Search Results for: Passo 13. Analizzare le codifiche dei propri assistiti per ottimizzare le analisi

Background
Governments used travel bans during the COVID-19 pandemic to limit the introduction of new variant of concern (VoC). In the Netherlands, direct flights from South Africa were banned from 26 November 2021 onwards to curb Omicron (B.1.1.529) importation.

Objectives
This study retrospectively evaluated the effect of the South African travel ban and the timing of its implementation on subsequent Omicron infections in the Netherlands and, in order to help inform future decision-making, assessed alternative scenarios in which the reproduction number (Re) and volume of indirectly imported cases were varied.

Design
Descriptive analysis and modelling study.

Outcome measure
Time (days) from 26 November 2021 to reach 10 000 cumulative Omicron infections in the Netherlands.

Methods
To benchmark the direct importation rate of Omicron from South Africa, we used the proportion (n/N, %) of passengers arriving on two direct flights from South Africa to the Netherlands on 26 November 2021 with a positive PCR sequencing result for Omicron VoC infection. We scaled the number of directly-imported Omicron infections before and after the travel ban to the incidence in South Africa. We assumed that 10% of all cases continued to arrive via indirect routes, a ‘failure rate’ of 2% (ie, incoming Dutch citizens not adhering to quarantine on arrival) and an effective reproduction number (Re) of Omicron of 1.3. In subsequent analyses, we varied, within plausible limits, the Re (1.1–2.0) and proportion of indirectly-imported cases (0–20%).

Results
Compared with no travel ban, the travel ban achieved a 14-day delay in reaching 10 000 Omicron cases, with an additional day of delay if initiated 2 days earlier. If all indirect importation had been prevented (eg, European-wide travel ban), a 21-day delay could have been achieved. The travel ban’s effect was negligible if Re was ≥2.0 and with a greater volume of ongoing importation.

Conclusions
Travel bans can delay the calendar timing of an outbreak but are substantially less effective for pathogens where importation cannot be fully controlled and tracing every imported case is unfeasible. When facing future disease outbreaks, we urge policy-makers to critically weigh up benefits against the known socioeconomic drawbacks of international travel restrictions.

Circulation, Ahead of Print. BACKGROUND:Homozygous familial hypercholesterolemia (HoFH) is a genetic disease characterized by high levels of low-density lipoprotein cholesterol (LDL-C) present from birth, leading to early-onset and progressive atherosclerotic cardiovascular disease. Early treatment initiation is crucial for cardiovascular risk reduction; however, many patients do not reach LDL-C treatment goals. Inclisiran, a small interfering RNA targeting hepatic PCSK9 (proprotein convertase subtilisin/kexin type 9), is effective and well tolerated in adult patients with hyperlipidemia; however, it has not yet been studied in pediatric patients.METHODS:Herein we report results of the 1-year, double-blind, placebo-controlled part of the phase 3 study ORION-13 (Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia) in adolescents with HoFH. This 2-part multicenter study included 13 patients ≥12 to 130 mg/dL) on maximally tolerated statin treatment, with or without other lipid-lowering therapies. Eligible patients were randomized 2:1 to receive either 300 mg of inclisiran sodium or placebo, administered on days 1, 90, and 270. The primary end point was the mean percentage change in LDL-C from baseline to day 330.RESULTS:The mean age of patients was 14.8 years, and mean baseline LDL-C was 272 mg/dL. The placebo-adjusted mean (95% CI) percentage change in LDL-C from baseline to day 330 was −33.3% (−59.2% to −7.3%). Six of 9 (66.7%) inclisiran-treated patients (versus 1 of 4 [25%] on placebo) achieved a >15% reduction in LDL-C, and 5 of 9 (55.6%) inclisiran-treated patients (versus none on placebo) achieved a >20% reduction. The placebo-adjusted mean (95% CI) percentage change in PCSK9 from baseline to day 330 was −60.2% (−79.8% to −40.7%); corresponding changes in apoB (apolipoprotein B), non–high-density lipoprotein cholesterol, and total cholesterol were −23.0%, −32.7%, and −27.8%, respectively. No serious adverse events, treatment discontinuations because of adverse events, or deaths occurred. No new safety findings were reported.CONCLUSIONS:In a 1-year randomized controlled study (part 1 of ORION-13), inclisiran was effective in lowering LDL-C in adolescents with HoFH and was well tolerated. These results support inclisiran as a potentially useful addition for the treatment of adolescents with HoFH and a minimum of LDLR residual activity.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT04659863.

