bluuebunny/crossref_metadata_2025_split huggingface dataset:
How do different brands of size 1 laryngeal mask airway compare with face mask ventilation in a dedicated laryngeal mask airway teaching manikin?
Authors: Tracy Mark Brian , Priyadarshi Archana , Goel Dimple , Lowe Krista , Huvanandana Jacqueline , Hinder Murray 
Published: August 2017

BackgroundInternational neonatal resuscitation guidelines recommend the use of laryngeal mask airway (LMA) with newborn infants (≥34 weeks’ gestation or >2 kg weight) when bag-mask ventilation (BMV) or tracheal intubation is unsuccessful. Previous publications do not allow broad LMA device comparison.ObjectiveTo compare delivered ventilation of seven brands of size 1 LMA devices with two brands of face mask using self-inflating bag (SIB).Design40 experienced neonatal staff provided inflation cycles using SIB with positive end expiratory pressure (PEEP) (5 cmH2O) to a specialised newborn/infant training manikin randomised for each LMA and face mask. All subjects received prior education in LMA insertion and BMV.Results12 415 recorded inflations for LMAs and face masks were analysed. Leak detected was lowest with i-gel brand, with a mean of 5.7% compared with face mask (triangular 42.7, round 35.7) and other LMAs (45.5–65.4) (p<0.001). Peak inspiratory pressure was higher with i-gel, with a mean of 28.9 cmH2O compared with face mask (triangular 22.8, round 25.8) and other LMAs (14.3–22.0) (p<0.001). PEEP was higher with i-gel, with a mean of 5.1 cmH2O compared with face mask (triangular 3.0, round 3.6) and other LMAs (0.6–2.6) (p<0.001). In contrast to other LMAs examined, i-gel had no insertion failures and all users found i-gel easy to use.ConclusionThis study has shown dramatic performance differences in delivered ventilation, mask leak and ease of use among seven different brands of LMA tested in a manikin model. This coupled with no partial or complete insertion failures and ease of use suggests i-gel LMA may have an expanded role with newborn resuscitation as a primary resuscitation device.
Primary care physicians’ utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study
Authors: Mehta Sandhya , Mocarski Michelle , Wisniewski Tami , Gillespie Karin , Narayan K M Venkat , Lang Kathleen 
Published: August 2017

ObjectiveTo assess primary care physicians’ (PCPs) knowledge of type 2 diabetes screening guidelines (American Diabetes Association (ADA) and 2008 US Preventive Services Task Force (USPSTF)), the alignment between their self-reported adherence and actual practice, and how often PCPs recommended diabetes prevention and self-management education programs (DPP/DSME).Research design and methodsAn online survey of PCPs to understand knowledge and adherence toward use of USPSTF/ADA guidelines and recommendation of DPP/DSME. Patient data from electronic medical records (EMRs) for each PCP were used to identify rates of screening in eligible patients as per guidelines and the two sources were compared to assess concordance.ResultsOf 305 surveyed physicians, 38% reported use of both guidelines (33% use ADA only, 25% USPSTF only). Approximately one-third of physicians who reported use of USPSTF/ADA guidelines had non-concordant EMR data. Similarly, while most PCPs reported they are ‘very likely’ to screen patients with risk factors listed in guidelines, for each criterion at least one-fourth (24%) of PCPs survey responses were non-concordant with EMRs. PCPs reported they provide referral to DPP and DSME on average to 45% and 67% of their newly diagnosed patients with pre-diabetes and diabetes, respectively.ConclusionFindings show disconnect between PCPs’ perceptions of adherence to screening guidelines and actual practice, and highlight limited referrals to DPP/DSME programs. More research is needed to understand barriers to guideline consistent screening and uptake of DPP/DSME, particularly in light of recent policy changes such as the linking USPSTF criteria to reimbursement and expected Medicare DPP reimbursement in 2018.
Association of tobacco advertising, promotion and sponsorship (TAPS) exposure and cigarette use among Nigerian adolescents: implications for current practices, products and policies
Authors: Chido-Amajuoyi Onyema G , Mantey Dale S , Clendennen Stephanie L , Pérez Adriana 
Published: August 2017

