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

Introduction
Early and lifelong treatment is essential in patients with familial hypercholesterolaemia (FH) due to genetically elevated low-density lipoprotein cholesterol (LDL-C) from the first years of life. In women with FH, lipid-lowering treatment is interrupted during childbearing years due to contraindication of the medication during conception, pregnancy and breastfeeding. However, little is known about the impact of breastfeeding on lipid profile and other risk markers for atherosclerotic cardiovascular disease (ASCVD) in women with FH compared with women without hypercholesterolaemia, and to what extent statins transfer into breast milk.
We aim to investigate (1) the association between breastfeeding and serum lipid profile in women with and without FH; (2) the association between breastfeeding and other ASCVD risk markers in women with and without FH and (3) the concentration of statins in breast milk of women with FH.

Methods and analysis
FH-FEMINA is a prospective study aiming to include 50 women with FH in Norway, the Netherlands and the Czech Republic. Additionally, 20 women without hypercholesterolaemia will be enrolled as a control group in Norway. Women will be included at the first study visit in gestational week 36, and follow-up visits will be scheduled at 2–4 weeks, and at 3, 6, 9 and 12 months postpartum. Information on lifestyle factors, treatment history and current and previous pregnancies will be collected. At each visit, a non-fasting blood sample, breast milk sample and information on diet, body mass index and blood pressure will be collected. Additional blood samples will be collected from the women with FH at 2, 4, 5, 7, 8, 10 and 11 months postpartum for as long as they are breastfeeding. At (re-)initiation of statin treatment, breast milk samples from women with FH will be collected for drug concentration measurements.

Ethics and dissemination
Ethical approval will be obtained prior to study start in all three countries. Participants will be informed about the study and receive ample time to ask questions before the informed consent form is signed. The findings from this study will be disseminated to healthcare professionals, researchers and patients via peer-reviewed scientific article(s), conferences, patient organisations and social media.

Trial registration number
NCT05367310.

Introduction
Although most cochlear implant (CI) users achieve good speech understanding in quiet without visual cues, they may have limited speech understanding in noise and often have poor music perception. The present study was designed to investigate the degree to which the use of Meludia training can improve music perception, music enjoyment and speech understanding in paediatric and postlingually deafened adult CI users. The study also aims to assess the participants’ changes in cognitive skills (attention and memory) and quality of life.

Methods and analysis
This randomised controlled trial will randomise new CI users and experienced CI users older than 6 years who meet the inclusion criteria in a 1:1 ratio to either a musical training (MT) group or a non-MT (NMT) group. The NMT group will receive standard care that does not include MT. Participants in the MT group will practise with Meludia software for 4 weeks and later for 12 additional weeks. Outcomes will include scores in: ‘Listening Up’ exercises, the -Music-Related Quality of Life questionnaire, the Music Questionnaire for Paediatric Population, Disyllables in silence, Matrix test, Mini Mental State Examination, Performance IQ and the Wechsler intelligence scale for children and the Assessment of Quality of Life—8 Dimensions questionnaire. The NMT group will receive standard care that does not include MT.

Ethics and dissemination
On 16 October 2023, the study protocol was approved by the La Paz Hospital in Madrid (Spain). The findings of this study will be published in peer-reviewed publications and presented at appropriate conferences.

Trial registration number
NCT06540677.

Introduction
Childbirth-related perineal trauma (CRPT) is the most common complication of childbirth, affecting 80% of women after a vaginal birth. However, there is a lack of evidence regarding the care of women following CRPT. Specifically, there is a lack of understanding regarding appropriate postnatal CRPT management, wound assessment and treatment of complications. To improve maternal outcomes, this qualitative study aims to explore women’s and healthcare professionals’ (HCPs) views and experiences of current CRPT wound management and healing to understand what they would want from an assessment tool and related care pathway being developed by the Chapter programme of research.

