inaccurate. This study aimed to describe the treatment of COPD patients in Italy and possible switches following an exacerbation., Methods: This observational retrospective analysis of Italian administrative healthcare data from the Fondazione Ricerca e Salute (ReS) database identified patients aged ≥ 45 years with COPD in 2019 and 2020. At least 6 years of look-back period and absence of concomitant asthma were required. COPD patients were categorized by treatment (SI-single/MI-multiple inhalers, TT-triple therapy, DT-dual therapy, other respiratory treatments, untreated) at index date (first dispensation during accrual period). Occurrence of moderate/severe exacerbation during one-year preceding index date and treatments during one-year preceding the exacerbation (possible switch) were evaluated., Results: From ~ 4.7 million beneficiaries of the Italian National Health Service in 2019 and 2020, respectively, 105,828 and 103,729 (43 and 41 × 1,000 inhabitants aged ≥ 45 years) were identified as having COPD. Of 2019/2020 patients: 3.4%/5.2% received SI-TT, 20.7%/17.5% MI-TT, 35.9%/38.1% DT, 33.0%/33.1% other treatments, and 7.0%/6.0% were untreated. Males were prevalent and median age was > 73 years for all groups. Of 2019/2020 cohorts, heart failure and coronary artery disease affected 24/20%, 18/17%, and 11%/16% patients with SI-TT, MI-TT, DT, and other treatments, respectively. A previous moderate/severe exacerbation (2019/2020 patients) occurred to 60.5%/56.6%, 39.9%/37.4%, 30.8%/29.2% and 31.9%/29.7% patients treated with SI-TT, MI-TT, DT, and other treatments, respectively. Of 2019/2020 patients experiencing moderate/severe exacerbation: 6.0%/7.0% receiving DT, 5.1%/7.0% receiving other treatments and 4.5%/10.0% untreated, switched to SI-TT; 23.7%/16.9% receiving DT, 21.4%/17.7% receiving other treatments and 15.4%/12.0% untreated, switched to MI-TT., Conclusions: COPD patients receiving TT were older and had more comorbidities, especially cardiovascular diseases, than patients receiving DT or other treatments. The limited number of patients switching after exacerbation suggests that many COPD patients may be inappropriately treated. Ensuring early and adequate treatment, combination of in-hospital and outpatient management, and integration of specialist and primary care is pivotal for the appropriate clinical management of COPD patients., (© 2024. The Author(s).)

Background: The FIBRONET study was an observational study of patients with idiopathic pulmonary fibrosis (IPF) in Italy. Objectives: In this post hoc descriptive analysis, we describe changes in lung function, anxiety/depression, coughing, exacerbations, and adverse events (AEs) in patients receiving nintedanib treatment. Methods: Patients with IPF from 20 centers in Italy, aged ≥40 years who received nintedanib for ≥7 months, were followed up for 12 months from study enrollment, attending clinic visits every 3 months. Outcomes included change in forced vital capacity (FVC)% predicted from baseline to 12 months, anxiety/depression measured by the Hospital Anxiety and Depression Scale (HADS), and the proportion of patients with cough, AEs, and exacerbations. Results: In total, 52 patients received nintedanib (mean duration of 11.6 months). Ten patients had dose reductions from 150 mg to 100 mg twice daily, due to AEs. FVC% predicted was unchanged in the overall nintedanib population (78.7% at baseline; 79.8% at 12 months) and those with a reduced dose (77.7% at baseline; 81.0% at 12 months). HADS score was low at baseline and throughout the study. The proportion of patients with cough decreased from 50.0% to 21.2% over 12 months. Two patients experienced exacerbations, 2 patients discontinued treatment, and 27 (51.9%) reported AEs. The most common AE was diarrhea (34.6%). Conclusions: In patients with IPF who received nintedanib in the FIBRONET study, FVC% predicted was stable over 12 months, and the proportion of patients with cough decreased. The safety profile was consistent with the known safety profile for nintedanib in IPF. [ABSTRACT FROM AUTHOR]

