title: Medium-term cost-effectiveness of an automated non-invasive ventilation outpatient set-up versus a standard fixed level non-invasive ventilation inpatient set-up in obese patients with chronic respiratory failure: a protocol description.
abstract: BACKGROUND
  Obesity is an escalating issue, with an accompanying increase in referrals of patients with obesity-related respiratory failure. Currently, these patients are electively admitted to hospital for initiation of non-invasive ventilation (NIV), but it is unknown whether outpatient initiation is as effective as inpatient set-up. We hypothesise that outpatient set-up using an autotitrating NIV device will be more cost-effective than a nurse-led inpatient titration and set-up.
  
  
  METHODS
  We will undertake a multinational, multicentre randomised controlled trial. Participants will be randomised to receive the usual inpatient set-up, which will include nurse-led initiation of NIV or outpatient set-up with an automated NIV device. They will be stratified according to the trial site, gender and previous use of NIV or continuous positive airway pressure. Assuming a 10% dropout rate, a total sample of 82 patients will be required. Cost-effectiveness will be evaluated using standard treatment costs and health service utilisation as well as health-related quality of life measures (severe respiratory insufficiency (SRI) and EuroQol-5 dimensions (EQ-5D)). A change in the SRI questionnaire will be based on the analysis of covariance adjusting for the baseline measurements between the two arms of patients.
  
  
  BACKGROUND
  This study has been approved by the Westminster National Research Ethics Committee (11/LO/0414) and is the trial registered on the UKCRN portfolio. The trial is planned to start in January 2015 with publication of the trial results in 2017.
  
  
  BACKGROUND
  ISRCTN 51420481.
authors.affiliation: Lane-Fox Respiratory Unit, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK Division of Asthma Allergy and Lung Biology, King's College London, London, UK.
authors.forename: S
authors.initials: S
authors.lastname: Mandal
authors.affiliation: Lane-Fox Respiratory Unit, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.
authors.forename: G
authors.initials: G
authors.lastname: Arbane
authors.affiliation: Lane-Fox Respiratory Unit, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK Division of Asthma Allergy and Lung Biology, King's College London, London, UK.
authors.forename: P
authors.initials: P
authors.lastname: Murphy
authors.affiliation: St James Hospital, Leeds, UK.
authors.forename: M W
authors.initials: MW
authors.lastname: Elliott
authors.affiliation: Hôpitaux Universitaires de Genève, Geneva, Switzerland.
authors.forename: J P
authors.initials: JP
authors.lastname: Janssens
authors.affiliation: Hôpital Universitaire de Grenoble, Grenoble, France.
authors.forename: J L
authors.initials: JL
authors.lastname: Pepin
authors.affiliation: Pulmonary and Intensive Care Department, Rouen University Hospital & UPRES EA 3830, Institute for Biomedical Research, University of Rouen, Rouen, France.
authors.forename: J F
authors.initials: JF
authors.lastname: Muir
authors.affiliation: Pulmonary and Intensive Care Department, Rouen University Hospital & UPRES EA 3830, Institute for Biomedical Research, University of Rouen, Rouen, France.
authors.forename: A
authors.initials: A
authors.lastname: Cuvelier
authors.affiliation: Royal Brompton and Harefield NHS Trust, London, UK.
authors.forename: M
authors.initials: M
authors.lastname: Polkey
authors.affiliation: Department of Primary Care and Public Health Sciences & NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
authors.forename: D
authors.initials: D
authors.lastname: Parkin
authors.affiliation: Department of Primary Care and Public Health Sciences & NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Douiri
authors.affiliation: Lane-Fox Respiratory Unit, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK Division of Asthma Allergy and Lung Biology, King's College London, London, UK.
authors.forename: N
authors.initials: N
authors.lastname: Hart
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care / Q000191:economics*; D002908:Chronic Disease; D003362:Cost-Benefit Analysis; D005260:Female; D006760:Hospitalization / Q000191:economics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D063087:Noninvasive Ventilation / Q000191:economics* / Q000379:methods; D009765:Obesity / Q000150:complications*; D012131:Respiratory Insufficiency / Q000209:etiology / Q000628:therapy*
keywords: HEALTH ECONOMICS; SLEEP MEDICINE