Methods and analysis
A qualitative study guided by an interpretive descriptive approach will be undertaken to explore the views and experiences around CRPT. This will be conducted through individual interviews and focus groups with women (n~40 participants) who have experienced CRPT within the last 12 months and individual interviews with HCPs (n~25) who care for women who have experienced CRPT. Supported by specialist interpreters where needed, data collection will be audio recorded and transcribed. Data will initially be analysed using codebook thematic analysis for targeted analysis and then using the Framework Method to facilitate a systematic and flexible exploration of themes within and between groups.

Ethics and dissemination
This study has received ethical approval from the University of Birmingham Science, Technology, Engineering and Mathematical Ethics Review Committee (ERN_23–0666). Supported by a Patient Advisory Group, this study will contribute to the overall outputs and dissemination of the Chapter programme of research, including a core outcome set for trials investigating the care of women experiencing CRPT, the development of a Wound Assessment Tool, professional resources and guidelines for best practice and patient resources. Findings will be disseminated via conference presentations, peer-reviewed publications, the National Institute for Health and Care Research Journals Library, relevant media platforms and plain language summaries, including infographics.

ISRCTN registration number
45172.

Objectives
This study systematically characterises policies related to the prevention and control of non-communicable diseases (NCDs) at the provincial primary healthcare (PHC) level, identifying key characteristics and potential gaps compared with national policies.

Study design
Policy review and thematic content analysis.

Methods
Policy documents from Guangdong and Heilongjiang provinces (2009–2023) were analysed using the WHO’s six building blocks framework. A total of 135 eligible documents were included, with thematic analysis conducted to categorise policies as ‘extension’ or ‘reduction’ based on their alignment with national directives.

Results
12 major policy initiatives were identified, with most themes reflecting provincial adaptations (‘extension’) of national strategies. Leadership and governance, medicines and technologies and service delivery received robust policy support, while health information systems lagged. Provincial policies demonstrated significant multisectoral collaboration, though gaps in health financing and workforce capacity persisted.

Conclusions
To strengthen PHC-based NCD control, future reforms must prioritise multisectoral collaboration, interoperable digital health systems and tailored health education. Addressing regional disparities in policy implementation is critical for equitable outcomes.

Objectives
Considerable resources are invested in health system innovation and strengthening. This calls for efforts to ensure the sustainability of such interventions. We conducted a scoping review to identify factors influencing the sustainability of externally funded health system strengthening interventions targeting primary healthcare, the sustainability outcomes observed in such interventions and the methods used to measure sustainability.

Design
Scoping review following the Joanna Briggs Institute scoping review guidelines.

Data sources
Web of Science, Ovid Medline and Embase databases were searched through 11 March 2024.

Eligibility criteria
Studies in English with no restriction on study type or country. Externally funded health system strengthening interventions targeting primary health systems and measuring sustainability.

Data extraction and synthesis
One reviewer screened all titles and abstracts, and two independent pairs of reviewers read full texts. Relevant study data were extracted from the articles and descriptively analysed.

Results
From the 6439 titles retrieved, eight eligible studies were identified and included in the final analysis. Only four studies presented a sustainability definition. Institutionalisation and continued programme activities were described four times as sustainability outcomes, followed by capacity building twice and continued health impact and benefits once. Sustainability was assessed in five studies after intervention completion and in three studies during the implementation period. The sustainability factors were mostly related to processes (n=19), inner context (n=18), intervention characteristics (n=12) and outer context (n=11), with stakeholder engagement and partnership (n=6) as well as funding (n=3) being the most reported factors.

Conclusion
This review highlights the limited documentation on the sustainability of externally funded health system strengthening interventions. Sustainability was mainly assessed retrospectively. Influencing factors spanned over all categories of the integrated sustainability framework, with stakeholder engagement and funding playing key roles. Planning for sustainability assessments with clear definitions, methods and timeframes can enhance evidence on achieving lasting impacts of health system strengthening interventions.

Registration
Open Science Framework, https://osf.io/hazqp/?view_only=d53472afbba447e790049d81ca60aa29.

