Abstract
ObjectiveLong-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/designPatients 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.DiscussionThe 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 registrationClinical Trial registered with www.clinicaltrials.gov, Title: REgistry-based Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX); ID: NCT03441204.
Highlights
Long-Term Oxygen Therapy (LTOT) is an established treatment to improve survival in patients with chronic daytime hypoxemia due to chronic obstructive pulmonary disease (COPD) [1]
This paper presents the protocol for a Swedish national multisite R-RCT; REgistry based randomized controlled trial of treatment Duration and mortality in long-term OXygen therapy (REDOX), to test the primary research hypothesis that LTOT 24 h/day does not reduce all-cause mortality compared with LTOT 15 h/day in patients with oxygen-dependent COPD
Research in LTOT has been held back by problems and high cost of recruitment and follow-up of patients with advanced disease, and challenges with ethical justification to withhold oxygen 24 h/day in patients with severe hypoxemia for the purpose of conducting a clinical trial even though there is no clear evidence of difference in outcomes between shorter and longer duration LTOT
Summary
This is the first study to compare effectiveness of LTOT duration of 24 and 15 h/day on clinical outcomes in people with chronic respiratory failure, with a potential direct impact on research and clinical management. The R-RCT design is a paradigm shift and enables a large-scale, randomized trial in a representative sample of people with very advanced disease, with complete follow-up of main endpoints. This will be the first trial investigating whether LTOT 24 h/day improves important patient outcomes − survival time, risk of hospitalization, levels of symptoms, oxygen side effects, and HrQoL compared with LTOT 15 h/day, or whether LTOT 24 h/day might unnecessarily constraint and burden patients. The study aims to take forward an infrastructure for randomized trials that can be used to facilitate research and improved evidence-based treatment in patients with chronic respiratory failure
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