Search Results for: Follow-up ottimale dopo embolia polmonare acuta

Objectives
To systematically assess the robustness of meta-analyses based on randomised controlled trials (RCTs) in vascular surgery using the Fragility Index (FI).

Design
Cross-sectional study.

Setting
Meta-analyses published in English from January 2019 to April 2025, identified from EMBASE, PubMed and Web of Science.

Participants
67 articles, with 291 meta-analyses involving RCTs evaluating vascular surgical interventions, covering venous, aortic, peripheral arterial, vascular access and other relevant fields.

Main outcome measures
FI, defined as the minimum number of event changes required to alter the statistical significance of meta-analysis results, and its association with sample size and total number of events, analysed using frequency distribution histograms and restricted cubic spline models.

Results
The median FI was 7, with considerable variation across different fields. Aortic meta-analyses demonstrated higher robustness compared with venous and vascular access meta-analyses. FI showed a non-linear relationship with sample size and total number of events, indicating robustness improved only up to specific thresholds, beyond which robustness declined or plateaued.

Conclusion
Overall robustness of meta-analyses in vascular surgery was moderate, with notable variability among research areas. FI provides valuable insight into the stability of synthesised evidence, suggesting the need for improved methodological quality and advocating broader adoption of FI in meta-analytical research.

Stroke, Ahead of Print. BACKGROUND:There is a paucity of evidence on whether gestational diabetes (GDM) is a risk factor for cerebral vascular disease for Black women and lack of data on incident stroke as end point.METHODS:We conducted a large prospective cohort study of Black women across the United States and assessed the association between self-reported history of GDM and incident stroke. The study began when participants became parous or enrolled in 1995. We followed up 41 143 parous Black women who were free of cerebral vascular disease or cancer and followed up until incident stroke, death, or the end of 2021. Our exposure was self-reported history of GDM, and outcome was incident stroke. Multivariable Cox proportional hazards model was used to estimate hazard ratios (HRs) and 95% CIs, adjusting for major known risk factors for stroke.RESULTS:A total of 1495 incident stroke cases were identified among 41 143 Black women from 1995 until 2021 (881 505 person-years of follow-up). Black women with a history of GDM had a consistent 1.4-fold increased risk of stroke compared with those with a healthy pregnancy (age-adjusted HR, 1.44 [95% CI, 1.14–1.82]; multivariable HR, 1.41 [95% CI, 1.11–1.79]). Compared with healthy parous women with neither GDM nor type 2 diabetes, women with a history of both had a 2.6-fold increased stroke risk (multivariable HR, 2.59 [95% CI, 1.88–3.57]); women with only type 2 diabetes have 2-fold increased stroke risk (multivariable HR, 2.04 [95% CI, 1.79–2.32]); women with a history of GDM but no progression to type 2 diabetes do not have an increased risk of stroke (multivariable HR, 1.22 [95% CI, 0.86–1.73]).CONCLUSIONS:In this large prospective study of Black women, a vulnerable population at high risk for stroke, a history of GDM increased stroke incidence by 41%. There was no elevated risk of stroke for Black women with a history of GDM and no progression to type 2 diabetes, while the stroke risk increased by 2.6-fold for Black women with GDM and progression to type 2 diabetes. Our results highlight the importance of consideration of history of GDM for stroke early prevention, especially Black women with progression to T2DM after GDM.

Introduction
Individuals with spinal cord injury (SCI) face heightened cardiovascular disease (CVD) risks. While general exercise guidelines are promoted for SCI individuals, when and how to incorporate exercise during the subacute phase post-SCI remains unclear. Consequently, early aerobic exercise to reduce CVD risks is not standard practice in subacute SCI care, potentially missing an opportunity for optimal cardiovascular rehabilitation, especially given observed reductions in cardiac structure and function within the first year post-SCI. Addressing this gap could improve long-term cardiovascular health and health-related quality of life (HRQOL) for individuals with SCI. Early intervention might prevent worsening cardiovascular function and establish beneficial exercise habits. However, few studies have evaluated the effectiveness of early exercise interventions in this population. This study aims to provide insight into the impact of moderate-intensity arm-crank exercise training (ACET) on cardiometabolic, HRQOL, functional and fitness parameters in individuals with subacute (

Objectives
Frail older adults need to improve their health through exercise, and effective interventions are necessary to ensure their participation. Exercise with music has been shown to enhance adherence among older adults and improve both physical and mental health outcomes, making it a suitable intervention for frail older adults. This study evaluated the impact of exercise with music on the physical and emotional health of frail, community-dwelling older adults.