Stroke, Ahead of Print. BACKGROUND:The long-term benefits of endovascular thrombectomy (EVT) for basilar artery occlusion (BAO) in patients with low National Institutes of Health Stroke Scale scores upon admission remain unclear. This study aimed to compare the 1-year clinical follow-up outcomes of best medical management (BMM) alone versus BMM plus EVT.METHODS:Patients with BAO and admission National Institutes of Health Stroke Scale score of ≤10 at 65 stroke centers in China from December 2015 to June 2022 were retrospectively enrolled. The primary outcome was favorable functional outcome (a modified Rankin Scale score of 0–3 at 1 year). Early (door-to-puncture time ≤120 minutes) and late EVT (door-to-puncture time >120 minutes) classifications were defined as surrogates for comparing initial treatment with EVT versus late (potentially rescue) EVT after initially being treated with BMM only. Multivariable logistic regression and propensity score matching analyses were used to assess the association between treatment and outcomes.RESULTS:Among 1232 patients who had 1-year follow-up data, 856 (69.5%) were male, and the mean (SD) age was 65 (12) years. After adjustment for confounders, there were no significant differences between EVT and BMM in favorable functional outcome (odds ratio, 0.96 [95% CI, 0.71–1.29];P=0.778). The cumulative 1-year mortality rate was 16.4% in the EVT group versus 13.7% in the BMM group (odds ratio, 1.23 [95% CI, 0.86–1.77];P=0.262). Predefined subgroup analyses revealed that late EVT was inferior to early EVT (odds ratio, 0.47 [95% CI, 0.28–0.79];P=0.005), while no significant difference was observed between BMM and early EVT in 1-year outcomes (odds ratio, 0.87 [95% CI, 0.63–1.21];P=0.421).CONCLUSIONS:In this long-term follow-up study among patients with BAO admitted with a National Institutes of Health Stroke Scale score of ≤10, there were no significant differences in functional outcomes and mortality at 1 year between BMM plus EVT and BMM alone.

Stroke, Ahead of Print. BACKGROUND:Although many studies have suggested that white matter hyperintensity (WMH) severity predicts naming and aphasia severity in chronic poststroke aphasia, there are inconsistencies in the literature. WMHs are typically symmetrical in neurotypical controls, and measuring WMH in the contralateral hemisphere is likely the best option to estimate brain health independently from the stroke lesion and avoid measurement contamination from stroke-related gliosis. In this study, we aimed to clarify the discrepancies in the literature by testing whether WMH rating methods are related to clinical outcomes.METHODS:Ninety-five participants with chronic aphasia at least 12 months after their left-hemisphere stroke completed a baseline Western Aphasia Battery and the Philadelphia Naming Test. All participants then underwent 6 weeks of phonological and semantic naming treatments focused on improving lexical processing, and the Philadelphia Naming Test was readministered immediately following treatment. Using the Fazekas scale, WMH severity was independently rated on the whole brain and the right hemisphere only. Their relationship of WMH behavior was calculated by accounting for age, lesion volume, time poststroke, years of education, and sex.RESULTS:There were significant positive correlations between whole-brain and right-hemisphere ratings of WMH, but Wilcoxon signed-rank tests revealed that whole-brain ratings were consistently higher (whole brain M=3.337, right hemisphere M=2.899;P

New England Journal of Medicine, Volume 392, Issue 16, Page 1637-1645, April 24, 2025.

Objective
To assess the association of C-reactive protein (CRP) with postoperative infections for eight different types of surgery using big data.

Design
A multicentre cohort study with longitudinally collected data from electronic health records, collected from 1 January 2011 to 22 September 2023.

Setting
Data of two tertiary medical centres in the Netherlands were used.

Participants
This study included all procedures (42 125 in total) in adult patients undergoing surgery in two tertiary medical centres in the Netherlands.

Outcome measures
The primary outcome was the association between CRP and a postoperative infection in the first 30 days postoperatively. Postoperative infection was defined by an action-based definition, that is, patients had to be treated for an infection with anti-microbial treatment and/or an intervention (eg, surgical drainage) to be classified as having a postoperative infection. CRP measurements were divided into a reference group (0–5.0 mg/dL) and four groups for comparison (5.1–10.0 mg/dL, 10.1–15.0 mg/dL, 15.1–20.0 mg/dL and >20.0 mg/dL). Subgroup analyses were performed for eight major surgical subspecialties and for the two medical centres separately.

