bluuebunny/crossref_metadata_2025_split huggingface dataset:
Physiological-based cord clamping in preterm infants using a new purpose-built resuscitation table: a feasibility study
Authors: Brouwer Emma , Knol Ronny , Vernooij Alex S N , van den Akker Thomas , Vlasman Patricia E , Klumper Frans J C M , DeKoninck Philip , Polglase Graeme R , Hooper Stuart B , te Pas Arjan B 
Published: October 2018

ObjectivePhysiological-based cord clamping (PBCC) led to a more stable cardiovascular adaptation and better oxygenation in preterm lambs, but in preterm infants, this approach has been challenging. Our aim was to assess the feasibility of PBCC, including patterns of oxygen saturation (SpO2) and heart rate (HR) during stabilisation in preterm infants using a new purpose-built resuscitation table.DesignObservational study.SettingTertiary referral centre, Leiden University Medical Centre, The Netherlands.PatientsInfants born below 35 weeks’ gestational age.InterventionsInfants were stabilised on a new purpose-built resuscitation table (Concord), provided with standard equipment needed for stabilisation. Cord clamping was performed when the infant was stable (HR >100 bpm, spontaneous breathing on continuous positive airway pressure with tidal volumes >4 mL/kg, SpO2 ≥25th percentile and fraction of inspired oxygen (FiO2) <0.4).ResultsThirty-seven preterm infants were included; mean (SD) gestational age of 30.9 (2.4) weeks, birth weight 1580 (519) g. PBCC was successful in 33 infants (89.2%) and resulted in median (IQR) cord clamping time of 4:23 (3:00–5:11) min after birth. There were no maternal or neonatal adverse events. In 26/37 infants, measurements were adequate for analysis. HR was 113 (81–143) and 144 (129–155) bpm at 1 min and 5 min after birth. SpO2 levels were 58%(49%–60%) and 91%(80%–96%)%), while median FiO2 given was 0.30 (0.30–0.31) and 0.31 (0.25–0.97), respectively.ConclusionPBCC in preterm infants using the Concord is feasible. HR remained stable, and SpO2 quickly increased with low levels of oxygen supply.Trial registration numberNTR6095, results.
Collaboration between academics and industry in clinical trials: cross sectional study of publications and survey of lead academic authors
Authors: Rasmussen Kristine , Bero Lisa , Redberg Rita , Gøtzsche Peter C , Lundh Andreas 
Published: October 2018

Abstract

Objectives
To determine the role of academic authors, funders, and contract research organisations in industry funded trials of vaccines, drugs, and devices and to determine lead academic authors’ experiences with industry funder collaborations.

Design
Cross sectional analysis of trial publications and survey of lead academic authors.

Eligibility criteria for selecting studies

The most recent 200 phase III and IV trials of vaccines, drugs, and devices with full industry funding, at least one academic author, published in one of the top seven high impact general medical journals (
New England Journal of Medicine
,
Lancet
,
JAMA
,
BMJ
,
Annals of Internal Medicine
,
JAMA Internal Medicine
, and
PLoS Medicine
).

Results
Employees of industry funders co-authored 173 (87%) of publications; 183 (92%) trials reported involvement of funders in design, and 167 (84%) reported involvement of academic authors. Data analysis involved the funder in 146 (73%) trials and the academic authors in 79 (40%). Trial reporting involved the funder in 173 (87%) trials and academic authors in 197 (99%). Contract research organisations were involved in the reporting of 123 (62%) trials.
Eighty (40%) of 200 lead academic authors responded to the survey. Twenty nine (33%) of the 80 responders reported that academics had final say on the design. Ten responders described involvement of an unnamed funder and/or contract research organisation employee in the data analysis and/or reporting. Most academic authors found the collaboration with industry funder beneficial, but 3 (4%) experienced delay in publication due to the industry funder and 9 (11%) reported disagreements with the industry funder, mostly concerning trial design and reporting.

