title: Early initiation of night-time NIV in an outpatient setting: a randomized non-inferiority study in ALS patients.
abstract: BACKGROUND
  In patients with amyotrophic lateral sclerosis (ALS), non-invasive ventilation (NIV) is usually initiated in an in-hospital regime.
  
  
  OBJECTIVE
  We investigated if NIV initiated in an outpatient setting can be as effective in terms of patients' acceptance/adherence. We also evaluated factors predicting NIV acceptance and adherence and disease progression.
  
  
  METHODS
  Prospective randomized study.
  
  
  METHODS
  Outpatient versus inpatient rehabilitation.
  
  
  METHODS
  ALS patients.
  
  
  METHODS
  ALS patients were randomized to two groups for NIV initiation: outpatients versus inpatients. At baseline (T0), end of NIV trial program (T1) and after 3 months from T1 (T2), respiratory function tests, blood gas analysis, and sleep study were performed. At T1, we assessed: NIV acceptance (>4 h/night), and dyspnea symptoms (day/night) by Visual analogue scale (VAS), staff and patients' experience (how difficult NIV was to accept, how difficult ventilator was to manage, satisfaction); at T2: NIV adherence (>120 h/month) and patients' experience.
  
  
  RESULTS
  Fifty patients participated. There were no differences in acceptance failure (P=0.733) or adherence failure (P=0.529). At T1, outpatients had longer hours of nocturnal ventilation (P<0.02), at T2 this was similar (P=0.34). Female gender and spinal onset of the disease were predictors for NIV acceptance/adherence failure. There were no between-group differences in progression of respiratory impairment, symptoms and sleep quality.
  
  
  CONCLUSIONS
  Early outpatient initiation of NIV in ALS is as effective as inpatient initiation.
authors.affiliation: Division of Respiratory Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Lumezzane, Brescia, Italy - enrica.bertella@icsmaugeri.it.
authors.forename: Enrica
authors.initials: E
authors.lastname: Bertella
authors.affiliation: Don Gnocchi Foundation, S. Maria Nascente Institute for Research and Care, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Banfi
authors.affiliation: Division of Respiratory Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Lumezzane, Brescia, Italy.
authors.forename: Mara
authors.initials: M
authors.lastname: Paneroni
authors.affiliation: Don Gnocchi Foundation, S. Maria Nascente Institute for Research and Care, Milan, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Grilli
authors.affiliation: Division of Respiratory Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Lumezzane, Brescia, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Bianchi
authors.affiliation: Don Gnocchi Foundation, S. Maria Nascente Institute for Research and Care, Milan, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Volpato
authors.affiliation: Division of Respiratory Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Lumezzane, Brescia, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Vitacca
mesh_terms: D000368:Aged; D000553:Ambulatory Care; D000690:Amyotrophic Lateral Sclerosis / Q000150:complications / Q000503:physiopathology / Q000534:rehabilitation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D063087:Noninvasive Ventilation; D010349:Patient Compliance; D017060:Patient Satisfaction; D011446:Prospective Studies; D016896:Treatment Outcome