Management of asthma includes monitoring of inhaler technique and level of adherence to treatment. Both factors could be influenced by high frequency of switching inhaler devices. We explored whether switching inhalers is an independent predictive factor of exacerbations. Data were collected from 2015 to 2017 from the outpatient clinic of asthma at the University of Palermo, Italy. This observational study consisted of two phases: Phase 1 included subjects of at least three visits in the previous year who reported the frequency of inhalers switched; Phase 2 included subjects of at least two visits during the second year, and the rate of switches and exacerbations was recorded. We included adult (24–84 years old) mild/moderate asthmatics under regular inhaled treatment; uncontrolled asthma was defined as poor symptom control, exacerbations (≥2/year) requiring oral corticosteroids (OCS), or serious exacerbations (≥1/year) requiring hospitalization. A total of 109 records were retrieved for the analysis. A significant correlation between the rate of switches in Phase 1 and exacerbations in Phase 2 was found (p = 0.001). Age and the rates of exacerbations in Phase 1 were also independently associated with a higher number of exacerbations in Phase 2 (p < 0.0001). The multivariate regression model showed that the numbers of switches, as well as exacerbations in Phase 1, were independently correlated to the number of exacerbations in Phase 2 (p = 0.003). The frequency of switching inhalers independently affects the risk of exacerbations in asthma. These results imply that changing inhaler requires careful management in clinical practice. [ABSTRACT FROM AUTHOR]

Objectives Environmental air pollution has been linked to the pathogenesis of RA. Nevertheless, evidence linking higher concentrations of air pollutants with the risk of RA reactivations is missing. The objective of the present study was to determine the association between RA flares and air pollution. Methods We collected longitudinal data of patients affected by RA and of the daily concentration of air pollutants in the Verona area. We designed a case-crossover study. We compared the exposure to pollutants in the 30‐day and 60-day periods preceding an arthritic flare referent to the 30‐day and 60-day preceding a low-disease activity visit. Results The study included 888 patients with RA with 3396 follow-up visits; 13 636 daily air pollution records were retrieved. We found an exposure–response relationship between the concentration of air pollutants and the risk of having abnormal CRP levels. Patients exposed to greater concentrations of air pollutants were at higher risk of having CRP levels ≥5 mg/l. Concentrations of CO, NO, NO2, NOx, PM10, PM2.5 and O3 were higher in the 60-day period preceding a flare. Conclusions We found a striking association between air pollution and RA disease severity and reactivations in a cohort of patients followed over a 5-year period. The exposure to high levels of air pollutants was associated with increased CRP levels and a higher risk of experiencing a flare of arthritis. This excessive risk was evident at very low levels of exposure. [ABSTRACT FROM AUTHOR]

Aims and objectives: To understand the experiences and support needs of informal caregivers of patients with chronic obstructive pulmonary diseases chronic obstructive pulmonary disease who return home following an acute exacerbation. Background: The presence of an informal caregiver is important to provide practical and emotional support after an episode of acute exacerbation of chronic obstructive pulmonary disease. However, caregiving in such circumstances can be challenging and stressful. Design: Phenomenology. Methods: This is a phenomenological study based on semi‐structured interviews with sixteen primary caregivers of chronic obstructive pulmonary disease patients. Interview data were analysed using Colaizzi's descriptive analysis framework, to identify significant themes and sub‐themes. Data were collected between April‐December 2017 in a Teaching Hospital in Italy. The study was designed and reported following the COREQ guidelines and checklist. Results: Analysis elicited five themes embracing various aspects of the caregivers' lived experiences: (a) a home disrupted, (b) living with constant vigilance and anxiety, (c) feeling the need to escape (d) self‐justifications for caregiving role/duty, and (e) feeling abandoned by professionals. Conclusions: Our results show that carers experience a range of difficulties when caring for their relative at home with chronic obstructive pulmonary disease. Some of these are linked to the physical disruption of their home but many are linked to feelings of inability to cope and the psycho‐social impact of the caring role. The study also shows how participants felt unsupported by professionals. Focused support for carers is required to enable them to meet these challenges. Relevance to clinical practice: Healthcare professionals should be trained to provide technical and psychological support to caregivers especially during the phases of disease that may involve episodes of exacerbation. Home care and continuity of care can work if there is excellent communication and collaboration between healthcare professionals and caregivers. Developing appropriate support for family caregivers is essential to address the problems they can face. [ABSTRACT FROM AUTHOR]

