The Impact of Mobile Phone Reminders on Perceived Self-Care Levels of Informal Caregivers

: Informal caregivers play a fundamental role in caring for people that need assistance and provide an effective service in managing their loved ones’ health. Because of this, they have little time to attend to themselves and perform self-care practices. Some of these practices can improve mental health. By snowball sampling, we recruited 15 informal caregivers, 12 females and three males. Using the Wilcoxon signed-rank test, we analyzed the impact of the reminders on a self-care scale. We used the Mindful Self-Care Scale, comparing the same population without reminders and with reminders. Results indicated that total self-care scores with reminders increased statistically significantly, T = 13, Z = −2.481, p ≤ 0.013, with a large effect size (r = 0.64). This study shows a significant self-care increase in informal caregivers after using reminders. Future development of a reminders-based approach could focus on increasing self-care and the time caregivers take for themselves, empowering them to take a more active role in meeting their own needs.info:eu-repo/semantics/publishedVersio

Comparability and similarity protocols for biotechnology products

Over lifecycle, from development through all industrialization stages and then over manufacturing history across multiple sites, a biotechnology product must show very high levels of quality consistency, as that is a pre-requisite for safety and efficacy to patients (cf. ICH Q5E, 2004). Recently, FDA defined different levels of similarity (Draft Guidance, May 2014, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product”) namely the concepts of (1) “highly similar with fingerprint-like similarity” and that of (2) “residual uncertainty” in regard to similarity. Here we present a new approach to combine whole analytical domains from different techniques used in comparability protocols (to support change management for same product and process) that also is applicable to assess similarity in biocomparability investigations. Our approach ensures much higher levels of confidence in Comparability Protocols by not overlooking differences that might be unnoticed or overlooked due to incomplete prior-knowledge in regards to methods used and attributes considered. Our approach can (a) detect very small differences, (b) establish therefore the exact level of comparability / similarity and (c) provides a sound statistical foundation to assess residual uncertainties. We will illustrate our approach on reference products over their lifecycle and to compare reference with putatively similar products. The outcome of assessments (a) through (c) can then be linked to pharmacological performance or both types of biotechnology products, and support regulatory or other decisions related to managing filings

Integrating analysis with process control for continuous bioprocessing: Extending the lifecycle concept to process analytical technologies

The most notable trends in the use of PAT tools in bioprocessing nowadays are: (1) the combined use of multiple tools to a product & process and (2) that information fusion provides a better process estimation and product quality knowledge foundation than the use classical use of one analytical method The lifecycle management aspects of validation launched by FDA in its 2011 Validation Guidance, arrived - through ICH Q11 (2012) and the forth coming ICH Q12 (2017), to all aspects of development, qualification and commercial manufacturing of large molecule drug substances. For continuous bioprocessing that challenges are significantly different and more complex than for batch processing of small molecules. The homeostasis state that are targeted for most continuous bioprocesses, puts specific requirements in each individual PAT tool chosen and in their combined use over lifecycle. Here, using case-studies, a discussion is done of specific challenges at each of the three stages of lifecycle, about how and when the shift is made from understanding (acquiring data & information) to enhanced bioprocess control (knowledge-based decisions) to realize product quality by design (predictive product quality). Finally, we show how platform knowledge can be managed across multiple products for a company’s own portfolio benefit, through aggregation and high-level visualization of multiple PAT projects

3D digital breast cancer models with multimodal fusion algorithms

Breast cancer image fusion consists of registering and visualizing different sets of a patient synchronized torso and radiological images into a 3D model. Breast spatial interpretation and visualization by the treating physician can be augmented with a patient-specific digital breast model that integrates radiological images. But the absence of a ground truth for a good correlation between surface and radiological information has impaired the development of potential clinical applications. A new image acquisition protocol was designed to acquire breast Magnetic Resonance Imaging (MRI) and 3D surface scan data with surface markers on the patient's breasts and torso. A patient-specific digital breast model integrating the real breast torso and the tumor location was created and validated with a MRI/3D surface scan fusion algorithm in 16 breast cancer patients. This protocol was used to quantify breast shape differences between different modalities, and to measure the target registration error of several variants of the MRI/3D scan fusion algorithm. The fusion of single breasts without the biomechanical model of pose transformation had acceptable registration errors and accurate tumor locations. The performance of the fusion algorithm was not affected by breast volume. Further research and virtual clinical interfaces could lead to fast integration of this fusion technology into clinical practice.publishersversionpublishe

Machining Duplex Stainless Steel: Comparative Study Regarding End Mill Coated Tools