Results
A total of 175,779 CRP measurements were performed, of which the majority was drawn in the first postoperative week. The ORs for developing a postoperative infection varied between 1.0 (0.9–1.1 95% CI) and 12.0 (9.5–15.1 95% CI), with a stronger association for the higher level of CRP categories and when more time had elapsed since surgery. Sensitivity ranged between 11% and 34%, specificity ranged between 64 and 95%, and the positive and negative predicting value ranged between 12% and 51% and 88% and 94%, respectively. For the surgical subspecialties and the two hospitals separately, similar results were found.

Conclusion
In this study, an elevated postoperative CRP was associated with postoperative infections with a stronger association for higher CRP levels. The association was stronger if a longer time had elapsed since surgery, which contrasts with the moment most CRP measurements were done, namely in the first postoperative week. Clinicians should take the evolving value of CRP in mind when using it in the diagnosis of postoperative infections.

Introduction
The human papillomavirus (HPV) vaccine can effectively prevent cervical cancer, yet HPV vaccine uptake is particularly low in some low-income settings, due to supply and vaccine confidence barriers. HPV vaccine confidence has also been found to be lacking among healthcare workers in some countries, including Nigeria. Nigeria has a long history of low vaccine confidence in some parts of the country. HPV vaccine rumours and concerns have been observed throughout the country, including among healthcare workers. Interventions that specifically address healthcare workers’ vaccine confidence are limited, since vaccine confidence is often assumed among this group. The aim of our pilot cluster randomised control trial (cRCT) is to evaluate the feasibility of conducting a trial that evaluates codesigned interventions to improve HPV vaccine confidence in healthcare workers and the acceptability and feasibility of delivering this intervention.

Methods and analysis
This is a 3-arm pilot cRCT, using a mixed-methods approach to assess the feasibility of the trial design, alongside the feasibility and acceptability of intervention delivery in two states in Nigeria (Jigawa and Oyo). We will implement two interventions: one with a focus on digital delivery, and one with an HPV champion present at a health facility. Both will be compared with a control arm, providing standard information on HPV vaccine only. Overall, 12 trial clusters (six in Jigawa and six in Oyo), defined as government primary healthcare facilities, will be randomised using a 1:1:1 ratio, stratified by state. All healthcare workers within these facilities will be eligible to take part in the intervention and evaluation. The primary outcome of interest will be intervention uptake, as a measure of subsequent trial feasibility given concerns around contamination in control clusters. This will be assessed through an endline healthcare worker survey. Intervention feasibility and acceptability will be assessed through quantitative intervention monitoring and qualitative interviews with healthcare workers.

Ethics and dissemination
We received approval from Jigawa State Ethics Committee (ref: JGHREC/2023/151), Jigawa Ministry of Health (ref: MOH/PH/PHRAT/MN/23/003), Oyo State Research Ethics Review Committee (ref: AD/13/479/362A), The University of Ibandan and University College Hospital Research Ethics Committee (UI/UCH Ethics Committee) (ref: UI/EC/23/308) and from the Swedish National Ethics Review Board (2023-04772-01-471058). Data will be presented in manuscript form and submitted to relevant conferences for dissemination.

Registration details
The pilot trial has been registered with ISRCTN—the UK’s Clinical Study Registry, registration number ISRCTN37847119.

Objectives
To evaluate whether loneliness was associated with transition rates to and between healthcare settings and death in older adults and to examine whether associations were modified by sex.

Design
Retrospective cohort study.

Setting
Ontario, Canada, from December 2008 to February 2020.

Participants
Community-dwelling, Ontario respondents (≥65 years) to the 2008/2009 Canadian Community Health Survey—Healthy Aging (CCHS-HA).

Exposure
Baseline loneliness was measured with the Three-Item Loneliness Scale in the CCHS-HA. Respondents were classified as not lonely, moderately lonely or severely lonely.

