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Search Results for: Il significato della carica virale e l’effetto del vaccino anti-COVID-19
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Randomised trial of home sleep apnoea testing compared to in-lab polysomnography for the evaluation of obstructive sleep apnoea in children: rationale and study protocol
Introduction
Obstructive sleep apnoea (OSA) affects 1–5% of the paediatric population, including 55–90% of children with Down syndrome (DS), and has been associated with negative effects on neurocognitive development, cardiovascular health, immune development and quality of life. In-lab attended polysomnography (PSG) is currently the gold standard for the diagnosis of OSA in children, but it poses challenges due to the burden on families and limited testing facilities. Home sleep apnoea testing (HSAT), an unattended sleep test done at home, is an accepted alternative for adults but lacks sufficient evidence to be used clinically for the evaluation of OSA in children. HSAT may be especially beneficial for children with DS or others with sensory issues or those who struggle with sleeping in a laboratory setting overnight.
Methods and analysis
This single-centre trial compares HSAT to PSG for the diagnosis of OSA in children, including those with DS. The trial will enrol 317 children 5–12 years old, including approximately 100 with DS. The primary outcome is the diagnostic accuracy of HSAT compared with PSG for OSA evaluated through ROC. Secondary outcomes include the agreement between HSAT and PSG for therapeutic decision-making and comparison of preference and acceptability of HSAT versus PSG. This trial seeks to evaluate HSAT as an alternative diagnostic tool for paediatric OSA, potentially expanding testing options for clinicians and families.
Ethics and dissemination
This study has been approved by the Institutional Review Board at Children’s Hospital of Philadelphia (#21–0 19 533). Informed consent will be obtained from all participants, and no identifiable data will be reported.
Trial registration number
NCT05382754.
Beyond the puff: qualitative insights into smoking behaviours and societal perceptions among university students in India
Objectives
The objective of the study was to understand the smoking behaviour of adults and how societal perceptions influence the smoking behaviour of university students.
Design
Qualitative study.
Setting
National Institute of Medical Sciences university, India.
Participants
20 face-to-face interviews were carried out among university students who were in the age group of 19–30 years using a combination of purposive sampling, followed by snowball sampling methods.
Results
Qualitative responses revealed that stress, cravings for cigarettes and mealtimes were key triggers for smoking behaviour. Many participants felt guilty about their smoking and often became irritated by advice from non-smoking friends. All participants had experienced negative health effects, including physical and sensory issues, as well as other adverse experiences. Students expressed a dislike for judgemental attitudes from society. They respected elders and found it difficult to smoke in front of them. Rather than being blamed for their smoking, they preferred supportive assistance to help them quit.
Conclusions
The study highlights the importance of understanding college students’ smoking behaviour, as it greatly influences their smoking habits. Cessation efforts should target this group and emphasise the negative experiences associated with smoking. Additionally, students recommend creating a non-judgemental and supportive environment to aid in quitting, rather than a judgemental and blaming society.
Cost-effectiveness analysis of the Assessment of Burden of Chronic Conditions (ABCC) tool in primary care in the Netherlands
Objectives
The increasing prevalence of chronic conditions and multimorbidity places a significant burden on patients and leads to increasing challenges for healthcare systems, especially in primary care. Recognising the multifaceted nature of chronic conditions, the Assessment of Burden of Chronic Conditions (ABCC) tool was developed to support person-centred care, by facilitating shared decision-making and self-management. This study aims to evaluate the cost-effectiveness of the ABCC tool in primary care.
Design and setting
This cost-effectiveness analysis was conducted over 18 months alongside a clustered, two-arm quasi-experimental study in primary care in the Netherlands.
Participants
The study included 231 participants diagnosed with chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF). Of these, 173 were assigned to the intervention group and 58 to the control group.
Interventions
The intervention group was intended to incorporate the ABCC tool into routine consultations, while the control group had to continue care as usual.