Conclusions
Industry employees and academic authors are involved in the design, conduct, and reporting of most industry funded trials in high impact journals. However, data analysis is often conducted without academic involvement. Academics view the collaboration as beneficial, but some report loss of academic freedom.
Safety and efficacy of self-administered inhaled loxapine (ADASUVE) in agitated patients outside the hospital setting: protocol for a phase IV, single-arm, open-label trial
Authors: Gil Emilio , Garcia- Alonso Fernando , Boldeanu Anca , Baleeiro Teixeira Thaïs 
Published: October 2018

IntroductionThere is a need for fast-acting, non-injection antiagitation treatments that are well tolerated and can be used outside of healthcare facilities. In phase II/III trials, an inhaled formulation of loxapine (ADASUVE®), a well-established, first-generation antipsychotic agent, provided rapid control of mild to moderate agitation in the hospital setting. The present study was designed to investigate the safety and efficacy of inhaled loxapine when self-administered outside the hospital setting.Methods and analysisThis phase IV, multicentre, single-arm, open-label clinical trial is being conducted in five countries in Europe: Spain, Germany, Norway, Romania and Austria. The aim is to include approximately 500 patients with schizophrenia or bipolar disorder who previously received and responded well to inhaled loxapine in the hospital setting. Eligible patients will be followed up for 6 months from baseline. They will be given a 10 mg dose of inhaled loxapine to self-administer outside the hospital setting to treat an agitation episode, should one occur. Patients will also be given a short-acting beta-agonist bronchodilator for treatment of possible severe respiratory side effects. The primary endpoint is incidence of serious adverse events (AEs) and respiratory AEs of special interest related to use of inhaled loxapine outside the hospital setting. Secondary endpoints include incidence of other AEs, Clinical Global Impression-Improvement scores up to 2 hours after self-administration of inhaled loxapine, time to improvement of agitation, patient satisfaction with treatment, treatment outcomes according to agitation severity and concordance between the patient (or a family member/caregiver) and the physician in scoring of agitation severity and the decision to self-administer inhaled loxapine.Ethics and disseminationThe protocol received ethics committee approval in the participating countries between January and August 2016. The results of this study will be disseminated through one or more scientific papers.Trial registration numberEudraCT2015-003331-36;NCT02525991; Pre-results.
Association of Meniere’s disease and retinal vascular calibre: a prospective observational study in China
Authors: Wang Yixu , Diao Tongxiang , Han Lin , Tao Ye , Yu Lisheng 
Published: October 2018

ObjectiveIt is believed that Meniere’s disease (MD) is associated with vascular disorders, but few studies have reported the relationship between retinal vascular disorders and MD. We evaluated and compared the retinal vascular calibres in patients with MD with healthy subjects matched for age, sex and vascular risk factors using retinal photographs to explore the association between MD and retinal vascular calibre.Study designA prospective study.SettingTertiary referral centre.ParticipantsSixty patients with MD and 62 healthy subjects matched for age, sex and vascular risk factors were enrolled in this study. Twenty-four patients with MD had migraines, and 36 patients with MD did not have migraines.Main outcome measureRetinal vascular calibres were calculated and compared not only between patients with MD and healthy subjects but also between subgroups of patients with MD.ResultsCompared with healthy subjects, patients with MD had a slightly larger retinal artery calibre (126.30±10.45vs 119.61±15.86, p=0.006) and a higher retinal artery/vein ratio (0.79±0.09vs 0.75±0.10, p=0.005). Among patients with MD, those with migraines had a larger retinal artery calibre (130.73±11.55vs 123.35±8.61, p=0.006) than those without migraines. Moreover, the presence of migraines and the high frequency of vertigo attacks appeared to increase the retinal artery calibre.ConclusionsOur study suggests that a relationship exists between retinal vascular calibre and MD. Although the pathophysiological relationship between migraine and MD remains unclear, the presence of migraine attacks may aggravate endolymphatic hydrops (EH) and accelerate the outflow of EH in patients with MD. More extensive studies are required to explore the association between retinal vascular calibre and MD.
Getting the most out of intensive longitudinal data: a methodological review of workload–injury studies
Authors: Windt Johann , Ardern Clare L , Gabbett Tim J , Khan Karim M , Cook Chad E , Sporer Ben C , Zumbo Bruno D 
Published: October 2018

