Search Results for: Sorveglianza nella post polipectomia nel cancro al colon-retto

Objectives
Prediction models for post-stroke mortality can support medical decision-making. Although numerous models have been developed, external validation studies determining the models’ transportability beyond the original settings are lacking. We aimed to assess the performance of two prediction models for post-stroke mortality in Berlin, Germany.

Design
We used data from the Berlin-SPecific Acute Treatment in Ischaemic or hAemorrhagic stroke with Long-term follow-up (B-SPATIAL) registry.

Setting
Multicentre stroke registry in Berlin, Germany.

Participants
Adult patients admitted within 6 hours after symptom onset and with a 10th revision of the International Classification of Diseases discharge diagnosis of ischaemic stroke, haemorrhagic stroke or transient ischaemic attack at one of 15 hospitals with stroke units between 1 January 2016 and 31 January 2021.

Primary outcome measures
We evaluated calibration (calibration-in-the-large, intercept, slope and plot) and discrimination performance (c-statistic) of Bray et al’s 30-day mortality and Smith et al’s in-hospital mortality prediction models. Information on mortality was supplemented by Berlin city registration office records.

Results
For the validation of Bray et al’s model, we included 7879 patients (mean age 75; 55.0% men). We observed 763 (9.7%) deaths within 30 days of stroke compared with 680 (8.6%) predicted. The model’s c-statistic was 0.865 (95% CI: 0.851 to 0.879). For Smith et al’s model, we performed the validation among 1931 patients (mean age 75; 56.2% men), observing 105 (5.4%) in-hospital deaths compared with the 92 (4.8%) predicted. The c-statistic was 0.891 (95% CI: 0.864 to 0.918). The calibration plots of both models revealed an underestimation of the mortality risk for high-risk patients.

Conclusions
Among Berlin stroke patients, both models showed good calibration performance for low and medium-risk patients and high discrimination while underestimating risk among high-risk patients. The acceptable performance of Bray et al’s model in Berlin illustrates how a small number of routinely collected variables can be sufficient for valid prediction of post-stroke mortality.

Introduction
Spinal cord injury (SCI) has been linked to increased frequencies of sleep-related breathing disorders (SRBDs) (≤50% after paraplegia and ≤90% following tetraplegia). However, SRBDs have been under-recognised and undertreated among individuals with SCI. The OPTIMISE SCI (Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI) is an ongoing phase 3 clinical trial focused on the effects of the early use of continuous positive airway pressure (CPAP) therapy to treat individuals with moderate-to-severe SRBDs in the acute/subacute stage after SCI.

Methods and analysis
A total of 44 participants with SCI who are newly diagnosed with moderate-to-severe SRBD are randomised into early CPAP therapy (initiated within the first 8 weeks postinjury) versus delayed CPAP therapy (initiated at 6 months postinjury). Participants with no/mild SRBDs are included in the control group (n=22). Primary outcome measures include neurological and functional recovery after SCI.

Ethics and dissemination
The protocol for this randomised clinical trial (RCT) raised an interesting discussion with our research ethics board about delaying CPAP therapy by 3 months when a participant is diagnosed with moderate-to-severe SRBD. Given that the current standard of care does not include screening for SRBDs in individuals who are admitted for spinal cord rehabilitation, most individuals are screened for SRBDs during the chronic stage post-SCI, which represents a greater delay in the diagnosis and treatment of SRBDs in this population. Because the potential impact of the OPTIMISE SCI trial on the current standard of care outweighs the risk of delaying CPAP therapy by 3 months, this trial protocol was approved. The dissemination plan includes presentations at scientific meetings and publication of the results in a peer-reviewed scientific journal.

Trial registration number
ClinicalTrials.gov (NCT05473689).

Purpose
The pathogenesis of the long-lasting symptoms which can follow an infection with the SARS-CoV-2 virus (‘long covid’) is not fully understood. The ‘COroNaVirus post-Acute Long-term EffectS: Constructing an evidENCE base’ (CONVALESCENCE) study was established as part of the Longitudinal Health and Wellbeing COVID-19 UK National Core Study. We performed a deep phenotyping case-control study nested within two cohorts (the Avon Longitudinal Study of Parents and Children and TwinsUK) as part of CONVALESCENCE.

