Current pharmacological treatment options for painful diabetic neuropathy (PDN) often fail to provide adequate pain relief. However, in the recent SENZA-PDN study, high-frequency 10 kHz spinal cord stimulation (SCS) demonstrated significant long-term improvements in lower limb pain and health-related quality of life (HRQoL) in a PDN population. Furthermore, more than half of 10 kHz SCS recipients showed improved sensory function based on non-blinded clinical assessments in post hoc analysis. We report the design of the PDN-Sensory study, which aims to evaluate changes in pain and neurological function with 10 kHz SCS in the treatment of PDN. The study will include objective measures of neurological function, including the modified Toronto Clinical Neuropathy Score (mTCNS) and intraepidermal nerve fibre density (IENFD).
This multicentre, prospective, randomised controlled trial will compare conventional medical management (CMM) with 10 kHz SCS+CMM in individuals with diabetes and chronic, intractable lower limb pain due to PDN. Participants will be randomised 1:1 to CMM alone or 10 kHz SCS+CMM, with optional crossover at 6 months. The primary outcome is the proportion of participants at 6 months achieving ≥50% pain relief from baseline. The key secondary endpoint is the proportion of participants at 6 months with a reduction in mTCNS of ≥3 points from baseline (excluding changes in foot pain). Additional endpoints at 6 and 12 months include changes from baseline in mTCNS, IENFD, 7-day averaged pain score, pain-related interference, HRQoL, sleep, psychological outcomes, functional status and metabolic parameters.
The study protocol received central approval from the Western Institutional Review Board (IRB #20230954). Local IRB approval will be required before initiation of the study at each participating clinical site. The study complies with Good Clinical Practice guidelines (ISO 14155), the Declaration of Helsinki, and all applicable national, federal and local regulatory requirements. Dissemination plans include presentations at national and international conferences and publication in a peer-reviewed journal with open access.
Introducción: La identidad e imagen de las enfermeras son conceptos interrelacionados que reflejan el sentido de uno mismo y las percepciones sociales sobre la profesión. Ambos son esenciales para el desarrollo de una práctica confiada y respetada. Objetivo: Develar el marco conceptual asociado a la imagen e identidad profesional de enfermería desde la perspectiva de enfermeras jubiladas. Materiales y Métodos: Estudio cualitativo basado en el paradigma constructivista y Teoría Fundamentada según Morse, que explora la identidad e imagen profesional de enfermería en Chile mediante entrevistas y grupos focales con enfermeras jubiladas. Para el análisis de los datos, se siguió la metodología propuesta por Charmaz. Sobre el rigor ético del estudio, se contó con la evaluación y aprobación de un Comité de Ética Científica independiente. Resultados: Participaron de este estudio 20 enfermeras jubiladas con una edad promedio de 74 años. Se establecieron 4 categorías que construyen la imagen social de las enfermeras y 3 categorías que construyen su identidad profesional. Discusión: Este estudio explora la imagen e identidad profesional de las enfermeras jubiladas, destacando cómo la pandemia mejoró la percepción pública de la profesión, de acuerdo con estudios internacionales. Han disminuido estereotipos como la feminización de la enfermería y su subordinación a la medicina, ampliamente descritos en la literatura. Las participantes se ven como líderes naturales, pero señalan deshumanización debido al agotamiento, tareas administrativas y los avances tecnológicos. Conclusiones: Resaltar una imagen auténtica y una identidad profesional coherente de la profesión fortalece su valor, estatus y reconocimiento social, lo que, a su vez, impacta positivamente en la calidad de los cuidados prestados a los pacientes.
Acknowledging equality, diversity and inclusion (EDI) in research is not only a moral imperative but also an important step in avoiding bias and ensuring generalisability of results. This protocol describes the development of STAndards for ReporTing EDI (START-EDI) in research, which will provide a set of minimum standards to help researchers improve their consistency, completeness and transparency in EDI reporting. We anticipate that these guidelines will benefit authors, reviewers, editors, funding organisations, healthcare providers, patients and the public.
To create START-EDI reporting guidelines, the following five stages are proposed: (i) establish a diverse, multidisciplinary Steering Committee that will lead and coordinate guideline development; (ii) a systematic review to identify the essential principles and methodological approaches for EDI to generate preliminary checklist items; (iii) conduct an international Delphi process to reach a consensus on the checklist items; (iv) finalise the reporting guidelines and create a separate explanation and elaboration document; and (v) broad dissemination and implementation of START-EDI guidelines. We will work with patient and public involvement representatives and under-served groups in research throughout the project stages.
The study has received ethical approval from the Imperial College London Research Ethics Committee (study ID: 7592283). The reporting guidelines will be published in open access peer-reviewed publications and presented in international conferences, and disseminated through community networks and forums.
The project is pre-registered within the Open Science Framework (https://osf.io/8udbq/) and the Enhancing the Quality and Transparency of Health Research Network.
Introducción. El clima organizacional es el conjunto de percepciones que los individuos y los grupos que trabajan en una organización tienen de su lugar de trabajo; se hace referencia general a que se trata de una característica colectiva, formada por las interacciones entre los trabajadores; fenómeno que se relaciona con la satisfacción y productividad en las organizaciones y de allí el interés por su estudio. Objetivo. Identificar el tipo de clima organizacional en una institución educativa de enfermería durante el periodo de marzo a abril de 2022, con la finalidad de elaborar propuestas de intervención. Metodología. El presente estudio es de tipo transversal, descriptivo de corte cuantitativo, que se llevará a cabo en una institución educativa en San Luis Potosí, en el periodo de abril a mayo de 2023. Se utilizarán dos instrumentos para la recolección de datos: una cédula de datos sociodemográficos y el instrumento para caracterizar el clima organizacional en profesores de centros escolares de educación superior. Se utilizará el programa SPSS versión 21.0 para él análisis y procesamiento de los datos. Relevancia. Se espera que el presente trabajo aporte los suficientes insumos para el diseño de intervenciones centradas en mejorar o potenciar el clima organizacional de la institución educativa.
ABSTRACT
Introduction. The organizational climate is the set of perceptions that individuals and groups working in an organization have of their workplace; general reference is made to the fact that it is a collective characteristic, formed by interactions between workers; phenomenon that is related to satisfaction and productivity in organizations and hence the interest in its study. Objective. To identify the type of organizational climate in an educational institution of nursing during the period from March to April 2022, in order to develop intervention proposals. Methodology. The present study is a cross-sectional, descriptive, and quantitative study, which will be carried out in an educational institution in San Luis Potosi, during the period from April to May 2023. Two instruments will be used for data collection: a sociodemographic data form and an instrument to characterize the organizational climate in teachers at higher education schools. The SPSS version 21.0 program will be used for data analysis and processing. Relevance. It is expected that the present work will provide sufficient inputs for the design of interventions focused on improving or enhancing the organizational climate of the educational institution.