bluuebunny/crossref_metadata_2025_split huggingface dataset:
Wearable technology in an international telementoring setting during surgery: a feasibility study
Authors: Meijer Henriëtte A W , Sánchez Margallo Juan A , Sánchez Margallo Francisco M , Goslings J Carel , Schijven Marlies P 
Published: September 2017

BackgroundTelemedicine holds promise for improving access to care. Telementoring—defined as mentoring by means of telecommunication and computer networks—can be used for remote education of healthcare professionals. Furthermore, it is rapidly establishing itself as a valuable asset in medicine and education. This paper aims to establish a financially and practically feasible, stable telementoring network using wearables for sterile and hands-free remote control, to be used during surgical procedures.MethodsTwo stand-alone computer systems, located at an academic hospital in the Netherlands and at a surgical research facility in Spain, were connected using TeamViewer software allowing for remote, hands-free controlling of radiological images using Myo gesture control armband. The operating surgeon consulted the remote surgeon through an audio, video and desktop sharing system during a live surgical procedure on a single porcine model. The system was analysed for feasibility and connection quality.ResultsThe sensors used were commercially available and relatively cheap, with the integrating computer system being responsible for the majority of costs. A successful connection was established without any downtime and with only a minor time lag, not interfering with the telementoring procedures. The operating surgeon effectively consulted with and was mentored by the remote surgeon, through video, audio and the desktop sharing system, using the wearable sensors.ConclusionsThis proof of principle shows the feasibility of using an internet-based remote desktop sharing system in combination with wearable sensors and TedCube technology for telementoring purposes during surgical procedures.
New technical solution to minimise noise exposure for surgical staff: the ‘silent operating theatre optimisation system’
Authors: Friedrich Martin G , Boos Margarete , Pagel Manuela , Thormann Tobias , Berakdar Adel , Russo Sebastian , Tirilomis Theodor 
Published: September 2017

The increasing number of technical equipment in the operating room (OR) is resulting in significantly higher noise levels. The more complex and sophisticated the surgical procedure is, the more essential it is for all team members of the OR to work together in a harmonious fashion to process and manage their demanding team tasks. With increasing noise in OR, the risk of more frequent errors also increases. The reduction of noise production in the OR is possible but limited. The aim of this study was to develop a device that reduces ambient noise for the operating team without hindering their ability to communicate.We developed a new communication technology set-up for the OR to meet all needed requirements. All members of the operating team are issued headsets with microphones. The headsets filter out background noises (active and passive noise cancelling) and the microphones enable interactive communication among and between OR subgroups through targeted information selection (signal selection). Any remaining background noise is overshadowed by music, which is quiesced by direct speech into the microphone (ducking). Information flow is programmed on a digital workstation, providing each team member a selection of acoustic signals from the OR on their bidirectional headset. A complex matrix of connections in this audio technology allows a predefined communication structure. These procedures were assembled in the Silent Operating Theatre Optimisation System (SOTOS). The technical specifications and user interface are described. A pilot study in 2015 using the SOTOS in cardiac surgery showed very positive feedback from the participating operating team members. Further studies focusing on communicational psychology perspective and physiological reaction are recommended.
A priori consent within pragmatic randomised controlled trials: a web-based survey of statin use in primary care
Authors: Semprini Alex , Hills Thomas , Braithwaite Irene , Weatherall Mark , Beasley Richard 
Published: September 2017

