bluuebunny/crossref_metadata_2025_split huggingface dataset:
Psychiatric disorders as risk factors for the development of type 2 diabetes mellitus: an umbrella review protocol
Authors: Lindekilde Nanna , Nefs Giesje , Henriksen Jan Erik , Lasgaard Mathias , Schram Miranda , Rubin Katrine , Rutters Femke , Kivimaki Mika , Pouwer Frans 
Published: May 2019

IntroductionNumerous longitudinal studies, systematic reviews and meta-analyses have examined psychiatric disorders as risk factors for the development of type 2 diabetes mellitus. A more comprehensive overview of the area is warranted to summarise current evidence and discuss strengths and weaknesses to guide future research.AimThe aim of this umbrella review is to determine whether and to what extent different psychiatric disorders are associated with the development of type 2 diabetes mellitus. Furthermore, the umbrella review also assesses the evidence on potential mediating mechanisms.Methods and analysisThe present umbrella review will consist of a comprehensive systematic search of published systematic reviews and meta-analyses of observational longitudinal studies investigating whether a psychiatric disorder is associated with the risk of developing type 2 diabetes. PubMed, Embase, PsychINFO and the Cochrane Database of Systematic Reviews will be searched, and the results will be screened for inclusion by two independent reviewers. Furthermore, the reference lists of included publications will be manually searched. Two independent reviewers will extract data and assess the methodological quality in the included systematic reviews and meta-analyses. Evidence on potential mediating mechanisms included in the systematic reviews and meta-analyses will also be reviewed. The implications of the overview will be discussed in light of the quality of the included studies, and suggestions for clinical practice and future research will be made.Ethics and disseminationEthical approval is not required for this umbrella review. Our review will be submitted for publication in a peer-reviewed international journal using open access option if available. The results will also be disseminated at international conferences.PROSPERO registration numberCRD42018096362
Inequalities in realised access to healthcare among recently arrived refugees depending on local access model: study protocol for a quasi-experimental study
Authors: Wenner Judith , Rolke Kristin , Breckenkamp Jürgen , Sauzet Odile , Bozorgmehr Kayvan , Razum Oliver 
Published: May 2019

IntroductionIn many countries, including Germany, newly arriving refugees face specific entitlement restrictions and access barriers to healthcare. While entitlement restrictions apply to all refugees who seek protection in Germany during the first months, the barriers to access depend on the model that the states and the municipalities implement locally. Currently, two different models exist: the healthcare voucher model (HcV) and the electronic health card model (eHC). The aim of the study is to analyse the consequences of these two different access models on newly arrived refugees’ realised access to healthcare.Methods and analysisThe random assignment of refugees to municipalities allows for a quasi-experimental design by comparing realised access to healthcare among refugees in six municipalities in North Rhine-Westphalia which have implemented HcV or eHC. We compare realised access to healthcare using ambulatory care sensitive conditions and health expenditure as outcome indicators, and use of emergency care, preventive care, psychotherapeutic or psychiatric care, and of therapeutic devices as process indicators. Results will be adjusted for aggregated information on age, sex, socioeconomic structure of the municipalities and density of general practitioners or specialists.Ethics and disseminationWe cooperated with local welfare offices and the statutory health insurance for data collection. Thereby, we were able to avoid recruiting large numbers of refugee patients immediately after arrival while their access and entitlement to healthcare are restricted. We developed an extensive data protection concept and ensured that all data collected are fully anonymised. Results will be published in peer-reviewed journals and summarised in reports to the funding agency.
Effects of epidural analgesia on cancer recurrence and long-term mortality in patients after non-small-cell lung cancer resection: a propensity score-matched study
Authors: Wu Hsiang-Ling , Tai Ying-Hsuan , Chan Min-Ya , Tsou Mei-Yung , Chen Hsiu-Hsi , Chang Kuang-Yi 
Published: May 2019

