Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD

Clinical manifestations of chronic obstructive pulmonary disease (COPD), including airflow limitation, dyspnea, and activity limitation, ultimately lead to impaired health-related quality of life (HRQoL). This 9-month, randomized, double-blind, multicenter study compared the effect of once-daily tiotropium 18 μg and placebo on HRQoL, spirometric parameters, and exacerbations in 554 patients with moderate-to-severe COPD. HRQoL was assessed using the St. George’s Respiratory Questionnaire (SGRQ) and the new 8-item Visual Simplified Respiratory Questionnaire (VSRQ), which is currently being validated. The primary efficacy endpoint was the proportion of patients achieving a reduction of at least 4 units in the SGRQ total score at study end (Month 9). Mean ± SD baseline SGRQ total score was 47.4 ± 18.1. Significantly more tiotropium-treated patients achieved a reduction of at least 4 units in the SGRQ score vs placebo at study end (59.1% vs 48.2%, respectively; p = 0.029). Tiotropium significantly improved spirometric parameters (forced expiratory volume in 1 second [FEV1]: 0.11 ± 0.02 L vs 0.01 ± 0.02 L; between-group difference: 0.10 ± 0.03 L, p = 0.0001) and reduced exacerbations vs placebo. Maintenance treatment with tiotropium provided significant and clinically relevant improvements in HRQoL, as measured by the SGRQ

Early intensive physical rehabilitation combined with a protocolized decannulation process in tracheostomized survivors from severe COVID-19 pneumonia with chronic critical illness

(1) Background: Intensive care unit (ICU) survivors from severe COVID-19 acute respiratory distress syndrome (CARDS) with chronic critical illness (CCI) may be considered vast resource consumers with a poor prognosis. We hypothesized that a holistic approach combining an early intensive rehabilitation with a protocol of difficult weaning would improve patient outcomes (2) Methods: A single-center retrospective study in a five-bed post-ICU weaning and intensive rehabilitation center with a dedicated fitness room specifically equipped to safely deliver physical activity sessions in frail patients with CCI. (3) Results: Among 502 CARDS patients admitted to the ICU from March 2020 to March 2022, 50 consecutive tracheostomized patients were included in the program. After a median of 39 ICU days, 25 days of rehabilitation were needed to restore patients’ autonomy (ADL, from 0 to 6; p < 0.001), to significantly improve their aerobic capacity (6-min walking test distance, from 0 to 253 m; p < 0.001) and to reduce patients’ vulnerability (frailty score, from 7 to 3; p < 0.001) and hospital anxiety and depression scale (HADS, from 18 to 10; p < 0.001). Forty-eight decannulated patients (96%) were discharged home. (4) Conclusions: A protocolized weaning strategy combined with early intensive rehabilitation in a dedicated specialized center boosted the physical and mental recovery

Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in healthy people aged 60 years or older: a randomized Phase III trial

A quadrivalent high-dose inactivated influenza vaccine (IIV4-HD) is licensed for adults 6565&nbsp;y of age based on immunogenicity and efficacy studies. However, IIV4-HD has not been evaluated in adults aged 60\u201364&nbsp;y. This study compared immunogenicity and safety of IIV4-HD with a standard-dose quadrivalent influenza vaccine (IIV4-SD) in adults aged 6560&nbsp;y. This Phase III, randomized, modified double-blind, active-controlled study enrolled 1,528 participants aged 6560&nbsp;y, randomized 1:1 to a single injection of IIV4-HD or IIV4-SD. Hemagglutination inhibition (HAI) geometric mean titers (GMTs) were measured at baseline and D 28 and seroconversion assessed. Safety was described for 180&nbsp;d after vaccination. The primary immunogenicity objective was superiority of IIV4-HD versus IIV4-SD, for all four influenza strains 28&nbsp;d post vaccination in participants aged 60\u201364 and 6565&nbsp;y. IIV4-HD induced a superior immune response versus IIV4-SD in terms of GMTs in participants aged 60\u201364 y and those aged 6565&nbsp;y for all four influenza strains. IIV4-HD induced higher GMTs in those aged 60\u201364 y than those aged 6565 y. Seroconversion rates were higher for IIV4-HD versus IIV4-SD in each age-group for all influenza strains. Both vaccines were well tolerated in participants 6560&nbsp;y of age, with no safety concerns identified. More solicited reactions were reported with IIV4-HD than with IIV4-SD. IIV4-HD provided superior immunogenicity versus IIV4-SD and was well tolerated in adults aged 6560 y. IIV4-HD is assumed to offer improved protection against influenza compared with IIV4-SD in adults aged 6560 y, as was previously assessed for adults aged 6565&nbsp;y

A multi-metric approach to investigate the effects of weather conditions on the demographic of a terrestrial mammal, the European badger (Meles meles)

Models capturing the full effects of weather conditions on animal populations are scarce. Here we decompose yearly temperature and rainfall into mean trends, yearly amplitude of change and residual variation, using daily records. We establish from multi-model inference procedures, based on 1125 life histories (from 1987 to 2008), that European badger (Meles meles) annual mortality and recruitment rates respond to changes in mean trends and to variability in proximate weather components. Variation in mean rainfall was by far the most influential predictor in our analysis. Juvenile survival and recruitment rates were highest at intermediate levels of mean rainfall, whereas low adult survival rates were associated with only the driest, and not the wettest, years. Both juvenile and adult survival rates also exhibited a range of tolerance for residual standard deviation around daily predicted temperature values, beyond which survival rates declined. Life-history parameters, annual routines and adaptive behavioural responses, which define the badgers’ climatic niche, thus appear to be predicated upon a bounded range of climatic conditions, which support optimal survival and recruitment dynamics. That variability in weather conditions is influential, in combination with mean climatic trends, on the vital rates of a generalist, wide ranging and K-selected medium-sized carnivore, has major implications for evolutionary ecology and conservation

Physiological Arousal and Emotion Regulation Strategies in Young Children with Autism Spectrum Disorders

Development Psychopathology in context: clinical setting

Trace metal distribution in the bed, bank and suspended sediment of the Ravensbourne River and its implication for sediment monitoring in an urban river

Purpose This study aims to identify a suitable sediment compartment for sediment quality monitoring by: (a) studying the concentration of trace metals (Cd, Cu, Ni, Pb and Zn) in the bed, bank and suspended sediment compartments of the Ravensbourne River to establish any differences in trace metal concentrations with compartment; (b) determining the influence of sediment particle size fractions ( 0.05) in the concentrations of metals between the suspended sediment and the < 63 μm bed sediment fraction, but there was a significant difference (p < 0.05) between the suspended sediment and the < 63 μm bank sediment fraction. There were also significant differences between the concentrations of metals in the < 63 μm and the 63 μm–2 mm fractions. Generally, the Ravensbourne River did not comply with the draft UK sediment quality guidelines for the metals analysed. Conclusions This study shows the importance of identifying a suitable sediment compartment to sample for compliance with sediment quality standards. The bed and suspended sediments are the most widely used sediment compartments for sediment monitoring, but collecting sufficient mass of the < 63 μm sediment fraction for monitoring presents a challenge for urban gravel bed rivers like the Ravensbourne River. It seems appropriate to establish individual monitoring regimes for different rivers