Search Results for: Come si esegue la raccolta delle urine delle 24 ore

Introduction
International survivorship guideline consortia have developed strategies to prevent, detect and manage late effects of childhood cancer survivors. However, recommendations do not adequately reflect the everyday reality of paediatric oncology care in low- and middle-income countries. In this study protocol, a survivorship intervention programme, comprising an educational component and a follow-up component, is described. The Educational Programme aims to improve follow-up adherence of childhood cancer survivors through increasing survivorship knowledge of caregivers. The Follow-up Programme aims to map late effects by implementing a follow-up form at the outpatient clinic to be used by trained healthcare providers.

Methods and analysis
This non-randomised prospective clinical trial will be performed at a referral hospital in Western Kenya. 100 caregivers of children diagnosed with cancer, who will complete treatment within 2 months, will be enrolled and followed for 24 months after completion of treatment. A caregiver control group receiving usual care will be recruited, and sequentially, caregivers will be included in an intervention group to attend an educational group session where they receive educational materials (video, booklet and Survivorship Card). Primary study outcome will be survivors’ follow-up adherence. Survivors will be considered lost to follow-up after they miss a scheduled appointment and do not revisit the clinic for more than 6 months. Mixed models regression analyses will be performed to determine intervention effects on follow-up adherence and on caregiver survivorship knowledge uptake. Additionally, healthcare providers will be trained on follow-up care, whereafter a form will be introduced at the outpatient clinic to document late effects in paediatric survivors attending the clinic for the period of a year. Secondary outcomes will be late effects prevalence as documented in the follow-up form and caregiver and healthcare provider survivorship knowledge uptake. Implementation measures (reach, potential effectiveness, adoption, satisfaction and maintenance) will be evaluated for both programmes.

Ethics and dissemination
The Institutional Research and Ethics Committee has approved the study protocol. Findings will also be shared with governmental and non-governmental organisations that support children with cancer in Kenya to inform their target audiences and guide their policy development.
Lessons learnt from this study could inform healthcare providers and policy makers on how to shape survivorship programmes in the Kenyan context and possibly implement similar programmes in other centres in Sub-Saharan Africa.

Trial registration number
NCT06680687.

Introduction
Symptom management is crucial in cancer care, yet patient symptoms are often overlooked in routine care. There is some evidence that electronic symptom monitoring and management can improve patients’ physical function, symptom control, quality of life and survival outcomes. However, the evidence of the impact on survival outcomes in patients with advanced cancer is still limited and debated. This study aims to conduct a prospective randomised controlled trial by a professional symptom management team to monitor and manage symptoms in advanced cancer patients via an electronic information systems for patient-reported outcomes (ePRO) system (WeChat mini-program) and to verify its effectiveness on improving overall survival.

Methods and analysis
This is a single-centre, prospective, open-labelled, randomised, parallel-controlled clinical trial targeting patients with advanced cancer. We plan to recruit 940 patients using a stratified block randomisation method based on different tumour types. The control group will receive a symptom management self-care manual (both electronic and paper versions). Similarly, the intervention group will receive the same manual and education while also received symptom management by the hospital’s specialised symptom management team through the ePRO system. The primary outcome is comparison of overall survival between groups at the 24-month follow-up. Secondary outcomes will include quality of life, psychological status and incidence of adverse events.

Ethics and dissemination
The study protocol and related documents received approval from the Ethics Committee of Peking University Cancer Hospital (IRB) in December 2023 (2023YJZ99). Ethical approval will be obtained before implementing any major study revisions in the future. The results of this study will be disseminated through academic seminars, peer-reviewed publications and academic conferences.

Trial registration number
ChiCTR2400081247.

Introduction
Persistent musculoskeletal pain is a leading cause of disability and need for rehabilitation globally. Many people with the condition attend pain management programmes (PMPs) for rehabilitation and support with self-management. Physical activity (PA) is an essential self-management strategy facilitated on PMPs as it benefits symptoms, general health and well-being. PA needs to be maintained in the long term to continue to be beneficial. However, while many patients increase their PA during or immediately after a PMP, they commonly find it difficult to maintain it in the long term. This study aims to address this problem by developing an intervention to support PA maintenance after a PMP.

