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Background: Phase 3 COMET trial (NCT02782741) compares avalglucosidase alfa (n=51) with alglucosidase alfa (n=49) in treatment-naïve LOPD. Methods: Primary objective: determine avalglucosidase alfa effect on respiratory muscle function. Secondary/other objectives include: avalglucosidase alfa effect on functional endurance, inspiratory/expiratory muscle strength, lower/upper extremity muscle strength, motor function, health-related quality of life, safety. Results: At Week 49, change (LSmean±SE) from baseline in upright forced vital capacity %predicted was greater with avalglucosidase alfa (2.89%±0.88%) versus alglucosidase alfa (0.46%±0.93%)(absolute difference+2.43%). The primary objective, achieving statistical non-inferiority (p=0.0074), was met. Superiority testing was borderline significant (p=0.0626). Week 49 change from baseline in 6-minute walk test was 30.01-meters greater for avalglucosidase alfa (32.21±9.93m) versus alglucosidase alfa (2.19±10.40m). Positive results for avalglucosidase alfa were seen for all secondary/other efficacy endpoints. Treatment-emergent adverse events (AEs) occurred in 86.3% of avalglucosidase alfa-treated and 91.8% of alglucosidase alfa-treated participants. Five participants withdrew, 4 for AEs, all on alglucosidase alfa. Serious AEs occurred in 8 avalglucosidase alfa-treated and 12 alglucosidase alfa-treated participants. IgG antidrug antibody responses were similar in both. High titers and neutralizing antibodies were more common for alglucosidase alfa. Conclusions: Results demonstrate improvements in clinically meaningful outcome measures and a more favorable safety profile with avalglucosidase alfa versus alglucosidase alfa. Funding: Sanofi Genzyme
A four-pronged approach to climate policy is presented consisting of carbon pricing, subsidies for renewable energies, transformative green investments and climate finance and engendering flywheel effects. Then, a variety of societal and political challenges and obstacles faced by such a climate policy and what can be done to overcome them are discussed. These range from stranded assets, the very long time scales needed to adapt and deal with global warming, intergenerational conflict, international free-rider problems, carbon leakage, green paradoxes, policy failure and capture, adverse income distributional effects and spatial scarcity to the problem of climate deniers and sceptics. The paper also discusses the various tools that are needed for the analysis of both ideal and workable climate policies, and the need to collaborate with complexity scholars, political scientists, sociologists and psychologists.
To study the long term effects of delirium in elderly hip-surgery patients on cognitive mortality.
This is a prospective study. Medical school-affiliated general hospital in Alkmaar, The Netherlands. Participants (n=603) from the €Haloperidol Prophylaxis for Elderly Hip-Surgery Patients at Risk for Delirium. A Randomized Placebo-Controlled Study (Kalisvaart et al., 2005). Patients with and without post-operative delirium were followed for 2 years. Mortality risk associated with delirium was estimated using a Cox proportional hazards regression model; the outcome was time to death.
A total of 75/603 patients (12.4%) died during the study period (table 1). Incidence of delirium was higher in patients who died compared with those who survived (HR 2.16, CI 1.30-3.58). They were more often at risk for delirium as indicated by higher rates of cognitive impairment and visual impairment.
Delirium after hip-surgery and delirium risk factors are associated with long-term follow-up mortality.
To study the long term effects of delirium in elderly hip-surgery patients on cognitive outcome.
Prospective matched controlled cohort study. Medical school-affiliated general hospital in Alkmaar, The Netherlands.
Hip-surgery patients (n=112) aged 70 and older who participated in a controlled clinical trial of haloperidol prophylaxis for delirium, were followed for an average of 30 months after discharge. Patients with a diagnosis of dementia or mild cognitive impairment (MCI) were identified based on psychiatric interviews. Proportions of patients with dementia or MCI were compared across patients who had postoperative delirium and selected control patients matched for preoperatively assessed risk factors who had not developed delirium during hospitalization. Other outcomes were mortality rate and rate of institutionalization.
