Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/20765
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dc.contributor.authorSundh, Josefin-
dc.contributor.authorBornefalk-Hermansson, Anna-
dc.contributor.authorAhmadi, Zainab-
dc.contributor.authorBlomberg, Anders-
dc.contributor.authorJanson, Christer-
dc.contributor.authorCurrow, David C-
dc.contributor.authorMcDonald, Christine F-
dc.contributor.authorMcCaffrey, Nikki-
dc.contributor.authorEkström, Magnus-
dc.date2019-
dc.date.accessioned2019-05-15T05:53:29Z-
dc.date.available2019-05-15T05:53:29Z-
dc.date.issued2019-02-26-
dc.identifier.citationBMC Pulmonary Medicine 2019; 19(1): 50en_US
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/20765-
dc.description.abstractLong-term oxygen therapy (LTOT) during 15 h/day or more prolongs survival in patients with chronic obstructive pulmonary disease (COPD) and severe hypoxemia. No randomized controlled trial has evaluated the net effects (benefits or harms) from LTOT 24 h/day compared with 15 h/day or the effect in conditions other than COPD. We describe a multicenter, national, phase IV, non-superiority, registry-based, randomized controlled trial (R-RCT) of LTOT prescribed 24 h/day compared with 15 h/day. The primary endpoint is all-cause-mortality at 1 year. Secondary endpoints include cause-specific mortality, hospitalizations, health-related quality of life, symptoms, and outcomes in interstitial lung disease. Patients qualifying for LTOT are randomized to LTOT 24 h/day versus 15 h/day during 12 months using the Swedish Register for Respiratory Failure (Swedevox). Planned sample size in this pragmatic study is 2126 randomized patients. Clinical follow-up and concurrent treatments are according to routine clinical practice. Mortality, hospitalizations, and incident diseases are assessed using national Swedish registries with expected complete follow-up. Patient-reported outcomes are assessed using postal questionnaire at 3 and 12 months. The R-RCT approach combines the advantages of a prospective randomized trial and large clinical national registries for enrollment, allocation, and data collection, with the aim of improving the evidence-based use of LTOT. Clinical Trial registered with www.clinicaltrials.gov , Title: REgistry-based Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX); ID: NCT03441204.en_US
dc.language.isoeng-
dc.subjectChronic obstructive pulmonary diseaseen_US
dc.subjectHealth-related quality of lifeen_US
dc.subjectHospitalizationsen_US
dc.subjectHypoxaemiaen_US
dc.subjectInterstitial lung diseaseen_US
dc.subjectLong-term oxygen therapyen_US
dc.subjectMortalityen_US
dc.subjectOxygen durationen_US
dc.subjectRegister-based randomized controlled trialen_US
dc.subjectSymptomsen_US
dc.titleREgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol.en_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleBMC Pulmonary Medicineen_US
dc.identifier.affiliationDepartment of Respiratory Medicine, School of Medical Sciences, Örebro University, Örebro, Swedenen_US
dc.identifier.affiliationUCR Uppsala Clinical Research Center, Uppsala University, Uppsala, Swedenen_US
dc.identifier.affiliationDepartment of Clinical Sciences, Division of Respiratory Medicine & Allergology, Lund University, Lund, Swedenen_US
dc.identifier.affiliationDepartment of Public Health and Clinical Medicine, Division of Medicine/Respiratory Medicine, Umeå University, Umeå, Swedenen_US
dc.identifier.affiliationDepartment of Medical Sciences, Respiratory, Allergy & Sleep Research, Uppsala University, Uppsala, Swedenen_US
dc.identifier.affiliationFaculty of Health, University of Technology, Sydney, Australiaen_US
dc.identifier.affiliationInstitute for Breathing and Sleepen_US
dc.identifier.affiliationDeakin Health Economics, Deakin University, Burwood, Victoria, Australiaen_US
dc.identifier.affiliationDepartment of Clinical Sciences, Division of Respiratory Medicine & Allergology, Lund University, Lund, Swedenen_US
dc.identifier.doi10.1186/s12890-019-0809-7en_US
dc.type.contentTexten_US
dc.identifier.orcid0000-0003-1926-8464en_US
dc.identifier.orcid0000-0001-9934-8485en_US
dc.identifier.orcid0000-0003-1434-5715en_US
dc.identifier.orcid0000-0002-2452-7347en_US
dc.identifier.orcid0000-0001-5093-6980en_US
dc.identifier.orcid0000-0003-1988-1250en_US
dc.identifier.orcid0000-0001-6481-3391en_US
dc.identifier.orcid0000-0003-3684-3723en_US
dc.identifier.orcid0000-0002-7227-5113en_US
dc.identifier.pubmedid30808321-
dc.type.austinJournal Article-
local.name.researcherMcDonald, Christine F
item.cerifentitytypePublications-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.openairetypeJournal Article-
item.fulltextNo Fulltext-
item.languageiso639-1en-
item.grantfulltextnone-
crisitem.author.deptInstitute for Breathing and Sleep-
crisitem.author.deptRespiratory and Sleep Medicine-
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