Methods and analysis
This mixed-methods study will be guided by the Medical Research Council guidelines for developing complex interventions and the Behaviour Change Wheel intervention development framework. Participants will be recruited from multiple UK National Health Service PMPs. Participants will include patients with persistent musculoskeletal pain who have completed PMPs, their PA partners (people who support them with PA) and healthcare professionals who facilitate PA on PMPs. The study will be conducted in three phases. In phase 1, qualitative interviews will explore the experiences, barriers and facilitators of PA maintenance after a PMP and potential characteristics for a PA maintenance intervention from patient, PA partner and healthcare professional perspectives. Phase 2 will consist of a prospective longitudinal pilot study to identify factors associated with PA maintenance after a PMP. Phase 3 will involve developing a logic model and co-designing the intervention with patient, PA partner and healthcare professional stakeholder groups.

Ethics and dissemination
The project received research ethics committee (REC) and Health Research Authority approval on 4 June 2024 (REC: North West—Liverpool Central, REC reference: 24/NW/0174, IRAS Project ID: 340674). Findings will be disseminated by peer-reviewed publications, conference presentations, social media and lay summaries for patients and the public.

Akseer N, Tasic H, Adeyemi O, et al. Concordance and determinants of mothers’ and children’s diets in Nigeria: an in-depth study of the 2018 Demographic and Health Survey. BMJ Open 2023;13:e070876. doi: 10.1136/bmjopen-2022-070876
This article was previously published with an error.
Figure 2 contains an error. Rather than presenting different findings for three age groups, the results were duplicated three times for a single age group. The corrected figure is displayed below for your reference.
Figure 2 (A) Percentage concordance and discordance between maternal and child consumption of specific food groups in past 24 hours. (B) Percentage concordance between maternal and child consumption of specific food groups in past 24 hours (child age 6–11 months). (C) Percentage concordance between maternal and child consumption of food groups (child age 12–23 months).

Una squadra di 50 professionisti al Gaslini

Stroke, Ahead of Print. BACKGROUND:Early reocclusion following successful recanalization through mechanical thrombectomy is linked to poor clinical outcomes in patients with stroke with intracranial atherosclerotic occlusion (ICAS-O). However, the factors influencing early reocclusion remain inadequately understood. This study is a post hoc analysis of 24-hour reocclusion in patients with successfully recanalized ICAS-O from a multicenter trial.METHODS:Patients with successfully recanalized ICAS-O were selected from the ANGEL-REBOOT trial (Randomized Study of Bailout Intracranial Angioplasty Following Thrombectomy for Acute Large Vessel Occlusion). Reocclusion was defined as a 24-hour arterial occlusive lesion score of 0 to 1, determined by magnetic resonance or computed tomography angiography. Possible factors associated with early reocclusion were screened through univariable analysis, and then, multivariable logistic regression was used to identify independent factors associated with early reocclusion.RESULTS:Among the 348 patients in the ANGEL-REBOOT trial, 21 could not be diagnosed with ICAS-O, 14 failed recanalization by the end of the procedure, and 14 had no follow-up angiography data. Finally, a total of 299 subjects were included, with a median age of 63 (interquartile range, 55–69) years, and 77 of 299 (25.75%) were females. The 24-hour reocclusion rate was 9.7% (29/299). Through backward elimination, 3 independent factors remained in the final multivariable logistic regression model. Specifically, puncture-to-recanalization time (per hour increase: odds ratio, 1.80 [95% CI, 1.31–2.47]) was positively associated with reocclusion, while general anesthesia (odds ratio, 0.25 [95% CI, 0.10–0.65]) and a postprocedural expanded Thrombolysis in Cerebral Infarction score of 2c-3 (odds ratio, 0.35 [95% CI, 0.14–0.85]) were negatively associated with reocclusion. Compared with patients without reocclusion, those with reocclusion had significantly greater 90-day modified Rankin Scale scores (median 4 versus 1, Mann-WhitneyUtest;P

Introduction
Sepsis is a common condition with significant morbidity, mortality and annual costs of care in the billions of dollars. Despite innumerable studies on the causes of, and therapies for, sepsis, the mortality rate has not changed substantially in the last 20 years. Treatments remain generic, with current guidelines recommending the same approach for all patients, regardless of the litany of differences that exist at baseline. Moreover, the blanket administration of 30 cc/kg of intravenous fluid (IVF) to all patients is recognised as being directly harmful to some. Patient-level heterogeneity in prior sepsis trials is recognised as a substantial contributor to all these problems, yet no prior investigation has attempted to identify volume-informed septic phenotypes, a necessary first step towards precision care.

