bluuebunny/crossref_metadata_2025_split huggingface dataset:
Increased stress, weight gain and less exercise in relation to glycemic control in people with type 1 and type 2 diabetes during the COVID-19 pandemic
Authors: Ruissen Merel M , Regeer Hannah , Landstra Cyril P , Schroijen Marielle , Jazet Ingrid , Nijhoff Michiel F , Pijl Hanno , Ballieux Bart E P B , Dekkers Olaf , Huisman Sasja D , de Koning Eelco J P 
Published: January 2021

IntroductionLockdown measures have a profound effect on many aspects of daily life relevant for diabetes self-management. We assessed whether lockdown measures, in the context of the COVID-19 pandemic, differentially affect perceived stress, body weight, exercise and related this to glycemic control in people with type 1 and type 2 diabetes.Research design and methodsWe performed a short-term observational cohort study at the Leiden University Medical Center. People with type 1 and type 2 diabetes ≥18 years were eligible to participate. Participants filled out online questionnaires, sent in blood for hemoglobin A1c (HbA1c) analysis and shared data of their flash or continuous glucose sensors. HbA1c during the lockdown was compared with the last known HbA1c before the lockdown.ResultsIn total, 435 people were included (type 1 diabetes n=280, type 2 diabetes n=155). An increase in perceived stress and anxiety, weight gain and less exercise was observed in both groups. There was improvement in glycemic control in the group with the highest HbA1c tertile (type 1 diabetes: −0.39% (−4.3 mmol/mol) (p<0.0001 and type 2 diabetes: −0.62% (−6.8 mmol/mol) (p=0.0036). Perceived stress was associated with difficulty with glycemic control (p<0.0001).ConclusionsAn increase in perceived stress and anxiety, weight gain and less exercise but no deterioration of glycemic control occurs in both people with relatively well-controlled type 1 and type 2 diabetes during short-term lockdown measures. As perceived stress showed to be associated with glycemic control, this provides opportunities for healthcare professionals to put more emphasis on psychological aspects during diabetes care consultations.
Protocol for a young adult mental health (Uspace) cohort: personalising multidimensional care in young people admitted to hospital
Authors: Tickell Ashleigh M , Rohleder Cathrin , Garland Alexandra , Song Yun Ju Christine , Carpenter Joanne Sarah , Harel Kate , Parker Lisa , Hickie Ian B , Scott Elizabeth 
Published: January 2021

IntroductionCurrently, the literature on personalised and measurement-based mental healthcare is inadequate with major gaps in the development and evaluation of 21st century service models. Clinical presentations of mental ill health in young people are heterogeneous, and clinical and functional outcomes are often suboptimal. Thus, treatments provided in a person-centred and responsive fashion are critical to meet the unique needs of young people and improve individual outcomes. Personalised care also requires concurrent assessment of factors relating to outcomes and underlying neurobiology. This study builds on a completed feasibility study and will be the first to incorporate clinical, cognitive, circadian, metabolic and hormonal profiling with personalised and measurement-based care in a cohort of young people admitted to hospital.Methods and analysisThis prospective, transdiagnostic, observational study will be offered to all young people between the ages of 16 and 30 years admitted to the inpatient unit of the participating centre. In total, 400 participants will be recruited. On admission to hospital, young people will undergo clinical and diagnostic assessment, cognitive testing, self-report questionnaires, metabolic and hormonal data collection, and anthropomorphic measurements. Participants will wear an actigraphy watch for at least 1 week during admission to measure circadian patterns and sleep-wake cycles. A feedback session between clinician and participant will occur after clinical and other laboratory assessments to tailor individual treatment plans, explain the ongoing process of measurement-based care, and provide participant and family education. Associations between cognitive impairments, disturbed sleep-wake behaviours, circadian rhythms, clinical symptoms and functional impairments will be evaluated to improve the understanding of parameters affecting clinical outcomes.Ethics and disseminationThis study protocol was approved by the Human Research Ethics Committees of the University of Sydney (HREC USYD 2015/867) and St Vincent’s Hospital (HREC SVH 17/045). This study will be published on completion in a peer-reviewed journal.
Effects of family history of diabetes on pancreatic β-cell function and diabetic ketoacidosis in newly diagnosed patients with type 2 diabetes: a cross-sectional study in China
Authors: Xiong Xiaofen , Wei Ling , Xiao Ying , Han Yachun , Yang Jinfei , Zhao Hao , Yang Ming , Sun Lin 
Published: January 2021

