bluuebunny/crossref_metadata_2025_split huggingface dataset:
Early cryoprecipitate transfusion versus standard care in severe postpartum haemorrhage: a pilot cluster‐randomised trial
Authors: Green L. , Daru J. , Gonzalez Carreras F. J. , Lanz D. , Pardo M. C. , Pérez T. , Philip S. , Tanqueray T. , Khan K. S. 
Published: October 2021

SummaryThere is a lack of evidence evaluating cryoprecipitate transfusion in severe postpartum haemorrhage. We performed a pilot cluster‐randomised controlled trial to evaluate the feasibility of a trial on early cryoprecipitate delivery in severe postpartum haemorrhage. Pregnant women (>24 weeks gestation), actively bleeding within 24 h of delivery and who required at least one unit of red blood cells were eligible. Women declining transfusion in advance or with inherited clotting deficiencies were not eligible. Four UK hospitals were randomly allocated to deliver either the intervention (administration of two pools of cryoprecipitate within 90 min of first red blood cell unit requested plus standard care), or the control group treatment (standard care, where cryoprecipitate is administered later or not at all). The primary outcome was the proportion of women who received early cryoprecipitate (intervention) vs. standard care (control). Secondary outcomes included consent rates, acceptability of the intervention, safety outcomes and preliminary clinical outcome data to inform a definitive trial. Between March 2019 and January 2020, 199 participants were recruited; 19 refused consent, leaving 180 for analysis (110 in the intervention and 70 in the control group). Adherence to assigned treatment was 32% (95%CI 23–41%) in the intervention group vs. 81% (95%CI 70–90%) in the control group. The proportion of women receiving cryoprecipitate at any time‐point was higher in the intervention (60%) vs. control (31%) groups; the former had fewer red blood cell transfusions at 24 h (mean difference −0.6 units, 95%CI −1.2 to 0); overall surgical procedures (odds ratio 0.6, 95%CI 0.3–1.1); and intensive care admissions (odds ratio 0.4, 95%CI 0.1–1.1). There was no increase in serious adverse or thrombotic events in the intervention group. Staff interviews showed that lack of awareness and uncertainty about study responsibilities contributed to lower adherence in the intervention group. We conclude that a full‐scale trial may be feasible, provided that protocol revisions are put in place to establish clear lines of communication for ordering early cryoprecipitate in order to improve adherence. Preliminary clinical outcomes associated with cryoprecipitate administration are encouraging and merit further investigation.
ECM algorithm for estimating vector ARMA model with variance gamma distribution and possible unbounded density
Authors: Nitithumbundit Thanakorn , Chan Jennifer S.K. 
Published: October 2021

SummaryThe simultaneous analysis of several financial time series is salient in portfolio setting and risk management. This paper proposes a novel alternating expectation conditional maximisation (AECM) algorithm to estimate the vector autoregressive moving average (VARMA) model with variance gamma (VG) error distribution in the multivariate skewed setting. We explain why the VARMA‐VG model is suitable for high‐frequency returns (HFRs) because VG distribution provides thick tails to capture the high kurtosis in the data and unbounded central density further captures the majority of near‐zero HFRs. The distribution can also be expressed in normal‐mean‐variance mixtures to facilitate model implementation using the Bayesian or expectation maximisation (EM) approach. We adopt the EM approach to avoid the time‐consuming Markov chain Monto Carlo sampling and solve the unbounded density problem in the classical maximum likelihood estimation. We conduct extensive simulation studies to evaluate the accuracy of the proposed AECM estimator and apply the models to analyse the dependency between two HFR series from the time zones that only differ by one hour.
Variable selection using penalised likelihoods for point patterns on a linear network
Authors: Rakshit Suman , McSwiggan Greg , Nair Gopalan , Baddeley Adrian 
Published: October 2021