Methods and analysis
Predicated on prior studies demonstrating detectability of organ-level congestion, we hypothesise that central venous hypertension (1) is deleterious to the function of the lungs, liver, kidneys and vascular endothelium; (2) is worsened by cardiac dysfunction and IVF administration; and (3) contributes to adverse organ-specific and overall outcomes. Beginning in the emergency department, cardiac function will be assessed with echocardiography while congestion in the lungs and kidneys will be assessed using previously validated sonographic markers of congestion. Biomarkers for each organ will be collected concurrently, thereby increasing the fidelity of our phenotypic profiles by pairing indicators of macroscopic and microscopic stress and dysfunction. Data will also be collected at 24 hours and 7 days (or discharge, whichever comes first) after presentation. Classical and machine learning approaches will be used to analyse our large data stream and develop a rule-based system to identify distinct subpopulations of patients with sepsis who have greater risk/likelihood of both organ-specific and overall adverse outcomes.

Ethics and dissemination
This project has been approved by the Wayne State University Institutional Review Board, with patient enrolment beginning in April 2024. Findings will be reported and disseminated via conference presentations and open-access publications.

Introduction
Antenatal corticosteroid (ACS) regimens have remained unchanged since the initial trials in 1972, with the optimal regimen still undetermined. The WHO ACTION (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns)-III trial is a three-arm individually randomised double-blind trial evaluating the efficacy and safety of two different ACS dosing regimens (currently used and lower-dose ACS regimens vs placebo) in women with a high probability of having a late preterm birth. This study protocol nested within this trial aims to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) effects of two different ACS dosing regimens in pregnant women in the late preterm period (34–36 weeks) to help inform an optimal dosing regimen.

Methods and analysis
The study will be conducted in two of the five countries participating in the WHO ACTION-III trial—India (Delhi, Belagavi) and Nigeria (Ibadan and Ile-Ife). We will use a population PK approach using sparse sampling to study the PK effects of the two ACS regimens, that is, 6 mg dexamethasone phosphate (DEXp) or 2 mg betamethasone phosphate (BETp), administered intramuscularly every 12 hours for a maximum of four doses or till birth, whichever is earlier, compared with placebo. We will also ascertain the fetal–maternal ratio of DEXp and BETp at birth.
Maternal venous blood samples will be collected at 0, 1–4 hours, 8–12 hours after the first dose, and at 24–36 hours, 48–60 hours, 72–96 hours after the last dose, and immediately after birth, along with cord blood. Concentrations of DEXp and BETp will be measured at set time points using a validated liquid chromatography mass spectroscopy assay. PD parameters measured will include total and differential white blood cell count (by automated analysers using electrical impedance), plasma glucose (hexokinase method) and serum cortisol (using a validated electrochemiluminescence immunoassay), at predefined time points. PK models will be developed for each drug using non-linear mixed effects methods. Optimal dosing will be investigated using Monte Carlo simulations.

Ethics and dissemination
The study has been approved by the WHO Ethics Review Committee and the site-specific ethics committees of the participating leading institutions. Written informed consent will be obtained from all participants. The study results will be published in a peer-reviewed journal and presented at scientific conferences.

Trial registration number
ISRCTN11434567.

Background
24-Nor-ursodeoxycholic acid (NorUDCA) is a novel therapeutic bile acid for treating immune-mediated cholestatic liver diseases, such as primary sclerosing cholangitis (PSC).

Objective
Since PSC strongly associates with T helper-type-like 17 (TH17)-mediated intestinal inflammation, we explored NorUDCA’s immunomodulatory potential on TH17 cells.

Design
NorUDCA’s impact on TH17 differentiation was assessed using a CD4+TNaive adoptive transfer mouse model, and on intraepithelial TH17 pathogenicity and transdifferentiation using an αCD3 stimulation model combined with interleukin-17A-fate-mapping. Mechanistic studies used molecular and multiomics approaches, flow cytometry and metabolic assays with pathogenic (p) TH17. Pathogenicity of pTH17 exposed to NorUDCA in vitro was evaluated following adoptive transfer in intestinal tissues or the central nervous system (CNS). Key findings were validated in an αCD3-stimulated humanised NSG mouse model reconstituted with peripheral blood mononuclear cells from patients with PSC.

Results
NorUDCA suppressed TH17 effector function and enriched regulatory T cell (Treg) abundance upon CD4+TNaive cell transfer. NorUDCA mitigated intraepithelial TH17 pathogenicity and decreased the generation of proinflammatory ‘TH1-like-TH17’ cells, and enhanced TH17 transdifferentiation into Treg and Tr1 (regulatory type 1) cells in the αCD3-model. In vivo ablation revealed that Treg induction is crucial for NorUDCA’s anti-inflammatory effect on TH17 pathogenicity. Mechanistically, NorUDCA restrained pTH17 effector function and simultaneously promoted functional Treg formation in vitro, by attenuating a glutamine-mTORC1-glycolysis signalling axis. Exposure of pTH17 to NorUDCA dampened their pathogenicity and expansion in the intestine or CNS upon transfer. NorUDCA’s impact on TH17 inflammation was corroborated in the humanised NSG mouse model.