Design
A systematic review and meta-analysis were conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines.

Data sources
MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Embase, Cochrane Library, PsycINFO, Google Scholar and the Virginia Henderson International Nursing Library were last searched on 14 March 2025.

Eligibility criteria for selecting studies
We included randomised controlled trials (RCTs) and non-RCTs that applied exercise with music to community-dwelling frail older adults.

Data extraction and synthesis
Five independent reviewers used standardised methods to search, screen and code included studies. Study quality was assessed using the revised Cochrane Risk of Bias 2 tool and the Risk of Bias in Non-Randomized Studies of Interventions tool. A meta-analysis and narrative synthesis were conducted, and the findings were summarised using Grading of Recommendation, Assessment, Development, and Evaluation evidence profiles. Publication bias was checked, and sensitivity analyses were used to assess the robustness of the results.

Results
After screening the initial 1425 studies, 17 studies (13 RCTs and 4 non-RCTs) were analysed. The overall risk of bias indicated that two had high risk and three had serious risk among the RCTs, and two had serious risk and two had moderate risk among the non-RCTs included in the meta-analysis. As for physical health outcomes, studies reported on frailty, Timed Up and Go (TUG), handgrip strength, falls, balance, gait speed, endurance and other performance. As for emotional health outcomes, studies reported on depression, social support and activities, quality of life or satisfaction and cognitive function. The pooled analysis suggested that exercise with music may have a positive effect on reducing frailty (standardised mean difference (SMD)=–0.20, 95% CI=–0.34 to –0.07, p=0.003, I2=0%; very low certainty) and decreasing depression levels (SMD=–0.40, 95% CI=–0.65 to –0.15, p=0.002, I2=0%; very low certainty) compared with control group outcomes in non-RCTs. However, there was no effect on the TUG and handgrip strength. A narrative synthesis of evidence suggested potential beneficial effects on frailty and depression.

Conclusions
Exercise with music may help improve frail older adults’ physical and emotional health and potentially reduce the burden of frailty. However, further rigorous investigation is needed, as the evidence has a very low level of certainty. Additionally, results from this review should be interpreted with caution because of concerns associated with the risk of bias. Community-based health professionals should consider using music when providing exercise interventions to frail older adults, while applying tailored approaches that consider their unique needs.

PROSPERO registration number
CRD42022369774.

Introduction
Intra-articular injections of mesenchymal stromal cells concentrates showed promising results in the treatment of knee osteoarthritis (OA). Among these, bone marrow aspirate concentrate (BMAC) has been widely adopted in clinical practice. More recently, microfragmented adipose tissue (MFAT) has been proposed as a more suitable solution. However, there is still no high-level evidence demonstrating the superiority of MFAT to BMAC. The aim of this randomised controlled trial is to compare the safety and clinical outcomes of a single intra-articular injection of BMAC versus a single intra-articular injection of MFAT in patients with knee OA.

Methods and analysis
204 patients aged 40–75 years and affected by knee OA are randomised to receive a single injection of BMAC or MFAT in a 1:1 ratio. The primary outcome of the study is the Western Ontario and McMaster University OA index (WOMAC) pain score at 6 months. The secondary outcomes of the study are the WOMAC pain score at 2 months and 12 months and the WOMAC subscales, the total WOMAC score, the International Knee Documentation Committee subjective and objective scores, the Knee Injury and OA Outcome score, the visual analogue scale (VAS) for pain evaluation, the EuroQol VAS and the Tegner score at 2 months, 6 months and 12 months. Moreover, the study aims at demonstrating whether these products have disease-modifying effects: radiographs and magnetic resonance evaluations are performed at baseline and at 12 months of follow-up, while systemic OA biomarkers are evaluated at baseline and after 2 months, 6 months and 12 months. As a tertiary outcome, this study aims at identifying the factors that influence the clinical response, including baseline patient clinical characteristics, biological features of the OA joint, as well as anabolic and anti-inflammatory properties of the injected products.

