Search Results for: Standard di qualità sulla Fibrillazione Atriale

Introduction
People living with HIV/AIDS (PLWHA) have complex physical, psychological, social and spiritual needs following diagnosis and poorer health-related quality of life than the general population. Holistic assessment and care delivery incorporating person-centred principles is required to address these needs. This protocol describes a cluster randomised controlled trial (cRCT) and process evaluation to evaluate the effectiveness of the extra community-based enhanced care intervention (ExtraCECI) to improve the quality of life and person-centred outcomes for PLWHA in Ghana.

Methods and analysis
This cRCT will randomly assign 26 recruited HIV clinics using 1:1 allocation to either ExtraCECI intervention or standard HIV care, with each clinic recruiting an average of 25 participants, that is, 650 in total. Eligible participants are adult PLWHA aged at least 18 years and in HIV care for at least 6 months, with cognitive ability to consent as guided by the Mental Capacity Act, clinically well to participate, attending an outpatient clinic. Healthcare professionals (HCP) at clinics randomised to the ExtraCECI intervention arm will receive training on person-centred care and holistic assessment of PLWHA in the domains of physical, psychological, social and spiritual well-being. PLWHA will be empowered to contribute to their care decisions including HCP using telehealth for ExtraCECI delivery with ongoing mentorship, while participants in the Standard HIV Care arm continue with usual care. The primary outcome is quality of life measured at the individual level using Medical Outcomes Study-HIV (MOS-HIV). The primary analysis will compare MOS-HIV total scores between groups using repeated measure linear mixed model and adjusting for important baseline characteristics (including stratification factors) and random effect of clinic. The incremental cost-effectiveness ratio will be used to estimate the cost-effectiveness of the ExtraCECI intervention, and a process evaluation will be conducted.

Ethics and dissemination
This protocol was approved by Edinburgh Napier University School of Health and Social Care Research Integrity Committee (REF: SHSC3681836) and the Ghana Health Service Ethics Review Committee (GHS-ERC:010/07/24). Results from this study whether positive or negative will be presented to participating sites, communities, at scientific conferences and published in peer-reviewed journals.

Trial registration number
ISRCTN77405303.

Per numero e qualità, secondo report pubblicato da Ministero

Obiettivo aumentare qualità vita pazienti e delle loro famiglie

Objective
To assess the effectiveness of random capillary blood glucose as a diagnostic tool for type 2 diabetes and determine optimal cut-off values for adults in Bangladesh.

Design
Cross-sectional diagnostic accuracy study.

Setting
16 diabetes centres were selected randomly from all eight administrative divisions of Bangladesh.

Participants
A total of 3200 adults aged 18 years and older were recruited using systematic random sampling between May and September 2022.

Primary and secondary outcome measures
The primary outcome was the diagnostic accuracy of random capillary blood glucose compared to fasting plasma glucose, 2-hour plasma glucose after a 75-gram glucose load and glycated haemoglobin. Secondary outcomes included sensitivity, specificity, area under the curve and agreement with the other diagnostic tests.

Results
Random capillary blood glucose showed a strong positive correlation and high concordance with fasting plasma glucose, 2-hour plasma glucose and glycated haemoglobin. A cut-off value of ≥8.7 mmol/L demonstrated improved diagnostic performance compared with the currently used cut-off of ≥11.1 mmol/L. This new threshold yielded higher sensitivity, specificity, area under the curve and agreement with other standard diagnostic tests. Notably, hyperglycaemic symptoms were not required for diagnosis. The number needed to screen to identify one case of type 2 diabetes using the ≥8.7 mmol/L cut-off was 2.74, lower than that for fasting plasma glucose (2.86) and random capillary blood glucose ≥11.1 mmol/L (4.68).

Conclusions
Random capillary blood glucose may be an effective and affordable diagnostic tool for type 2 diabetes in resource-limited settings. The proposed cut-off of ≥8.7 mmol/L offers improved diagnostic accuracy and reflects the population’s glucose distribution pattern.

Introduction
Mental health is a fundamental component of overall well-being, underpinning our ability to make both individual and collective decisions. In Mozambique, estimates suggest that a significant number of Mozambicans suffer from common mental disorders such as depression and anxiety, yet the majority go undiagnosed and untreated. In recognition of this burden, the Mozambican Ministry of Health had approved the country’s first Mental Health Strategy and Action Plan in 2007, alongside the National Health Policy Mental Health Guidelines (2006–2015). However, the implementation of this plan and strategy has been challenged by a severely limited mental health workforce and fragile infrastructure. Despite these challenges, recent years have seen some progress, including multisite studies and international collaborations aiming to understand the burden of disease and improve services. Yet, the mental health literature in Mozambique remains fragmented, with significant gaps regarding specific population groups, barriers to care and the effectiveness of interventions. This fragmentation highlights the need for a comprehensive scoping review to map the current state of mental health research in the country and to guide future studies, policy development and clinical practice.

