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

Thanks to Dr Zeng for his insightful comments1 about our recent publication on 12-month outcomes of endoscopic retrograde cholangiopancreatography (ERCP) for sphincterotomy for sphincter of Oddi disorders (SOD).2 Many of the comments were addressed in the discussion of the paper, especially the significance of the unmeasured placebo response and greater importance of patient characteristics such as somatisation and opioid exposure compared with physician-defined factors like a dilated duct. We disagree that RESPOnD’s heterogeneous patient population reduces the study’s generalisability. RESPOnD subjects represent the full spectrum of SOD subtypes and thus have lower selection bias compared with more stringent enrolment criteria. For example, restricting subjects to those with a dilated bile duct would have precluded our observation that duct size correlated poorly with response to sphincterotomy. As noted by Dr Zeng, sphincterotomy does not seem to be a promising intervention for idiopathic acute recurrent pancreatitis because…

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.

Introduction
To assess the effects of oral dydrogesterone on the recurrence rate of endometrial polyps (EPs) and abnormal uterine bleeding (AUB) symptoms after transcervical resection of polyps (TCRP).

Methods and analysis
A randomised, parallel, open-label, multicentre study will be conducted across 12 hospitals in China, including general and women’s specialty hospitals. In this study, we will recruit female patients aged 18–46 years diagnosed with EPs using transvaginal ultrasonography during two menstrual cycles. Eligible participants who have not received other oestrogen or progesterone treatments will be randomly assigned in a 1:1 ratio to either an intervention or control group. All participants will undergo TCRP, with the time between randomisation and surgery not exceeding 14 days. The intervention group will receive oral dydrogesterone for three menstrual cycles, whereas the control group will receive no hormonal treatment. The primary outcome is the recurrence rate of EPs, which will be evaluated using follow-up transvaginal ultrasonography at 1, 3, 6, 12, 18 and 24 months postsurgery. Secondary outcomes include assessment of AUB and menstrual status. For statistical analyses, a multivariate regression will be used to adjust for confounding factors.

Ethics and dissemination
This study protocol adheres to the Declaration of Helsinki and has been approved by the Women’s Hospital, School of Medicine, Zhejiang University (IRB-20240077-R). All participants in the trial will provide written informed consent. The study findings will be published in peer-reviewed journals and presented at academic conferences.

Trial registration number
ChiCTR2400083097.

Proietti (Gemelli), ‘colpito il 2-12% della popolazione. Più a rischio chi effettua lavori pesanti’

Introduction
Musculoskeletal shoulder pain is a common reason for people to be treated in physiotherapy services, but diagnosis can be difficult and often does not guide treatment or predict outcome. People with shoulder pain cite a need for clear information, and timely, tailored consultations for their pain. This trial will evaluate the introduction of a personalised guided consultation to help physiotherapists manage care for individuals with shoulder pain.

Methods and analysis
This is a cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of introducing a personalised guided consultation compared with usual UK NHS physiotherapy care. Physiotherapy services (n=16) will be randomised in a 1:1 ratio to either intervention (physiotherapy training package and personalised guided consultation incorporating a new prognostic tool) or control (usual care); 832 participants (416 in each arm) identified from participating physiotherapy service waiting lists aged 18 years or over with shoulder pain will be enrolled. Follow-up will occur at 3 time points: 6 weeks, 6 months and 12 months. The primary outcome will be the Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes include global perceived change of the shoulder condition, sleep, work absence and the impact of shoulder pain on work performance, healthcare utilisation and health-related quality of life (using EuroQol 5 Dimension 5 Level (EQ-5D-5L)). A multimethod process evaluation will investigate views and experiences of participants and physiotherapists, assess uptake, facilitators and barriers to delivery, and changes in factors assumed to explain intervention outcomes. Primary analysis of effectiveness will be by intention-to-treat, and a health economic evaluation will assess cost-utility of introducing the personalised consultation.

Ethics and dissemination
The trial received ethics approval from the Yorkshire & The Humber (South Yorkshire) Research Ethics Committee (REC reference: 23/YH/0070). Findings will be shared through journal publications, media outlets and conference presentations. Supported by patient contributors and clinical advisors, we will communicate findings through a designated website, networks, newsletters, leaflets and in the participating physiotherapy services.