ObjectivesPrevious studies showed reductions in recurrence and mortality rate of several cancer types in patients receiving perioperative epidural analgesia. This study aimed to investigate the effects of thoracic epidural analgesia on oncological outcomes after resection for lung cancer.DesignRetrospective study using propensity score matching methodology.SettingSingle medical centre in Taiwan.ParticipantsPatients with stages I–III non-small-cell lung cancer undergoing primary tumour resection between January 2005 and December 2015 and had either epidural analgesia, placed preoperatively and used intra- and postoperatively, or intravenous analgesia were evaluated through May 2017.Primary and secondary outcome measuresPrimary endpoint was postoperative recurrence-free survival and secondary endpoint was overall survival.ResultsThe 3-year recurrence-free and overall survival rates were 69.8% (95% CI 67.4% to 72.2%) and 92.4% (95% CI 91% to 93.8%) in the epidural group and 67.4% (95% CI 62.3% to 72.5%) and 89.6% (95% CI 86.3% to 92.9%) in the non-epidural group, respectively. Multivariable Cox regression analysis before matching demonstrated no significant difference in recurrence or mortality between groups (adjusted HR: 0.93, 95% CI 0.76 to 1.14 for recurrence; 0.81, 95% CI 0.58 to 1.13 for mortality), similar to the results after matching (HR: 0.97, 95% CI 0.71 to 1.31; 0.94, 95% CI 0.57 to 1.54). Independent risk factors for both recurrence and mortality were male, higher pretreatment carcinoembryonic antigen level, advanced cancer stage, poor differentiation, lymphovascular invasion, microscopic necrosis and postoperative radiotherapy.ConclusionsThoracic epidural analgesia was not associated with better recurrence-free or overall survival in patients receiving surgical resection for stages I–III non-small-cell lung cancer.
Design of a prospective observational study on the effectiveness and real-world usage of recombinant factor VIII Fc (rFVIIIFc) compared with conventional products in haemophilia A: the A-SURE study
Authors: Oldenburg Johannes , Hay Charles R M , Jiménez-Yuste Víctor , Peyvandi Flora , Schved Jean-François , Szamosi Johan , Winding Bent , Lethagen Stefan 
Published: May 2019

IntroductionHaemophilia A is a rare bleeding disorder caused by coagulation factor VIII (FVIII) deficiency. This is treated with factor VIII, conventionally using products with a half-life of 8–12 hours typically administered every 2–3 days. Recombinant FVIII Fc (rFVIIIFc) represents a new generation of products with an extended half-life allowing higher FVIII levels and longer dosing interval. The efficacy and safety of rFVIIIFc have been established in clinical studies and several years of postmarketing use. However, there remains a need to compare treatment outcome with conventional products in routine clinical use.Methods and analysisA-SURE is an ongoing, non-interventional European study with the primary objective to compare the clinical effectiveness of rFVIIIFc with conventional factor products used for haemophilia A prophylaxis. Data covering a 24-month prospective period and a 12-month retrospective period will be collected. Three primary endpoints: bleeding rate, injection frequency and factor consumption will be used to evaluate treatment outcomes. Enrolment of 175 patients on rFVIIIFc and 175 on conventional products is planned. All eligible patients from participating centres will be invited to participate. Visits and treatments follow routine clinical practice. Bias will be reduced by patient matching for age at baseline and the last weekly prophylaxis dose of a conventional product prior to baseline. Propensity scores will be calculated based on prognostic factors and potential confounders assessed at baseline and adjusted for in the estimation of the treatment effect.Ethics and disseminationStudy approval was obtained by local independent ethics committees and/or authorities, and informed consent from patients or their legal representative is a requirement for participation. Names of ethical committees and approval numbers are provided as supplementary information. The study results will be submitted for publication in a peer-reviewed scientific journal and presented at scientific conferences.Trial registration numberNCT02976753, Pre-results.
User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial
Authors: Melnick Edward R , Jeffery Molly Moore , Dziura James D , Mao Jodi A , Hess Erik P , Platts-Mills Timothy F , Solad Yauheni , Paek Hyung , Martel Shara , Patel Mehul D , Bankowski Laura , Lu Charles , Brandt Cynthia , D’Onofrio Gail 
Published: May 2019

