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Craig LaForce,1 Frank C Albers,2 Mark Cooper,3 Anna Danilewicz,4 Lynn Dunsire,3 Robert Rees,4 Christy Cappelletti5 1North Carolina Clinical Research, Chapel Hill, NC, USA; 2Avillion, Northbrook, IL, USA; 3BioPharmaceuticals Research and Development, AstraZeneca, Cambridge, UK; 4Avillion, London, UK; 5BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC, USACorrespondence: Mark Cooper, BioPharmaceuticals Reseach and Development, AstraZeneca, Cambridge, UK, Email mark.cooper1@astrazeneca.comPurpose: Decentralized clinical trials, where trial-related activities occur at locations other than traditional clinical sites(eg participant homes, local healthcare facilities), have the potential to improve trial access for people for whom time and/or distance constraints may impede participation. Albuterol–budesonide 180/160 μg pressurized metered-dose inhaler (pMDI) is FDA approved for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years or older. BATURA (NCT05505734) is a fully decentralized study, investigating as-needed albuterol–budesonide in participants with mild asthma.Methods: BATURA is a fully decentralized, phase 3b, randomized, double-blind, event-driven exacerbation study conducted in the United States. Participants aged ≥ 12 years using as-needed short-acting β2-agonist (SABA), alone or with low-dose inhaled corticosteroid or leukotriene receptor antagonist maintenance, are randomized 1:1 to as-needed albuterol–budesonide 180/160 μg or albuterol 180 μg pMDI for up to 52 weeks (minimum 12 weeks). Participants continue their current maintenance therapy, if applicable. Participants must have used SABA for ≥ 2 days in the 2 weeks pre-enrollment and have an Asthma Impairment Risk Questionnaire score ≥ 2 at screening and randomization. All trial-related visits, including screening and consent, are conducted virtually, with study medication shipped directly to each participant’s residence. The primary objective is to evaluate the efficacy of as-needed albuterol–budesonide versus albuterol on severe asthma exacerbation risk, measured by time-to-first severe asthma exacerbation (primary endpoint). Secondary endpoints include annualized rate of severe asthma exacerbation and total systemic corticosteroid exposure. Study medication use is captured via a Hailie sensor attached to the study medication pMDI. The intended sample size is 2500 participants.Conclusion: BATURA evaluates as-needed albuterol–budesonide in participants with mild asthma. The decentralized study model enables the trial to move out of research sites into participant homes, reducing participant burden and improving access.Keywords: decentralized clinical trials, trial design, albuterol–budesonide, SABA–ICS

Simulations were used to investigate the performance of lifeboats in high sea states using a virtual wave tank. Numerical simulations were performed in regular and irregular waves to study launch performance in extreme weather conditions. Limitations in launch equipment and the role of the timing of coxswains' actions were investigated. The study indicated that the lifeboat may not be able to successfully launch when significant wave heights are above 8 m and the lifeboat is launched near the trough of a wave. High initial setback and continuous wave forces result in the vessel being unable to clear away from the launch platform. As wave heights increase, the amount of setback and time to exit the launch area increases. Over 35% of launches resulted in the lifeboat being unable to clear from the launch area when significant wave heights were 10 m or above. The study also identified that delay in completion of actions performed by the coxswain, such as releasing the lifeboat hooks and applying throttle, can increase setback and time to exit the launch area. [ABSTRACT FROM AUTHOR]

When identifying phonemes in new spoken words, lipreading is an important source of information for many deaf people. Because many groups of phonemes are virtually indistinguishable by sight, deaf people are able to identify about 30% of phonemes when lipreading non-words. Cued speech (CS) is a system of hand shapes and hand positions used alongside speech to disambiguate similarities in lip patterns. Deaf children exposed to CS from under 3 years of age go on to develop age-appropriate language and literacy skills. However, there are no studies evaluating the explicit training of CS with older deaf children. This study is the first part of a long-term project to develop and evaluate a computer-delivered programme to teach school-aged deaf children to recognize cued phonemes. Sixty-two adult hearing participants were allocated to a single training session in one of three training conditions: cued speech training (CST), lipreading training and auditory training in noise. They were all tested on their ability to identify 13 phonemes in non-words when denied access to sound. The CST group made highly significant improvements in identifying cued phonemes and these changes could not be explained by lipreading practice or familiarization with a closed set of phonemes. Improvements generalized to non-words that were not used in training. This suggests that explicit training in CS could help deaf children to identify cued phonemes in new words. Practical implications of introducing the teaching of CS to selected deaf children are discussed.