ObjectivesTo systematically identify and qualitatively review the statistical approaches used in prospective cohort studies of team sports that reported intensive longitudinal data (ILD) (>20 observations per athlete) and examined the relationship between athletic workloads and injuries. Since longitudinal research can be improved by aligning the (1) theoretical model, (2) temporal design and (3) statistical approach, we reviewed the statistical approaches used in these studies to evaluate how closely they aligned these three components.DesignMethodological review.MethodsAfter finding 6 systematic reviews and 1 consensus statement in our systematic search, we extracted 34 original prospective cohort studies of team sports that reported ILD (>20 observations per athlete) and examined the relationship between athletic workloads and injuries. Using Professor Linda Collins’ three-part framework of aligning the theoretical model, temporal design and statistical approach, we qualitatively assessed how well the statistical approaches aligned with the intensive longitudinal nature of the data, and with the underlying theoretical model. Finally, we discussed the implications of each statistical approach and provide recommendations for future research.ResultsStatistical methods such as correlations, t-tests and simple linear/logistic regression were commonly used. However, these methods did not adequately address the (1) themes of theoretical models underlying workloads and injury, nor the (2) temporal design challenges (ILD). Although time-to-event analyses (eg, Cox proportional hazards and frailty models) and multilevel modelling are better-suited for ILD, these were used in fewer than a 10% of the studies (n=3).ConclusionsRapidly accelerating availability of ILD is the norm in many fields of healthcare delivery and thus health research. These data present an opportunity to better address research questions, especially when appropriate statistical analyses are chosen.
Cognitive control and daily affect regulation in major depression and borderline personality disorder: protocol for an experimental ambulatory assessment study in Berlin, Germany
Authors: Schulze Lars , Bürkner Paul-Christian , Bohländer Julian , Zetsche Ulrike 
Published: October 2018

IntroductionAffective disturbances and difficulty in affect regulation are core features of major depressive disorder (MDD) as well as borderline personality disorder (BPD). Whereas depressed individuals are characterised by affective inertia, individuals with BPD are characterised by affective instability. Both groups have been found to use more maladaptive affect regulation strategies than healthy controls. Surprisingly, however, there have been hardly any studies directly comparing these two disorders to disentangle shared and disorder-specific deficits in affective dynamics and affect regulation.Furthermore, theoretical models link deficits in affect regulation to deficits in cognitive control functions. Given that individuals with MDD or BPD are both characterised by impairments in cognitive control, the present study will further examine the link between individual differences in cognitive control and disturbances in affect dynamics and regulation in the daily life of individuals with MDD or BPD.Methods and analysesWe will use a smartphone application to assess negative and positive affect as well as affect regulation strategies at eight times a day for 7 days. We will further employ four computerised tasks to assess two cognitive control functions, namely interference control and discarding irrelevant information from working memory. Our hypotheses will be tested using a multimethod approach. Power analyses determined a sample size of 159 (53 MDD, 53 BPD, 53 controls) to detect medium effect sizes.Ethics and disseminationEthics approval has been obtained from the Freie Universität Berlin. Data collection started in January 2017 and will last until the end of 2018. Results will be disseminated to relevant psychotherapeutic and patient communities in peer-reviewed journals, and at scientific conferences.
Opportunistic HPV vaccination at age 16–23 and cervical screening attendance in Sweden: a national register-based cohort study
Authors: Kreusch Teresa , Wang Jiangrong , Sparén Pär , Sundström Karin 
Published: October 2018