Bedside chest ultrasonography, when integrated with clinical data, is an accurate tool for improving the diagnostic process of many respiratory diseases. This study aims to evaluate the feasibility of a chest ultrasonographic screening program in nursing homes for detecting coronavirus disease-19 (COVID-19)–related pneumonia and improving the appropriateness of hospital referral of residents. Pragmatic, descriptive, feasibility study from April 2 to April 9, 2020. A total of 83 older residents (age 85 ± 8) presenting mild to moderate respiratory symptoms and not previously tested for COVID-19, residing in 5 nursing homes in Northern Italy. Chest ultrasonography was performed at the bedside by a team of hospital specialists with certified expertise in thoracic ultrasonography, following a systematic approach exploring 4 different areas for each hemithorax, from the anterior and posterior side. Presence of ultrasonographic signs of interstitial pneumonia, including comet-tail artifacts (B-lines) with focal or diffuse distribution, subpleural consolidations, and pleural line indentation, was detected. The specialist team integrated ultrasonography data with clinical and anamnestic information, and gave personalized therapeutic advice for each patient, including hospital referral when needed. The most frequent reasons for ultrasonographic evaluation were fever (63% of participants) and mild dyspnea (40%). Fifty-six patients (67%) had abnormal ultrasonographic findings. The most common patterns were presence of multiple subpleural consolidations (32 patients) and diffuse B-lines (24 patients), with bilateral involvement. A diagnosis of suspect COVID-19 pneumonia was made in 44 patients, and 6 of them required hospitalization. Twelve patients had ultrasonographic patterns suggesting other respiratory diseases, and 2 patients with normal ultrasonographic findings were diagnosed with COPD exacerbation. In nursing home residents, screening of COVID-19 pneumonia with bedside chest ultrasonography is feasible and may represent a valid diagnostic aid for an early detection of COVID-19 outbreaks and adequate patient management. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to investigate the relationship between adherence to statin therapy and the risk of exacerbation among elderly individuals affected by chronic obstructive pulmonary disease and cardiovascular disease.Methods: Using the healthcare utilisation databases of five Italian territorial units accounting for nearly 35% of the Italian population, we recruited a cohort of 6263 elderly persons (i.e. aged 65 years or older) with co-existing chronic obstructive pulmonary disease and cardiovascular disease who initiated statin therapy. Exposure was adherence to statins measured by the proportion of days of follow-up covered. Outcome was the first hospital admission for chronic obstructive pulmonary disease occurring in the period of observation. A proportional hazards model was used to estimate the hazard ratio and 95% confidence intervals for the exposure-outcome association, after adjusting for several covariates. A set of sensitivity analyses was performed to account for sources of systematic uncertainty.Results: During an average follow-up of about 4 years, 1307 cohort members experienced the outcome. Compared with patients with low adherence (proportion of days of follow-up covered ≤ 40%), those with intermediate (proportion of days of follow-up covered 41-80%) and high (proportion of days of follow-up covered > 80%) adherence exhibited a lower risk of exacerbation of 16% (95% confidence interval 3-27) and 23% (95% confidence interval 10-34).Conclusions: In a real-world setting, we observed evidence that adherence to statin therapy markedly reduced the risk of chronic obstructive pulmonary disease exacerbations in elderly patients with co-existing chronic obstructive pulmonary disease and cardiovascular disease. Given the limited and controversial evidence from trials, more randomised controlled trials are urgently needed to better examine the potential benefits of statins as adjunct therapy in chronic obstructive pulmonary disease. [ABSTRACT FROM AUTHOR]

