{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T08:46:47Z","timestamp":1789980407491,"version":"4.0.1"},"reference-count":19,"publisher":"BMJ","issue":"4","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2015,1,7]]},"published-print":{"date-parts":[[2015,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ISRCTN 51420481.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2014-007082","type":"journal-article","created":{"date-parts":[[2015,4,23]],"date-time":"2015-04-23T22:52:03Z","timestamp":1429829523000},"page":"e007082","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"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"],"prefix":"10.1136","volume":"5","author":[{"given":"S","family":"Mandal","sequence":"first","affiliation":[{"name":"Lane-Fox Respiratory Unit, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK"},{"name":"Division of Asthma Allergy and Lung Biology, King's College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G","family":"Arbane","sequence":"additional","affiliation":[{"name":"Lane-Fox Respiratory Unit, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P","family":"Murphy","sequence":"additional","affiliation":[{"name":"Lane-Fox Respiratory Unit, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK"},{"name":"Division of Asthma Allergy and Lung Biology, King's College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M W","family":"Elliott","sequence":"additional","affiliation":[{"name":"St James Hospital, Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J P","family":"Janssens","sequence":"additional","affiliation":[{"name":"H\u00f4pitaux Universitaires de Gen\u00e8ve, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J L","family":"Pepin","sequence":"additional","affiliation":[{"name":"H\u00f4pital Universitaire de Grenoble, Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J F","family":"Muir","sequence":"additional","affiliation":[{"name":"Pulmonary and Intensive Care Department, Rouen University Hospital & UPRES EA 3830, Institute for Biomedical Research, University of Rouen, Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Cuvelier","sequence":"additional","affiliation":[{"name":"Pulmonary and Intensive Care Department, Rouen University Hospital & UPRES EA 3830, Institute for Biomedical Research, University of Rouen, Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Polkey","sequence":"additional","affiliation":[{"name":"Royal Brompton and Harefield NHS Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D","family":"Parkin","sequence":"additional","affiliation":[{"name":"Department of Primary Care and Public Health Sciences & NIHR Biomedical Research Centre at Guy's and St Thomas\u2019 NHS Foundation Trust and King's College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Douiri","sequence":"additional","affiliation":[{"name":"Department of Primary Care and Public Health Sciences & NIHR Biomedical Research Centre at Guy's and St Thomas\u2019 NHS Foundation Trust and King's College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N","family":"Hart","sequence":"additional","affiliation":[{"name":"Lane-Fox Respiratory Unit, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK"},{"name":"Division of Asthma Allergy and Lung Biology, King's College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2015,4,23]]},"reference":[{"key":"2025121512180407000_5.4.e007082.1","unstructured":"Butland B , Jebb S , Kopelman P , et al . 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