Objectives
Amidst low recognition and treatment for mental health conditions among people living with heart failure (PLWHF), this study aimed to identify factors affecting access to mental health services for PLWHF.

Design
Semi-structured phone interviews were conducted with PLWHF (n=13) and clinicians and researchers (n=9).

Setting
Heart failure remote management programme at a large urban academic hospital in Ontario, Canada.

Results
Using inductive reflexive thematic analysis, 14 themes were created and mapped to Levesque’s patient-centred access to care framework, revealing barriers at the system and patient levels. System-level barriers included service approachability (ie, difficulties detecting mental health concerns; unpreparedness for referral conversations), availability and accommodation (ie, limited mental health services; poorly timed services; inconsistent care pathways) and affordability (ie, limited human resources; lack of options for choice or finding fit; insufficiency of generic mental health services). Patient-level barriers included limitations in the ability to perceive mental health needs (ie, low mental health literacy), as well as seek (ie, stigma), reach (ie, inconvenience of in-person delivery) and pay (ie, lack of full insurance coverage and high cost of psychological services) for mental healthcare.

Conclusions
The findings suggest enhancing the approachability, availability and appropriateness of mental health services and promoting the ability of PLWHF to recognise their mental health needs as potential interventional targets.

Objectives
Children with medical complexity (CMC) frequently experience acute deterioration requiring paediatric intensive care unit (PICU) hospitalisation. Collaboration between families and healthcare professionals (HCPs) is vital yet often challenging, suggesting a new care approach is needed. This study explored the PICU care experiences of CMC, parents and HCPs and identified common priorities and practice changes to enhance care.

Design
An experience-based co-design (EBCD) approach was used. Semistructured interviews were conducted with CMC and parents (stage 1) and HCPs (stage 2). A co-design event with parents and HCPs followed (stage 3).

Setting
Interviews took place in family homes, hospital meeting rooms and virtually. The co-design event took place at the hospital.

Participants
Interviews: CMC and parents (n=21, 13 families) within 1 year of their most recent PICU discharge. PICU and complex care service HCPs (n=15). Co-design event: parents and HCPs (n=22). Maximum variation sampling was used.

Results
Stage 1: Child and family-related themes included becoming known, becoming a parent caregiver or child care receiver, establishing caregiver relationships, and expecting a responsive and dignified caregiving environment. Stage 2: HCP-related themes included adapting to a different care approach, positioning parents as collaborators, navigating personal connections, and providing continuity of care. Stage 3: Two videos (sharing child and family perspectives, and HCPs’ perspectives) were produced to promote discussion at the co-design event. Common care priorities included increase HCPs’ awareness of who the child is when they are well; improve interdepartmental communication; enhance HCPs’ understanding of families’ expertise and needs; enhance parent-HCP partnerships and develop HCP training programmes. Potential practice changes were identified.

Conclusions
Participants identified the need for a collaborative approach to care for critically ill CMC, integrating the expertise of children, parents and HCPs. EBCD can help ground the perspectives and needs of HCPs, children and families in future PICU patient and family-centred care interventions.

Objective
Adolescents and young adults (AYA) with HIV are a population at high risk of experiencing mental issues and sleep disorder. We aim to summarise the global prevalence and risks of depression, anxiety, post-traumatic stress disorder (PTSD) and sleep disorder among AYA with HIV.

Design
Systematic review and meta-analysis.

