Hypoxemia, a low blood oxygen level, is a hallmark feature of moderate to severe chronic lung disease including chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD).
Associated with poor prognosis, hypoxemia severity typically correlates with disease progression, and can exist either in a state of rest during waking hours (resting hypoxemia), physical strain (exertional hypoxemia) or sleep (nocturnal hypoxemia). Domiciliary oxygen therapy is commonly prescribed to those with hypoxemia to revert blood oxygen levels to normal physiological ranges.
Various domiciliary oxygen therapy interventions exist and can be used either as standalone intervention or in unison with one another (i.e. ambulatory oxygen therapy (AOT), nocturnal oxygen therapy (NOT) and/or long-term oxygen therapy (LTOT)).
Despite popular clinical utility, the therapeutic role of oxygen therapy in those with ILD and those with moderate to mild COPD remains controversial. There is a lack of high-quality evidence to guide the use of oxygen therapy in those with ILD as the therapeutic effects of LTOT and NOT have yet to be assessed via randomised trial, and while AOT is a conditional recommendation in the presence of severe exertional room air hypoxia, the evidence base to support this guideline is regarded as poor in quality.
Although a greater body of work pertaining to the use of LTOT to address hypoxemia in those with COPD exits compared to ILD literature, data to support the prescription of AOT are considered to be of low quality. Substantial variation in methodology, including heterogeneity in outcome reporting, exists between studies evaluating the effect of oxygen therapy interventions in adults with chronic lung disease.
Currently, no COS designed to standardise outcome reporting for the intervention of domiciliary oxygen therapy in clinical trials or practice exists. Therefore, the primary aim of this COS is to develop an international consensus on a COS suitable for clinical trials and clinical practice regarding home oxygen therapy interventions in adults with chronic lung disease.
Cassidy Du Berry - Monash University
Dr Shohei Kawachi - Monash University
A/Prof Yet Khor - Monash University
A/Prof Magnus Ekström - Lund University
Dr Yves Lacasse - Institut Universitaire de Cardiologie et de Pneumologie de Québec
Dr Thomas Ringbaek - University of Copenhagen
Susan Jacobs - Stanford University
Prof Jerry Krishnan - University of Illinois
Prof Anne Holland (Principal Investigator) - Monash University
Disease Category: Lungs & airways
Disease Name: Chronic Lung Disease
Age Range: 18 - 110
Sex: Either
Nature of Intervention: Other
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- Charities
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Focus group(s)
- Literature review
- Semi structured discussion
This COS will be designed using methods recommended by the Core Outcome Set-STAndardised Protocol (COS-STAD) and the COMET guidelines. The study will consist three distinct stages: (1) generating the preliminary list of outcomes; (2) consumer group focus sessions; and (3) Delphi surveys among key stakeholders to prioritise core outcomes.
Stage 1:
As several systematic reviews on oxygen therapy use for adults with respiratory disease have already been conducted, we will identify potential outcomes for COS inclusion by identifying an initial list of outcome measures for consideration. Systematic reviews of quantitative and qualitative studies to assess the efficacy of oxygen therapy in adults with obstructive and/or restrictive lung disease will be included. To achieve this, we will search two databases (Cochrane Database of Systematic Reviews and MEDLINE) using a predefined search criteria. In addition, we will review established oxygen registries and relevant clinical practise guidelines produced by peak professional bodies as identified by the steering committee.
Stage 2:
Using key consumer groups, we aim to conduct 3 focus groups held virtually, with at maximum of 8 participants per group. The focus group session will last for 60 minutes. The OMERACT Filter 2.1 framework, findings from the overview of systematic reviews and the COMET Checklist for public research partners and COS study developers involved in designing a COS study will be used to inform a topic guide to be presented to consumers during each focus group sessions.
Stage 3:
Representatives from relevant stakeholder groups will be invited to participate in a two-round international, web-based, modified Delphi study used to reach consensus on this COS. Using a 9-point Likert scale, where 1-3 corresponds to ‘not important’, 4-6 corresponds to ‘important but not critical’ and 7-9 corresponds to ‘critically important’, participants will be asked to rate each listed core domain and associated core outcomes separately. An ‘Unsure/I do not know’ option will also be provided for instances where panellists feel that they are unable to grade either domain or associated outcome due to lack of relevance to professional or personal experience.