Participants
From September 2021 to May 2023, 349 participants attended the CONVALESCENCE deep phenotyping clinic at University College London. Four categories of participants were recruited: cases of long covid (long covid(+)/SARS-CoV-2(+)), alongside three control groups: those with neither long covid symptoms nor evidence of prior COVID-19 (long covid(-)/SARS-CoV-2(-); control group 1), those who self-reported COVID-19 and had evidence of SARS-CoV-2 infection, but did not report long covid (long covid(-)/SARS-CoV-2(+); control group 2) and those who self-reported persistent symptoms attributable to COVID-19 but no evidence of SARS-CoV-2 infection (long covid(+)/SARS-CoV-2(-); control group 3). Remote wearable measurements were performed up until February 2024.

Findings to date
This cohort profile describes the baseline characteristics of the CONVALESCENCE cohort. Of the 349 participants, 141 (53±15 years old; 21 (15%) men) were cases, 89 (55±16 years old; 11 (12%) men) were in control group 1, 75 (49±15 years old; 25 (33%) men) were in control group 2 and 44 (55±16 years old; 9 (21%) men) were in control group 3.

Future plans
The study aims to use a multiorgan score calculated as the cumulative total for each of nine domains (ie, lung, vascular, heart, kidney, brain, autonomic function, muscle strength, exercise capacity and physical performance). The availability of data preceding acute COVID-19 infection in cohorts may help identify the consequences of infection independent of pre-existing subclinical disease and also provide evidence of determinants that influence the development of long covid.

Introduction
Striking the balance in 24-hour movement behaviour (sedentary behaviour, physical activity and sleep) is expected to reduce the risk of a new major cardiovascular event or death (MACE). We aim to determine the effectiveness and cost-effectiveness of the RISE (Reduce and Interrupt sedentary behaviour using a blended behavioural intervention to Empower people at risk towards sustainable 24-hour movement behaviour change) intervention by improving 24-hour movement behaviour for prevention of MACE and gaining quality-adjusted life years (QALYs) in community-dwelling people at risk with a first-ever stroke.

Methods and analysis
This assessor-blinded multicentre randomised controlled trial includes about 1000 participants with a first-ever stroke, of which 752 participants require secondary prevention based on their 24-hour movement behaviour. Participants will be randomly assigned to the experimental group (RISE intervention + usual care) or control (usual care) group. RISE is a 15-week blended care intervention: primary care physiotherapists coach people in their home setting using behaviour change techniques and the RISE eCoaching system. This system consists of: (1) an activity monitor, (2) a smartphone application that provides real-time feedback and contains e-learning modules and (3) a monitoring dashboard for the physiotherapist. A close relative of the participant is involved during the intervention to provide social support. The primary outcome is the effectiveness of the RISE intervention regarding the prevention of MACE measured at one year post randomisation using survival analysis comparing the experimental and control groups. Secondary outcomes include cost-effectiveness for MACE prevention and QALYs and changes in 24-hour movement behaviour over time using compositional data analysis.

Ethics and dissemination
Ethical approval is obtained from Medical Ethics Review Committee Utrecht, NedMec NL83940.000.23. Findings will be disseminated through international peer-reviewed journals and conferences. A sustainable 24-hour movement behaviour change is needed to gain long-term benefits of lowering MACE in patients with stroke. The RISE intervention offers this foundation by integrating behaviour change techniques, the RISE eCoaching system, involvement of participatory support and extensively trained RISE physiotherapists. Consequently, the RISE intervention is expected to be (cost-)effective compared with usual care, and hence, this study will offer a foundation for implementing the RISE intervention in standard poststroke care.

Trial registration number
NCT06124248.

Introduction
Dyslipidaemia, affecting approximately 39% of adults worldwide, is a major risk factor for cardiovascular disease. Individuals with dyslipidaemia are often prescribed statins, which effectively lower plasma low-density lipoprotein cholesterol (LDL-C), thereby reducing the risk of cardiovascular events and mortality. Although statins lower LDL-C, emerging evidence suggests that they may counteract the beneficial adaptations to exercise in skeletal muscle mitochondria and whole-body aerobic capacity. The underlying mechanisms remain unclear, and there is a need for studies investigating how statins influence molecular adaptations to exercise. The primary objective of this study is to investigate the combined effects of statin therapy and focused exercise training on mitochondrial function and whole-body aerobic capacity in people with dyslipidaemia. The untargeted proteomic analysis will be incorporated to provide detailed insights into how statins may affect mitochondrial proteins and other muscle metabolic traits, offering molecular explanations for altered functional readouts at both the muscle and whole-body levels.