BACKGROUND: The diaphragm changes in COPD lead to functional inefficiency correlated to lung function loss. Muscle-fiber shortening follows lung hyperinflation, which results in a chronic mechanical disadvantage that impairs diaphragmatic mobility that worsens in COPD exacerbations. OBJECTIVES: To correlate the diaphragmatic mobility loss to COPD severity by using M-mode ultrasonography and to verify if the diaphragmatic mobility can improve after in-patient pulmonary rehabilitation. METHODS: We used M-mode ultrasonography to access diaphragmatic mobility during normal breathing or breathing at rest and deep inspiration in 52 subjects with moderate to very severe COPD who underwent pulmonary rehabilitation and 16 healthy subjects. Lung function test, arterial blood gas analysis, and a 6-min walk test were also performed. The measurements were performed at rehabilitation admission and discharge. RESULTS: We screened 30 subjects with severe to very severe COPD who had completed pulmonary rehabilitation. At discharge, inspiratory capacity improved, from 1.58 ± 0.5L to 1.7 ± 0.6 L(P = .04). Diaphragmatic mobility during deep inspirations increased from (mean ± SD) 4.58 ± 1.83 cm to 5.45 ± 1.56 cm (P = .05) after pulmonary rehabilitation. The diaphragmatic mobility during rest breathing was higher in the subjects with COPD (2.25 ± 0.83 cm) than in the healthy subjects (1.27 ± 0.3 cm) (P = .01). The diaphragmatic mobility for the rest breathing and deep inspirations were correlated to an FEV1 decrease (r = -0.74, P < .001; and r = 0.8, P < .001, respectively). CONCLUSIONS: Our findings demonstrated diaphragmatic mobility loss in the subjects with moderate to very severe COPD. These changes were correlated with COPD severity, and diaphragmatic mobility loss improved after in-patient pulmonary rehabilitation. (ClinicalTrial.gov registration NCT02838953.) [ABSTRACT FROM AUTHOR]

Aims and objectives: To explore the experience of patients affected by chronic obstructive pulmonary disease following hospitalisation due to an acute exacerbation event. Background: Chronic obstructive pulmonary disease is a progressively debilitating disease, often with very burdensome symptoms such as acute and chronic breathlessness and fatigue. Acute exacerbation often creates a life‐threatening event. Exacerbation can also have substantial psychological effects including anxiety and depression although this aspect is less well researched—especially amongst people with chronic obstructive pulmonary disease recovering from an acute event and facing a return home. Design: A descriptive phenomenological study. Methods: In‐depth interviews were conducted with 12 chronic obstructive pulmonary disease patients recently recovering from an acute exacerbation of their chronic obstructive pulmonary disease. Data were analysed using Colaizzi's phenomenological framework. Results: Four themes were identified from the data: a sense of loss and frustration, hopelessness, uncertainty about the future and fear of becoming a burden. Participants expressed quite negative views including a loss of hope, uncertainty about their future care and the burden they may become on their families. They appeared stressed and anxious as a result of the acute event they had experienced. Conclusions: This study shows that an acute episode of illness can generate a sense of hopelessness and uncertainty about their future care in people with chronic obstructive pulmonary disease. This occurs as they recover physically and think about the future, often in quite negative terms. Relevance to clinical practice: For healthcare professionals, it is important to take into account the potential feelings of loss, hopelessness and uncertainty that people can experience following an acute exacerbation of their chronic obstructive pulmonary disease and ensure that psychological care is available as physical recovery takes place. Such care to include good discharge planning, giving patients time to express concerns and referral to counselling services if appropriate. [ABSTRACT FROM AUTHOR]

