bluuebunny/crossref_metadata_2025_split huggingface dataset:
Peanut‐induced anaphylaxis in children and adolescents: Data from the European Anaphylaxis Registry
Authors: Maris Ioana , Dölle‐Bierke Sabine , Renaudin Jean‐Marie , Lange Lars , Koehli Alice , Spindler Thomas , Hourihane Jonathan , Scherer Kathrin , Nemat Katja , Kemen C. , Neustädter Irena , Vogelberg Christian , Reese Thomas , Yildiz Ismail , Szepfalusi Zsolt , Ott Hagen , Straube Helen , Papadopoulos Nikolaos G. , Hämmerling Susanne , Staden Ute , Polz Michael , Mustakov Tihomir , Cichocka‐Jarosz Ewa , Cocco Renata , Fiocchi Alessandro Giovanni , Fernandez‐Rivas Montserrat , Worm Margitta ,   Network for Online Registration of Anaphylaxis (NORA)
Published: December 2020

AbstractBackgroundPeanut allergy has a rising prevalence in high‐income countries, affecting 0.5%–1.4% of children. This study aimed to better understand peanut anaphylaxis in comparison to anaphylaxis to other food triggers in European children and adolescents.MethodsData was sourced from the European Anaphylaxis Registry via an online questionnaire, after in‐depth review of food‐induced anaphylaxis cases in a tertiary paediatric allergy centre.Results3514 cases of food anaphylaxis were reported between July 2007 ‐ March 2018, 56% in patients younger than 18 years. Peanut anaphylaxis was recorded in 459 children and adolescents (85% of all peanut anaphylaxis cases). Previous reactions (42% vs. 38%; p = .001), asthma comorbidity (47% vs. 35%; p < .001), relevant cofactors (29% vs. 22%; p = .004) and biphasic reactions (10% vs. 4%; p = .001) were more commonly reported in peanut anaphylaxis. Most cases were labelled as severe anaphylaxis (Ring&Messmer grade III 65% vs. 56% and grade IV 1.1% vs. 0.9%; p = .001). Self‐administration of intramuscular adrenaline was low (17% vs. 15%), professional adrenaline administration was higher in non‐peanut food anaphylaxis (34% vs. 26%; p = .003). Hospitalization was higher for peanut anaphylaxis (67% vs. 54%; p = .004).ConclusionsThe European Anaphylaxis Registry data confirmed peanut as one of the major causes of severe, potentially life‐threatening allergic reactions in European children, with some characteristic features e.g., presence of asthma comorbidity and increased rate of biphasic reactions. Usage of intramuscular adrenaline as first‐line treatment is low and needs to be improved. The Registry, designed as the largest database on anaphylaxis, allows continuous assessment of this condition.
Review article: pathophysiology and management of primary biliary cholangitis
Authors: Leung Kristel K. , Deeb Maya , Hirschfield Gideon M. 
Published: December 2020

SummaryBackgroundPrimary biliary cholangitis (PBC), an immune‐mediated disease characterised by destruction of intrahepatic bile ducts, results in progressive damage to the biliary tree, cholestasis and ultimately advanced liver disease. In the last decade, advances in practice have improved clinical care, driven novel therapeutic options and improved risk stratification tools.AimsTo provide an overview of the disease characteristics of PBC and review a patient‐centred management approach for the clinical team caring for those with PBC.MethodsWe reviewed the current literature and guidelines on PBC with a focus on management and therapies.ResultsA confident diagnosis of PBC is usually made based on serum liver tests and immune serology. Management of PBC should focus on three main ‘process’ pillars: (a) treat and risk‐stratify through use of biochemical and prognostic criteria; (b) manage concurrent symptoms and other associated diseases; and (c) stage disease, monitor progression and prevent complications. With ongoing complexities in management, including a newly licensed therapy (obeticholic acid) and alternative non‐licensed treatments and ongoing clinical trials, discussion with PBC expert centres is encouraged.ConclusionsPBC is a dynamic disease wherein current treatment goals have become appropriately ambitious. Goals of care should prioritise prevention of end‐stage liver disease and amelioration of patient symptom burden for all.
Systematic review with meta‐analysis: the efficacy and safety of direct‐acting antivirals in children and adolescents with chronic hepatitis C virus infection
Authors: Indolfi Giuseppe , Giometto Sabrina , Serranti Daniele , Bettiol Alessandra , Bigagli Elisabetta , De Masi Salvatore , Lucenteforte Ersilia 
Published: December 2020