Trial registration number
ISRCTN45377604.

Introduction
Sodium-glucose co-transporter inhibitors have potential glycaemic and non-glycaemic benefits in people with type 1 diabetes (T1D). However, the increased risk of diabetic ketoacidosis (DKA) limits their widespread use. We hypothesise that dapagliflozin 10 mg daily, combined with the use of continuous ketone monitoring (CKM) and education strategies to mitigate progression to DKA, will demonstrate improved glycaemic control without increasing DKA events.

Methods and analysis
PARTNER is a multisite 6-month randomised crossover double-masked study involving Australian adults with T1D who have a Haemoglobin A1c (HbA1c)

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
The objective of the Chinese Neonatal Follow-Up Network (CHNFUN) is to establish a standardised follow-up protocol for the assessment of high-risk preterm infants, and collaborative research aimed at improving early intervention and neurodevelopmental outcomes for preterm infants with gestational age less than 32 weeks in China. The CHNFUN is the first national neonatal follow-up network and has the largest geographically representative cohort from neonatal intensive care units (NICUs) in China.

Methods and analysis
A survey of neonatal follow-up clinics participating in CHNFUN was used to inform the development of a standardised protocol for the assessment of high-risk preterm infants in China. Training in the use of assessment tools and data collection was provided to all participating centres. Individual-level neurodevelopmental outcomes data from participating neonatal follow-up clinics will be collected at corrected age, 40 weeks, 3–4 months, 12 months, 18–24 months, 3 years and 6 years of age, using a unique database developed by the CHNFUN and linked to NICU outcomes data in the CHNN Database. Data will be prospectively collected on an ongoing basis from all surviving infants born at

Objectives
There is a lack of information about household factors associated with delayed measles, mumps and rubella (MMR) vaccination. We examined whether timeliness of first MMR (MMR1) receipt is associated with sharing a household with an older child with non-receipt of MMR1 independent of household composition and size.

Design
Longitudinal observational study using linked electronic health records.

Setting
North East London, UK.

Participants
The index cohort comprised 71 509 children (51.0% males) eligible to receive MMR1 between 1 January 2014 and 28 February 2020.

Methods
The primary outcome was MMR1 receipt between 12 months and 24 months of age. The explanatory variable was non-receipt of MMR1 between age 12 months and 24 months in the oldest child sharing the same household. We examined the likelihood of MMR1 receipt in index children sharing a household with an older child with non-receipt of MMR1 between 12 months and 24 months using logistic regression to estimate ORs and 95% CIs before and after adjustment for individual-level, household-level and area-level covariates. We carried out sensitivity analyses excluding households with an age interval between oldest and youngest child greater than 5 years.

Results
59 851 (83.6%) index children received MMR1 between 12 months and 24 months of age. After adjustment for household composition and size, MMR1 receipt was less likely in index children sharing a household with an older child with non-receipt of MMR1 between 12 months and 24 months of age: OR: 0.19 (95% CI: 0.18, 0.20). This association strengthened after excluding households with an age interval greater than 5 years: OR: 0.14 (0.13, 0.15).

Conclusions
There is strong concordance within households of delay in MMR1 receipt independent of household size and composition. Lack of timely protection within households increases the risk of measles outbreaks. There is a need for household-based interventions to improve MMR1 timeliness.

Introduction
Among lower extremity artery disease (LEAD), symptomatic carotid stenosis (SCS) and abdominal aortic aneurysm (AAA), the disease burden is insufficiently illuminated from a patient and societal perspective. Such knowledge is central to identifying patients at risk of poorer outcomes. Therefore, the Danish Vascular (DanVasc) survey aims to describe self-reported health status, health literacy, medication adherence and loneliness, including changes over time, and investigate characteristics associated with worse self-reported health at baseline and their associations with poorer outcomes within 1 year (healthcare utilisation and mortality) in patients with LEAD, SCS and AAA.

