Effect of ambulatory oxygen on quality of life for patients with fibrotic lung disease (AmbOx): a prospective, open-label, mixed-method, crossover randomised controlled trial

Visca, Dina; Mori, Letizia; Tsipouri, Vicky; Fleming, Steven D.; Firouzi, Ashi; Bonini, Matteo; Pavitt, Matthew J; Alfieri, Veronica; Canu, Sara; Bonifazi, Martina; Boccabella, Cristina; Lauretis, Angelo De; Stock, Carmel; Saunders, Peter; Montgomery, Andrew J.; Hogben, Charlotte; Stockford, Anna; Pittet, Margaux; Brown, J R; Chua, Felix; George, Peter M.; Molyneaux, Philip L.; Margaritopoulos, Georgios; Kokosi, Maria; Kouranos, Vasileios; Russell, Anne-Marie; Birring, Surinder S.; Chetta, Alfredo; Maher, Toby M.; Cullinan, Paul; Hopkinson, Nicholas S; Banya, Winston; Whitty, Jennifer A.; Adamali, Huzaifa; Spencer, Lisa; Farquhar, Morag; Sestini, Piersante; Wells, Athol U.; Renzoni, Elisabetta A.

doi:10.1016/s2213-2600(18)30289-3

Cited by 171 publications

(136 citation statements)

References 41 publications

(25 reference statements)

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“…King's Brief Interstitial Lung Disease questionnaire (K-BILD) was developed as a HRQL instrument for patients with ILD [9] and has recently been validated in IPF [10]. Even though K-BILD is used in clinical trials [11,12], responsiveness and MCID have not yet been sufficiently determined [13,14]. Validation of an instrument is an iterative process increasing robustness by evaluation in different cohorts.…”

Section: Introductionmentioning

confidence: 99%

Responsiveness and minimal clinically important difference of SGRQ-I and K-BILD in idiopathic pulmonary fibrosis

et al. 2020

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Background: Idiopathic pulmonary fibrosis (IPF) specific version of St. George's Respiratory Questionnaire (SGRQ-I) and King's Brief Interstitial Lung Disease questionnaire (K-BILD) are validated health-related quality of life (HRQL) instruments, but no or limited data exist on their responsiveness and minimal clinically important difference (MCID). The objectives of this study were to assess responsiveness of SGRQ-I and K-BILD and determine MCID separately for deterioration and improvement in a large, prospective cohort of patients with IPF in a real-world setting. Methods: Consecutive patients with IPF were recruited. SGRQ-I, K-BILD, SGRQ, Shortness of Breath Questionnaire, pulmonary function tests and 6-min walk test measurements were obtained at baseline and at six and 12 months; at six and 12 months, patients also completed Global Rating of Change Scales. Responsiveness was assessed using correlation coefficients and linear regression. Cox regression was used for mortality analyses. MCID was estimated using receiver operating characteristic curves with separate analyses for improvement and deterioration.Results: A total of 150 IPF patients were included and 124 completed the 12-month follow-up. Based on all HRQL anchors and most physiological anchors, responsiveness analyses supported the evidence pointing towards SGRQ-I and K-BILD as responsive instruments. Multivariate analyses showed an association between SGRQ-I and mortality (HR: 1.18, 95% CI: 1.02 to 1.36, p = 0.03) and a trend was found for K-BILD (HR: 0.82, 95% CI: 0.64 to 1.05, p = 0.12). MCID was estimated for all domains of SGRQ-I and K-BILD. MCID for improvement differed from deterioration for both SGRQ-I Total (3.9 and 4.9) and K-BILD Total (4.7 and 2.7).Conclusions: SGRQ-I and K-BILD were responsive to change concerning both HRQL and most physiological anchors. MCID was determined separately for improvement and deterioration, resulting in different estimates; especially a smaller estimate for deterioration compared to improvement in K-BILD. Trial registration: Clinicaltrials.gov, no. NCT02818712. Registered 30 June 2016.