Methods and analysis
A total of 100 women and men (aged 40–65 years) diagnosed with dyslipidaemia without atherosclerotic cardiovascular disease will be enrolled in this 12-week, double-blinded, randomised, placebo-controlled trial. Participants will be randomised into one of four groups using a block randomisation approach to ensure an allocation ratio of 60:40 for exercise and non-exercise conditions, respectively. The four groups will be: (1) exercise+placebo, (2) exercise+atorvastatin (80 mg/day), (3) atorvastatin (80 mg/day) and (4) placebo. The primary outcome is mitochondrial function, measured by changes in skeletal muscle citrate synthase activity from baseline to post-intervention. Secondary outcomes include whole-body aerobic capacity (VO2peak) and proteomic analyses. Genetic analysis will be conducted to assess the role of genetic polymorphisms in individual responses to statins and exercise.

Ethics and dissemination
The trial has received ethical approval from the Faroe Islands Ethical Committee (2024-10) and adheres to the Declaration of Helsinki and General Data Protection Regulation (GDPR). Results will be published in peer-reviewed international journals.

Trial registration number
NCT06841536.

Introduction
The first 3 months post partum is a critical transition period for women and families, which is characterised by physical, psychological and social adaptation. The first year post partum is also a critical phase for women’s health, given their physical recovery and adjustment to motherhood. The WHO 2023 recommendations highlight the importance of a postnatal care focus, including maternal health assessment, mental health support, nutritional interventions, postpartum contraceptive use and home care visits. This scoping review aims to map the evidence of the effectiveness of postpartum care on women’s health and quality of life in the Southeast Asia region.

Methods and analysis
This scoping review will be guided by the methodological principles developed by Arksey and O’Malley. This review will also consider observational studies, including cohort studies, case-control studies and cross-sectional studies. For inclusion, studies should be selected for eligibility based on the following criteria: articles investigating the uptake of postpartum women (women who have had childbirth up to 42 days after delivery) in Southeast Asian countries. The search will comprise peer-reviewed articles from 2013 to 2023 from the following electronic databases: PubMed/MEDLINE, ProQuest, EBSCO, Scopus, Web of Science and Google Scholar. We use both keywords in the title and/or abstract and subject headings as appropriate. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Protocols to develop the protocol and use the PRISMA flow diagram to present the results for scoping reviews.

Ethics and dissemination
A scoping review is a novel approach for examining the breadth of literature regarding the connection between the effectiveness of postpartum care and women’s health and quality of life and, as a secondary analysis, does not require ethics approval. The results of this review will be submitted for publication in a peer-reviewed journal and presented at relevant conferences.

Introduction
Hypernatraemia, defined as a plasma sodium concentration >145 mmol/L, is a frequent complication in critically ill patients treated in the intensive care unit (ICU) (= ICU-acquired hypernatraemia), with reported prevalence ranging from 4% to 26%. Hypernatraemia adversely affects various physiological functions and is associated with delirium, prolonged length of stay and increased ICU and post-discharge mortality. The sodium load from intravenous drug diluents significantly contributes to ICU-acquired hypernatraemia, with drug infusions comprising about 30% of the daily fluid volume of an average ICU patient. This study aims to investigate if using glucose 5% solution as the default drug diluent, instead of sodium chloride 0.9%, can reduce the prevalence of ICU-acquired hypernatraemia and improve patient outcomes.

Methods and analysis
To test the effectiveness of glucose 5% solution as the default drug diluent, we will conduct a multicentre, pragmatic, embedded, open-label, stepped-wedge, cluster-randomised trial. The study will include twelve clusters (ICUs and one intermediate care unit) across six hospitals in Germany, with a projected total sample size of 4485 patients. In line with the stepped-wedge cluster-randomised design, one ICU will transition every 4 weeks, in a randomised sequence, from using sodium chloride 0.9% as the default drug diluent to glucose 5%.
The primary endpoint is the prevalence of hypernatraemia >150 mmol/L through day 28. The number of days alive and free of the ICU through day 28 will be tested hierarchically as a key secondary endpoint. Other exploratory endpoints include ICU mortality, ICU-free days, hospital-free days and other clinical outcomes. The primary endpoint will be analysed using a logistic mixed-effects model.

Ethics and dissemination
The trial was approved by the Charité—Universitätsmedizin Berlin Ethics Board and by the ethics board of each enrolled hospital. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

Trial registration number
The trial protocol was registered with the German Clinical Trials Register on 21 June 2024 prior to initiation of patient enrolment (DRKS00033397).

