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

• Objective:Long-term oxygen therapy (LTOT) during 15 h/day or more prolongs survival in patients with chronicobstructive pulmonary disease (COPD) and severe hypoxemia. No randomized controlled trial has evaluated the neteffects (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) ofLTOT prescribed 24 h/day compared with 15 h/day. The primary endpoint is all-cause-mortality at 1 year. Secondaryendpoints include cause-specific mortality, hospitalizations, health-related quality of life, symptoms, and outcomes ininterstitial lung disease. Methods/design:Patients qualifying for LTOT are randomized to LTOT 24 h/day versus 15 h/day during 12 monthsusing the Swedish Register for Respiratory Failure (Swedevox). Planned sample size in this pragmatic study is 2126randomized 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 nationalregistries for enrollment, allocation, and data collection, with the aim of improving the evidence-based use of LTOT. Trial registration:Clinical Trial registered withwww.clinicaltrials.gov, Title: REgistry-based Treatment Duration andMortality in Long-term OXygen Therapy (REDOX); ID: NCT03441204. 

Ämnesord

Medical and Health Sciences  (hsv)

Clinical Medicine  (hsv)

Respiratory Medicine and Allergy  (hsv)

Medicin och hälsovetenskap  (hsv)

Klinisk medicin  (hsv)

Lungmedicin och allergi  (hsv)

Genre

government publication  (marcgt)

Indexterm och SAB-rubrik

Register-based randomized controlled trial

Hypoxaemia

Long-term oxygen therapy

Oxygen duration

Chronic obstructive pulmonary disease

Interstitial lung disease

Mortality

Hospitalizations

Health-related quality of life

Symptoms