bluuebunny/crossref_metadata_2025 huggingface dataset:
User Interactive Flexible Fixturing System
Authors: Kwasny D. M. , Cipra R. J.
Published: March 2021

The focus of this work is on developing a user interactive flexible fixturing system which is used for synthesizing and testing fixture layouts for use in assembly operations. The system is designed to develop fixtures that utilize a specific type of three-point frictional constraint The first component of the system is the synthesis program which employs an analysis strategy that uses graphical techniques to characterize the stability of given fixture configurations. A stability threshold based on fixture element contact friction is identified to provide an indicator for the stability of layouts, and on-screen graphical displays are available to compare the stabilities of multiple configurations. A synthesis strategy is introduced to provide a guide to aid in the selection of constraining element arrangements on part surfaces. The second component of the system is the verification phase which allows arbitrary polygonal objects to be constrained with newly synthesized fixture layouts in a flexible test cell so that experimental results can be compared to analysis results. The entire system is demonstrated through examples and comparisons are made between the analytical results and experimental verification data.
Generalized Topology Optimization of Linear Elastic Structures Subjected to Thermal Loads
Authors: Rodrigues Helder C. , Fernandes Paulo A.
Published: March 2021

This paper presents the development of a computational model for the generalized topology optimization problem, using a material distribution approach, of 2-D linear elastic solids subjected to thermal loads, with compliance objective function and an isoperimetric constraint on volume.

The model relies on homogenization asymptotic methods to characterize the influence of the material periodic microstructure and a finite element displacement formulation is used to approximate the homogenized equilibrium equations obtained.

The computational model developed is tested in several examples considering different finite element approximations and the influence of the design variables (material density and orientation) is analyzed.
Derivation of Generalized Datum Reference Frames for Geometric Tolerance Analysis
Authors: Nigam Swami D. , Guilford James D. , Turner Joshua U.
Published: March 2021

Datum reference frames define coordinate systems for use in determining part compliance with geometric tolerances. A datum reference frame is specified based on the perfect nominal geometry of the part features called out as datums. However, the actual computation of a coordinate system frame of reference from the datum callouts becomes quite challenging when the features depart from nominal location, orientation, size, and form. We present a general method for representing datum reference frames (both partial and complete), and for computing a coordinate system from a simulated varianced part and a datum reference frame specification. The method makes use of built-in construction procedures, and derived or “virtual” geometry, in conjunction with a powerful parts positioning module that simulates the placement of the varianced part in a fixture represented by the datum surfaces. The reliance on virtual geometry as an intermediate representation, permits the concise representation of not only the datum reference frame types defined in the standard, but also allows for any arbitrary datum reference frames constructed by the user.
Some New Developments in Tolerance Design in CAD
Authors: Zhang Genbao , Porchet Michel
Published: March 2021

This paper presents some recent developments in tolerance design in CAD. An Oriented Functional Relationship Graph (OFRG) is developed to identify all the relevant functional components which have an impact on the (evaluated) performance of a product. It is proposed to use expert system technique to determine all the functional surfaces and necessary relational tolerance types on functional surfaces. Using an OFRG, it is easy to determine dimensional chains, error transmission chains, functional dimension trees and the functional dimensioning mode of a component. We propose to use a transformation matrix technique to determine the sensitivity of each tolerance. A new practical cost model, serving as the criterion for tolerance allocation, is presented. In contrast to empiric data (they are nearly uncollectible) based cost model, the cost model presented in this paper is a process data (they are collectable) based one. The discussion on optimal tolerance shows that optimal functional tolerances can not be obtained without considering the method in machining the workpieces. Hence, the concept of concurrent engineering must be introduced into tolerance design. Finally a mathematic model for tolerance design, called simultaneous tolerancing, in the context of concurrent engineering is proposed.
Validity Check for a Function-Oriented Modeler
Authors: Zhang K. F. , ElMaraghy Hoda H.
Published: March 2021

This paper presents a method for validity check for a feature-oriented modeler which is developed at the center for flexible manufacturing at McMaster University. Maintaining feature validity after feature deletion or modification is, an important issue in product modelling. Among the current commercial modelling systems, it is the designers’ responsibility to create a valid product model. The graphical display of the model provides an auxiliary means for feature verification. However such visual checking is incomplete, unreliable and time-consuming. In the case of invalid internal features, such as, holes and pockets, the visual check usually fails. The approach proposed by authors intends to maintain a valid model by the system automatically. Any interference between features which occurs after an addition, deletion or edition operation will be detected by the system and is resolved by either built-in rules or user’s assistance.
Kinematic Synthesis of Tendon-Driven Manipulators With Isotropic Transmission Characteristics
Authors: Ou Yeong-Jeong , Tsai Lung-Wen
Published: March 2021

This paper presents a methodology for kinematic synthesis of tendon-driven manipulators with isotropic transmission characteristics. The force transmission characteristics, from the end-effector space to the actuator space, has been investigated. It is shown that tendon forces required to act against externally applied forces are functions of the structure matrix, its null vector, and the manipulator Jacobian matrix. Design equations for synthesizing a manipulator to possess isotropic transmission characteristics are derived. It is shown that manipulators which possess isotropic transmission characteristics do have much better force distribution among their tendons.
A Free-Form Mesh Generator for Three-Dimensional Surfaces
Authors: Hua Tienyong , Zeid Ibrahim
Published: March 2021