This paper describes how barriers to, and facilitators of, good mental health amongst young people (11-21 years) were elucidated from a systematic review of studies of young people's views and how these barriers and facilitators were compared with effectiveness studies to identify effective and appropriate interventions, promising interventions needing further evaluation and the need for further intervention. All studies were published before 2000. No clear pattern for effectiveness emerged in terms of mental health promotion focus, the type of intervention, intervention provider or young people. Well-evaluated interventions neither always target what we know young people themselves see as important barriers to their mental health (for instance, loss of friends and family, violence and bullying) nor always build on what they see as key facilitators, particularly their preferred coping strategies. In particular, while young people see material and physical resources as major influences on their mental health, few evaluated interventions targeted these. Rigorously evaluated interventions more often addressed priorities not raised by young people themselves and populations at low risk for mental health problems. These innovative review methods can inform intervention development and evaluation in a new way based on the strengths and needs identified by the target population. (Contains 2 tables and 5 figures.)

A systematic review was conducted to examine the barriers to, and facilitators of, healthy eating among young people (11-16 years). The review focused on the wider determinants of health, examining community- and society-level interventions. Seven outcome evaluations and eight studies of young people's views were included. The effectiveness of the interventions was mixed, with improvements in knowledge and increases in healthy eating but differences according to gender. Barriers to healthy eating included poor school meal provision and ease of access to, relative cheapness of and personal taste preferences for fast food. Facilitators included support from family, wider availability of healthy foods, desire to look after one's appearance and will-power. Friends and teachers were generally not a common source of information. Some of the barriers and facilitators identified by young people had been addressed by soundly evaluated effective interventions, but significant gaps were identified where no evaluated interventions appear to have been published (e.g. better labelling of food products), or where there were no methodologically sound evaluations. Rigorous evaluation is required particularly to assess the effectiveness of increasing the availability of affordable healthy food in the public and private spaces occupied by young people. (Contains 1 figure and 3 tables.)

Whale sharks are known to aggregate in coastal areas. In the South Ari Marine Protected Area (Maldives) a aggregation, mostly represented by young males with a high level of residency, has been described in the literature. Despite the worldwide interest in the natural resources of the Maldives, this population is increasingly subjected to anthropogenic pressure and major concern regards the flourishing tourist industry. In this study, data collected by the Maldives Whale Shark Research Programme between 2014 and 2017 have been used to detect both temporal and spatial patterns of occurrence. Favourable environmental conditions to visually detect whale sharks have been defined for the studied area. Accordingly, a total of 1077 shark encounters have been analysed in this study. Environmental conditions (i.e. sea surface temperature, monsoon occurrence) have been used to detect possible factors affecting the spatial and temporal variability of Rhincodon typus aggregations. A two-way ANOVA has been performed to detect temporal trends in animal occurrence, sea surface temperature pattern and to investigate the sea bottom depth variability during encounters. Significant differences in the monthly occurrence of whale sharks within the same year and among different years have been detected. Similar patterns have been observed for environmental parameters such as sea surface temperature and depth. A different spatial distribution has also been detected as a function of the Indian Monsoon reversal (north-eastern and south-western) affecting the area. During the northeast monsoon period, whale sharks appeared to concentrate in a smaller longitudinal range closer to the western-central part of the MPA, where deeper water conditions occur due to the proximity of a deep depression (submarine canyon). Results from this study provide new pieces of information for the implementation of dedicated management actions to protect the whale sharks population inhabiting the South Ari Marine Protected Area. [ABSTRACT FROM AUTHOR]