SummaryMotivated by the analysis of a comprehensive database of road traffic accidents, we investigate methods of variable selection for spatial point process models on a linear network. The original data may include explanatory spatial covariates, such as road curvature, and ‘mark’ variables attributed to individual accidents, such as accident severity. The treatment of mark variables is new. Variable selection is applied to the canonical covariates, which may include spatial covariate effects, mark effects and mark‐covariate interactions. We approximate the likelihood of the point process model by that of a generalised linear model, in such a way that spatial covariates and marks are both associated with canonical covariates. We impose a convex penalty on the log likelihood, principally the elastic‐net penalty, and maximise the penalised loglikelihood by cyclic coordinate ascent. A simulation study compares the performances of the lasso, ridge regression and elastic‐net methods of variable selection on their ability to select variables correctly, and on their bias and standard error. Standard techniques for selecting the regularisation parameterγoften yielded unsatisfactory results. We propose two new rules for selectingγwhich are designed to have better performance. The methods are tested on a small dataset on crimes in a Chicago neighbourhood, and applied to a large dataset of road traffic accidents in Western Australia.
Limited evidence of moderation of the association between gastrointestinal symptoms and prospective healthcare utilisation by quality of life
Authors: McNaughton David T. , Andreasson Anna , Ljótsson Brjánn , Beath Alissa P. , Hush Julia M. , Ljunggren Gunnar , Schmidt Peter T. , Talley Nicholas J. , Agréus Lars , Jones Michael P. 
Published: October 2021

SummaryBackgroundAn individual’s drive to seek medical help remains a complex behavioural process, incorporating psychological, social and symptom‐specific factors. Within irritable bowel syndrome (IBS), gastrointestinal symptoms only predict a small portion of the high healthcare‐seeking experienced.AimTo examine the moderating role of quality of life (QoL) domains on this relationship to help explain the variance observed.MethodsThis is an analysis of a Swedish population‐based prospective study of healthcare use over a 12‐year period. At baseline, gastrointestinal symptoms were measured with the valid Gastrointestinal Symptom Rating Scale, and QoL via the SF‐36. 1159 subjects (57% female; mean age 48.6 years) had their health records matched with the initial survey. 164 were classified as IBS by Rome II criteria. Negative binomial or logistic models were fit to evaluate the moderating effect of particular QoL domains on the relationship between gastrointestinal symptoms and prospective healthcare utilisation.ResultsGastrointestinal symptoms were associated with prospective healthcare use, but moderation in this relationship by particular QoL domains was not supported; most models did not reach statistical significance. Furthermore, the impact of IBS status did not alter the moderation hypotheses.ConclusionsParticular QoL domains did not impact the relationship between gastrointestinal symptoms on prospective healthcare seeking. Future research should continue to examine other psychological, social and symptom variables to identify predictors of high healthcare consumers in IBS.
Randomised clinical trial: A phase 2 double‐blind study of namodenoson in non‐alcoholic fatty liver disease and steatohepatitis
Authors: Safadi Rifaat , Braun Marius , Francis Adi , Milgrom Yael , Massarwa Muhammad , Hakimian David , Hazou Wadi , Issachar Assaf , Harpaz Zivit , Farbstein Motti , Itzhak Inbal , Lev‐Cohain Naama , Bareket‐Samish Avital , Silverman Michael H. , Fishman Pnina 
Published: October 2021

SummaryBackgroundNamodenoson, an A3 adenosine receptor (A3AR) agonist, improved liver function/pathology in non‐alcoholic steatohepatitis (NASH) preclinical models.AimTo evaluate the efficacy and safety of namodenoson for the treatment of non‐alcoholic fatty liver disease (NAFLD) with or without NASHMethodsThis phase 2 study included 60 patients with NAFLD (ALT ≥60 IU/L) who were randomised (1:1:1) to oral namodenoson 12.5 mg b.d. (n = 21), 25 mg b.d. (n = 19), or placebo (n = 20) for 12 weeks (total follow‐up: 16 weeks). The main efficacy endpoint involved serum ALT after 12 weeks of treatment.ResultsSerum ALT decreased over time with namodenoson in a dose‐dependent manner. The difference between change from baseline (CFB) for ALT in the namodenoson 25 mg b.d. arm vs placebo trended towards significance at 12 weeks (P = 0.066). Serum AST levels also decreased with namodenoson in a dose‐dependent manner; at 12 weeks, the CFB for 25 mg b.d. vs placebo was significant (P = 0.03). At Week 12, 31.6% in the namodenoson 25 mg b.d. arm and 20.0% in the placebo arm achieved ALT normalisation (P = 0.405). At week 16, the respective rates were 36.8% and 10.0% (P = 0.038). A3AR expression levels were stable over time across study arms. Both doses of namodenoson were well tolerated with no drug‐emergent severe adverse events, drug‐drug interactions, hepatotoxicity, or deaths. Three adverse events were considered possibly related to study treatment: myalgia (12.5 mg b.d. arm), muscular weakness (25 mg b.d. arm), and headache (25 mg b.d. arm).ConclusionA3AR is a valid target; namodenoson 25 mg b.d. was safe and demonstrated efficacy signals (ClinicalTrials.gov #NCT02927314).
How participation in Covid‐19 mutual aid groups affects subjective well‐being and how political identity moderates these effects
Authors: Mao Guanlan , Drury John , Fernandes‐Jesus Maria , Ntontis Evangelos 
Published: October 2021

