Balloon-Expandable TAVR Bioprostheses: Area or Perimeter Sizing? A Prospective Pilot Study.

OBJECTIVE: In TAVR, area sizing is used for balloon-expandable (BE) valves, whereas self-expanding valves are sized to annulus perimeter. For BE valves, this seems illogical: these frames force a circular shape even on an ellipsoid annulus. This can potentially lead to relative undersizing when area sizing is being applied. We developed a perimeter-based sizing algorithm to evaluate the safety and feasibility of perimeter sizing for the Myval BE valve. METHODS: In this prospective single-center study, 60 patients with severe aortic stenosis treated with the Myval BE valve were included. Perimeter sizing was used with limited oversizing of 3.7% ± 1.3% compared to the annulus perimeter. After TAVR, clinical outcomes were evaluated at 30 days and 1 year. An echocardiographic follow-up took place at 30 days. RESULTS: At 30 days, the need for PPI and stroke occurred in 2% and 3% of the patients, respectively. Moreover, cardiac death and moderate-severe PVL were absent. At 1-year, cardiac death and stroke were observed in 3% and 8% of the patients, respectively. In 33.3% of the patients, a larger valve size was implanted compared to the valve size calculated by area sizing. CONCLUSIONS: Perimeter sizing with the Myval BE valve leads to substantial use of larger valve sizes and favorable clinical outcomes, with low PPI and the absence of significant PVL. A randomized controlled trial is being planned to prove the superiority of this alternative sizing method

The implementation of the serial trial intervention for pain and challenging behaviour in advanced dementia patients (STA OP!): a clustered randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Pain (physical discomfort) and challenging behaviour are highly prevalent in nursing home residents with dementia: at any given time 45-80% of nursing home residents are in pain and up to 80% have challenging behaviour. In the USA Christine Kovach developed the serial trial intervention (STI) and established that this protocol leads to less discomfort and fewer behavioural symptoms in moderate to severe dementia patients. The present study will provide insight into the effects of implementation of the Dutch version of the STI-protocol (STA OP!) in comparison with a control intervention, not only on behavioural symptoms, but also on pain, depression, and quality of life. This article outlines the study protocol.</p> <p>Methods/Design</p> <p>The study is a cluster randomized controlled trial in 168 older people (aged >65 years) with mild or moderate dementia living in nursing homes. The clusters, Dutch nursing homes, are randomly assigned to either the intervention condition (training and implementation of the STA OP!-protocol) or the control condition (general training focusing on challenging behaviour and pain, but without the step-wise approach). Measurements take place at baseline, after 3 months (end of the STA OP! training period) and after 6 months.</p> <p>Primary outcome measures are symptoms of challenging behaviour (measured with the Cohen-Mansfield Agitation Inventory (CMAI) and the Neuropsychiatric Inventory-Nursing Home version (NPI-NH)), and pain (measure with the Dutch version of the Pain Assessment Checklist for Seniors (PACSLAC-D) and the Minimum Data Set of the Resident Assessment Instrument (MDS-RAI) pain scale). Secondary outcome measures include symptoms of depression (Cornell and MDS-RAI depression scale), Quality of Live (Qualidem), changes in prescriptions of analgesics and psychotropic drugs, and the use of non-pharmacological comfort interventions (e.g. snoezelen, reminiscence therapy).</p> <p>Discussion</p> <p>The transfer from the American design to the Dutch design involved several changes due to the different organisation of healthcare systems. Specific strengths and limitations of the study are discussed.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1967">NTR1967</a></p

Adapting the adult social care outcomes toolkit (ASCOT) for use in care home quality monitoring: conceptual development and testing

Background: Alongside an increased policy and practice emphasis on outcomes in social care, English local authorities are now obliged to review quality at a service level to help in their new role of ensuring the development of diverse and high-quality care markets to meet the needs of all local people, including self-funders. The Adult Social Care Outcomes Toolkit (ASCOT) has been developed to measure the outcomes of social care for individuals in a variety of care settings. Local authorities have expressed an interest in exploring how the toolkit might be used for their own purposes, including quality monitoring. This study aimed to explore how the care homes version of the ASCOT toolkit might be adapted for use as a care home quality indicator and carry out some preliminary testing in two care homes for older adults. Methods: Consultations were carried out with professional and lay stakeholders, with an interest in using the tool or the ratings it would produce. These explored demand and potential uses for the measure and fed into the conceptual development. A draft toolkit and method for collecting the data was developed and the feasibility of using it for quality monitoring was tested with one local authority quality monitoring team in two homes for older adults. Results: Stakeholders expressed an interest in care home quality ratings based on residents’ outcomes but there were tensions around who might collect the data and how it might be shared. Feasibility testing suggested the measure had potential for use in quality monitoring but highlighted the importance of training in observational techniques and interviewing skills. The quality monitoring officers involved in the piloting recommended that relatives’ views be collected in advance of visits, through surveys not interviews. Conclusions: Following interest from another local authority, a larger evaluation of the measure for use in routine quality monitoring is planned. As part of this, the ratings made using this measure will be validated against the outcomes of individual residents and compared with the quality ratings of the regulator, the Care Quality Commission

Multivariate non-normally distributed random variables in climate research &ndash; introduction to the copula approach

Probability distributions of multivariate random variables are generally more complex compared to their univariate counterparts which is due to a possible nonlinear dependence between the random variables. One approach to this problem is the use of copulas, which have become popular over recent years, especially in fields like econometrics, finance, risk management, or insurance. Since this newly emerging field includes various practices, a controversial discussion, and vast field of literature, it is difficult to get an overview. The aim of this paper is therefore to provide an brief overview of copulas for application in meteorology and climate research. We examine the advantages and disadvantages compared to alternative approaches like e.g. mixture models, summarize the current problem of goodness-of-fit (GOF) tests for copulas, and discuss the connection with multivariate extremes. An application to station data shows the simplicity and the capabilities as well as the limitations of this approach. Observations of daily precipitation and temperature are fitted to a bivariate model and demonstrate, that copulas are valuable complement to the commonly used methods

