84 research outputs found
Healthy ageing: una sfida per l'impresa sociale
Nel nostro Paese le speranze di vita sono in continua crescita e l\u2019Italia \ue8 classi-ficata tra le nazioni
pi\uf9 longeve e con la pi\uf9 alta quota di ultra-85enni (3,0% a fronte di una media UE pari al 2,3%). La
longevit\ue0 \ue8 sicuramente una conquista, ma una societ\ue0 che invecchia deve confrontarsi con radicali
cambiamenti, che richiedono soluzioni politiche e organizzative adeguate. Se sotto il profilo biomedico
l\u2019et\ue0 che avanza si caratterizza per una progressiva riduzione delle capacit\ue0 fisiche ed un
tendenziale aumento della fragilit\ue0, dal punto di vi-sta socio-economico implica il rischio di perdita di
ruolo (de-socializzazione), un possibile calo di produttivit\ue0 ed un pi\uf9 ampio utilizzo dei servizi
sanitari e previdenziali. E\u2019 pertanto una priorit\ue0 sociale e sanitaria sviluppare conoscenze ed
esperienze per promuovere un invecchiamento sano e attivo della popola-zione, anche e
soprattutto per le sue ricadute sul sistema di welfare. A partire da alcune esperienze territoriali in
tema di healthy ageing il paper analizza il potenziale progettuale e gestionale delle imprese sociali,
sia nel quadro dei servizi alla persona sia sul versante delle dinamiche organizzative (age
management)
Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial:
IMPORTANCE: Therapeutic options for severe emphysema are limited. Lung volume reduction using nitinol coils is a bronchoscopic intervention inducing regional parenchymal volume reduction and restoring lung recoil.
OBJECTIVE: To evaluate the efficacy, safety, cost, and cost-effectiveness of nitinol coils in treatment of severe emphysema.
DESIGN, SETTING, AND PARTICIPANTS: Multicenter 1:1 randomized superiority trial comparing coils with usual care at 10 university hospitals in France. Enrollment of patients with emphysema occurred from March to October 2013, with 12-month follow-up (last follow-up, December 2014).
INTERVENTIONS: Patients randomized to usual care (n = 50) received rehabilitation and bronchodilators with or without inhaled corticosteroids and oxygen; those randomized to bilateral coil treatment (n = 50) received usual care plus additional therapy in which approximately 10 coils per lobe were placed in 2 bilateral lobes in 2 procedures.
MAIN OUTCOMES AND MEASURES: The primary outcome was improvement of at least 54 m in the 6-minute walk test at 6 months (1-sided hypothesis test). Secondary outcomes included changes at 6 and 12 months in the 6-minute walk test, lung function, quality of life as assessed by St George's Respiratory Questionnaire (range, 0-100; 0 being the best and 100 being the worst quality of life; minimal clinically important difference, ≥4), morbidity, mortality, total cost, and cost-effectiveness.
RESULTS: Among 100 patients, 71 men and 29 women (mean age, 62 years) were included. At 6 months, improvement of at least 54 m was observed in 18 patients (36%) in the coil group and 9 patients (18%) in the usual care group, for a between-group difference of 18% (1-sided 95% CI, 4% to ∞; P = .03). Mean between-group differences at 6 and 12 months in the coil and usual care groups were +0.09 L (95% CI, 0.05 L to ∞) (P = .001) and +0.08 L (95% CI, 0.03 L to ∞) (P = .002) for forced expiratory volume in the first second, +21 m (95% CI, -4 m to ∞) (P = .06) and +21 m (95% CI, -5 m to ∞) (P = .12) for 6-minute walk distance, and -13.4 points (95% CI, -8 points to ∞) and -10.6 points (95% CI, -5.8 points to ∞) for St George's Respiratory Questionnaire (1-sided P < .001 for both). Within 12 months, 4 deaths occurred in the coil group and 3 in the usual care group. The mean total 1-year per-patient cost difference between groups was 47,879-782,598 per additional quality-adjusted life-year.
CONCLUSIONS AND RELEVANCE: In this preliminary study of patients with severe emphysema followed up for 6 months, bronchoscopic treatment with nitinol coils compared with usual care resulted in improved exercise capacity with high short-term costs. Further investigation is needed to assess durability of benefit and long-term cost implications.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01822795.Comment in :
*Lung Volume Reduction Coils for Severe Emphysema--Reply. [JAMA. 2016]
*Coils implanted into lungs show promise for emphysema. [BMJ. 2016]
*Lung Volume Reduction Coils for Severe Emphysema. [JAMA. 2016]
*Bronchoscopic Lung Volume Reduction in COPD: Lessons in Implementing Clinically Based Precision Medicine. [JAMA. 2016
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