AbstractMutual aid groups have flourished during the Covid‐19 pandemic. However, a major challenge is sustaining such groups, which tend to decline following the initial upsurge immediately after emergencies. The present study investigates one possible motivation for continued participation: the well‐being benefits associated with psychological membership of groups, as suggested by the “social cure” approach. Interviews were conducted with 11 volunteers in a mutual aid group organized by ACORN, a community union and anti‐poverty campaigning organization. Through qualitative analysis, we show that participation provided well‐being in different ways: positive emotional experiences, increased engagement in life, improved social relationships, and greater sense of control. Participants also reported some negative emotional experiences. While all interviewees experienced benefits from participation, those who viewed their participation through a political lens were able to experience additional benefits such as feelings of empowerment. Moreover, the benefits conferred by a shared political identity appeared to be qualitatively different from the benefits conferred by other forms of shared identity. The interview data is used to hypothesize an overall process by which participants may come to attain a political identity via mutual aid. These findings have implications for how such groups retain their members and how authorities support these groups.
Laparoscopic left‐sided mesocolic leaf flap repair for pelvic reconstruction after sacral tissue necrosis. A case report
Authors: Koyama Makoto , Miyagawa Yusuke , Kitazawa Masato , Tanaka Atsushi , Yanagisawa Daisuke , Muranaka Futoshi , Tokumaru Shigeo , Nakamura Satoshi , Yamamoto Yuta , Hondo Nao , Takahata Shugo , Tanaka Hirokazu , Kuroiwa Masatsugu , Soejima Yuji 
Published: October 2021

AbstractRadical surgical procedures for malignant diseases of the pelvis result in a large pelvic defect that requires soft tissue reconstruction. The mesentery can be used for pelvic floor reconstruction when debridement with intestinal resection is required. A 75‐year‐old woman was diagnosed with sacral necrosis, infection and sepsis after carbon ion radiotherapy for sacral chordoma. She underwent sacral debridement three times, which resulted in a large pelvic defect of 14 × 13 cm. Surgery was performed to completely resect the necrotic tissue. We performed extended debridement of sacrum and adjacent tissue around the rectum and anus. Since it was impossible to preserve the anus, laparoscopic left hemicolectomy, abdominosacral resection, and left‐sided mesocolic leaf repair for the pelvic defect, and reconstructed the pelvis and buttocks using a gluteal thigh flap were performed. Indocyanine green fluorescent (ICG) imaging was used to detect the margin of the pelvic floor and necrotic tissue and the blood flow of the left‐sided mesocolic leaf flap. Left‐sided mesocolic leaf reconstruction is useful for large pelvic defects. ICG imaging enabled the detection of the resection margins and the blood flow of the mesocolic leaf.
Invasive experimental brain surgery for dementia: Ethical shifts in clinical research practices?
Authors: Gilbert Frederic , Viaña John Noel M. , Bittlinger Merlin , Stevens Ian , Farrow Maree , Vickers James , Dodds Susan , Illes Judy 
Published: October 2021