IntroductionThe goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD).MethodsA pragmatic cluster randomised trial is planned to be carried out in 20 emergency departments (EDs) across five healthcare systems over 18 months. The intervention consists of a user-centred CDS integrated into ED clinician electronic workflow and available for guidance to: (1) determine whether patients presenting to the ED meet criteria for OUD, (2) assess withdrawal symptoms and (3) ascertain and motivate patient willingness to initiate treatment. The CDS guides the ED clinician to initiate BUP and facilitate follow-up. The primary outcome is the rate of BUP initiated in the ED. Secondary outcomes are: (1) rates of receiving a referral, (2) fidelity with the CDS and (3) rates of clinicians providing any ED-initiated BUP, referral for ongoing treatment and receiving Drug Addiction Act of 2000 training. Primary and secondary outcomes will be analysed using generalised linear mixed models, with fixed effects for intervention status (CDS vs usual care), prespecified site and patient characteristics, and random effects for study site.Ethics and disseminationThe protocol has been approved by the Western Institutional Review Board. No identifiable private information will be collected from patients. A waiver of informed consent was obtained for the collection of data for clinician prescribing and other activities. As a minimal risk implementation study of established best practices, an Independent Study Monitor will be utilised in place of a Data Safety Monitoring Board. Results will be reported in ClinicalTrials.gov and published in open-access, peer-reviewed journals, presented at national meetings and shared with the clinicians at participating sites via a broadcast email notification of publications.Trial registration numberNCT03658642; Pre-results.
Association of low birth weight with thinness and severe obesity in children aged 3–12 years: a large-scale population-based cross-sectional study in Shanghai, China
Authors: Chen Chang , Jin Zhijuan , Yang You , Jiang Fan , Huang Hong , Liu Shijian , Jin Xingming 
Published: May 2019

ObjectivesLow birth weight (BW) is a general symbol of inadequate intrauterine conditions that elicit abnormal fetal growth and development. The aim of current study is to investigate the relationship between low BW and thinness or severe obesity during maturation.DesignA large-scale cross-sectional population-based survey.Setting134 kindergartens and 70 elementary schools.Participants70 284 Chinese children aged 3–12 years.Outcome measuresInternational Obesity Task Force body mass index (BMI) cut-offs were used to define grade 1, grade 2 and grade 3 thinness, overweight, obesity and severe obesity. Multinomial logistic regression was used to estimate the association between BW and BMI category.ResultsA total of 70 284 children participated in the survey. The percentage of grade 1 thinness and severe obesity in children with low BW is significantly higher than that in children with normal BW (p<0.05). Low BW was associated with an increased risk of grade 1 thinness (OR 1.56, 95% CI 1.38 to 1.75), grade 2 thinness (OR 1.34, 95% CI 1.10 to 1.64), grade 3 thinness (OR 1.99, 95% CI 1.63 to 2.42) and severe obesity (OR 1.27, 95% CI 1.03 to 1.55) but was not associated with obesity (OR 0.85, 95% CI 0.67 to 1.06).ConclusionThere is a positive association between low BW and thinness or severe obesity risk.
Supporting the spread and scale-up of electronic consultation across Canada: cross-sectional analysis
Authors: Liddy Clare , Bello Aminu , Cook Jean , Drimer Neil , Pilon Maxine Dumas , Farrell Gerard , Glassford Jodi , Ireland Laurie , McDonald Rana , Nabelsi Véronique , Oppenheimer Luis , Singer Alex , Keely Erin 
Published: May 2019

