Search Results for: Follow-up ottimale dopo embolia polmonare acuta

Stroke, Ahead of Print. BACKGROUND:Branch atherosclerosis disease (BAD) is prone to early neurological deterioration (END). The purpose of this study was to assess the efficacy and safety of argatroban plus dual antiplatelet therapy (DAPT) for preventing END in high-risk branch atherosclerosis disease patients.METHODS:This multicenter, open-label, blinded end point, randomized controlled trial including branch atherosclerosis disease patients with mild stroke (National Institutes of Health Stroke Scale score ≤5) was conducted at 4 centers in China from May 18, 2021 to February 8, 2023. Within 48 hours after symptom onset, patients were randomly assigned to receive argatroban plus DAPT or DAPT alone in a 1:1 ratio. The primary end points were the incidence of END (National Institutes of Health Stroke Scale score increase ≥2) within 7 days and excellent functional outcome (modified Rankin Scale score of 0 to 1) at 90 days.RESULTS:A total of 111 patients were randomized, with 11 excluded for specific reasons, resulting in 100 patients included in the modified intention-to-treat population. Among the 100 patients, 49 received argatroban plus DAPT and 51 received DAPT alone, 63 (63.0%) were men, and the median age was 64 (range, 55–74) years. END occurred in 20.4% (10/49) of the argatroban plus DAPT group and 47.1% (24/51) of the DAPT group (risk difference, 26.7% [95% CI, 14.1–39.2]; risk ratio, 2.31 [95% CI, 1.49–3.58];P=0.006). At the 90-day follow-up, 87.8% (43/49) in the argatroban plus DAPT group and 68.6% (35/51) in the DAPT group achieved an excellent functional outcome (risk difference, −19.1% [95% CI, −30.3 to −8.0]; risk ratio, 0.78 [95% CI, 0.67–0.91];P=0.025). There was 1 minor hemorrhage in each group.CONCLUSIONS:Argatroban plus DAPT is a safe and effective strategy to reduce END occurrence and improve 90-day functional outcome in high-risk branch atherosclerosis disease patients.REGISTRATION:URL:https://www.chictr.org.cn; Unique Identifier: ChiCTR21000 46487.

New England Journal of Medicine, Volume 392, Issue 15, Page 1508-1517, April 17, 2025.

Introduction
The multifaceted impact of dementia means that people living with dementia require multidisciplinary care across different services and settings; however, these care transitions pose a risk of fragmented care. Models that improve integration and coordination of care in the community are needed.

Methods and analysis
This randomised control trial will test the effectiveness and cost effectiveness of a dementia nurse-led intervention to: (1) increase days lived in the community at 12-month follow-up (primary outcome) among people living with dementia and (2) improve quality of life for people living with dementia and their carers, compared with usual care. Participants are recruited from several sources including private and public geriatric medicine clinics, carer support groups and self-referral. People living with dementia and their carers are randomised as a dyad to (1) usual care or (2) dementia nurse-led care-coordination. The dementia nurse will provide care coordination and direct support through a tailored, integrated and patient-centred approach. The needs of people living with dementia will be identified and addressed, with a focus on improving the management of comorbidities, risk reduction and symptoms. Carers will also receive support. The model for people living with dementia will focus on days lived in their community as the outcome variable. Differences between groups in quality of life at 12-month follow-up will be assessed using linear mixed effects regression. Analysis will follow the intention to treat principles. People living with dementia and carers’ data will be analysed separately and collectively for the economic study.

Ethics and dissemination
The trial has been approved by the Hunter New England Research Ethics Committee (2023/ETH01221) and the University of Newcastle Ethics Committee (R-2024–0021). Trial findings will be disseminated via peer-reviewed publications and conference presentations. If the intervention is effective, the research team aims to further implement the intervention as usual care within the participating services and beyond.

Trial registration number
The trial was prospectively registered via the Australian New Zealand Clinical Trials Registry: ACTRN12624000235505. Registration date: 11 March 2024.

Background
Non-adherence to antidiabetic medication remains a major barrier to achieve optimal health outcomes among individuals with diabetes, particularly in developing countries. This issue exacerbates poor health outcomes and leads to the wastage of limited healthcare resources.

Objective
This study aimed to assess the prevalence of non-adherence to antidiabetic medications and identify associated factors among adult type 2 diabetes mellitus (DM) patients in the North Wollo zone.

Study design
An institutional-based cross-sectional study.

Setting
The study was conducted in three randomly selected public hospitals in the North Wollo zone: Woldia Comprehensive Specialized Hospital, Lalibela General Hospital and Mersa Primary Hospital.

Participants
A total of 327 adult type 2 DM patients receiving follow-up care were included. Participants were selected proportionally from each hospital using consecutive sampling. Inclusion criteria included individuals aged ≥18 years, on antidiabetic treatment for at least 6 months and actively on follow-up care during the study period. Patients with hearing impairment, severe illness or incomplete medical records were excluded.

Main outcome measures
Adherence was assessed using the Morisky Medication Adherence Scale-8, a validated eight-item, self-reported questionnaire. Scores ranged from 0 to 8, with adherence levels classified as high (≥8), medium (6–7.75) and low (

Introduction
Prolonged grief disorder (PGD) represents a substantial public health issue, especially in oncology settings where it affects up to 30% of bereaved carers. Current best-practice treatments are lengthy, and up to 50% of participants have persistent PGD. Building on encouraging recent research with psychedelic-assisted therapies, the Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief (PARTING) trial is the first study to consider psilocybin-assisted psychotherapy as a potential treatment for prolonged grief.

