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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

Sundh, Josefin; Bornefalk-Hermansson, Anna; Ahmadi, Zainab LU ; Blomberg, Anders; Janson, Christer; Currow, David C.; McDonald, Christine F.; McCaffrey, Nikki and Ekström, Magnus LU (2019) In BMC Pulmonary Medicine 19(1).
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... (More)

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.

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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
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
in
BMC Pulmonary Medicine
volume
19
issue
1
publisher
BioMed Central
external identifiers
  • scopus:85062262637
ISSN
1471-2466
DOI
10.1186/s12890-019-0809-7
language
English
LU publication?
yes
id
4fff4afc-d3a7-47a7-bc95-91bfd7f257a7
date added to LUP
2019-03-13 11:13:50
date last changed
2019-04-02 04:15:17
@article{4fff4afc-d3a7-47a7-bc95-91bfd7f257a7,
  abstract     = {<p>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.</p>},
  articleno    = {50},
  author       = {Sundh, Josefin and Bornefalk-Hermansson, Anna and Ahmadi, Zainab and Blomberg, Anders and Janson, Christer and Currow, David C. and McDonald, Christine F. and McCaffrey, Nikki and Ekström, Magnus},
  issn         = {1471-2466},
  keyword      = {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},
  language     = {eng},
  month        = {02},
  number       = {1},
  publisher    = {BioMed Central},
  series       = {BMC Pulmonary Medicine},
  title        = {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},
  url          = {http://dx.doi.org/10.1186/s12890-019-0809-7},
  volume       = {19},
  year         = {2019},
}