Ethics and dissemination
The study protocol has been approved by Emilia Romagna’s Ethics Committee Comitato Etico Area Vasta Emilia Centro (CE-AVEC), Bologna, Italy (protocol number: 150/2023/Sper/IOR). Written informed consent is obtained from all participants. The findings of this study will be disseminated through peer-reviewed publications and conference presentations.

Protocol version
March 2023.

Trial registration number
NCT06040957.

AbstractBackground
Cerebral palsy (CP) is the most common physical disability of childhood, affecting movement and posture, resulting from a neurological insult during pregnancy or the neonatal period. While the brain lesion is static, the musculoskeletal sequelae in CP are often progressive and lifelong, associated with pain and can impact the lives of children with CP, their families and the healthcare system. The Australasian Cerebral Palsy Musculoskeletal Health Network (AusCP MSK) study will conduct comprehensive, population-based surveillance of children with moderate to severe functional mobility limitations (Gross Motor Function Classification System (GMFCS) levels III–V) to explore the early biomarkers of, and interactions between, musculoskeletal complications related to CP, including hip displacement, scoliosis and skeletal fragility.

Methods
The AusCP MSK study involves three cohorts of children. Cohort A (n=500) is a multicentre retrospective (3 years) and prospective (4 years) cohort study in children aged 4–9 years that will be implemented at five sites across Australia and New Zealand. Retrospective data will include clinical history, information on CP diagnosis and other investigations (previous X-rays and biochemistry). Primary prospective outcomes will involve measures of hip displacement (migration percentage, acetabular index, femoral head orientation, Hilgenreiner’s epiphyseal angle), scoliosis (Anteroposterior/Posteroanterior and lateral spine X-ray), skeletal fragility (Dual Energy X-ray Absorptiometry, peripheral quantitative computed tomography), motor function (GMFCS, Manual Ability Classification System (MACS) and Communication Function Classification System (CFCS)) and range of movement (lower limb and spine). Cohort B (n=4000) is a retrospective analysis of data to evaluate fractures in children up to 18 years of age with CP (GMFCS I–V) from the New South Wales (NSW)/Australian Capital Territory CP Registers linked with corresponding records from NSW administrative health data (n=3000), and a New Zealand cohort of linked data from the New Zealand Cerebral Palsy Register to the Accident Compensation Corporation data for fracture claims (n=1000). Cohort C (n=30) will cross-sectionally examine bone quality through a transiliac bone biopsy in children undergoing scheduled hip surgery. Relationships between early biomarkers, early brain structure and musculoskeletal complications will be explored using multilevel mixed-effect models.

Ethics and dissemination
Ethical approval for this study was granted by Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee, The University of Queensland Human Research Ethics Committee and the New Zealand Health and Disability Ethics Committee.
Research outcomes will be disseminated via scientific conferences and publications in peer-reviewed journals; to the National Bodies and Clinicians; and to people with CP and their families.

Trial registration number
Australian New Zealand Clinical Trials Registry number: ACTRN12622000788774p

Introduction
Recurrent urinary tract infections (rUTIs) are typically treated using antibiotics. Given the growing issue of antimicrobial resistance, non-antibiotic management options for rUTIs have faced a recent resurgence in popularity. Methenamine hippurate is a urinary antiseptic used as a non-antibiotic prophylactic measure in those with rUTIs. The results of a recent randomised controlled trial showed methenamine hippurate to perform on par with antibiotic prophylaxis in adult women with rUTIs. However, little is known about the efficacy of methenamine hippurate in vulnerable patient populations, such as children, the elderly, patients with indwelling catheters and those with renal tract abnormalities. Moreover, an up-to-date, comprehensive evaluation of the entirety of the literature surrounding methenamine hippurate has yet to be carried out. As such, key trends within the literature, such as common side effects and specific avenues for future research, are difficult to determine. Therefore, we developed the methodology for a scoping review to map the entirety of the existing evidence base for methenamine hippurate.

