Treatment of Asthma Exacerbations with the Human-Powered Nebuliser: A Randomised Parallel-Group Clinical Trial

Aims: The aim of this study was to compare a low-cost, human-powered nebuliser compressor with an electric nebuliser compressor for the treatment of mild to moderate asthma exacerbations in adults and children. Methods: This was a non-blinded, parallel-group, equivalence study, with 110 subjects between 6 and 65 years of age, conducted in the emergency department of a district hospital in Ilopango, El Salvador. Participants were assigned by random allocation to receive a 2.5-mg dose of salbutamol from the experimental human-powered nebuliser or the electric nebuliser control. All assigned participants completed treatment and were included in analysis. The study was not blinded as this was clinically unfeasible; however, data analysis was blinded. Results: The mean improvement in peak flow of the experimental and control groups was 37.5 (95% confidence interval (CI) 26.7–48.2) l/min and 38.7 (95% CI, 26.1–51.3) l/min, respectively, with a mean difference of 1.3 (95% CI, −15.1 to 17.7) l/min. The mean improvement in percent-expected peak flow for the experimental and control groups was 12.3% (95% CI, 9.1–15.5%) and 13.8% (95% CI, 9.8–17.9%), respectively, with a mean difference of 1.5% (95% CI, −3.6 to 6.6%). Conclusions: The human-powered nebuliser compressor is equivalent to a standard nebuliser compressor for the treatment of mild-to-moderate asthma. (Funded by the Opus Dean’s Fund, Marquette University College of Engineering; ClinicalTrials.gov NCT01795742.

Randomised multicentre clinical trial to evaluate voriconazole pre-emptive genotyping strategy in patients with risk of aspergillosis: vorigenipharm study protocol.

Introduction Invasive aspergillosis is the most important cause of morbidity and mortality in patients with haematological diseases. At present, voriconazole is the first-line treatment for invasive fungal disease. The pharmacokinetic interindividual variability of voriconazole depends on genetic factors. CYP450 is involved in 70%–75% of total metabolism of voriconazole, mainly CYP3A4 and CYP2C19, with the remaining 25%–30% of metabolism conducted by monooxygenase flavins. CYP2C19 single nucleotide polymorphisms could explain 50%–55% of variability in voriconazole metabolism. Materials and methods The main objective is to compare efficiency of pre-emptive voriconazole genotyping with routine practice. The primary outcome is serum voriconazole on the fifth day within the therapeutic range. The secondary outcome is the combined variables of therapeutic failure and adverse events within 90 days of first administration, associated with voriconazole. A total of 146 patients at risk of invasive aspergillosis who will potentially receive voriconazole will be recruited, and CYP2C19 will be genotyped. If the patient ultimately receives voriconazole, they will be randomised (1:1 experimental/control). In the experimental arm, patients will receive a dose according to a pharmacogenetic algorithm, including CYP2C19 genotype and clinical and demographic information. In the control arm, patients will receive a dose according to clinical practice guidelines. In addition, a Spanish National Healthcare System (NHS) point-of-view cost-effectiveness evaluation will be performed. Direct cost calculations for each arm will be performed. Conclusion This trial will provide information about the viability and cost-effectiveness of the mplementation of a pre-emptive voriconazole genotyping strategy in the Spanish NHS. Ethics and dissemination A Spanish version of this protocol has been evaluated and approved by the La Paz University Hospital Ethics Committee and the Spanish Agency of Medicines and Medical Devices. Trial results will be submitted for publication in an open peer-reviewed medical speciality-specific publication. Trial registration number Eudra-CT: 2019-000376-41 and NCT04238884; Pre-results.post-print441 K

The development and validation of a scoring tool to predict the operative duration of elective laparoscopic cholecystectomy