Methods and analysis
This scoping review aims to map the existing scientific literature on mental health in Mozambique over the past 15 years, focusing on study types, target populations, methodological approaches and key findings. Employing a two-stage screening process and both quantitative and a thematic synthesis approach, the review will analyse studies meeting predefined eligibility criteria. A rigorous search strategy will be implemented across identified electronic databases and grey literature sources, including published studies from 2009 to the present. Data will be charted using a standardised form, and information regarding study characteristics, scope of the research, population involved, geographic distribution and reported outcomes/findings will be collected. This scoping review will follow a standard protocol adhering to the methodological framework outlined by Arksey and O’Malley (2005).

Ethics and dissemination
Ethical considerations involve respecting original authors, maintaining integrity and transparency, managing data ethically and disclosing conflicts of interest. Dissemination will occur through publication in peer-reviewed journals, conference presentations, open-access repositories, policy briefs, stakeholder engagement activities and social media platforms.

Registration details
Open Science Framework DOI 10.17605/OSF.IO/8R2P7.

Objectives
Hearing loss (HL) affects 20% of the world’s population, with shortages of audiologists and audiometric sound booths unable to meet demand for hearing care services. We aimed to assess the accuracy of tablet-based audiometry (TA) to screen for HL at standard (0.25–8 kHz) and extended high frequencies ( >8 kHz).

Design
Diagnostic accuracy study.

Setting
Two secondary care audiology and ear, nose and throat outpatient clinics in the UK between April 2022 and September 2023.

Participants
Adults aged≥16 years undergoing sound booth audiometry (SBA).

Interventions
TA, hearing-related questionnaires and patient usability questionnaires.

Outcome measures
Sensitivity, specificity and accuracy of TA compared with SBA for detecting HL. Patient usability assessment of TA and SBA.

Results
129 patients were enrolled with 127 patients (254 ears) included in the final analysis. Median age was 43 years (IQR 33–56), 55% (70/127) were women. 76% (96/127) and 68% (86/127) of patients had HL defined by British Society of Audiology (BSA) and American Speech–Language–Hearing Association (ASHA) criteria. Age was significantly associated with HL (p85%, respectively, between 0.25 and 12.5 kHz. In terms of patient usability, TA showed significantly higher scores in attractiveness (p

Introduction
With the inspiring results of the PACIFIC trial in non-small-cell lung cancer (NSCLC), and the CAPIAN and IMpower133 trials in extensive-stage small-cell lung cancer (SCLC), immunotherapy has increasingly gained attention. Serplulimab, a PD-1 inhibitor, showed great antitumour activity in the ASTRUM-005 trial and has been recommended as first-line therapy in extensive-stage SCLC. Whether serplulimab following hypofractionation radiotherapy and chemotherapy could bring better outcomes in limited-stage SCLC remains to be answered.

Methods and analysis
We designed a prospective multicentre single-arm phase II clinical trial to evaluate both the efficacy and safety of chemoradiotherapy and consolidation by serplulimab in limited-stage SCLC. Eligible patients will receive standard chemotherapy for four cycles and concurrent thoracic radiotherapy with a total dose of 45 Gy in 3 weeks and a 3 Gy dose per fraction. Prophylactic cranial irradiation is recommended for responding patients. Serplulimab will be delivered afterwards every 3 weeks for up to 1 year. Based on sample size estimation, 55 patients will be enrolled in total.

Ethics and dissemination
Ethics approval was obtained from the Independent Ethics Committee of National Cancer Centre/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (22/236-3438).

Trial registration number
NCT05443646.

Objectives
This study evaluates the diagnostic value of the BNLF2b antibody, dual antibody testing and Epstein-Barr virus DNA (EBV-DNA) individually and in combination for nasopharyngeal carcinoma (NPC) detection.

Design
A prospective cohort study.

Setting
The study was conducted at Hunan Cancer Hospital, in a region in China with a high incidence of NPC, between January 2024 and June 2024.

Participants
A total of 350 patients with suspected NPC were enrolled based on clinical suspicion (eg, metastatic cervical lymph nodes or nasopharyngeal abnormalities with non-specific symptoms). The inclusion criteria included age ≥18 years, residency in Hunan Province, and provision of informed consent. The exclusion criteria included prior history of NPC or other head and neck malignancies, severe immunological/systemic diseases and inability to complete diagnostic evaluations.

