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BackgroundCurrent guidelines recommend that patients with obesity hypoventilation syndrome (OHS) are electively admitted for inpatient initiation of home non-invasive ventilation (NIV). We hypothesised that outpatient NIV setup would be more cost-effective.MethodsPatients with stable OHS referred to six participating European centres for home NIV setup were recruited to an open-labelled clinical trial. Patients were randomised via web-based system using stratification to inpatient setup, with standard fixed level NIV and titrated during an attended overnight respiratory study or outpatient setup using an autotitrating NIV device and a set protocol, including home oximetry. The primary outcome was cost-effectiveness at 3 months with daytime carbon dioxide (PaCO2) as a non-inferiority safety outcome; non-inferiority margin 0.5 kPa. Data were analysed on an intention-to-treat basis. Health-related quality of life (HRQL) was measured using EQ-5D-5L (5 level EQ-5D tool) and costs were converted using purchasing power parities to £(GBP).ResultsBetween May 2015 and March 2018, 82 patients were randomised. Age 59±14 years, body mass index 47±10 kg/m2and PaCO26.8±0.6 kPa. Safety analysis demonstrated no difference in ∆PaCO2(difference −0.27 kPa, 95% CI −0.70 to 0.17 kPa). Efficacy analysis showed similar total per-patient costs (inpatient £2962±£580, outpatient £3169±£525; difference £188.20, 95% CI −£61.61 to £438.01) and similar improvement in HRQL (EQ-5D-5L difference −0.006, 95% CI −0.05 to 0.04). There were no differences in secondary outcomes.DiscussionThere was no difference in medium-term cost-effectiveness, with similar clinical effectiveness, between outpatient and inpatient NIV setup. The home NIV setup strategy can be led by local resource demand and patient and clinician preference.Trial registration numbersNCT02342899andISRCTN51420481.

IntroductionAlthough home non-invasive ventilation (NIV) is increasingly used to manage patients with chronic ventilatory failure, there are limited data on the long-term outcome of these patients. Our aim was to report on home NIV populations and the long-term outcome from two European centres.MethodsCohort analysis including all patients established on home NIV from two European centres between 2008 and 2014.ResultsHome NIV was initiated in 1746 patients to treat chronic ventilatory failure caused by (1) obesity hypoventilation syndrome±obstructive sleep apnoea (OHS±OSA) (29.5%); (2) neuromuscular disease (NMD) (22.7%); and (3) obstructive airway diseases (OAD) (19.1%). Overall cohort median survival following NIV initiation was 6.6 years. Median survival varied by underlying aetiology of respiratory failure: rapidly progressive NMD 1.1 years, OAD 2.7 years, OHS±OSA >7 years and slowly progressive NMD >7 years. Multivariate analysis demonstrated higher mortality in patients with rapidly progressive NMD (HR 4.78, 95% CI 3.38 to 6.75), COPD (HR 2.25, 95% CI 1.64 to 3.10), age >60 years at initiation of home NIV (HR 2.41, 95% CI 1.92 to 3.02) and NIV initiation following an acute admission (HR 1.38, 95% CI 1.13 to 1.68). Factors associated with lower mortality were NIV adherence >4 hours per day (HR 0.64, 95% CI 0.51 to 0.79), OSA (HR 0.51, 95% CI 0.31 to 0.84) and female gender (HR 0.79, 95% CI 0.65 to 0.96).ConclusionThe mortality rate following initiation of home NIV is high but varies significantly according to underlying aetiology of respiratory failure. In patients with chronic respiratory failure, initiation of home NIV following an acute admission and low levels of NIV adherence are poor prognostic features and may be amenable to intervention.

In the year since its discovery, the novel virus SARS-CoV-2 has spread across the world and ignited, in a short pace of time, an entire area of research into its origins, symptoms and outcomes of the resultant disease (COVID-19), possible treatments and contributing risk factors. The speed at which this field has grown has enabled us to more proactively treat individuals with COVID-19 and has brought us to the precipice of mass vaccination against this virus. But, despite being a new field of study led by 21st century scientists, research into COVID-19 has fallen into the same pitfall present in older, more established areas of research—namely, the unconscious biases associated with ethnicity. In the spring of 2020, the first evidence from the UK was published showing that COVID-19 has a greater impact on black and minority ethnic (BME) populations than white population. Amid calls for further investigation, more and more studies have included ethnicity as a possible predictor for COVID-related outcomes.1 While these studies have demonstrated the greater impact of COVID-19 on these communities, they have re-established, again, the innate biases present within both human society and scientific research. The inclusion of ethnicity as a predictive factor for COVID-19 infection or mortality contains the flawed logic that people of different ethnicities are biological distinct,2 with different genetic factors that may predispose or protect them from a disease such as COVID-19. This concept is not a new one, originating first in 1795 with the description of five different races by Johann Friedrich Blumenbach. Even in this first instant, the described races were not described as genetically distinct but equal …