Outcome measures
Outcomes were assessed from a societal perspective, including quality-adjusted life years (QALYs) derived via the EuroQol-5D-5L (EQ-5D-5L) questionnaire. Costs were measured using adapted versions of the Productivity Costs Questionnaire (PCQ) and Medical Consumption Questionnaire (MCQ). Sensitivity analyses (SAs) included a healthcare perspective, per-protocol analysis (to account for disruptions caused by COVID-19) and exclusion of home care costs (to address extreme outliers). Moreover, all analyses were performed for well-being-adjusted life years (WALYs), derived from the ICEpop CAPability measure for Adults (ICECAP-A) questionnaire.
Results
The ABCC tool was more expensive and effective than usual care, with an incremental cost-effectiveness ratio (ICER) of 64 525 per QALY and a 29% probability of cost-effectiveness. With the exception of the healthcare perspective, the SAs yielded more favourable outcomes in terms of cost-effectiveness, with ICERs (probability of cost-effectiveness) of 41 484 (31%), 8683 (58%) and 23 905 (48%) for a healthcare perspective, per-protocol analysis and exclusion of home care costs, respectively. Outcomes for QALY and WALY were comparable.
Conclusion
While the primary analysis suggested a relatively low probability of cost-effectiveness, the SAs showed higher probabilities. The per-protocol analysis suggested that the ABCC tool can be cost-effective when actually used.
Trial registration number
NCT04127383.
WHO Warns of Preventable Disease Outbreaks Amid Immunization Disruptions
As immunization programs face ongoing disruptions across the globe, the threat of preventable disease outbreaks is growing, the World Health Organization (WHO) recently cautioned. Factors include potential funding cuts, misinformation, and humanitarian crises as countries attempt to recover from COVID-19 pandemic disruptions.
Clinically directed initiation versus routine use of amoxicillin-clavulanate and the risk of local complications among patients with haemotoxic snakebite envenomation treated at a teaching hospital in southern India: a randomised, non-inferiority trial
Objective
Amoxicillin-clavulanate is commonly used to prevent infections following snakebites despite the lack of clinical evidence. We aimed to demonstrate that clinically directed initiation of amoxicillin-clavulanate would be non-inferior to routine use in this setting.
Design
Open-label, randomised, non-inferiority trial with blinded adjudication of endpoints.
Setting
Emergency department of a teaching hospital in southern India.
Participants
Adults with local swelling following snakebites within 24 hours of bite.
Interventions
In the routine use strategy, intravenous followed by oral amoxicillin-clavulanate was administered for at least 5 days. In the clinically directed strategy, the antibiotic was only initiated for clinical failures.
Primary and secondary outcome measures
Primary outcomes were protocol-defined clinical failure and total antibiotic consumption. Non-inferiority margin was prespecified as 10%. Secondary outcomes were the length of hospital stay, total antivenom consumption, new-onset organ failure, bleeding requiring transfusion, death/need for surgical intervention and drug-related adverse events.