A fully automatic 3D free-form mesh generation method is developed in this paper. The method is capable of meshing 3D parametric surfaces, both analytic and synthetic. Surfaces may have holes and may be composite, i.e. consisting of more than one patch. In addition to being fully automatic, the method produces quadrilateral or triangular elements with aspect ratio near one. The input to this method includes surface definition points, the element size, and mesh grading information. The method begins by calculating patch boundary curve lengths so that boundary nodes are determined. Utilizing these boundary nodes, the 3D surface patch is mapped from its Cartesian space into its parametric space where it becomes a 2D region. In this parametric region, a 2D mesh generator is utilized to mesh the region. The final mesh is transformed back to the Cartesian space via transforming the coordinates of its nodal points based upon the surface equation. The free-form generator and its related method have been tested extensively and applied to a wide number of surfaces. Sample examples are presented.
Scallop Elimination Based on Precise 5-Axis Tool Placement, Orientation, and Step-Over Calculations
Authors: Mullins S. H. , Jensen C. G. , Anderson D. C.
Published: March 2021

This paper presents algorithms for computing precise 5-axis placement, orientation, and step-over calculations for end mill cutters at a single point on a sculptured surface. Present methods leave irregular scallops between finishing tool passes that require manual grinding to prepare the machined surface for polishing. The relationship between scallop height and step-over is well known for 3-axis movement of a ball end mill across a planar surface but no such relationship exists for 5-axis movement of end mills of other types. Manual grinding of machined surfaces is a time consuming process that generally results in a significant difference between the surface as designed and the actual machined surface. The goal of this approach is the elimination of rough grinding by eliminating scallops between adjacent points on consecutive finish machining passes. An example of a computer implementation of the method using a filleted end mill is also presented.
Optimizaton-Based Design of Hub-and-Shaft Assemblies for Dual-Wheel Excavators
Authors: Wilson L. A. , Azarm S. , Kotras T. V.
Published: March 2021

In this paper, optimization-based design for a minimum weight hub-and-shaft assembly for dual-wheel excavators is presented. Two optimization models are developed: one is based on a keyed hub-to-shaft connection, and the other based on a threaded hub-to-shaft connection. The optimization models are tested and compared with test designs for dual-wheel excavators that are currently in use in industry. It is found that for the test designs: (1) both optimization models generated weight reductions averaging 17%, with reductions ranging from 3% to 30%, (2) both optimization models exhibit significant increases in their weight when subjected to an increasing transverse load on the hub, and (3) hub width is the most influential design variable in determining the weight of the hub-and-shaft assembly.
Heterogeneous Distributed Data Storage for an Object-Oriented Engineering Design Environment
Authors: Brintle Lee P. , Koppes Elizabeth A. , Wu J. K.
Published: March 2021

The Tracked Vehicle Workstation (TVWS) is a distributed, object-oriented design environment that stores the large amounts of data associated with mechanical system’s design and analysis across heterogeneous UNIX† machines on a network. A Distributed ASCII File Storage (DAFS) server was developed to provide an easy to port, easy to modify means of retrieving and updating files on remote machines. This paper describes the different techniques and difficulties of methods the TVWS environment has used previously, including commercial solutions, single-node storage and the Network File System (NFS)‡, as well as a description of the current method utilizing DAFS.
Stability of Heart Rate at Physiological Thresholds Between Temperate and Heat Stress Environments in Endurance-Trained Males
Authors: Maunder Ed , Plews Daniel J. , Merien Fabrice , Kilding Andrew E.
Published: March 2021

Many endurance athletes perform specific blocks of training in hot environments in “heat stress training camps.” It is not known if physiological threshold heart rates measured in temperate conditions are reflective of those under moderate environmental heat stress. A total of 16 endurance-trained cyclists and triathletes performed incremental exercise assessments in 18°C and 35°C (both 60% relative humidity) to determine heart rates at absolute blood lactate and ventilatory thresholds. Heart rate at fixed blood lactate concentrations of 2, 3, and 4 mmol·L−1 and ventilatory thresholds were not significantly different between environments (P > .05), despite significant heat stress-induced reductions in power output of approximately 10% to 17% (P < .05, effect size = 0.65–1.15). The coefficient of variation for heart rate at these blood lactate concentrations (1.4%−2.9%) and ventilatory thresholds (2.3%−2.7%) between conditions was low, with significant strong positive correlations between measurements in the 2 environments (r = .92–.95, P < .05). These data indicate heart rates measured at physiological thresholds in temperate environments are reflective of measurements taken under moderate environmental heat stress. Therefore, endurance athletes embarking on heat stress training camps can use heart rate–based thresholds ascertained in temperate environments to prescribe training under moderate environmental heat stress.
“Playing With Apartheid”: Irish and South African Rugby, 1964–19891
Authors: Bolsmann Chris
Published: March 2021

