Search Results for: Linee Guida per le cure post-parto

Introduction
The COVID-19 pandemic disrupted healthcare delivery for patients with breast cancer. eHealth solutions enable remote care and may improve patient activation, which is defined as having the knowledge, skills and confidence to manage one’s health. Thus, we developed the Breast Cancer Treatment Application (app) for patients and practitioners to use throughout the cancer care continuum. The app facilitates virtual assistance, delivers educational resources, collects patient-reported outcome measures and provides individualised support via volunteer e-coaches. Among newly diagnosed patients with breast cancer, we will compare changes in patient activation, other patient-reported outcomes and health service outcomes over 1 year between those using the app and Fitbit, and those receiving standard care and Fitbit only.

Methods and analysis
This randomised controlled trial will include 200 patients with breast cancer seen at a tertiary care cancer centre in Ontario, Canada. The intervention group (n=100) will use the app in addition to standard care and Fitbit for 13 months following diagnosis. The control group (n=100) will receive standard care and Fitbit only. Patients will complete questionnaires at enrolment, 6 and 12 months post-diagnosis to measure patient activation (Patient Activation Measure-13 score), distress, anxiety, quality of life and experiences with their care and information received. All patients will also receive Fitbits to measure activity and heart rate. We will also measure wait times and number of visits to ambulatory care services to understand the impact of the app on the use of in-person services.

Ethics and dissemination
Ethics approval was obtained on 6 January 2023. Protocol version 2.0 was approved on 6 January 2023. The trial is registered with ClinicalTrials.gov. Study findings will be disseminated via publication in a peer-reviewed journal and shared with participants, patient programmes and cancer awareness groups. The app has also been approved as a secure communication method at our trial institution, thus we are well-positioned to support future integration of the app into standard care through collaboration with our hospital network.

Trial registration number
NCT05989477.

A Roma Villaggio della Salute. Il Vespucci si illumina di rosa

Introduction
Excessive sedentary time (ST) is linked to dementia risk, poorer attentional control and episodic memory. These cognitive decrements have been associated with decreased functional connectivity (FC) in the frontoparietal network (FPN) and default mode networks (DMN) with ageing. Physical activity (PA) interventions can enhance FC in these networks, but these interventions are not designed to decrease ST among older adults. Prolonged sitting (ie, sitting continuously for ≥20 min) can acutely reduce frontoparietal brain function and attentional control, while a single PA bout lasting at least 20 min can enhance them. It has been theorised that stimulation of the cerebral norepinephrine release through peripheral increase in catecholamines may explain this effect. In contrast, the effects of shorter (

Stroke, Ahead of Print. BACKGROUND:Persistent upper extremity (UE) impairment is common after stroke. Durable treatment benefits for chronic ischemic stroke are needed. The purpose of this report is to determine the long-term effects of vagus nerve stimulation paired with rehabilitation on impairment, activity, and participation in people with UE impairment after ischemic stroke.METHODS:This is a post hoc analysis of data from the VNS-REHAB (A Pivotal Randomized Study Assessing Vagus Nerve Stimulation [VNS] During Rehabilitation for Improved Upper Limb Motor Function After Stroke) randomized clinical trial. Here, we report unblinded, partial crossover, and pooled 1-year outcomes. Initially, 108 participants across 19 sites with chronic ischemic stroke and moderate-to-severe UE impairment were enrolled in VNS-REHAB. Participants received 18 sessions of in-clinic intensive task-specific rehabilitation and 3 months of self-initiated home-based exercise with either real (active) or sham (control) vagus nerve stimulation. Thereafter, Control participants crossed over to receive in-clinic therapy paired with active stimulation. All participants performed home-based exercises paired with self-initiated active stimulation for 1 year. The Fugl-Meyer Assessment UE, Wolf Motor Function Test, and participation outcomes were assessed through 12 months.RESULTS:Seventy-four participants (69%; 51 male; age, mean±SD, 59.6±8.9) completed 1-year follow-up and provided pooled data through 1 year. At 1 year, compared with baseline, there were improvements in impairment (Fugl-Meyer Assessment UE, 5.23 [95% CI, 4.08–6.39];P