Background: This study assessed if bronchiectasis (BR) and rheumatoid arthritis (RA), when manifesting as an overlap syndrome (BROS), were associated with worse outcomes than other BR etiologies applying the Bronchiectasis Severity Index (BSI).Methods: Data were collected from the BSI databases of 1,716 adult patients with BR across six centers: Edinburgh, United Kingdom (608 patients); Dundee, United Kingdom (n = 286); Leuven, Belgium (n = 253); Monza, Italy (n = 201); Galway, Ireland (n = 242); and Newcastle, United Kingdom (n = 126). Patients were categorized as having BROS (those with RA and BR without interstitial lung disease), idiopathic BR, bronchiectasis-COPD overlap syndrome (BCOS), and "other" BR etiologies. Mortality rates, hospitalization, and exacerbation frequency were recorded.Results: A total of 147 patients with BROS (8.5% of the cohort) were identified. There was a statistically significant relationship between BROS and mortality, although this relationship was not associated with higher rates of BR exacerbations or BR-related hospitalizations. The mortality rate over a mean of 48 months was 9.3% for idiopathic BR, 8.6% in patients with other causes of BR, 18% for RA, and 28.5% for BCOS. Mortality was statistically higher in patients with BROS and BCOS compared with those with all other etiologies. The BSI scores were statistically but not clinically significantly higher in those with BROS compared with those with idiopathic BR (BSI mean, 7.7 vs 7.1, respectively; P < .05). Patients with BCOS had significantly higher BSI scores (mean, 10.4), Pseudomonas aeruginosa colonization rates (24%), and previous hospitalization rates (58%).Conclusions: Both the BROS and BCOS groups have an excess of mortality. The mechanisms for this finding may be complex, but these data emphasize that these subgroups require additional study to understand this excess mortality. [ABSTRACT FROM AUTHOR]

BACKGROUND: COPD is currently recognized as a syndrome associated with a high prevalence of comorbidities and various phenotypes. Exacerbations are very important events in the clinical history of COPD because they drive the decline in lung function. In the present study, we aim to identify whether there are any clinical and functional specific features of frequent exacerbators in a population of patients with severe COPD. METHODS: We conducted a cross-sectional, case control study. All subjects had Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 3 or 4 COPD (FEV1 < 50% predicted). Frequent exacerbators (n = 183) reported ≥2 exacerbations or ≥1 determining hospitalization during the previous 12 months, and infrequent exacerbators (n = 162) reported <2 exacerbations over the last 12 months without hospitalization. Multivariate logistic regression was performed to determine the clinical and functional factors significantly associated with frequent exacerbator status. RESULTS: Frequent exacerbators had a significantly lower inspiratory capacity percentage predicted. The Motley index (residual volume/total lung capacity percentage) was significantly increased in frequent exacerbators. Infrequent exacerbators had lower Modified Medical Research Council dyspnea scale and BODE index than frequent exacerbators. In the multivariate model, a reduced inspiratory capacity percentage predicted and an increase of residual volume/total lung capacity percentage, BODE index and Modified Medical Research Council dyspnea scale were associated with the frequent exacerbation phenotype. CONCLUSIONS: Static hyperinflation and respiratory disability, measured by Motley index and Modified Medical Research Council dyspnea scale, respectively, in the same way as the multidimensional BODE index staging system, were independently associated with frequent exacerbation status in subjects with severe COPD. [ABSTRACT FROM AUTHOR]

Objectives To investigate frailty state transitions in a cohort of older Italian adults to identify factors exacerbating or improving frailty conditions. Design Population-based longitudinal study with mean follow-up of 4.4 years. Setting Community. Participants Individuals enrolled in the Progetto Veneto Anziani (Pro.V.A.) (N = 2,925; n = 1,179 male, n = 1,746 female; mean age 74.4 ± 7.3). Measurements Frailty was identified at baseline and follow-up based on the presence of at least three Fried criteria; prefrailty was defined as the presence of one or two Fried criteria. Anthropometric, socioeconomic, and clinical characteristics were assessed at baseline in a personal interview and clinical examination using validated scales and medical history. Results During the study period, 1,114 (38.1%) subjects retained their baseline frailty status, 1,066 (36.4%) had a transition in frailty status, and the remainder of the sample died. Older age, female sex, obesity, cardiovascular disease, osteoarthritis, smoking, loss of vision, low levels of self-sufficiency and physical performance, cognitive impairment, hypovitaminosis D, hyperuricemia, and polypharmacy were associated with increasing frailty and greater mortality. Conversely, overweight, low to moderate drinking, high educational level, and living alone were associated with decreasing frailty. Conclusions Frailty was confirmed as a dynamic syndrome, with socioeconomic and clinical factors that could be targets of preventive actions influencing transitions to better or worse frailty status. [ABSTRACT FROM AUTHOR]

