bluuebunny/crossref_metadata_2025_split huggingface dataset:
Absolute cardiovascular disease risk score and pharmacotherapy at the time of admission in patients presenting with acute coronary syndrome due to coronary artery disease in a single Australian tertiary centre: a cross-sectional study
Authors: Bailey Amy , Korda Rosemary , Agostino Jason , Stanton Tony , Kelly Gabriela , Richman Tuppence , Greaves K 
Published: February 2021

ObjectivesTo describe (1) absolute cardiovascular disease risk (ACVDR) scores in patients presenting to hospital with acute coronary syndrome (ACS) and (2) proportions of these patients on guideline-recommended pharmacotherapy according to their ACVDR score.DesignCross-sectional study.SettingSingle-site tertiary centre hospital, Queensland, Australia over a 12-month period.ParticipantsPatients >18 years of age presenting to hospital with ACS due to coronary artery disease (CAD) confirmed by angiography.Primary and secondary outcome measuresProportion of patients without prior history of CVD with a high ACVDR score, and of patients with a prior history of CVD, who are on guideline-recommended pharmacotherapy.Results527 ACS patients were included of whom the mean age was 63 years and 75% were male. Overall, 66% (350) had no prior CVD and 34% (177) patients had prior CVD.In patients with no prior CVD, the proportions of patients with low, intermediate and high CVD risk scores were 41%, 24% and 36%. In the no prior CVD, high-risk patient group, 48% were on no preventative pharmacotherapy, 32% on single pharmacotherapy and 20% patients on complete guideline-recommended pharmacotherapy. In the prior CVD group, 7% patients were on no pharmacotherapy, 40% on incomplete pharmacotherapy and 53% were on complete guideline-recommended pharmacotherapy.ConclusionThis study adds to the evidence on implementation gaps in guideline-recommended management of ACVDR, showing that a large proportion of patients presenting with ACS due to CAD were at high risk of developing CVD prior to the event and most were not on guideline-recommended treatment. A significant proportion of these events are likely to have been preventable, and therefore, increased assessment and appropriate treatment of ACVDR in primary care is needed to reduce the incidence of CVD events in the population.
Piperacillin–tazobactam versus meropenem for treatment of bloodstream infections caused by third-generation cephalosporin-resistant Enterobacteriaceae: a study protocol for a non-inferiority open-label randomised controlled trial (PeterPen)
Authors: Bitterman Roni , Koppel Fidi , Mussini Cristina , Geffen Yuval , Chowers Michal , Rahav Galia , Nesher Lior , Ben-Ami Ronen , Turjeman Adi , Huberman Samuel Maayan , Cheng Matthew P , Lee Todd C , Leibovici Leonard , Yahav Dafna , Paul Mical 
Published: February 2021

IntroductionThe optimal treatment for extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae bloodstream infections has yet to be defined. Retrospective studies have shown conflicting results, with most data suggesting the non-inferiority of beta-lactam–beta-lactamase inhibitor combinations compared with carbapenems. However, the recently published MERINO trial failed to demonstrate the non-inferiority of piperacillin–tazobactam to meropenem. The potential implications of the MERINO trial are profound, as widespread adoption of carbapenem treatment will have detrimental effects on antimicrobial stewardship in areas endemic for ESBL and carbapenem-resistant bacteria. Therefore, we believe that it is justified to re-examine the comparison in a second randomised controlled trial prior to changing clinical practice.Methods and analysisPeterPen is a multicentre, investigator-initiated, open-label, randomised controlled non-inferiority trial, comparing piperacillin–tazobactam with meropenem for third-generation cephalosporin-resistantEscherichia coliandKlebsiellabloodstream infections. The study is currently being conducted in six centres in Israel and one in Canada with other centres from Israel, Italy and Canada expected to join. The two primary outcomes are all-cause mortality at day 30 from enrolment and treatment failure at day seven (death, fever above 38°C in the last 48 hours, continuous symptoms, increasing Sequential Organ Failure Assessment Score or persistent blood cultures with the index pathogen). A sample size of 1084 patients was calculated for the mortality endpoint assuming a 12.5% mortality rate in the control group with a 5% non-inferiority margin and assuming 100% follow-up for this outcome.Ethics and disseminationThe study is approved by local and national ethics committees as required. Results will be published, and trial data will be made available.Trial registration numbersClinicalTrials.gov Registry (NCT03671967); Israeli Ministry of Health Trials Registry (MOH_2018-12-25_004857).
Outcomes of hyperglycaemia in pregnancy in Africa: systematic review study protocol
Authors: Musa Ezekiel , Chivese Tawanda , Werfalli Mahmoud , Matjila Mushi , Norris Shane A , Levitt Naomi 
Published: February 2021