The struggle against apartheid was fought on many fronts. Internationally, the Anti-Apartheid Movement (AAM) across a number of countries engaged in a range of activities that highlighted the atrocities of the Pretoria regime and the plight of the majority in South Africa. An important site of struggle against apartheid was in the sports sphere. Ireland and the Irish AAM played a significant role in this regard. The AAMs in Australia, Britain, Ireland, New Zealand, and the United States, among others, recorded victories against apartheid through demonstrations, boycotts, and the ban on participation of South African teams in international tours, tournaments, and events. A number of scholars have highlighted the role of the international AAM and its campaigns against apartheid sport. To date, historical studies of the anti-apartheid struggle and South African sport have primarily focused on Britain and New Zealand and, to a lesser extent, the United States. Irish sporting contacts with South Africa extend back over a century. Thus, focusing on the case study of Irish AAM activism against segregated sport further adds to the literature on the sports boycott and the struggle against apartheid. This article draws on Jacob Dlamini’s notion of “moral agents” in understanding players’, teams’, and sports associations’ decisions to continue to play with apartheid, despite international opposition. Drawing from archives in Ireland and South Africa, this article adds new details to the struggle against apartheid rugby in South African sport between 1964 and 1989.
Genome reveals giraffe's recipe for standing tall
Authors: Moutinho Sofia
Published: March 2021

Transgenic mice with giraffe's mutations may suggest high blood pressure treatments.
Europe may bar neighbors from key research
Authors: Wallace Nicholas
Published: March 2021

Quantum and space grant rules would exclude U.K., Swiss, and Israeli researchers.
Medicine's longest year
Authors: Servick Kelly , Couzin-Frankel Jennifer , Matacic Catherine
Published: March 2021

Physicians sift through a torrent of research to find what works to treat COVID-19.
DNA sensor in standby mode during mitosis
Authors: Ablasser Andrea
Published: March 2021

Distinct control mechanisms restrict innate DNA sensor activity on mitotic chromosomes
Increasing Inundation Frequencies Enhance the Stochastic Process and Network Complexity of the Soil Archaeal Community in Coastal Wetlands
Authors: Gao Gui-Feng , Peng Dan , Wu Di , Zhang Yihui , Chu Haiyan
Published: March 2021

Coastal wetlands, subjected to regular disturbances by periodic tidal, are highly productive and important in the regulation of climate change. However, the assembly mechanisms and co-occurrence patterns of soil archaeal communities in coastal areas remain poorly known, especially for their responses to increasing inundation frequencies.
Reappraisal of the Mesozoic tectonic transition from the Paleo-Tethyan to Paleo-Pacific domains in South China
Authors: Gan Chengshi , Zhang Yuzhi , Wang Yuejun , Qian Xin , Wang Yang
Published: March 2021

The southeastern (SE) South China Block was mainly influenced by the Paleo-Tethyan and Paleo-Pacific dynamic domains during the Mesozoic. The initial timing of the tectonic transition between these two domains in the SE South China Block still remains debated. The transition would affect the nature of the lithosphere and material provenance of sediments, and, therefore, igneous and sedimentary rocks in the area could record such dynamic processes. In this study, published geochronological and geochemical data of the Triassic and Jurassic igneous rocks and detrital zircon data of contemporaneous sedimentary rocks in the SE South China Block were compiled, aiming to provide constraints on the tectonic transition via tracing the spatial-temporal variations in the nature of the lithosphere and sedimentary provenance signals. The compiled results suggest that the magmatic intensity and volume decreased significantly from the Late Triassic to Early–Middle Jurassic, with an obvious magmatic quiescence between them, and increased from the Early–Middle Jurassic to Late Jurassic. The εNd(t) and zircon εHf(t) values of mafic rocks, granitoids, and shoshonitic rocks remarkably increased from the Late Triassic to Early–Middle Jurassic, indicative of variations in the lithospheric mantle and continental crust. Such variations suggest that the initial tectonic transition occurred at the earliest Early Jurassic. Based on the southward paleocurrents from Early Jurassic sandstone, E-W–trending extension of Early–Middle Jurassic mafic and shoshonitic rocks, and similar sedimentary provenances of Late Triassic and Early–Middle Jurassic sedimentary rocks, these features imply that the SE South China Block was not immediately influenced by the Paleo-Pacific domain during the Early–Middle Jurassic. However, from the Early–Middle Jurassic to Late Jurassic and Early Cretaceous, the spatial distribution, geochemical signatures, magmatic intensity, and magmatic volume of igneous rocks and provenance of sedimentary rocks exhibit obvious variations, and the regional fold hinge direction changed from E-W–trending to NE-trending, suggesting significant effects from Paleo-Pacific subduction on the SE South China Block. Thus, the Mesozoic tectonic transition from the Paleo-Tethyan to the Paleo-Pacific dynamic domain in the SE South China Block likely occurred during the Early–Middle Jurassic.
Supplemental Material: Mid-Cretaceous thick carbonate accumulation in Northern Lhasa (Tibet): eustatic vs. tectonic control?
Authors: Xu Yiwei , Hu Xiumian , al. et
Published: March 2021

Biozones of the Baoji, Xiongmei, Xiagezi and other central sections, and stratigraphic data used to reconstruct tectonic subsidence of the north Lhasa.
Supplemental Material: Early Cenozoic partial melting of meta-sedimentary rocks of the eastern Gangdese arc, southern Tibet, and its contribution to syn-collisional magmatism
Authors: Jiang Yuan-Yuan , al. et
Published: March 2021

The chemical compositions of minerals from the paragneisses (Tables S1–S3), the zircon and monazite age and trace element data of the paragneisses and leucosome (Tables S4–S5), and the zircon Lu-Hf isotope data of the paragneisses and leucosome (Table S6) from the eastern Gangdese magmatic arc.
High-dose electronic media use in five-year-olds and its association with their psychosocial symptoms: a cohort study
Authors: Niiranen Janette , Kiviruusu Olli , Vornanen Riitta , Saarenpää-Heikkilä Outi , Paavonen E Juulia
Published: March 2021

Objectives

This study investigated the frequency of electronic media (e-media) usage by preschool children and the risks of high-dose e-media use on young children’s psychosocial well-being.

