bluuebunny/crossref_metadata_2025_split huggingface dataset:
Procedurally Robust Risk Assessment Framework for Novel Genetically Engineered Organisms and Gene Drives
Authors: Kuzma Jennifer 
Published: March 2019

AbstractIn this article, a new framework for improving risk assessments of novel genetically engineered organisms (GEOs) is developed and applied. The Procedurally Robust Risk Assessment Framework (PRRAF) provides a set of principles and criteria for assessing and enhancing risk assessment protocols for GEOs under conditions of high uncertainty. The application of PRRAF is demonstrated using the case of a genetically engineered mosquito designed to kill its wild population and therefore decrease disease transmission. Assessments for regulatory approval of this genetically engineered insect fall short of several PPRAF criteria under the principles of humility, procedural validity, inclusion, anticipation, and reflexivity. With the emergence of GEOs designed to spread in ecosystems, such as those with gene drives, it will become increasingly important for regulatory agencies and technology developers to bolster their risk analysis methods and processes prior to field testing. PRRAF can be used as a flexible guide for doing so within a variety of institutional, regulatory, and governance contexts.
Concept of Triple Heat Exchanger-Assisted Solar Pond Through an Improved Analytical Model
Authors: Verma Sunirmit , Das Ranjan 
Published: March 2019

Abstract
A new three-zone heat extraction system and its analytical model for maximizing the thermal power output of salt gradient solar ponds against a given volume is proposed. The present study considers internal heat exchangers installed within the non-convective zone (NCZ), lower-convective zone (LCZ), and the ground below the pond. The work is validated against a simplified version of the model (eliminating ground and bottom-zone heat extractions) available in the existing literature. Contrary to the conventional practice of optimizing only the middle-zone pond thickness, here, the newly proposed expression is used to find ideal values of both the middle- and bottom-zone thicknesses of the pond along with its cross-sectional area. The present work acknowledges that although the three-zone heat extraction system is the best, yet if a choice for two-zone heat extraction is to be made between the NCZ–LCZ and ground–LCZ, then the former is a better alternative. The power output is observed to increase asymptotically with mass flow rates of the three heat exchangers. However, their values must lie much below their theoretical asymptotic limits and their selection is regulated by constructional and operational constraints. These involve a minimum pond depth to offset surface evaporation, ground seepage water loss, and constraints preventing turbulent flow in heat exchangers to reduce friction loss and pumping power. This work recommends using three heat exchangers instead of either one or two and provides cardinal guidelines to extract heat in an ideal manner for a fixed solar pond volume.
Prevalence of and risk factors for chronic kidney disease of unknown aetiology in India: secondary data analysis of three population-based cross-sectional studies
Authors: O’Callaghan-Gordo Cristina , Shivashankar Roopa , Anand Shuchi , Ghosh Shreeparna , Glaser Jason , Gupta Ruby , Jakobsson Kristina , Kondal Dimple , Krishnan Anand , Mohan Sailesh , Mohan Viswanathan , Nitsch Dorothea , P A Praveen , Tandon Nikhil , Narayan K M Venkat , Pearce Neil , Caplin Ben , Prabhakaran Dorairaj 
Published: March 2019

ObjectivesTo assess whether chronic kidney disease of unknown aetiology (CKDu) is present in India and to identify risk factors for it using population-based data and standardised methods.DesignSecondary data analysis of three population-based cross-sectional studies conducted between 2010 and 2014.SettingUrban and rural areas of Northern India (states of Delhi and Haryana) and Southern India (states of Tamil Nadu and Andhra Pradesh).Participants12 500 individuals without diabetes, hypertension or heavy proteinuria.Outcome measuresMean estimated glomerular filtration rate (eGFR) and prevalence of eGFR below 60 mL/min per 1.73 m2(eGFR <60) in individuals without diabetes, hypertension or heavy proteinuria (proxy definition of CKDu).ResultsThe mean eGFR was 105.0±17.8 mL/min per 1.73 m2. The prevalence of eGFR <60 was 1.6% (95% CI=1.4 to 1.7), but this figure varied markedly between areas, being highest in rural areas of Southern Indian (4.8% (3.8 to 5.8)). In Northern India, older age was the only risk factor associated with lower mean eGFR and eGFR <60 (regression coefficient (95% CI)=−0.94 (0.97 to 0.91); OR (95% CI)=1.10 (1.08 to 1.11)). In Southern India, risk factors for lower mean eGFR and eGFR <60, respectively, were residence in a rural area (−7.78 (-8.69 to –6.86); 4.95 (2.61 to 9.39)), older age (−0.90 (–0.93 to –0.86); 1.06 (1.04 to 1.08)) and less education (−0.94 (-1.32 to –0.56); 0.67 (0.50 to 0.90) for each 5 years at school).ConclusionsCKDu is present in India and is not confined to Central America and Sri Lanka. Identified risk factors are consistent with risk factors previously reported for CKDu in Central America and Sri Lanka.
Validation of adverse events after hip arthroplasty: a Swedish multi-centre cohort study
Authors: Magnéli Martin , Unbeck Maria , Rogmark Cecilia , Rolfson Ola , Hommel Ami , Samuelsson Bodil , Schildmeijer Kristina , Sjöstrand Desirée , Gordon Max , Sköldenberg Olof 
Published: March 2019