Conclusion
NorUDCA restricts TH17 inflammation in multiple mouse models, potentiating future clinical applications for treating TH17-mediated intestinal diseases and beyond.

Objectives
We aimed to analyse the trends, age distribution and disease burden of maternal sepsis and other maternal infections (MSMI) to improve management strategies.

Design
We extracted data from the global burden of disease (GBD) 2021 database to evaluate MSMI burden with different measures for the whole world, 21 GBD regions and 204 countries from 1990 to 2021.

Setting
Studies from the GBD 2021 database generated by population-representative data sources identified through a literature review and research collaborations were included.

Participants
Patients with an MSMI diagnosis.

Outcomes
Total numbers, age-standardised rates (ASRs) of incidence, prevalence, mortality and disability-adjusted life years (DALYs) on MSMI from the GBD 2021 study and their estimated annual percentage changes (EAPCs) were the primary outcomes.

Results
There were 19 047 404 (95% uncertainty interval (UI) 14 608 563 to 24 086 486) annual incident cases, 2 376 876 (95% UI 1 678 868 to 3 421 377) prevalent cases at a single time point, 17 665 (95% UI 14 628 to 21 191) death cases and 1 144 233 (95% UI 956 988 to 1 352 034) DALYs of total MSMI in 2021. From 1990, the case number and ASRs of incidences and prevalence showed decreasing trends, while the case number and ASRs of mortality and DALYs gradually increased with time, reaching the peak in 2001, and then declined. In 2021, the ASRs of incidence, prevalence, mortality and DALYs sharply increased with age, which reached the peak in the 20–24 age group. The ASRs were decreased with increasing sociodemographic index (SDI). In 2021, it showed a positive correlation between EAPC and ASR of DALYs (r=0.3398, p

Objective
Adolescence is a critical period characterised by significant biological growth and transformative changes in social relationships. No authoritative study has provided a comprehensive analysis of the global burden attributed to alcohol and drug use among adolescents and young adults.

Study design, participants and methods
Data on alcohol and drug use among people aged 10–24 years were extracted from the Global Burden of Disease Study 2019. We reported the trends of death and disability-adjusted life years (DALYs) at the global, regional and national levels. We explored the sex and sociodemographic index distribution of disease burden.

Primary outcome measures
DALYs and deaths.

Results
In 2019, the number of deaths attributed to alcohol use and drug use among people aged 10–24 years was 59 855 and 16 391, respectively. The numbers of DALYs attributed to alcohol use and drug use were 5.9 million and 4.1 million, respectively. From 1990–2019, the global DALYs rate caused by alcohol use exhibited a downward trend for both males and females. The DALYs rate attributed to drug use in females among people aged 10–24 years exhibited a downward trend, while the DALYs rate attributed to drug use in males among people aged 10–24 years exhibited an upward trend. Furthermore, the burden attributed to alcohol use and drug use was significantly higher in males than in females. Eastern Europe had the highest burden attributed to alcohol use, and High-income North America had the highest burden of drug use.

Conclusions
Alcohol and drug use remain an important risk factor that poses substantial challenges to adolescent health, particularly among males. Countries must develop effective health policies and implement targeted regulatory measures.

Introduction
The widespread use of digital devices in modern workplaces has led to a rise in visual health problems, such as myopia and dry eye syndrome, among the working-age population. This study aims to investigate the incidence of eye disorders, associated risk factors and relevant biomarkers in Shenzhen, addressing a crucial gap in the research on visual health in rapidly urbanising Chinese cities.

Methods
This prospective observational cohort study, conducted from September 2024 to December 2029, will recruit 3000 full-time employees aged 18–65 in Shenzhen through multistage sampling across five job sectors. Data collection will include questionnaire surveys, standardised scale assessments, ophthalmic examinations, ophthalmic imaging and biomarker testing. Annual follow-ups will track the incidence of high myopia and dry eye, as well as associated factors and biomarker changes. Data accuracy will be ensured through double entry and continuous quality control.

Ethics and dissemination
The study has been approved by the Ethics Committee of Shenzhen Eye Hospital (2024KYPJ012; 04 February 2024). The results will be presented at professional conferences and submitted for publication in peer-reviewed journals.

Trial registration number
National Health Information Platform (MR-44-24-026548).