During follow-up 54.9% of delirium patients had died compared to 34.1% controls (relative risk = 1.5, 95% CI = 1.04-2.1). Dementia or MCI was diagnosed in 77.8% of the surviving patients with postoperative delirium and in 40.1% of control patients (relative risk = 2.7, 95% CI = 1.2-5.8). Group differences for rate of institutionalization were not significant.
The risk of dementia or MCI at follow-up is more than doubled in elderly hip-surgery patients with postoperative delirium compared with patients without delirium.
Compassion is the capacity to be sensitive to pain and suffering of ourselves and others, accompanied by the commitment to alleviate it. Self-compassion has a positive effect on mental health (stress reduction and preventing recurrence of depression) and increases with the practice of mindfulness. For the general population several loving-kindness and compassion training programmes have been studied with promising results. At our outpatient center for integrative psychiatry, a novel compassion-focused training was developed: Mindfulness Based Compassionate Living training (MBCL) for patients who already followed a mindfulness training. MBCL consists of explicit exercises in loving-kindness and compassion, so that patients can deepen their skills in mindfulness and particularly in self-compassion in a safe way.
To examine the effects of MBCL training in a heterogeneous psychiatric outpatient population on levels of depression, anxiety, mindfulness and compassion.
The training consists of nine 1,5-hour sessions. Patients completed four questionnaires before and after the training (Beck Depression Inventory-II, Generalized Anxiety Disorder Scale, Five Facet Mindfulness Questionnaire, Self Compassion Scale).
Thirty-three patients participated in this pilot study (mean age 47,6 years; 82% female). MBCL training reduced levels of depression and anxiety, although results for anxiety were not significant. Levels of mindfulness and self-compassion increased significantly.
The outcome of this pilot study was judged very encouraging and MBCL training was therefore included in the treatment program of our center, enabling us to further investigate its effects as well as the underlying working mechanisms.
One-on-one structured Montessori-based activities conducted with people with dementia can improve agitation and enhance engagement. These activities may however not always be implemented by nursing home staff. Family members may present an untapped resource for enabling these activities. This study aimed to evaluate the impact of the Montessori activities implemented by family members on visitation experiences with people who have dementia.
Cluster-randomized crossover design.
General and psychogeriatric nursing homes in the state of Victoria, Australia.
Forty participants (20 residents and 20 carers) were recruited.
During visits, family members interacted with their relative either through engaging in Montessori-based activities or reading a newspaper (the control condition) for four 30-minute sessions over 2 weeks.
Residents’ predominant affect and engagement were rated for each 30-second interval using the Philadelphia Geriatric Center Affect Rating Scale and the Menorah Park Engagement Scale. The Pearlin Mastery Scale was used to rate carers satisfaction with visits. The 15-item Mutuality Scale measured the carers quality of their relationship with the resident. Carers’ mood and overall quality of life were measured using the Center for Epidemiological Studies Depression Scale and Carer-QoL questionnaires, respectively.
Linear regressions within the generalized estimating equations approach assessed residents’ and carers’ outcomes. Relative to the control condition, the Montessori condition resulted in more positive engagement (b = 13.0, 95%CI 6.3–19.7, p < 0.001) and affect (b = 0.4, 95%CI 0.2–0.6, p < 0.001) for the residents and higher satisfaction with visits for carers (b = 1.7, 95%CI 0.45–3.00, p = 0.008). No correction was applied to p-values for multiple comparisons.
This study strengthens the evidence base for the use of the Montessori programs in increasing well-being in nursing home residents. The findings also provide evidence that family members are an additional valuable resource in implementing structured activities such as the Montessori program with residents.
The regulation of civil society provides the framework under which those organisations can most effectively provide services in education, health, social services, housing, development aid and so on. Civil Society in Europe identifies common principles of civil society law in two ways. First, the approaches of the Council of Europe and the European Union are explored. Next, civil society regulation in twelve domestic legal systems are investigated on a broad range of substantive areas of law including internal organisation, registration, external supervision, public benefit organisations and international activities. From these, the authors distill a set of minimum norms and optimal conditions under which civil society can deliver its aims most effectively. This book is essential reading for policymakers and legislators across Europe and beyond.