ObjectiveTo investigate the association between a parental and/or sibling history of diabetes and clinical characteristics.DesignA cross-sectional study.SettingThe data were collected from the endocrinology department of The Second Xiangya Hospital of Central South University from June 2017 to October 2019.ParticipantsA total of 894 newly diagnosed patients with type 2 diabetes were recruited. Data on clinical characteristics were collected from patient medical records. Pancreatic β-cell function and insulin resistance were calculated with the homeostatic model assessment. SPSS V.25.0 was used to perform the analysis.ResultsThe percentages of patients with parental and sibling histories of diabetes were 14.8% and 9.8%, respectively. The prevalence of diabetic ketoacidosis (DKA) was 3.9%. Compared with those with no parental history of diabetes, patients with a parental history of diabetes were characterised by early-onset disease (41.70±10.88 vs 51.17±14.09 years), poor glycaemic control of fasting blood glucose (10.84±5.21 vs 8.91±4.38 mmol/L) and a high prevalence of DKA (7.6% vs 3.3%). The patients with a sibling history of diabetes had later disease onset (56.05±9.86 vs 49.09±14.29 years) and lower BMI (24.49±3.48 vs 25.69±3.86 kg/m2) than those with no sibling history of diabetes. Univariate regression suggested that both parental history (p=0.037) and sibling history (p=0.011) of diabetes were associated with β-cell function; however, multiple regression analysis showed that only a sibling history of diabetes was associated with β-cell function (p=0.038). Univariate regression revealed a positive correlation between parental history of diabetes (p=0.023, OR=2.416, 95% CI 1.132 to 5.156) and DKA. Unfortunately, this correlation was not statistically significant for either patients with a parental history (p=0.234, OR=1.646, 95% CI 0.724 to 3.743) or those with a sibling history (p=0.104, OR=2.319, 95% CI 0.841 to 6.389) after adjustments for confounders.ConclusionA sibling history of diabetes was associated with poor β-cell function, and a parental history of diabetes was associated with poor glycaemic control and a high prevalence of DKA.
Multiplicity and complexity: a qualitative exploration of influences on prescribing in UK general practice
Authors: Carter Mary , Chapman Sarah , Watson Margaret C 
Published: January 2021

ObjectivesDespite widespread availability of evidence-based guidelines to inform rational use of medicines, considerable unwarranted variation exists in prescribing. A greater understanding of key determinants of contemporary prescribing in UK general practice could inform strategies to promote evidence-based prescribing. This study explored (1) current influences on prescribing in general practice and (2) the possibility that general practice-based pharmacists (PBPs) may contribute to greater engagement with evidence-based prescribing.DesignSemistructured, telephone interviews and a focus group were conducted, audio-recorded and transcribed verbatim. Thematic analysis was undertaken.ParticipantsGeneral practice prescribers: general practitioners (GPs), PBPs, nurses.Key informants: individuals within the National Health Service (NHS) with responsibility for influencing, monitoring and measuring general practice prescribing.SettingGeneral practices and NHS organisations in England.ResultsInterviews with 17 prescribers (GPs (n=6), PBPs (n=6), nurses (n=5)) and 6 key informants, and one focus group with five key informants were undertaken between November 2018 and April 2019. Determinants operating at individual, practice and societal levels impacted prescribing and guideline use. Prescribers’ professional backgrounds, for example, nursing, pharmacy, patient populations and patient pressure were perceived as substantial influences, as well as media portrayal and public perceptions of medicines.Prescribers identified practice-level determinants of prescribing, including practice culture and shared beliefs. Key informants tended to emphasise higher-level influences, including NHS policies, availability of support and advice from secondary care and generic challenges associated with medicines use, for example, multimorbidity.Participants expressed mixed views about the potential of PBPs to promote evidence-based prescribing in general practice.ConclusionPrescribing in UK general practice is influenced by multiple intersecting factors. Strategies to promote evidence-based prescribing should target modifiable influences at practice and individual levels. Customising strategies for medical and non-medical prescribers may maximise their effectiveness.
Study protocol of RESCUE-ALS: A Phase 2, randomised, double-blind, placebo-controlled study in early symptomatic amyotrophic lateral sclerosis patients to assess bioenergetic catalysis with CNM-Au8 as a mechanism to slow disease progression
Authors: Vucic Steve , Kiernan Matthew C , Menon Parvathi , Huynh William , Rynders Austin , Ho Karen S , Glanzman Robert , Hotchkin Michael T 
Published: January 2021

