Risultati per: Standard di qualità sulla Fibrillazione Atriale

Circulation, Volume 150, Issue Suppl_1, Page A4138167-A4138167, November 12, 2024. Background:Intracerebral hemorrhage (ICH) has high morbidity and mortality. Traditional craniotomy causes significant trauma and lacks proven benefits. Minimally invasive techniques (MIT) like CT-guided thrombolysis, endoscopic, and neuronavigation surgeries show promise in reducing secondary neurotoxicity. Our meta-analysis compares MIT with standard treatments for supratentorial spontaneous intracerebral hematomas (SSICHs) to evaluate their effectiveness in improving clinical outcomes.Methods:We comprehensively searched PubMed, EMBASE, and Cochrane Library for studies published before June 1, 2024, comparing MIT versus standard treatment for ICH. Data were analyzed using R (v.4.3). Pooled proportions with 95% confidence intervals (CIs) were calculated using a random effects model. Odds ratios (ORs) and mean differences (MDs) with 95% CIs were used for dichotomous and continuous variables. Outcomes included overall survival, functional neurological outcome, hospitalization length, recurrent bleeding, volume reduction, and Glasgow Coma Scale (GCS) score at discharge.Results:We identified six studies, including 1,117 patients. There were 463 patients who underwent MIT and 654 patients who received standard treatment. The MIT group exhibited statistically significant increased odds of survival (OR: 1.98 [1.25, 3.15]; I2=26%; p=0.004) and functional neurological outcome (OR: 1.94 [1.27, 2.96]; I2=25%; p=0.002) compared to the standard treatment group. The MIT group demonstrated statistically significant lower length of hospitalization (MD: -2.89 [-4.49, -1.30]; I2=47%; p=0.0004) and better GCS score at discharge (MD: 1.50 [1.00, 2.00]; I2=0%; p

Circulation, Volume 150, Issue Suppl_1, Page A4141224-A4141224, November 12, 2024. Background:Glycated albumin (GA) has been demonstrated to be associated with adverse outcomes in patients with acute coronary syndrome (ACS). However, as a specific subgroup of ACS, a significant proportion of patients with ACS without standard modifiable cardiovascular risk factors (SMuRFs) are currently being identified. The prognostic value of serum GA for adverse events in such patients remains unexplored.Aims:This study aims to evaluate the prognostic value of GA in predicting adverse outcomes in patients with ACS without SMuRFs.Methods:This study involved 1,140 consecutive patients who were diagnosed with ACS without SMuRFs at the Beijing Anzhen Hospital between May 2018 and December 2020 and underwent coronary angiography. Each patient was followed up for a period of 35–66 months after discharge. The primary endpoint of this study was major adverse cardiovascular and cerebrovascular events (MACCEs) that included all-cause mortality, non-fatal myocardial infarction, non-fatal ischemic stroke, and ischemia-driven revascularization.Results:The average age of the study participants was 59.55 ± 10.98 years, and men accounted for 61.8%. The average GA level was 14.37 ± 2.42. The median follow-up duration was 48.3 months, during which 220 cases (19.3%) experienced MACCEs. In the fully adjusted model, with GA as a continuous variable, the hazard ratio (HR) for MACCEs in the high GA group was 1.069 (95% confidence interval (CI): 1.008, 1.133), the HR for ischemia-driven revascularization was 1.095 (95% CI: 1.021, 1.175), and the HR for all-cause mortality was 1.155 (95% CI: 1.021, 1.306), all with P values less than 0.05. Similarly, when GA was considered as a categorical variable, in the fully adjusted model, GA was associated with MACCEs, ischemia-driven revascularization, and all-cause mortality, with P values all less than 0.05. The restricted cubic spline curve showed that the relationship between GA and MACCEs was linear (p for non-linear = 0.079; p for overall association = 0.026). Furthermore, GA levels were correlated with poor prognosis in the subgroups of patients.Conclusion:Serum GA might be an independent predictor of all-cause death, ischemia-driven revascularization, and MACCEs in patients with ACS without SMuRFs.

Introduction
In female patients diagnosed with gynaecological cancer, the main priority is treating cancer itself. However, a significant number of these patients develop lower limb lymphoedema (LLL), with its incidence strongly influenced by the diagnostic cut-off (a difference in leg circumference between both legs of 5% or 10%). LLL significantly impacts patients’ quality of life (QoL) due to functional impairment, the daily time investment required for treatment, financial costs and affected body image. Additionally, it increases the risk of cellulitis, often leading to hospitalisation for intravenous antibiotics. Timely recognition and acknowledgement of symptoms are crucial first steps in improving the QoL for these women. LLL is a common and irreversible complication following treatment for gynaecological cancer. Despite its clinical significance, there are limited prospective studies investigating LLL incidence, risk factors, early detection and clinical course in this patient population. Therefore, the objective of this observational cohort study is to investigate the incidence rate of stage 0–1 or stage 2–3 LLL based on the International Society of Lymphology criteria in the first 2 years after gynaecological cancer treatment. The embedded randomised control study (RCT) examines the added value of prophylactic compression garments (class II) to standard care in preventing irreversible lymphoedema after gynaeco-oncological therapy.