We read with interest the recently published randomised controlled trial (RCT) ‘SPHINX’,1 addressing the role of endoscopic sphincterotomy (ES) with fully covered s metal stent (FCSEMS) placement in preventing post-ERCP pancreatitis (PEP). Although this is the largest RCT on the topic, several concerns warrant discussion. Published data report variable rates of PEP after SEMS ranging from 0% to 26.8%,2–4 with lot of heterogeneity regarding the PEP preventive measures. Nevertheless severe pancreatitis remains rare. To assess the impact of ES a larger sample size will be required. The SPHINX trial sample estimation was based on two studies by Tol et al,5 which reported 18% PEP with FCSEMS placement in the preoperative biliary drainage setting, and Zhou et al,6 31.7% PEP in the non-ES group, which is way higher than the presumed 16% in the SPHINX trial. Furthermore, it…

We thank Ramchandani et al for their letter on the SPHINX trial and appreciate the opportunity to address their points.1 2 Sample size The SPHINX trial aimed to assess whether endoscopic sphincterotomy (ES) could reduce post-ERCP pancreatitis (PEP). However, quantifying this effect proved difficult due to conflicting results from previous, heterogeneous randomised controlled trials (RCTs), which differed in sample size, patient populations and stent types.3–5 The trial by Zhou et al (2012) reported a 69% relative risk reduction in PEP after ES, which served as reference for our sample size calculation.3 However, since the other trials did not show this benefit, we considered this effect overestimated.4 5 The SPHINX trial was designed to detect a 50% relative risk reduction in PEP in patients with suspected distal malignant biliary obstruction (MBO). Based on…

Background
Treatment strategies for Crohn’s disease (CD) suppress diverse inflammatory pathways but many patients remain refractory to treatment. Autologous haematopoietic stem cell transplantation (SCT) is an emerging therapy for medically refractory CD though the mechanisms through which it circumvents refractory pathophysiology are unknown.

Objective
The objective of this study is to understand how the immune system reconstitutes post-SCT and whether SCT may function as a cellular therapy restoring appropriately responsive immune cell populations from haematopoietic stem cells (HSCs).

Design
Adults with CD with active clinical and endoscopic disease who failed available medical therapies were enrolled in a phase II study of SCT for refractory CD (n=19). Blood and intestinal samples were collected longitudinally and analysed using CyTOF and scRNA-seq. Stem cell autografts were functionally assayed in mouse xenograft models.

Results
scRNA-seq and CyTOF analyses reveal that SCT predominantly affected the intestinal myeloid lineage with loss of inflammatory populations and return of macrophages capable of supporting mucosal healing. Xenograft models using patient HSCs suggested that HSCs support the early reconstitution of the myeloid lineage and reveal an impairment of short and long-term HSC engraftment that may determine SCT outcomes.

Conclusions
This study suggests SCT functions as a myeloid-directed cellular therapy reinforcing the critical role of macrophages in refractory CD pathophysiology and as a target for cellular therapies. Furthermore, we report an unrecognised functional heterogeneity among HSC subpopulations in CD that may be relevant to our understanding of CD treatment and pathophysiology.

Objectives
This study aims to identify factors influencing medication adherence for deep vein thrombosis (DVT) prophylaxis in post-discharge patients after joint replacement surgery using Protection Motivation Theory (PMT).

Design
This study employed qualitative semi-structured interviews with patients discharged after hip or knee replacement surgery.

Setting
Using purposive sampling to ensure a diverse representation of patient profiles, participants were recruited from patients who underwent total knee replacement surgery from April 2024 to May 2024 and were discharged 1-month prior.

Participants
12 patients who had undergone total knee replacement surgery participated in the study. The median (IQR) age of participants was 57.5 (55–67.25) years.

Analysis
Semi-structured interviews were conducted via online video calls. These interviews were audio recorded and transcribed verbatim. Data were analysed using Colaizzi’s seven-step method. Themes were identified based on the dimensions of the PMT: susceptibility, severity, internal rewards, external rewards, response efficacy, self-efficacy and response costs. Two researchers independently coded and extracted themes, with discrepancies resolved through team discussions and verification with respondents.

Results
Participants acknowledged the importance of adhering to anticoagulant medication to prevent DVT and its complications, understanding the severe consequences, such as the life-threatening nature of pulmonary embolism and the impact on daily activities. Perceived health status influenced adherence, with some participants feeling their good health negated the need for anticoagulants. External factors, including the desire to avoid side effects and financial constraints, also played significant roles in adherence decisions. Belief in the effectiveness of anticoagulants motivated adherence, but confidence in managing medication varied among participants. Practical barriers such as physical limitations and psychological burdens significantly impacted adherence.