SummaryBackgroundThe effect of direct‐acting anti‐virals (DAAs) in children and adolescents with chronic hepatitis C virus (HCV) infection is difficult to determine, since few, aged between 3 and 18 years, have been enrolled in clinical trials, and some data come from observational studies.AimTo summarise the evidence on efficacy and safety of DAAs in children and adolescents with chronic HCV infection.MethodsWe performed a systematic review and meta‐analysis of prospective studies on the efficacy and safety of DAAs in subjects <18 years of age. We considered the sustained virological response at post‐treatment week 12 as efficacy outcome and adverse events as safety outcome. We considered intervention effect for each study arm by calculating the proportion of sustained virologic response at post‐treatment week 12 in subjects receiving all doses of treatment and proportion of adverse events in subjects receiving at least one dose of treatment. Pooled proportions were calculated using the Freeman‐Tukey double arcsine transformation. Random effects model was used for all analyses.ResultsAmong 39 included studies (1796 subjects), the pooled proportion among those receiving all doses of treatment and reaching sustained virologic response at post‐treatment week 12 was 100% (95% confidence interval: 100‐100). Considering subjects receiving at least one dose of treatment, lowest estimates were reported among children with cirrhosis (83%). Headache and fatigue were the most common adverse events. Serious adverse events were uncommon.ConclusionsChildren and adolescents with chronic HCV infection can be safely treated with DAAs with similar efficacy as reported in adults.
Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) & Pharmacovigilance Risk Assessment Committee (PRAC)
Authors: Damkier Per , Kaplan Yusuf Cem , Shechtman Svetlana , Diav‐Citrin Orna , Cassina Matteo , Weber‐Schoendorfer Corinna 
Published: December 2020

AbstractOndansetron is an effective antiemetic that is being widely used as a second‐line treatment option for severe nausea and vomiting of pregnancy in accordance with clinical guidelines. The safety of ondansetron during pregnancy has—following publication of controversial and seemingly contradictory results—been subject to considerable academic turmoil, specifically with respect to the risk of congenital cardiac malformations and oral cleft. In July 2019, the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) released an updated, comprehensive assessment report on the use of ondansetron in the first trimester. The ensuing Summary of Product Characteristics (SmPC) was updated in November 2019 with important changes to section on “Fertility, pregnancy and lactation.” The SmPC now states that ondansetron should not be used in the first trimester of pregnancy. ENTIS, The European Network of Teratology Information Services, believes that the implementation of this regulatory step—which has important clinical consequences—is insufficiently substantiated and is not serving the interest of pregnant women with severe nausea and vomiting. Herein, we discuss the underlying evidence and argue the case against the EMA decision.
Contemporary duration of spontaneous labor and association with maternal characteristics: A French national population‐based study
Authors: Girault Aude , Blondel Béatrice , Goffinet François , Le Ray Camille 
Published: December 2020

AbstractBackgroundThe objective of this study was to describe labor duration of women managed with current obstetric practices in a French national population‐based cohort and to assess the association of age and BMI on this duration.MethodsAll women in the French perinatal survey of 2016 with a singleton cephalic fetus, delivering at term after a spontaneous labor were included. Duration of labor was defined as time between admission to the labor ward and birth. Duration of total labor and first and second stage of labor were described. Then, duration of labor was estimated according to maternal age and BMI, using Kaplan‐Meier's method and compared with the log‐rank test after stratification on parity. Intrapartum cesarean birth was considered as a censoring event. Multivariable modeling was performed using Cox's proportional hazard's method.ResultsData of 3120 nulliparous and 4385 multiparous women were analyzed. Median labor duration was 6.1 hours ([5th; 95th percentile]) [1.4; 12.6] and 3.1 hours [0.3; 8.5] in nulliparous and multiparous women. Multivariable Cox analysis showed no independent association of maternal age and duration of labor. Nulliparous obese women had significantly lower odds of having a shorter labor than women with a BMI < 25 kg/m2, HR: 0.75; 95% CI [0.64‐0.88], but BMI was not associated with labor duration in multiparous women.ConclusionsOur study provides important information for both women and care practitioners on what to expect when entering the labor ward. There appears to be little association between maternal characteristics and labor duration, with the exception of BMI in nulliparous women.
Comparative effectiveness of neoadjuvant chemotherapy in bladder and upper urinary tract urothelial carcinoma
Authors: D’Andrea David , Matin Surena , Black Peter C. , Petros Firas G. , Zargar Homayoun , Dinney Colin P. , Cookson Michael S. , Kassouf Wassim , Dall'Era Marc A. , McGrath John S. , Wright Jonathan L. , Thorpe Andrew C. , Morgan Todd M. , Holzbeierlein Jeffrey M. , Bivalacqua Trinity J. , Sridhar Srikala S. , North Scott , Barocas Daniel A. , Lotan Yair , Stephenson Andrew J. , van Rhijn Bas W. , Spiess Philippe E. , Daneshmand Siamak , Shariat Shahrokh F. 
Published: December 2020

