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Keratorefractive lenticule extraction (KLEx) versus femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for the treatment of myopia and compound myopic astigmatism: study protocol of a randomised clinical trial in Mexico

Introduction

Kerato-lenticule extraction (KLEx) is a refractive surgery technique that, in contrast with femtosecond laser-assisted in situ keratomileusis (FS-LASIK), does not require the creation of a flap to correct refractive defects. The potential advantages of this technique are related to the absence of a flap and its complications. On the other hand, FS-LASIK is the most widely practised refractive surgery worldwide, as it offers excellent visual outcomes and is currently the gold standard of refractive surgery. The objective of this study is to compare the effectiveness and safety of KLEx versus FS-LASIK as a treatment option in patients with myopia or myopic astigmatism.

Methods and analysis

This double-masked, parallel-group, single-centre randomised clinical trial will enrol 80 eyes from adults with myopia or compound myopic astigmatism within the ranges sphere –0.50 to –12.00 D and cylinder –0.50 to –6.00 D, recruited at the Instituto de Oftalmología Conde de Valenciana, Mexico City, Mexico. Participants will be allocated to KLEx or FS-LASIK and assessed at baseline and 1 day, 1 week, 1, 3, 6 and 12 months postoperatively. The primary outcome is uncorrected visual acuity at all postoperative visits. Secondary outcomes include postoperative spherical equivalent, best-corrected visual acuity (BCVA), loss of ≥2 BCVA lines, the proportion of eyes within ±0.50 D of the refractive target, corneal aberrations over a 5 mm pupil, epithelial changes and adverse events. Participants and outcome assessors will be masked to the assigned surgical technique.

Ethics and dissemination

Participant confidentiality will be maintained with the publication of results. This study was approved by the research and ethics committee of the Instituto de Oftalmología Fundación de Asistencia Privada Conde Valenciana (CI-017-2024). The study results will be disseminated in scientific articles published in peer-reviewed journals and presented through research posters at national and international conferences.

Trial registration number

ClinicalTrials.gov registry (NCT06477081).

Validation and selection of criteria for evaluating apps for managing depression: a Delphi study

Por: Robles · N. · Fuster-Casanovas · A. · Moreto · S. · Duarte-Diaz · A. · Gelabert · E. · Padilla-Ruiz · M. · Gomez · C. · Perez-Navarro · A. · Vidal-Alaball · J. · Subira · S. · Davins · M. · Saigi-Rubio · F. · Carrion · C.
Background

Despite a lack of evidence relating to effectiveness and safety, the use of apps in the field of mental health is increasing due to their ease of use and accessibility. The aim of the EvalDepApps project is to develop and validate an assessment tool for evaluating depression management apps based on scientific evidence, expert judgement and end-user needs.

Objective

The purpose of this study was to determine the most relevant criteria for evaluating apps intended to manage depression through consensus-based assessment.

Methods

A total of 43 individuals were invited to participate in an online modified Delphi study of 51 criteria identified from the literature. In Round 1, participants rated criteria according to relevance and three levels of consensus were defined: high level when ≥80% of respondents scored the criterion at 5 or 6; medium when 60%–79% of respondents scored the criterion at 5 or 6 and low when

Findings

The response rate was 59.0% (26/43) in Round 1 and 53.4% (23/43) in Round 2. In Round 1, 24 criteria (47.1%) attained the maximum level of consensus, 20 (39.2%) the medium level and 7 (13.7%) the lowest level. In Round 2, 4 out of 20 criteria (20.0%) attained the maximum consensus. Participant comments reinforced the relevance of the selected criteria. The final list consisted of 28 criteria, the majority relating to Safety and Privacy and Clinical Effectiveness (25.0% each), followed by Usability and Functionality (17.9%).

