Search Results for: Passo 12. Ripulire in modo mirato le cartelle cliniche degli assisiti

Passo verso normalità, ma terapie long acting poco diffuse

Introduction
Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers.

Methods and analysis
REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients’ disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient’s exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver’s HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators’ experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked.

Ethics and dissemination
The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers.

Trial registration number
ISRCTN47894539.

Introduction
Olfactory dysfunction (OD) following COVID-19 affected up to 70% of patients, with more than 30% still reporting lingering symptoms a year later. Treatment is essential, as previous research has linked (postviral) OD to depression, impaired quality of life (QoL) and even heightened mortality rates.

Methods and analysis
We designed a monocentric, single-blinded randomised controlled trial evaluating the efficacy of olfactory training (OT) in individuals with persisting COVID-19-associated loss of smell. Randomisation will be done in a 1:1 manner. OT will be performed using the Sniffin’ Sticks Duft Quartett over a period of 12 weeks, two times per day. The primary endpoint of this study is the change in olfactory score between baseline and after 12 weeks, measured by the combined score of the identification and discrimination subscales of the Sniffin’ Sticks testing battery. QoL, overall health, mood, personal well-being and symptom severity will be assessed at baseline and during a follow-up visit, using multiple validated questionnaires and scales. OT is offered to the second cohort during an open-label phase extension. This manuscript highlights and discusses the study protocol.

Ethics and dissemination
Ethical approval for the study was obtained from the Ethics Commission of the Medical University of Innsbruck, Austria. Results of this study will be shared through conferences and publications in peer-reviewed journals.

Trial registration number
NCT05421221.

Introduction
Amyotrophic lateral sclerosis (ALS) is a devastating illness that leads to muscle weakness and death usually within around 3 years of diagnosis. People with ALS (pwALS) often lose weight due to raised energy requirements and symptoms of the disease presenting significant challenges to taking adequate oral diet, with those who lose more weight being at a greater chance of earlier death. There is also some evidence to suggest that a higher calorie diet may benefit the disease course in pwALS, but further research is needed.

Methods and analysis
Two armed, parallel group, superiority, open labelled, randomised controlled trial, with internal pilot, to assess the effectiveness of an early high calorie diet on functional outcomes in ALS, comprising two treatment arms: (1) standard care, (2) standard care with additional active management using the OptiCALS complex intervention to achieve a high calorie diet (initially randomised 1:1, then 1:2 following a protocol amendment). Using a food first approach, pwALS will be encouraged and supported to follow a diet that meets an individualised calorie target from food before prescribing oral nutritional supplements. 259 pwALS will be recruited from up to 20 ALS centres across the United Kingdom and Ireland and followed up for a period of 12 months. Primary outcome is functional change measured over 12 months, using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale. Secondary end points include measures of functional health, quality of life, calorie intake and weight, as well as time to gastrostomy and survival. A health economic analysis and process evaluation will also be undertaken. Participant recruitment is expected to complete in September 2025, and participant follow-up is expected to complete in September 2026. The results of this study are expected in March 2027.

Ethics and dissemination
The trial was approved by Greater Manchester—North West Research Ethics Committee, reference 20/NW/0334 on 8 September 2020. We will publish the study findings in peer-reviewed academic journals and present at local, national and international conferences where possible.

Trial registration number
ISRCTN30588041.

Stroke, Ahead of Print. BACKGROUND:The SPAN (Stroke Preclinical Assessment Network) is a confirmatory multicenter trial network to test cerebroprotective interventions in experimental acute stroke. In a first-of-its-kind trial, SPAN tested 6 interventions in a rodent model of transient focal ischemic stroke. Here, we report the efficacy of fasudil, an isoform-nonselective rho-associated kinase inhibitor, on primary and secondary outcomes in the SPAN trial.METHODS:Fasudil was administered at 10 mg/kg intraperitoneally every 12 hours for 6 doses starting 5 minutes before reperfusion in a 60-minute endovascular filament middle cerebral artery occlusion model. The active treatment arm (n=345) was compared with the pooled intraperitoneal and intravenous vehicle arms (n=344). In addition to healthy young mice, the trial included aging mice (16±1 months), diet-induced obese mice, and spontaneously hypertensive rats. The a priori fasudil substudy design stipulated the modified corner test performance on day 28 as the primary end point and separate analyses for mice and spontaneously hypertensive rats using the modified intention-to-treat cohort.RESULTS:Fasudil improved the primary outcome end point in mice (probabilistic index point estimate, 0.57;P=0.022). The effect appeared stronger in aging mice and when ischemia was induced during the active circadian stage. Fasudil did not show any benefit in the spontaneously hypertensive rats. Alternative analyses using the per-protocol population and imputation generally yielded similar conclusions.CONCLUSIONS:Our results reveal a favorable therapeutic profile for fasudil, supporting future translational development of rho-associated kinase inhibitors in ischemic stroke.