ObjectivesPreventing adverse events (AEs) after orthopaedic surgery is a field with great room for improvement. A Swedish instrument for measuring AEs after hip arthroplasty based on administrative data from the national patient register is used by both the Swedish Hip Arthroplasty Register and the Swedish Association of Local Authorities and Regions. It has never been validated and its accuracy is unknown. The aim of this study was to validate the instrument’s ability to detect AEs, and to calculate the incidence of AEs following primary hip arthroplasties.DesignRetrospective cohort study using retrospective record review with Global Trigger Tool methodology in combination with register data.Setting24 different hospitals in four major regions of Sweden.Participants2000 patients with either total or hemi-hip arthroplasty were recruited from the SHAR. We included both acute and elective patients.Primary and secondary outcome measuresThe sensitivity and specificity of the instrument. Adjusted cumulative incidence and incidence rate.ResultsThe sensitivity for all identified AEs was 5.7% (95% CI: 4.9% to 6.7%) for 30 days and 14.8% (95% CI: 8.2 to 24.3) for 90 days, and the specificity was 95.2% (95% CI: 93.5% to 96.6%) for 30 days and 92.1% (95% CI: 89.9% to 93.8%) for 90 days. The adjusted cumulative incidence for all AEs was 28.4% (95% CI: 25.0% to 32.3%) for 30 days and 29.5% (95% CI: 26.0% to 33.8%) for 90 days. The incidence rate was 0.43 AEs per person-month (95% CI: 0.39 to 0.47).ConclusionsThe AE incidence was high, and most AEs occurred within the first 30 days. The instrument sensitivity for AEs was very low for both 30 and 90 days, but the specificity was high for both 30 and 90 days. The studied instrument is insufficient for valid measurements of AEs after hip arthroplasty.
Clustering of cardiovascular disease biological risk factors among older adults in Shenzhen City, China: a cross-sectional study
Authors: Ni Wenqing , Weng Rongxing , Yuan Xueli , Lv Deliang , Song Jinping , Chi Hongshan , Liu Hailong , Xu Jian 
Published: March 2019

ObjectivesFew studies reported the clustering of cardiovascular disease (CVD) biological risk factors among older adults. The objective of this study was to characterise the clustering of CVD biological risk factors among adults aged 65 or older in Shenzhen city, China.DesignCross-sectional study.SettingGeneral communities in Shenzhen, Guangdong, China.ParticipantsA representative sample of 5635 participants aged 65 or older participated in the survey with a response rate of 93.6%.Main outcome measuresIndividual CVD biological risk factors (overweight/obesity, central obesity, hypertension, dyslipidaemia and diabetes) and their clustering.ResultsThe prevalence of overweight, obesity, central obesity, hypertension, dyslipidaemia and diabetes in this study was 37.4%, 10.8%, 37.0%, 51.9%, 40.2% and 18.0%, respectively. The mean count of CVD biological risk factors per participant was 1.95. The 86.0% of the participants presented at least one CVD biological risk factor and 33.8% of the participants presented clustering of CVD biological risk factors, that is, presenting three or more CVD biological risk factors, as defined in this study. Multivariable logistic regression analysis showed that gender, age, and drinking and smoking status were significantly associated with clustering of CVD biological risk factors (P<0.05). Women, the older and alcohol drinkers were more likely to have clustering of CVD biological risk factors.ConclusionsThe prevalence of CVD biological risk factors is fairly high in the older adults with a tendency of clustering in Shenzhen. The findings highlight the need for integrated management of CVD biological risk factors among older adults.
PrEP Implementation for Mothers in Antenatal Care (PrIMA): study protocol of a cluster randomised trial
Authors: Dettinger Julia C , Kinuthia John , Pintye Jillian , Mwongeli Nancy , Gómez Laurén , Richardson Barbra A , Barnabas Ruanne , Wagner Anjuli D , O’Malley Gabrielle , Baeten Jared M , John-Stewart Grace 
Published: March 2019

