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dc.contributor.authorMcDermott, CJ
dc.contributor.authorShaw, PJ
dc.contributor.authorCooper, CL
dc.contributor.authorDixon, S
dc.contributor.authorBaird, WO
dc.contributor.authorBradburn, MJ
dc.contributor.authorFitzgerald, P
dc.contributor.authorMaguire, C
dc.contributor.authorWilliams, T
dc.contributor.authorBaudouin, SV
dc.contributor.authorKarat, D
dc.contributor.authorTalbot, K
dc.contributor.authorStradling, J
dc.contributor.authorMaynard, N
dc.contributor.authorTurner, M
dc.contributor.authorBianchi, S
dc.contributor.authorAckroyd, R
dc.contributor.authorBourke, SC
dc.contributor.authorEaling, J
dc.contributor.authorHamdalla, H
dc.contributor.authorBentley, A
dc.contributor.authorGalloway, S
dc.contributor.authorOrrell, RW
dc.contributor.authorWedzicha, W
dc.contributor.authorElliot, M
dc.contributor.authorHughes, P
dc.contributor.authorHanemann, Clemens Oliver
dc.contributor.authorCollaborators, DSG
dc.date.accessioned2015-09-29T10:34:45Z
dc.date.available2015-09-29T10:34:45Z
dc.date.issued2015-09
dc.identifier.issn1474-4422
dc.identifier.issn1474-4465
dc.identifier.urihttp://hdl.handle.net/10026.1/3556
dc.description.abstract

BACKGROUND: Non-invasive ventilation is part of the standard of care for treatment of respiratory failure in patients with amyotrophic lateral sclerosis (ALS). The NeuRx RA/4 Diaphragm Pacing System has received Humanitarian Device Exemption approval from the US Food and Drug Administration for treatment of respiratory failure in patients with ALS. We aimed to establish the safety and efficacy of diaphragm pacing with this system in patients with respiratory muscle weakness due to ALS. METHODS: We undertook a multicentre, open-label, randomised controlled trial at seven specialist ALS and respiratory centres in the UK. Eligible participants were aged 18 years or older with laboratory supported probable, clinically probable, or clinically definite ALS; stable riluzole treatment for at least 30 days; and respiratory insufficiency. We randomly assigned participants (1:1), via a centralised web-based randomisation system with minimisation that balanced patients for age, sex, forced vital capacity, and bulbar function, to receive either non-invasive ventilation plus pacing with the NeuRx RA/4 Diaphragm Pacing System or non-invasive ventilation alone. Patients, carers, and outcome assessors were not masked to treatment allocation. The primary outcome was overall survival, defined as the time from randomisation to death from any cause. Analysis was by intention to treat. This trial is registered, ISRCTN number 53817913. FINDINGS: Between Dec 5, 2011, and Dec 18, 2013, we randomly assigned 74 participants to receive either non-invasive ventilation alone (n=37) or non-invasive ventilation plus diaphragm pacing (n=37). On Dec 18, 2013, the Data Monitoring and Ethics Committee (DMEC) recommended suspension of recruitment on the basis of overall survival figures. Randomly assigned participants continued as per the study protocol until June 23, 2014, when the DMEC advised discontinuation of pacing in all patients. Follow-up assessments continued until the planned end of the study in December, 2014. Survival was shorter in the non-invasive ventilation plus pacing group than in the non-invasive ventilation alone group (median 11·0 months [95% CI 8·3-13·6] vs 22·5 months [13·6-not reached]; adjusted hazard ratio 2·27, 95% CI 1·22-4·25; p=0·009). 28 (76%) patients died in the pacing group and 19 (51%) patients died in the non-invasive ventilation alone group. We recorded 162 adverse events (5·9 events per person-year) in the pacing group, of which 46 events were serious, compared with 81 events (2·5 events per person-year) in the non-invasive ventilation alone group, of which 31 events were serious. INTERPRETATION: Addition of diaphragm pacing to standard care with non-invasive ventilation was associated with decreased survival in patients with ALS. Our results suggest that diaphragmatic pacing should not be used as a routine treatment for patients with ALS in respiratory failure. FUNDING: The National Institute for Health Research Health Technology Assessment Programme; the Motor Neurone Disease Association of England, Wales, and Northern Ireland.

dc.format.extent883-892
dc.format.mediumPrint-Electronic
dc.languageen
dc.language.isoeng
dc.publisherElsevier BV
dc.subjectAdult
dc.subjectAged
dc.subjectAmyotrophic Lateral Sclerosis
dc.subjectDiaphragm
dc.subjectFemale
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectRespiratory Insufficiency
dc.subjectRespiratory Therapy
dc.subjectTreatment Outcome
dc.titleSafety and efficacy of diaphragm pacing in patients with respiratory insufficiency due to amyotrophic lateral sclerosis (DiPALS): a multicentre, open-label, randomised controlled trial
dc.typejournal-article
dc.typeJournal Article
dc.typeMulticenter Study
dc.typeRandomized Controlled Trial
dc.typeResearch Support, Non-U.S. Gov't
plymouth.author-urlhttps://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000359889800008&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008
plymouth.issue9
plymouth.volume14
plymouth.publication-statusPublished
plymouth.journalThe Lancet Neurology
dc.identifier.doi10.1016/s1474-4422(15)00152-0
plymouth.organisational-group/Plymouth
plymouth.organisational-group/Plymouth/Faculty of Health
plymouth.organisational-group/Plymouth/Faculty of Health/Peninsula Medical School
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CBR
plymouth.organisational-group/Plymouth/Users by role
plymouth.organisational-group/Plymouth/Users by role/Academics
plymouth.organisational-group/Plymouth/Users by role/Researchers in ResearchFish submission
dc.publisher.placeEngland
dcterms.dateAccepted2015-06-25
dc.identifier.eissn1474-4465
dc.rights.embargoperiodNot known
rioxxterms.versionofrecord10.1016/s1474-4422(15)00152-0
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2015-09
rioxxterms.typeJournal Article/Review


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