BackgroundThis study investigates the association between exposure to tobacco advertising, promotion and sponsorship (TAPS) and cigarette use behaviours among adolescents in five Nigerian regions. This is imperative given a 2015 WHO report on the global tobacco epidemic, revealing Nigeria has not met any of the MPOWER TAPS ban indicators instituted since 2008.MethodsSecondary data analysis of the 2008 Global Youth Tobacco Survey for Nigeria. Participants were 1399 adolescents, representative of 5 Nigerian regions. Weighted multivariable logistic regression models were used to assess the relationship between TAPS exposure and (1) past 30-day (current) cigarette use, (2) ever cigarette use and (3) susceptibility to use cigarettes among never cigarette users. Sensitivity analysis via complete case analysis and multiple imputation were conducted.ResultsNinety-five per cent of Nigerian adolescents reported exposure to TAPS. Among adolescents who had never smoked, 15% were susceptible to use cigarettes. Cumulative TAPS exposure was significantly associated with both an increased odds of current cigarette use (AOR: 1.73; 95% CI 1.09 to2.99) and ever cigarette use (AOR: 1.29; 95% CI 1.15 to1.45); as well as increased susceptibility to cigarette smoking (AOR: 1.18; 95% CI 1.03 to 1.34), among non-smokers.ConclusionGiven study results, the emergence of new tobacco products and novel platforms for TAPS globally, implementation of existing policies and enhancement of efforts to attain comprehensive bans on all forms of direct and indirect TAPS in line with article 13 of the WHO Framework Convention on Tobacco Control are needed to reduce TAPS exposure and curtail tobacco use in Nigeria.
Causes of and contributors to infant mortality in a rural community of North India: evidence from verbal and social autopsy
Authors: Rai Sanjay Kumar , Kant Shashi , Srivastava Rahul , Gupta Priti , Misra Puneet , Pandav Chandrakant Sambhaji , Singh Arvind Kumar 
Published: August 2017

ObjectiveTo identify the medical causes of death and contribution of non-biological factors towards infant mortality by a retrospective analysis of routinely collected data using verbal and social autopsy tools.SettingThe study site was Health and Demographic Surveillance System (HDSS), Ballabgarh, North IndiaParticipantsAll infant deaths during the years 2008–2012 were included for verbal autopsy and infant deaths from July 2012 to December 2012 were included for social autopsy.Outcome measuresCause of death ascertained by a validated verbal autopsy tool and level of delay based on a three-delay model using the INDEPTH social autopsy tool were the main outcome measures. The level of delay was defined as follows: level 1, delay in identification of danger signs and decision making to seek care; level 2, delay in reaching a health facility from home; level 3, delay in getting healthcare at the health facility.ResultsThe infant mortality rate during the study period was 46.5/1000 live births. Neonatal deaths contributed to 54.3% of infant deaths and 39% occurred on the first day of life. Birth asphyxia (31.5%) followed by low birth weight (LBW)/prematurity (26.5%) were the most common causes of neonatal death, while infection (57.8%) was the most common cause of post-neonatal death. Care-seeking was delayed among 50% of neonatal deaths and 41.2% of post-neonatal deaths. Delay at level 1 was most common and occurred in 32.4% of neonatal deaths and 29.4% of post-neonatal deaths. Deaths due to LBW/prematurity were mostly followed by delay at level 1.ConclusionA high proportion of preventable infant mortality still exists in an area which is under continuous health and demographic surveillance. There is a need to enhance home-based preventive care to enable the mother to identify and respond to danger signs. Verbal autopsy and social autopsy could be routinely done to guide policy interventions aimed at reduction of infant mortality.
Can promoting awareness of fetal movements and focusing interventions reduce fetal mortality? A stepped-wedge cluster randomised trial (AFFIRM)
Authors: Heazell Alexander E P , Weir Christopher J , Stock Sarah J E , Calderwood Catherine J , Burley Sarah Cunningham , Froen J Frederik , Geary Michael , Hunter Alyson , McAuliffe Fionnuala M , Murdoch Edile , Rodriguez Aryelly , Ross-Davie Mary , Scott Janet , Whyte Sonia , Norman Jane E 
Published: August 2017