Conclusions
Improving medication adherence requires a multifaceted approach addressing cognitive, motivational and practical barriers. Continuous education, financial assistance, support systems and tailored interventions are crucial. PMT provides a robust framework for understanding and enhancing adherence behaviours, ultimately improving health outcomes in post-discharge joint replacement patients.

Objective
To explore female sex workers’ perception, concern and acceptability of OraQuick HIV self-test (HIVST) in Woldia town, North Wollo, Ethiopia, in 2024.

Design
The study used a phenomenological design and the Integrated Behaviour Model as a theoretical framework.

Setting
Woldia town, Ethiopia, is the capital city of North Wollo Zone.

Participants
Twenty female sex workers and 18 key informants in Woldia town were involved.

Results
Most participants had a positive attitude towards testing with these devices and anticipated positive consequences, such as enhanced privacy, decreased waiting time, reduced transportation costs, increased accessibility for immobile individuals, elevated utility in index case screening and testing programmes and the provision of confidential, trustworthy and reliable test results. Most female sex workers perceived that significant people in their social environment approved and used OraQuick HIVST. The facilitators to uptake of OraQuick HIVST among female sex workers included privacy, ease of use and nonrequierement for trained healthcare providers when testing. Thus, most female sex workers were confident in their ability to test themselves and interpret their test result using OraQuick HIVST.
To optimise uptake of testing using OraQuick, female sex workers proposed supplying kits in an easily accessible manner, increasing awareness about the kit and advocating for and promoting that the kits are strategies to facilitate HIVST uptake and maximise individuals’ self-efficacy. The perceived possible concerns or barriers to the uptake of OraQuick HIVST included a shortage of kits, doubts about reliability prior to education, absence of policies or guidelines for HIVST, lack of post-test counselling and immediate treatment for positive individuals, potential psychological trauma such as suicidal ideation or attempts, lack of linkage to care for those with reactive results and inaccurate reporting of positive results or result concealment.

Conclusion
This finding suggests that OraQuick HIVST was acceptable to female sex workers in the study area, with the majority of female sex workers having a positive attitude, supportive social norms and self-efficacy. Therefore, interventions to increase awareness, advocate for the kit and address perceived concerns or barriers to HIVST are needed to maximise its uptake in the study setting.

Introduction
Patients with chronic limb-threatening ischaemia (CLTI) are often prescribed clopidogrel in order to reduce their risk of major adverse limb and cardiovascular events. Clopidogrel is metabolised by the CYP2C19 enzyme and genetic variations in CYP2C19 are common. These variants can influence an individual’s ability to metabolise clopidogrel to its active metabolite. Few studies have investigated the relationship between patient genotype and outcomes in vascular surgery. This work aims to establish the relationship between patient genotype and outcomes after revascularisation in patients with CLTI who are prescribed clopidogrel. It will consider whether pharmacogenetics can be used to ensure patients are prescribed effective medications to optimise their outcomes.

Methods and analysis
This is an observational cohort study of patients undergoing lower limb surgical, endovascular or hybrid revascularisation for CLTI at Manchester University NHS Foundation Trust. Patients taking clopidogrel post-procedure, as well as those prescribed a non-clopidogrel based medication regimen, will be recruited prior to or shortly after revascularisation. Patients will undergo CYP2C19 genotyping and will be followed up using online records. The study has 90% power to detect 114 amputations with a target sample size of 483 participants. The primary outcomes are risk of amputation at 1 year and a composite endpoint for the risk of major adverse limb events (MALE) or death from any cause at 1 year. Secondary outcomes are risk of MALE at 1 year, risk of major adverse cardiovascular events (MACE) or death from any cause at 1 year, death within 30 days of revascularisation, minor re-interventions at 1 year, total number of re-interventions at 1 year and rate of systemic or gastrointestinal bleed at 1 year.
Risk of amputation, MALE and MACE will be analysed using Cox models. All remaining outcomes will be analysed using negative binomial models. Potential competing events for the risk of amputation will be investigated as part of a sensitivity analysis. Patients given a non-clopidogrel-based medication will be compared as an additional analysis.

