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Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study

Por: Rodrigues · C. B. · Soares · P. N. C. · Schmitt · A. C. B. · Sacco · I. C. N.
Introduction

Diabetes is a highly prevalent disease that negatively impacts people’s health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention—a foot-ankle exercises programme alongside educational strategies—in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes.

Methods and analysis

This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, São Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12 week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed.

Ethics and dissemination

This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals.

Trial registration number

NCT05639478.

Assessment of quality of life for frail, elderly patients post-ICU discharge: a protocol for a scoping review

Por: Kjaergaard-Andersen · G. · Bauer · E. H. · Bhavsar · R. P. · Jensen · H. I. · Ahrenfeldt · L. J. · Hvidt · N. C. · Stroem · T.
Introduction

Rises in average life expectancy, increased comorbidities and frailty among older patients lead to higher admission rates to intensive care units (ICU). During an ICU stay, loss of physical and cognitive functions may occur, causing prolonged rehabilitation. Some functions may be lost permanently, affecting quality of life (QoL). There is a lack of understanding regarding how many variables are relevant to health-related outcomes and which outcomes are significant for the QoL of frail, elderly patients following discharge from the ICU. Therefore, this scoping review aims to identify reported variables for health-related outcomes and explore perspectives regarding QoL for this patient group.

Methods and analysis

The Joanna Briggs Institute guidelines for scoping reviews will be employed and original, peer-reviewed studies in English and Scandinavian languages published from 2013 to 2023 will be included. The search will be conducted from July 2023 to December 2023, according to the inclusion criteria in Embase, MEDLINE, PsycINFO and CINAHL. References to identified studies will be hand-searched, along with backward and forward citation searching for systematic reviews. A librarian will support and qualify the search strategy. Two reviewers will independently screen eligible studies and perform data extraction according to predefined headings. In the event of disagreements, a third reviewer will adjudicate until consensus is achieved. Results will be presented narratively and in table form and discussed in relation to relevant literature.

Ethics and dissemination

Ethical approval is unnecessary, as the review synthesises existing research. The results will be disseminated through a peer-reviewed publication in a scientific journal.

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.

What is the aetiology of dysnatraemia in COVID-19 and how is this related to outcomes in patients admitted during earlier and later COVID-19 waves? A multicentre, retrospective observational study in 11 Dutch hospitals

Por: de Haan · L. · ten Wolde · M. · Beudel · M. · Olde Engberink · R. H. G. · Appelman · B. · Haspels-Hogervorst · E. K. · Rusch · D. · Gritters van den Oever · N. C. · Simsek · S. · Paternotte · N. · van den Bergh · J. P. · Wyers · C. E. · de Kruif · M. D. · Dormans · T. · Moeniralam
Objectives

To evaluate the relationship among dysnatraemia at hospital presentation and duration of admission, risk of intensive care unit (ICU) admission and all-cause mortality and to assess the underlying pathophysiological mechanism of hyponatraemia in patients with COVID-19. Our hypothesis is that both hyponatraemia and hypernatraemia at presentation are associated with adverse outcomes.

Design

Observational study.

Setting

Secondary care; 11 Dutch hospitals (2 university and 9 general hospitals).

Participants

An analysis was performed within the retrospective multicentre cohort study COVIDPredict. 7811 patients were included (60% men, 40% women) between 24 February 2020 and 9 August 2022. Patients who were ≥18 years with PCR-confirmed COVID-19 or CT with COVID-19 reporting and data system score≥4 and alternative diagnosis were included. Patients were excluded when serum sodium levels at presentation were not registered in the database or when they had been transferred from another participating hospital.

Outcome measures

We studied demographics, medical history, symptoms and outcomes. Patients were stratified according to serum sodium concentration and urinary sodium excretion.

Results

Hyponatraemia was present in 2677 (34.2%) patients and hypernatraemia in 126 (1.6%) patients. Patients with hyponatraemia presented more frequently with diarrhoea, lower blood pressure and tachycardia. Hyponatraemia was, despite a higher risk for ICU admission (OR 1.27 (1.11–1.46; p

Conclusions

Hypernatraemia at presentation was associated with adverse outcomes in patients with COVID-19. Hypovolaemic hyponatraemia was found to be the most common aetiology of hyponatraemia. Hyponatraemia of unknown aetiology was associated with a higher risk for ICU admission and intubation and longer duration of admission.

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