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To translate, culturally adapt and validate the first Spanish version of the Person-centred Practice Inventory-Care (PCPI-C) instrument.
Cross-cultural adaptation and psychometric validation.
Two-phase research design: (1) the PCPI-C's translation and cultural adaptation from English to Spanish following the ‘Translation and Cultural Adaptation of Patient-Reported Outcomes Measures-Principles Guide of Good Practice’ tool; and (2) a cross-sectional quantitative survey to assess the Spanish version's psychometric properties.
A sample of 200 patients participated to obtain the PCPI-C's Spanish version. No significant issues arose during the translation process or the consulting sessions. No item exhibited an inadequate value following adjustment via the weighted kappa index (−scale-level content validity average of 0.95 for clarity and 0.97 for relevance). Psychometric evaluation revealed acceptable internal consistency (Cronbach's alpha from 0.67 to 0.84) and strong construct validity. Exploratory and confirmatory factor analyses supported a five-dimensional structure consistent with the domain Person-Centred Processes. Fit indices improved after model refinements, achieving CFI = 0.92, SRMR = 0.05 and RMSEA = 0.07. This study's observed psychometric properties confirm that the PCPI-C's Spanish version retains the original instrument's theoretical integrity, while showing strong reliability and validity in the new context.
The PCPI-C's Spanish translation was psychometrically valid when tested with Spanish patients, thus providing a culturally appropriate, psychometrically sound tool to evaluate Spanish-speaking patients' perception of person-centred care.
This study provides a validated instrument that allows for the assessment of person-centred practice in Spanish-speaking clinical environments. It enables healthcare professionals to measure patients' perceptions, track the implementation of person-centred principles and supports international comparative studies, contributing to the development of more ethical and responsive models of care.
Patients participated in cognitive consultations and completed the survey for psychometric testing, ensuring that the translated items were understandable, culturally appropriate and reflective of their experiences of person-centred care.
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.
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