IntroductionAmyotrophic lateral sclerosis (ALS) is an adult-onset, progressive and universally fatal neurodegenerative disorder. In Europe, Australia and Canada, riluzole is the only approved therapeutic agent for the treatment of ALS, while in the USA, riluzole and edaravone have been approved by the Food and Drug Administration (FDA) . Neither riluzole nor edaravone treatment has resulted in substantial disease-modifying effects. There is, therefore, an urgent need for drugs that result in safe and effective treatment. Here, we present the design and rationale for the phase 2 RESCUE-ALS study, investigating the novel nanocatalytic drug, CNM-Au8, as a therapeutic intervention that enhances the metabolic and energetic capacity of motor neurones. CNM-Au8 is an aqueous suspension of clean-surfaced, faceted gold nanocrystals that have extraordinary catalytic capabilities, that enhance efficiencies of key metabolic reactions, while simultaneously reducing levels of reactive oxygen species. This trial utilises a novel design by employing motor unit number index (MUNIX), measured by electromyography, as a quantitative measure of lower motor neurone loss and as an early marker of ALS disease progression.Methods and analysisThis is a multicentre, randomised, double-blind, parallel group, placebo-controlled study of the efficacy, safety, pharmacokinetics and pharmacodynamics of CNM-Au8 in ALS patients. Patients will be randomised 1:1 to either receive 30 mg of CNM-Au8 once daily or matching placebo over a 36-week double-blind treatment period. Efficacy will be assessed as the change in motor neurone loss as measured by electromyography (eg, MUNIX, the primary endpoint; and secondary endpoints including MScanFit, motor unit size index, Split Hand Index, Neurophysiology Index). Exploratory endpoints include standard clinical and quality of life assessments.Ethics and disseminationRESCUE-ALS was approved by the Western Sydney Local Health District Human Research Ethics Committee (Ethics Ref: 2019/ETH12107). Results of the study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04098406
Low acuity paediatric emergency visits under single-payer universal health insurance in Taiwan, 2000–2015: a population-based repeated cross-sectional design
Authors: Huang I-Anne , Chou Yiing-Jenq , Chou I-Jun , Huang Yu-Tung , Huang Jhen-Ling , Jaing Tang-Her , Wu Chang-Teng , Hsiao Hsiang-Ju , Huang Nicole 
Published: January 2021