IntroductionWomen in regions with high HIV prevalence are at high risk of HIV acquisition during pregnancy and postpartum, and acute maternal HIV contributes a substantial proportion of infant HIV infections. Pre-exposure prophylaxis (PrEP) could prevent HIV during pregnancy/postpartum; however, identifying women who would most benefit from PrEP in this period is challenging. Women may not perceive risk, may not know partner HIV status and partners may have external partners during this period. PrEP offer in pregnancy could be universal or risk guided.Methods and analysisThe PrEP Implementation for Mothers in Antenatal Care (PrIMA) study is a cluster randomised trial that aims to determine the best model for PrEP implementation in pregnancy, among women attending public sector maternal child health clinics in Western Kenya (HIV prevalence >25%). Twenty clinics are randomised to either universal PrEP offer following standardised counselling (‘Universal arm’ 10 clinics) or risk screening with partner self-test option (‘Targeted arm’ 10 clinics). Four thousand women will be enrolled and followed through 9-month postpartum. The primary analysis will be intention to treat. Outcomes reflect the balance between HIV preventive effectiveness and avoiding unnecessary PrEP exposure to women at low risk and include: maternal HIV incidence, PrEP uptake, PrEP adherence, PrEP duration, ‘appropriate’ PrEP use (among women with objective evidence of potential risk), infant birth outcomes, infant growth and partner self-testing uptake. To better understand the feasibility and acceptability of the provision of PrEP in these settings, qualitative interviews and cost-effectiveness analyses will be conducted.Ethics and disseminationThe protocol was approved by the institutional review boards at Kenyatta National Hospital and the University of Washington. An external advisory panel monitors adverse and social harm events. Results will be disseminated through peer-reviewed journals, presentations at local and international conferences to national and global policy makers, community and participants.Trial registration numberNCT03070600.
Community ageing research 75+ study (CARE75+): an experimental ageing and frailty research cohort
Authors: Heaven Anne , Brown Lesley , Young John , Teale Elizabeth , Hawkins Rebecca , Spilsbury Karen , Mountain Gail , Young Tracey , Goodwin Victoria , Hanratty Barbara , Chew-Graham Carolyn , Brundle Caroline , Mahmood Farhat , Jacob Ikhlaq , Daffu-O’Reilly Amrit , Clegg Andrew 
Published: March 2019

IntroductionThe Community Ageing Research 75+ Study (CARE75+) is a longitudinal cohort study collecting an extensive range of health, social and economic data, with a focus on frailty, independence and quality of life in older age. CARE75+ is the first international experimental frailty research cohort designed using Trial within Cohorts (TwiCs) methodology, to align applied epidemiological research with clinical trial evaluation of interventions to improve the health and well-being of older people living with frailty.Methods and analysisProspective cohort study using a TwiCs design. One thousand community-dwelling older people (≥75 years) will be recruited from UK general practices. Nursing home residents, those with an estimated life expectancy of 3 months or less and people receiving palliative care will be excluded. Data collection assessments will be face to face in the person’s home at baseline, 6 months, 12 months, 24 months and 48 months, including assessments of frailty, cognition, mood, health-related quality of life, comorbidity, medications, resilience, loneliness, pain and self-efficacy. A modified protocol for follow-up by telephone or web based will be offered at 6 months. Consent will be sought for data linkage and invitations to additional studies, including intervention studies using the TwiCs design. A blood sample biobank will be established for future basic science studies.Ethics and disseminationCARE75+ was approved by the NRES Committee Yorkshire and the Humber—Bradford Leeds 10 October 2014 (14/YH/1120). Formal written consent is sought if an individual is willing to participate and has capacity to provide informed consent. Consultee assent is sought if an individual lacks capacity.Study results will be disseminated in peer-reviewed scientific journals and scientific conferences. Key study results will be summarised and disseminated to all study participants via newsletters, local older people’s publications and local engagement events. Results will be reported on a bespoke CARE75+ website.Trial registration numberISRCTN16588124;Results stage
Community-based testing of migrants for infectious diseases (COMBAT-ID): impact, acceptability and cost-effectiveness of identifying infectious diseases among migrants in primary care: protocol for an interrupted time-series, qualitative and health economic analysis
Authors: Pareek Manish , Eborall Helen C , Wobi Fatimah , Ellis Kate S , Kontopantelis Evangelos , Zhang Fang , Baggaley Rebecca , Hollingsworth T Deirdre , Baines Darrin , Patel Hemu , Haldar Pranabashis , Patel Mayur , Stephenson Iain , Browne Ivan , Gill Paramjit , Kapur Rajesh , Farooqi Azhar , Abubakar Ibrahim , Griffiths Chris 
Published: March 2019