Long-term ventilation has been a successful part of the management of chronic respiratory failure since the use of the iron lungs was introduced during the polio epidemics in the 1930s and 1940s. The transition from hospital-based therapy to genuine home ventilation was pioneered by a number of physicians and patients including Robert Cavendish whose story was dramatised in the recent biopic ‘Breathe’. Robert Cavendish used his financial backing and engineering contacts to develop the first wheelchair mounted ventilator marking a watershed in the management of ventilator-dependent patients; empowering patients with chronic respiratory failure to live independent of a healthcare environment. Improvements in technology, for example, positive pressure ventilation, have facilitated the move from hospital to community support for complex respiratory patients; however, this comes at a cost to the patient, caregivers and the health system. The cost to the health system is rising as the number of patients’ requiring home mechanical ventilation (HMV) increases1 in line with growing data to demonstrate its effectiveness in chronic respiratory failure secondary to different …

BackgroundRespiratory management of obesity hypoventilation syndrome (OHS) focusses on the control of sleep-disordered breathing rather than the treatment of obesity. Currently, there are no data from randomised trials of weight loss targeted rehabilitation programmes for patients with OHS.InterventionA 3-month multimodal hybrid inpatient–outpatient motivation, exercise and nutrition rehabilitation programme, in addition to non invasive ventilation (NIV), would result in greater per cent weight loss compared with standard care.MethodsA single-centre pilot randomised controlled trial allocated patients to either standard care or standard care plus rehabilitation. Primary outcome was per cent weight loss at 12 months with secondary exploratory outcomes of weight loss, exercise capacity and health-related quality of life (HRQOL) at the end of the rehabilitation programme to assess the intervention effect.ResultsThirty-seven patients (11 male, 59.8±12.7 years) with a body mass index of 51.1±7.7 kg/m2 were randomised. At 12 months, there was no between-group difference in per cent weight loss (mean difference −5.9% (95% CI −14.4% to 2.7%; p=0.17)). At 3 months, there was a greater per cent weight loss (mean difference −5% (95% CI −8.3% to −1.4%; p=0.007)), increased exercise capacity (6 min walk test 60 m (95% CI 29.5 to 214.5) vs 20 m (95% CI 11.5 to 81.3); p=0.036) and HRQL (mean difference SF-36 general health score (10 (95% CI 5 to 21.3) vs 0 (95% CI −5 to 10); p=0.02)) in the rehabilitation group.ConclusionIn patients with OHS, a 3-month comprehensive rehabilitation programme, in addition to NIV, resulted in improved weight loss, exercise capacity and QOL at the end of the rehabilitation period, but these effects were not demonstrated at 12 months, in part, due to the limited retention of patients at 12 months.Trial registration numberPre-results; NCT01483716.

RATIONALE: Hospitalised patients with acute exacerbation of COPD may deteriorate despite treatment, with early readmission being common.OBJECTIVES: To investigate whether neural respiratory drive, measured using second intercostal space parasternal muscle electromyography (EMGpara), would identify worsening dyspnoea and physician-defined inpatient clinical deterioration, and predict early readmission.METHODS: Patients admitted to a single-site university hospital with exacerbation of COPD were enrolled. Spirometry, inspiratory capacity (IC), EMGpara, routine physiological parameters, modified early warning score (MEWS), modified Borg scale for dyspnoea and physician-defined episodes of deterioration were recorded daily until discharge. Readmissions at 14 and 28 days post discharge were recorded.MEASUREMENTS AND MAIN RESULTS: 120 patients were recruited (age 70±9 years, forced expiratory volume in 1 s (FEV1) of 30.5±11.2%). Worsening dyspnoea, defined as at least one-point increase in Borg scale, was associated with increases in EMGpara%max and MEWS, whereas an increase in EMGpara%max alone was associated with physician-defined inpatient clinical deterioration. Admission-to-discharge change (Δ) in the normalised value of EMGpara (ΔEMGpara%max) was inversely correlated with ΔFEV1 (r=-0.38, pCONCLUSIONS: Measurement of neural respiratory drive by EMGpara represents a novel physiological biomarker that may be helpful in detecting inpatient clinical deterioration and identifying the risk of early readmission among patients with exacerbations of COPD.TRIAL REGISTRATION: NCT01361451.