BackgroundIn 2013, the stillbirth rate in the UK was 4.2 per 1000 live births, ranking 24th out of 49 high-income countries, with an annual rate of reduction of only 1.4% per year. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency the most common clinical finding. Maternal perception of reduced fetal movements (RFM) is associated with placental insufficiency and increased risk of subsequent stillbirth.This study will test the hypothesis that the introduction of a package of care to increase women's awareness of the need for prompt reporting of RFM and standardised management to identify fetal compromise with timely delivery in confirmed cases, will reduce the rate of stillbirth. Following the introduction of a similar intervention in Norway the odds of stillbirth fell by 30%, but the efficacy of this intervention (and possible adverse effects and implications for service delivery) has not been tested in a randomised trial.MethodsWe describe a stepped-wedge cluster trial design, in which participating hospitals in the UK and Ireland will be randomised to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from detailed routinely collected maternity data, allowing us to robustly test our hypothesis. The degree of implementation of the intervention will be assessed in each site. A nested qualitative study will examine the acceptability of the intervention to women and healthcare providers and identify process issues including barriers to implementation.Ethics and disseminationEthical approval was obtained from the Scotland A Research Ethics Committee (Ref 13/SS/0001) and from Research and Development offices in participating maternity units. The study started in February 2014 and delivery of the intervention completed in December 2016. Results of the study will be submitted for publication in peer-reviewed journals and disseminated to local investigating sites to inform education and care of women presenting with RFM.Trial registration numberwww.clinicaltrials.govNCT01777022.VersionProtocol Version 4.2, 3 February 2017.
Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India
Authors: Jha Dilip , Gupta Priti , Ajay Vamadevan S , Jindal Devraj , Perel Pablo , Prieto-Merino David , Jacob Pramod , Nyong Jonathan , Venugopal Vidya , Singh Kavita , Goenka Shifalika , Roy Ambuj , Tandon Nikhil , Patel Vikram , Prabhakaran Dorairaj 
Published: August 2017

IntroductionRising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system.Methods and analysismWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness.Ethics and disseminationThe study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms.Trial registrationmWellcare trial is registered with Clinicaltrial.gov (Registration numberNCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is Version 2 dated 19 October 2015 and the study sponsor is Public Health Foundation of India, Gurgaon, India (www.phfi.org).
The involvement of early stage breast cancer patients during oncology consultations in Italy: a multi-centred, randomized controlled trial of a question prompt sheet versus question listing
Authors: Bottacini Alessandro , Goss Claudia , Mazzi Maria Angela , Ghilardi Alberto , Buizza Chiara , Molino Annamaria , Fiorio Elena , Nortilli Rolando , Amoroso Vito , Vassalli Lucia , Brown Richard F 
Published: August 2017

ObjectivesTo investigate, prior to an oncology consultation, the use of a pre-prepared list of evidence based questions, Question Prompt Sheet (QPS), compared with a Question List (QL), a patient self-generated list of questions.DesignMulti-centred, randomised controlled trial.SettingSecondary-care patients attending three outpatient oncology clinics in Northern Italy.Participants308 women completed the study. Inclusion criteria were an age between 18 and 75 years, a recent diagnosis of early stage, non-metastatic breast cancer, adequate Italian language skills, no previous oncology visits and no evidence of cognitive impairment.InterventionPatients received the QPS or the QL prior to the consultation, completed it without suggestion or coaching session and delivered back before the visit.The consultations were audio-recorded and analysed for the number and content of questions. Multilevel linear models were used to compare the two groups.Outcome measuresThe primary outcome was the comparison of questions asked between QPS and QL group. Secondary outcomes included satisfaction about questions asked, satisfaction with decision, and level of anxiety.ResultsPatients in the QPS and QL group asked 13 and 16 questions respectively. The difference was not significant (b=1.7, CI –0.3 to 3.6, p=0.10). A mean of 22 questions was selected in the QPS, while a mean of 2 questions was written in the QL. Patients in the QPS group were significantly less satisfied (t=3.60, p<0.01) with questions asked but wanted less additional information (t=2.20, p<0.05). Levels of patient decisional satisfaction were equivalent between groups. Similarly, anxiety levels were equal between groups prior to the consultation and decreased in similar way after the consultation.ConclusionsBoth interventions have similar impact on patients’ participation in terms of question asking during the consultation. Future research is needed in order to explore which components of the interventions are really useful and efficacious.Trial registrationClinicalTrials.govNCT01510964
The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial
Authors: Abdel-Fattah Mohamed , MacLennan Graeme , Kilonzo Mary , Assassa R Phil , McCormick Kirsty , Davidson Tracey , McDonald Alison , N’Dow James , Wardle Judith , Norrie John 
Published: August 2017

IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.
Getting the right balance? A mixed logit analysis of the relationship between UK training doctors’ characteristics and their specialties using the 2013 National Training Survey
Authors: Rodriguez Santana Idaira , Chalkley Martin 
Published: August 2017

