REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol 11 Medical and Health Sciences 1102 Cardiorespiratory Medicine and Haematology

Research output: Contribution to journalArticle

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.

Details

Authors
  • Josefin Sundh
  • Anna Bornefalk-Hermansson
  • Zainab Ahmadi
  • Anders Blomberg
  • Christer Janson
  • David C. Currow
  • Christine F. McDonald
  • Nikki McCaffrey
  • Magnus Ekström
Organisations
External organisations
  • Örebro University
  • Uppsala University Hospital
  • Umeå University
  • Uppsala University
  • University of Technology Sydney
  • Deakin University
  • Institute for Breathing and Sleep (IBAS)
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Respiratory Medicine and Allergy

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
Original languageEnglish
Article number50
JournalBMC Pulmonary Medicine
Volume19
Issue number1
Publication statusPublished - 2019 Feb 26
Publication categoryResearch
Peer-reviewedYes