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Quality of Split-Mouth Trials in Dentistry: 1998, 2008 and 2018
No full textThe objectives of this study were to assess the reporting quality and methodological quality of split-mouth trials (SMTs) published during the last two decades, and to determine whether there has been an improvement in their quality over time. We searched the MEDLINE database via PubMed to identify SMTs published in 1998, 2008, and 2018. For each included SMT, we used the CONsolidated Standards Of Reporting Trials (CONSORT) 2010 guideline, CONSORT for within-person trial (WPT) extension and a new three-item checklist to assess its trial reporting quality (TRQ), WPT-specific reporting quality (WRQ) and SMT-specific methodological quality (SMQ), respectively. Multivariable generalized linear models were performed to analyze the quality of SMTs over time, adjusting for potential confounding factors. A total of 119 SMTs were included. The mean overall score for TRQ (score range, 0 to 32), WRQ (0 to 15) and SMQ (0 to 3) was 15.77 (SD 4.51), 6.06 (2.06) and 1.12 (0.70), respectively. The primary outcome was clearly defined in only 28 SMTs (23.5%), and only 27 (22.7%) presented a replicable sample size calculation. Only forty-five SMTs (37.8%) provided the rationale for using a split-mouth design. The correlation between body sites was reported in only 5 studies (4.2%) for sample size calculation, and 4 studies (3.4%) for statistical results. Only 2 studies (1.7%) performed an appropriate sample size calculation, and 46 (38.7%) chose appropriate statistical methods both accounting for the correlation among treatment groups and the clustering / multiplicity of measurements within an individual. Results of regression analyses suggested that the TRQ of SMTs improved significantly with time (P < 0.001), while there was no evidence of improvement in WRQ or SMQ. Both the reporting quality and methodological quality of SMTs still have much room for improvement. Concerted efforts are needed to improve the execution and reporting of SMTs
Investigation of the Outcome of Pregnancies Complicated by Increased Fetal Movements and Their Relationship to Underlying Causes – A Prospective Cohort Study
No full textIntroduction: Retrospective studies have reported an association between a single episode of significantly increased fetal movements (IFMs) and stillbirth after 28 weeks’ gestation. This prospective study aimed to report the outcome of pregnancies associated with maternal perception of IFMs and determine whether this symptom is associated with adverse pregnancy outcome, a pathological intrauterine environment or placental dysfunction. Methods: Women reporting IFMs after 28 weeks’ gestation were recruited from St Mary’s Hospital, Manchester and Liverpool Women’s Hospital, UK between 01.11.2017-01.05.2019. Demographic and clinical information were obtained and an ultrasound scan was performed to assess fetal biometry, liquor volume and umbilical artery Doppler. Maternal serum samples were collected for analysis of placentally-derived biomarkers using ELISA. After delivery, maternal and fetal outcome data were collected and placentas and umbilical cord blood were obtained for analysis using immunohistochemistry and ELISA respectively. Placental and serum samples were matched by gestation and maternal characteristics to participants with normal fetal activity. Results: Seventy-seven women presented with IFM representing 0.45% of the maternity population; 64 women consented to participate in the study of which 7 (10.9%) experienced adverse pregnancy outcome (birthweight <3rd centile, 2 (3.1%), pH7.10, 1 (1.6%), NICU admission, 4 (6.3%)). Women had IFM for varying lengths of time before presenting: 17.2% had IFM for less than 1 hour and 29.7% reported IFM lasting longer than 24 hours. Four women (6.3%) had abnormalities of the fetal heart rate trace on assessment. Women with IFM had similar modes of birth to women giving birth in participating maternity units. There was no evidence of macroscopic placental or umbilical cord abnormalities, alterations in microscopic placental structure, placental endocrine dysfunction, or intrauterine hypoxia or infection in women with IFM compared to controls. Discussion: This prospective study did not find evidence of an association between IFM and adverse pregnancy outcome. It also did not find evidence of underlying placental dysfunction, cord anomalies, intrauterine hypoxia or infection in pregnancies with IFM. Further work is required to determine the strength of association between IFM and adverse pregnancy outcome and its origins. Presently, IFM cannot be used to identify fetuses at increased risk of adverse outcome