ObjectiveTo assess the differential response to neoadjuvant chemotherapy (NAC) in patients with urothelial carcinoma of the bladder (UCB) compared to upper tract urothelial carcioma (UTUC) treated with radical surgery.Patients and MethodsData from 1299 patients with UCB and 276 with UTUC were obtained from multicentric collaborations. The association of disease location (UCB vs UTUC) with pathological complete response (pCR, defined as a post‐treatment pathological stage ypT0N0) and pathological objective response (pOR, defined as ypT0‐Ta‐Tis‐T1N0) after NAC was evaluated using logistic regression analyses. The association with overall (OS) and cancer‐specific survival (CSS) was evaluated using Cox regression analyses.ResultsA pCR was found in 250 (19.2%) patients with UCB and in 23 (8.3%) with UTUC (P < 0.01). A pOR was found in 523 (40.3%) patients with UCB and in 133 (48.2%) with UTUC (P = 0.02). On multivariable logistic regression analysis, patients with UTUC were less likely to have a pCR (odds ratio [OR] 0.45, 95% confidence interval [CI] 0.27–0.70; P < 0.01) and more likely to have a pOR (OR 1.57, 95% CI 1.89–2.08; P < 0.01). On univariable Cox regression analyses, UTUC was associated with better OS (hazard ratio [HR] 0.80, 95% CI 0.64–0.99, P = 0.04) and CSS (HR 0.63, 95% CI 0.49–0.83; P < 0.01). On multivariable Cox regression analyses, UTUC remained associated with CSS (HR 0.61, 95% CI 0.45–0.82; P < 0.01), but not with OS.ConclusionsOur present findings suggest that the benefit of NAC in UTUC is similar to that found in UCB. These data can be used as a benchmark to contextualise survival outcomes and plan future trial design with NAC in urothelial cancer.
Global Assessment of Urological Endoscopic Skills (GAUES): development and validation of a novel assessment tool to evaluate endourological skills
Authors: Biyani Chandra Shekhar , Kailavasan Mithun , Rukin Nicholas , Palit Victor , Somani Bhaskar , Jain Sunjay , Myatt Andy , Nabi Ghulam , Patterson Jake 
Published: December 2020

ObjectiveTo develop and evaluate an assessment tool for endourological skills during simulation including cystoscopy, ureteroscopy (URS) and transurethral resection (TUR) procedures.MethodsWe designed a Global Assessment of Urological Endoscopic Skills (GAUES) tool, comprised of nine endourology task‐specific and two global‐rating skills items. The tool was developed through two rounds of the Delphi process. The GAUES tool was used to assess acquisition of URS and TUR skills of novices (Year 2 core surgical trainees, CT2) and intermediate level trainees (residents at the start of the UK higher surgical training programme in Urology, Speciality Trainee Year 3, ST3) at the Urology Simulation Boot Camp (USBC) between 2016 and 2018. Validity was evaluated by comparing scores between trainees with different levels of urological experience. Inter‐rater reliability was also assessed.ResultsWe evaluated 130 residents, 52% of trainees were at an intermediate stage of training and 39% were novices. In all, 9% of the anonymous forms were missing demographics. The completion rate of the GAUES tool during the USBC for URS and TUR was 85% and 89%, respectively. Our analysis demonstrated a significant difference in all domains between intermediates and novices at assessment in URS, except for one domain more suited to clinical assessment (P = 0.226). There was excellent intraclass correlation (ICC) overall between the two experts’ judgements, ICC = 0.841 (95% confidence interval 0.767–0.893; P < 0.001, n = 88).ConclusionsWe have developed the novel GAUES tool for cystoscopic, URS and TUR skills. Overall, we demonstrated good face, content and construct validity and excellent reliability, suggesting that the GAUES tool can be useful for endourological skills assessment.
Nephrometry scores: a validation of three systems for peri‐operative outcomes in retroperitoneal robot‐assisted partial nephrectomy
Authors: Crockett Matthew G. , Giona Simone , Whiting Danielle , Whitehurst Lily , Agag Ayman , Malki Manar , Hussain Muddassar , Barber Neil J. 
Published: December 2020