Design

Longitudinal associations between e-media use at 18 months and psychosocial symptoms at 5 years of age were studied, as well as cross-sectional associations between e-media use and psychosocial symptoms at 5 years.

Setting

Between 2011 and 2017 in Finland.

Participants

Children aged 5 years (n=699).

Primary and secondary outcome measures

Children’s psychosocial symptoms were determined at the age of 5 years using the parent-reported questionnaires Five-to-Fifteen (FTF) and the Strengths and Difficulties Questionnaire (SDQ).

Results

Based on our results, 95% of the preschool children exceeded the daily recommended use of e-media set by health professionals. Our results indicate that increased screen time at 5 years of age is associated with a risk of multiple psychosocial symptoms (OR 1.53–2.18, 95% CI 1.05 to 3.34, p<0.05), while increased levels of e-media use at 18 months was only associated with FTF peer problems (OR 1.59, 95% CI 1.04 to 2.41, p=0.03). Moreover, high-dose use of electronic games at the age of 5 years seems to be associated with fewer risks for psychosocial well-being than programme viewing, as it was only associated with SDQ hyperactivity (OR 1.65, 95% CI 1.08 to 2.51, p=0.02).

Conclusion

Increased screen time has multiple risks for children’s psychosocial well-being. These risk factors seem to be significant in the long term, and are related to problems in children’s socio-emotional development later on. Health professionals and paediatricians have an important role as communicators of the current research results on the safe usage time of e-media for families, and enhancing parents’ skills as regulators of children’s safe e-media use. More research is needed on the family conditions of high-dose e-media users.
What are parents’ perceptions related to barriers in diagnosing swallowing dysfunction in children? A grounded theory approach
Authors: Baqays Abdulsalam , Rashid Marghalara , Johannsen Wendy , Seikaly Hadi , El-Hakim Hamdy
Published: March 2021

Objectives

Swallowing dysfunction (SwD) is under-reported in otherwise healthy infants and toddlers (OHITs). The identification of parental perceptions of factors that may hinder the diagnosis could help clinicians manage these children in a more expeditious manner. This study investigated the barriers to diagnosing SwD, as reported by the families.

Design

Grounded theory study.

Setting

This study was performed in a tertiary care paediatric centre in Canada.

Participants

Parents of OHITs were recruited using purposeful sampling.

Intervention

We used detailed, semistructured, in-person interviews and the audiotapes and transcriptions were thematically analysed. From the parental insights, we built a framework composed of three themes of barriers.

Result

Ten parents of OHITs with SwD were interviewed. The children presented with recurrent coughing, choking, cold-like symptoms, recurring/consistent illnesses and feeding difficulties. They were managed with multiple rounds of antibiotics and diagnosed with allergies, asthma or recurrent viral infections before considering SwD. The three emerging themes are false beliefs about SwD among parents and some physicians, parent-related barriers and physician-related barriers. These barriers had severely impacted the parents, impairing work productivity and leading to work-related reprimands and changes in the family dynamics.

Conclusion

This study suggests that there are several barriers that face the parents of OHITs when seeking a diagnosis of SwD and initiating appropriate management. These barriers likely interact with one another and amplify their effects on the family and the child. A common denominator is a lack of education regarding SwD, its clinical manifestations and the available expertise to manage this condition.
Breastfeeding education, early skin-to-skin contact and other strong determinants of exclusive breastfeeding in an urban population: a prospective study
Authors: Dueñas-Espín Iván , León Cáceres Ángela , Álava Angelica , Ayala Juan , Figueroa Karina , Loor Vanesa , Loor Wilmer , Menéndez Mónica , Menéndez David , Moreira Eddy , Segovia René , Vinces Johanna
Published: March 2021

Objective

The current study aims to demonstrate independent associations between social, educational and health practice interventions as determinants of exclusive breastfeeding in an urban Ecuadorian population.

Design

Prospective survival analyses.

Setting

Ecuadorian mother–child dyads in urban settings.

Participants

We followed-up 363 mother–baby dyads who attended healthcare centres in Portoviejo, province of Manabi, for a median time (P25–P75) of 125 days (121–130 days).

Main outcome measures

We performed a survival analysis, by setting the time-to-abandonment of exclusive breastfeeding measured in days of life, that is, duration of exclusive breastfeeding, periodically assessed by phone, as the primary outcome. Crude and adjusted mixed-effects Cox proportional hazards model were performed to estimate HRs for each explanatory variable.

