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REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol
Örebro University, School of Medical Sciences. Department of Respiratory Medicine.
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.
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2019 (English)In: BMC Pulmonary Medicine, ISSN 1471-2466, E-ISSN 1471-2466, Vol. 19, no 1, article id 50Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
BioMed Central, 2019. Vol. 19, no 1, article id 50
Keywords [en]
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
National Category
Respiratory Medicine and Allergy
Identifiers
URN: urn:nbn:se:oru:diva-72876DOI: 10.1186/s12890-019-0809-7ISI: 000459873800001PubMedID: 30808321Scopus ID: 2-s2.0-85062262637OAI: oai:DiVA.org:oru-72876DiVA, id: diva2:1293272
Funder
Swedish Heart Lung FoundationSwedish Society of MedicineThe Crafoord FoundationSwedish Society for Medical Research (SSMF)
Note

Funding Agency:

Emil and Wera Cornell Foundation

Available from: 2019-03-04 Created: 2019-03-04 Last updated: 2019-06-19Bibliographically approved

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Sundh, Josefin

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