ObjectivesEmergency services utilisation is a critical policy concern. The paediatric population is the main user of emergency department (ED) services, and the main contributor to low acuity (LA) ED visits. We aimed to describe the trends of ED and LA ED visits under a comprehensive, universal health insurance programme in Taiwan, and to explore factors associating with potentially unnecessary ED utilisation.Design and settingWe used a population-based, repeated cross-sectional design to analyse the full year of 2000, 2005, 2010 and 2015 National Health Insurance claims data individually for individuals aged 18 years and under.ParticipantsWe identified 5 538 197, 4 818 213, 4 401 677 and 3 841 174 children in 2000, 2005, 2010 and 2015, respectively.Primary and secondary outcome measuresWe adopted a diagnosis grouping system and severity classification system to define LA paediatric ED (PED) visits. Generalised estimating equation was applied to identify factors associated with LA PED visits.ResultsThe annual LA PED visits per 100 paediatric population decreased from 10.32 in 2000 to 9.04 in 2015 (12.40%). Infectious ears, nose and throat, dental and mouth diseases persistently ranked as the top reasons for LA visits (55.31% in 2000 vs 33.94% in 2015). Physical trauma-related LA PED visits increased most rapidly between 2000 and 2015 (0.91–2.56 visits per 100 population). The dose–response patterns were observed between the likelihood of incurring LA PED visit and either child’s age (OR 1.06–1.35 as age groups increase, p<0.0001) or family socioeconomic status (OR 1.02–1.21 as family income levels decrease, p<0.05).ConclusionDespite a comprehensive coverage of emergency care and low cost-sharing obligations under a single-payer universal health insurance programme in Taiwan, no significant increase in PED utilisation for LA conditions was observed between 2000 and 2015. Taiwan’s experience may serve as an important reference for countries considering healthcare system reforms.
Systematic and continuous collection of patient-reported outcomes and experience in women with cancer undergoing mastectomy and immediate breast reconstruction: a study protocol for the Tuscany Region (Italy)
Authors: Ferrè Francesca , De Rosis Sabina , Murante Anna Maria , Gilmore Kendall Jamieson , Ghilli Matteo , Mariniello Donatella , Nuti Sabina , Roncella Manuela 
Published: January 2021

IntroductionMonitoring how patients feel and what they experience during the care process gives health professionals data to improve the quality of care, and gives health systems information to better design and implement care pathways. To gain new insights about specific gaps and/or strengths in breast cancer care, we measure patient-reported outcomes (PROs) and patient-reported experiences (PREs) for women receiving immediate breast reconstruction (iBR).Methods and analysisProspective, multicentre, cohort study with continuous and systematic web-based data collection from women diagnosed with breast cancer, who have an indication for iBR after mastectomy treated at any Breast Unit (BU) in Tuscany Region (Italy). Patients are classified into one of two groups under conditions of routine clinical practice, based on the type of iBR planned (implant and autologous reconstruction). Patient-reported information are obtained prior to and after surgery (at 3-month and 12-month follow-up). We estimate that there are around 700 annual eligible patients.Descriptive analyses are used to assess trends in PROs over time and differences between types of iBR in PROs and PREs. Additionally, econometric models are used to analyse patient and BU characteristics associated with outcomes and experiences. PREs are evaluated to assess aspects of integrated care along the care pathway.Ethics and disseminationThe study has been reviewed and obtained a nihil obstat from the Tuscan Ethics Committees of the three Area Vasta in 2017. Dissemination of results will be via periodic report, journal articles and conference presentations.
Non-pharmacological strategies for self-directed and interpersonal violence in people with severe mental illness: a rapid overview of systematic reviews
Authors: Moreno-Calvete Maria Concepcion , Ballesteros-Rodriguez Francisco Javier 
Published: January 2021

IntroductionSelf-directed and interpersonal violence among people with severe mental illness has become a health priority. Though non-pharmacological interventions have been investigated, to our knowledge, no summary of all systematic reviews on this topic has been reported. We will conduct a rapid overview of reviews to synthesise evidence available by identifying systematic reviews on non-pharmacological interventions for self-directed or interpersonal violence in people with severe mental illness.Methods and analysisThis is a protocol for a rapid overview of reviews. The overview will include any systematic reviews (with or without meta-analyses) of randomised controlled trials (RCTs) or cluster RCTs that examine the effect of non-pharmacological interventions on self-directed or interpersonal violence in people with severe mental illness. This protocol applies the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Protocols, the criteria for conducting overviews of reviews in the Cochrane Handbook of Systematic Reviews of Interventions and the criteria for the Cochrane Rapid Reviews. To identify studies, a search will be performed in the following databases: PubMed, EMBASE, PsycINFO, CINAHL, LILACS, SciELO, Web of Science, Scopus, ProQuest, the Cochrane Database of Systematic Reviews through the Cochrane Library and the Epistemonikos database of systematic reviews. The searches date from inception to September 2020. The study selection process will be described using a PRISMA flow diagram, we will assess the quality of evidence in systematic reviews included and the quality of the systematic reviews themselves and the main results will be summarised in categories to provide a map of the evidence available.Ethics and disseminationNo patients or other participants will be involved in this study. The results will be presented at mental health conferences and for publication in a peer-reviewed journal.Registration detailsThe protocol was registered on the Open Science Framework (https://osf.io/myzd9/).
Demographic risk factors for COVID-19 infection, severity, ICU admission and death: a meta-analysis of 59 studies
Authors: Pijls Bart G , Jolani Shahab , Atherley Anique , Derckx Raissa T , Dijkstra Janna I R , Franssen Gregor H L , Hendriks Stevie , Richters Anke , Venemans-Jellema Annemarie , Zalpuri Saurabh , Zeegers Maurice P 
Published: January 2021