Introduction Patient-ventilator asynchrony (PVA) can adversely affect the successful initiation of non-invasive home mechanical ventilation (HMV). The aim of this observational study was to quantify the prevalence of PVA during initiation of HMV and to determine the relationship between PVA and nocturnal gas exchange. Method Type and frequency of PVA were measured by surface parasternal intercostal muscle electromyography, thoracoabdominal plethysmography and mask pressure during initiation of HMV. Severe PVA was defined, as previously, as asynchrony affecting ≥10% of breaths. Results 28 patients (18 male) were enrolled aged 61±15 years and with a body mass index of 35±9 kg/m 2 . Underlying diagnoses were neuromuscular disease with or without chest wall disease (n=6), obesity related chronic respiratory failure (n=12) and COPD (n=10). PVA was observed in all patients with 79% of patients demonstrating severe PVA. Triggering asynchrony was most frequent, observed in 24% (IQR: 11–36%) of breaths, with ineffective efforts accounting for 16% (IQR: 4–24%). PVA types were similar between disease groups, with the exception of auto-triggering, which was higher in patients with COPD (12% (IQR: 6–26%)). There was no correlation observed between PVA and time spent with oxygen saturations ≤90%, mean oxygen saturations or transcutaneous carbon dioxide levels during overnight ventilation. Conclusions Severe PVA was identified in the majority of patients, irrespective of pathophysiological disease state. This was not associated with ineffective ventilation as evidenced by gas exchange.

Introduction Transcutaneous electrical stimulation (TES) provides neuromuscular tone to the pharyngeal dilator muscles of the upper airway (UA) while asleep, but feasibility of this method to treat obstructive sleep apnoea (OSA) throughout the whole night has not been tested. Patients and methods We conducted a phase two double-blind, sham-controlled, randomised controlled trial using TES of the UA muscles in 36 patients with confirmed OSA to assess patients’ device acceptance and the side effect profile. Patients were studied using polysomnography during randomly assigned nights of sham-stimulation and active treatment following titration of the current while awake. Assessment of patients’ device acceptance and experience of side effects was measured using a visual analogue scale (0–10 points) where high scores indicated better outcomes. Results We included 36 patients (age mean 50.8 (SD 11.2) years, male/female 30/6, body mass index median 29.6 (IQR 26.9–34.9) kg/m2, Epworth Sleepiness Scale 10.5 (4.6) points, oxygen desaturation index median 25.7 (16.0–49.1)/hour, apnoea-hypopnoea index median 28.1 (19.0–57.0)/hour). None of the patients reported skin discomfort, unpleasant tongue sensations or morning headache. There was no difference in patients’ perceived sleep quality. There was a 59% reduction in mouth dryness after active treatment compared to sham-stimulation. There were no severe adverse events (Table). Conclusion TES of the UA dilator muscles in OSA can be delivered throughout the night with few side effects and does not lead to arousal from sleep, if appropriately titrated.