Primary and secondary outcome measures
Demographic, clinical and biomarker data were collected, including BNLF2b antibody, EBV-DNA and dual antibody testing. Diagnostic performance metrics were calculated against histopathological confirmation as the gold standard. Follow-up assessments were conducted for non-NPC cases.

Results
Among 350 suspected NPC participants, 74 were diagnosed with NPC through biopsy. BNLF2b antibody exhibited the highest sensitivity (83.78%) and specificity (95.65%) among single biomarkers in NPC diagnosis, outperforming dual-antibody testing and EBV-DNA. Combining BNLF2b with dual-antibody testing improved specificity to 99.64%, although with reduced sensitivity (67.57%). NPC-diagnosed participants and those testing positive for BNLF2b or dual antibody biomarkers had a significantly higher prevalence of family history of NPC (p

Introduction
Postoperative pain management is a major concern for patients undergoing distal radius open reduction internal fixation (ORIF). Inadequate pain control negatively impacts patient’s satisfaction and may increase opioid use. Topical tranexamic acid (TXA) has been demonstrated as an effective intervention that reduced acute postoperative pain in total knee arthroplasty. There is no study evaluating the effects of TXA on acute postoperative pain for distal radius ORIF. This study aims to evaluate the effect of topical TXA administration during isolated distal radius ORIF on early postoperative pain.

Methods and analysis
The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation (TRADR) study is a randomised controlled double-blinded trial that will enrol 90 patients, 18 years of age or older, undergoing volar open reduction internal fixation. Patients will be randomly assigned to topical TXA versus topical saline (placebo) in a 1:1 ratio. The surgeon at the time of surgical closure after standard distal radius fixation will apply either 1 g of topical TXA (100 mg/mL; treatment group) or 10 mL of saline (control group) to the wound and let it sit for 5 min. Surgeons, patients, and outcome assessors will be blinded to the treatment group. The primary outcome is acute postsurgical pain as measured by the visual analogue scale (VAS). Pain outcomes will be between postoperative days 0 to 7, and at 2 and 6 weeks postsurgery. The secondary outcomes include opioid usage, unscheduled emergency visits, wrist swelling and adverse events.

Ethics and dissemination
This study was approved by the University Health Network Research Ethics Board (REB 23–5708). The results of this trial will be disseminated through peer-reviewed journals and presented at related conferences. The principal investigator will communicate the results with patients who have indicated an interest in knowing the results.

Trial registration number
Clinicaltrials.gov NCT06384456, April 26, 2024; Pre-enrolment.

Protocol version
Version 2.0: August 26, 2024.

Introduction
Intensive care units (ICUs) manage patients with or likely to have one or more life-threatening acute organ failures that might require the use of invasive supportive therapies. The use of physical restraint is frequent, with rates up to 50%, and usually initiated to maintain patient safety especially if the patient is agitated. Physical restraints have been associated with delirium, post-traumatic stress disorder and physical injuries while restricting patients’ individual freedom. Moreover, the incidence of invasive therapeutic devices’ self-removal by patients might not be decreased by physical restraint use. No recommendation is available concerning ICU patients and physical restraint management, despite being a daily practice. The main objective is to evaluate whether a strategy aimed at decreasing physical restraint use in ICU patients with that of a strategy based on routine and subjective caregivers’ decision is safe and efficient.

Methods and analysis
ARBORea is a multicentre randomised, stepped-wedge trial testing an innovative, dedicated web-based, multiprofessionally developed, experts validated, nursing management strategy in comparison with standard care. The primary outcome is physical restraint use rate (effectiveness) measured at least every 8 hours and incidents’ rate (tolerance) defined as the rate of incidents attributable to non-compliance, corresponding to the deterioration or self-removal of critical devices, a fall or self-aggressive or heteroaggressive behaviours. Planned enrolment is 4000 ICU adult participants at 20 French academic and non-academic centres. Safety and long-term outcomes will be evaluated.

Ethics and dissemination
Trial results will be reported according to the Consolidated Standards of Reporting Trials 2010 guidelines. Findings will be published in peer-reviewed journals and presented at local, national and international meetings and conferences to publicise and explain the research to clinicians, commissioners and service users. The trial is funded by the French Ministry of Health and has been approved by the French local ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 2, Toulouse, France with registration number: 2020-A02904-35).

Trial registration number
(ClinicalTrials.gov) NCT04957238 on 12 July 2021 before first inclusion in study.