Introduction
Cervical cancer is a major global health issue. The standard treatment for locally advanced disease involves radiochemotherapy followed by uterovaginal brachytherapy (UBT). UBT requires several days of hospitalisation and strict bed rest. UBT often induces pain, anxiety, stress, distress and a decline in physical capacity during and after treatment. Previous research suggests that non-pharmacological interventions, such as yoga, may help alleviate these issues. However, few studies have specifically evaluated their effectiveness in reducing stress during UBT. Furthermore, patient education has been shown to facilitate autonomous practice and to improve patient empowerment. This study aims to evaluate the impact of the KYOCOL protocol, which integrates both a physiotherapy-yoga intervention and an educational programme, on perceived stress and its correlates in patients undergoing UBT.

Methods and analysis
KYOCOL is an ongoing randomised, prospective trial carried out in three French comprehensive cancer centres, using a quantitative approach complemented by a qualitative component. Eighty patients are planned to be randomised (1:1) into a control arm (standard care) or an intervention arm. In the intervention arm, patients will be educated and supervised by a trained physiotherapist in a physiotherapy-yoga programme and will then perform daily autonomous sessions during UBT and for up to 15 days post-treatment. The primary objective is to assess the impact of the KYOCOL intervention compared with standard care during UBT, on perceived stress 15 days post-UBT, using the 10-item Perceived Stress Scale. Secondary objectives include evaluating the safety of the intervention, its effects on stress, pain and fatigue during UBT, and patient adherence to the programme. Qualitative analyses based on semistructured interview surveys will be conducted to gather valuable information and analyse in depth patients’ experiences with the intervention and UBT.

Ethics and dissemination
This study was approved by the French ethics committee (Comité de Protection des Personnes Ouest V, reference number 2023-A01491-44) on 22 February 2024 and will be carried out in accordance with the good clinical practice guidelines and the Declaration of Helsinki. The results will be shared with patients and healthcare professionals and published in a peer-reviewed journal.

Trial registration number
NCT06263283.

Objective
Surgical site infections (SSI) after hysterectomy constitute significant postoperative complications, affecting patient recovery and healthcare costs. We conducted a systematic review of risk factors for SSI in patients undergoing hysterectomy.

Design
The current study conducted a systematic review with meta-analysis to identify and summarise risk factors for SSI following hysterectomy.

Data sources
PubMed, Medline, Embase, Web of Science and Cochrane Central Register of Controlled Trials were searched through 1 November 2023.

Eligibility criteria
The inclusion criteria were (1) population: female participants who had post-hysterectomy SSI; (2) intervention: hysterectomy surgeries; (3) comparators: the number of participants who had or had not post-hysterectomy SSI; (4) outcomes: the number of participants exposed and not exposed to the risk factors of SSI. The exclusion criteria were (1) non-English studies and (2) studies that provided insufficient data.

Data extraction and synthesis
Two reviewers conducted the screening process independently. Articles that did not meet the inclusion criteria were excluded. For those that met the criteria, full-text papers were procured. Any discrepancies between the reviewers were resolved through discussion. The meta-analysis synthesised risk factors reported in ≥4 datasets via random-effects models, assessing heterogeneity, sensitivity (leave-one-out), publication bias (Egger’s test/funnel plots) and subgroup analyses (incision types).

Results
Blood transfusion emerged as the largest risk factor (OR=2.55, 95% CI (1.84, 3.56)), followed by tumour presence (OR=2.23, 95% CI (1.86, 2.66)), obesity (OR=1.79, 95% CI (1.43, 2.23)), diabetes (OR=1.70, 95% CI (1.26, 2.29)) and tobacco use (OR=1.43, 95% CI (1.26, 1.63)). The ORs varied by incision type.

Conclusions
The study establishes blood transfusion, tumour presence, obesity, diabetes and tobacco use as significant risk factors for SSI after hysterectomy, with variations in risk evident across different incision types. The findings also suggest vaginal and laparoscopic hysterectomies as preferable alternatives to abdominal hysterectomy in mitigating SSI risk. Future research should aim for more granular data to untangle the interplay between comorbidities and further elucidate the differential risk across SSI types.

