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

Josefin Sundh, Anna Bornefalk-Hermansson, Zainab Ahmadi, Anders Blomberg, Christer Janson, David C Currow, Christine F McDonald, Nikki McCaffrey, Magnus Ekström, Josefin Sundh, Anna Bornefalk-Hermansson, Zainab Ahmadi, Anders Blomberg, Christer Janson, David C Currow, Christine F McDonald, Nikki McCaffrey, Magnus Ekström

Abstract

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.

Keywords: 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.

Conflict of interest statement

Ethics approval and consent to participate

The study (Protocol version 1.5, dated 2016-09-13) is approved by the Ethical Board of Lund, Sweden (DNr 2016/190) and by the Swedish Medical Products Agency (DNr: 5.1–2016-71,695). Written informed consent to obtained from all participants.

Consent for publication

The ethical approval and patient information include consent to publish collected data.

Competing interests

The authors declare they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the outline of the study. aRandomization at or within four weeks of starting LTOT. Abbreviations: LTOT = Long-term oxygen therapy. COPD = Chronic Obstructive Pulmonary Disease

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