Primary outcome measures
Healthcare transitions were assessed over a 12-year period through linkage to health administrative records. Relative rates of transition to and between community, inpatient hospitalisation, home care and long-term care (LTC) settings, as well as death, were estimated using a continuous-time multistate transition framework. Adjusted models were weighted and tested for sex interactions.

Results
Of 2671 respondents (weighted n=1 398 180), 20.9% were moderately lonely and 12.0% were severely lonely. Compared with those who were not lonely, moderately lonely respondents transitioned at a faster rate from the community to home care, and severely lonely respondents transitioned at a faster rate from the community to LTC; although, both associations were attenuated with adjustment (RRML 1.37; 95% CI 1.00 to 1.85 and RRSL 1.96; 95% CI 0.99 to 4.12, respectively). Female and male respondents had mostly similar transition patterns.

Conclusions
Our findings suggest that loneliness may hasten transitions from the community to home care and LTC settings in older adults, although these transitions are mostly driven by related health and social factors.

Introduction
Irritable bowel syndrome (IBS) is one of the most common chronic gut–brain interaction disorders. Nevertheless, there is currently no treatment for IBS. Low-grade inflammation and oxidative stress are contributing factors to the increased perception of abdominal pain and heightened sensitivity of the nervous system in these patients. Spirulina platensis is a rich source of essential nutrients, including amino acids, vitamins, minerals, phytochemicals, essential fatty acids and fibre. It has been found that Spirulina possesses a variety of therapeutic properties such as antioxidant, anti-inflammatory and antidepressant effects, which may be advantageous in reducing complications of IBS. The aim of present randomised clinical trial (RCT) is to assess the efficacy of Spirulina supplementation on IBS.

Methods and analysis
This study is a 12-week, 1:1 parallel-group, double-blinded, randomised controlled trial. Sixty adult individuals diagnosed with IBS according to the Rome IV criteria will be randomised to consume either Spirulina capsules (500 mg) or a placebo, two times a day. The primary outcomes of this RCT are the changes in the IBS quality of life, severity of IBS symptoms, and gut permeability from baseline to 12 weeks of the intervention. The secondary outcomes are the changes in the serum total antioxidant capacity and serum malondialdehyde from baseline to the end of intervention. If this RCT demonstrates significant results in gut permeability, antioxidant status and reduction in IBS symptoms, it could support the use of Spirulina in managing IBS and could potentially reduce healthcare costs.

Ethics and dissemination
The study protocol has been approved by the Medical Ethics Committee of Isfahan University of Medical Sciences, Isfahan, Iran (ID: IR.MUI.RESEARCH.REC.1401.370). Findings will be presented in subsequent publications.

Trial registration number
IRCT20140208016529N8; Iranian Registry of Clinical Trials; registered on 25 April 2023.

We walk past the old, slump block house, & I can’t help but glance at the blinds, drawn down like surrendering eyelids. The front yard has a small, white statue of Mary Magdalene with her palms turned up in what could either be a gesture of welcome or a sign of dismay. Once, as part of a home health care company, I was inside, speaking with a woman who thought I was her grandson. I corrected her the first time, but afterwards, I went along with the story. It was easier. My job was to get her up & walk with her around the home, where residents gazed with peach-pit eyes at the television & waited for a savior to come. We walked on a thin, cement path that lined the backyard, between geraniums arranging their lipstick toward the light. We came to know each other. I learned that she grew up in a small farming town not far from my real grandmother, which explained her familiar tenderness & prolonged drawl. After several days of this, she asked if I would go to her house & check on the roses, like her husband & son had done before they died, tragically, in the same 12 months. I don’t know why, but I did. It was summer, & roses are not a hardy plant. The raised bed held nothing but a crisp, brown carcass. Rather than lie, I bought a 3-gallon rose plant at the nursery & returned with a shovel. That way, I could say Don’t worry, as she breathed more heavily, as the day came she could not leave her bed, they are doing alright. It was true— I’d managed to fix her irrigation, & I shouldn’t have expected, I guess, more than one miracle. So when she died two weeks later, her room a blank slate, all I could think about— & all I can see for a block after passing that house— was that she’d never said goodbye to her grandson & the deep, deep red of those roses.