BackgroundMigration is a major global driver of population change. Certain migrants may be at increased risk of infectious diseases, including tuberculosis (TB), HIV, hepatitis B and hepatitis C, and have poorer outcomes. Early diagnosis and management of these infections can reduce morbidity, mortality and onward transmission and is supported by national guidelines. To date, screening initiatives have been sporadic and focused on individual diseases; systematic routine testing of migrant groups for multiple infections is rarely undertaken and its impact is unknown. We describe the protocol for the evaluation of acceptability, effectiveness and cost-effectiveness of an integrated approach to screening migrants for a range of infectious diseases in primary care.Methods and analysisWe will conduct a mixed-methods study which includes an observational cohort with interrupted time-series analysis before and after the introduction of routine screening of migrants for infectious diseases (latent TB, HIV, hepatitis B and hepatitis C) when first registering with primary care within Leicester, UK. We will assess trends in the monthly number and rate of testing and diagnosis for latent TB, HIV, hepatitis B and hepatitis C to determine the effect of the policy change using segmented regression analyses at monthly time-points. Concurrently, we will undertake an integrated qualitative sub-study to understand the views of migrants and healthcare professionals to the new testing policy in primary care. Finally, we will evaluate the cost-effectiveness of combined infection testing for migrants in primary care.Ethics and disseminationThe study has received HRA and NHS approvals for both the interrupted time-series analysis (16/SC/0127) and the qualitative sub-study (16/EM/0159). For the interrupted time-series analysis we will only use fully anonymised data. For the qualitative sub-study, we will gain written, informed, consent. Dissemination of the results will be through local and national meetings/conferences as well as publications in peer-reviewed journals.
Corticolimbic fast-tracking: enhanced multimodal integration in functional neurological disorder
Authors: Diez Ibai , Ortiz-Terán Laura , Williams Benjamin , Jalilianhasanpour Rozita , Ospina Juan Pablo , Dickerson Bradford C , Keshavan Matcheri S , LaFrance Jr W Curt , Sepulcre Jorge , Perez David L 
Published: March 2019

ObjectiveSome individuals with functional neurological disorder (FND) exhibit motor and affective disturbances, along with limbic hyper-reactivity and enhanced motor-limbic connectivity. Given that the multimodal integration network (insula, dorsal cingulate, temporoparietal junction (TPJ)) is implicated in convergent sensorimotor, affective and interoceptive processing, we hypothesised that patients with FND would exhibit altered motor and amygdalar resting-state propagation to this network. Patient-reported symptom severity and clinical outcome were also hypothesised to map onto multimodal integration areas.MethodsBetween-group differences in primary motor and amygdalar nuclei (laterobasal, centromedial) were examined using graph-theory stepwise functional connectivity (SFC) in 30 patients with motor FND compared with 30 healthy controls. Within-group analyses correlated functional propagation profiles with symptom severity and prospectively collected 6-month outcomes as measured by the Screening for Somatoform Symptoms Conversion Disorder subscale and Patient Health Questionnaire-15 composite score. Findings were clusterwise corrected for multiple comparisons.ResultsCompared with controls, patients with FND exhibited increased SFC from motor regions to the bilateral posterior insula, TPJ, middle cingulate cortex and putamen. From the right laterobasal amygdala, the FND cohort showed enhanced connectivity to the left anterior insula, periaqueductal grey and hypothalamus among other areas. In within-group analyses, symptom severity correlated with enhanced SFC from the left anterior insula to the right anterior insula and TPJ; increased SFC from the left centromedial amygdala to the right anterior insula correlated with clinical improvement. Within-group associations held controlling for depression, anxiety and antidepressant use.ConclusionsThese neuroimaging findings suggest potential candidate neurocircuit pathways in the pathophysiology of FND.
Multicentre, population-based, case–control study of particulates, combustion products and amyotrophic lateral sclerosis risk
Authors: Visser Anne E , D'Ovidio Fabrizio , Peters Susan , Vermeulen Roel CH , Beghi Ettore , Chiò Adriano , Veldink Jan H , Logroscino Giancarlo , Hardiman Orla , van den Berg Leonard H 
Published: March 2019