Results
The trial was prematurely stopped due to the COVID-19 situation after randomising 66 patients—34 to clinically directed initiation and 32 to routine use arms. Russell’s viper was the most common (21 (32%)) biting snake species identified; 52 (79%) patients had evidence of haemotoxic envenomation at baseline, and 24 (36%) patients developed AKI. There were 10 clinical failures—six in the clinically directed initiation arm and four in the routine use arm. The difference in clinical failure between the two arms was 5.2% (–12.0%–21.7%; p=0.291); the upper bound of the CI exceeded the prespecified non-inferiority margin. Total antibiotic consumption, expressed in DDDs, was significantly lower in the clinically directed initiation arm (0 (0–1) vs 5.31 (4.67–6.17); p
Vaccini Covid: 36 decessi nel 2023 ma la correlazione non è stata mai provata
Le segnalazioni con almeno un evento grave associato ai vaccini anti-Covid-19 sono state 572 nel 2023, pari al 46,7% delle segnalazioni totali su questi vaccini. Lo rileva il rapporto 2023…
Aifa, 36 decessi dopo vaccini Covid ma correlazione non provata
Rapporto 2023,sospetto legame solo per 1 caso shock anafilattico
Aifa, 36 decessi dopo vaccini Covid ma correlazione non provata
Rapporto 2023,sospetto legame solo per 1 caso shock anafilattico
Development of prediction models for screening depression and anxiety using smartphone and wearable-based digital phenotyping: protocol for the Smartphone and Wearable Assessment for Real-Time Screening of Depression and Anxiety (SWARTS-DA) observational study in Korea
Introduction
Depression and anxiety are highly prevalent mental health conditions that significantly affect quality of life and cause societal burdens. However, their detection and diagnosis rates remain low owing to the limitations of the current screening methods. With rapid technological advancements and the proliferation of consumer-grade wearable devices and smartphones, their integration into digital phenotyping research has enabled the unobtrusive screening for depression and anxiety in natural settings. The Smartphone and Wearable Assessment for Real-Time Screening of Depression and Anxiety study aims to develop prediction algorithms to identify individuals at risk for depressive and anxiety disorders, as well as those with mild-to-severe levels of either condition or both. By collecting comprehensive data using smartphones and smartwatches, this study aims to facilitate the translation of artificial intelligence-based early detection research into clinical impact, thereby potentially enhancing patient care through more accurate and timely interventions.
Methods and analysis
This cross-sectional observational study will enrol up to 2500 participants (at least 1000) aged 19-59 years from South Korea via social media outreach and clinical referrals. The eligible participants must use a compatible smartphone. Each participant will be followed up for 4 weeks. Data will be collected using a custom-developed smartphone application called PixelMood. Active data collection will include daily, weekly and monthly self-report questionnaires incorporating validated scales, such as the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7. Passive data from smartphones include information on physical activity, location, ambient light and smartphone usage patterns. Optionally, participants using the Apple Watch or Galaxy Watch devices can provide additional data on physiological responses and sleep health. The primary outcome will be the development of machine-learning algorithms to predict depression and anxiety based on these digital biomarkers. We will employ various machine-learning techniques, including random forest, support vector machine and deep-learning models. The secondary outcomes will include the association between digital biomarkers and clinical measures, and the feasibility and acceptability of data collection methods. Various features characterising mobile usage behaviours, physical/social activity, sleep patterns, resting physiological states and circadian rhythms will be exploited to serve as potential digital phenotyping markers. Advanced machine-learning and deep-learning techniques will be applied to multimodal data for model generation.
Ethics and dissemination
This study protocol was reviewed and approved by the Institutional Review Board of the Korea University Anam Hospital (approval number: 2023AN0506). The results of this study will be disseminated via multiple channels. The findings will be presented at local, national and international conferences in relevant fields, such as psychiatry, psychology and digital health. Manuscripts detailing the study results will be submitted to peer-reviewed journals for publication.
Trial registration number
The present study was registered with the Clinical Research Information Service (CRIS, https://cris.nih.go.kr; identifier: KCT0009183).
Uno studio smentisce il legame tra le bibite dolci e la demenza
Nessun effetto sul cervello se vengono consumate da adulti
Prevalence and determinants of hypertension among adults of reproductive age in Tanzania: analysis of a cross-sectional Demographic and Health Survey
Objective
We aimed to estimate prevalence and identify determinants of hypertension in adults aged 15–49 years in Tanzania.
Design
We analysed cross-sectional survey data from the 2022 Tanzania Demographic and Health Survey and Malaria Indicator Survey conducted between February and July 2022. Descriptive statistical analysis, logistic regression, machine learning and geospatial methods were used to estimate prevalence and determine determinants of hypertension.
Setting
Tanzania.
Participants
A total of 13 385 participants aged 15–49 years were included in the analysis.