Impact of COVID-19 in Paediatric Early Phase Cancer Clinical Trials in Europe: A report from the Innovative Therapies for Children with Cancer consortium (ITCC)
No full textIntroductionData regarding real-world impact on cancer clinical research during COVID-19 are scarce. We analysed the impact of the COVID-19 pandemic on the conduct of paediatric cancer phase I-II trials in Europe through the experience of the Innovative Therapies for Children with Cancer (ITCC).Methods:A survey was sent to all ITCC-accredited Early-Phase Clinical Trial Hospitals including questions about impact on staff activities, recruitment, patient care, supply of investigational products and legal aspects, between 1/March and 30/April/2020.Results:Thirty-one out of 53 hospitals from 12 countries participated. Challenges reported included staff constraints (30% drop), reduction in planned monitoring activity (67% drop of site initiation visits and 64% of monitoring visits) and patient recruitment (61% drop compared to 2019). The percentage of phase I, phase II trials and molecular platforms closing to recruitment in at least one site was 48.5%, 61.3% and 64.3%, respectively. Additionally, 26% of sites had restrictions on performing trial assessments due to local contingency plans. Almost half of the units suffered impact upon pending contracts. Most hospitals (65%) are planning on improving organizational and structural changes.Conclusion:The study reveals a profound disruption of paediatric cancer early phase clinical research due to the COVID-19 pandemic across Europe. Reported difficulties affected both patient care and monitoring activity. Efforts should be made to reallocate resources to avoid lost opportunities for patients and to allow the continued advancement of oncology research. Identified adaptations to clinical trial procedures may be integrated to increase preparedness of clinical research to futures crises
The effect of the Carer Support Needs Assessment Tool intervention (CSNAT-I) in the Danish specialised palliative care setting: a stepped wedge cluster randomised controlled trial
No full textBackground: The Carer Support Needs Assessment Tool intervention (CSNAT-I) has been shown to improve end-of-life care support for informal caregivers. This study investigated the impact of the CSNAT-I on caregivers of patients recently enrolled in specialised palliative care (SPC) at home in Denmark. Methods: A stepped-wedge cluster randomised controlled trial with nine clusters (i.e., SPC teams). Outcome measures were collected using caregiver questionnaires at baseline (T0) and two (T1) and four (T2) weeks follow-up. ClinicalTrials.gov ID: NCT03466580. Results: A total of 437 caregivers were enrolled (control group, n=255; intervention group, n=182). No intervention effect was found on the primary outcome, caregiver strain at T1 (p = 0.1865). However, positive effects were found at T1 and T2 on attention to caregivers’ wellbeing (p < 0.0001), quality of information and communication (p < 0.0001), amount of information (T1: p = 0.0002; T2: p < 0.0001), involvement (T1: p = 0.0045; T2: p < 0.0001), talking about greatest burdens (p < 0.0001) and assistance in managing greatest burdens (p < 0.0001). The effect sizes of these differences were medium or large and seemed to increase from T1 to T2. At T1, positive effects were found on distress (p = 0.0178) and home care responsibility (p = 0.0024). No effect was found on the remaining outcomes. Conclusion: Although no effect was found on caregiver strain, the CSNAT-I showed positive effects on caregiver distress, home care responsibility and key outcomes regarding caregivers’ experience of the interaction with health care professionals
The importance of genetic counselling and screening for people with pathogenic SMARCE1 variants:a family study
No full textClear cell meningioma (CCM) is a rare variant of meningioma. In recent years, an association between cranial and spinal CCMs and germline loss of function muta-tions in the SMARCE1 gene (SWI/SNF chromatin remodeling complex subunit gene) has been discovered. We report a family with an incidental large spinal clear cell meningioma in a young adult following reflex screening for a germline loss of function pathogenic variant (PV) in the SMARCE1 gene. The index patient’s moth-er and maternal grandfather were both also tested positive pre-symptomatically for SMARCE1. His mother developed intracranial and spinal meningiomas and his ma-ternal grandfather developed a spinal CCM 4 years following a clear spinal MRI scan which required surgical excision. In this report we particularly emphasise the importance of genetic counselling and screening in siblings, parents and offspring of patients who are diagnosed with in-tracranial or spinal CCM in the context of SMARCE1 PVs. We recommend brain and spine Imaging screening of asymptomatic SMARCE1 PV carriers at least every 3 years, even if the baseline scan did not show any tumours. <br/
