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

Una goccia di sangue, raccolta nelle prime 72 ore di vita, può fare la differenza tra una diagnosi precoce e un destino segnato. Lo screening neonatale esteso (Sne), reso obbligatorio…

When implemented in routine health systems at primary care level in India and Tanzania, contrary to expectations, pulse oximetry and CDSAs were not found to increase rates of hospitalisation within 24 h of primary care referral, nor to decrease deaths, or delayed or un-referred hospitalisations. Wider health system challenges, including referral barriers, inequitable oxygen access and hospital care quality must be addressed if the potential of these tools in delivering child outcome benefits is to be realised.

Background
Fathers are intricately bound to the experience of adolescent mothers and their children. Yet, fathers of children born to adolescent mothers, particularly within the context of HIV, remain neglected in the literature. These exploratory analyses provide insight into the characteristics of fathers of children born to adolescent mothers affected by HIV in South Africa.

Setting
Eastern Cape Province, South Africa.

Design
Cross-sectional data from a prospective cohort study.

Participants
Young mothers (10–24 years of age) and their children (0–68 months). All mothers completed detailed study questionnaires, including standardised and study-specific measures, relating to their self, their children and the fathers of their children. Summary statistics are presented based on maternal self-report of father characteristics. 2 tests and t-tests (Fisher’s exact/Kruskal-Wallis tests, where appropriate) were additionally used to explore sample characteristics (including father characteristics, maternal experience and child characteristics) according to paternal age and father involvement in childcare (defined by responses to four maternal self-report questions). Father characteristics were also explored according to maternal HIV status and maternal mental health status.

Results
40% of fathers were adolescents (10–19 years) at the birth of their children. Overall, father involvement was low (19.5%). Compared with noninvolved fathers, involved fathers were more likely to be older when their child was born (21 years vs 20 years, t=4.30, p=0.04), to be in a relationship with the mothers of their children (74.8% vs 47.2%, 2=40.8, p≤0.0001), to reside with their children and their mothers (14.7% vs 3.7%, 2=49.3, p≤0.0001) and to attend the first antenatal appointment (4.3% vs 1.5%, 2=5.21, p=0.02). A quarter (25.4%; 227/894) of the adolescent mothers in the sample were living with HIV. The prevalence of maternal HIV was found to be higher among adolescent mothers of children born to older fathers compared with adolescent fathers (31.7% vs 15.9%, 2=28.3, p≤0.001). Likewise, depressive symptoms were more prevalent among adolescent mothers of children born to older fathers compared with adolescent fathers (9.9% vs 5.3%, 2=6.08, p=0.01). Adolescent mothers reporting poor mental health were less likely to be in a relationship with the fathers of their children (41.8% vs 54.1%, 2=7.32, p=0.03) and more likely to experience domestic violence perpetrated by the fathers of their children (8.2% vs 3.3%, 2=6.07, p=0.01) and to engage in arguments about finances with the fathers of their children (30.0% vs 17.0%, 2=10.8, p=0.001). While some differences in individual subscales were identified, overall composite scores of child cognitive development did not differ according to father age or father involvement.

Conclusions
Analyses provide the first preliminary description of the fathers of children born to adolescent mothers affected by HIV in South Africa. Fathers are inherently tied to the experiences of adolescent mothers and their children. Father involvement with their children was low. Further research is required to explore the potential barriers to father involvement and pathways to overcome these. Efforts to bolster father engagement, such as the inclusion of fathers within maternal and child service provision, may have benefits for fathers, adolescent mothers and their children. There was a high prevalence of adolescent fatherhood in the study. Adolescent fathers may have specific needs requiring tailored intervention for adolescent parent families. The need for the inclusion of fathers within policy, programming and research remains.

Objectives
For several decades, mortality has decreased more rapidly among individuals with a higher socioeconomic position than among those with a lower position. This widening social inequality gap has increasingly been recognised as an important aspect of public health research and policies. The objective of this study was to examine trends in educational inequality in healthy life expectancy (HLE) in Denmark between 2010 and 2021 at the age of 30 years.

Design
The study is a population-based study based on register data on longest attained education, standard life tables and self-reported health information from nationwide health surveys.