The difficulties in the machining of duplex stainless steel are well known. However, research on this matter is rather limited. Suppliers offer quite different cutting tools for the same raw material, with end mills of two, three or even four knives and a huge number of distinct coatings, some of them under commercial brands, making it difficult to assess the advantages they offer. Furthermore, there is a remarkable difference among the several types of duplex stainless steel available nowadays on the market. The present work intends to assess the machining performance of different tools, analyzing the behavior and wear mechanisms with two different cutting lengths, keeping constant the machining trajectory. Some other parameters were also kept constant, such as cutting speed, depth of cut and cutting width, as well as feed per tooth. The machining process was carried out under lubricated conditions, using an emulsion of 5% oil in water. Tools provided with a different number of teeth and surface coatings were tested, analyzing the wear behavior of each cutting length using scanning electron microscopy, trying to identify wear performance and how each coating contributes to increased tool life. The surfaces produced were also analyzed by means of profilometry measurements, correlating tool wear and part surface roughness. This comparative study allows determining the advantages of different tools relative to others, based on coatings and tool geometry.info:eu-repo/semantics/publishedVersio

A scoping review

Funding Information: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: MMM is funded by a Marie-Sklodowska-Curie (EDGE) Fellowship programme (grant agreement No. 713567). This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 643309. The material presented and views expressed here are the responsibility of the authors only. Publisher Copyright: © The Author(s) 2022.Objective: To identify the core components of digital behaviour change interventions for weight loss maintenance targeting physical activity, in terms of: (i) behaviour change techniques, (ii) mechanisms of action, (iii) modes of delivery, (iv) dose and (v) tailoring/personalization. In addition, the links between these components were investigated. Methods: A literature search was performed in five electronic databases: PubMed, Embase, CINHAL, PsycINFO and Web of Science. Two reviewers independently screened the identified articles and extracted data related with the study characteristics and behaviour change techniques, mechanism of action, mode of delivery, dose, and tailoring, using standardized classifications whenever available (e.g. behaviour change techniques taxonomy). Results: Seventeen articles reporting 11 original studies were selected. Two studies were protocols, 9 studies presented results for weight change and all but one showed no significant differences between the intervention and control groups. Eight studies (73%) provided adequate information on behaviour change techniques. Five studies (45%) provided partial information about how the behaviour change techniques were linked to mechanisms of action, and only one study (0.9%) described these links for all the techniques. Around half of the studies reported the modes through which behaviour change techniques were delivered. Descriptions of dose were present in most studies, but with minimal information. The use of tailoring or personalization approaches was mentioned in eight studies (73%), but descriptions of what was tailored and how were minimal. Conclusions: The compilation of information regarding intervention components was difficult due to the lack of information and systematization in reporting across papers. This is particularly true for the reporting of the links between behaviour change techniques and the other core intervention components. This information is crucial to help us understand in the context of behaviour change interventions what works or does not work, how it works and why.publishersversionpublishe

ZmOrphan94 Transcription Factor Downregulates ZmPEPC1 Gene Expression in Maize Bundle Sheath Cells

Spatial separation of the photosynthetic reactions is a key feature of C4 metabolism. In most C4 plants, this separation requires compartmentation of photosynthetic enzymes between mesophyll (M) and bundle sheath (BS) cells. The upstream region of the gene encoding the maize PHOSPHOENOLPYRUVATE CARBOXYLASE 1 (ZmPEPC1) has been shown sufficient to drive M-specific ZmPEPC1 gene expression. Although this region has been well characterized, to date, only few trans-factors involved in the ZmPEPC1 gene regulation were identified. Here, using a yeast one-hybrid approach, we have identified three novel maize transcription factors ZmHB87, ZmCPP8, and ZmOrphan94 as binding to the ZmPEPC1 upstream region. Bimolecular fluorescence complementation assays in maize M protoplasts unveiled that ZmOrphan94 forms homodimers and interacts with ZmCPP8 and with two other ZmPEPC1 regulators previously reported, ZmbHLH80 and ZmbHLH90. Trans-activation assays in maize M protoplasts unveiled that ZmHB87 does not have a clear transcriptional activity, whereas ZmCPP8 and ZmOrphan94 act as activator and repressor, respectively. Moreover, we observed that ZmOrphan94 reduces the trans-activation activity of both activators ZmCPP8 and ZmbHLH90. Using the electromobility shift assay, we showed that ZmOrphan94 binds to several cis-elements present in the ZmPEPC1 upstream region and one of these cis-elements overlaps with the ZmbHLH90 binding site. Gene expression analysis revealed that ZmOrphan94 is preferentially expressed in the BS cells, suggesting that ZmOrphan94 is part of a transcriptional regulatory network downregulating ZmPEPC1 transcript level in the BS cells. Based on both this and our previous work, we propose a model underpinning the importance of a regulatory mechanism within BS cells that contributes to the M-specific ZmPEPC1 gene expression