ObjectiveWe aimed to describe the associations of age and sex with the risk of COVID-19 in different severity stages ranging from infection to death.DesignSystematic review and meta-analysis.Data sourcesPubMed and Embase through 4 May 2020.Study selectionWe considered cohort and case–control studies that evaluated differences in age and sex on the risk of COVID-19 infection, disease severity, intensive care unit (ICU) admission and death.Data extraction and synthesisWe screened and included studies using standardised electronic data extraction forms and we pooled data from published studies and data acquired by contacting authors using random effects meta-analysis. We assessed the risk of bias using the Newcastle-Ottawa Scale.ResultsWe screened 11.550 titles and included 59 studies comprising 36.470 patients in the analyses. The methodological quality of the included papers was high (8.2 out of 9). Men had a higher risk for infection with COVID-19 than women (relative risk (RR) 1.08, 95% CI 1.03 to 1.12). When infected, they also had a higher risk for severe COVID-19 disease (RR 1.18, 95% CI 1.10 to 1.27), a higher need for intensive care (RR 1.38, 95% CI 1.09 to 1.74) and a higher risk of death (RR 1.50, 95% CI 1.18 to 1.91). The analyses also showed that patients aged 70 years and above have a higher infection risk (RR 1.65, 95% CI 1.50 to 1.81), a higher risk for severe COVID-19 disease (RR 2.05, 95% CI 1.27 to 3.32), a higher need for intensive care (RR 2.70, 95% CI 1.59 to 4.60) and a higher risk of death once infected (RR 3.61, 95% CI 2.70 to 4.84) compared with patients younger than 70 years.ConclusionsMeta-analyses on 59 studies comprising 36.470 patients showed that men and patients aged 70 and above have a higher risk for COVID-19 infection, severe disease, ICU admission and death.PROSPERO registration numberCRD42020180085.
Over-the-counter oral contraceptive use among women in Mexico: results from a national survey
Authors: Grindlay Kate , Wollum Alexandra , Karver Jonathan , Grossman Daniel 
Published: January 2021

AimIn Mexico, many pharmacies sell oral contraceptives (OCs) over the counter (OTC); however, little is known about the background characteristics of OTC pill users. The primary objective of this study was to understand the characteristics of OTC OC users in Mexico, including whether there were differences by age, urbanicity, and insurance status. This information is instructive as other countries explore allowing OTC access to OCs.MethodsWe analysed the nationally representative 2014 Mexican National Survey of Demographic Dynamics (ENADID) among a sample of OC users aged 15–54 years (n=1970). We performed multivariable logistic models to understand the characteristics associated with OTC access, with age, urbanicity, and insurance status as our primary predictors of interest. Additionally, we descriptively explored knowledge of how frequently to take OCs by pill source and age.ResultsSome 54% of pill users, including 66% of those aged 15–17 years, obtained their OCs OTC. In multivariable regression we found no differences in OTC access by age. However, being uninsured (adjusted odds ratio (AOR) 1.86, 95% CI 1.23 to 2.82) (compared with employer-based public insurance) and living in an urban area (AOR 4.73, 95% CI 3.37 to 6.66) (compared with rural area) were associated with a higher odds of OTC access among pill users. Women’s knowledge of how frequently to take OCs was similar between OTC and prescription users within age groups.ConclusionsThese findings point to the importance of OTC availability of OCs for pill users of all ages and uninsured and urban women in Mexico in particular.