Setting
The study is conducted among the general adult population in Denmark.

Participants
Participants include respondents from the Danish National Health Survey and the Danish Health and Morbidity Survey in 2010, 2013, 2017 and 2021 aged ≥30 years.

Primary and secondary outcome measures
Expected lifetime in good self-rated health, with no long-standing illness and with no activity limitations was estimated by Sullivan’s method, and educational inequality was expressed by the Slope Index of Inequality.

Results
Between 2010 and 2021, educational inequality in HLE increased among both men and women for long-standing illness (5-year trend: +1.1 and +1.2 years) and activity limitations (+2.4 and +2.6 years) but remained stable among men (+0.1 year) and decreased among women (–0.3 year) for self-rated health. For the latter two indicators, the inequality gap narrowed after 2017.

Conclusion
Trends in educational inequality in HLE in Denmark 2010–2021 vary by health indicator. Steadily widening gaps were demonstrated for long-standing illness, while narrowing gaps were seen after 2017 for activity limitations and self-rated health. Future studies are encouraged to explore potential health risk behaviours that may explain or modify these inequality trends.

Introduction
Cardiovascular disease (CVD) represents a public health burden, with high prevalence and significant morbidity and mortality. Although evidence-based interventions exist, there is a need for more individualised care. The European project Individualised care from early risk of cardiovascular disease to established heart failure (iCARE4CVD) aims to personalise CVD prevention and treatment. Participatory health research, which actively involves patients in the planning, implementation and evaluation of projects, plays a crucial role here. However, patient participation is often unsuccessful due to the lack of a representative patient sample who is involved throughout the project’s duration, has knowledge of the project and can contribute their experience.

Methods and analysis
Participative Research for Individualised Care in Cardiovascular Diseases is a non-interventional, non-randomised, multicentre mixed-methods study. The aim is to incorporate patients’ insights into several key activities within iCARE4CVD by establishing country-specific patient panels in Belgium, Germany, Ireland and the UK. The primary objective is to identify patients’ preferences, experiences, requirements and needs for better diagnosis, treatment and self-care of CVD. Therefore, 10–12 patients across the CVD spectrum, from early risk to established CVD and heart failure, will be included in each country (40–48 in total). Over 3.5 years, patient panel members are required to complete four tasks: (1) identification of meaningful Patient-Reported Outcome and Experiences Measures, (2) development of a motivational model to increase adherence, (3) feedback on CVD care processes and (4) usability testing of new digital tools developed within iCARE4CVD. These tasks comprise eight activities in the form of paper-based or digital exercises, telephone surveys, written surveys and in-person focus groups. The results will be continuously incorporated into iCARE4CVD.

Ethics and dissemination
This study received ethical approval by the Ethics Committee at the Faculty of Medicine of RWTH Aachen University (EK 24-172) and St. Vincent’s University Hospital (RS24-027), Research Ethics Committee. In Geel and Belfast, positive ethics approval is pending. All participants will provide written informed consent prior to enrolment in the study and participation in the first patient panel task. Results will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number
DRKS00034899.

Protocol version
V2.1, 6 June 2024.

Stroke, Ahead of Print. BACKGROUND:Intravenous antihypertensives are frequently used to control blood pressure after successful endovascular thrombectomy (EVT), yet studies investigating the relationship between intravenous antihypertensive use and functional outcomes after successful EVT remain limited.METHODS:We conducted an exploratory secondary analysis of the OPTIMAL-BP trial (Outcome in Patients Treated With Intra-Arterial Thrombectomy–Optimal Blood Pressure Control), which compared intensive (systolic blood pressure

The US Food and Drug Administration (FDA) recently accepted a new drug application for oral semaglutide. If approved, it would be the first oral glucagon-like peptide-1 (GLP-1) receptor agonist authorized for long-term weight management. The 25-mg semaglutide pill would be marketed as Wegovy, the same name used for Novo Nordisk’s FDA-approved 2.4-mg semaglutide injection.