Structural monitoring and modeling of the mechanical deformation of three-dimensional printed poly(ε-caprolactone) scaffolds

Three-dimensional (3D) printed poly(ε-caprolactone) (PCL) based scaffolds have being proposed for different tissue engineering applications. This study addresses the design and fabrication of 3D PCL constructs with different struts alignments at 90°, 45° and 90° with offset. The morphology and the mechanical behavior under uniaxial compressive load were assessed at different strain percentages. The combination of a new compressionCT device and micro computed tomography (micro-CT) allowed understanding the influence of pore geometry under controlled compressive strain in the mechanical and structural behavior of PCL constructs. Finite element analysis (FEA) was applied using the micro-CT data to modulate the mechanical response and compare with the conventional uniaxial compression tests. Scanning electron microscopic analysis showed a very high level of reproducibility and a low error comparing with the theoretical values, confirming that the alignment and the dimensional features of the printed struts are reliable. The mechanical tests showed that the 90° architecture presented the highest stiffness. With the compressionCT device was observed that the 90° and 90° with offset architectures presented similar values of porosity at same strain and similar pore size, contrary to the 45° architecture. Thus, pore geometric configurations affected significantly the deformability of the all PCL scaffolds under compression. The prediction of the FEA showed a good agreement to the conventional mechanical tests revealing the areas more affected under compression load. The methodology proposed in this study using 3D printed scaffolds with compressionCT device and FEA is a framework that offers great potential in understanding the mechanical and structural behavior of soft systems for different applications, including for the biomedical engineering field.The author Fernandes E M acknowledges the financial support from the Portuguese Foundation for Science and Technology (FCT) and 'Programa Operacional Potencial Humano-POPH' and 'Fundo Social Europeu-FSE' for the post-doctoral grant (SFRH/BPD/96197/2013).info:eu-repo/semantics/publishedVersio

Mitral annular disjunction in myxomatous mitral valve disease: a relevant abnormality recognizable by transthoracic echocardiography

<p>Abstract</p> <p>Background</p> <p>Mitral annular disjunction (MAD) consists of an altered spatial relation between the left atrial wall, the attachment of the mitral leaflets, and the top of the left ventricular (LV) free wall, manifested as a wide separation between the atrial wall-mitral valve junction and the top of the LV free wall. Originally described in association with myxomatous mitral valve disease, this abnormality was recently revisited by a surgical group that pointed its relevance for mitral valve reparability. The aims of this study were to investigate the echocardiographic prevalence of mitral annular disjunction in patients with myxomatous mitral valve disease, and to characterize the clinical profile and echocardiographic features of these patients.</p> <p>Methods</p> <p>We evaluated 38 patients with myxomatous mitral valve disease (mean age 57 ± 15 years; 18 females) and used standard transthoracic echocardiography for measuring the MAD. Mitral annular function, assessed by end-diastolic and end-systolic annular diameters, was compared between patients with and without MAD. We compared the incidence of arrhythmias in a subset of 21 patients studied with 24-hour Holter monitoring.</p> <p>Results</p> <p>MAD was present in 21 (55%) patients (mean length: 7.4 ± 8.7 mm), and was more common in women (61% vs 38% in men; p = 0.047). MAD patients more frequently presented chest pain (43% vs 12% in the absence of MAD; p = 0.07). Mitral annular function was significantly impaired in patients with MAD in whom the mitral annular diameter was paradoxically larger in systole than in diastole: the diastolic-to-systolic mitral annular diameter difference was -4,6 ± 4,7 mm in these patients vs 3,4 ± 1,1 mm in those without MAD (p < 0.001). The severity of MAD significantly correlated with the occurrence of non-sustained ventricular tachycardia (NSVT) on Holter monitoring: MAD›8.5 mm was a strong predictor for (NSVT), (area under ROC curve = 0.74 (95% CI, 0.5-0.9); sensitivity 67%, specificity 83%). There were no differences between groups regarding functional class, severity of mitral regurgitation, LV volumes, and LV systolic function.</p> <p>Conclusions</p> <p>MAD is a common finding in myxomatous mitral valve disease patients, easily recognizable by transthoracic echocardiography. It is more prevalent in women and often associated with chest pain. MAD significantly disturbs mitral annular function and when severe predicts the occurrence of NSVT.</p