BackgroundClinical research methodology is evolving with the advent of pragmatic randomised controlled trials (PRCTs). Novel approaches for informed consent in PRCTs are needed.ObjectiveTo explore public opinion about different ways of giving informed consent for PRCTs.DesignWeb-based survey assessing acceptability of three PRCT consent scenarios for statin use.SettingCommunity-based study.Participants678 (12%) adults responded to an open-access web-based survey.MeasurementsParticipant-rated acceptability of three different options for giving informed consent for a PRCT testing two commonly prescribed, effective treatments: statins for hyperlipidaemia. Option A was written informed consent given a priori for a specific study, with verbal confirmation of consent at time of randomisation. Option B was written informed, general consent a priori for multiple comparative effectiveness studies, with verbal confirmation for a specific study at time of randomisation. Option C was written informed consent for a specific study at time of randomisation.ResultsAcceptability was higher for option A (475/529 (89.9%)) and B (441/487 (90.6%)) compared with C (339/481 (70.5%)). The estimates of differences in paired proportions were A versus C, 19.4% (95% CI 14.4 to 24.5), p<0.001; B versus C, 20.1% (95% CI 15.2 to 25.0), p<0.001.LimitationsThe study design may have been subject to cognitive biases such as framing and anchoring effects. The anonymised web-based survey allowed no follow-up or verification for missing data. The sampling frame used an institutional database and social media and selection bias and halo effects may have been present. The 12.3% response rate may represent poor generalisability.ConclusionThe concept of giving a priori consent, with subsequent confirmation at time of randomisation in a PRCT, was more favourable than the traditional model of consent in a general-practice-based study of statin use.
Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States
Authors: Lassman Scott M , Shopshear Olivia M , Jazic Ina , Ulrich Jocelyn , Francer Jeffrey 
Published: September 2017

ObjectiveTo evaluate the accuracy of a 2015 cross-sectional analysis published in theBMJ Openwhich reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies.DesignWe performed a reassessment of the data reported in Milleret alto evaluate whether statutory compliance analyses and conclusions were valid.Data sourcesInformation from the Dryad Digital Repository, ClinicalTrials.gov, Drugs@FDA and direct communications with sponsors.Main outcome measuresCompliance with the clinical trial registration and results reporting requirements under the Food and Drug Administration Amendments Act (FDAAA).ResultsIndustry compliance with FDAAA disclosure requirements was notably higher than reported by Milleret al.Among trials subject to FDAAA, Milleret alreported that, per drug, a median of 67% (middle 50% range: 0%–100%) of trials fully complied with registration and results reporting requirements. On reanalysis of the data, we found that a median of 100% (middle 50% range: 93%–100%) of clinical trials for a particular drug fully complied with the law. When looking at overall compliance at the trial level, our reassessment yields 94% timely registration and 90% timely results reporting among the 49 eligible trials, and an overall FDAAA compliance rate of 86%.ConclusionsThe claim by Milleret althat industry compliance is below legal standards is based on an analysis that relies on an incomplete dataset and an interpretation of FDAAA that requires disclosure of study results for drugs that have not yet been approved for any indication. On reanalysis using a different interpretation of FDAAA that focuses on whether results were disclosed within 30 days of drug approval, we found that industry compliance with US statutory disclosure requirements for the 15 reviewed drugs was consistently high.
Paradigm shift: should the elderly undergo propofol sedation for DBE? A prospective cohort study
Authors: Ching Hey-Long , Branchi Federica , Sanders David S , Turnbull David , Sidhu Reena 
Published: September 2017

ObjectiveEvaluate the safety of propofol-assisted double balloon enteroscopy (DBE) in elderly patients against a younger cohort.DesignProspective cohort studySettingAll patients undergoing DBE over a 30-month period were recruited at our tertiary centre.Patients215 procedures in 161 patients were performed. An age cut-off of 65 years and above was used to define those who were elderly.InterventionsPatients were subcategorised into four groups: elderly or young undergoing DBE with propofol or conventional sedation (with midazolam±fentanyl).Main outcome measuresPatient demographics, comorbidities, procedural data, complications, diagnostic and therapeutic yield were compared.ResultsCardiovascular disease and a higher American Society of Anaethesiologists (ASA) status were more prevalent in elderly patients undergoing DBE with propofol (p<0.05). Common indications for DBE were occult and overt obscure gastrointestinal bleeding and suspected Crohn’s disease (elderly vs young: 50.7% vs 42.3%, 17.8% vs 12% and 19.2% vs 26.1%, respectively). Diagnostic yield was higher in elderly compared with young patients (75.3% vs 58.5%, p=0.016). The most common findings in elderly and young patients were angioectasia (30.1% and. 18.3%, respectively) and ulcers (17.8% and 9.2%, respectively), while therapeutic intervention rates were comparable (42.5% vs 32.4%, p=0.18). ASA status did not affect propofol dose (p=0.55) or procedure duration (p=0.31). Tolerance scores were favourable in those receiving propofol compared with conventional sedation (p<0.05). There was no difference in complications between the four groups (p=0.17).ConclusionCompared with young patients, propofol-assisted DBE in the elderly is safe and has a high diagnostic yield.
Trends in UK endoscopy training in the BSG trainees’ national survey and strategic planning for the future
Authors: Biswas Sujata , Alrubaiy Laith , China Louise , Lockett Melanie , Ellis Antony , Hawkes Neil 
Published: September 2017