ObjectivesTo investigate whether cervical screening attendance differs between human papillomavirus (HPV)-vaccinated and unvaccinated women and to investigate potential underlying socioeconomic factors.DesignProspective cohort using registry linkage of vaccinations, screening invitations, screening attendance and socioeconomic covariates.SettingSwedish national HPV vaccination and cervical screening programmes.ParticipantsAll Swedish women born between 1988 and 1991 and invited to screening (n=261 434).Outcome measuresAll participants were followed for up to 3 years. Screening attendance was compared between HPV-vaccinated and unvaccinated women. HR and 95% CI were estimated using Cox regression.ResultsVaccination age averaged 18.1 years and the coverage for≥1 dose was 13.5%. In HPV-vaccinated women (n=35 460), screening attendance was higher than in unvaccinated women (n=225 974) (74%vs69%, p<0.001). The crude HR of attendance in HPV-vaccinated women was 1.32 (95% CI 1.30 to 1.34). A positive association remained after adjustment for education, income and migration history (HR=1.10, 95% CI 1.09 to 1.12).ConclusionHPV-vaccinated women were more likely to attend screening than unvaccinated women. Yet, the question needs to be reassessed in routinely vaccinated cohorts, since the vaccinated women included here represent a selected group and may be prone to more health-conscious habits.
Randomised controlled trial of the Limit of Detection of Troponin and ECG Discharge (LoDED) strategy versus usual care in adult patients with chest pain attending the emergency department: study protocol
Authors: Carlton Edward , Campbell Sarah , Ingram Jenny , Kandiyali Rebecca , Taylor Hazel , Aziz Shahid , Beresford Peter , Kendall Jason , Reuben Adam , Smith Jason , Vickery Patricia Jane , Benger Jonathan Richard 
Published: October 2018

IntroductionObservational data suggest a single high-sensitivity troponin blood test taken at emergency department (ED) presentation could be used to rule out major adverse cardiac events (MACE) in 10%–60% of ED patients with chest pain. This is done using an ‘undetectable’ cut-off (the Limit of Detection: LoD). We combined the LoD cut-off with ECG findings to create the LoDED strategy. We aim to establish whether the LoDED strategy works under real-life conditions, when compared with existing strategies, in a way that is cost-effective and acceptable to patients.Methods and analysisThis is a parallel-group pragmatic randomised controlled trial across UK EDs. Adults presenting to ED with suspected cardiac chest pain will be randomised 1:1. Existing rule-out strategies in current use across study centres, using serial high-sensitivity troponin testing, will be compared with the LoDED strategy. The primary outcome is successful early discharge (discharge from hospital within 4 hours of arrival) without MACE occurring within 30 days. Secondary outcomes include initial length of hospital stay; comparative costs; patient satisfaction and acceptability to patients. To detect a 9% difference between the early discharge rates (assuming an 8% rate in the standard care group) with 90% power, 594 patients need to be recruited, assuming a 95% follow-up rate.Ethics and disseminationThe study has been approved by the Frenchay Research Ethics Committee (reference 18/SW/0038). Results will be published in an international peer-reviewed journal. Lay summaries will be made available to patients.Trial registration numberISRCTN86184521; Pre-results.
Systematic review and meta-analysis of community pharmacy error rates in the USA: 1993–2015
Authors: Campbell Patrick J , Patel Mira , Martin Jennifer R , Hincapie Ana L , Axon David Rhys , Warholak Terri L , Slack Marion 
Published: October 2018

ImportanceWhile much is known about hospital pharmacy error rates in the USA, comparatively little is known about community pharmacy dispensing error rates.ObjectiveThe aim of this study was to determine the rate of community pharmacy dispensing errors in the USA.MethodsEnglish language, peer-reviewed observational and interventional studies that reported community pharmacy dispensing error rates in the USA from January 1993 to December 2015 were identified in 10 bibliographic databases and topic-relevant grey literature. Studies with a denominator reflecting the total number of prescriptions in the sample were necessary for inclusion in the meta-analysis. A random effects meta-analysis was conducted to estimate an aggregate community pharmacy dispensing error rate. Heterogeneity was assessed using the I2statistic prior to analysis.ResultsThe search yielded a total of 8490 records, of which 11 articles were included in the systematic review. Two articles did not have adequate data components to be included in the meta-analysis. Dispensing error rates ranged from 0.00003% (43/1 420 091) to 55% (55/100). The meta-analysis included 1 461 128 prescriptions. The overall community pharmacy dispensing error rate was estimated to be 0.015 (95% CI 0.014 to 0.018); however, significant heterogeneity was observed across studies (I2=99.6). Stratification by study error identification methodology was found to have a significant impact on dispensing error rate (p<0.001).Conclusion and relevanceThere are few published articles that describe community pharmacy dispensing error rates in the USA. Thus, there is limited information about the current rate of community pharmacy dispensing errors. A robust investigation is needed to assess dispensing error rates in the USA to assess the nature and magnitude of the problem and establish prevention strategies.
Impact of the NHS Health Check on inequalities in cardiovascular disease risk: a difference-in-differences matching analysis
Authors: Chang Kiara C-M , Vamos Eszter P , Palladino Raffaele , Majeed Azeem , Lee John Tayu , Millett Christopher 
Published: October 2018