ObjectiveTo examine the process of implementing an electronic consultation (eConsult) service and evaluate its impact along key metrics outlined by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework.DesignCross-sectional study.SettingClinics using eConsult in four provinces across Canada: Alberta, Manitoba, Quebec and Newfoundland and Labrador.ParticipantsAll eConsult cases submitted in four participating provinces were included.InterventionThe eConsult service is a secure online application that allows primary care providers and specialists to communicate regarding a patient’s care. We measured the impact using system utilisation data and mandatory close-out surveys completed at the end of each eConsult.Main outcome measuresImplementation progress and impact were examined using the five categories outlined by the RE-AIM framework: reach, effectiveness, adoption, implementation and maintenance.ResultsFour provinces provided data from different periods, ranging from 4 years (Alberta) to 10 months (Manitoba). Total cases completed ranged from 96 (Manitoba) to 6885 (Alberta). Newfoundland had the largest menu of available specialties (n=35), while Alberta and Quebec had the smallest (n=22). The most frequently requested groups varied across provinces, with only endocrinology appearing in the top five for all provinces. The average specialist response time ranged from 3 days (Manitoba) to 16.7 days (Alberta). Between 54% (Newfoundland) and 66% (Manitoba) of cases resulted in new or additional information. Primary care providers avoided completing referrals they had originally considered in 36% (Newfoundland) to 53% of cases (Manitoba), while only between 27 % (Quebec) and 29% (Newfoundland) of cases resulted in a referral. In every province, services demonstrated higher rates of usage in their last quarter of data than their first.ConclusionseConsult was successfully implemented in four new provinces across Canada. Implementation strategies and scope varied, but services demonstrated substantial consistency on several key metrics, most notably on whether new information was learnt and impact on decision to refer.
Dose and formulation of azithromycin in mass drug administration studies: a systematic review protocol
Authors: Yue Yan , Xiong Tao , Zeng Linan , Choonara Imti , Qazi Shamim , Chen Hongju , Mu Dezhi 
Published: May 2019

IntroductionAzithromycin has been given for tropical infectious diseases such as trachoma and yaws by mass drug administration (MDA). As well as controlling the infectious disease in question, MDA may have a beneficial effect in reducing mortality in young children. However, the dose, formulation, frequency and duration of azithromycin used in certain infectious diseases may vary in different studies, and these differences may have impacts on the effectiveness of azithromycin MDA. Furthermore, whether the dose, formulation, frequency and duration are associated with the effectiveness of azithromycin for reducing child mortality—if indeed this effect can be confirmed—remain unknown. In this study, we will investigate whether different strategies such as different dose, formulation, frequency and duration affect the effectiveness of azithromycin MDA on the prevalence of certain infectious diseases or child mortality.Methods and analysisA narrative systematic review will be conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform will be searched. No language restrictions will be applied. All randomised/quasi-controlled trials, observational studies (cross-sectional studies, cohort studies and case–control studies), case series and registered protocols will be considered. Dose, duration, frequency, rounds and formulations of azithromycin used in MDA will be collected and reviewed. The outcomes will be disease prevalence/control in children and child mortality. Data from the individual studies will not be pooled.Ethics and disseminationFormal ethical approval is not required since data will be collected from published studies. This systematic review will be published in a peer-reviewed journal and presented at conference meetings.PROSPERO registration numberCRD42018114902
Loss-of-function mutations in SPEF2 cause multiple morphological abnormalities of the sperm flagella (MMAF)
Authors: Liu Wensheng , Sha Yanwei , Li Yang , Mei Libin , Lin Shaobin , Huang Xianjing , Lu Jinhua , Ding Lu , Kong Shuangbo , Lu Zhongxian 
Published: May 2019

BackgroundMultiple morphological abnormalities of the sperm flagella (MMAF) is a kind of severe teratozoospermia. Patients with the MMAF phenotype are infertile and present aberrant spermatozoa with absent, short, coiled, bent and/or irregular flagella. Mutations in several genes can explain approximately 30%–50% of MMAF cases and more genetic pathogenies need to be explored. SPEF2 was previously demonstrated to play an essential role in sperm tail development in mice and pig. Dysfunctional mutations inSPEF2impair sperm motility and cause a short-tail phenotype in both animal models.ObjectiveBased on 42 patients with severe infertility and MMAF phenotype, we explored the new genetic cause of human MMAF phenotype.Methods and resultsBy screening gene variants in 42 patients with MMAF using whole exome sequencing, we identified the c. 12delC, c. 1745-2A > G, c. 4102 G > T and c. 4323dupA mutations in theSPEF2gene from two patients. Both of these mutations are rare and potentially deleterious. Transmission electron microscope (TEM) analysis showed a disrupted axonemal structure with mitochondrial sheath defects in the patients’ spermatozoa. The SPEF2 protein level was significantly decreased in the spermatozoa of the patients revealed by Western blot (WB) and immunofluorescence (IF) analyses.ConclusionOur experimental findings indicate that loss-of-function mutations in theSPEF2gene can cause the MMAF phenotype in human.
Treatment of broad-based intracranial aneurysms with low profile braided stents: a single center analysis of 101 patients
Authors: Djurdjevic Tanja , Young Victoria , Corkill Rufus , Briley Dennis , Küker Wilhelm 
Published: May 2019