BackgroundImprovements in the structure of endoscopy training programmes resulting in certification from the Joint Advisory Group in Gastrointestinal Endoscopy have been acknowledged to improve training experience and contribute to enhanced colonoscopy performance.ObjectivesThe 2016 British Society of Gastroenterology trainees’ survey of endoscopy training explored the delivery of endoscopy training - access to lists; level of supervision and trainee’s progression through diagnostic, core therapy and subspecialty training. In addition, the barriers to endoscopy training progress and utility of training tools were examined.MethodsA web-based survey (Survey Monkey) was sent to all higher specialty gastroenterology trainees.ResultsThere were some improvements in relation to earlier surveys; 85% of trainees were satisfied with the level of supervision of their training. But there were ongoing problems; 12.5% of trainees had no access to a regular training list, and 53% of final year trainees had yet to achieve full certification in colonoscopy. 9% of final year trainees did not feel confident in endoscopic management of upper GI bleeds.ConclusionsThe survey findings provide a challenge to those agencies tasked with supporting endoscopy training in the UK. Acknowledging the findings of the survey, the paper provides a strategic response with reference to increased service pressures, reduced overall training time in specialty training programmes and the requirement to support general medical and surgical on-call commitments. It describes the steps required to improve training on the ground: delivering additional training tools and learning resources, and introducing certification standards for therapeutic modalities in parallel with goals for improving the quality of endoscopy in the UK.
Impact and cost-effectiveness of formal gastroenterology outpatient referral Clinical Assessment Service
Authors: Pelitari Stavroula , Hathaway Charlotte , Gritton Dean , Smith Andrea , Bush David , Menon Shyam , McKaig Brian 
Published: September 2017

ObjectiveThe aim was to assess the financial and operational impact of our new gastroenterology referral pathway model on our services.DesignAn electronic ‘Clinical Assessment Service’ (CAS) proforma and an information platform were developed, and all data were analysed retrospectively.SettingRoyal Wolverhampton NHS Trust.Patients14 245 general practitioner (GP) referrals were received during January 2014–December 2016 with 9773 of them being triaged via our CAS.Main outcome measuresWe looked into patients’ clinical outcome along with departmental performance and finances.ResultsA new outpatient appointment was offered to 60.1% (n=5873) of the CAS referred patients. Endoscopic or radiological investigations were requested for 29.2% (n=2854) of patients prior to deciding on further management plan. Out of those, 27% (n=765) went on to receive another gastroenterology (GI) clinic appointment. The remaining 21.3% (n=2089) of the CAS patients were discharged back to their GP following initial investigations. 5.5% (n=538) were discharged back to primary care with a letter of advice, whereas 5.2% (n=509) were deemed inappropriate for GI clinic and were redirected to other specialists. Overall, 32% (n=3127) of patients were managed without a face to face consultation in the GI clinic. This corresponds to 3136 less outpatient appointments with estimated reduced expenditure by the Clinical Commissioning Group (CCG) of £481K. The 18-week performance and waiting times remained stable despite the increasing referral population. The DNA rate dropped from 14% pre to 8.5%.ConclusionsOur clinical assessment model has, in addition to the clinical benefits, a considerable positive financial impact to the health economy.
How are we managing fistulating perianal Crohn’s disease? Results of a national survey of consultant gastroenterologists
Authors: Lee Matthew James , Brown Steven R , Fearnhead Nicola S , Hart Ailsa , Lobo Alan J 
Published: September 2017