Construction of a chassis for hydrogen production: physiological and molecular characterization of a Synechocystis sp. PCC 6803 mutant lacking a functional bidirectional hydrogenase

[EN] Cyanobacteria are photosynthetic prokaryotes that are promising 'low-cost' microbial cell factories due to their simple nutritional requirements and metabolic plasticity, and the availability of tools for their genetic manipulation. The unicellular non-nitrogen-fixing Synechocystis sp. PCC 6803 is the best studied cyanobacterial strain and its genome was the first to be sequenced. The vast amount of physiological and molecular data available, together with a relatively small genome, makes Synechocystis suitable for computational metabolic modelling and to be used as a photoautotrophic chassis in synthetic biology applications. To prepare it for the introduction of a synthetic hydrogen producing device, a Synechocystis sp. PCC 6803 deletion mutant lacking an active bidirectional hydrogenase (Delta hoxYH) was produced and characterized at different levels: physiological, proteomic and transcriptional. The results showed that, under conditions favouring hydrogenase activity, 17 of the 210 identified proteins had significant differential fold changes in comparisons of the mutant with the wild-type. Most of these proteins are related to the redox and energy state of the cell. Transcriptional studies revealed that only six genes encoding those proteins exhibited significant differences in transcript levels. Moreover, the mutant exhibits similar growth behaviour compared with the wild-type, reflecting Synechocystis plasticity and metabolic adaptability. Overall, this study reveals that the Synechocystis Delta hoxYH mutant is robust and can be used as a photoautotrophic chassis for the integration of synthetic constructs, i.e. molecular constructs assembled from well characterized biological and/or synthetic parts (e.g. promoters, regulators, coding regions, terminators) designed for a specific purpose.This work was financially supported by EU FP6-NEST-2005-Path-SYN project BioModularH2 (contract no. 043340); Fundacao para a Ciencia e a Tecnologia (SFRH/BD/36378/2007, SFRH/BPD/64095/2009, PTDC/BIA-MIC/100370/2008); European Science Foundation (III Quadro Comunitario de Apoio), COMPETE - Programa Operacional Eactores de Competitividade na sua componente FEDER; Accoes Integradas Luso-Britanicas, Treaty of Windsor Programme 2010-11 (Processo B18/10); Engineering and Physical Sciences Research Council (EP/E036252/1), under the ChELSI initiative; Generalitat Valenciana grant BFPI/2007/283; and MICINN project ArtBioCom (TIN2009-12359). The authors are grateful to Dr Alan Dunbar (Chemical and Biological Engineering, University of Sheffield) and Dr Saw Ow Yen (Chemical and Biological Engineering, University of Sheffield) for helpful discussion. The authors would also like to thank the 'National BioResource Project (NIG, Japan): E. coli for providing the plasmid pK18mobsacB.Pinto, F.; Van Elburg, K.; Pacheco, C.; Lopo, M.; Noirel, J.; Montagud Aquino, A.; Urchueguía Schölzel, JF.... (2012). Construction of a chassis for hydrogen production: physiological and molecular characterization of a Synechocystis sp. PCC 6803 mutant lacking a functional bidirectional hydrogenase. Microbiology. 158(2):448-464. https://doi.org/10.1099/mic.0.052282-0S4484641582Abed, R. M. M., Dobretsov, S., & Sudesh, K. (2009). Applications of cyanobacteria in biotechnology. Journal of Applied Microbiology, 106(1), 1-12. doi:10.1111/j.1365-2672.2008.03918.xAgafonov, D. E., Kolb, V. A., & Spirin, A. S. (2001). 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Kwaliteit van leven bij dementie Opvattingen onder mensen met dementie, hun zorgverleners en in de literatuur

Different definitions of quality of life (QOL) are found in the literature. This raised the question which domains are viewed as really important by persons with dementia. In an explorative study the opinions of persons with dementia (community-dwelling and living in nursing homes), were compared to those of professional carers and instruments for QOL in dementia. Data were gathered through interviews, focus groups and literature study. Most QOL-domains mentioned as important by persons with dementia were also acknowledged by carers and in measurement instruments. Some domains, however, were not mentioned by the carers ('sense of aesthetics', 'financial situation', 'being useful' and 'spirituality'), or not selected in the measuring instruments ('security and privacy', 'self-determination and freedom', 'being useful' and 'spirituality'). This indicates differences in perspectives on quality of life between persons with dementia, professional caregivers and researchers. Subsequently it was studied to what degree professionals focus on the QoL-domains that persons with dementia consider essential. Caregivers working on 29 units and 3 day care facilities of 13 nursing homes and in 12 meeting centers filled out a questionnaire (N=374). They reported to focus at least to some degree on most domains considered important by persons with dementia. However, little attention was paid to the domains 'financial situation' and 'being useful'. Professionals offering daytime activities focused more than 24-hour care staff on 'attachment', 'enjoyment of activities', 'sense of aesthetics', and 'being useful'. This article is a translation and merging of 1) Dröes et al. Quality of life in dementia in perspective; an explorative study of variations in opinions among people with dementia and their professional caregivers, and in literature. Dementia: The International Journal 2006; 5 (4): 533-558, and 2) Gerritsen et al. Differences in perspective: do professional caregivers focus on the Quality of life domains that are important for people with dementia? American Journal of Alzheimer's Disease and Other Dementias 2007; 22: 176-183