Background and purposeLow profile braided stents have facilitated the endovascular treatment of broad-based intracranial aneurysms.MethodsBetween 2013 and June 2018, we attempted 104 Leo baby stent placements in 101 patients. Locations were the anterior communicating artery (AcomA) (37 aneurysms, 35.6%), middle cerebral artery (MCA) bifurcation (29 aneurysms, 27.9%) and basilar artery (23aneurysms, 22.1%). Mean neck size was 4.9 mm (2.2–8.2). 60 aneurysms were incidental, 31 of 37 recurrent aneurysms had ruptured before.ResultsStent deployment was successful in 89.4% of cases. Common reasons for failure were inability to access the parent artery (n=5) or to deploy the stent across the aneurysm neck (n=4). Two patients had poor outcomes within 24 hours. One patient developed a brain hemorrhage caused by guide wire perforation (MRS 5), the other an early thrombotic stent occlusion (MRS 4). No patient died. Nine (8.7%) patients experienced transient neurological deficits with ischemic lesions on diffusion weighted imaging (DWI). Initially Raymond-Roy class 1 occlusion was achieved in 23 aneurysms (24.7%), class 2 occlusion in 40 (43%), class 3a occlusion in 14 (15.0%), and 3b occlusion in 16 aneurysms (17.2%). Follow-up imaging in 87 patients showed stable or improved occlusion grades in 76%. Six patients required retreatment while the rest were managed conservatively. Four delayed stent occlusions occurred in three patients, with severe morbidity in one patient (MRS 5). There were no aneurysm ruptures or deaths.ConclusionStent assisted treatment of broad-based aneurysms with the Leo baby stent is safe and effective. The frequency of delayed thrombotic complications is low and similar to other stents.
Strategies and barriers to achieving the goal of Finland’s tobacco endgame
Authors: Timberlake David S , Laitinen Ulla , Kinnunen Jaana M , Rimpela Arja H 
Published: May 2019

ObjectivesFinland boldly legislated the end of tobacco use in its 2010 Tobacco Act, and subsequently expanded the goal in 2016 to eradicate other nicotine-containing products. This study explored stakeholders’ perceptions about the strengths, barriers, solutions and rationale for Finland’s comprehensive but conventional strategy to achieve its nicotine-free goal.DesignStudy participants were selected based on expertise in policy or practice of tobacco control (n=32). Semi-structured interviews, conducted in 2017 and 2018, covered topics ranging from consensus among stakeholders to Finland’s ranking on the 2016 Tobacco Control Scale. The framework method was chosen for analysing interview transcripts.ResultsA perceived strength of Tobacco-Free Finland 2030 was the consensus and cooperation among members of the tobacco control community. The objective of becoming a nicotine- versus smoke-free society had almost unanimous support, challenged by a small minority who argued for greater discussion of harm reduction approaches. The need for maintaining legitimacy and historical successes in tobacco control were reasons for using a conventional strategy. Barriers to achieving the endgame goal included insufficient funding and over-reliance on non-governmental organisations, political/legal constraints, impact of institutional practices on tobacco disparities, ambivalence about the role of mass media and lack of prioritising smoking cessation.ConclusionsStakeholders’ broad confidence in reaching the goal of Finland’s tobacco endgame suggests that future policy initiatives will reflect the current, conventional strategy. If the Finnish government chooses to continue this approach, then it should designate separate funds for Tobacco-Free Finland 2030 and implement structural changes that will facilitate tobacco control initiatives.