Introduction
Children with Medical Complexities (CMC) often require 24/7 expert care, which frequently necessitates prolonged (re)admissions to a university medical centre (UMC), thereby impeding discharge to home. The transition from hospital to home for CMC is a multifaceted process with numerous challenges and obstacles. This protocol describes the evaluation of an innovative transitional care unit (TCU), where families can stay together in a home-like environment between hospital and home. Under the supervision of healthcare professionals, parents are supported in preparing for a sustainable home situation. We hypothesise that an intermediate stay at the Jeroen Pit Huis (JPH) will have a favourable effect on healthcare consumption, patient, parent and family-relevant outcomes in comparison to discharge directly from a hospital ward to home. Therefore, the purpose of this study is to compare the transition via the TCU JPH versus transition from hospital ward to home as provided elsewhere for CMC patients in the Netherlands.

Methods and analysis
This observational prospective cohort study compares patients who transition directly from hospital to home with those who transition via the TCU. The control group comprises five UMCs in the Netherlands. Data will be collected by extracting information from electronic health records and through online questionnaires. Parents complete questionnaires at three time points: on discharge home, 3 months and 12 months postdischarge. Bayesian inverse probability weighting will be used to control for confounding effects and analyse the results.

Ethics and dissemination
Ethical approval was granted by the Amsterdam UMC Medical Ethics Committee (W20_220#20.007). The need for ethical approval was waived by all other participating UMCs. Results will be disseminated through peer-reviewed scientific journals and conference presentations. The insights gained from this study will contribute to the development of a national care pathway to enhance transitional care for CMC and their families in the future.

Trial registration number
NCT06599398 (ClinicalTrials.gov) – Bridging Hospital to Home for CMC and Their Families.

Introduction
As the global population ages, the incidence of cardiometabolic diseases and associated healthcare costs rise. There is a critical need for preventive interventions enabling long-lasting treatment effects to address the decline in physical performance and metabolic health among older adults. The RESTART (RE-inventing Strategies for healthy Ageing: Recommendations and Tools) randomised controlled trial (RCT) aims to evaluate whether a complex lifestyle intervention can improve and maintain cardiorespiratory fitness, muscle strength and body composition among older adults with elevated cardiometabolic risk.

Methods and analysis
This is the study protocol for the RESTART trial, a two-arm, open-label, parallel-group RCT conducted in Tromsø, Norway, targeting adults aged 60–75 with obesity, a sedentary lifestyle and high cardiovascular risk. Participants are block-randomised (1:1) into either an intervention or active control group. The initial intervention phase (12 months) includes: (a) supervised high-intensity aerobic and strength training (≥85% of maximum capacity) performed two times weekly, (b) behavioural counselling based on acceptance and commitment therapy during six group sessions and (c) dietary guidance based on national nutrition recommendations during two group/two individual sessions. After 12 months, participants are gradually introduced to exercise sessions offered by local organisations and fitness centres, to enable independent maintenance of lifestyle change. The primary outcome is a change in cardiorespiratory fitness (VO2max) at 24 months. Secondary and tertiary outcomes include additional parameters potentially sensitive to lifestyle change, such as 1-repetition maximum muscle strength, muscular power, device-measured physical activity levels, body composition, waist circumference, body weight, cognitive function and self-reported health-related quality of life. Data collection is scheduled at baseline, 6, 12 and 24 months, with health economic and qualitative analyses to evaluate the intervention’s impact and participant experiences.

Ethics and dissemination
Ethical approval for the RESTART trial was obtained from the Regional Committee for Medical Research Ethics in Northern Norway. Results will be disseminated through peer-reviewed publications, conferences and community-based channels targeting older adults, healthcare providers and municipal health organisations. This trial will also inform public health strategies for lifestyle interventions among ageing populations.

Trial registration number
NCT06122441.