REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol

Sundh, J; Bornefalk-Hermansson, A; Ahmadi, Z; Blomberg, A; Janson, C; Currow, DC; McDonald, CF; McCaffrey, N; Ekström, M

REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol

Sundh, J Bornefalk-Hermansson, A Ahmadi, Z Blomberg, A Janson, C Currow, DC

McDonald, CF McCaffrey, N Ekström, M

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Publication Type:: Journal Article
Citation:: BMC Pulmonary Medicine, 2019, 19 (1)
Issue Date:: 2019-02-26

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Field	Value	Language
dc.contributor.author	Sundh, J	en_US
dc.contributor.author	Bornefalk-Hermansson, A	en_US
dc.contributor.author	Ahmadi, Z	en_US
dc.contributor.author	Blomberg, A	en_US
dc.contributor.author	Janson, C	en_US
dc.contributor.author	Currow, DC https://orcid.org/0000-0003-1988-1250	en_US
dc.contributor.author	McDonald, CF	en_US
dc.contributor.author	McCaffrey, N	en_US
dc.contributor.author	Ekström, M	en_US
dc.date.available	2019-02-11	en_US
dc.date.issued	2019-02-26	en_US
dc.identifier.citation	BMC Pulmonary Medicine, 2019, 19 (1)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/135689
dc.description.abstract	© 2019 The Author(s). Objective: Long-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. Methods/design: 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. Discussion: 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.	en_US
dc.relation.ispartof	BMC Pulmonary Medicine	en_US
dc.relation.isbasedon	10.1186/s12890-019-0809-7	en_US
dc.rights	info:eu-repo/semantics/openAccess
dc.subject.classification	Respiratory System	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Lung Diseases, Interstitial	en_US
dc.subject.mesh	Pulmonary Disease, Chronic Obstructive	en_US
dc.subject.mesh	Treatment Outcome	en_US
dc.subject.mesh	Hospitalization	en_US
dc.subject.mesh	Oxygen Inhalation Therapy	en_US
dc.subject.mesh	Registries	en_US
dc.subject.mesh	Survival Rate	en_US
dc.subject.mesh	Single-Blind Method	en_US
dc.subject.mesh	Health Status	en_US
dc.subject.mesh	Time Factors	en_US
dc.subject.mesh	Quality of Life	en_US
dc.subject.mesh	Sweden	en_US
dc.title	REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	19	en_US
utslib.for	1102 Cardiorespiratory Medicine and Haematology	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
utslib.copyright.status	open_access	*
pubs.issue	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	19	en_US

Abstract:

© 2019 The Author(s). Objective: Long-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. Methods/design: 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. Discussion: 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.

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http://hdl.handle.net/10453/135689