IntroductionThe prevalence of diabetes mellitus globally has increased considerably over the past decades with a resultant increase in the incidence of diabetes-complicated pregnancies. Hyperglycaemia in pregnancy is the most common metabolic complication encountered during pregnancy and is associated with adverse maternal and fetal outcomes. This systematic review aims to examine maternal, fetal, neonatal, childhood and long-term maternal outcomes of hyperglycaemia in pregnancy in Africa.Methods and analysisA systematic review of all studies that investigated hyperglycaemia in pregnancy outcomes, carried out in Africa from 1998 to 2019. A comprehensive search of all published articles indexed in PubMed-MEDLINE, Cochrane Library, Scopus, CINAHL (EBSCOhost), Embase and Web of Science databases will be performed. Studies will be screened for eligibility by title, abstract and full text in duplicate by two independent reviewers. For data where meta-analysis is not possible, narrative analysis will be carried out using themes from data. For data where meta-analysis is possible, random effects meta-analysis will be conducted. This systematic review will be reported according to the Meta-analyses of Observational Studies in Epidemiology.Ethics and disseminationEthical approval is not required for this study considering this is a systematic review protocol that uses only published data. The findings of this study will be disseminated through peer-reviewed publications and conference presentations.PROSPERO registration numberCRD42020184573.
Evaluation of eight-style Tai chi on cognitive function in patients with cognitive impairment of cerebral small vessel disease: study protocol for a randomised controlled trial
Authors: Zhong Xiaoyong , Yan Xinghui , Liang Hui , Xia Rui , Chen Bin , Zhao Hong-Jia 
Published: February 2021

IntroductionCerebral small vessel disease (CSVD) is a critical factor that causes cognitive decline and progresses to vascular dementia and acute cerebrovascular events. Tai chi has been proven to improve nerve plasticity formation and directly improve cognitive function compared with other sports therapy, which has shown its unique advantages. However, more medical evidence needs to be collected in order to verify that Tai chi exercises can improve cognitive impairment due to CSVD. The main purposes of this study are to investigate the effect of Tai chi exercise on neuropsychological outcomes of patients with cognitive impairment related to CSVD and to explore its mechanism of action with neuroimaging, including functional MRI (fMRI) and event-related potential (P300).Methods and analysisThe design of this study is a randomised controlled trial with two parallel groups in a 1:1 allocation ratio with allocation concealment and assessor blinding. A total of 106 participants will be enrolled and randomised to the 24-week Tai chi exercise intervention group and 24-week health education control group. Global cognitive function and the specific domains of cognition (memory, processing speed, executive function, attention and verbal learning and memory) will be assessed at baseline and 12 and 24 weeks after randomisation. At the same time, fMRI and P300 will be measured the structure and function of brain regions related to cognitive function at baseline and 24 weeks after randomisation. Recruitment is currently ongoing (recruitment began on 9 November 2020). The approximate completion date for recruitment is in April 2021, and we anticipate to complete the study by December 2021.Ethics and disseminationEthics approval was given by the Medical Ethics Committee of the Affiliated People’s Hospital of Fujian University of Traditional Chinese Medicine (approval number: 2019-058-04). The findings will be disseminated through peer-reviewed publications and at scientific conferences.Trial registration numberChiCTR2000033176; Pre-results.
Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial
Authors: von Korn Pia , Sydow Hanna , Neubauer Sarah , Duvinage André , Mocek Anja , Dinges Sophia , Hackenberg Bjoern , Weichenberger Mario , Schoenfeld Julia , Amelung Volker , Mueller Stephan , Halle Martin 
Published: February 2021