AbstractThe increasing dementia prevalence worldwide is driving the testing of novel therapeutic approaches, such as invasive brain technologies, despite limited clinical evidence and the risk of accelerating cognitive decline. Our manuscript (a) reviews the NIH Clinicaltrials.gov database for deep brain stimulation, stem cell implantation, and gene therapy trials on people with dementia; (b) discusses issues on beneficence, nonmaleficence, and autonomy associated with these trials; and (c) proposes nine recommendations that build on elements from the Declaration of Helsinki. We found 49 preregistered high‐risk trials from nine countries planning to or involving 11,801 people with Alzheimer's or Lewy body dementia or dementia secondary to Parkinson's or Huntington's disease. Most of the people with Alzheimer's who are in these trials are from North America and East Asia. There is substantial heterogeneity in the enrolment criteria, even for trials recruiting only those with Alzheimer's disease. Although most trials enrol people in mild to moderate stages of Alzheimer's disease, trials in China enrol people who have severe Alzheimer's. Our findings highlight a pressing need to review and refine the enrolment criteria for invasive neural trials in people with dementia, considering risks, potential benefits, and capacity for informed consent. As a multidisciplinary team from Australia, the USA, Canada, and Germany with expertise in neurology, neuroscience, and ethics, we examine how it is essential to balance the risks of invasive neural research in a vulnerable population with limited capacity to provide informed consent to help advance the body of knowledge regarding a disease with limited therapeutic options.
The importance of developing care‐worker‐centered robotic aides in long‐term care
Authors: Apostolova Iva , Lanoix Monique 
Published: October 2021

AbstractRecent research points to the fact that new medical technological innovations are just as relevant in the context of long‐term care or chronic care as they are in the context of acute care. In the spirit of the Nuffield Foundation recommendations, this paper explores the possibilities of using robotic aides in long‐term care and identifies the tensions that must be considered and addressed if robotics is to be introduced successfully in nursing homes. Our examination is two‐pronged. First, we delve into a fundamental issue surrounding AI, namely that of consciousness. We argue that automation will always have only a limited use in caregiving since caregiving as an activity requires the use of human‐type, that is, organic, consciousness. We support the thesis that the emergence and formation of human‐type consciousness require feelings such as empathy and the sense of touch, which, in turn, create the sense of kinship with fellow human beings. And second, we examine the benefits as well as risks of using robotic aides such as ZORA and PARO in long‐term care facilities. More specifically, we look at ZORA's use in a group setting, and PARO's use in an individual setting. We emphasize that long‐term care is one‐on‐one care, including but not limited to intimate care. Crucially, we argue that touch is at the heart of this type of care. We argue that some of the tensions with the use of robotic aides are generated precisely because of the lack of human touch.
Promise and pitfalls of allogeneic chimeric antigen receptor therapy in plasma cell and lymphoid malignancies
Authors: Dhakal Binod , Chhabra Saurabh , Savani Bipin N. , Hamadani Mehdi 
Published: October 2021

SummaryChimeric antigen receptor (CAR) T‐cell therapy is a promising immunotherapy in haematological malignancies. However, the currently approved products are generated from autologous T cells that require orchestration of several logistically complex steps, which include patient eligibility, apheresis capability, complex manufacturing processes and shipping logistics. Use of third‐party donor‐derived (allogeneic) effector cells that allows the generation of ‘off‐the‐shelf” CAR T cells (allo‐CAR) could circumvent many of the problems associated with autologous CAR T‐cell therapy. Several allogeneic products are entering clinical trials, and though early, the results look promising. The recognised potential benefits of allo‐CAR do not come without significant challenges, that must be overcome for their widespread use. Alloreactivity, i.e. graft‐versus‐host disease (GVHD), and rejection of donor T cells is one of the major barriers, while other potential barriers include immunogenicity, unknown in vivo persistence, and CAR T‐cell yield. In the present review, we provide a comprehensive review of the challenges associated with autologous CAR, the benefits and potential challenges associated with allo‐CAR. Finally, we review the available platforms for allo‐CAR for B‐cell and plasma cell malignancies.
The Triple‐Tracer strategy against Metastatic PrOstate cancer (3TMPO) study protocol
Authors: Pouliot Frédéric , Beauregard Jean‐Mathieu , Saad Fred , Trudel Dominique , Richard Patrick O. , Turcotte Éric , Rousseau Étienne , Probst Stephan , Kassouf Wassim , Anidjar Maurice , Camirand Lemyre Félix , Bouvet Guillaume F. , Neveu Bertrand , Tétu Amélie , Guérin Brigitte 
Published: October 2021

