Cost-effectiveness of outpatient versus inpatient non-invasive ventilation setup in obesity hypoventilation syndrome: the OPIP trial.

BACKGROUND: Current 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. METHODS: Patients 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). RESULTS: Between May 2015 and March 2018, 82 patients were randomised. Age 59±14 years, body mass index 47±10 kg/m2 and PaCO2 6.8±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. DISCUSSION: There 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 NUMBERS: NCT02342899 and ISRCTN51420481.

Longitudinal Timed Up and Go Assessment in Amyotrophic Lateral Sclerosis: A Pilot Study.

Progressive loss of walking ability in amyotrophic lateral sclerosis (ALS) has been scarcely studied as a potential predictive factor for survival in motor neuron disease. We aimed to assess the progression of gait decline and its association with mortality in ALS using the Timed Up and Go test (TUG). Patients were followed up prospectively at the Centre for ALS and Related Disorders in Geneva University Hospitals between 2012 and 2016. The TUG was performed at baseline and subsequent evaluations occurred every 3 months. At inclusion, patients were classified as unable to perform the TUG, "slow TUG" (>10.6 s), and "fast TUG" (≤10.6 s). In total, 68 patients with ALS (mean ± SD age: 68.6 ± 11.9 years; 50% female) were included. Baseline TUG was negatively correlated with the total ALSFRS-R score (r = -0.63, p < 0.001). At baseline, ALS patients with bulbar onset performed the TUG faster (9.9 ± 3.7 s) than the non-bulbar ones (17.3 ± 14.9 s, p = 0.008). Thirty of 68 (44%) patients died by the end of the follow-up period. The TUG performance at the first visit did not predict mortality. While we did not find any association with mortality in ALS and gait quantification, the TUG was feasible in a majority of ALS patients, was correlated with functional status, and could be of interest in the follow-up of non-bulbar ALS patients.

Impact of Confinement in Patients under Long-Term Noninvasive Ventilation during the First Wave of the SARS-CoV-2 Pandemic: A Remarkable Resilience.

BACKGROUND: During the first wave of the SARS-CoV-2 pandemic in Switzerland, confinement was imposed to limit transmission and protect vulnerable persons. These measures may have had a negative impact on perceived quality of care and symptoms in patients with chronic disorders. OBJECTIVES: To determine whether patients under long-term home noninvasive ventilation (LTHNIV) for chronic respiratory failure (CRF) were negatively affected by the 56-day confinement (March-April 2020). METHODS: A questionnaire-based survey exploring mood disturbances (HAD), symptom scores related to NIV (S3-NIV), and perception of health-care providers during confinement was sent to all patients under LTHNIV followed up by our center. Symptom scores and data obtained by ventilator software were compared between confinement and the 56 days prior to confinement. RESULTS: Of a total of 100 eligible patients, 66 were included (median age: 66 years [IQR: 53-74]): 35 (53%) with restrictive lung disorders, 20 (30%) with OHS or SRBD, and 11 (17%) with COPD or overlap syndrome. Prevalence of anxiety (n = 7; 11%) and depressive (n = 2; 3%) disorders was remarkably low. Symptom scores were slightly higher during confinement although this difference was not clinically relevant. Technical data regarding ventilation, including compliance, did not change. Patients complained of isolation and lack of social contact. They felt supported by their relatives and caregivers but complained of the lack of regular contact and information by health-care professionals. CONCLUSIONS: Patients under LTHNIV for CRF showed a remarkable resilience during the SARS-CoV-2 confinement period. Comments provided may be helpful for managing similar future health-care crises.

Disadvantaged Early-Life Socioeconomic Circumstances Are Associated With Low Respiratory Function in Older Age.

BACKGROUND: Poor lung function in late life may stem from early-life risk factors, but the epidemiological evidence is inconsistent. We investigated whether individuals who experienced disadvantageous socioeconomic circumstances (SEC) in early life showed lower levels of respiratory function in older age, a steeper decline over time, and whether these relationships were explained by adult-life SEC, body mass index, and physical inactivity in older age. METHODS: We used data from the Survey of Health Ageing and Retirement in Europe (2004-2015). Participants' peak expiratory flow (PEF) was assessed with a mini-Wright peak flow meter at second, fourth, and sixth waves. Confounder-adjusted linear mixed-effect models were used to examine the associations between early-life SEC and PEF in older age. A total of 21,734 adults aged 50-96 years (46,264 observations) were included in the analyses. RESULTS: Older adults with disadvantaged early-life SEC showed lower levels of PEF compared with those with advantaged early-life SEC. The association between early-life SEC and late-life PEF persisted after adjusting for adult-life SEC, smoking, physical inactivity, and body mass index. PEF declined with age, but the effect of early-life SEC on this decline was not consistent across robustness and sensitivity analyses. CONCLUSIONS: Early life is a sensitive period for respiratory health. Further considering the effect of SEC arising during this period may improve the prevention of chronic respiratory diseases.

Development and validation of a simple tool for the assessment of home noninvasive ventilation: the S3-NIV questionnaire.