Results

The incidence rate of abandonment of breastfeeding was 8.9 per 1000 person-days in the whole sample. Multivariate analysis indicated the three most significant protective determinants of exclusive breastfeeding were (a) sessions of prenatal breastfeeding education with an HR of 0.7 (95% CI: 0.5 to 0.9) per each extra session, (b) self-perception of milk production, with an HR of 0.4 (95% CI: 0.3 to 0.6) per each increase in the perceived quantity of milk production and (c) receiving early skin-to-skin contact with an HR of 0.1 (95% CI: <0.1 to 0.3) compared with those not receiving such contact, immediately after birth.

Conclusions

Prenatal education on breastfeeding, self-perception of sufficient breast-milk production and early skin-to-skin contact appear to be strong protectors of exclusive breastfeeding among urban Ecuadorian mother–baby dyads.
Potential impact of physical distancing on physical and mental health: a rapid narrative umbrella review of meta-analyses on the link between social connection and health
Authors: Morina Nexhmedin , Kip Ahlke , Hoppen Thole Hilko , Priebe Stefan , Meyer Thomas
Published: March 2021

Background

The imperative for physical distancing (mostly referred to as social distancing) during COVID-19 pandemic may deteriorate physical and mental health. We aimed at summarising the strength of evidence in the published literature on the association of physical and mental health with social connection via social isolation, living alone and loneliness.

Methods

We conducted a systematic search in April 2020 to identify meta-analyses using the Medline, PsycINFO and Web of Science databases. The search strategy included terms of social isolation, loneliness, living alone and meta-analysis. Eligible meta-analyses needed to report any sort of association between an indicator of social connection and any physical or mental health outcome. The findings were summarised in a narrative synthesis.

Results

Twenty-five meta-analyses met our criteria, of which 10 focused on physical health and 15 on mental health outcomes. The results suggest that lack of social connection is associated with chronic physical symptoms, frailty, coronary heart disease, malnutrition, hospital readmission, reduced vaccine uptake, early mortality, depression, social anxiety, psychosis, cognitive impairment in later life and suicidal ideation.

Conclusions

The existing evidence clearly indicates that social connection is associated with a range of poor physical and mental health outcomes. A potential negative impact on these outcomes needs to be considered in future decisions on physical distancing measures.
Mid-German Sepsis Cohort (MSC): a prospective observational study of sepsis survivorship
Authors: Fleischmann-Struzek Carolin , Kesselmeier Miriam , Ouart Dominique , Hartog Christiane S. , Bauer Michael , Bercker Sven , Bucher Michael , Meier-Hellmann Andreas , Petros Sirak , Schreiber Torsten , Simon Philipp , Weidhase Lorenz , Born Sebastian , Braune Anke , Chkirni Hicham , Eichhorn Cornelia , Fiedler Sandra , Gampe Christin , König Christian , Platzer Stephanie , Romeike Heike , Töpfer Kristin , Reinhart Konrad , Scherag André
Published: March 2021

Purpose

The Mid-German Sepsis Cohort (MSC) aims to investigate mid-term and long-term functional disabilities in sepsis survivors from intensive care unit (ICU) discharge until 1 year after. Secondary, post-acute mortality and morbidity, health-related quality of life and healthcare utilisation will be investigated.

Participants

The MSC comprises adult (aged ≥18 years) patients who were treated for (severe) sepsis or septic shock on ICU. The participants were recruited between 15 April 2016 and 30 November 2018 from five German centres. Three thousand two hundred and ten patients with sepsis were identified, of which 1968 survived their ICU stay and were eligible for enrolment in the follow-up cohort. Informed consent for follow-up assessment was provided by 907 patients (46.1% of eligible patients).

Findings to date

The recruitment of the participants for follow-up assessments and the baseline data collection is completed. Incidence of sepsis was 116.7 patients per 1000 ICU patients. In this cohort profile, we provide an overview of the demographics and the clinical characteristics of both the overall sepsis cohort and the ICU survivors who provided informed consent for follow-up assessment (907 out of 1968 ICU survivors (46.1%)).

Future plans

The follow-ups are conducted 3, 6 and 12 months after ICU discharge. Another yearly follow-up up to 5 years after ICU discharge is pursued. Several cooperation and satellite projects were initiated. This prospective cohort offers a unique resource for research on long-term sequelae of sepsis survivors.

Trial registration number

German Clinical Trials Registry (DRKS00010050).
International multicentre observational study to evaluate the association between perioperative red blood cell transfusions and 1-year mortality after major cancer surgery (ARCA-1): study design, statistical analysis plan and study protocol
Authors: Cata Juan , Ramirez Maria , Forget Patrice , Chen Lee-Lynn , Diaz-Cambronero Oscar , Chen Wankun , Warner Matthew A , Knopfelmacher Couchonal Adriana , Pelosi Paolo , Cuellar Luis , Corrales German , Romero Carlos , Lobo Francisco , Saager Leif , Castro Tapia Jorge , Kiberenge Roy , Feng Lei , Serpa Neto Ary
Published: March 2021

Introduction

Blood transfusion is still common in patients undergoing major cancer surgery. Blood transfusion can be associated with poor prognosis in patients with cancer. Perioperative Care in the Cancer Patient -1 (ARCA-1) aims to assess in a large cohort of patients the current incidence, pattern of practice and associations between perioperative blood transfusions and 1-year survival in patients undergoing major cancer surgery.