ObjectiveTo investigate whether exposure to particulates and combustion products may explain the association between certain occupations and amyotrophic lateral sclerosis (ALS) risk in a large, multicentre, population-based, case–control study, based on full job histories, using job-exposure matrices, with detailed information on possible confounders.MethodsPopulation-based patients with ALS and controls were recruited from five registries in the Netherlands, Ireland and Italy. Demographics and data regarding educational level, smoking, alcohol habits and lifetime occupational history were obtained using a validated questionnaire. Using job-exposure matrices, we assessed occupational exposure to silica, asbestos, organic dust, contact with animals or fresh animal products, endotoxins, polycyclic aromatic hydrocarbons and diesel motor exhaust. Multivariate logistic regression models adjusting for confounding factors were used to determine the association between these exposures and ALS risk.ResultsWe included 1557 patients and 2922 controls. Associations were positive for all seven occupational exposures (ORs ranging from 1.13 to 1.73 for high vs never exposed), and significant on the continuous scale for silica, organic dust and diesel motor exhaust (p values for trend ≤0.03). Additional analyses, adding an exposure (one at a time) to the model in the single exposure analysis, revealed a stable OR for silica. We found similar results when patients with a C9orf72 mutation were excluded.ConclusionIn a large, multicentre study, using harmonised methodology to objectively quantify occupational exposure to particulates and combustion products, we found an association between ALS risk and exposure to silica, independent of the other occupational exposures studied.
Frequency of molecular detection of equine coronavirus in faeces and nasal secretions in 277 horses with acute onset of fever
Authors: Pusterla Nicola , James Kaitlyn , Mapes Samantha , Bain Farifield 
Published: March 2019

ContextDue to the inconsistent development of enteric signs associated with ECoV infection in adult horses, many practitioners collect nasal secretions rather than feces for the molecular diagnostic work‐up of such horses.Main conclusionECoV infection should be considered in horses presenting with acute onset of fever, especially when nasal discharge is absent as one of the cardinal clinical sign.ApproachA total of 277 adult horses with acute onset of fever were enrolled in this study. Feces were tested for ECoV and nasal secretions for common respiratory pathogens (equine herpesvirus (EHV)‐1, EHV‐4, equine influenza virus (EIV), equine rhinitis viruses (ERVs) and Streptococcus equi ss. equi) and ECoV by qPCR. Each submission was accompanied by a questionnaire requesting information pertaining to signalment, use, recent transportation, number of affected horses on the premise and presence of clinical signs at the time of sample collection.ResultsThe total number of horses testing qPCR‐positive for ECoV in feces was 20 (7.2%), 4 of which also tested qPCR‐positive for ECoV in nasal secretions. In the same population 9.0% of horses tested qPCR‐positive for EHV‐4, 6.1% for EIV, 4.3% for Streptococcus equi ss. equi, 3.2% for ERVs and 0.7% for EHV‐1. Draft horses, pleasure use, multiple horses affected on a premise and lack of nasal discharge were significantly associated with ECoV qPCR‐positive horses.InterpretationThe present study results showed that 7.2% of horses with acute onset of fever tested qPCR‐positive for ECoV in feces, highlighting the importance of testing such horses for ECoV in feces. The various prevalence factors associated with ECoV qPCR‐positive status likely relate to the high infectious nature of ECoV and breed‐specific differences in management and husbandry practices.Significance of findingsECoV infection should be suspected and tested for in horses presenting with acute onset of fever, lethargy and anorexia with no respiratory signs. A two‐step approach should be consider in which respiratory secretions and feces should be collected from such horses and submitted to a diagnostic laboratory. If the respiratory secretions test negative by qPCR for a panel of respiratory pathogens, feces already submitted to the laboratory should be tested for ECoV.