Methods and analysis
The protocol for this scoping review was developed in accordance with the framework set out by Arksey and O’Malley. We will search MEDLINE, Embase, Scopus, the Cochrane Central Register of Controlled Trials and ProQuest Dissertation and Theses from inception until August 2024, with no language restrictions applied. Studies including patients of any age and sex receiving methenamine hippurate treatment, either as a primary or adjunct treatment for rUTIs, will be eligible for inclusion. Interventional studies, such as randomised controlled trials and their protocols, non-randomised clinical trials, cohort studies, case-control studies and observational studies of any design, will be included. Grey literature, systematic reviews and qualitative studies will also be included. Two independent reviewers blinded to each other’s decisions will assess the eligibility of articles at each stage using the Covidence review platform. After the relevant data from each study has been extracted, we will report the results of our scoping review using descriptive summary statistics and a narrative thematic analysis.

Ethics and dissemination
Due to the nature of the present study, ethical approval was not required for this scoping review. The final manuscript of this scoping review will be published in an international, peer-reviewed journal and the findings of the review presented in relevant national and international conferences.

Introduction
Accidental falls are a common geriatric syndrome that hinders healthy ageing in older adults. Older adults who live in nursing homes (NHs) are at a greater risk of accidental falls than those who reside in communities. Intrinsic capacity (IC) decline has been shown to be an independent influencing factor for fall risk. Moreover, healthy behaviour is a prerequisite for IC. Therefore, this study considers IC as a starting point, with an aim of developing, implementing and evaluating a low-administration-cost multidomain fall risk management intervention programme based on the Health Action Process Approach.

Methods and analysis
The target population includes older adults with declining IC in Chinese NHs. A random lottery method will be adopted to divide the 100 participants into the control group and intervention group. The project will be conducted in three parts over 24 weeks. In the first part, a fall risk management intervention pathway and programme will be developed with the theoretical and IC framework, which will be refined via the Delphi method. In the second part, a randomised controlled trial will be implemented. The control group will receive usual care and health education, and the intervention group will complete a three-stage process to complete fall risk management behaviour intention and behaviour maintenance. In the third part, follow-up will be conducted to clarify the maintenance effectiveness of the programme in fall risk management. Behaviour change techniques and an interactive handbook will be used to increase the feasibility of the programme. The primary outcomes will include the IC composite score (cognition, locomotion, vitality, sensation and psychology) and fall risk. The secondary outcomes will include gait and balance, strength, fall efficacy, fall prevention self-management, fall management behaviour stages and healthy ageing. The outcomes will be assessed at baseline, and then after 4 weeks, 16 weeks and 24 weeks in both groups. The effectiveness of the intervention will be analysed via linear mixed models on a range of outcomes.

Ethics and dissemination
The trial was approved by the Huzhou University Committee (No.2023-06-06). The results will be submitted for publication in a peer-reviewed journal and presented at conferences.

Trial registration number
NCT05891782.

Introduction
Cancer is the second leading cause of death in the USA. Cancer genetics and genomic studies have improved our understanding of risk, onset and progression. However, disparities by race and ethnicity have resulted in a lack of representation for minorities in these studies, contributing to unequal reductions in the cancer burden across populations. Moreover, the reasons why some individuals decline to participate in cancer genetics and/or genomic studies across diverse populations remain unclear. This review will summarise the main reasons (concerns) associated with declining to participate in cancer genetics and/or genomic studies for individuals with a history of cancer living in the USA and Puerto Rico (PR), considering race and ethnicity.

Methods and analysis
We will follow the methodology presented by the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews Statement extended to Scoping Reviews to guide manuscript generation. A standardised search strategy developed in collaboration with a health sciences librarian will be deployed in Medline (PubMed), Embase (Ovid) and Scopus from database inception till present. The search strategy consists of three concepts: (1) cancer; (2) genetics and genomic research; (3) declination to participate in research studies. Title and abstract screening, followed by full-text review, will be conducted by independent reviewers to determine study inclusion. Only the peer-reviewed literature in English, conducted in the USA and PR will be considered. Findings will be presented as a numerical summary, graphical presentation and narrative review of the literature.

