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Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials

Por: Bansal · S. · Canziani · M. E. F. · Birne · R. · Anker · S. D. · Bakris · G. L. · Filippatos · G. · Rossing · P. · Ruilope · L. M. · Farjat · A. E. · Kolkhof · P. · Lage · A. · Brinker · M. · Pitt · B.
Objectives

This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.

Design

FIDELITY post hoc analysis; median follow-up of 3 years.

Setting

FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.

Participants

Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026).

Interventions

Randomised 1:1; finerenone or placebo.

Primary and secondary outcome measures

Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.

Results

Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged interaction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups interaction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were

Conclusions

Finerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.

Trial registration numbers

NCT02540993, NCT02545049.

Oral intake of solid medications in patients with post‐stroke dysphagia. A challenge for nurses?

Abstract

Aim

To provide a comprehensive overview of how stroke nurses manage solid medication (SM) delivery to patients with post-stroke dysphagia.

Design

Cross-sectional study.

Methods

A self-administered online survey was carried out among nurses in German-speaking countries between September and December 2021.

Results

Out of a total of 754 responses, analysis was conducted on 195 nurses who reported working on a stroke unit. To identify swallowing difficulties in acute stroke care, 99 nurses indicated routinely administering standardised screenings, while 10 use unvalidated screenings, and 82 are waiting for a specialist evaluation. Regardless of whether screening methods are used or not, most preferred a non-oral route of medication administration for patients with suspected dysphagia. None of the respondents reported administering whole SMs orally to patients. If screening methods indicate dysphagia, approximately half of the respondents would modify SMs. Participants who stated to use the Gugging Swallowing Screen managed the SM intake guided by its severity levels. One-third of the group who awaited assessment by the dysphagia specialist provided modified medication before the consultation.

Conclusion

Most of the nurses on stroke units use swallowing screens and avoid the administration of whole SMs in post-stroke dysphagia. In addition to the non-oral administration, SMs are modified if dysphagia is suspected. Precise guidance on the administration of SM is needed, based on screening tests and prior to expert consultation.

Trial and Protocol Registration

ClinicalTrials.gov: Registration ID: NCT05173051/ Protocol ID: 11TS003721.

Implications for the profession and/or patient care

The present paper serves to alert nurses to the issue of patient safety when administering medication for acute stroke-induced dysphagia.

Impact

SM delivery after acute stroke-induced dysphagia is often neglected. While nurses are aware of the risk associated with dysphagia and would not give whole SMs to patients, the modification of tablets and their administration with semisolids are common.

Reporting Method

This study was reported according to the Checklist for Reporting of Survey Studies (CROSS).

Evaluating deep learning-based melanoma classification using immunohistochemistry and routine histology: A three center study

by Christoph Wies, Lucas Schneider, Sarah Haggenmüller, Tabea-Clara Bucher, Sarah Hobelsberger, Markus V. Heppt, Gerardo Ferrara, Eva I. Krieghoff-Henning, Titus J. Brinker

Pathologists routinely use immunohistochemical (IHC)-stained tissue slides against MelanA in addition to hematoxylin and eosin (H&E)-stained slides to improve their accuracy in diagnosing melanomas. The use of diagnostic Deep Learning (DL)-based support systems for automated examination of tissue morphology and cellular composition has been well studied in standard H&E-stained tissue slides. In contrast, there are few studies that analyze IHC slides using DL. Therefore, we investigated the separate and joint performance of ResNets trained on MelanA and corresponding H&E-stained slides. The MelanA classifier achieved an area under receiver operating characteristics curve (AUROC) of 0.82 and 0.74 on out of distribution (OOD)-datasets, similar to the H&E-based benchmark classification of 0.81 and 0.75, respectively. A combined classifier using MelanA and H&E achieved AUROCs of 0.85 and 0.81 on the OOD datasets. DL MelanA-based assistance systems show the same performance as the benchmark H&E classification and may be improved by multi stain classification to assist pathologists in their clinical routine.

Recovering from physical trauma in late life, a struggle to recapture autonomy: A grounded theory study

Abstract

Aim

The study aimed to explore the experiences of care and recovery among older patients treated for physical trauma.

Design

A qualitative study with a constructivist grounded theory design.

Methods

Fifteen in-depth interviews with older adults recovering from physical trauma were conducted and analysed between 2019 and 2023, in accordance with grounded theory methodology.

Results

The findings show that for older patients who suffered physical trauma, the core category was the strive to recapture autonomy. This was achieved by means of Adaptation, Reflection and Interactions, which constitute the three main categories. Recovery involves facing and navigating various new life challenges, such as increased dependency on others, managing difficult symptoms and adapting in various ways to everyday life. The recovery process was influenced by fear, hope and the attitude towards new challenges.