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Section: Introductionmentioning

confidence: 99%

Responsiveness and minimal clinically important difference of SGRQ-I and K-BILD in idiopathic pulmonary fibrosis

et al. 2020

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“…Another study demonstrated reduced dyspnoea, improved capacity and decreased desaturation degree in patients receiving oxygen during exercise, with high oxygen concentrations in inspiratory air (FiO 2 > 0.50) [338]. In another randomised, cross-over, two-week, prospective trial comparing the effects of two-week oxygen therapy using a portable oxygen source with a period without oxygen therapy in IPF patients with latent hypoxaemic respiratory failure, oxygen therapy was found to have a beneficial effect on the quality of life [339]. Oxygen therapy using a portable oxygen source does not reduce exercise-induced increase in pulmonary artery pressure [340].…”

Section: Question 23 Should Oxygen Be Used During Exercise In Ipf Pamentioning

confidence: 99%

“…It should, however, be recommended to LTOT patients who are still involved in outdoor activities as well as patients participating in pulmonary rehabilitation programmes if improved physical capacity has been demonstrated as a result of using a portable oxygen source [341]. The AmbOx trial results suggest that, compared with lack of oxygen therapy, the use of oxygen from portable sources during exercise decreases desaturation and dyspnoea during exercise and also improves the quality of life in patients with ILDs, without resting hypoxaemia [339]. When recommending the use of oxygen from portable sources, one should remember the costs and physical strain associated with carrying or pulling an oxygen-delivering device as well as the need for frequent refilling [342].…”

Section: Commentarymentioning

confidence: 99%

Guidelines of the Polish Respiratory Society for Diagnosis and Treatment of Idiopathic Pulmonary Fibrosis

Piotrowski

Bestry²,

Białas

et al. 2020

Advances in Respiratory Medicine

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“…The only published randomised prospective trial in patients with ILD, evaluating longer-term effects of AOT, delivered via compressed oxygen cylinders, is the Ambulatory Oxygen in Fibrotic Lung Disease (AmbOx) trial [69]. The AmbOx trial was a multicentre randomised controlled crossover trial in the UK comparing the effects of AOT with no AOT during activities in patients with fibrotic ILD and isolated exertional desaturation.…”

Section: Ambulatory Oxygen Therapy In Copd and Ildmentioning

confidence: 99%

Oxygen therapy in COPD and interstitial lung disease: navigating the knowns and unknowns

et al. 2019

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Domiciliary oxygen therapy is often prescribed for patients with hypoxaemia due to advanced lung disease, most commonly chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). Long-term oxygen therapy (LTOT) trials conducted in patients with COPD in the 1980s remain the basis for clinical decisions and guideline recommendations regarding LTOT for patients with non-COPD conditions as there is a lack of high-quality evidence concerning its use in the non-COPD population. There is also a lack of evidence for the use of ambulatory and nocturnal oxygen therapy in patients with isolated exertional and nocturnal hypoxaemia. These deficiencies pose significant challenges in patient care, with consequent discrepancies in guideline recommendations and clinical approaches. In recent years, new studies have been and are currently being conducted to fill the gaps in our understanding and use of domiciliary oxygen therapy for other indications, including ILD. This article provides a comparison of the epidemiology and significance of hypoxaemia in patients with COPD and ILD, with an up-to-date review of current evidence regarding the role of different types of domiciliary oxygen therapy in these conditions.

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Effect of ambulatory oxygen on quality of life for patients with fibrotic lung disease (AmbOx): a prospective, open-label, mixed-method, crossover randomised controlled trial

Abstract: UK National Institute for Health Research.

Cited by 171 publications

References 41 publications

Responsiveness and minimal clinically important difference of SGRQ-I and K-BILD in idiopathic pulmonary fibrosis

Responsiveness and minimal clinically important difference of SGRQ-I and K-BILD in idiopathic pulmonary fibrosis

Guidelines of the Polish Respiratory Society for Diagnosis and Treatment of Idiopathic Pulmonary Fibrosis

Oxygen therapy in COPD and interstitial lung disease: navigating the knowns and unknowns

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