Introduction
Adenoid hypertrophy has a high prevalence in children, often causing early orofacial muscle dysfunction that worsens facial deformities over time. While adenoidectomy (AT) alleviates airway obstruction, it only partially addresses the condition, leaving persistent neuromuscular habits. Orofacial myofunctional therapy is necessary for post-AT recovery but faces challenges such as poor adherence and ineffective parent-child communication. Dyadic interventions, which actively involve both parents and children, have shown advantages in improving treatment adherence and enhancing orofacial muscle function. Evidence suggests that dyadic intervention addresses both the child’s recovery needs and the caregiving capacity of parents, offering a more comprehensive solution for long-term intervention. Therefore, our team developed a parent-child dyadic orofacial myofunctional therapy (PCD-OMT) programme, offering insights into its potential application in paediatric healthcare to support comprehensive family-centred care.

Method and analysis
This two-arm, parallel-design, randomised controlled trial will recruit 80 dyads whose children performed AT from two hospitals in Qingdao, China. Dyads will be randomly allocated to two arms. Dyads randomly assigned to the intervention group will receive the PCD-OMT programme. Dyads randomly assigned to the control group will receive regular care. The primary outcomes are orofacial myofunction in children and parental care abilities. The secondary outcomes are children’s engagement and parental functioning. A feasibility and acceptability process will be employed to evaluate the viability in clinical practice. Outcomes will be collected at three checkpoints: baseline (T0), postintervention (T1) and after a 12-week follow-up phase (T2).

Ethics and dissemination
This study was approved by the Ethics Committee of Medical College of Qingdao University (QDU-HEC-2023216). The results will be published in peer-reviewed publications and presented in international conferences.

Trial registration number
ChiCTR2400091466.

Objectives
This study aimed to explore the experience of online sexual abuse among school-going Bangladeshi youth.

Design
A convergent parallel mixed-method study. The quantitative strand employed a self-administered questionnaire survey conducted in classroom settings, while the qualitative strand used in-depth interviews guided by semistructured protocols. Data from both strands were analysed separately and then merged.

Participants and settings
Grade 9–10 students from four randomly selected schools in both an urban and a rural area of Bangladesh participated in the study. A total of 456 students participated in the quantitative survey, and 16 were subsequently interviewed for qualitative data.

Outcome measures
The frequency of online sexual abuse along with its contributing factors and patterns, including victim’s characteristics, perpetrator’s identity, potential avenue of abuse, knowledge and psychosocial consequences.

Results
About 88% of the participants reported using the Internet, and nearly 53% reported being victims of online sexual abuse at some point in their lives. The occurrence of common sexual abuses included online grooming (53%), cyberflashing (38%), sexting (35%), sexual solicitation (18%) and sextortion (12%) among Internet users. The odds of being sexually abused online were higher among urban children (OR=2.04, 95% CI 1.21–3.45), who spent more hours daily on the Internet (OR=1.09, 95% CI 1.01–1.18), who visited more social media (OR=1.42, 95% CI 1.27–1.59) and who used more Internet devices (OR=1.93, 95% CI 1.25–2.98). Many participants were aware of these incidents but did not know how to respond to online sexual abuse. Social media, chat groups and video games were described as primary avenues for abuse, while unemployed male young adults and partners in love affairs were identified as the possible perpetrators. Psychosocial consequences such as anxiety, depression, helplessness, stress, distrust, lack of concentration, social isolation, self-hate and suicidal attempts were reported by the victims. Encountering online sexual abuse also manifested in academic underperformance.

Conclusion
Urgent multisectoral measures are needed to address online sexual abuse to safeguard children’s right to be protected on online platforms.

La campagna su giornali e muri. Il 12 scade domanda al concorso

Objective
This study aimed to explore the challenges and opportunities in engaging health development partners in planning healthcare services at a sub-national level in Uganda.

Design
An exploratory qualitative study involving selected health development partner organisations and district local governments.

Setting
A study was conducted in Northern Uganda, specifically in 12 districts that comprise the Lango and Acholi sub-regions. The study area has many health development partners compared with the other regions in the country.

Participants
A total of 18 participants were enrolled in the study. To be considered for inclusion, a participant had to be working for a district local government in Northern Uganda and involved in planning health services or working for a development partner supporting health services in the region. Most of the participants were men aged between 41 and 50 years.