Ethics and dissemination
Manchester University Research Ethics Committee approval obtained as part of the Implementing Pharmacogenetics to Improve Prescribing (IPTIP) trial process (IRAS 305751). The results of the study will be published in a peer-reviewed journal and presented at international conferences.

Registration
This work is a sub-protocol for the IPTIP study which is registered as ISRCTN14050335.

Previsti in 30 milioni. Le raccomandazioni di Oms, Ecdc e Iss

This study examines post–COVID-19 pandemic cancer screening rates in 2023 relative to previously documented declines through 2021.

Objectives
To monitor the safety and utilisation of AZD1222 under real-world use in the UK.

Design
A non-interventional post-authorisation active surveillance study.

Setting
Vaccination sites in the UK.

Participants
A total of 17 945 participants were eligible and provided consent to participate in the study between 1 March 2021 and 6 April 2023. Participants were followed up at weeks 1, 4 and 14 and at months 6, 9, 12 and 18 after the first dose of AZD1222 vaccination and prompted to complete electronic data capture forms. A total of 11 219 participants submitted a Follow-Up 1 form and 5189 participants submitted a Follow-Up 7 form (at 18 months).

Primary and secondary outcome measures
The safety of AZD1222, including the identification, assessment and quantification of serious adverse events (SAEs) and adverse events of special interest (AESI), was examined. The utilisation of AZD1222 was described and characterised, including populations with missing information.

Results
The majority of participants were women (n=10 845; 60.4%) and the median age (IQR) was 50 (43, 62) years. Most participants were from white ethnic groups (n=13 112; 73.1%). Headache and fatigue had the highest reported incidence rate (421.28 cases per 1000 person years and 386.00 cases per 1000 person years, respectively). The most frequently reported AESI was anosmia (6.25 cases per 1000 person years). An increased Observed versus Expected (O:E) ratio was seen for anaphylaxis (O:E 7.38 (95% CI 2.80 to 11.95); based on 10 observed cases (expected cases: 1.36)) and anosmia and/or ageusia (O:E 39.23 (95% CI 29.13 to 49.32), based on 58 observed cases (expected cases: 1.48)).

Conclusions
The most frequent vaccinee-reported adverse events (AEs) were headache and fatigue. An increased O:E ratio was seen for the AEs of anaphylaxis and anosmia and/or ageusia. No safety signals were identified throughout the course of this study.

Trial registration number
This study is registered with the HMA-EMA Catalogue of RWD studies (EUPAS44035).

Introduction
Care transitions, particularly hospital discharge, present significant risks to patient safety. Deficient medication-related discharge communication is a major contributor, posing substantial risk of harm to older patients. This protocol outlines the Improved Medication communication and Patient involvement At Care Transitions (IMPACT-care) intervention study, designed to evaluate the effects of a multifaceted intervention for older hospitalised patients on medication-related discharge communication compared with usual hospital care.

Methods and analysis
A pre–post intervention study will be conducted in two surgical and one geriatric ward of a university hospital in Sweden. The study will begin with a control period delivering usual care, followed by a training period and then an intervention period. The intervention comprises four components performed by clinical pharmacists: (1) information package provided to patients and/or informal caregivers, (2) preparation of medication-related discharge documentation, (3) facilitation of discharge communication and (4) follow-up call to patients or their informal caregiver. Eligible participants are aged ≥65 years, manage their own medications independently or with informal caregiver support, and are admitted to the study wards. Each study period (control and intervention) will last until 115 patients have been included. The primary outcome is the quality of medication-related discharge documentation, assessed using the Complete Medication Documentation at Discharge Measure (CMDD-M). Secondary outcomes include patients’ perceptions of knowledge and involvement in discharge medication communication, and their sense of security in managing medication post-discharge; adherence to medication changes from hospitalisation that persist after discharge; and unplanned healthcare visits following discharge. A process evaluation is planned to explore how the intervention was implemented. Patient inclusion began in September 2024.

Ethics and dissemination
The study protocol has been approved by the Swedish Ethical Review Authority (registration no.: 2023-03518-01 and 2024-04079-02). Results will be published in open-access international peer-reviewed journals, and presented at national and international conferences.

Trial registration number
NCT06610214.