Combined inhaled therapy in chronic obstructive pulmonary disease (COPD) is commonly used, but its benefits remain controversial. We assessed the effect of tiotropium in reducing COPD exacerbations when combined with long-acting β2 agonists (LABA) and/or inhaled corticosteroids (ICS). This new-user cohort study is based on administrative data from 3 Italian regions. We identified adults hospitalized for COPD from 2006 to 2009 who were newly prescribed a fixed LABA/ICS combination (double therapy). We classified patients according to whether tiotropium was also prescribed (triple therapy), using both intention-to-treat and as-treated approaches, and followed them for 1 year. COPD exacerbations were measured as outcomes. Multivariate and propensity score-adjusted hazard ratios (HRs, 95%CI) were calculated with Cox regression models. We identified 5717 new users of LABA/ICS of which 31.9% initiated triple therapy. In the intention-to-treat analysis, the multivariate adjusted HR for moderate, severe, and any exacerbations were 1.02 (95%CI 0.89-1.16), 0.92 (95%CI 0.76-1.12), and 1.08 (95%CI 0.91-1.28), respectively. The propensity score adjustment produced similar results. In the subcohort of patients with previous exacerbations, triple therapy was significantly associated with reduced risk of moderate exacerbations, compared to double therapy (HR 0.68, 95%CI 0.48-0.98 in intention-to-treat approach). In conclusion, the addition of tiotropium to LABA/ICS did not reduce COPD exacerbations compared to LABA/ICS alone. A protective role for moderate exacerbations was found in patients at risk of frequent exacerbations. Given the impact of exacerbations on health status and prognosis, it is crucial to target COPD patients for optimal treatment. [ABSTRACT FROM AUTHOR]

Background Chronic Obstructive Pulmonary Disease (COPD) is a chronic and progressive lung disease characterized by irreversible airflow obstruction, airway inflammation, oxidative stress and, often, mucus hypersecretion. The aim of this study is to determine if carbocisteine, a mucolytic and antioxidant agent, administered daily for 12 months, can reduce exacerbation frequency in COPD patients. Methods This observational study was conducted in Naples (population approximately 1000,000), Italy. It included 85 out-patients (mean age of 67.8 ± 8.6 years) followed by Clinic of Respiratory Diseases of the University Federico II. Every patient underwent spirometry demonstrating airflow obstruction not fully reversible according to ERS/ATS criteria for COPD diagnosis (Tiffenau index less than 70% after administration of salbutamol, a beta2 agonist drug). Patients enrolled had diagnosed COPD since 2 years and suffered at least one exacerbation in the previous year. None of the patients had been treated with carbocisteine or other mucolytic agent for a longer period of time than 7 days and no more than 4 times in the previous year to the enrollment. All of them assumed daily 2.7 g of carbocisteine lysine salt for a year in addition to their basic therapy. Results The comparison of exacerbation frequency between the previous year (T0) and the end of study treatment (T12), documents a statistically significant reduction of exacerbations(number of exacerbations at T0: 2 [1,3] vs number of exacerbations at T12: 1 [1,2]; p < 0.001).Quality of life was also reported and showed a statistically significant improvement at the end of the study (p < 0.001).We did not find correlation between reducing exacerbation frequency and exposure to cigarette smoking, passive smoking exposure in childhood, the use of inhaled steroids, the level of education of our patients and the GOLD stadium. Interpretation Daily administration of a mucolytic drug such as carbocisteine for prolonged periods in addition to the bronchodilator therapy can be considered a good strategy for reducing exacerbation frequency in COPD. [ABSTRACT FROM AUTHOR]