Methods and analysis

ARCA-1 is a prospective international multicentre observational study that will include adult patients scheduled to have major cancer surgical procedures with the intention to cure, and an overnight planned hospital admission. The study will be opened for 1 year for enrolment (7 January 2020–7 February 2021). Each centre will enrol patients for 30 days. The primary endpoint of this study is all-cause mortality 1 year after major cancer surgery. Secondary endpoints are rate of perioperative blood product use, cancer-specific mortality at 1 year and PFSs and 30-day morbidity and mortality.

Ethics and dissemination

This study was approved by the Institutional Review Board at The University of Texas—MD Anderson Cancer Center. The study results will be published in peer-reviewed journals and disseminated at international conferences.

Trial registration number

NCT04491409.
Urgent assessment and ongoing care for infection in community-dwelling older people: a qualitative study of patient experience
Authors: Moore Abigail , McKelvie Sara , Glogowska Margaret , Lasserson Daniel S , Hayward Gail
Published: March 2021

Objectives

To explore the experience of infection from the perspective of community-dwelling older people, including access and preferences for place of care.

Design

Qualitative interview study, carried out between March 2017 and August 2018.

Setting

Ambulatory care units in Oxfordshire, UK.

Participants

Adults >70 years with a clinical diagnosis of infection.

Methods

Semistructured interviews based on a flexible topic guide. Participants were given the option to be interviewed with their caregiver. Thematic analysis was facilitated by NVivo V.11.

Results

Participants described encountering several barriers when accessing an urgent healthcare assessment which were hard to negotiate when they felt unwell. They valued home comforts and independence if they received care for their infection at home, though were worried about burdening their family. Most talked about hospital admission being a necessity in the context of more severe illness. Perceived advantages included monitoring, availability of treatments and investigations. However, some recognised that admission put them at risk of a hospital-acquired infection. Ambulatory care was felt to be convenient if local, but daily transport was challenging.

Conclusions

Providers may need to think about protocols and targeted advice that could improve access for older people to urgent healthcare when they feel unwell. General practitioners making decisions about place of care may need to better communicate risks associated with the available options and think about balancing convenience with facilities for care.
Association of outpatient ACE inhibitors and angiotensin receptor blockers and outcomes of acute respiratory illness: a retrospective cohort study
Authors: Jeffery Molly Moore , Cummins Nathan W , Dempsey Timothy M , Limper Andrew H. , Shah Nilay D , Bellolio Fernanda
Published: March 2021

Objectives

Evaluate associations between ACE inhibitors (ACEis) and angiotensin receptor blockers (ARBs) and clinical outcomes in acute viral respiratory illness (AVRI).

Design

Retrospective cohort analysis of claims data.

Setting

The USA; 2018–2019 influenza season.

Participants

Main cohort: people with hypertension (HTN) taking an ACEi, ARB or other HTN medications, and experiencing AVRI. Falsification cohort: parallel cohort receiving elective knee or hip replacement.

Main outcome measures

Main cohort: hospital admission, intensive care unit, acute respiratory distress (ARD), ARD syndrome and all-cause mortality. Falsification cohort: complications after surgery and all-cause mortality.

Results

The main cohort included 236 843 episodes of AVRI contributed by 202 629 unique individuals. Most episodes were in women (58.9%), 81.4% in people with Medicare Advantage and 40.3% in people aged 75+ years. Odds of mortality were lower in the ACEi (0.78 (0.74 to 0.83)) and ARB (0.64 (0.61 to 0.68)) cohorts compared with other HTN medications. On all other outcomes, people taking ARBs (but not ACEis) had a >10% reduction in odds of inpatient stays compared with other HTN medications.

In the falsification analysis (N=103 353), both ACEis (0.89 (0.80 to 0.98)) and ARBs (0.82 (0.74 to 0.91)) were associated with decreased odds of complications compared with other HTN medications; ARBs (0.64 (0.47 to 0.87)) but not ACEis (0.79 (0.60 to 1.05)) were associated with lower odds of death compared with other HTN medications.

Conclusions

Outpatient use of ARBs was associated with better outcomes with AVRI compared with other medications for HTN. ACEis were associated with reduced risk of death, but with minimal or no reduction in risk of other complications. A falsification analysis conducted to provide context on the possible causal implications of these findings did not provide a clear answer. Further analysis using observational data will benefit from additional approaches to assess causal relationships between these drugs and outcomes in AVRI.
Lifelines COVID-19 cohort: investigating COVID-19 infection and its health and societal impacts in a Dutch population-based cohort
Authors: Mc Intyre Katherine , Lanting Pauline , Deelen Patrick , Wiersma Henry H , Vonk Judith M , Ori Anil P S , Jankipersadsing Soesma A , Warmerdam Robert , van Blokland Irene , Boulogne Floranne , Dijkema Marjolein X L , Herkert Johanna C , Claringbould Annique , Bakker Olivier , Lopera Maya Esteban A , Bültmann Ute , Zhernakova Alexandra , Reijneveld Sijmen A , Zijlstra Elianne , Swertz Morris A , Brouwer Sandra , van Ooijen Raun , Angelini Viola , Dekker Louise H , Sijtsma Anna , Scherjon Sicco A , Wijmenga Cisca , Dekens Jackie A M , Mierau Jochen , Boezen H Marike , Franke Lude
Published: March 2021

Purpose

The Lifelines COVID-19 cohort was set up to assess the psychological and societal impacts of the COVID-19 pandemic and investigate potential risk factors for COVID-19 within the Lifelines prospective population cohort.