Moving Compute towards Data in Heterogeneous multi-FPGA Clusters using Partial Reconfiguration and I/O Virtualisation
No full textProcesses of Knowledge Recombination in Two-Person Teams: Resource Pool and Resource Integration
No full textKnowledge recombination is a process through which distant fields of knowledge are brought together to solve complex problems and has important outcomes, such as scientific, technical, or social innovation. However, although recombination is both a cognitive and social process, there is little theoretical and empirical evidence on what happens between people while they arecreating bridges between their different and complex fields of knowledge. In this study, we draw on problem solving research and social cognition models to provide and test a model of recombination. We predict that (1) two-person teams map larger areas of the problem domain if they explore that domain using dissimilar problem models and (2) an implicit cognitive intervention can help team members integrate their diverse problem definitions. We tested these predictions in an experiment with N = 31 dyads. Our results show that dissimilar problem models lead to more comprehensive problem definitions which in turn increase solution creativity when members are primed to combine unrelated concepts. This work advances understanding of knowledge recombination processes and sets the stage for more comprehensive models
Distributed finite-time output consensus tracking for a class of high-order nonlinear multiagent systems with the powers of positive odd rational numbers and output constraints
No full textThis paper considers the distributed finite-time output consensus tracking problem for a class of high-order nonlinear multiagent systems with the powers of positive odd rational numbers and output constraints. First, since the finite-time tracking design method for a single system with the powers of positive odd rational numbers cannot be extended to the finite-time consensus tracking for multiagent systems, an especial configuration method of the powers is constructed. Second, a new exponential brake function (EBF) which purely depends on the outputs is proposed to address the asymmetric output constraints directly. By adjusting a related parameter, the large converted value can be avoided when the output approaches the constrained boundaries, which may reduce the control input over a large output scale. Third, given some reasonable assumptions, a distributed finite-time output consensus tracking controller is proposed to guarantee that the tracking error converges to an adjustable small region around the origin in a finite time and that the output constraints of all subsystems are not violated. The result with output constraints can also be extended to the case without output constraints. Finally, simulation verifications also confirm the benefits and effectiveness of the proposed control methods
Thin-sheet theory for soft materials
No full textSlender sheets of viscous liquid can show features characteristic of elastic materials, such as buckling under compression. Likewise, thin sheets of solid material subject to sufficiently high stress can deform plastically, i.e. flow. In this volume, Hewitt & Balmforth (2020) explore the territory between these regimes, by developing asymptotic theories for thin viscoelastic and elasto-viscoplastic sheets, focusing primarily on regimes in which bending deformations dominate stretching. Their results reveal a rich phenomenology and provide new theoretical tools with which to probe thin layers of soft materials
High-grip and hard-wearing graphene reinforced polyurethane coatings
No full textLiquid polyurethane (PU) resins are used to form anti-slip surface coatings. In this work, we reinforce PU resin films with few-layer graphene (FLG) nanoparticles incorporated by high-shear mixing. This process gives excellent dispersion as evidenced by optical and X-ray tomography. The FLG does not appreciably change the tensile strength or Shore hardness of the PU, but we report modest increase of 10% in tear strength and Young’s modulus, accompanied by a similar decrease in elongation to failure. However, significant improvement of over 100% is observed in the abrasion resistance. At the same time, we report a 25% increase in the coefficient of static friction and 200% increase in the coefficient of dynamic friction. These results, taken together, suggests that graphene can significantly improve the grip and durability of PU anti-slip coatings, without significantly affecting the other mechanical properties of the coating