IntroductionGuidelines recommend lifestyle intervention in chronic ischaemic heart disease (CIHD) and type 2 diabetes mellitus (T2DM). However, evidence from randomised controlled trials is scarce in patients with combined entities.Methods and analysisThe Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (LeIKD) trial is a prospective, multicentre study that will randomise (1:1) patients with CIHD (ICD-10: I20-I25) and T2DM (ICD-10: E11) from one health insurance company into a lifestyle intervention (LS) or usual care (UC). Active LS consists of an individual combined exercise programme of strength and endurance training and nutritional counselling with regular feedback for 6 months. Intervention is supported by telemedicine. Follow-up without individualised feedback will continue for 6 months. The study aims to investigate whether an individualised telemedical supported LS intervention is superior to UC in improving cardiovascular risk factors, physical activity, quality of life, health literacy, major cardiovascular events and health economics in patients with both CIHD and T2DM. Primary endpoint is the change in HbA1cfrom baseline to 6 months.Ethics and disseminationThe study has been approved by the ethics committee of the Technical University of Munich (registration number: 144/18-S) and at each study site. The study will be conducted according to the World Medical Association Declaration of Helsinki, and results will be published in articles and reports. It is funded by the Federal Joint Committee (www.innovationsfonds.g-ba.de), reference number 01NVF17015, which has no impact on data collection, analysis or interpretation. Dissemination is independent of the funding source.Trial registration numberClinical trials.gov identifier:NCT03835923. German registry for clinical studies (DRKS): DRKS00015140.
Multiple system atrophy in Hokkaido, Japan: a prospective registry study of natural history and symptom assessment scales followed for 5 years
Authors: Matsushima Masaaki , Yabe Ichiro , Sakushima Ken , Kanatani Yasuhiro , Nishimoto Naoki , Matsuoka Takeshi , Sawada Jun , Uesugi Haruo , Sako Kazuya , Takei Asako , Tamakoshi Akiko , Shimohama Shun , Sato Norihiro , Kikuchi Seiji , Sasaki Hidenao 
Published: February 2021

ObjectivesMultiple system atrophy (MSA) is a refractory neurodegenerative disease, but novel treatments are anticipated. An accurate natural history of MSA is important for clinical trials, but is insufficient. This regional registry was launched to complement clinical information on MSA.SettingPatient recruitment started in November 2014 and is ongoing at the time of submission. The number of participating facilities was 66. Postal surveys were sent to medical facilities and patients with MSA in Hokkaido, Japan.ParticipantsAfter obtaining written consent from 196 participants, 184 overview surveys and 115 detailed surveys were conducted.Primary and secondary outcome measuresAn overview survey evaluated conformity to diagnostic criteria and a detailed survey implemented an annual assessment based on the Unified Multiple System Atrophy Rating Scale (UMSARS).ResultsAt the time of registration, 58.2% of patients were diagnosed with cerebellar symptoms predominant type MSA (MSA-C) and 29.9% were diagnosed with parkinsonism predominant type MSA (MSA-P). UMSARS Part Ⅳ score of 4 or 5 accounted for 53.8% of participants. The higher the UMSARS Part Ⅳ score, the higher the proportion of MSA-P. At baseline, levodopa was used by 69 patients (37.5%) and the average levodopa dose was 406.7 mg/day. The frequency of levodopa use increased over time. Eleven cases changed from MSA-C to MSA-P during the study, but the opposite was not observed. Information about survival and causes of death was collected on 54 cases. Half of deaths were respiratory-related. Sudden death was recorded even in the group with UMSARS Part Ⅳ score of 1.ConclusionsThis study is the first large-scale prospective MSA cohort study in Asia. MSA-C was dominant, but the use of antiparkinsonian drugs increased over the study period. Changes from MSA-C to MSA-P occurred, but not vice versa.
Measurement of unnecessary psychiatric readmissions in the context of care transition interventions: a scoping review
Authors: Kim Bo , Weatherly Christopher , Wolk Courtney Benjamin , Proctor Enola K 
Published: February 2021

