563 research outputs found
Translation of questions: the international study of asthma and allergies in childhood (ISAAC) experience
No full textOBJECTIVE:
To explore the consequences of translating the International Study of Asthma and Allergies in Childhood (ISAAC) English core questionnaires on asthma, rhinitis and eczema symptoms into other languages.
DESIGN:
ISAAC Phase III developed 49 language translations for adolescents and 42 for children following standardised guidelines, which included back-translating the questionnaires into English to check their accuracy and meaning. Language deviations were categorised and analysed with regard to influences on the reported symptom prevalence.
RESULTS:
Category 1 deviations for one or more questions were found in seven translations (14%) for adolescents and in three translations (7%) for children. Data for these questions were excluded from the worldwide analyses. Category 2 deviations were identified in the publications, and Category 3 deviations were ignored.
CONCLUSIONS:
Translations of questionnaires should follow a consistent protocol in global epidemiological research. Cultural norms need to be considered when evaluating back-translations into English, as disease labels are not available in every language, nor are they understood in the same way. Deviations from literal translations of English should be permitted if the intent of the original meaning is retained. A web-based tool of medical terminology would be useful for international research requiring the use of translations
Efficacy and Safety of Sarilumab in patients with COVID19 Pneumonia : A Randomized, Phase III Clinical Trial (SARTRE Study)
No full textPublisher Copyright: © 2021, The Author(s).Introduction: SARS-CoV-2 pneumonia is often associated with hyper-inflammation. The cytokine-storm-like is one of the targets of current therapies for coronavirus disease 2019 (COVID-19). High Interleukin-6 (IL6) blood levels have been identified in severe COVID-19 disease, but there are still uncertainties regarding the actual role of anti-IL6 antagonists in COVID-19 management. Our hypothesis was that the use of sarilumab plus corticosteroids at an early stage of the hyper-inflammatory syndrome would be beneficial and prevent progression to acute respiratory distress syndrome (ARDS). Methods: We randomly assigned (in a 1:1 ratio) COVID-19 pneumonia hospitalized patients under standard oxygen therapy and laboratory evidence of hyper-inflammation to receive sarilumab plus usual care (experimental group) or usual care alone (control group). Corticosteroids were given to all patients at a 1 mg/kg/day of methylprednisolone for at least 3 days. The primary outcome was the proportion of patients progressing to severe respiratory failure (defined as a score in the Brescia-COVID19 scale ≥ 3) up to day 15. Results: A total of 201 patients underwent randomization: 99 patients in the sarilumab group and 102 patients in the control group. The rate of patients progressing to severe respiratory failure (Brescia-COVID scale score ≥ 3) up to day 15 was 16.16% in the Sarilumab group versus 15.69% in the control group (RR 1.03; 95% CI 0.48–2.20). No relevant safety issues were identified. Conclusions: In hospitalized patients with Covid-19 pneumonia, who were under standard oxygen therapy and who presented analytical inflammatory parameters, an early therapeutic intervention with sarilumab plus standard of care (including corticosteroids) was not shown to be more effective than current standard of care alone. The study was registered at EudraCT with number: 2020-002037-15.Peer reviewe
Efficacy and Safety of Budesonide Orodispersible Tablets for Eosinophilic Esophagitis up to 3 Years: An Open-Label Extension Study
No full textBudesonide orodispersible tablets (BOT) have been shown to be safe and effective in phase III double-blind trials of induction and 48-week maintenance therapy of eosinophilic esophagitis (EoE). We now analyzed the long-term efficacy and safety of BOT in a 96-week open-label extension (OLE) study.
All patients with EoE in the 48-week double-blind maintenance study were eligible to receive BOT treatment for up to 96 weeks. Dosage was 0.5 or 1.0 mg BOT, twice daily, at investigator's discretion. Clinical, histologic, endoscopic, quality of life, and safety measures were assessed.
A total of 186 patients participated in the OLE up to 96 weeks. At week 96, 81.9% of patients had clinical remission, defined as an EoE Symptom Activity Index (EEsAI) score of ≤20 vs 77.7% at OLE baseline. A further 80.1% of patients were in histologic remission, defined as peak eosinophils per high-power field of <5, at week 96 vs 91.8% at OLE baseline. Mean EoE endoscopic reference scores (EREFS) were 1 at all time points measured. Mean EoE Quality of Life (EoE-QoL-A) Scale scores improved from 3.3 at OLE baseline to 3.5 at week 96. No new safety concerns were observed across 96 weeks of treatment. Suspected symptomatic candidiasis occurred at similar rates to prior BOT studies and was predominantly mild and resolved with treatment.
Clinical and histologic remission of EoE could be maintained with BOT in a large majority of patients for up to 96 weeks, and for up to 144 weeks in patients with uninterrupted BOT therapy across all trials. No additional safety concerns were identified with long-term BOT treatment (ClinicalTrials.gov, Number: NCT02493335).
Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved
Adapting to a new role: a study designed to help senior managers adapt to new positions after organisation restructuring
No full textThe work on which this thesis is based, studies the implementation phase of the total organisation restructure of the National Health Service in 1974 as experienced by a large group of Senior Pharmaceutical Managers who found it difficult to establish themselves in their new positions. The study starts in 1976 and researches to identify the nature and cause of the difficulties facing the managers. It is concluded that the probable cause is rooted in the sudden destruction of mechanisms developed before 1974 to assist new managers establish themselves in their positions. A solution is designed and tested before being implemented with the Senior Pharmaceutical Managers, By 1977 it had become clear that a similar situation faced other large groups of Senior Managers belonging to the Nursing and Works professions of the Health Service. As a result the project and study is continued to help these two other professions and with apparent equal success until 1985.A number of objectives are met during this study. A system is developed for facilitating role identification and implementation during a period of organisation restructuring as a means to help new managers adapt and become established in equally new positions. In addition this project is an example of the use of collaboration as a method to assist large numbers of senior managers belonging to Health Service professions meet radically new demands of role
Applications of Ring Resonators and fiber delay lines for sensors and WDM Networks
No full textEn esta tesis doctoral, se presentan diversas aportaciones científicas en el ámbito de las aplicaciones de la fibra óptica y de las comunicaciones ópticas.
En primer lugar, la tesis doctoral describe nuevas técnicas de medida remota y multiplexación en longitud de onda (WDM), a través de fibra óptica monomodo, para sensores ópticos.
Las técnicas de medida están orientadas a sensores de intensidad óptica y se basan en configuraciones ópticas implementadas mediante redes de Bragg en fibra y líneas de retardo en fibra recirculantes (anillo resonante) y no recirculantes.
En el documento se describen matemáticamente dichas técnicas y se presentan medidas experimentales que verifican los modelos teóricos.
En segundo lugar, la tesis contiene diversas contribuciones novedosas al diseño y simulación por ordenador de filtros fotónicos compuestos basados en el anillo resonante con interferómetro Sagnac, para la compensación de la dispersión cromática en enlaces de transmisión digital con fibra óptica.
Por último, el documento incluye un listado de todas las referencias empleadas, un listado de los acrónimos empleados, así como las publicaciones y patentes obtenidas por el autor hasta la fecha.Los proyectos de la Comisión Interministerial de Ciencia y Tecnología (CICYT): TIC2003-03783 (DISFOTON) y TEC2006-13273-C03-03-MIC (FOTOCOMIN).
El programa de I+D+i de la Comunidad Autónoma de Madrid: FACTOTEM-CM (S-0505/ESP/000417). La Acción Integrada Hispano-Portuguesa del Plan Nacional de I+D+i 2004-2007:
Self-referenced fibre optic intensity configurations for single and multi-sensors (HP2007-0093). El proyecto cofinanciado por la Universidad Carlos III de Madrid y la Comunidad Autónoma de Madrid: Fotónica en visualización, comunicaciones y sensores
(CCG06-UC3M/TIC-0619). Las ayudas a la movilidad de investigadores en formación que me concedió la Universidad Carlos III de Madrid en 2006 y 2007.
La Red Temática Europea SAMPA (HPRN-CT-2002-00202) del 5º Programa Marco de la Unión Europea. La Acción Europea FIDES (COST Action 299) del 6º Programa Marco de la Unión
Europea. Y las Redes de Excelencia Europea ePhoton/ONe+ (FP6-IST-027497) y BONE (FP7-ICT-216863), del 6º y 7º Programa Marco de la Unión Europea, respectivamente
Research priorities for antimicrobial stewardship nurses in a middle‑income country: a nominal group technique study
No full textAvailability of data and materials: All data generated or analysed during this study are included in this published article [and its supplementary additional les]. Original data are available from the corresponding author upon reasonable request. Supplementary Information is available online at: https://bmcnurs.biomedcentral.com/articles/10.1186/s12912-024-02504-9#Sec13 .Consortia:
Workshop Participants Group:
Monik Gomes do Nascimento Lousada, Claudia Silva Marinho, Eliana Auxiliadora Magalhães Costa, Nayara Carvalho Oliveira, Waldélia Monteiro, Beatriz Murata Murakami, Andreza Manhezi, José Rodrigues do Carmo Filho, Zilah Cândida Pereira das Neves, Viviane Gonçalves Sena, Glaucia Ribeiro Goncalves, Ieda Pontes da Cruz, Fernando Augusto Pinheiro, Camila Piuco Preve, Eliane Carlosso Krummenauer, Renata Neto Pires, Amanda Luiz Pires Maciel, Ana Claudia Cascardo, Daiane Patrícia Cais, James Francisco Pedro dos Santos, Lilian Farah, Maria Fernanda Zorzi Gatti, Meire Cristina Novelli e Castro, Mônica Taminato, Thatiara Cardoso da Silva & Tiago Cristiano de LimaA preprint version of this article is available online at https://doi.org/10.21203/rs.3.rs-4391774/v1 under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/). It has not been certified by peer review.Background:
Antimicrobial stewardship programs (ASPs) have become important strategies for addressing antimicrobial resistance (AMR). Despite the increasing number of international publications identifying the important roles played by nurses as part of ASPs in low- and middle-income countries, this topic is yet poorly researched. This study aimed to identify priority research gaps in the Brazilian context concerning nurses’ performance in ASPs from the perspective of nursing professionals and explore the main themes among the ideas generated by these nurses.