Introduction Refractory chronic cough has a significant negative impact on HRQoL. There are currently limited effective antitussive therapies. Few studies have explored the effectiveness of nonpharmacological interventions for refractory chronic cough. This study investigated the efficacy of PSALTI on HRQoL for people with refractory chronic cough in a multi-centred RCT. Methods Participants were recruited across five NHS hospitals trusts. 76 participants were randomised to PSALTI or placebo (equal attention) intervention. PSALTI consisted of education, laryngeal hygiene and hydration advice, cough control techniques and psycho-educational counselling. Placebo consisted of general education on exercise, diet, stress and relaxation. Both groups attended 4 weekly sessions of 1:1 therapy. HRQoL was measured at baseline, four weeks (end of treatment) and 3 month follow up by Leicester cough questionnaire (LCQ). Cough reflex sensitivity was assessed at baseline and four weeks by capsaicin cough challenge (C2, C5, concentration that caused first urge to cough (Cu)) and was analysed by geometric means (GM). Outcomes between groups were analysed using ANCOVA. Results The PSALTI (n = 35) and Placebo groups (n = 41) were well matched (p > 0.05) for age [mean (SD)] 58(15) vs. 56(11) years; gender 71% vs 63% females; cough duration [median (IQR)] 60(30 to 126) vs 48(24 to 126) months and baseline LCQ [mean (SD)] 10.4(3.6) vs 11.9(3.5). At four weeks HRQoL improved in both groups, mean LCQ increase in PSALTI was 3.4 (95% CI 2.26 to 4.55) vs placebo 1.7 (95% CI 0.78 to 2.54); difference in LCQ change between groups was 1.5 (95% CI 0.27 to 7.31, p = 0.02) points more on average in the PSALTI group. This effect is greater than the MCID for LCQ and was sustained at 3 months (mean difference change between groups after 4 weeks to 3 months was -0.28 (95% CI -1.83 to 1.38). There was a significant increase in Cu in the PSALTI group compared to placebo (GM(SD) change 2 µm (5.07) vs 0.612 µm (3.26), p = 0.02). There was no significant difference in cough reflex sensitivity between the groups (C2, p = 0.46; C5, p = 0.74). Conclusions PSALTI significantly improved HRQoL compared with equal attention placebo intervention and this improvement was sustained at three months. PSALTI also significantly increased Cu compared to placebo.

Introduction The pictorial Epworth Sleepiness Scale (ESS) (Ghiassi et al., Thorax 2011) has been developed and validated against the traditional ESS and allows subjects to intuitively answer the questions related to daytime sleepiness with pictorial items. Although non-specific, the ESS has been validated for sleep apnoea patients and it is widely used for screening patients. We hypothesised that the use of an online pictorial ESS can promote public awareness and help to screen for patients with undiagnosed sleep disorders. Methods Between 2011 and 2012, we collected the pictorial ESS data of 24,272 subjects on the official webpage of the British Lung Foundation. Following a short explanation to the questionnaire, eight items are marked and given a score from `0` (not likely todoze) to `3` (very likely to doze) using pictorial items, the range of the total score for the pictorial ESS being `0` to `24`. The cut-off for excessive daytime sleepiness (EDS, more than 10 points) was chosen in line with the traditional ESS. In 3,265 questionnaires the subjects’ age and gender were also recorded (starting from 03/2012). Chi-square test was used to compare the proportion of different groups. Results The total 24,272 subjects scored a mean of 9.3 (5.1) points on the pictorial ESS. Of those, 38.0% were excessively sleepy (14.6 (3.2) points) and 62.0% had normal levels of sleepiness (5.9 (2.7) points, p Conclusion The online pictorial ESS identifies gender differences in EDS on a large scale and reveals more severe levels of sleepiness associated with higher age. The use of modern media facilitates reaching out to the general population to raise awareness of conditions associated with daytime sleepiness such as sleep apnoea.

Introduction Pulmonary rehabilitation (PR) is a proven effective treatment, however benefits tend to decline between 6 and 12 months post rehabilitation. Randomised controlled trials of maintenance programmes show little effect of supervised maintenance after PR However, a short intense bout of physical training, provided post rehabilitation may be sufficient to restore exercise tolerance. This study tests the hypothesis that a Physical Activity Top up programme (PAT on the back) will result in improvements in exercise tolerance as compared with no top up. Methods 31 patients with stable COPD, who had undertaken Pulmonary rehabilitation (PR) at least 6 months previously were randomised to 4 weeks of PAT exercise once weekly or usual care. Incremental Shuttle Walk Test (ISWT) data were collected pre PAT (T1), post PAT (T2) and 3 months end of PAT programme (T3). QoL (SGRQ) and breathlessness (LCADL) were measured at the same time points. Generalised estimating equation (GEE) regression models and univariate analysis of variance were used to analyse data where subjects performed all assessments and ISWT results from end PR was used as covariate, with ISWT as dependant variable. Results 23 subjects completed all assessments. The intervention group increases 0.9 m for every 1 m increase achieved at T1, p=0.027. The intervention group shows an overall improvement of 47.3 m, with an average increase of 17.26 m per time point. A significant time effect (p = 0.02) mean difference (SD) T1–T3 in control group showed the intervention group were 79.6 m improved with CI 15 to 143.8. There was no group or time effect for QoL or LCADL (Abstract P46 Figure 1). Conclusion A brief 4 week intervention ‘PAT on the back’ did little to change QoL or breathlessness but was effective in maintaining exercise tolerance over a 3 month period compared to usual care in which walking distance significantly deteriorated.