Introduction
Molar incisor hypomineralisation (MIH) is a qualitative developmental defect of the enamel with a complex, multifactorial nature and a significant genetic component. Individuals with MIH have a compromised stomatognathic system manifested by muscle hyperactivity under postural and dynamic conditions. However, there is a gap in knowledge on the specific functional abnormalities that these individuals experience. Early identification and intervention, with a focus on the prevention of orofacial dysfunctions and deviations in facial growth and development, are aspects of the utmost importance. Therefore, the aim of the proposed study is to perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH. The secondary objective is to assess whether dentin hypersensitivity and the severity of MIH lesions are associated with alterations in orofacial functions.

Methods and analysis
Assessments will be performed using the Nordic Orofacial Test-Screening (NOT-S). Descriptive analyses will characterise the sample. The Shapiro-Wilk test will assess normality. For normally distributed data, analysis of variance and Tukey’s post hoc test will be used. For non-normal data, the Mann-Whitney U test will be applied. The 2 test will analyse categorical variables and compare NOT-S domains between groups. Potential confounders (eg, age, sex, socioeconomic status) will be controlled through stratification or as covariates. Logistic and Poisson regressions will model associations for categorical and count-based outcomes, respectively. Statistical significance will be set at p

Objective
To evaluate the association between the timing of invasive mechanical ventilation (MV) initiation and clinical outcomes in patients with cardiogenic shock (CS) secondary to ST-elevation myocardial infarction (STEMI).

Design
Retrospective analysis of a multicentre registry.

Setting
Data were obtained from the Gulf-Cardiogenic Shock registry, which includes hospitals across six countries in the Middle East.

Participants
1117 patients diagnosed with STEMI and CS. Of these, 672 (60%) required MV and were included in this analysis.

Primary and secondary outcome measures
The primary outcome was in-hospital mortality. Secondary outcomes included comparisons of baseline characteristics, Society of Coronary Angiogram and Intervention (SCAI) shock stage, and clinical parameters among groups based on time to MV.

Results
Participants were categorised by time from shock diagnosis to MV: early (≤15 min), intermediate (30 min) and late (≥60 min). Median times were 15 min (IQR 10–20), 30 min (IQR 25–35) and 60 min (IQR 45–70), respectively. Baseline characteristics were comparable across groups. Increased delay in MV was associated with a higher mortality risk during the first 60 min post-diagnosis, beyond which the risk plateaued. Delayed MV was an independent predictor of in-hospital mortality (OR 2.14, 95% CI 1.36 to 3.38, p

Introduction
Pharmacomechanical thrombectomy (PMT) can be a useful treatment for restoring vein patency quickly, especially for extensive acute deep vein thrombosis (DVT). However, previous evidence failed to validate the effectiveness of PMT in reducing the incidence of post-thrombotic syndrome (PTS). To address this controversy, the reformation study aims to improve rheolytic thrombectomy for acute DVT of the lower limb through primary popliteal vein thrombosis clearance.

Method and analysis
Reformation is a prospective randomised multicentre trial. It has 160 patients in two groups: the modified access group (80 patients) and the traditional access group (80 patients). The purpose of this study is to assess whether the modified access approach for removing inflow thrombus in a one-stage procedure is more effective in enhancing the success rate of the procedure and reducing the incidence of PTS during a 24-month follow-up period, for patients with acute whole limb DVT.

Ethics and dissemination
The reformation study has been registered at www.clinicaltrials.gov. The study protocol has been approved by the Institutional Review Board and Human Research Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiao Tong University (approved number: KY2021-067-A). The results will be disseminated by publication in a peer-reviewed journal.

Trial registration number
NCT05286710.

Protocol version and date
V.1.2, 20 August 2022.

-37%rischio morte con esercizio fisico.Banditi cibi infiammatori

New England Journal of Medicine, Ahead of Print.

Hospital-based recommendations for opioid use disorder (OUD) include offering evidence-based medications for OUD (MOUD) with post–hospital OUD treatment linkage. Hospitalization presents an ideal opportunity to initiate MOUD among out-of-treatment adults with OUD, yet only 5% of patients with an OUD-related hospitalization receive MOUD despite their increasing numbers. Innovative care models, including addiction consultation services and hospital-to-community treatment engagement strategies, optimize hospital-based OUD treatment provision and OUD treatment linkage. Clinical benefits of an addiction consultation service include greater likelihood of MOUD treatment initiation and post–hospital discharge OUD treatment linkage and a reduced risk of 30-day rehospitalization. There are also operational and educational benefits for hospitals and staff.