Outcome measures
Factors that affect the involvement of health development partners in planning health services at sub-national levels and opportunities that can facilitate involvement.

Results
The findings show that health development partners serve as a source of information and data, guide the planning and supervision of services, conduct community mobilisation and support infrastructure development. However, differing planning cycles, corruption, power dynamics and budget constraints affect their participation in district health planning. Continuous engagement, even outside budget periods, with respect to the terms agreed upon in the memoranda of understanding (MOU), equitable treatment of all partners and transparency from all parties emerged as opportunities to improve involvement.

Conclusion
The involvement and importance of health development partners in planning district-level health services cannot be overstated. Therefore, addressing the challenges that hinder joint planning through a focus on open communication, mutual respect and adherence to the terms of the MOU can improve working relationships.

Objectives
The aim of this study was to explore physicians’ experiences of the process leading up to their sick leave due to exhaustion disorder (ED).

Design
A qualitative study with a narrative approach was conducted.

Setting
The study was conducted in Sweden. Interviews with physicians were conducted face-to-face during the Spring and Autumn of 2022. Each interview lasted between 35 and 60 min.

Participants
Purposive sampling was employed to recruit physicians on long-term sick leave for ED. We used an interview guide with open-ended questions.

Results
12 physicians shared their experiences of the process leading to their ED-related sick leave. Four themes related to different phases of the process: Theme 1. Strongly motivated to become a physician, Theme 2. Demands delivering best practice, Theme 3. Symptoms of ill health and Theme 4. Managing symptoms of ED. The narrative analyses showed a holistic understanding of the personal consequences for the physicians and their families as well as the consequences in working life.

Conclusions
Politicians and leaders at different healthcare levels must take responsibility for strengthening the working environment, which is important for creating long-term and sustainable healthcare services.

Introduction
Children discharged from hospital following management of complicated severe acute malnutrition (SAM) have a high risk of mortality, readmission and failed nutritional recovery. Current management approaches fail to sufficiently promote convalescence after inpatient nutritional rehabilitation. Novel interventions during the post-discharge period could enhance convalescence to help children survive and thrive.

Methods and analysis
The Co-SAM trial is an adaptive, multicountry, phase III, individually randomised clinical trial, based on the principles that (i) interacting biological and social factors drive multimorbidity in children with SAM, and (ii) both medical and psychosocial interventions may therefore ameliorate underlying causal pathways to reduce morbidity and mortality and improve recovery. Children aged 6–59 months with complicated SAM, who have stabilised and started the transition to ready-to-use therapeutic food (RUTF), will be enrolled and randomised to one of five trial arms (standard-of-care alone; antimicrobials; reformulated RUTF; psychosocial support; or a combination of all strategies). Standard-of-care, which is provided in all trial arms, includes RUTF until nutritional recovery (defined as weight-for-height Z-score >–2, mid-upper arm circumference >12.5 cm and oedema-free since the last study visit), and other management recommended in WHO guidelines. The 12-week antimicrobial package provides daily co-formulated rifampicin and isoniazid (with pyridoxine) and 3 days of azithromycin monthly. The reformulated RUTF, which incorporates medium-chain triglycerides and hydrolysed protein to increase nutrient bioavailability and reduce metabolic stress, is provided at the same dose and duration as standard RUTF. The 12-week psychosocial package includes caregiver problem-solving therapy, educational modules, peer support groups and child play. The combined arm includes all interventions. Children start their intervention package prior to hospital discharge, with follow-up data collection in study clinics at 2, 4, 6, 8, 12 and 24 weeks. The primary composite outcome is death, hospitalisation or failed nutritional recovery within 24 weeks post-randomisation. An interim analysis will allow unpromising arms to be dropped, while the final analysis will be conducted when 1266 children have completed the study. Embedded process evaluation and laboratory substudies will explore the mechanisms of action of the interventions.

Ethics and dissemination
The trial has been approved by ethics committees in Zimbabwe, Zambia, Kenya and UK. Dissemination will be via community advisory boards in each country; Ministries of Health; and dialogue with policymakers including UNICEF.

Trial registration number
Clinicaltrials.gov: NCT05994742; Pan African Clinical Trials Registry: PACTR202311478928378.

Introduction
The current pharmacological management of type 2 diabetes mellitus (T2DM) faces challenges such as low rates of optimal glycaemic control, high incidences of adverse drug reactions and suboptimal treatment compliance. Pueraria lobata radix (PLR), a medicinal and edible herb, has shown hypoglycaemic effects in animal models. However, existing clinical studies have only assessed the hypoglycaemic effect of PLR-containing herb formulas or PLR extract preparations. The aim of this study is to investigate the efficacy and safety of using PLR solely as an adjuvant therapy for T2DM.