To the Editor Given its diminishing role as a diagnostic tool to differentiate between bacterial and nonbacterial infections, PCT is increasingly being investigated for its ability to reduce the duration of antibiotic therapy. The current study by the ADAPT-Sepsis Collaborators reported a mean reduction of 0.88 days in the daily PCT-guided protocol compared with a mean duration of 10.7 (SD, 7.6) days in the standard care group—a relative reduction of 8.2%.

In Reply We designed the ADAPT-Sepsis trial as a superiority study, addressing a prioritized research funding brief and international evidence gaps. Our sample size estimate, type I error rate, and power were largely driven by a clinical effectiveness outcome (total antibiotic treatment duration to 28 days after randomization) and not safety (28-day all-cause mortality). The resulting sample size estimate allowed us to measure safety with a noninferior 28-day all-cause mortality margin of 5.4%, the narrowest reported to date, as indicated by Dr Bosch and colleagues. We primarily reported trial safety for a reduction in total antibiotic duration for the PCT group compared with standard care using this approach. The 95% CI for the difference in 28-day mortality did not exceed 5.4% and crossed 0. Therefore, we have shown that PCT is not worse than standard care and that there is no difference between PCT and standard care. Furthermore, there were no differences in the survival curves to day 28 (Figure 2B in our article) or day 90 (eFigure 7 in the article’s Supplement 3). Unlike Bosch and colleagues, we do not believe that implementing daily PCT monitoring will result in excess mortality given the totality of our reported trial data and the body of open-label trial evidence. However, given our concealed trial intervention methods, we suggest that future systematic open implementation of our PCT protocol should be informed by evidence (inducing adherence data) to be presented from an in-trial process evaluation.

To the Editor We are writing to express some concerns about a recent trial of PCT-guided care compared with standard care to guide duration of antibiotics in hospitalized patients.

To the Editor The Biomarker-Guided Duration of Antibiotic Treatment in Hospitalised Patients With Suspected Sepsis (ADAPT-Sepsis) trial, which compared biomarker-guided antibiotic duration vs standard care in critically ill patients with sepsis, found that a procalcitonin (PCT) protocol decreased antibiotic duration (mean difference, 0.88 days; 95% CI, 0.19 to 1.58) but increased mortality (absolute difference, 1.57; 95% CI, −2.18 to 5.32). The authors, likely relying on the 95% CI for mortality being less than their 5.4% noninferiority margin, concluded, “Care guided by measurement of PCT reduces antibiotic duration safely compared with standard care.”

To the Editor Although the ADAPT-Sepsis multicenter randomized clinical trial found that care guided by PCT measurement safely reduced antibiotic duration compared with standard care, several important considerations warrant further discussion.

Introduction
Recently, immunotherapy has significantly transformed the treatment landscape of endometrial cancer (EC). Results from KEYNOTE-158, RUBY and AtTEnd showed programmed cell death 1 (PD-1) or programmed cell death-ligand 1 inhibitors with promising efficacy in primary advanced or recurrent EC. However, few studies focused on the role of dual immune checkpoints in primary advanced or recurrent EC. Cadonilimab is an immune checkpoint inhibitor targeting the PD-1 and T-lymphocyte antigen-4, which is expected to show substantial clinical efficacy in EC. Combining cadonilimab with standard chemotherapy may have synergistic effects, making this combination a promising first-line treatment for primary advanced or recurrent EC. Furthermore, incorporating molecular classification for guidance on the use of cadonilimab may hold valuable clinical benefits.

Methods and analysis
In this multicentre, open-label, phase II study, patients with histologically confirmed EC were eligible. Forty-five patients will be recruited. Seventeen patients will be enrolled in stage I, and at least seven cases of complete response (CR) and partial response (PR) should be observed before entering stage II. All patients will receive cadonilimab at a dosage of 10 mg/kg along with carboplatin (area under the curve (AUC)=4–5) plus paclitaxel (175 mg/m2) every 3 weeks (Q3W) for 6–8 cycles. Subsequently, patients with CR, PR or stable disease will receive maintenance of cadonilimab at 10 mg/kg Q3W for 24 months or until progressive disease or adverse events are reported. The objective response rate is the primary endpoint. The secondary endpoints include the disease control rate, duration of response, progression-free survival, overall survival and safety. Additionally, exploratory endpoints involve biomarkers that may predict the efficacy of cadonilimab and chemotherapy, as well as their relationship with molecular classifications. The interim analysis will be conducted after 17 patients have been enrolled.

Ethics and dissemination
The study protocol meets the approval of the ethical committee of Fujian Cancer Hospital (K2023-173-04) and all other participating hospitals. Study findings will be disseminated in peer-reviewed publications.

Trial registration number
NCT06066216.