Participants

Participants were recruited from the 140 000 eligible participants of Lifelines and the Lifelines NEXT birth cohort, who are all residents of the three northern provinces of the Netherlands. Participants filled out detailed questionnaires about their physical and mental health and experiences on a weekly basis starting in late March 2020, and the cohort consists of everyone who filled in at least one questionnaire in the first 8 weeks of the project.

Findings to date

>71 000 unique participants responded to the questionnaires at least once during the first 8 weeks, with >22 000 participants responding to seven questionnaires. Compiled questionnaire results are continuously updated and shared with the public through the Corona Barometer website. Early results included a clear signal that younger people living alone were experiencing greater levels of loneliness due to lockdown, and subsequent results showed the easing of anxiety as lockdown was eased in June 2020.

Future plans

Questionnaires were sent on a (bi)weekly basis starting in March 2020 and on a monthly basis starting July 2020, with plans for new questionnaire rounds to continue through 2020 and early 2021. Questionnaire frequency can be increased again for subsequent waves of infections. Cohort data will be used to address how the COVID-19 pandemic developed in the northern provinces of the Netherlands, which environmental and genetic risk factors predict disease susceptibility and severity and the psychological and societal impacts of the crisis. Cohort data are linked to the extensive health, lifestyle and sociodemographic data held for these participants by Lifelines, a 30-year project that started in 2006, and to data about participants held in national databases.
A randomised, open-label trial to assess the optimal treatment strategy in early diffuse cutaneous systemic sclerosis: the UPSIDE study protocol
Authors: Spierings Julia , van Rhenen Anna , Welsing Paco MW , Marijnissen Anne CA , De Langhe Ellen , Del Papa Nicoletta , Dierickx Daan , Gheorghe Karina R , Henes Joerg , Hesselstrand Roger , Kerre Tessa , Ljungman Per , van de Loosdrecht Arjan A , Marijt Erik WAF , Mayer Miro , Schmalzing Marc , Schroers Roland , Smith Vanessa , Voll Reinhard E , Vonk Madelon C , Voskuyl Alexandre E , de Vries-Bouwstra Jeska K , Walker Ulrich A , Wuttge Dirk M , van Laar Jacob M
Published: March 2021

Introduction

Systemic sclerosis (SSc) is a chronic, autoimmune connective tissue disease associated with high morbidity and mortality, especially in diffuse cutaneous SSc (dcSSc). Currently, there are several treatments available in early dcSSc that aim to change the disease course, including immunosuppressive agents and autologous haematopoietic stem cell transplantation (HSCT). HSCT has been adopted in international guidelines and is offered in current clinical care. However, optimal timing and patient selection for HSCT are still unclear. In particular, it is unclear whether HSCT should be positioned as upfront therapy or rescue treatment for patients refractory to immunosuppressive therapy. We hypothesise that upfront HSCT is superior and results in lower toxicity and lower long-term medical costs. Therefore, we propose this randomised trial aiming to determine the optimal treatment strategy for early dcSSc by comparing two strategies used in standard care: (1) upfront autologous HSCT versus (2) immunosuppressive therapy (intravenous cyclophosphamide pulse therapy followed by mycophenolate mofetil) with rescue HSCT in case of treatment failure.

Methods and analysis

The UPSIDE (UPfront autologous hematopoieticStem cell transplantation vsImmunosuppressive medication in earlyDiffusEcutaneous systemic sclerosis) study is a multicentre, randomised, open-label, controlled trial. In total, 120 patients with early dcSSc will be randomised. The primary outcome is event-free survival at 2 years after randomisation. Secondary outcomes include serious adverse events, functional status and health-related quality of life. We will also evaluate changes in nailfold capillaroscopy pattern, pulmonary function, cardiac MR and high-resolution CT of the chest. Follow-up visits will be scheduled 3-monthly for 2 years and annually in the following 3 years.

Ethics and dissemination

The study was approved by the Dutch Central Committee on Research Concerning Human Subjects (NL72607.041.20). The results will be disseminated through patient associations and conventional scientific channels.

Trial registration numbers

NCT04464434; NL 8720.
COVID-19 symptom surveillance in immunocompromised children and young people in the UK: a prospective observational cohort study
Authors: Shaunak Meera , Patel Ravin , Driessens Corine , Mills Lynne , Leahy Alice , Gbesemete Diane , Owens Daniel R , Lucas Jane S , Faust Saul N , de Graaf Hans
Published: March 2021

Objectives

To describe the frequency of symptoms compatible with SARS-CoV-2 infection in immunocompromised children and young people in the UK during the SARS-CoV-2 pandemic. To describe patient/parent anxiety regarding SARS-CoV-2 infection in this cohort.

Design

A prospective observational cohort study.

