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dc.contributor.authorVisca, Dina
dc.contributor.authorTsipouri, Vicky
dc.contributor.authorMori, Letizia
dc.contributor.authorFirouzi, Ashi
dc.contributor.authorFleming, Sharon
dc.contributor.authorFarquhar, Morag
dc.contributor.authorLeung, Elizabeth
dc.contributor.authorMaher, Toby M
dc.contributor.authorCullinan, Paul
dc.contributor.authorHopkinson, Nick
dc.contributor.authorWells, Athol U
dc.contributor.authorBanya, Winston
dc.contributor.authorWhitty, Jennifer A
dc.contributor.authorAdamali, Huzaifa
dc.contributor.authoret al.
dc.date.accessioned2020-10-26T06:15:35Z
dc.date.available2020-10-26T06:15:35Z
dc.date.issued2017
dc.identifier.issn1745-6215en_US
dc.identifier.doi10.1186/s13063-017-1912-9en_US
dc.identifier.urihttp://hdl.handle.net/10072/398712
dc.description.abstractBACKGROUND: Fibrotic interstitial lung diseases (ILDs) are chronic and often progressive conditions resulting in substantial morbidity and mortality. Shortness of breath, a symptom often linked to oxygen desaturation on exertion, is tightly linked to worsening quality of life in these patients. Although ambulatory oxygen is used empirically in their treatment, there are no ILD-specific guidelines on its use. To our knowledge, no studies are available on the effects of ambulatory oxygen on day-to-day life in patients with ILD. METHODS/DESIGN: Ambulatory oxygen in fibrotic lung disease (AmbOx) is a multicentre, randomised controlled crossover trial (RCT) funded by the Research for Patient Benefit Programme of the National Institute for Health Research. The trial will compare ambulatory oxygen used during daily activities with no ambulatory oxygen in patients with fibrotic lung disease whose oxygen saturation (SaO2) is ≥94% at rest, but drops to ≤88% on a 6-min Walk Test. The randomised controlled trial (RCT) will evaluate the effects on health status (measured by the King's Brief ILD Questionnaire: K-BILD) of ambulatory oxygen used at home, at an optimal flow rate determined by titration at screening visit, and administered for a 2-week period, compared to 2 weeks off oxygen. Key secondary outcomes will include breathlessness on activity scores, as measured by the University of California San Diego Shortness of Breath Questionnaire, global patient assessment of change scores, as well as quality of life scores (St George's Respiratory Questionnaire), anxiety and depression scores (Hospital Anxiety and Depression Scale), activity markers measured by SenseWear Armbands, pulse oximetry measurements, patient-reported daily activities, patient- and oxygen company-reported oxygen cylinder use. The study also includes a qualitative component and will explore in interviews patients' experiences of the use of a portable oxygen supply and trial participation in a subgroup of 20 patients and carers. DISCUSSION: This is the first RCT of the effects of ambulatory oxygen during daily life on health status and breathlessness in fibrotic lung disease. The results generated should provide the basis for setting up ILD-specific guidelines for the use of ambulatory oxygen. TRIAL REGISTRATION: National Clinical Trials Registry, identifier: NCT02286063 . Registered on 8 October 2014 (retrospectively registered).en_US
dc.description.peerreviewedYesen_US
dc.languageEnglishen_US
dc.language.isoeng
dc.publisherBMCen_US
dc.relation.ispartofpagefrom201en_US
dc.relation.ispartofissue1en_US
dc.relation.ispartofjournalTrialsen_US
dc.relation.ispartofvolume18en_US
dc.subject.fieldofresearchCardiorespiratory Medicine and Haematologyen_US
dc.subject.fieldofresearchClinical Sciencesen_US
dc.subject.fieldofresearchcode1102en_US
dc.subject.fieldofresearchcode1103en_US
dc.subject.keywordsScience & Technologyen_US
dc.subject.keywordsLife Sciences & Biomedicineen_US
dc.subject.keywordsMedicine, Research & Experimentalen_US
dc.subject.keywordsResearch & Experimental Medicineen_US
dc.subject.keywordsFibrotic interstitial lung diseaseen_US
dc.titleAmbulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trialen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Articlesen_US
dcterms.bibliographicCitationVisca, D; Tsipouri, V; Mori, L; Firouzi, A; Fleming, S; Farquhar, M; Leung, E; Maher, TM; Cullinan, P; Hopkinson, N; Wells, AU; Banya, W; Whitty, JA; Adamali, H; et al., Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial, Trials, 2017, 18 (1), pp. 201en_US
dcterms.dateAccepted2017-03-22
dcterms.licensehttp://creativecommons.org/licenses/by/4.0/en_US
dc.date.updated2020-10-26T06:05:41Z
dc.description.versionVersion of Record (VoR)en_US
gro.rights.copyright© The Author(s). 2017. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en_US
gro.hasfulltextFull Text
gro.griffith.authorWhitty, Jennifer A.


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