BackgroundWe assessed impacts of a large, nationwide cardiovascular disease (CVD) risk assessment and management programme on sociodemographic group inequalities in (1) early identification of hypertension, type 2 diabetes (T2D) and chronic kidney disease (CKD); and (2) management of global CVD risk among high-risk individuals.MethodsWe obtained retrospective electronic medical records from the Clinical Practice Research Datalink for a randomly selected sample of 138 788 patients aged 40–74 years without known CVD or diabetes, who were registered with 462 practices between 2009 and 2013. We estimated programme impact using a difference-in-differences matching analysis that compared changes in outcome over time between attendees and non-attendees.ResultsNational Health Service Health Check attendance was 21.4% (29 672/138 788). A significantly greater number of hypertension and T2D incident cases were identified in men than women (eg, an additional 4.02%, 95% CI 3.65% to 4.39%, and 2.08%, 1.81% to 2.35% cases of hypertension in men and women, respectively). A significantly greater number of T2D incident cases were identified among attendees living in the most deprived areas, but no differences were found for hypertension and CKD across socioeconomic groups. No major differences in CVD risk management were observed between sociodemographic subgroups (eg, programme impact on 10-year CVD risk score was −1.13%, −1.48% to −0.78% in male and −1.53%, −2.36% to −0.71% in female attendees).ConclusionDuring 2009–2013, the programme had low attendance and small overall impacts on early identification of disease and risk management. The age, sex and socioeconomic subgroups appeared to have derived similar level of benefits, leaving existing inequalities unchanged. These findings highlight the importance of population-wide interventions to address inequalities in CVD outcomes.
Young adult susceptible non-smokers’ and smokers’ responses to capsule cigarettes
Authors: Hoek Janet , Gendall Philip , Eckert Christine , Louviere Jordan , Blank Mei-Ling , Thrasher James F 
Published: October 2018

BackgroundFlavour capsule cigarette variants (FCVs), which allow users to customise their smoking experience and reduce the harshness of smoking, have captured an increasing share of many markets. We examined tobacco companies’ argument that such product innovations aim simply to shift market share, by estimating smokers’ and susceptible non-smokers’ responses to FCVs.MethodsWe conducted an online survey of 425 smokers (daily and non-daily), susceptible non-smokers (n=224) and former smokers (n=166) aged between 18 and 25. Restrpondents completed a choice experiment, a behavioural probability measure and a perception task. We analysed the choice data using a conditional logistic regression and a rank-ordered logistic regression, and the probability and perception data using t-tests and descriptive statistics.ResultsNon-smokers preferred an FCV relative to an unflavoured cigarette, whereas the opposite was the case for smokers. Susceptible non-smokers and former smokers were more likely to try a fruit flavoured FCV than an unflavoured stick, while daily smokers were more likely than non-daily smokers to do the same. Susceptible non-smokers, former smokers and non-daily smokers also had more positive perceptions of FCVs relative to unflavoured sticks than did daily smokers.ConclusionsFCVs appeal more to non-smokers than to smokers, and more to non-daily smokers than to daily smokers. They thus appear likely to recruit non-smokers and potentially increase overall smoking prevalence. Policy responses include ensuring standardised packaging legislation disallows FCVs by specifically regulating the appearance and design of tobacco products, or introducing bespoke regulation that addresses the threat posed by FCVs.