Methods and analysis
In June 2022, two university hospitals in Belgium initiated a multicentre observational cohort study, which also includes an embedded RCT. The study aims to enrol 400 patients before they begin cancer treatment or within 14 days of starting chemotherapy, radiotherapy or surgery. This cohort will be followed for up to 2 years. The embedded RCT will focus on patients who develop clinical lymphoedema stage 0–1 within the first 12 months following their initial cancer treatment. A total of 196 patients will be randomised into two groups: the intervention group (98 patients), receiving usual care plus prophylactic compression garments (compression class 2 (CCL2): 23–32 mm Hg), and the control group (98 patients), receiving only usual care. The RCT aims to assess the impact of adding prophylactic compression garments to standard care on further deterioration. Assessments will be conducted at baseline, and at 3, 12 and 24 months after initial cancer treatment. An additional assessment (T-visit) will be provided if there is a transition to LLL stage 0–1 or from stage 0–1 to stage 2–3 LLL, based on follow-up findings or patient initiative, using the predictive value of a validated self-report lower extremity questionnaire. This questionnaire is part of a lymph diary app provided to all patients. The primary outcome of the observational study is to determine the incidence rate of stage 0–1 or stage 2–3 LLL in the first 2 years after gynaecological cancer treatment. The primary outcome of the RCT is to evaluate the effect of wearing CCL2 preventive garments to avoid progression to higher-stage lymphoedema in patients who develop LLL within 1 year of treatment. Key secondary outcomes of the observational study include the timing of the development of LLL, risk factors for developing LLL and the impact of LLL on QoL and sexuality, as well as the evaluation of screening and diagnostic tools. The secondary outcomes of the RCT include tolerance and compliance with wearing the preventive compressive garments, the impact of the garments on limb volume and the patient’s time and financial investment.

Ethics and dissemination
The study was approved by the Ethics Committee of the two academic hospitals: the University Hospital of Ghent in September 2021 and the University Hospital of Leuven in December 2021. Approval has been granted for the study protocol, informed consent forms and other related documents by the main Ethics Committee of Ghent (BC-09915) and the local Ethics Committee of Leuven (S65724). All patients will provide written informed consent before participating in the trial. The results will be shared through peer-reviewed journals and presentations.

Trial registration number
NCT05469945.

Introduction
Linezolid is a broadly used antibiotic to treat complicated infections caused by gram-positive bacteria. Therapeutic drug monitoring of linezolid concentrations is recommended to maximise its efficacy and safety, mainly haematological toxicity. Different pharmacokinetic/pharmacodynamic targets have been proposed to improve linezolid exposure: the ratio of the area under the concentration–time curve during a 24-hour period to minimum inhibitory concentration (MIC) between 80 and 120; percentage of time that the drug concentration remains above the MIC during a dosing interval greater than 85% and the trough concentration between 2 and 7 mg/L. This clinical trial aims to evaluate the safety, efficacy and the clinical and economic utility of personalised dosing of linezolid using Bayesian forecasting methods to attain pharmacokinetic/pharmacodynamic targets, known as model-informed precision dosing.

Methods and analysis
This is a pragmatic, multicentre, randomised, parallel, controlled, phase IV and low intervention trial. Participants will be randomly assigned 1:1 to each group (n=346 per group). Control group will receive the standard dose of linezolid. Intervention group will receive personalised dosage of linezolid based on pharmacokinetic–pharmacodynamic adjustments. The primary outcome will be the incidence of thrombocytopenia in both groups.

Ethics and dissemination
This protocol was approved by the Ethical Committee of the Investigation with Medicines of Galicia (code 2022/140) and authorised by the Spanish Agency for Medicines and Medical Devices. The trial is implemented in accordance with the Declaration of Helsinki and the international ethical and scientific quality standard, the Good Clinical Practice. The results will be published in peer-reviewed journals.

Trial registration number
EudraCT registration code: 2022-000144-30.

Azienda ospedaliero universitaria Marche tra i migliori ospedali

Agenas, 8 milioni di ricoveri, convive alta e bassa qualità cure

Introduction
First-line oxygenation strategy in patients with acute hypoxaemic respiratory failure consists in standard oxygen or high-flow nasal oxygen therapy. Clinical practice guidelines suggest the use of high-flow nasal oxygen rather than standard oxygen. However, findings remain contradictory with a low level of certainty. We hypothesise that compared with standard oxygen, high-flow nasal oxygen may reduce mortality in patients with acute hypoxaemic respiratory failure.