Patient-centred outcomes are significantly modified by long-term home noninvasive ventilation (NIV), but a short, self-administered, specific tool for routine clinical assessment is lacking. The aim of this study was to develop and validate the S3-NIV questionnaire, a short questionnaire to measure respiratory symptoms, sleep quality and NIV-related side effects.Patients with stable disease who were under long-term home NIV were recruited from three outpatient NIV services. Questionnaire development consisted of a selection of core items for analysis, followed by item reduction, validation and test-retest reliability.338 patients completed a 22-item questionnaire. 11 items were removed because of non-scalability (n=2), redundancy (n=8) and lack of fit (n=1). The final version of the S3-NIV questionnaire consisted of 11 items covering two dimensions: "respiratory symptoms" (Cronbach's α=0.84) and "sleep & NIV-related side effects" (Cronbach's α=0.77). Convergent validity was high between the "respiratory symptoms" subscale of the S3-NIV questionnaire and the St George's Respiratory Questionnaire (rho= -0.76, p<0.001), and between the "sleep & NIV-related side effects" subscale and the Quebec Sleep Questionnaire (rho=0.51, p<0.001). The S3-NIV questionnaire had good test--retest reliability after 4 weeks (intraclass correlation coefficient=0.72).The S3-NIV questionnaire is a short, valid and repeatable self-completed tool for the routine clinical assessment of patients undergoing home NIV.

Reliability of Apnea-Hypopnea Index Measured by a Home Bi-Level Pressure Support Ventilator Versus a Polysomnographic Assessment.

BACKGROUND: Ventilators designed for home care provide clinicians with built-in software that records items such as compliance, leaks, average tidal volume, total ventilation, and indices of residual apnea and hypopnea. Recent studies have showed, however, an important variability between devices regarding reliability of data provided. In this study, we aimed to compare apnea-hypopnea indices (AHI) provided by home ventilators (AHINIV) versus data scored manually during polysomnography (AHIPSG) in subjects on noninvasive ventilation (NIV) for obesity-hypoventilation syndrome. METHODS: Stable subjects with obesity-hypoventilation syndrome on NIV, all using the same device, underwent 3 consecutive polysomnographic sleep studies with different backup breathing frequencies (spontaneous mode, low and high backup breathing frequencies). During each recording, AHINIV was compared with AHIPSG. RESULTS: Ten subjects (30 polysomnogram tracings) were analyzed. For each backup breathing frequency (spontaneous mode, low and high backup breathing frequencies), AHI values were 62 ± 7/h, 26 ± 7/h, and 17 ± 5/h (mean ± SD), respectively. Correlation between AHINIV and AHIPSG was highly significant (r(2) = 0.89, P < .001). As determined by Bland-Altman analysis, mean bias was 6.5 events/h, and limits of agreement were +26.0 and -12.9 events/h. Bias increased significantly with higher AHI values. Using a threshold AHI value of 10/h to define appropriate control of respiratory events, the ventilator software had a sensitivity of 90.9%, a specificity and positive predictive value of 100%, and a negative predictive value of 71%. CONCLUSIONS: In stable subjects with obesity-hypoventilation syndrome, the home ventilator software tested was appropriate for determining if control of respiratory events was satisfactory on NIV or if further testing or adjustment of ventilator settings was required. (ClinicalTrials.gov registration NCT01130090.).

Risk assessment of tuberculosis in immunocompromised patients. A TBNET study.

RATIONALE: In the absence of active tuberculosis, a positive tuberculin skin test (TST) or interferon-γ release assay (IGRA) result defines latent infection with Mycobacterium tuberculosis, although test results may vary depending on immunodeficiency. OBJECTIVES: This study compared the performance of TST and IGRAs in five different groups of immunocompromised patients, and evaluated their ability to identify those at risk for development of tuberculosis. METHODS: Immunocompromised patients with HIV infection, chronic renal failure, rheumatoid arthritis, solid-organ or stem-cell transplantation, and healthy control subjects were evaluated head-to-head by the TST, QuantiFERON-TB-Gold in-tube test (ELISA), and T-SPOT.TB test (enzyme-linked immunospot) at 17 centers in 11 European countries. Development of tuberculosis was assessed during follow-up. MEASUREMENTS AND MAIN RESULTS: Frequencies of positive test results varied from 8.7 to 15.9% in HIV infection (n = 768), 25.3 to 30.6% in chronic renal failure (n = 270), 25.0% to 37.2% in rheumatoid arthritis (n = 199), 9.0 to 20.0% in solid-organ transplant recipients (n = 197), 0% to 5.8% in stem-cell transplant recipients (n = 103), and 11.2 to 15.2% in immunocompetent control subjects (n = 211). Eleven patients (10 with HIV infection and one solid-organ transplant recipient) developed tuberculosis during a median follow-up of 1.8 (interquartile range, 0.2-3.0) years. Six of the 11 patients had a negative or indeterminate test result in all three tests at the time of screening. Tuberculosis incidence was generally low, but higher in HIV-infected individuals with a positive TST (3.25 cases per 100 person-years) than with a positive ELISA (1.31 cases per 100 person-years) or enzyme-linked immunospot result (1.78 cases per 100 person-years). No cases of tuberculosis occurred in patients who received preventive chemotherapy. CONCLUSIONS: Among immunocompromised patients evaluated in this study, progression toward tuberculosis was highest in HIV-infected individuals and was poorly predicted by TST or IGRAs. Clinical trial registered with www.clinicaltrials.gov (NCT 00707317).

[Latent M. tuberculosis infection, update 2011]. / Infection latente a M. tuberculosis, mise a jour 2011.

It is estimated that one third of the world population is latently infected by Mycobacterium tuberculosis and thus at risk of reactivation. Latent tuberculosis (TB) impact in Switzerland is often overlooked. Diagnosis and prophylaxis are insufficiently undertaken, especially for people at higher risk of reactivation due to immunosuppression. Interferon-gamma release assays replace tuberculosis skin tests for diagnosis of latent infection in adults. It is still recommended to treat prophylactically a case of latent TB infection with 9 months of isoniazid; however therapy with rifampicin for 4 months, currently an alternative option, is linked to improved adherence and favorable cost-benefit ratio.