Methods:
This qualitative study used the modified Nominal Group Technique (mNGT) during a three-day online workshop. Content analysis was performed on the basis of the ideas proposed by the participants after the clarification stage.
Results:
The participants suggested 68 ideas in the first phase. After the idea’s clarification phase, 45 ideas were included in the voting rounds. The ideas prioritized by participants voting addressed (i) attributions and competencies of nurses in the ASP; (ii) planning and implementation of ASP nurses’ activities; and (iii) use of information and communication technologies to assist nurses. The content analysis highlighted nine main themes in the initial ideas.
Conclusions:
The study identified significant gaps in research related to nurses’ roles in ASPs in the Brazilian context. These findings suggest that further investigation into nurses’ competences, the implementation of their roles, and the application of digital tools are priority subjects of future research to improve nurses’ participation in ASPs. These themes should be further studied in the Brazilian context but may be applicable to other similar socioeconomic contexts.This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES) - Finance Code 001
Systematic Review of Escalated Imatinib Doses Compared with Sunitinib or Best Supportive Care, for the Treatment of People with Unresectable/Metastatic Gastrointestinal Stromal Tumours Whose Disease has Progressed on the Standard Imatinib Dose
No full textPMID: 21971958 [PubMed - indexed for MEDLINE] PMCID: PMC3348468 Free PMC Article This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are creditedPeer reviewe
Enzalutamide versus abiraterone as a first-line endocrine therapy for castration-resistant prostate cancer (ENABLE study for PCa): A study protocol for a multicenter randomized phase III trial
No full textBackground: Both enzalutamide and abiraterone have demonstrated improved radiographic progression-free and overall survival for castration-resistant prostate cancer (CRPC) compared with placebo controls before docetaxel treatment in phase III studies. These oral agents target androgen and androgen receptor signaling and are thought to be less toxic than chemotherapy. Cross-resistance to these agents was recently reported because of their similar mechanism of action, and it is important to assess which agent is more effective to use initially for CRPC. Methods/design: The present study is a phase III, investigator-initiated, multicenter, head-to-head, randomized controlled trial investigating enzalutamide vs. abiraterone as a first-line treatment for CRPC patients. Patients will be randomly assigned to an enzalutamide or an abiraterone treatment group. The primary endpoint is the time to prostate-specific antigen progression. The target sample size is set at 100 patients per group (total, 200 patients). The study duration is 5 years, and the duration for recruitment is 2 years and 6 months. Discussion: Thus far, there have been no prospective head-to-head studies comparing enzalutamide and abiraterone. This ENABLE study will clarify which agent should be prioritized for CRPC patients and enable clinicians to decide the appropriate treatment before chemotherapy. Trial registration: University hospital Medical Information Network (UMIN) Center identifier UMIN000015529. Registrated 11/1/2014. © 2017 The Author(s).金沢大学附属病院泌尿器科journal articl
Treatment response and remission in a double-blind, randomized, head-to-head study of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit hyperactivity disorder
No full textA secondary objective of this head-to-head study of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) was to assess treatment response rates in children and adolescents with attention-deficit hyperactivity disorder (ADHD) and an inadequate response to methylphenidate (MPH). The primary efficacy and safety outcomes of the study, SPD489-317 (ClinicalTrials.gov NCT01106430), have been published previously
Analysis of immune-related loci identifies 48 new susceptibility variants for multiple sclerosis
No full textUsing the ImmunoChip custom genotyping array, we analyzed 14,498 subjects with multiple sclerosis and 24,091 healthy controls for 161,311 autosomal variants and identified 135 potentially associated regions (P < 1.0 × 10−4). In a replication phase, we combined these data with previous genome-wide association study (GWAS) data from an independent 14,802 subjects with multiple sclerosis and 26,703 healthy controls. In these 80,094 individuals of European ancestry, we identified 48 new susceptibility variants (P < 5.0 × 10−8), 3 of which we found after conditioning on previously identified variants. Thus, there are now 110 established multiple sclerosis risk variants at 103 discrete loci outside of the major histocompatibility complex. With high-resolution Bayesian fine mapping, we identified five regions where one variant accounted for more than 50% of the posterior probability of association. This study enhances the catalog of multiple sclerosis risk variants and illustrates the value of fine mapping in the resolution of GWAS signals
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