Risultati per: Standard di qualità sulla Fibrillazione Atriale

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

This randomized clinical trial compares the effectiveness and safety of a novel low-dose triple-pill protocol, compared with a standard-care protocol, for blood pressure lowering among Black African adults in Nigeria.

Introduction
Patients with advanced cancer frequently suffer from chronic, severe disabling pain. Opioids such as morphine and fentanyl are commonly used to manage this pain. Transdermal drug delivery systems are important technologies for administering drugs in a non-invasive, continuous and controlled manner. Due to the narrow therapeutic range of fentanyl, individualised dosing is essential to avoid underdosing or overdosing. Standard clinical calculation tools for opioid rotation however do not include important patient characteristics that account for interindividual variability of opioid pharmacology.

Methods and analysis
We developed a clinical protocol to optimise individual fentanyl dosing in patients with advanced cancer switching from oral or intravenous opioids to transdermal fentanyl by using a physics-based digital twin (DT) that is fed by important clinical and physiological parameters. Individual tailoring of transdermal fentanyl therapy is an approach with the potential for personalised and effective care with an improved benefit-risk ratio. However, clinical validation of physics-based digital twins (PBDT) dosing is crucial to proving clinical benefit.
Therapeutic drug monitoring will allow to validate the accuracy of PBDT predictions. Additional monitoring for breathing dynamics, sequential pain levels and fentanyl-related adverse events will contribute to evaluating the performance of PBDT-based dosing of transdermal fentanyl. The primary objective of the study is to develop an experimental protocol to validate DT-guided fentanyl dosing in patients with advanced cancer. This clinical study will bring individualised opioid dosing closer to clinical practice.

Ethics and dissemination
Study documents have been approved by the responsible Ethics Committee and study initiation is planned for late summer 2024. Data will be shared with the scientific community no more than 1 year following completion of the study and data assembly.

Introduction
Digital surgical wound monitoring for patients at home is becoming an increasingly common method of wound follow-up. This regular monitoring improves patient outcomes by detecting wound complications early and enabling treatment to start before complications worsen. However, reviewing the digital data creates a new and additional workload for staff. The aim of this study is to assess a surgical wound monitoring platform that uses artificial intelligence to assist clinicians to review patients’ wound images by prioritising concerning images for urgent review. This will manage staff time more effectively.

Methods and analysis
This is a feasibility study for a new artificial intelligence module with 120 cardiac surgery patients at two centres serving a range of patient ethnicities and urban, rural and coastal locations. Each patient will be randomly allocated using a 1:1 ratio with mixed block sizes to receive the platform with the new detection and prioritising module (for up to 30 days after surgery) plus standard postoperative wound care or standard postoperative wound care only. Assessment is through surveys, interviews, phone calls and platform review at 30 days and through medical notes review and patient phone calls at 60 days. Outcomes will assess safety, acceptability, feasibility and health economic endpoints. The decision to proceed to a definitive trial will be based on prespecified progression criteria.

Ethics and dissemination
Permission to conduct the study was granted by the North of Scotland Research Ethics Committee 1 (24/NS0005) and the MHRA (CI/2024/0004/GB). The results of this Wound Imaging Software Digital platfOrM (WISDOM) study will be reported in peer-reviewed open-access journals and shared with participants and stakeholders.

Trial registration numbers
ISRCTN16900119 and NCT06475703.

‘Uso corretto delle risorse non avviene in tutte le regioni’

Manca personale, problemi strutturali e tagli ai servizi

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Volume 177, Issue 9, Page 1209-1221, September 2024.

Introduction
The large reservoir of tuberculosis (TB) infections is one of the main reasons for the persistent incidence of TB. Accurate diagnostic tests are crucial to correctly identify and treat people with TB infection, which is vital to eliminate TB globally. The rdESAT-6 and rCFP-10 (Cy-Tb) injection (‘Cy-Tb’), a TB-specific antigen skin test and STANDARD F TB-Feron FIA (‘Standard F TB’) measuring interferon-gamma by fluorescence immunoassay assay are two novel tools for the diagnosis of TB infection which offer advantages compared with current tests in low-resource settings and reduced costs to both health systems and TB-affected people. The proposed study aims to evaluate the diagnostic accuracy of these two new tests for TB infection diagnosis.

Methods and analysis
This cross-sectional study aims to assess the diagnostic accuracy for TB infection of the Cy-Tb skin test and Standard F TB assay (investigational tests) compared with the QuantiFERON-TB Gold Plus (QFT-Plus) assay as the immunological reference standard. Three different cohorts of study participants will be recruited at the Vietnam National Lung Hospital: adults with bacteriologically confirmed pulmonary TB (n=100), household contacts of people with TB (n=200) and people without TB infection (n=50). All consenting participants will undergo simultaneous testing with Cy-Tb, Standard F TB and QFT-Plus. The primary endpoint is the diagnostic accuracy of the Cy-Tb skin test and Standard F TB assay, expressed as sensitivity and specificity against the reference standard.

