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Efficacy and safety of dexamethasone compared to placebo in patients with severe influenza infection. (FLUDEX study): a study protocol for a randomised controlled trial in Spain

Por: Ramos-RIncon · J.-M. · Cebollada · J. · Giner · L. · Paz Ventero · M. · Moreno-Perez · O. · Otero-Rodriguez · S. · Sanchez-Paya · J. · Rodriguez · J. C. · Merino · E.
Introduction

The combination with corticosteroids as immunomodulators has been the subject of debate in different infectious syndromes. The main objective of this study is to evaluate the efficacy (the percentage of patients hospitalised with influenza with a status of 3 or higher according to the Hospital Recovery Scale (HRS) on day 7 after the start of treatment) and safety of dexamethasone.

Methods and analysis

Investigator-initiated multicentre, blinded, randomised placebo-controlled trial with two parallel treatment arms. The study population will consist of adult patients (over 18 years of age) hospitalised with severe influenza. One arm will receive one capsule of 6 mg of dexamethasone for 7 days, and the other arm will receive one capsule of placebo for 7 days of antibiotic treatment for 7 days or longer. Both groups will receive oseltamivir (75 mg/12 hours orally) for 5 days, extendable to 10 days depending on the investigator decision. Randomisation will occur in equal proportion (1:1). Patients with bronchial hyper-responsiveness that requires systemic corticosteroids for more than 24 hours, preinclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methylprednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone), inability to administer oral oseltamivir, patients with severe comorbidity with a life expectancy of

Ethics and dissemination

The study is approved by the Institutional Review Board of Alicante Health Department—Dr. Balmis General University Hospital (LOC-100061146). The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal

Trial registration number

NCT06528444.

Measurement properties of instruments used to measure health-related quality of life in pediatric and adults patients with inherited epidermolysis bullosa: A systematic review and meta-analysis protocol

by Mario Gómez-Martínez, Greta Arias-Merino, Juan Benito-Lozano, Ana Villaverde-Hueso, Renata Linertová, Verónica Alonso-Ferreira

Inherited Epidermolysis Bullosa (EB) is a group of rare, genetic skin diseases characterized by extreme fragility of the skin and mucous membranes, leading to blistering and wounds in response to minimal trauma or friction. These clinical manifestations significantly reduce health-related quality of life (HRQoL). The objective of this protocol article is to provide information about the methods planned to be used to assess the measurement properties of HRQoL instruments specifically developed for EB patients of all age groups through a systematic review and meta-analysis. The protocol followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols (PRISMA-P) guideline. The literature search will be conducted in PubMed, Web of Science (WOS) and EMBASE, including terminology that aligns with the four key elements of the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) research question (construct, target population, measurement properties and type of PROM), as well as the terminology proposed by COSMIN for measurement properties. Studies that include information on measurement properties (specifically, validity and/or reliability) with a sample of patients with inherited EB will be selected. Both title and abstract screening and full text review, will be conducted by two independent reviewers using the Rayyan tool. In addition, the risk of bias will be assessed using the COSMIN-Risk of Bias checklist. The data from each study and each measurement property will be summarized in accordance with the COSMIN guidelines. The evidence gathered will strive to adjudicate data on measurements properties of HRQoL instruments used in EB patients, and the limitations of the future systematic review will be discussed. Ultimately, results of the future systematic review will help develop more personalized guidelines for the assessment of HRQoL in EB patients of all age groups. The protocol is registered in OSF with registration number vrm87: https://osf.io/vrm87/

Examining the Association Between Perceived Quality of Care and Experienced Coercion Among Patients in Acute Mental Health Units in Spain: A National Cross‐Sectional Study

ABSTRACT

Aim

To examine the association between perceived quality of care and the level of coercion experienced by individuals hospitalised in acute mental health units.

Design

National cross-sectional study.

Methods

Data were collected from 255 patients admitted to 12 acute mental health units across Spain. Standardised instruments assessed perceived quality of care and levels of coercion, humiliation and fear at discharge. Multiple linear regression analyses were used to explore associations between care quality dimensions and patients' experiences.

Results

Perceived quality of care was significantly associated with lower levels of perceived coercion and humiliation. All dimensions of care quality showed inverse associations, with the “secluded” dimension showing the strongest association. The association between care quality and perceived fear was less consistent. These findings are particularly relevant for mental health nurses, who play a central role in delivering relational care and ensuring patients' emotional safety.

Conclusion

Higher perceived quality of care is associated with lower levels of coercion, humiliation, and fear during hospitalisation in acute mental health settings.

Implications for the Profession and/or Patient Care

For mental health nursing, these results underscore the critical role of nurses in creating therapeutic environments that reduce coercive experiences. By fostering trust, promoting patient autonomy, and ensuring emotional and physical safety, nurses can significantly influence the quality of care and patient outcomes.

Impact

The study addresses the lack of evidence on how perceived quality of care influences experiences of coercion in acute mental health settings. Better perceived care quality is linked to reduced feelings of coercion, humiliation and fear. The research has direct implications for mental health nurses, clinical educators and healthcare managers aiming to improve patient experiences and reduce coercive practices in psychiatric care.

Reporting Method

STROBE reporting guideline.

Patient or Public Contribution

No patient or public contribution.

Patients experiences of atrial fibrillation and comorbidity management in clinical practice: a pan-European qualitative descriptive interview study

Por: Lee · G. · Baker · E. · Heidbuchel · H. · Önder · R. · Mulder · B. A. · Dabrowski · R. · Tzeis · S. · Karanikas · S. · Jauregui-Abularach · M. · Merino · D. · Desteghe · L.
Objective

The objective is to explore patients’ perceptions on the management of atrial fibrillation (AF) and associated comorbidities.

Design

A descriptive qualitative study involving in-depth individual interviews, analysed using Braun and Clarke's approach to Reflexive Thematic Analysis.

Setting

Cardiology departments in teaching hospitals in five geographically diverse European countries—Belgium, Greece, Poland, Spain and the Netherlands.

Participants

30 adults aged 65 years or older, diagnosed with AF, with two or more confirmed comorbidities were interviewed.

Results

The average age was 73 years, 37% were women and the most common comorbidity was hypertension (n=26, 87%), followed by hypercholesterolaemia (n=12, 40%), obesity (n=10, 33%), hypothyroidism (n=9, 30%) and diabetes (n=7, 23%). Three main themes were identified: (1) navigating the diagnosis path and adapting to life with AF, (2) normalising symptoms and treatment burden and (3) striving to build a therapeutic relationship.

Respondents had some knowledge about the relationship between comorbidities and AF but lacked understanding of how these comorbidities related to AF. Participants raised concerns regarding their medications, especially anticoagulants, with a desire to be given more information about them. Participants were motivated to make lifestyle adjustments but reported a lack of education and advice on how to implement and maintain these lifestyle changes. Overall, participants were very satisfied with their cardiology/AF teams, and they emphasised the importance of a person-centred approach. There was a perceived disjointedness to healthcare systems, with some reporting multiple appointments at different locations, leading to participants being frustrated and highlighting the lack of integrated care.

Conclusions

In-depth interviews provided an excellent platform to explore the perceptions and experiences of patients living with AF and associated comorbidities and highlighted the lack of an integrated approach to multimorbid AF management.

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