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Title: REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol.
Austin Authors: Sundh, Josefin;Bornefalk-Hermansson, Anna;Ahmadi, Zainab;Blomberg, Anders;Janson, Christer;Currow, David C;McDonald, Christine F ;McCaffrey, Nikki;Ekström, Magnus
Affiliation: Department of Respiratory Medicine, School of Medical Sciences, Örebro University, Örebro, Sweden
UCR Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden
Department of Clinical Sciences, Division of Respiratory Medicine & Allergology, Lund University, Lund, Sweden
Department of Public Health and Clinical Medicine, Division of Medicine/Respiratory Medicine, Umeå University, Umeå, Sweden
Department of Medical Sciences, Respiratory, Allergy & Sleep Research, Uppsala University, Uppsala, Sweden
Faculty of Health, University of Technology, Sydney, Australia
Institute for Breathing and Sleep
Deakin Health Economics, Deakin University, Burwood, Victoria, Australia
Department of Clinical Sciences, Division of Respiratory Medicine & Allergology, Lund University, Lund, Sweden
Issue Date: 26-Feb-2019
Date: 2019
Publication information: BMC Pulmonary Medicine 2019; 19(1): 50
Abstract: 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. 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 , Title: REgistry-based Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX); ID: NCT03441204.
DOI: 10.1186/s12890-019-0809-7
ORCID: 0000-0003-1926-8464
Journal: BMC Pulmonary Medicine
PubMed URL: 30808321
Type: Journal Article
Subjects: Chronic obstructive pulmonary disease
Health-related quality of life
Interstitial lung disease
Long-term oxygen therapy
Oxygen duration
Register-based randomized controlled trial
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