Ethics and dissemination
Ethical review is not required for scoping reviews. This review aims to facilitate the development of targeted strategies to increase participation in cancer genetics and/or genomic studies across diverse populations. Results will be disseminated through a peer-reviewed publication and conference presentations. The protocol is registered in the Open Science Framework (www.osf.io).

Introduction
The prevalence of dementia is increasing, both worldwide and in China. This disease is associated with numerous restrictions for those affected but also for caregivers and society. Due to the limited effectiveness of pharmacological interventions, more research on non-pharmacological interventions is needed. For the non-pharmacological multimodal MAKS (M: motor training, A: activities of daily living training, K: cognitive training, S: social-communicative setting) intervention, positive effects on cognition, activities of daily living, and the occurrence of behavioural and psychological symptoms of dementia were identified in two randomised controlled trials in different settings in Germany. Thus, the German MAKS intervention was culturally adapted for China and will now be tested for its efficacy in Chinese nursing homes in a randomised controlled trial.

Methods and analysis
Participants will be residents of Chinese nursing homes in Shenyang, Nanjing and Dalian, fulfilling the ICD-10 criteria for Alzheimer’s dementia, the psychometric criteria for mild to moderate dementia (MMSE 10–23) and none of the exclusion criteria. With n=200, effects with an effect size of Cohen’s d=0.45 and a power of 1-β = 0.80 can be detected. Screening and data collection at baseline, t6 and t12 will be conducted via face-to-face contact by proxy raters in the nursing homes (i.e., trained nursing staff not involved in the intervention) and master students as external testers for the performance tests on cognition and activities of daily living. Participants will be randomly allocated to the intervention or control group. SinoMAKS (i.e., the Chinese version of the MAKS intervention) will be conducted at least three times a week for six months by trained MAKS therapists. The control group will receive care as usual for 12 months after baseline. Thus, the treatment phase is six months with follow-ups after six and 12 months after baseline. In the open phase, from t6 to t12, the nursing homes are free to offer SinoMAKS to the intervention group residents. In line with international guidelines, the primary population for analysis is the intention-to-treat sample. Global cognition (measured with the Addenbrooke’s Cognitive Examination-III) is the primary outcome. The hypotheses will be analysed using multiple linear regression with the outcome variables as dependent variables.

Ethics and dissemination
All procedures were approved by the Ethics Committee of the Medical Faculty of the Friedrich-Alexander-Universität Erlangen-Nürnberg (Ref. 24–162-B) and the Ethics Committee of the China Medical University (Ref. [2024]181). Written informed consent will be obtained from all participants or—if applicable—their legal representatives. Results will be published in peer-reviewed scientific journals and conference presentations.

Trial registration number
ISRCTN10262531.

This Viewpoint reviews the accelerated approval process and lack of postapproval studies to verify its benefit as it applied to sotorasib, a treatment for non–small cell lung cancer with the KRASg12c mutation, and recommends measures to ensure confirmatory follow-up studies.

This review describes version 6.0 of the Children’s Oncology Group Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers.

In the Review titled “The Children’s Oncology Group Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers: A Review,” published online February 20, 2025, and in the May 2025 issue, there were errors in Figure 1. Several labels of columns in the “Task forces” box were corrected, and the box labeled “Neurologic” in the “Task force subcommittees” section was corrected to “Neurosensory.” This article was corrected online.