Methods and analysis
The DanVasc survey, a national prospective cohort study combining survey data measured at several time points with register-based data, includes validated patient-reported outcome measures (PROMs) and ancillary questions developed with patient representatives. Our baseline survey (T0) follows the index contact in vascular outpatient clinics with follow-up surveys determined by the patient’s trajectory: (1) newly referred patients in conservative treatment trajectories; the date for the outpatient visit activates 1-month (T1), 3-month (T2) and 12-month (T3) follow-ups. (2) Patients referred for vascular surgery; the surgery date activates 1-month (T1), 3-month (T2) and 12-month (T3) follow-ups. The included PROMs assess health-related quality of life (HRQoL), anxiety and depression, sleep, frailty status, health literacy, medication adherence and loneliness. For LEAD, a disease-specific PROM evaluates HRQoL. For AAA, disease-specific ancillary questions are added. Additionally, the DanVasc survey includes questions on health behaviour, preventive measures and sexual life. The DanVasc survey will be linked to national registries to obtain socio-demographic information and data on redeemed prescriptions, clinical information, healthcare utilisation, comorbidities and mortality. From December 2023 to December 2024, we aim to recruit approximately 5500 patients from all seven DanVasc surgery departments. Patient characteristics will be reported using descriptive statistics. Changes over time and factors associated with poorer health outcomes will be analysed using linear, logistic and Cox proportional hazard models, presented as univariate and multivariate regressions.

Ethics and dissemination
Approval for the collection of medical record data was granted by the Central Denmark Region, acting on behalf of all Danish regions (record 1-45-70-94-22). Consent to participate is obtained prior to answering the survey. Results will be disseminated through peer-reviewed scientific publications and conference presentations, and findings will be shared with patients and relevant stakeholders via public and social media.

Objective
To evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumour activity of AMG 404, a fully human IgG1 monoclonal antibody targeting programmed cell death-1, in patients with advanced solid tumours.

Design
First-in-human phase I study comprising eight dose expansion cohorts, including cohorts with microsatellite instability-high (MSI-H) tumours and non-small cell lung cancer with high programmed death-ligand 1 expression (NSCLC/PDL1-H, tumour proportion score ≥50%).

Setting
Conducted across 28 global sites.

Participants
This study enrolled adult patients with histologically or cytologically confirmed metastatic or locally advanced solid tumours not amenable to curative treatment with surgery or radiation. The inclusion criteria included a life expectancy of >3 months, ≥1 measurable or evaluable lesion per modified Response Evaluation Criteria in Solid Tumours (RECIST) V.1.1, an Eastern Cooperative Oncology Group performance status of ≤2 and adequate haematological, renal and hepatic function. Patients with prior treatment with checkpoint inhibitors, primary brain tumour or untreated or symptomatic brain metastases and leptomeningeal disease and history of other malignancy within the past 2 years were excluded.

Interventions
The planned doses were 240 mg, 480 mg and 1050 mg of AMG 404 administered every 4 weeks (Q4W).

Primary and secondary outcome measures
Primary endpoints were dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, changes in vital signs and clinical laboratory tests. Secondary endpoints included PK parameters, incidence of antidrug (AMG 404) antibodies and antitumour activity assessed per modified RECIST V.1.1 (objective response, duration of response, progression-free survival (PFS), disease control and duration of stable disease).

Results
A total of 171 patients were enrolled; 168 were treated. Median (range) follow-up was 36.3 weeks (1.6–137.1). No DLTs were observed. Grade 3 and serious treatment-related adverse events occurred in 16 (9.5%) and 12 (7.1%) patients, respectively. The 480 mg Q4W dose was selected as the recommended phase II dose. AMG 404 serum exposure increased approximately dose proportionally. The objective response rate (80% CI) was 19.6% (15.7–24.1) for the overall population and 36.6% (26.4–47.8) and 30.8% (14.2–‍52.3) for cohorts with MSI-H tumours (n=41) and NSCLC/PDL1-H (n=13), respectively. The overall disease control rate (80% CI) was 54.8% (49.5–59.9). The median (80% CI) PFS was 3.7 (3.5–4.5) months for the overall population and 14.8 (9.0–not estimable) and 4.4 (2.2–9.7) months for cohorts with MSI-H tumours and NSCLC/PDL1-H, respectively.

Conclusions
AMG 404 monotherapy was tolerable at the tested doses, with encouraging antitumour activity observed across tumour types.

Trial registration number
NCT03853109.

Background
Medical care for sleep-disordered breathing (SDB) in severe mental illness (SMI) is often ignored or poorly delivered. Here we describe an oximetry screening and management pathway for obstructive sleep apnoea (OSA) and assess the night-to-night reliability in a specialist cardiometabolic disease management clinic for patients with SMI.