Data sources
PubMed, Web of Science, Embase and PsycINFO were searched from inception to 3 August 2024.

Eligibility criteria
Observational studies reporting the prevalence of depression, anxiety, PTSD or sleep disorder among AYA with HIV and published in English were included. Reviews, case reports, conference papers, notes, editorials and non-observational research were excluded.

Data extraction and synthesis
Titles, abstracts and full texts were reviewed and screened, and data were independently extracted. A modified Newcastle-Ottawa Quality Assessment Scale (NOS) was used to evaluate study quality. Heterogeneity was assessed by I2 statistics, and subgroup analysis was performed to identify the source of heterogeneity. The pooled prevalence and the risks of depression, anxiety, PTSD and sleep disorder by comparison with HIV-uninfected peers were measured with random-effects and fixed-effects models. Publication bias was examined using Egger’s correlation tests and funnel plot. The Grading of Recommendations Assessment, Development and Evaluation was used to assess the certainty of evidence.

Results
56 articles were included in the final analysis. According to the modified NOS, 13 (23.2%) studies were considered good, 38 (67.9%) were satisfactory and 5 (8.9%) were unsatisfactory. 51 studies including 21 735 AYA with HIV contributed data for the pooled prevalence of depression (28%, 95% CI 24% to 32%, I2=98.68%; low certainty evidence); 21 studies including 8021 cases contributed data for the pooled prevalence of anxiety (22%, 95% CI 17% to 27%, I2=98.35%; low certainty evidence); 9 studies including 3691 cases contributed data for the pooled prevalence of PTSD (12%, 95% CI 8% to 17%, I2=95.60%; low certainty evidence); and 4 studies including 1909 cases contributed data for the pooled prevalence of sleep disorder (51%, 95% CI 31% to 70%, I2=98.37%; low certainty evidence). Compared with AYA without HIV, those with HIV had a higher risk of depression (OR=2.67, 95% CI 1.63 to 5.90, I2=84.0%), anxiety (OR=1.89, 95% CI 1.32 to 2.69, I2=50.3%), PTSD (OR=1.58, 95% CI 1.23 to 2.04, I2=40.1%) and sleep disorder (OR=2.11, 95% CI 1.51 to 2.95, I2=0.0%). A subgroup analysis found that studies conducted in Asia had a lower prevalence of depression (21.7% vs 29.6%, p

Objective
To evaluate the association between body composition from early pregnancy to 42 days postpartum and postpartum weight retention (PPWR).

Design
This retrospective cohort study was conducted at Chengdu Shuangliu Maternal and Child Health Care Hospital from June 2020 to December 2021.

Setting
The study was conducted in Sichuan Province, southwestern China.

Participants
A total of 673 pregnant women at 6–13 weeks of gestation were included.

Outcome measures
Demographic and health information of participants was collected from the electronic medical record system using a self-designed questionnaire. Body fat percentage (PBF), fat mass (FM), fat-free mass (FFM), lean mass (LM) and protein were measured using bioelectrical impedance analysis. Logistic regression and restricted cubic spline (RCS) analyses were performed to examine the association between body composition and PPWR.

Results
During early pregnancy, compared with the bottom quartile group, women in the top quartile group of PBF and FM levels had a 51% (95% CI 0.24 to 0.99) and 64% (95% CI 0.17 to 0.76) lower risk of PPWR, respectively. For each SD increase in PBF and FM levels, the risk of PPWR decreased by 29% (95% CI 0.55 to 0.91) and 35% (95% CI 0.50 to 0.85), respectively. In contrast, at 42 days postpartum, for each SD increase in PBF, FM, FFM and LM levels, the PPWR risk elevated by 251% (95% CI 2.70 to 4.62), 315% (95% CI 3.15 to 5.57), 56% (95% CI 1.30 to 1.89), and 71% (95% CI 1.42 to 2.09). RCS analysis revealed that PBF and FM levels during early pregnancy were negatively correlated with the risk of PPWR (p-overall

Objective
To determine whether an enhanced community rehabilitation intervention (the Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) intervention) was more effective than usual National Health Service care, following surgical repair of hip fracture, in terms of the recovery of activities of daily living (ADLs).