ObjectiveThe objective of this study was to examine how published studies of inpatient to outpatient mental healthcare transition processes have approached measuring unnecessary psychiatric readmissions.DesignScoping review using Levac et al’s enhancement to Arksey and O’Malley’s framework for conducting scoping reviews.Data sourcesMedline (Ovid), Embase (Ovid), PsycINFO, CINAHL, Cochrane and ISI Web of Science article databases were searched from 1 January 2009 through 28 February 2019.Eligibility criteria for selecting studiesWe included studies that (1) are about care transition processes associated with unnecessary psychiatric readmissions and (2) specify use of at least one readmission time interval (ie, the time period since previous discharge from inpatient care, within which a hospitalisation can be considered a readmission).Data extraction and synthesisWe assessed review findings through tabular and content analyses of the data extracted from included articles.ResultsOur database search yielded 3478 unique articles, 67 of which were included in our scoping review. The included articles varied widely in their reported readmission time intervals used. They provided limited details regarding which readmissions they considered unnecessary and which risks they accounted for in their measurement. There were no perceptible trends in associations between the variation in these findings and the included studies’ characteristics (eg, target population, type of care transition intervention).ConclusionsThe limited specification with which studies report their approach to unnecessary psychiatric readmissions measurement is a noteworthy gap identified by this scoping review, and one that can hinder both the replicability of conducted studies and adaptations of study methods by future investigations. Recommendations stemming from this review include (1) establishing a framework for reporting the measurement approach, (2) devising enhanced guidelines regarding which approaches to use in which circumstances and (3) examining how sensitive research findings are to the choice of the approach.
Engaging young people as simulated patients: a qualitative description of health professional educators’ perspectives
Authors: Gamble Andree , Bearman Margaret , Nestel Debra 
Published: February 2021

BackgroundReal patients in clinical placements are important for learning and may well be the ‘gold standard’. However, simulated patients (SPs) are a viable alternative in the absence of this opportunity. While adult SPs contribute to health professions education, child and adolescent simulated patients (CASPs) are less common. This research aims to explore the perspectives of healthcare educators regarding the engagement of young SPs, specifically the identification of barriers and enablers to involving CASPs.MethodsWe used an interpretive paradigm of qualitative description. Thirteen interviewees, all educators involved in SP programmes, participated in semistructured interviews. Data were transcribed verbatim and analysed using an inductive thematic approach.FindingsNot all participants saw value in engaging CASPs. A number of barriers and enablers to involving them were acknowledged in six themes: challenges and concerns; logistical barriers; benefits of CASPs; overcoming challenges; an ethical minefield; and child safety. Opinions differed with respect to feasibility and necessity for involving CASPs, particularly in the hospital setting where real patients are accessible. All participants articulated the critical importance of ensuring adequate support and adherence to ethical principles if CASPs were involved.ConclusionsThe involvement of CASPs in health professions education is a divisive issue. CASPs’ ability to provide a realistic option for supporting learning is recognised yet perhaps not wholly perceived as a feasible alternative to real patients. Their engagement raises critical ethical, practical, logistical and financial challenges.
Safety and related factors of treatment with long-term atypical antipsychotic in Chinese patients with schizophrenia: observational study
Authors: Yu Wenjuan , Huang Jingjing , He Sidi , Zhang Lei , Shen Yifeng , Li Huafang 
Published: February 2021

BackgroundAtypical antipsychotics as first-line drugs have been used in patients with schizophrenia in China and abroad. However, its safety still needs to be evaluated in a large population, especially in Chinese patients.ObjectiveThe main objective of this study is to evaluate the safety and related factors of long-term atypical antipsychotic use in patients with schizophrenia in China. The secondary objective includes the long-term efficacy of atypical antipsychotics in these patients, as well as pharmacoeconomic evaluation, population pharmacokinetic studies and pharmacogenomics studies.MethodsThis study has an observational design. The atypical antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone, amisulpride, perospirone and clozapine. Visits occur at 0, 4, 8, 13, 26, 52, 78, 104, 130 and 156 weeks. The efficacy evaluations include symptoms, social function, recurrence rate and hospitalisation. The safety measures include physical examination, vital signs, abdominal circumference, laboratory tests (such as blood cell analysis, blood biochemical tests and serum prolactin/thyroxine levels), 12-lead ECG, extrapyramidal syndrome assessment, sexual function evaluation, medication and other adverse events. The secondary measures include the Positive and Negative Syndrome Scale, Clinical Global Impression-Severity of Illness Scale, Calgary Depression Scale for Schizophrenia, Personal and Social Performance Scale, relapse rate, drug consolidation, medical-related expenses, income, drug plasma concentration and genetic information.ResultsThis is a large sample, non-interventional and long-term prospective clinical study designed to truly reflect the specific details of clinical practice, fully respect patients’ needs, and understand patients’ treatment intentions and actual treatment details.ConclusionsThis research method details the aims, methods, study design, strengths and limitations of the study.
Rapid gut dysbiosis induced by stroke exacerbates brain infarction in turn
Authors: Xu Kaiyu , Gao Xuxuan , Xia Genghong , Chen Muxuan , Zeng Nianyi , Wang Shan , You Chao , Tian Xiaolin , Di Huiling , Tang Wenli , Li Pan , Wang Huidi , Zeng Xiuli , Tan Chuhong , Meng Fanguo , Li Hailong , He Yan , Zhou Hongwei , Yin Jia 
Published: February 2021