Introduction
Sleep disturbance is prevalent in pregnancy and can result in significant adverse outcomes for women and their infants. Numerous clinical trials of various nonpharmacotherapies for preventing or treating sleep disturbances have been conducted previously; however, previous systematic reviews with direct comparisons have failed to demonstrate the best options for different kinds of treatments. This systematic review and network meta-analysis (NMA) aims to explore the comparative efficacy and acceptability of nonpharmacological interventions for sleep disturbances in pregnancy and to assist clinical decision-making through ranking interventions concerning critical clinical outcomes.

Methods and analysis
We will follow the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. Two reviewers will systematically search five major bibliographic databases (PubMed, Embase, Cochrane Library, Web of Science and Cumulative Index to Nursing and Allied Health Literature) and registries for published and unpublished randomised controlled trials (RCTs) of any nonpharmacological interventions for sleep disturbances from inception to 24 June 2025. To ensure the search is up to date, we will also perform an updated search up to the time of final analysis submission. Primary outcomes will consider efficacy (the overall mean change of any predefined sleep disturbances, including sleep quality, sleep duration and sleep-specific symptoms) and acceptability (all-cause discontinuation). The risk of bias of each included RCT will be assessed using the Cochrane Risk of Bias 2.0 Tool (RoB2). Traditional pairwise meta-analyses and NMAs will be performed to compare the efficacy and acceptability of different nonpharmacological interventions. Surface under the cumulative ranking curve for the outcomes of interest will be used to rank the competing interventions. The Grading of Recommendations, Assessment, Development and Evaluation system will be used to assess the quality of evidence associated with the main results.

Ethics and dissemination
This review is a secondary analysis of published data and, therefore, does not require ethical approval. The results will be disseminated in a peer-reviewed journal.

PROSPERO registration number
CRD42024546340.

Introduction
Aggressive natural killer cell leukaemia (ANKL) is a rare form of NK cell lymphoma with a very low incidence and poor prognosis. While multi-agent chemotherapy including L-asparaginase has been used to treat ANKL patients, they often cannot receive adequate chemotherapy at diagnosis due to liver dysfunction. PPMX-T003, a fully human monoclonal antibody targeting the transferrin receptor 1, shows promise in treating ANKL by helping patients recover from fulminant clinical conditions, potentially enabling a transition to chemotherapy. This study aimed to evaluate the tolerability, safety, efficacy, and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with ANKL.

Methods and analysis
This multicentre, open-label, dose-escalation phase I/II study will be conducted at nine hospitals in Japan. Patients diagnosed with ANKL (whether as a primary or recurrent disease) and exhibiting abnormal liver function or hepatomegaly due to the primary disease will be included. The primary endpoint is the tolerability and safety of repeated continuous intravenous administration of PPMX-T003 in the first course, based on adverse events and dose-limiting toxicities. PPMX-T003 will be administered as a continuous intravenous infusion every 24 hours for five consecutive days, followed by a 2-day break. Pretreatment will be provided to minimise the risk of infusion-related reactions. Initial doses of PPMX-T003 will be 0.5, 1.0 or 2.0 mg/kg, with subsequent dose increases determined by the Data and Safety Monitoring Committee. The sample size is set at seven participants, with enrolment increased to up to 12 participants if dose-limiting toxicities occur, based on feasibility due to the rarity of ANKL. Descriptive statistics will summarise data according to initial dose, and pharmacokinetic analysis will be conducted based on administered dose.

Ethics and dissemination
This study was approved by the institutional review boards at participating hospitals. The results will be disseminated in peer-reviewed journals.

Trial registration number
jRCT2061230008 (jRCT); NCT05863234 (ClinicalTrials.gov).

Introduction
Breast cancer survival rates in low-income and middle-income countries significantly differ from those in high-income countries, indicating limited access to first-line systemic therapy for advanced and metastatic tumours. Recent studies have demonstrated the benefits of combining cyclin-dependent kinase 4 and 6 inhibitors (CDK 4/6) with endocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. However, in Brazil, the population faces limited access to these drugs, particularly in the public healthcare system.

