Evidence map›Paper›PMID 30808321›Full record

ArticleBMC pulmonary medicine2019

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pulmonary medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03441204 (REgistry-based Randomized Controlled Trial of Treatment Duration and Mortality in Long-term OXygen Therapy), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03441204 phase4completednot on this map

REgistry-based Randomized Controlled Trial of Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX) A Multicenter, Phase IV, Registry-Based, Randomized Controlled Trial (R-RCT)

TypeinterventionalSponsorSkane University HospitalRan2018 to 2023Enrolled241ConditionsChronic Respiratory Failure With HypoxiaArmsLTOT 24 h/day, LTOT 15h/day
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  11. Do mHealth applications improve clinical outcomes of patients with cancer? A critical appraisal of the peer-reviewed literature.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 2 countries.

Josefin SundhDepartment of Respiratory Medicine, School of Medical Sciences, Örebro University, Örebro, Sweden. josefin.sundh@oru.se.ORCID http://orcid.org/0000-0003-1926-8464
Anna Bornefalk-HermanssonUCR Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.ORCID http://orcid.org/0000-0001-9934-8485
Zainab AhmadiDepartment of Clinical Sciences, Division of Respiratory Medicine & Allergology, Lund University, Lund, Sweden.ORCID http://orcid.org/0000-0003-1434-5715
Anders BlombergDepartment of Public Health and Clinical Medicine, Division of Medicine/Respiratory Medicine, Umeå University, Umeå, Sweden.ORCID http://orcid.org/0000-0002-2452-7347
Christer JansonDepartment of Medical Sciences, Respiratory, Allergy & Sleep Research, Uppsala University, Uppsala, Sweden.ORCID http://orcid.org/0000-0001-5093-6980
David C CurrowFaculty of Health, University of Technology, Sydney, Australia.ORCID http://orcid.org/0000-0003-1988-1250
Christine F McDonaldInstitute for Breathing and Sleep, Melbourne, Victoria, Australia.ORCID http://orcid.org/0000-0001-6481-3391
Nikki McCaffreyDeakin Health Economics, Deakin University, Burwood, Victoria, Australia.ORCID http://orcid.org/0000-0003-3684-3723
Magnus EkströmDepartment of Clinical Sciences, Division of Respiratory Medicine & Allergology, Lund University, Lund, Sweden.ORCID http://orcid.org/0000-0002-7227-5113
Lund University · SEUppsala University · SEDeakin University · AUInstitute for Breathing and Sleep · AUÖrebro University · SEUmeå University · SEUniversity of Technology Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. 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 registrationClinical Trial registered with www.clinicaltrials.gov , Title: REgistry-based Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX); ID: NCT03441204.

Indexed as

Lung Diseases, InterstitialOxygen Inhalation TherapyPulmonary Disease, Chronic ObstructiveRegistriesClinical Trials, Phase IV as TopicEquivalence Trials as TopicHealth StatusHospitalizationHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicSingle-Blind MethodSurvival RateSwedenChronic obstructive pulmonary diseaseHealth-related quality of lifeHospitalizationsHypoxaemiaInterstitial lung diseaseLong-term oxygen therapyMortalityOxygen durationRegister-based randomized controlled trialSymptoms

Identifiers

PMID30808321
PMCPMC6390558
OpenAlexW2937573955

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.