Primary outcome
The primary outcome variable was hypertension, defined as either systolic blood pressure (BP)≥140 and/or diastolic BP≥90 mm Hg or under anti-hypertensive drugs.
Results
The prevalence of hypertension among adults of reproductive age was 11% (95% CIs 10.09 to 11.56) in Tanzania, varying significantly across risk factors. Prevalence was high in people aged 40–49 (22.11%, 95% CI 20.07 to 24.29) and obese (23.69%, 95% CI 20.67 to 27.00). The mean prevalence of hypertension was also high in the southern, eastern, western, southern highlands, north-west and north-eastern part of the country, correlating with the spatial distribution of older age (30–49) and higher body mass index (BMI) (≥25). Individuals aged 40–49 had nearly six times (adjusted OR (AOR): 5.68, 95% CI 4.10 to 7.83) the odds of hypertension relative to those aged 15–19. Obese individuals had higher odds (AOR: 2.88, 95% CI 2.01 to 4.13) compared with overweight individuals (AOR: 1.93, 95% CI 1.36 to 2.74). Machine learning results showed age and BMI as the most important determinants of hypertension and that significant interactions between risk factors exist.
Conclusion
The prevalence of hypertension varied across risk factors and the strongest determinants of hypertension in adults of reproductive age were age and BMI.
Skills for adolescent WELLbeing (SWELL): protocol for a preventive effectiveness randomised controlled trial for young people at high-familial risk of depression with treatment optimisation for parents with depression at study entry comparing online group cognitive behavioural therapy (CBT) with treatment as usual
Introduction
Young people (YP) whose parents have depression are at elevated risk for developing depression themselves and could benefit from preventive interventions. However, when parents are in a depressive episode, this reduces the effects of psychological interventions for depression in YP. Moreover, parental depression is often managed suboptimally in usual care. There is, therefore, a case for identifying and optimising parental depression treatment to enhance the effectiveness of psychological preventive interventions for depression in YP.
Methods and analysis
This is a randomised controlled trial (Skills for adolescent WELLbeing) to determine the effectiveness of a cognitive behavioural therapy (CBT) intervention compared with usual care in increasing the time to a major depressive episode in YP by 9-month follow-up (primary outcome). The intervention offers a 12-week treatment-optimisation phase for parents depressed at study entry, followed by randomisation of the young person to a small group manualised online CBT programme facilitated by a therapist. YP allocated to the intervention will receive eight weekly sessions plus three monthly continuation sessions. Secondary outcomes include the number of depression-free weeks, mental health symptoms and functioning. Mechanisms of intervention action will be assessed with mediation analysis of quantitative data and thematic analysis of qualitative interviews. Participants (parents/carers with depression and their children aged 13–19 years) will be identified through existing cohorts of adults with depression, from primary care through health boards in Wales and England, UK, schools and advertising including via social media.
Ethics and dissemination
The trial has received ethical approval from Wales NHS Research Ethics Committee (REC) 5, the Health Research Authority and Health and Care Research Wales (IRAS 305331; REC 22/WA/0254). This manuscript is based on V.5.7 of the protocol (17 January 2025). Findings will be disseminated in peer-reviewed journals and conferences. Reports and social media messages will be used to disseminate findings to the wider public.
Trial registration number
ISRCTN13924193 (date registered: 15 March 2023).
Approvata la prima iniezione semestrale per prevenire l’Hiv. «È la cosa più vicina a un vaccino»
La Food and Drug Administration (Fda) statunitense ha approvato lenacapavir (Yeztugo), un nuovo farmaco che promette una protezione quasi totale contro l’Hiv con una semplice iniezione ogni sei mesi. È…
Unruptured Intracranial Aneurysms
New England Journal of Medicine, Volume 392, Issue 23, Page 2357-2366, June 19, 2025.
Three Cases of Vertical Transmission of Clade Ib Mpox Virus
New England Journal of Medicine, Volume 392, Issue 23, Page 2385-2387, June 19, 2025.