Methods and analysis
This prospective observational study will enrol 300 female patients from 20 cancer centres across Brazil, divided into two groups based on healthcare coverage: those treated in the public healthcare system (group 1) and those treated in the private healthcare system (group 2). The use or non-use of CDK 4/6 inhibitors is not dictated by the study protocol but rather reflects real-world treatment decisions made by attending physicians. Patients will be followed for 24 months, stratified according to CDK 4/6 inhibitor usage. The project aims to assess health inequities by evaluating the prognosis of patients treated in the public versus private healthcare systems. Outcomes include progression-free survival (PFS), overall survival (OS), quality of life and cost-effectiveness. Kaplan-Meier curves will be used to analyse PFS and OS, while the Cox proportional hazards frailty model will be employed to compare outcomes between healthcare systems, adjusting for prognostic variables.

Ethics and dissemination
The study protocol was approved by the Ethics Committee of the HCor Research Institute (Hospital do Coracão/Associacão Beneficente Síria), which served as the central ethics board for the trial (study number: CAAE 42538621.5.1001.0060; approval letter number: 4.571.507; date: 3 March 2021). All participating centres also obtained approval from their respective local ethics committees prior to patient enrolment: Ethics Committee of Hospital de Câncer de Barretos—Fundacão Pio XII; Ethics Committee of Universidade Estadual de Campinas—UNICAMP; Ethics Committee of Faculdade de Minas Muriaé—FAMINAS; Ethics Committee of Hospital Santa Paula—SP; Ethics Committee of Hospital Alemão Oswaldo Cruz—SP; Ethics Committee of Hospital Regional do Câncer de Presidente Prudente—HRCPP; Ethics Committee of Instituto Brasileiro de Controle do Câncer—IBCC/Oncologia Clínica—SP; Ethics Committee of Instituto de Medicina Integral Prof. Fernando Figueira—IMIP/PE; Ethics Committee of Hospital São Rafael; Ethics Committee of Universidade Federal de São Paulo—UNIFESP; Ethics Committee of Hospital Geral de Fortaleza—HGF; Ethics Committee of Casa de Saúde Santa Marcelina; Ethics Committee of Centro Universitário FMABC; Ethics Committee of Liga Norte Riograndense Contra o Câncer; Ethics Committee of Hospital Mãe de Deus/Associacão Educadora São Carlos—AESC; and Ethics Committee of Instituto do Câncer Brasil—ICB. All patients will provide written informed consent. Study findings will be disseminated through scientific publications and presented to a broad range of stakeholders, including patients, physicians, the general public and policymakers.

Trial registration number
ClinicalTrials.gov identifier: NCT05559528—BRaziLian outcomE for metAStatic breasT cancer (BREAST).

La raccolta dei dati sanitari non è più solo ricavata da un esame o dal risultato di un’analisi. Ora arriva direttamente dall’interno del nostro corpo e promette una rivoluzione per…

Introduction
Direct oral anticoagulants (DOACs) are preferred over vitamin K antagonists for stroke prophylaxis in non-valvular atrial fibrillation. Yet, DOAC use is regarded as a contraindication for intravenous thrombolysis in acute ischaemic stroke. The stratification of patients into ‘on-therapy’ and ‘off-therapy’ categories based on their plasma DOAC concentrations is particularly crucial in the acute phase of stroke when decisions for thrombolysis or anticoagulation reversal are time-sensitive. The novel point-of-care DOAC dipstick assay (DOASENSE) rapidly assesses urine for clinically significant DOAC levels, potentially broadening eligibility for thrombolysis or targeted reversal therapy. This multicentre prospective observational registry study aims to evaluate the accuracy and clinical utility of DOAC dipstick testing compared with plasma DOAC assays in acute stroke management across regional Australian hospitals.

Methods and analysis
This multicentre, prospective, observational study will enrol participants presenting to hospitals across Victoria and Tasmania with acute ischaemic stroke or intracerebral haemorrhage with DOAC ingestion within 48 hours of presentation. Plasma DOAC concentrations measured by chromogenic assays will be compared with rapid urine dipstick results from DOASENSE testing. There is a target sample size of 146 participants. The primary outcomes are as follows: (1) proportion of ischaemic stroke participants with off-therapy plasma DOAC levels and (2) eligibility for reperfusion therapy based on DOASENSE and plasma DOAC concentrations. Secondary outcomes are follows: (1) ischaemic stroke aetiology for participants with on-therapy vs off-therapy DOAC levels; (2) proportion of participants meeting criteria for pharmacological DOAC reversal based on DOASENSE outcomes; (3) incidence of false-negative and false positive DOASENSE results in clinically significant DOAC plasma concentrations at a threshold of ≥30 ng/mL and (4) an exploratory analysis of any false negative DOASENSE assays to identify potential contributing factors.