Background: The ability to accurately predict operative duration has the potential to optimise theatre efficiency and utilisation, thus reducing costs and increasing staff and patient satisfaction. With laparoscopic cholecystectomy being one of the most commonly performed procedures worldwide, a tool to predict operative duration could be extremely beneficial to healthcare organisations. Methods: Data collected from the CholeS study on patients undergoing cholecystectomy in UK and Irish hospitals between 04/2014 and 05/2014 were used to study operative duration. A multivariable binary logistic regression model was produced in order to identify significant independent predictors of long (> 90 min) operations. The resulting model was converted to a risk score, which was subsequently validated on second cohort of patients using ROC curves. Results: After exclusions, data were available for 7227 patients in the derivation (CholeS) cohort. The median operative duration was 60 min (interquartile range 45–85), with 17.7% of operations lasting longer than 90 min. Ten factors were found to be significant independent predictors of operative durations > 90 min, including ASA, age, previous surgical admissions, BMI, gallbladder wall thickness and CBD diameter. A risk score was then produced from these factors, and applied to a cohort of 2405 patients from a tertiary centre for external validation. This returned an area under the ROC curve of 0.708 (SE = 0.013, p  90 min increasing more than eightfold from 5.1 to 41.8% in the extremes of the score. Conclusion: The scoring tool produced in this study was found to be significantly predictive of long operative durations on validation in an external cohort. As such, the tool may have the potential to enable organisations to better organise theatre lists and deliver greater efficiencies in care

Centrality evolution of the charged-particle pseudorapidity density over a broad pseudorapidity range in Pb-Pb collisions at root s(NN)=2.76TeV

Peer reviewe

Transdiagnostic study of impulsivity and self-injurious behaviour in unstable and impulsive disorders

Introduction. High comorbidity between borderline personality disorder (BPD) and eating disorders (ED) shows the necessity of developing transdiagnostic models, where impulsivity could play a relevant role in the manifestations of self-injurious behaviour. Objectives: 1) To compare the levels of impulsivity and self-injurious behaviour among people with BPD, people with ED and controls. 2) To predict the presence of self-injurious behaviour based on impulsivity and other relevant clinical variables, such as the experience of traumatic events and sensitivity to rejection. Methods. 108 women (23 controls; 29 with a diagnosis of restrictive ACT (rED); 21 with a diagnosis of purgative ACT (pED); and 35 with a diagnosis of BPD) were assessed using the Barratt Impulsivity Scale, the Traumatic Experiences Questionnaire and the Sensitivity to Rejection Questionnaire. Information about self-injurious behaviour was collected through interview and clinical history. Results. Differences in impulsivity and self-injurious behaviour scores were found between the groups, with higher impulsivity in the BPD and pED groups, and higher rates of self-injurious behaviour in the BPD group followed by both ED groups. On the other hand, impulsivity predicted suicide attempts, and together with sensitivity to interpersonal rejection predicted nonsuicidal self-harm (NSSH). Conclusion. Impulsivity is a dimensional variable in BPD and ED, which in turn plays a relevant role in the prediction of self-injurious behaviour.Acknowledgements and conflicts of interest. This work has been supported by the project PI16/01949, integrated in the Plan Nacional de I+D+I, AES 2013-2016; funded by the ISCIII and co-financed by the Fondo Europeo de Desarrollo Regional (FEDER). “Una forma de hacer Europa

Cluster Randomized Trial of a Multicomponent School-Based Program in Mexico to Prevent Behavioral Problems and Develop Social Skills in Children

Background There is a signifcant gap between the prevalence of child and adolescent mental illness in Mexico and access to mental health services, especially those that are evidence-based. School-based interventions can signifcantly narrow this gap. Objective The study evaluated the efectiveness of the interventions Dejando Huellitas en tu Vida (Leaving Traces on Your Life [Huellitas]) and Criando con Amor, Promoviendo Armonía y Superación en México (Raising Children with Love, Promoting Harmony and Self-Improvement [CAPAS-Mx]). Methods Participants were 215 caregivers (Mage=38.4 years, SD=8.9, 82.9% women) and 202 children (Mage=8.6 years, SD=1.3, 44.06% girls) from four public schools randomly assigned to four experimental conditions (Huellitas, CAPAS-Mx, Huellitas-CAPAS-Mx, and Control) with pre-test and post-test assessments. Results Caregivers in the multicomponent condition reported signifcantly lower scores in child externalizing problems and higher scores in discipline, skills encouragement, social adaptation, emotional control and prosocial behavior than caregivers in the control group. There were also improvements in parents’ use of efective discipline and skills encouragement in the CAPAS-Mx group over the control group. Among the children, only those in the Huellitas condition showed a decrease in mediation. Conclusions Findings support the implementation of the multicomponent intervention in public school settings. Registry ID ISRCTN11345846, at https://www.isrctn.com