Conclusions

By prioritising criteria relating to data safety and clinical effectiveness, participants in this study emphasised that the assessment of apps for depression management must take both these aspects into full consideration. Despite some limitations of the study (eg, lack of participant sociodemographic data and its implications for generalisation, not face-to-face inter-round), the results of this study will enable the EvalDepApps project to develop an assessment tool for depression management apps that incorporates the most relevant criteria.

Clinical implications

EvalDepApps will support healthcare professionals and users in identifying safe, effective and user-friendly depression management apps.

Performance of an ultrasound diagnostic algorithm for acute dyspneic patients in the emergency department: an EMERALD-US protocol

Por: Jaeger · D. · Duchanois · C. · Duarte · K. · Lepage · X. · Merckle · L. · Bassand · A. · Buessler · A. · Chauvin · A. · Bokobza · J. · Penine · A. · Giacomin · G. · Brossard · C. · Girerd · N. · Chouihed · T.
Introduction

Dyspnoea frequently leads to admissions in the Emergency Department (ED). Rapid and accurate diagnosis, specifically to distinguish acute heart failure from pneumonia and exacerbations of chronic obstructive pulmonary disease (COPD), is imperative to initiate appropriate therapy. This study aims to evaluate the feasibility and performance of the EMERgency ALgorithm efficiency for Dyspneic patient-UltraSound (EMERALD-US) algorithm using ultrasound (US) to diagnose the etiology of dyspnea in the ED-admitted patients.

Method and analysis

225 patients of 50 years and above, presenting with acute non-traumatic dyspnoea, across six participating EDs will be enrolled. Patients will undergo a lung, a simplified four-chamber cardiac and a venous US. A physician, blinded to any clinical data or previous results, will execute the algorithm. The algorithm’s performance will be assessed using a receiver operating characteristic (ROC) curve. Secondary objectives include an evaluation of the protocol’s feasibility in the ED, an assessment of the concordance between the EMERALD-US algorithm diagnoses and results from other diagnostic tests (including laboratory work and imaging), as well as an evaluation of the algorithm’s performance in diagnosing other causes of dyspnoea, such as pulmonary embolism or pleural effusion, and the 30-day mortality rate.

Ethics and dissemination

The study protocol was approved by the French Committee for the Protection of Persons (CPP) (RCB n°2018-A02136-49). Misdiagnosis of dyspneic patients on ED admission has been associated with inappropriate treatment, prolonged hospital stays and increased mortality, particularly among elderly patients. The implementation of protocols like the EMERALD-US algorithm can help physicians in expedited decision-making and diagnosis without increasing ED visit durations.

Trial registration number

NCT03691857.

Business Intelligence como herramienta de apoyo en la identificación de casos de suicidio en RS – Brasil

Introducción: Actualmente, el uso de tecnologías innovadoras ha ayudado a los profesionales a gestionar mejor el volumen de información de manera inteligente, para facilitar y optimizar el uso de acciones y prácticas preventivas. Entendido como un recurso capaz de expandir o acceder a datos, nuestro objetivo es analizar el tema del suicidio en Rio Grande do Sul, en el período de 2010 a 2019, desde el portal municipal de Business Intelligence. Método: Una investigación es de naturaleza cuantitativa, de tipo descriptivo, basada en los registros de muertes por suicidio en el estado de Rio Grande do Sul, escuchada por el portal público de inteligencia empresarial (BI). Los datos fueron analizados, basados en el número bruto de muertes por suicidio en la macro-región del Sur, registrada en el Portal BI / DGTI. Se realizó una descripción del número de muertes según el año, el sexo, el grupo de edad y la tasa de suicidios. Resultados: un total de 11,774 muertes por suicidio, registradas en los últimos 10 años, o el número más alto que ocurrió en los años 2017 y 2019, entre los hombres, con tasas más altas en los grupos de edad entre 20 y 69 años. Una tasa más alta registrada fue en 2019, con 12.41 muertes por cada 100,000 habitantes. Concluimos con este estudio sobre el uso de Bussiness Intelligence, que permite acciones más efectivas en la prevención del suicidio.

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