Conclusion

Older adults being cared for after a traumatic event have a difficult path to recovery ahead of them. Dealing with increased unwanted dependency on others was a main concern for the participants. Undertreated symptoms can lead to undesired isolation, delayed recovery and further increase unwanted dependency. On the other hand, hope, which was defined as having a positive approach to life and longing for the future, was a strong accelerating factor in the recovery process.

Impact

As a result of this study, we have established that older patients experience the initial period after trauma as difficult and that support in the initial phase can be helpful when returning home. As healthcare services are under increasing pressure because of an ageing population, this study contributes by addressing an understudied population and clarifying their concerns.

Reporting Method

Reporting adheres to the COREQ (COnsolidated criteria for REporting Qualitative research) Checklist.

Patient or Public Contribution

No patient or public involvement.

Does atrial fibrillation affect prognosis in hospitalised COVID-19 patients? A multicentre historical cohort study in the Netherlands

Por: Spruit · J. R. · Jansen · R. W. M. M. · de Groot · J. R. · de Vries · T. A. C. · Hemels · M. E. W. · Douma · R. A. · de Haan · L. R. · Brinkman · K. · Moeniralam · H. S. · de Kruif · M. · Dormans · T. · Appelman · B. · Reidinga · A. C. · Rusch · D. · Gritters van den Oever · N. C.
Objectives

The aim of this multicentre COVID-PREDICT study (a nationwide observational cohort study that aims to better understand clinical course of COVID-19 and to predict which COVID-19 patients should receive which treatment and which type of care) was to determine the association between atrial fibrillation (AF) and mortality, intensive care unit (ICU) admission, complications and discharge destination in hospitalised COVID-19 patients.

Setting

Data from a historical cohort study in eight hospitals (both academic and non-academic) in the Netherlands between January 2020 and July 2021 were used in this study.

Participants

3064 hospitalised COVID-19 patients >18 years old.

Primary and secondary outcome measures

The primary outcome was the incidence of new-onset AF during hospitalisation. Secondary outcomes were the association between new-onset AF (vs prevalent or non-AF) and mortality, ICU admissions, complications and discharge destination, performed by univariable and multivariable logistic regression analyses.

Results

Of the 3064 included patients (60.6% men, median age: 65 years, IQR 55–75 years), 72 (2.3%) patients had prevalent AF and 164 (5.4%) patients developed new-onset AF during hospitalisation. Compared with patients without AF, patients with new-onset AF had a higher incidence of death (adjusted OR (aOR) 1.71, 95% CI 1.17 to 2.59) an ICU admission (aOR 5.45, 95% CI 3.90 to 7.61). Mortality was non-significantly different between patients with prevalent AF and those with new-onset AF (aOR 0.97, 95% CI 0.53 to 1.76). However, new-onset AF was associated with a higher incidence of ICU admission and complications compared with prevalent AF (OR 6.34, 95% CI 2.95 to 13.63, OR 3.04, 95% CI 1.67 to 5.55, respectively).

Conclusion

New-onset AF was associated with an increased incidence of death, ICU admission, complications and a lower chance to be discharged home. These effects were far less pronounced in patients with prevalent AF. Therefore, new-onset AF seems to represent a marker of disease severity, rather than a cause of adverse outcomes.

Characterising the interventions designed to affect the reporting of musculoskeletal imaging: a scoping review protocol using the COM-B model

Por: Kirby · E. · MacMillan · A. · Liew · B. X. W. · Brinkley · A. · Bateman · A.
Introduction

Attributing musculoskeletal (MSK) pain to normal and commonly occurring imaging findings, such as tendon, cartilage and spinal disc degeneration, has been shown to increase people’s fear of movement, reduce their optimism about recovery and increase healthcare costs. Interventions seeking to reduce the negative effects of MSK imaging reporting have had little effect. To understand the ineffectiveness of these interventions, this study seeks to scope their behavioural targets, intended mechanisms of action and theoretical underpinnings. This information alongside known barriers to helpful reporting can enable researchers to refine or create new more targeted interventions.

Methods and analysis

The scoping review will be conducted in accordance with the JBI methodology for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Search terms will be devised by the research team. Searches of MEDLINE, EMBASE, CINAHL, AMED and PsycINFO from inception to current day will be performed. The review will include studies, which have developed or evaluated interventions targeting the reporting of MSK imaging. Studies targeting the diagnosis of serious causes of MSK pain will be excluded. Two independent authors will extract study participant data using predefined extraction templates and intervention details using the Template for Intervention Description and Replication checklist. Interventions will be coded and mapped to the technique, mechanism of action and behavioural target according to the Capability, Opportunity, Motivation-Behaviour (COM-B) model categories. Any explicit models or theories used to inform the selection of interventions will be extracted and coded. The study characteristics, behaviour change techniques identified, behavioural targets according to the COM-B and context specific theories within the studies will be presented in narrative and table form.

Ethics and dissemination

The information from this review will be used to inform an intervention design process seeking to improve the communication of imaging results. The results will also be disseminated through a peer-reviewed publication, conference presentations and stakeholder events.

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