Objectives: The study aimed at prospectively evaluating the evolution of asthma control in Italy, to evaluate the reasons for lack of asthma control, perceived quality of life (QoL) and association with level of asthma control, the impact of pharmacological treatment, the number of exacerbations and the healthcare resource consumption. Methods: PRISMA (PRospectIve Study on asthMA control) was an observational study performed in asthmatic patients including a cross-sectional phase and a 12-month prospective phase. Asthma control was assessed with the Asthma Control Test™ (ACT) and QoL was evaluated with EuroQoL-5D questionnaire filled in and collected during 5 clinic visits together with all the other data. Results: The prospective phase included 1017 patients with uncontrolled (55.7%) or partly controlled asthma (44.3%). Out of the 739 patients evaluable after 12 months, 22.2% achieved full asthma control (ACT score = 25) and 58.7% reached a good control (ACT score: 20-24). The improvement in asthma control was associated with improved QoL and reduced hospital visits. The main reasons for lack of asthma control were comorbidities, continued exposure to irritants/triggers and poor adherence to therapy. The frequency of exacerbations was lower in patients with controlled asthma. A fixed combination therapy with an inhaled corticosteroid and a long-acting β2 agonist was reported by 77.0% of patients. A better asthma control and improved QoL were achieved with extrafine beclomethasone/formoterol compared to either budesonide/formoterol or fluticasone/salmeterol. Conclusions: An improvement in asthma control and QoL can be achieved during a 1-year monitoring in a real life setting. Extrafine beclomethasone/formoterol was associated with significant benefit in terms of asthma control and QoL compared to large-particles combinations. ClinicalTrials.gov number NCT01110460. [ABSTRACT FROM AUTHOR]

The article presents a study of how a different collaborative relationship with family doctors and specialized diabetologists could lead to a reduction in recurrent appointments because of procedural errors and a reduction in the average waiting times for a specialist medical visit. It discusses the Program for Research, Innovation, Health Technology and Assessment (PRIHTA) Project launched by the Veneto Regional Government. Through the project, primary care physicians rediscovered their role.

Background. The wide availability of monoclonal antibodies for the add-on therapy of severe asthma currently allows for the personalization of biologic treatment by selecting the most appropriate drug for each patient. However, subjects with overlapping allergic and eosinophilic phenotypes can be often eligible to more than one biologic, so that the first pharmacologic choice can be quite challenging for clinicians. Within such a context, the aim of our real-life investigation was to verify whether allergic patients with severe eosinophilic asthma, not adequately controlled by an initial biologic treatment with omalizumab, could experience better therapeutic results from a pharmacologic shift to benralizumab. Patients and methods. Twenty allergic patients with severe eosinophilic asthma, unsuccessfully treated with omalizumab and then switched to benralizumab, were assessed for at least 1 year in order to detect eventual changes in disease exacerbations, symptom control, oral corticosteroid intake, lung function, and blood eosinophils. Results. In comparison to the previous omalizumab therapy, after 1 year of treatment with benralizumab our patients experienced significant improvements in asthma exacerbation rate (p < 0.01), rescue medication need (p < 0.001), asthma control test (ACT) score (p < 0.05), forced expiratory volume in the first second (FEV1) (p < 0.05), and blood eosinophil count (p < 0.0001). Furthermore, with respect to the end of omalizumab treatment, the score of sino-nasal outcome test-22 (SNOT-22) significantly decreased after therapy with benralizumab (p < 0.05). Conclusion. The results of this real-life study suggest that the pharmacologic shift from omalizumab to benralizumab can be a valuable therapeutic approach for allergic patients with severe eosinophilic asthma, not adequately controlled by anti-IgE treatment. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the editor discusses various reports within the issue on topics including the therapeutic use of indacaterol/glycopyrronium, the treatment of sleep apnea in elderly patients and the management of chronic obstructive pulmonary disease (COPD).