ObjectiveStroke is a leading cause of death and disability worldwide. Neuroprotective approaches have failed in clinical trials, thus warranting therapeutic innovations with alternative targets. The gut microbiota is an important contributor to many risk factors for stroke. However, the bidirectional interactions between stroke and gut microbiota remain largely unknown.DesignWe performed two clinical cohort studies to capture the gut dysbiosis dynamics after stroke and their relationship with stroke prognosis. Then, we used a middle cerebral artery occlusion model to explore gut dysbiosis post-stroke in mice and address the causative relationship between acute ischaemic stroke and gut dysbiosis. Finally, we tested whether aminoguanidine, superoxide dismutase and tungstate can alleviate post-stroke brain infarction by restoring gut dysbiosis.ResultsBrain ischaemia rapidly induced intestinal ischaemia and produced excessive nitrate through free radical reactions, resulting in gut dysbiosis with Enterobacteriaceae expansion. Enterobacteriaceae enrichment exacerbated brain infarction by enhancing systemic inflammation and is an independent risk factor for the primary poor outcome of patients with stroke. Administering aminoguanidine or superoxide dismutase to diminish nitrate generation or administering tungstate to inhibit nitrate respiration all resulted in suppressed Enterobacteriaceae overgrowth, reduced systemic inflammation and alleviated brain infarction. These effects were gut microbiome dependent and indicated the translational value of the brain–gut axis in stroke treatment.ConclusionsThis study reveals a reciprocal relationship between stroke and gut dysbiosis. Ischaemic stroke rapidly triggers gut microbiome dysbiosis with Enterobacteriaceae overgrowth that in turn exacerbates brain infarction.
Mental distress among young people in inner cities: the Resilience, Ethnicity and AdolesCent Mental Health (REACH) study
Authors: Knowles Gemma , Gayer-Anderson Charlotte , Beards Stephanie , Blakey Rachel , Davis Samantha , Lowis Katie , Stanyon Daniel , Ofori Aisha , Turner Alice , Working Group Schools , Pinfold Vanessa , Bakolis Ioannis , Reininghaus Ulrich , Harding Seeromanie , Morgan Craig 
Published: February 2021

BackgroundRecent estimates suggest around 14% of 11–16 years in England have a mental health problem. However, we know very little about the extent and nature of mental health problems among diverse groups in densely populated inner cities, where contexts and experiences may differ from the national average.AimsTo estimate the extent and nature of mental health problems in inner city London, overall and by social group, using data from our school-based accelerated cohort study of adolescent mental health, Resilience, Ethnicity and AdolesCent Mental Health.MethodsSelf-report data on mental health (general mental health, depression, anxiety, self-harm) were analysed (n, 4353; 11–14 years, 85% minority ethnic groups). Mixed models were used to estimate weighted prevalences and adjusted risks of each type of problem, overall and by gender, cohort, ethnic group and free school meals (FSM) status.ResultsThe weighted prevalence of mental health problems was 18.6% (95% CI 16.4% to 20.8%). Each type of mental health problem was more common among girls compared with boys (adjusted risk ratios: mental health problems, 1.33, 95% CI 1.18 to 1.48; depression, 1.52, 1.30 to 1.73; anxiety, 2.09, 1.58 to 2.59, self-harm, 1.40, 1.06 to 1.75). Gender differences were more pronounced in older cohorts compared with the youngest. Mental health problems (1.28, 1.05 to 1.51) and self-harm (1.29, 1.02 to 1.56)—but not depression or anxiety—were more common among those receiving (vs not receiving) FSM. There were many similarities, with some variations, by ethnic group.ConclusionsAdolescent mental health problems and self-harm are common in inner city London. Gender differences in mental health problems may emerge during early adolescence.