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

Sundh, Josefin, Bornefalk-Hermansson, Anna, Ahmadi, Zainab, Blomberg, Anders, Janson, Christer, Currow, David C, McDonald, Christine F, McCaffrey, Nicola and Ekström, Magnus 2019, REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol, BMC pulmonary medicine, vol. 19, pp. 1-8, doi: 10.1186/s12890-019-0809-7.

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Title REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol
Author(s) Sundh, Josefin
Bornefalk-Hermansson, Anna
Ahmadi, Zainab
Blomberg, Anders
Janson, Christer
Currow, David C
McDonald, Christine F
McCaffrey, NicolaORCID iD for McCaffrey, Nicola orcid.org/0000-0003-3684-3723
Ekström, Magnus
Journal name BMC pulmonary medicine
Volume number 19
Article ID 50
Start page 1
End page 8
Total pages 8
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2019-02-26
ISSN 1471-2466
Keyword(s) Chronic obstructive pulmonary disease
Health-related quality of life
Hospitalizations
Hypoxaemia
Interstitial lung disease
Long-term oxygen therapy
Mortality
Oxygen duration
Register-based randomized controlled trial
Symptoms
Science & Technology
Life Sciences & Biomedicine
Respiratory System
Summary 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. TRIAL REGISTRATION: Clinical Trial registered with www.clinicaltrials.gov , Title: REgistry-based Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX); ID: NCT03441204.
Language eng
DOI 10.1186/s12890-019-0809-7
Field of Research 1102 Cardiorespiratory Medicine and Haematology
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2019, The Author(s)
Persistent URL http://hdl.handle.net/10536/DRO/DU:30119901

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