ObjectiveTo externally validate the RENAL, PADUA and SPARE nephrometry scoring systems for use in retroperitoneal robot‐assisted partial nephrectomy (RAPN).Materials and MethodsNephrometry scores were calculated for 322 consecutive patients receiving retroperitoneal RAPN at a tertiary referral centre from 2017. Patients with multiple tumours were excluded. Scores were correlated with peri‐operative outcomes, including the trifecta (warm ischaemia time <25 min, no peri‐operative complications and a negative surgical margin), both as continuous and categorical variables. Comparisons were performed using Spearman correlation and ability to predict the trifecta was assessed using binomial logistical regression.ResultsAll three scoring systems correlated significantly with the main variables (operating time, warm ischaemia time and estimated blood loss), both as continuous and categorical variables. Only PADUA and SPARE were able to predict achievement of the trifecta (PADUA area under the curve [AUC] 0.623, 95% confidence interval [CI] 0.559–0.668; SPARE AUC 0.612, 95% CI 0.548–0.677).ConclusionThis study validates the RENAL, PADUA and SPARE scoring systems to predict key intra‐operative outcomes in retroperitoneal RAPN. Only PADUA and SPARE were able to predict achievement of the trifecta. As a simplified version of the PADUA scoring system with comparable outcomes, we recommend using the SPARE system.
Holmium laser enucleation of the prostate using Moses 2.0 vs non‐Moses: a randomised controlled trial
Authors: Nevo Amihay , Faraj Kassem S. , Cheney Scott M. , Moore Jonathan P. , Stern Karen L. , Borofsky Michael , Gnessin Ehud , Humphreys Mitchell R. 
Published: December 2020

ObjectivesTo compare the enucleation efficiency of Moses 2.0 with non‐Moses technology in patients undergoing holmium laser enucleation of the prostate (HoLEP).Patients and MethodsA double‐blinded, randomised study of patients undergoing HoLEP at the Mayo Clinic in Arizona, using the Lumenis Pulse™ 120H laser system. Patients were randomised to either right lobe enucleation using Moses 2.0 and left lobe enucleation using non‐Moses, or the opposite. The primary outcome was individual lobe enucleation efficiency. Secondary outcomes included individual lobe laser time, laser energy, individual enucleation and haemostasis laser energies, and fibre burn back. Two independent reviewers watched videos of the procedures and provided a subjective evaluation of the technologies.ResultsA total of 27 patients were included in the study. For the entire cohort, Moses 2.0 had less fibre degradation (3.5 vs 16.8 mm, P < 0.01) compared to non‐Moses. When HoLEP procedures were performed by an expert, Moses 2.0 resulted in shorter enucleation time (21 vs 36.7 min, P = 0.016) and higher enucleation efficiency (1.75 vs 1.05 g/min, P = 0.05) compared to non‐Moses. When HoLEP was performed by trainees, the Moses 2.0 cohort had a shorter haemostasis laser time (4.1 vs 9 min, P = 0.035) compared to the non‐Moses. Fibre degradation was lower with Moses 2.0 compared to non‐Moses for both experts and trainees. Moses 2.0 received a higher score than the standard technology for the incision sharpness, fibre control, tissue separation, tissue damage, haemostasis, visibility, and charring. The overall inter‐observer correlation coefficient was 0.63.ConclusionMoses 2.0 has higher enucleation efficiency compared to non‐Moses when used by experts. The subjective evaluation favoured Moses 2.0.
The rising worldwide impact of benign prostatic hyperplasia
Authors: Launer Bryn M. , McVary Kevin T. , Ricke William A. , Lloyd Granville L. 
Published: December 2020