Ethics and dissemination
Ethics approval has been granted by the Eastern Health Human Research Ethics Committee (reference number: 99628). Dissemination of findings will occur through peer-reviewed publications and academic conferences.

Introduction
Though prior trials have shown the effectiveness of community-based hypertension detection and care delivery models, their adoption and translation to practice has been slow. In this study, we will develop and test strategies for the implementation and scale-up of a proven multicomponent hypertension intervention (MCHI) in Pakistan that comprises health education, blood pressure (BP) monitoring and referrals by lady health workers (LHWs) and hypertension management by physicians in primary care settings.

Methods and analysis
In this 24-month hybrid type III implementation-effectiveness cluster-randomised controlled trial, we will recruit 3000 adult hypertensive patients from two rural districts of Pakistan. We will engage public health sector managers, physicians and LHWs and use the Consolidated Framework for Implementation Research to identify barriers and facilitators to the implementation of an already proven-to-be-effective MCHI. Using Expert Recommendations for Implementing Change and the modified Delphi technique, a set of implementation strategies addressing barriers will be identified. The strategies will be categorised as level 1 (requiring a change in processes), level 2 (requiring a change in infrastructure) and level 3 (financial restructuring). Basic health units and 250–300 households from their catchment will be considered as clusters. Clusters will be randomised in a ratio of 1:1 to intervention and control. While MCHI will be offered in both trial arms (intervention and control), the aforementioned implementation strategies will be randomised to the intervention arm only, starting with level 1 and moving to levels 2 and 3 as needed. Baseline and 6-monthly follow-up surveys, each of 6 months duration, will be conducted to collect data from the recruited participants on sociodemographics, cardiovascular disease (CVD) risk factors, CVD-related expenses and quality of life. The primary outcome will be the mean difference in BP-lowering medications per participant between the intervention and control arms. The primary outcome will be analysed using a linear mixed model with fixed effects for baseline value of the outcome. Additional outcomes include implementation outcomes: proportion of LHWs conducting health education, BP screening and monitoring, facility referrals and proportion of physicians diagnosing and treating hypertensive patients; effectiveness outcomes: proportion of participants with controlled BP and improved EQ-5D-5L score.

Ethics and dissemination
Ethical approval has been obtained from the Ethics Review Committee of Aga Khan University Pakistan (ERC # 2023-9084-26739). Findings will be reported to: (1) study participants; (2) funding body and institutes collaborating and supporting the study; (3) provincial and district health departments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications

Trial registration number
NCT06726057.

Introduction
Maternal and child malnutrition is a significant public health concern in Pakistan, with 40% of children under five being stunted. In response, the Government of Pakistan initiated the Benazir Nashonuma Programme (BNP), a nutritional supplementation programme for pregnant women, mothers of children aged 0 to 23 months and children aged 6 to 24 months. This study aims to evaluate the effectiveness of the BNP in reducing childhood stunting and improving maternal and child health outcomes.

Methods and analysis
A quasi-experimental longitudinal study comprising baseline, midline and endline surveys will be conducted across 18 districts (9 intervention and 9 control) in Pakistan. The surveys will use a two-stage cluster sampling method to enrol 13 200 children aged 0–59 months and their mothers from the Benazir Income Support Programme households. The primary outcome of interest is the prevalence of under-five stunting. We will use a difference-in-differences approach to estimate the impact by comparing the documented changes over time between the intervention and control groups.

Ethics and dissemination
This study will provide critical insights into the effectiveness of the BNP in addressing childhood undernutrition in Pakistan. The findings will inform policy and programmatic decisions aimed at reducing undernutrition in resource-constrained settings. Ethical approval has been obtained from the Ethics Review Committee of Aga Khan University and the Pakistan National Bioethics Committee.

Trial registration number
NCT06025786.