ObjectiveFistulating perianal Crohn’s disease represents a significant challenge to both clinicians and patients. This survey set out to describe current practice and variation in the medical management of this condition.DesignA survey was designed by an expert group of gastroenterologists and surgeons with an inflammatory bowel disease (IBD) interest. The questionnaire aimed to capture opinions from consultant gastroenterologists with a UK practice on the management of acutely symptomatic fistula, assessment of a new fistula presentation, medical management strategies and surgical intervention. The survey was piloted at the British Society of Gastroenterology Clinical Research Group meeting, and distributed at UK gastroenterology meetings.ResultsThere were 111 completed responses (response rate 55%). Following clearance of sepsis, 22.1% of respondents would wait 6 weeks or more before commencing medical therapy. Antibiotics were used by 89.2%, with a variable duration. First-line medical therapy was thiopurine for 48% and antitumour necrosis factor (TNF) for 50% of respondents. These were used in combination by 44.4%. Interval to escalation of therapy (if required) varied from 1 month to a year. Anti-TNF therapies were favoured in deteriorating patients. An IBD multidisciplinary team was accessible to 98%, although only 23.6% routinely discussed these patients. Optimisation strategies for anti-TNF and thiopurines were used by 70% of respondents. Recurrent sepsis, refractory disease and patient choice are indications for surgical referral.ConclusionThese results illustrate the huge variation in practice and lack of consensus among physicians for the optimal medical management of perianal Crohn’s disease. There are gaps in knowledge that require targeted research.
Prognostic value of galectin-3 in adults with congenital heart disease
Authors: Baggen Vivan J M , van den Bosch Annemien E , Eindhoven Jannet A , Menting Myrthe E , Witsenburg Maarten , Cuypers Judith A A E , Boersma Eric , Roos-Hesselink Jolien W 
Published: September 2017

ObjectiveGalectin-3 is an emerging biomarker for risk stratification in patients with heart failure. This study aims to investigate the release of galectin-3 and its association with cardiovascular events in patients with adult congenital heart disease (ACHD).MethodsIn this prospective cohort study, 602 consecutive patients with ACHD who routinely visited the outpatient clinic were enrolled between 2011 and 2013. Galectin-3 was measured in thaw serum by batch analysis. The association between galectin-3 and a primary endpoint of all-cause mortality, heart failure, hospitalisation, arrhythmia, thromboembolic events and cardiac interventions was investigated using multivariable Cox models. Reference values and reproducibility were established by duplicate galectin-3 measurements in 143 healthy controls.ResultsGalectin-3 was measured in 591 (98%) patients (median age 33 (25–41) years, 58% male, 90% New York Heart Association (NYHA) class I). Median galectin-3 was 12.7 (range 4.2–45.7) ng/mL and was elevated in 7% of patients. Galectin-3 positively correlated with age, cardiac medication use, NYHA class, loss of sinus rhythm, cardiac dysfunction and N-terminal pro-B-type natriuretic peptide (NT-proBNP). During a median follow-up of 4.4 (IQR 3.9–4.8) years, the primary endpoint occurred in 195 patients (33%). Galectin-3 was significantly associated with the primary endpoint in the univariable analysis (HR per twofold higher value 2.05; 95% CI 1.44 to 2.93, p<0.001). This association was negated after adjustment for NT-proBNP (HR 1.04; 95% CI 0.72 to 1.49, p=0.848).ConclusionsGalectin-3 is significantly associated with functional capacity, cardiac function and adverse cardiovascular events in patients with ACHD. Nevertheless, the additive value of galectin-3 to a more conventional risk marker such as NT-proBNP seems to be limited.
Increased incidence of BK virus viraemia among patients undergoing chronic haemodialysis: a case–control study
Authors: Swedan Samer Fuad 
Published: September 2017