ObjectivesTo describe the trend in the impact of lower urinary tract symptoms attributed to benign prostatic hyperplasia (LUTS/BPH) on a global scale using the Global Burden of Disease (GBD) database.Materials and MethodsUsing the GBD database, worldwide data aggregated from registries and health systems from 1990 to 2017 were filtered for LUTS/BPH diagnoses. Calculation of years lived with disability (YLD) were compared with other urological diseases. YLD were calculated by a standardized method using assigned disability weights. The GBD‐defined sociodemographic index (SDI) was used to assess impact of LUTS/BPH by global SDI quintile.ResultsGlobal Burden of Disease data over the 1990–2017 study period were summarized and global numbers and trends noted with other urological diseases for comparison. A total of 2 427 334 YLD were attributed to BPH in 2017 alone, almost three times more than those attributed to the next highest urological disease, prostate cancer (843 227 YLD). When stratified by SDI quintile, a much lower impact of BPH was found in the bottom three quintiles, despite this subset representing 66.9% of the 2017 world population.ConclusionsLower urinary tract symptoms attributed to benign prostatic hyperplasia exert a rapidly rising human burden far exceeding other urological diseases. As the population ages and men in a lower SDI enjoy increased life expectancy and decreased competing mortalities, a continually accelerating wave of LUTS/BPH can be forecast. These epidemiological trends have serious implications for the future allocation of resources and the global urological workforce.
Management of patients who opt for radical prostatectomy during the coronavirus disease 2019 (COVID‐19) pandemic: an international accelerated consensus statement
Authors: Tandogdu Zafer , Collins Justin , Shaw Greg , Rohn Jennifer , Koves Bela , Sachdeva Ashwin , Ghazi Ahmed , Haese Alexander , Mottrie Alex , Kumar Anup , Sivaraman Ananthakrishnan , Tewari Ashutosh , Challacombe Benjamin , Rocco Bernardo , Giedelman Camilo , Wagner Christian , Rogers Craig G. , Murphy Declan G. , Pushkar Dmitry , Ogaya‐Pinies Gabriel , Porter James , Seetharam Kulthe Ramesh , Graefen Markus , Orvieto Marcelo A. , Moschovas Marcio Covas , Schatloff Oscar , Wiklund Peter , Coelho Rafael , Valero Rair , de Reijke Theo M. , Ahlering Thomas , Rogers Travis , van der Poel Henk G. , Patel Vipul , Artibani Walter , Wagenlehner Florian , Maes Kris , Rha Koon H. , Nathan Senthil , Bjerklund Johansen Truls Erik , Hawkey Peter , Kelly John 
Published: December 2020

ObjectiveCoronavirus disease‐19 (COVID‐19) pandemic caused delays in definitive treatment of patients with prostate cancer. Beyond the immediate delay a backlog for future patients is expected. The objective of this work is to develop guidance on criteria for prioritisation of surgery and reconfiguring management pathways for patients with non‐metastatic prostate cancer who opt for surgical treatment. A second aim was to identify the infection prevention and control (IPC) measures to achieve a low likelihood of coronavirus disease 2019 (COVID‐19) hazard if radical prostatectomy (RP) was to be carried out during the outbreak and whilst the disease is endemic.MethodsWe conducted an accelerated consensus process and systematic review of the evidence on COVID‐19 and reviewed international guidance on prostate cancer. These were presented to an international prostate cancer expert panel (n = 34) through an online meeting. The consensus process underwent three rounds of survey in total. Additions to the second‐ and third‐round surveys were formulated based on the answers and comments from the previous rounds. The Consensus opinion was defined as ≥80% agreement and this was used to reconfigure the prostate cancer pathways.ResultsEvidence on the delayed management of patients with prostate cancer is scarce. There was 100% agreement that prostate cancer pathways should be reconfigured and measures developed to prevent nosocomial COVID‐19 for patients treated surgically. Consensus was reached on prioritisation criteria of patients for surgery and management pathways for those who have delayed treatment. IPC measures to achieve a low likelihood of nosocomial COVID‐19 were coined as ‘COVID‐19 cold’ sites.ConclusionReconfiguring management pathways for patients with prostate cancer is recommended if significant delay (>3–6 months) in surgical management is unavoidable. The mapped pathways provide guidance for such patients. The IPC processes proposed provide a framework for providing RP within an environment with low COVID‐19 risk during the outbreak or when the disease remains endemic. The broader concepts could be adapted to other indications beyond prostate cancer surgery.