Objective
The implementation and evaluation of a sleep service for patients living with SMI.

Design
Prospective evaluation of a translational programme.

Setting
A multidisciplinary outpatient clinic for patients with SMI.

Methods
The clinic was prospectively evaluated between May 2019 and December 2020. We used questionnaires and three nights of oximetry to screen patients for OSA. A project coordinator managed the testing-treatment pathway while liaising with health care providers. We also evaluated the agreement between two nights of oximetry.

Results
It is feasible to integrate sleep service into a cardiometabolic clinic for patients with SMI. Oximetry data were collected from 140/153 patients and 129/140 had at least adequate oximetry data for one night, and 107 (82%) had two nights. Oximetry indicated likely moderate-to-severe OSA in 33 patients and severe OSA in 22 patients. A total of 96/140 patients were referred to the SMI sleep clinic, and 40 (42%) recommended polysomnography (PSG) and 31 (78%) completed PSG. Of the 44 patients recommended continuous positive airway pressure (CPAP) therapy, 38 initiated CPAP and 20 (51.3%) demonstrated adherence ( >4 hours 70% of nights over 30 days). Bland-Altman analysis of two nights of oxygen desaturation events greater than 4% per hour found a mean difference of –0.2 (95% CI –14.0 to 14.0). Misclassification of OSA severity was seen in 12 patients (18.7%).

Conclusions
Our recount shows the feasibility and effectiveness of implementing a sleep service in a cardiometabolic clinic for patients with SMI, and using oximetry is an effective diagnostic test of SDB. Having a dedicated project coordinator to oversee the clinical pathway avoids fragmentation of clinical services.

Introduction
Pancreatic cancer, an aggressive cancer that presents with few or unspecific symptoms, has a poor prognosis. Thus, diagnosis at an early stage is vital for survival and a chance for curative treatment. Therefore, surveillance programmes for high-risk individuals are of the utmost importance. However, data on the psychological burden among participants in these programmes are limited.

Aims
This study aimed to investigate the psychological burden for participants in a pancreatic cancer surveillance programme and explore whether the psychological burden was related to the individual’s risk level for pancreatic cancer.

Methods
This single-centre cross-sectional study investigated cancer worry, anxiety, coping and perceived physical and mental health using a digital questionnaire, including the following instruments: Cancer Worry Scale (CWS), State–Trait Anxiety Inventory (STAI), 13-Item Sense of Coherence and 12-Item Short-Form Survey. The invited participants (n=413) were healthy individuals with an increased risk of pancreatic cancer enrolled in a pancreatic cancer surveillance programme.

Results
The results indicated high cancer worry among respondents (n=78) with high scores on CWS (mean, 16.45). The majority (69.3%) had scores indicating high cancer worry (≥14). Anxiety was not equally high among respondents (mean STAI-T, 35.13; STAI-S, 35.9). Female sex and younger age were significantly correlated with higher cancer worry and anxiety (p < 0.001). Outcomes in coping and perceived health were similar to those of the normal population. Conclusions Cancer worry is particularly high among participants. No correlation was found between the risk level and psychological burden.

Introduction
Intra-articular injections of mesenchymal stromal cells concentrates showed promising results in the treatment of knee osteoarthritis (OA). Among these, bone marrow aspirate concentrate (BMAC) has been widely adopted in clinical practice. More recently, microfragmented adipose tissue (MFAT) has been proposed as a more suitable solution. However, there is still no high-level evidence demonstrating the superiority of MFAT to BMAC. The aim of this randomised controlled trial is to compare the safety and clinical outcomes of a single intra-articular injection of BMAC versus a single intra-articular injection of MFAT in patients with knee OA.