Setting

46 centres across the UK between 16 March and 4 July 2020. A weekly online questionnaire based on the International Severe Acute Respiratory and emerging Infections Consortium-WHO Case Report Form was used to collect participant reported data on symptoms, test results, National Health Service attendance, hospital admission and impact on daily life.

Participants

1490 immunocompromised children, defined as those requiring an annual influenza vaccination due to their underlying condition or medication.

Main outcome measures

Incidence of SARS-CoV-2-like symptoms and patient/parent anxiety score.

Results

Over 16 weeks during the first wave of the pandemic, no SARS-CoV-2 infection was diagnosed in this large immunocompromised paediatric cohort (median age 11 years, 54.4% female). 110 symptomatic participants underwent a test for SARS-CoV-2; all were negative. 922 (67.4%) participants reported at least one symptom consistent with suspected SARS-CoV-2 infection over the study period. 476 (34.8%) reported three or more symptoms. The most frequently reported symptoms included joint pain, fatigue, headache, nausea and muscle pain. SARS-CoV-2 testing during this period was performed on admitted patients only. 137 participants had their medication suspended or changed during the study period due to assumed COVID-19 disease risk. 62% reported high levels of anxiety (scores of 7–10 out of 10) at the start of the study, with anxiety levels remaining high throughout the study period.

Conclusions

Although symptoms related to SARS-CoV-2 infection in children were common, there were no positive tests in this large immunocompromised cohort. Symptom-based screening to facilitate early detection of SARS-CoV-2 infection may not be helpful in these individuals. Patient/parent anxiety about SARS-CoV-2 infection was high.

Trial registration number

NCT04382508.
Patient and public involvement in numerical aspects of trials: a mixed methods theory-informed survey of trialists’ current practices, barriers and facilitators
Authors: Goulao Beatriz , Poisson Camille , Gillies Katie
Published: March 2021

Objective

We aimed to find out if trialists involve patients and the public in numerical aspects of trials, how and what are the barriers and facilitators to doing it.

Design

We developed a survey based on the Theoretical Domains Framework. We used a mixed methods approach to analyse the data and to identify important domains.

Setting

Online survey targeting UK-based trial units.

Participants

Stakeholders working in UK-based clinical trials, 18 years old or over, understand English and agree to take part in the study.

Outcome measures

Trialists’ behaviour of involving patients and the public in numerical aspects of trials and its determinants.

Results

We included 187 respondents. Majority were female (70%), trial managers (67%) and involved public and patient partners in numerical aspects of trials (60%). We found lack of knowledge, trialists’ perception of public and patient partners’ skills, capabilities and motivations, scarce resources, lack of reinforcement, and lack of guidance were barriers to involving public and patient partners in numerical aspects of trials. Positive beliefs about consequences were an incentive to doing it.

Conclusions

More training, guidance and funding can help trialists involve patient and public partners in numerical aspects, although they were uncertain about public and patient partners’ motivation to be involved. Future research should focus on identifying public and patient partners’ motivations and develop strategies to improve the communication of numerical aspects.
Prospective observational study of SARS-CoV-2 infection, transmission and immunity in a cohort of households in Liverpool City Region, UK (COVID-LIV): a study protocol
Authors: Setiabudi Wega , Hungerford Daniel , Subramaniam Krishanthi , Vaselli Natasha Marcella , Shaw Victoria E , Wilton Moon , Vivancos Roberto , Aston Stephen , Platt Gareth , Moitt Tracy , Jones Ashley P , Gabbay Mark , Buchan Iain , Carrol Enitan D , Iturriza-Gomara Miren , Solomon Tom , Greenhalf William , Naisbitt Dean J , Adams Emily R , Cunliffe Nigel A , Turtle Lance , French Neil
Published: March 2021

Introduction

The emergence and rapid spread of COVID-19 have caused widespread and catastrophic public health and economic impact, requiring governments to restrict societal activity to reduce the spread of the disease. The role of household transmission in the population spread of SARS-CoV-2, and of host immunity in limiting transmission, is poorly understood. This paper describes a protocol for a prospective observational study of a cohort of households in Liverpool City Region, UK, which addresses the transmission of SARS-CoV-2 between household members and how immunological response to the infection changes over time.

Methods and analysis

Households in the Liverpool City Region, in which members have not previously tested positive for SARS-CoV-2 with a nucleic acid amplification test, are followed up for an initial period of 12 weeks. Participants are asked to provide weekly self-throat and nasal swabs and record their activity and presence of symptoms. Incidence of infection and household secondary attack rates of COVID-19 are measured. Transmission of SARS-CoV-2 will be investigated against a range of demographic and behavioural variables. Blood and faecal samples are collected at several time points to evaluate immune responses to SARS-CoV-2 infection and prevalence and risk factors for faecal shedding of SARS-CoV-2, respectively.

Ethics and dissemination

The study has received approval from the National Health Service Research Ethics Committee; REC Reference: 20/HRA/2297, IRAS Number: 283 464. Results will be disseminated through scientific conferences and peer-reviewed open access publications. A report of the findings will also be shared with participants. The study will quantify the scale and determinants of household transmission of SARS-CoV-2. Additionally, immunological responses before and during the different stages of infection will be analysed, adding to the understanding of the range of immunological response by infection severity.