ObjectiveTo determine the prevalence of intra‐patient inter‐metastatic heterogeneity based on positron emission tomography (PET)/computed tomography (CT) in patients with metastatic castration‐resistant prostate cancer (mCRPC) and to determine the prevalence of neuroendocrine disease in these patients and their eligibility for radioligand therapies (RLTs).Patients and MethodsThis multicentre observational prospective clinical study will include 100 patients with mCRPC from five Canadian academic centres. Patients with radiological or biochemical progression and harbouring at least three metastases by conventional imaging will be accrued. Intra‐patient inter‐metastatic heterogeneity will be determined with triple‐tracer imaging using fluorine‐18 fluorodeoxyglucose (18F‐FDG), gallium‐68‐(68Ga)‐prostate‐specific membrane antigen (PSMA)‐617 and 68Ga‐DOTATATE, which are a glucose analogue, a PSMA receptor ligand and a somatostatin receptor ligand, respectively. The 68Ga‐PSMA‐617 and 18F‐FDG PET/CT scans will be performed first. If at least one PSMA‐negative/FDG‐positive lesion is observed, an additional PET/CT scan with 68Ga‐DOTATATE will be performed. The tracer uptake of individual lesions will be assessed for each PET tracer and patients with lesions presenting discordant uptake profiles will be considered as having inter‐metastatic heterogeneous disease and may be offered a biopsy.Expected ResultsThe proposed triple‐tracer approach will allow whole‐body mCRPC characterisation, investigating the inter‐metastatic heterogeneity in order to better understand the phenotypic plasticity of prostate cancer, including the neuroendocrine transdifferentiation that occurs during mCRPC progression. Based on 68Ga‐PSMA‐617 or 68Ga‐DOTATATE PET positivity, the potential eligibility of patients for PSMA and DOTATATE‐based RLT will be assessed. Non‐invasive whole‐body determination of mCRPC heterogeneity and transdifferentiation is highly innovative and might establish the basis for new therapeutic strategies. Comparison of molecular imaging findings with biopsies will also link metastasis biology to radiomic features.ConclusionThis study will add novel, biologically relevant dimensions to molecular imaging: the non‐invasive detection of inter‐metastatic heterogeneity and transdifferentiation to neuroendocrine prostate cancer by using a multi‐tracer PET/CT strategy to further personalise the care of patients with mCRPC.
A comparative evaluation of factor‐ and component‐based structural equation modelling approaches under (in)correct construct representations
Authors: Cho Gyeongcheol , Sarstedt Marko , Hwang Heungsun 
Published: October 2021

Structural equation modelling (SEM) has evolved into two domains, factor‐based and component‐based, dependent on whether constructs are statistically represented as common factors or components. The two SEM domains are conceptually distinct, each assuming their own population models with either of the statistical construct proxies, and statistical SEM approaches should be used for estimating models whose construct representations correspond to what they assume. However, SEM approaches have often been evaluated and compared only under population factor models, providing misleading conclusions about their relative performance. This is partly because population component models and their relationships have not been clearly formulated. Also, it is of fundamental importance to examine how robust SEM approaches can be to potential misrepresentation of constructs because researchers may often lack clear theories to determine whether a factor or component is more representative of a given construct. Addressing these issues, this study begins by clarifying several population component models and their relationships and then provides a comprehensive evaluation of four SEM approaches – the maximum likelihood approach and factor score regression for factor‐based SEM as well as generalized structured component analysis (GSCA) and partial least squares path modelling (PLSPM) for component‐based SEM – under various experimental conditions. We confirm that the factor‐based SEM approaches should be preferred for estimating factor models, whereas the component‐based SEM approaches should be chosen for component models. Importantly, the component‐based approaches are generally more robust to construct misrepresentation than the factor‐based ones. Of the component‐based approaches, GSCA should be chosen over PLSPM, regardless of whether or not constructs are misrepresented.
Online sales, home delivery, and the platform economy
Authors: Yu Eden S. H. , Chao Chi‐Chur 
Published: October 2021

AbstractThis paper examines the income distribution and welfare effects of online sales and home delivery by considering an emerging platform economy with urban and rural regions. With a given number of urban manufacturing firms, a rise in online sales, which boosts home delivery, can reduce the wage inequality between skilled and unskilled labor in the short run. The wage gap can be narrowed further in the long run with the exit of manufacturing firms. Moreover, firm exit can mitigate the excessive number of firms in the urban manufacturing sector, thus improving the welfare of the platform economy and increasing the optimal size of online sales in the long run.