Methods and analysis
This study is a multicentre, randomised, double-blind, placebo-controlled trial. 200 patients with T2DM will be randomly allocated to either the PLR group or the placebo group for a consecutive 12-week intervention. Regular visits will be conducted at weeks 4, 8 and 12, following the initiation of the study to evaluate the efficacy and safety of PLR. The primary outcome is the change in haemoglobin A1c (HbA1c) from baseline at week 12. Secondary outcomes include changes in HbA1c from baseline at weeks 4 and 8; the HbA1c response rate (< 7%), changes in fasting blood glucose, 2-hour blood glucose, fasting C-peptide, body mass index, severity of diabetes symptoms, quality of life from baseline at weeks 4, 8 and 12; and changes in blood lipid indicators at week 12. Safety outcomes include the incidences of total adverse events (AEs), serious AEs and PLR-related AEs. Ethics and dissemination The protocol has been approved by the Ethics Committees of the First Affiliated Hospital of Nanchang University (approval number: IIT[2024]LLS No.303) and the Affiliated Hospital of Jiangxi University of Chinese Medicine (approval number: JZFYLL2024006200087). We will disseminate the study findings through publications in peer-reviewed journals and conference presentations. Trial registration number ClinicalTrials.gov NCT06494683.

Background
Rapid urbanisation and the dense population of Bangladesh foster the growth of slum settlements, where poverty and food insecurity are magnified by economic instability and inflationary pressures, adversely affecting psychological health.

Objectives
This study aimed to assess household food security and its influence on psychological well-being among adults living in urban slums of Bangladesh.

Methods
A cross-sectional study using convenient sampling was conducted among 300 adults in slums in Dhaka, Bangladesh, using a semistructured questionnaire to collect data on sociodemographics, food security and mental health status. Multivariable logistic regression analyses were conducted to observe the influence of food insecurity on mental health status, controlling for other covariates.

Results
The majority of the participants experienced food insecurity, with 38.0% expressing severe food insecurity. High levels of psychological distress were observed, including stress (54.7%), anxiety (63.3%) and depression (73.3%). Older adults (aOR 4.5, 95% CI 1.3 to 15.5) and females (aOR 4.1, 95% CI 2.0 to 8.4) had higher odds of experiencing anxiety. Single individuals were more prone to experience depression, while homemakers exhibited elevated levels of both depression and anxiety. Furthermore, moderate to severe food insecurity was significantly associated with higher odds of depression (aOR 2.8, 95% CI 1.2 to 6.7) and anxiety (aOR 8.2, 95% CI 3.3 to 20.3) compared with no or mild food insecurity.

Conclusions
This study highlights the pervasive influence of household food insecurity on urban slum dwellers’ psychological well-being. Addressing vulnerabilities tied to age, marital status and occupation is crucial for alleviating mental health burdens.

Objectives
We aimed to evaluate the effect of projection mapping (PM) on the quality and safety of central venous catheter (CVC) insertion under real-time ultrasound guidance.

Design
Prospective, observational, simulation study.

Setting
This study was conducted at the Yokohama City University Medical Center (Yokohama, Japan). Volunteer residents were enrolled over 12 months from January to December 2023.

Participants and methods
12 rotating residents (postgraduation year (PGY) 1 and 2) and eight anaesthesia residents (PGY 3–5) placed the CVC in the internal jugular vein in a simulator under the real-time ultrasound guidance using the short-axis out-of-plane approach. The ultrasound image was provided either just caudad to the puncture site using the PM method or on the monitor of the ultrasound machine (conventional method) placed next to the simulator’s right shoulder. Each resident performed four punctures alternating between the PM and conventional methods, and the first method for each resident was chosen randomly. Eye-tracking analysis was also used to evaluate differences in gaze behaviour.

Primary and secondary outcome measures
The primary outcome was the procedure time defined as the time from the application of the ultrasound probe on the puncture field until successful puncture of the vein. The secondary outcomes were incidence of complications and eye-tracking analysis data.

Results
The time to complete the line placement was significantly shorter for the PM than for the conventional method (median (IQR) 22.5 (15.5–30.6) s vs 30.0 (20.4–95.4) s; p=0.02, Wilcoxon’s signed-rank test). The incidence of posterior vessel wall puncture was significantly lower in the PM method (0% vs 25%; p=0.02, McNemar’s test). Eye-tracking analysis revealed that the percentage of time spent gazing at the ultrasound image was higher in the PM than in the conventional method (61.6% (55.0–69.2) vs 45.7% (34.1–54.5); p