ObjectiveTo analyse how training doctors’ demographic and socioeconomic characteristics vary according to the specialty that they are training for.DesignDescriptive statistics and mixed logistic regression analysis of cross-sectional survey data to quantify evidence of systematic relationships between doctors’ characteristics and their specialty.SettingDoctors in training in the United Kingdom in 2013.Participants27 530 doctors in training but not in their foundation year who responded to the National Training Survey 2013.Main outcome measuresMixed logit regression estimates and the corresponding odds ratios (calculated separately for all doctors in training and a subsample comprising those educated in the UK), relating gender, age, ethnicity, place of studies, socioeconomic background and parental education to the probability of training for a particular specialty.ResultsBeing female and being white British increase the chances of being in general practice with respect to any other specialty, while coming from a better-off socioeconomic background and having parents with tertiary education have the opposite effect. Mixed results are found for age and place of studies. For example, the difference between men and women is greatest for surgical specialties for which a man is 12.121 times more likely to be training to a surgical specialty (relative to general practice) than a woman (p-value<0.01). Doctors who attended an independent school which is proxy for doctor’s socioeconomic background are 1.789 and 1.413 times more likely to be training for surgical or medical specialties (relative to general practice) than those who attended a state school (p-value<0.01).ConclusionsThere are systematic and substantial differences between specialties in respect of training doctors’ gender, ethnicity, age and socioeconomic background. The persistent underrepresentation in some specialties of women, minority ethnic groups and of those coming from disadvantaged backgrounds will impact on the representativeness of the profession into the future. Further research is needed to understand how the processes of selection and the self-selection of applicants into specialties gives rise to these observed differences.
Protein misfolding, amyotrophic lateral sclerosis and guanabenz: protocol for a phase II RCT with futility design (ProMISe trial)
Authors: Bella Eleonora Dalla , Tramacere Irene , Antonini Giovanni , Borghero Giuseppe , Capasso Margherita , Caponnetto Claudia , Chiò Adriano , Corbo Massimo , Eleopra Roberto , Filosto Massimiliano , Giannini Fabio , Granieri Enrico , Bella Vincenzo La , Lunetta Christian , Mandrioli Jessica , Mazzini Letizia , Messina Sonia , Monsurrò Maria Rosaria , Mora Gabriele , Riva Nilo , Rizzi Romana , Siciliano Gabriele , Silani Vincenzo , Simone Isabella , Sorarù Gianni , Volanti Paolo , Lauria Giuseppe 
Published: August 2017

IntroductionRecent studies suggest that endoplasmic reticulum stress may play a critical role in the pathogenesis of amyotrophic lateral sclerosis (ALS) through an altered regulation of the proteostasis, the cellular pathway-balancing protein synthesis and degradation. A key mechanism is thought to be the dephosphorylation of eIF2α, a factor involved in the initiation of protein translation. Guanabenz is an alpha-2-adrenergic receptor agonist safely used in past to treat mild hypertension and is now an orphan drug. A pharmacological action recently discovered is its ability to modulate the synthesis of proteins by the activation of translational factors preventing misfolded protein accumulation and endoplasmic reticulum overload. Guanabenz proved to rescue motoneurons from misfolding protein stress both in in vitro and in vivo ALS models, making it a potential disease-modifying drug in patients. It is conceivable investigating whether its neuroprotective effects based on the inhibition of eIF2α dephosphorylation can change the progression of ALS.Methods and analysesProtocolised Management In Sepsis is a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial with futility design. We will investigate clinical outcomes, safety, tolerability and biomarkers of neurodegeneration in patients with ALS treated with guanabenz or riluzole alone for 6 months. The primary aim is to test if guanabenz can reduce the proportion of patients progressed to a higher stage of disease at 6 months compared with their baseline stage as measured by the ALS Milano-Torino Staging (ALS-MITOS) system and to the placebo group. Secondary aims are safety, tolerability and change in at least one biomarker of neurodegeneration in the guanabenz arm compared with the placebo group. Findings will provide reliable data on the likelihood that guanabenz can slow the course of ALS in a phase III trial.Ethics and disseminationThe study protocol was approved by the Ethics Committee of IRCCS ‘Carlo Besta Foundation’ of Milan (Eudract no. 2014-005367-32 Pre-results) based on the Helsinki declaration.