Method and analysis
The Standard Oxygen versus High-flow nasal Oxygen-trial is an investigator-initiated, multicentre, open-label, randomised controlled trial comparing high-flow nasal oxygen versus standard oxygen in patients admitted to an intensive care unit (ICU) for acute respiratory failure with moderate-to-severe hypoxaemia. 1110 patients will be randomly assigned to one of the two groups with a ratio of 1:1. The primary outcome is the number of patients who died 28 days after randomisation. Secondary outcomes include comfort, dyspnoea and oxygenation 1 hour after treatment initiation, the number of patients intubated at day 28, mortality in ICU, in hospital and until day 90, and complications during ICU stay.

Ethics and dissemination
The study has been approved by the central Ethics Committee ‘Sud Méditerranée III’ (2020-07-05) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial registration number
NCT04468126.

Introduction
Patients with generalised joint hypermobility, including knee hypermobility (GJHk), often experience knee pain and are typically managed with low-intensity strength training and/or proprioceptive training as part of standard care. However, not all patients experience satisfactory outcomes. High-load strength training may offer additional benefits, such as increased muscle cross-sectional area, neural drive and tendon stiffness, which may reduce pain and improve active knee joint stability during movement tasks and daily activities. So far, no randomised controlled trials (RCTs) have compared high-load strength training with traditional treatment strategies (standard care) for this patient group.

Methods and analysis
In this RCT, we aim to recruit patients with GJHk and knee pain from primary care physiotherapy clinics in the Region of Southern Denmark and via social media. Patients with competing injuries or experience with high-load strength training will be excluded. Patients will be randomised (1:1 ratio) to either 2 weekly sessions of high-load strength training or standard care for 12 weeks. The primary outcome is self-reported knee pain during an activity nominated by the patient as the most aggravating for their present knee pain measured using the Visual Analogue Scale for Nominated Activity (VASNA, 0–100; 0=no pain and 100=worst imaginable pain). This will be collected at baseline, 6 weeks, 12 weeks and 12 months. Secondary outcomes include self-reported knee function and adverse events (collected at baseline, 12 weeks and 12 months), objective measurements including a 5-repetition maximum single-leg press, proprioception and single-leg-hop for distance (collected at baseline and 12 weeks), and a range of other outcome measures such as fear of movement, tendon stiffness and global perceived effect. We aim to recruit 90 patients in total to detect a 10 mm group difference in the primary outcome with 80% power.

Ethics and dissemination
This study was funded by Independent Research Fund Denmark (grant number 2034-00088B) on 14 June 2022; the Regional Committees on Health Research Ethics for Southern Denmark approved it (S-20230050) on 30 August 2023. The first recruitment site opened on 15 February 2024, and the final results will be submitted to a peer-reviewed journal to inform rehabilitation strategies for symptomatic GJHk.Protocol version 1, dated 4 July 2024.

Trial registration number
NCT06277401.

New England Journal of Medicine, Volume 391, Issue 15, Page 1454-1455, October 17, 2024.

Introduction
Research has provided novel insights into how light stimulates circadian rhythms through specialised retinal ganglion cells to the suprachiasmatic nucleus. In addition, there has been a revolution in light-emitting diode (LED) technology, leading to tunable LED light sources and lighting systems, enabling 24-hour dynamic light scenarios with bright blue-enriched short wavelength light during the day and dim evening light, stimulating the circadian system. These dynamic LED lighting systems are now being implemented at hospitals without adequate understanding of how it may affect the health and well-being of patients and staff.

Methods and analysis
An optimised dynamic LED lighting scenario is investigated at a newly built psychiatric hospital in Copenhagen. In the 12 months baseline period, a standard lighting scenario with dynamic colour temperature and fixed light intensity is investigated. In the following 12-month intervention period, a new DEL scenario is investigated, having dynamic colour temperature as well as dynamic light intensity with a higher daytime and lower evening-time melanopic daylight equivalent illuminance. This setting is furthermore adjusted for geographical orientation to compensate for differences in sunlight access in wintertime. The study uses a quasiexperimental design comparing patients admitted in the two study periods. Prior to each of the study periods, daylight and the contribution from the LED-lighting scenarios was measured. Patient sociodemographic and mental health data will be retrieved retrospectively from electronic medical records and by questionnaires administered in the two periods, evaluating lighting, noise, sleep quality and quality of life. Primary outcome is the proportion of patients receiving pro re nata medications. Secondary outcomes are the length of stay, sleep onset latency, sleep quality and quality of life.

Ethics and dissemination
No ethical issues are expected. The results will be disseminated through peer-reviewed international journal, lectures, posters and interviews.

Trial registration number
NCT05868291.

Così si riducono gli anni di vita sana persi in Italia rispetto all’EU

Tra le raccomandazioni, aprire spesso le finestre e non fumare

Così si riducono gli anni di vita sana persi in Italia rispetto all’EU

In a retrospective cohort study in France, high-dose influenza vaccine was associated with 23% lower hospitalization rates among those aged ≥65.

New England Journal of Medicine, Volume 391, Issue 13, Page 1206-1216, October 3, 2024.

Annals of Internal Medicine, Ahead of Print.