Objective
To compare recovery after laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH).

Design
A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial.

Setting
10 NHS (National Health Service) hospitals within the UK.

Participants
Women undergoing hysterectomy for a benign gynaecological condition.

Interventions
Consenting women of 18–55 years were randomised to LH or AH using a secure internet facility by a surgeon with self-declared expertise. Major complications were recorded by clinicians, and recovery was assessed by regular text messaging and postal questionnaires.

Primary and secondary outcome measures
Major surgical complications (Clavien-Dindo≥level 3) up to six completed weeks postsurgery, time to resumption of normal activities measured by the Patient-Reported Outcomes Measurement Information System Physical Function tool and quality of recovery at 24 hours (Quality of Recovery 15 score; 0–150).

Results
75 women were randomised before early curtailment of the trial; 32/39 (82%) and 30/36 (83%) women underwent LH and AH, respectively. Major complications occurred in 2/32 (6%) LH versus 4/30 (13%) AH groups. No difference in time to resumption of usual activities was found (median [IQR, n] 7.5 weeks (3.6–8.2, 25) LH vs 7.5 weeks (5.5–10.6, 26) AH groups or quality of recovery (mean [SD, n] 81.1 (13.4, 27) vs 72.3 (17.6, 22), respectively; adjusted mean difference 7.2, 95% CI –3.2 to 17.6).

Conclusions
No differences were found in complications or recovery between LH and AH. However, early cessation of the trial due to recruitment challenges limits clinical inferences. It is important that larger comparative trials are conducted now that LH, including robotics, is becoming adopted as standard practice.

Trial registration number
ISRCTN14566195, IRAS ID 287988.

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
Uterine serous carcinoma (USC) accounts for 40% of endometrial cancer-related deaths. The standard of care for stages III and IV USC yields a 20%–30% survival at 2 years and a 10%–20% survival at 3–5 years. Recent advances in the second-line treatment of advanced or recurrent USC are rapidly evolving. Targeted therapeutic approaches with the use of lenvatinib plus pembrolizumab, as well as the use of trastuzumab deruxtecan, offer new hope for successful second-line therapies for patients. However, further investigation into novel targeted therapeutic approaches is warranted, given the high burden of disease associated with this aggressive histological subtype. USC shares clinical and genomic similarities with epithelial ovarian cancer, suggesting a correlation with ‘BRCAness’. Niraparib, a potent PARP1 and PARP2 inhibitor, was shown to have a positive impact on platinum-sensitive recurrent ovarian cancer, regardless of the presence or absence of BRCA status. Our hypothesis is that patients with stage III, stage IV and platinum-sensitive recurrent USC receiving niraparib maintenance in addition to standard therapy for USC may have an improved progression-free survival.

Methods and analysis
Participating sites include the primary site, Northwell Health Zucker Cancer Centre, and secondary site, Rutgers Cancer Institute of NJ. Females over the age of 18 with stage III, stage IV or platinum-sensitive recurrent USC will be recruited and enrolled based on inclusion/exclusion criteria. 24 subjects will be enrolled during phase 1 and 21 subjects will be enrolled during phase 2, over a total of 3 years. Patients will receive an individualised dose of niraparib daily every 28 days per cycle for 1 year or until progression of disease. Follow-up of disease status will continue for 5 years poststudy treatment. This phase II clinical trial will employ a Simon two-stage minimax design to test the null hypothesis that the 1 year response rate is

Objectives
To investigate the knowledge of stroke and the attitudes towards stroke and prehospital delay among patients who had an acute ischaemic stroke (AIS) and their family members.

Design
This cross-sectional study was conducted through a self-designed questionnaire.

Setting
The study took place in a Grade-A tertiary hospital in Zhejiang Province, China, between July 2023 and November 2023.

Participants
A total of 521 valid questionnaires were collected from 367 patients who had an AIS and 154 family members.

Interventions
Participants provided demographic information and answered questions related to stroke knowledge, attitudes towards stroke and prehospital delay.

Primary and secondary outcome measures
The primary outcome measures included scores on stroke knowledge, attitudes towards stroke and attitudes towards prehospital delay. Secondary outcomes focused on identifying correlations and independent factors influencing prehospital delay.

Results
The average scores for patients were stroke knowledge 8.74±6.16 (range: 0–24), stroke attitude 23.52±2.73 (range: 7–35) and prehospital delay attitude 38.65±7.68 (range: 10–50). Family members scored 12.66±6.85, 23.60±2.57 and 40.02±7.45, respectively. Significant correlations were found between stroke knowledge and attitude (r=0.2262, p