Methods and analysis
204 patients aged 40–75 years and affected by knee OA are randomised to receive a single injection of BMAC or MFAT in a 1:1 ratio. The primary outcome of the study is the Western Ontario and McMaster University OA index (WOMAC) pain score at 6 months. The secondary outcomes of the study are the WOMAC pain score at 2 months and 12 months and the WOMAC subscales, the total WOMAC score, the International Knee Documentation Committee subjective and objective scores, the Knee Injury and OA Outcome score, the visual analogue scale (VAS) for pain evaluation, the EuroQol VAS and the Tegner score at 2 months, 6 months and 12 months. Moreover, the study aims at demonstrating whether these products have disease-modifying effects: radiographs and magnetic resonance evaluations are performed at baseline and at 12 months of follow-up, while systemic OA biomarkers are evaluated at baseline and after 2 months, 6 months and 12 months. As a tertiary outcome, this study aims at identifying the factors that influence the clinical response, including baseline patient clinical characteristics, biological features of the OA joint, as well as anabolic and anti-inflammatory properties of the injected products.

Ethics and dissemination
The study protocol has been approved by Emilia Romagna’s Ethics Committee Comitato Etico Area Vasta Emilia Centro (CE-AVEC), Bologna, Italy (protocol number: 150/2023/Sper/IOR). Written informed consent is obtained from all participants. The findings of this study will be disseminated through peer-reviewed publications and conference presentations.

Protocol version
March 2023.

Trial registration number
NCT06040957.

Introduction
Individuals with spinal cord injury (SCI) face heightened cardiovascular disease (CVD) risks. While general exercise guidelines are promoted for SCI individuals, when and how to incorporate exercise during the subacute phase post-SCI remains unclear. Consequently, early aerobic exercise to reduce CVD risks is not standard practice in subacute SCI care, potentially missing an opportunity for optimal cardiovascular rehabilitation, especially given observed reductions in cardiac structure and function within the first year post-SCI. Addressing this gap could improve long-term cardiovascular health and health-related quality of life (HRQOL) for individuals with SCI. Early intervention might prevent worsening cardiovascular function and establish beneficial exercise habits. However, few studies have evaluated the effectiveness of early exercise interventions in this population. This study aims to provide insight into the impact of moderate-intensity arm-crank exercise training (ACET) on cardiometabolic, HRQOL, functional and fitness parameters in individuals with subacute (

Introduction
The prevalence of dementia is increasing, both worldwide and in China. This disease is associated with numerous restrictions for those affected but also for caregivers and society. Due to the limited effectiveness of pharmacological interventions, more research on non-pharmacological interventions is needed. For the non-pharmacological multimodal MAKS (M: motor training, A: activities of daily living training, K: cognitive training, S: social-communicative setting) intervention, positive effects on cognition, activities of daily living, and the occurrence of behavioural and psychological symptoms of dementia were identified in two randomised controlled trials in different settings in Germany. Thus, the German MAKS intervention was culturally adapted for China and will now be tested for its efficacy in Chinese nursing homes in a randomised controlled trial.

Methods and analysis
Participants will be residents of Chinese nursing homes in Shenyang, Nanjing and Dalian, fulfilling the ICD-10 criteria for Alzheimer’s dementia, the psychometric criteria for mild to moderate dementia (MMSE 10–23) and none of the exclusion criteria. With n=200, effects with an effect size of Cohen’s d=0.45 and a power of 1-β = 0.80 can be detected. Screening and data collection at baseline, t6 and t12 will be conducted via face-to-face contact by proxy raters in the nursing homes (i.e., trained nursing staff not involved in the intervention) and master students as external testers for the performance tests on cognition and activities of daily living. Participants will be randomly allocated to the intervention or control group. SinoMAKS (i.e., the Chinese version of the MAKS intervention) will be conducted at least three times a week for six months by trained MAKS therapists. The control group will receive care as usual for 12 months after baseline. Thus, the treatment phase is six months with follow-ups after six and 12 months after baseline. In the open phase, from t6 to t12, the nursing homes are free to offer SinoMAKS to the intervention group residents. In line with international guidelines, the primary population for analysis is the intention-to-treat sample. Global cognition (measured with the Addenbrooke’s Cognitive Examination-III) is the primary outcome. The hypotheses will be analysed using multiple linear regression with the outcome variables as dependent variables.

Ethics and dissemination
All procedures were approved by the Ethics Committee of the Medical Faculty of the Friedrich-Alexander-Universität Erlangen-Nürnberg (Ref. 24–162-B) and the Ethics Committee of the China Medical University (Ref. [2024]181). Written informed consent will be obtained from all participants or—if applicable—their legal representatives. Results will be published in peer-reviewed scientific journals and conference presentations.

Trial registration number
ISRCTN10262531.