Ethics and dissemination
Ethical approval was granted by the Vietnam National Lung Hospital Institutional Review Board (65/23/CN-HDDD-BVPTU) and the Swedish Ethical Review Authority (Dnr 2023-04271-01). Study results will be disseminated to the scientific community and policymakers through scientific publications.

Trial registration number
NCT06221735.

Introduction
Poverty, HIV and perinatal depression represent a triple threat to public health in sub-Saharan Africa because of their combined negative effects on parenting and child development. In the resource-constrained context of low-income and middle-income countries, a lay-counsellor-delivered intervention that combines a psychological and parenting intervention could offer the potential to mitigate the consequences of perinatal depression while also optimising scarce resources for healthcare.
Measuring the cost-effectiveness of such a novel intervention will help decision-makers to better understand the relative costs and effects associated with replicating the intervention, thereby supporting evidence-based decision-making. This protocol sets out the methodological framework for analysing the cost-effectiveness of a cluster randomised controlled trial (RCT) that compares a combined intervention to enhanced standard of care when treating depressed, HIV-positive pregnant women and their infants in rural South Africa.

Methods and analysis
This cost-effectiveness analysis (CEA) protocol complies with the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist. A societal perspective will be chosen.
The proposed methods will determine the cost and efficiency of implementing the intervention as per the randomised control trial protocol, as well as the cost of replicating the intervention in a non-research setting. The costs will be calculated using an appropriately adjusted version of the Standardised Early Childhood Development Costing Tool.
Primary health outcomes will be used in combination with costs to determine the cost per improvement in maternal perinatal depression at 12 months postnatal and the cost per improvement in child cognitive development at 24 months of age. To facilitate priority setting, the incremental cost-effectiveness ratios for improvements in child cognitive development will be ranked against six other child cognitive-development interventions according to Verguet et al’s methodology (2022).
A combination of activity-based and ingredient-based costing approaches will be used to identify, measure and value activities and inputs for all alternatives. Outcomes data will be sourced from the RCT team.

Ethics and dissemination
The University of Oxford is the sponsor of the CEA. Ethics approval has been obtained from the Human Sciences Research Council (HSRC, #REC 5/23/08/17), South Africa and the Oxford Tropical Research Ethics Committee (OxTREC #31–17), UK.
Consent for publication is not applicable since no participant data are used in this protocol.
We plan to disseminate the CEA results to key policymakers and researchers in the form of a policy brief, meetings and academic papers.

Trial registration details
ISRCTN registry #11 284 870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017).

This observational study assesses incidence of wound hematoma diagnoses up to 6 weeks post partum among obstetric patients who received thromboprophylaxis according to less selective vs more selective hospital chemoprophylaxis protocols.

Stroke, Ahead of Print. BACKGROUND:Visuospatial neglect is a common consequence of stroke and is characterized by impaired attention to contralesional space. Currently, the extent and time course of recovery from neglect are not clearly established. This systematic review and meta-analysis aimed to determine the recovery trajectory of poststroke neglect with standard treatment.METHODS:PsycInfo, Embase, and MEDLINE were searched for articles reporting recovery rates of neglect after stroke. Time since stroke was categorized into early (0–3 months), mid (3–6 months), and late ( >6 months) recovery phases. Random-effects models for pooled prevalence were generated for each phase, and potential sources of heterogeneity were explored with metaregressions. Methodological quality of each study was assessed using the Joanna Briggs Institute checklist, with low-quality studies excluded in sensitivity analyses.RESULTS:The search captured 4130 articles including duplicates, and 111 full-text reviews were undertaken. A total of 27 studies reporting data from 839 stroke survivors with neglect were included for review. Meta-analyses indicated a recovery rate of 42% in the early phase, which increased to 53% in the mid-recovery phase. Additional recovery in the late phase was minimal, with an estimated 56% recovery rate. Heterogeneity of studies was high (I2 >75%) in all 3 phases of recovery. Estimates were robust to sensitivity analyses. Metaregressions showed significantly greater recovery in studies that included patients with left-hemisphere lesions (β=0.275,P

Objective
The utilisation of pH level measurements from gastric contents may indicate the preferred tip position of a nasogastric tube or monitor the efficacy of stress ulcer prophylaxis in critically ill patients. We aimed to determine the accuracy of pH strip (pHS) tests and pH liquid (pHL) tests compared with the standard pH meter (pHM).

Design
Diagnostic accuracy study.

Setting
Gastric contents from medically critically ill patients.

Participants
In total, 113 gastric samples were collected from 27 critically ill patients.

Outcome measure
The level of pH measured by pHM, pHS and pHL.

Results
The pH values measured by pHM, pHS and pHL were 5.83 (IQR 5.12–6.61), 5.50 (IQR 5.00–6.00) and 5.75 (IQR 5.25–6.25), respectively. The pHS test showed greater accuracy, exhibiting a more positive correlation with the standard pHM measurement than the pHL test, with Y=0.95*X+0.56; rho=0.91, p