In the Research Letter titled “Kidney Transplantation Among Presumed Undocumented Immigrants After Changes in US State Policies,” published online November 11, 2024, and in the January 2025 issue, clarification was required in the first sentence of the Results. The first sentence given as “Presumed undocumented immigrants (median follow-up, 1.1 [IQR, 0.3-2.8] years) represented a higher proportion of patients listed during the postpolicy relative to the prepolicy period in crude (postpolicy, 62%; prepolicy, 38%) (Figure) and adjusted analyses (overall adjusted IRR, 2.21; 95% CI, 1.15-4.27)” should have been 2 sentences: “Among 576 presumed undocumented immigrants listed for transplantation (median follow-up, 1.1 [IQR, 0.3-2.8] years) in 3 states, 220 were listed prepolicy and 356 were listed postpolicy (Figure). Overall, presumed undocumented immigrants were more likely to be listed postpolicy than prepolicy (adjusted IRR, 2.21; 95% CI, 1.15-4.27).” This article has been corrected.

Stroke, Ahead of Print. BACKGROUND:Bone marrow mononuclear cell (BM-MNC) intraarterial transplantation has emerged as a potential stroke therapy. We aimed to determine whether BM-MNC therapy induces changes in diffusion tensor imaging metrics of major white matter tracts.METHODS:The IBIS trial was an investigator-initiated multicenter, phase IIb, randomized, controlled, assessor-blinded, clinical trial. Seventy-seven patients (aged 18–80 years) with a nonlacunar middle cerebral artery ischemic stroke within 1 to 7 days from stroke onset and a National Institutes of Health Stroke Scale score of 6 to 20 were included. The primary outcome was the modified Rankin Scale score at 6 months. Among these participants, 38 patients (20 BM-MNCs-treated and 18 controls) had diffusion tensor imaging data available at both baseline and 6-month follow-up. Fractional anisotropy, mean diffusivity, axial diffusivity, and radial diffusivity for white matter tracts were obtained. We determined the average changes in diffusion tensor imaging-metric values over the follow-up period and correlated corticospinal tract integrity with clinical outcomes using Spearman´s correlation coefficient.RESULTS:The mean (SD) age was 60.7 (14.01) years; 22 (57.9%) were men, and 31 (81.6%) underwent thrombectomy. The median (IQR) National Institutes of Health Stroke Scale score before randomization was 12 (9–15). Baseline diffusion tensor imaging metrics were comparable between groups. Fractional anisotropy values of patients treated with BM-MNC decreased significantly less throughout corticospinal tract ipsilateral to stroke lesion (−0.05 [95% CI, −0.07 to −0.03] versus −0.06 [95% CI, −0.09 to −0.04];P

Introduction
Falls can lead to serious health-related consequences in the older population. If an emergency occurs within the home environment of an older person living alone, the initiation of emergency care can be delayed, leading to even worse outcomes for this population. Smart home emergency call systems (HECSs) can detect falls and automatically trigger an emergency alarm, potentially reducing time to emergency care and improving outcomes. The INES (Intelligentes NotfallErkennungsSystem—smart emergency detection system) study is a prospective randomised controlled trial conducted in three German federal states that aims to investigate the effectiveness and cost-effectiveness of a smart HECS.

Methods and analysis
Following a telephone interview, individuals aged 70 years or older, living alone, at risk of falling and willing to participate are included in the study. Participants are assigned to one of two groups depending on their previous use of a HECS. Based on the sample size calculation, the study aims to recruit n=498 participants already using a standard HECS (group A) and n=1378 participants who have not used a HECS before (group B). Within both groups, participants are randomised into the intervention arm (IA) and control arm (CA). The IA receives a smart HECS during the 21-month follow-up period. In addition to a standard HECS with a base station and a wearable radio transmitter, the smart HECS includes sensors that can detect falls and automatically trigger an alarm. The primary outcome assessed will be the days spent in the hospital after an emergency admission. Secondary outcomes include the utilisation of healthcare services and their total costs, progression of care dependency, fear of falling (Falls Efficacy Scale—International), health-related quality of life (EQ-5D-5L) and well-being (ICEpop CAPability measure for Older people).

Ethics and dissemination
The design and conceptualisation of the INES study were approved by the ethics committee of the Hamburg Medical Association on 26 June 2023 (2023-101032-BO-ff). Results of the INES study will be published in peer-reviewed articles.

Trial registration number
Deutsches Register Klinischer Studien, German Clinical Trials Register DRKS00031408. Registered on 28 June 2023.