AimsIncidence of BK virus (BKV) viraemia, a major risk factor for nephropathy, among patients undergoing chronic haemodialysis remains poorly investigated. This case–control study evaluated the risk of infection by BKV, in addition to hepatitis C virus (HCV) among haemodialysis subjects (n=100), compared with age-matched controls (n=100).MethodsSubjects’ blood plasma samples were subjected to nucleic acid extraction, followed by real-time PCR to evaluate viraemia by BKV and HCV, while sera samples were subjected to ELISA, to identify IgG seropositivity for HCV.ResultsMean age±SD was 47.8±20.4 and 48.9±17.6 years for the haemodialysis and control groups, respectively. BKV and HCV viraemia was observed among 19% versus 8% (OR 2.38, 95% CI 1.09 to 5.18; p=0.023) and 3% versus 0% (p=0.081) of the haemodialysis and control groups, respectively. Mean BK viral load±SD did not vary significantly among the two groups; 914.8±2868 versus 44.30±74.04 copies/mL for the haemodialysis and control groups, respectively (p=0.4041). HCV seropositivity rates were 6% versus 2% (p=0.149), among the haemodialysis and control groups, respectively.ConclusionsSubjects on haemodialysis may be at increased risk of nephropathy due to increased incidence of BK virus reactivations and may require optimisation of immunosuppressive therapy.
Radiation dose reduction during neuroendovascular procedures
Authors: Morris Pearse P , Geer Carol P , Singh Jasmeet , Brinjikji Waleed , Carter Rickey E 
Published: September 2017

AimTo describe the impact of steps towards reduction of procedural doses of radiation during neuroendovascular procedures.MethodsPhantom exposures under controlled circumstances were performed using a Rando-Alderson adult-sized head phantom. Customized imaging protocols were devised for pediatric and adult imaging and implemented in clinical use. Outcome data for estimated skin doses (ESD) and dose–area product (DAP) following pediatric and adult diagnostic and interventional procedures over 4.5 years were analyzed retrospectively.ResultsDose estimates were reduced by 50% or more after introduction of customized imaging protocols in association with modification of personnel behavior compared with doses recorded with previously used vendor-recommended protocols.DiscussionSubstantial reductions in radiation use during neuroendovascular procedures can be achieved through a combination of equipment modification and operator behavior.
Efficacy and safety of non-vitamin K antagonist oral anticoagulants compared with warfarin in patients with atrial fibrillation
Authors: Friberg Leif , Oldgren Jonas 
Published: September 2017

AimsNon-vitamin K antagonist oral anticoagulants (NOACs) were in pivotal randomised controlled trials at least non-inferior to warfarin for stroke prevention in atrial fibrillation, but time in therapeutic range (TTR) for warfarin was lower (mean 55%–65%) than in Swedish general care where TTR is >70%. We compared efficacy and safety of NOACs and warfarin treatment for stroke prevention in Sweden.MethodsRetrospective cohort study of all non-selected oral anticoagulation naïve atrial fibrillation patients with first prescription for NOACs or warfarin between December 2011 and December 2014, excluding patients with mitral stenosis or mechanical valvular prosthesis. Data were obtained from cross-linked national registers, propensity scores were used as continuous covariates, and associations between treatment and outcomes were evaluated by multivariable Cox regressions.ResultsThe study comprised 18 638 patients on NOAC and 49 418 on warfarin treatment, with 90 204 patient-years follow-up. Age (mean) was 73.4 vs 73.7 years, p<0.001, and CHA2DS2-VASc points (mean) 3.38 vs 3.24, p<0.001, in NOAC and warfarin groups, respectively. HRs (95% CI) for NOACs versus warfarin were 1.04 (0.91–1.19) for all-cause stroke or systemic embolism, 1.16 (1.00–1.35) for ischaemic stroke, 0.85 (0.76–0.96) for major bleeding, 1.22 (1.01–1.46) for gastrointestinal bleeding, 0.60 (0.47–0.76) for intracranial haemorrhage and 0.89 (0.81–0.96) for all-cause mortality.ConclusionIn this large non-selected anticoagulation naïve Swedish atrial fibrillation cohort, the risks for all-cause stroke or systemic embolism were similar with NOACs and warfarin, but NOACs were associated with significantly lower risks of all-cause mortality, major bleeding and intracranial haemorrhage but higher risk of gastrointestinal bleeding. Better safety suggests NOACs as preferred treatment for patients with atrial fibrillation starting oral anticoagulation.