Design
Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio.

Setting
Participant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community.

Participants
Patients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture.

Interventions
Usual rehabilitation care (control) was compared with usual rehabilitation care plus the FEMuR intervention, which comprised a patient-held workbook and goal-setting diary to improve self-efficacy, and six additional therapy sessions delivered in-person in the community, or remotely during COVID-19 restrictions (intervention), to increase the practice of exercise and ADL.

Primary and secondary outcome measures
Primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy-International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Outcomes were collected by research assistants in participants’ homes, whenever possible, but had to be collected remotely during COVID-19 restrictions.

Results
In total, 205 participants were randomised (n=104 experimental; n=101 control). Trial processes were adversely affected by the COVID-19 pandemic. There were 20 deaths, 34 withdrawals and three lost to follow-up. At 52 weeks, there was no significant difference in NEADL score between the FEMuR intervention and control groups. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values also found no significant difference with a mean difference of 0.1 (95% CI –1.1, 1.3). There were no significant between-group differences in secondary outcomes. Sensitivity analyses, examining the impact of COVID-19 restrictions, produced similar results. A median of 4.5 extra rehabilitation sessions were delivered to the FEMuR intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events (SAEs) including 11 deaths in the control group: 41 SAEs including nine deaths in the FEMuR intervention group.

Conclusions
The FEMuR intervention was not more effective than usual rehabilitation care. The trial was severely impacted by COVID-19. Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.

Trial registration number
ISRCTN28376407.

Objective
To determine whether an enhanced community rehabilitation intervention (the Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) intervention) was more effective than usual National Health Service care, following surgical repair of hip fracture, in terms of the recovery of activities of daily living (ADLs).

Design
Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio.

Setting
Participant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community.

Participants
Patients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture.

Interventions
Usual rehabilitation care (control) was compared with usual rehabilitation care plus the FEMuR intervention, which comprised a patient-held workbook and goal-setting diary to improve self-efficacy, and six additional therapy sessions delivered in-person in the community, or remotely during COVID-19 restrictions (intervention), to increase the practice of exercise and ADL.

Primary and secondary outcome measures
Primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy-International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Outcomes were collected by research assistants in participants’ homes, whenever possible, but had to be collected remotely during COVID-19 restrictions.

Results
In total, 205 participants were randomised (n=104 experimental; n=101 control). Trial processes were adversely affected by the COVID-19 pandemic. There were 20 deaths, 34 withdrawals and three lost to follow-up. At 52 weeks, there was no significant difference in NEADL score between the FEMuR intervention and control groups. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values also found no significant difference with a mean difference of 0.1 (95% CI –1.1, 1.3). There were no significant between-group differences in secondary outcomes. Sensitivity analyses, examining the impact of COVID-19 restrictions, produced similar results. A median of 4.5 extra rehabilitation sessions were delivered to the FEMuR intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events (SAEs) including 11 deaths in the control group: 41 SAEs including nine deaths in the FEMuR intervention group.

Conclusions
The FEMuR intervention was not more effective than usual rehabilitation care. The trial was severely impacted by COVID-19. Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.

Trial registration number
ISRCTN28376407.

Circulation, Volume 151, Issue 19, Page e1001-e1001, May 13, 2025.

Circulation, Volume 151, Issue 19, Page e986-e987, May 13, 2025.

Circulation, Volume 151, Issue 19, Page 1430-1432, May 13, 2025.

Circulation, Volume 151, Issue 19, Page e988-e989, May 13, 2025.

Circulation, Volume 151, Issue 19, Page e1000-e1000, May 13, 2025.

Circulation, Volume 151, Issue 19, Page 1409-1411, May 13, 2025.

Circulation, Volume 151, Issue 19, Page 1375-1377, May 13, 2025.