Methods and analysis
PARTING is an open-label pilot trial of psilocybin-assisted psychotherapy for approximately 15 people with cancer-related PGD. It aims to investigate feasibility, safety, acceptability, participant experience and participant-reported therapeutic effects. Over a 5-week intervention period, participants will undergo three preparation sessions before receiving a psychoactive (25 mg) dose of psilocybin alongside non-directive supportive guidance, followed by four integration sessions. All sessions will be delivered by a psychologist and either a nurse or Indigenous Therapist. An artificial intelligence-assisted tool will be used to create an artwork of participants’ psychedelic experience.
Outcomes will be investigated over a 12-month follow-up period. Feasibility will be assessed through recruitment/retention rates and completion of follow-up assessments. Safety will be evaluated via adverse events over 12 months and the comparison of physiological measures (vital signs, biochemistry, haematology, ECG) recorded during screening and 1 day after the psilocybin dose. Qualitative thematic analysis of semistructured interviews with participants and trial therapists will assess acceptability and the therapeutic potential of the treatment. Diagnostic clinical interviews for PGD and quantitative participant-reported measures of therapeutic effects are also being collected. Participant-reported measures include grief severity, depression, anxiety, grief avoidance, psychological flexibility, connectedness, and quality of life.

Ethics and dissemination
Ethics approval has been obtained from QIMR Berghofer Medical Research Institute Human Research Ethics Committee (P3801). Dissemination of results will occur via conference presentations, peer-reviewed publications and media.

Trial registration number
Australian New Zealand Clinical Trials Registry (ACTRN12623000827639).

Objective
This study aimed to describe how healthcare providers perceived the impacts of implementing and using an electronic health record (EHR) on quality, safety and person-centredness of care.

Design
A qualitative descriptive design using semistructured interviews.

Setting
In October 2020, a large Canadian community hospital implemented a new EHR system (Epic) across three sites, transitioning from a previously fragmented (combination of paper-based and electronic) system.

Participants
Sixty-two healthcare providers and clinical leaders.

Results
Participants shared their experiences regarding the impact of EHR implementation on quality of care, which were analysed into common themes including task efficiency, information management, patient interactions and patient safety. While the system significantly altered their routines and introduced new responsibilities like additional documentation requirements, it also facilitated adherence to clinical guidelines, improved information visibility and enhanced documentation, benefiting overall quality of care and patient safety. Participants reported that EHR implementation led to increased efficiency, freeing up time for patient care and improving communication with patients and other providers.

Conclusion
EHRs have the potential to improve quality of care and patient safety, but this depends on their perceived value and how well healthcare providers can integrate their various features into clinical routines.

Objectives
To determine uptake of the COVID-19 vaccine and identify the associated factors among health professionals in major cities of the Amhara region in Ethiopia.

Design
Institution-based, cross-sectional study.

Setting
The study was conducted from July to September 2022 across 40 health centres and 13 hospitals, representing 10 major cities within the Amhara region.

Participants
1251 participants, all of whom were vaccine-eligible health professionals, were selected using a systematic random sampling procedure.

Outcome measures
The level of vaccine uptake in the study was determined by the proportion of health professionals who had received at least one dose of a COVID-19 vaccine.

Results
1251 health professionals participated, with 848 (67.8%) reporting that they had received at least one dose of a COVID-19 vaccine. Key findings from the multivariable logistic regression analysis revealed that health professionals aged 46 years and older were four times more likely to be vaccinated (95% CI, 1.656 to 9.510), married participants were 1.4 times more likely to take the vaccine (95% CI, 1.010 to 1.933) and those with good knowledge of COVID-19 vaccines were 1.75 times more likely to get vaccinated (95% CI, 1.307 to 2.331). Additionally, participants with a positive attitude towards vaccination were 3.65 times more likely to have received a vaccine (95% CI, 2.753 to 4.732).

Conclusions
The study reveals a commendable level of COVID-19 vaccine uptake among health professionals, emphasising their critical role in public health initiatives. However, the observed disparities in vaccination rates indicate the need for targeted interventions to improve vaccine coverage, particularly among younger professionals and those with limited knowledge of the vaccine. Addressing these gaps requires the implementation of tailored educational programmes that enhance understanding of COVID-19 vaccines. Furthermore, fostering positive attitudes through targeted campaigns, workplace-based initiatives and peer influence, particularly among younger and unmarried professionals, will be crucial. Encouraging vaccinated professionals to share their experiences and establishing regular follow-ups will also be essential strategies to improve vaccine acceptance and coverage in the region.

Introduction
Postdischarge suicide risk among psychiatric patients is a great concern. Gamified interventions have demonstrated promise in reducing the risk. This study aims to reduce postdischarge suicide risk through a mHealth intervention that engages and supports patients through gamified features. Built on our previous research, this study will develop, optimise and evaluate a gamified intervention under the Multi-phase Optimization Strategy (MOST) framework in implementation science.

Methods and analysis
This study will be conducted at the Shenzhen Kangning Hospital. Following the MOST framework, we will develop the gamified mHealth app (Tailored Evidence-based Enhancements in Mental Health (TEEM)) with four intervention components in the selection phase. In the optimisation phase, a factorial design randomised controlled trial (RCT) will be conducted to identify the optimised configuration. A total of 320 patients with mental disorders will be recruited and randomised into 16 groups to receive TEEM with different combinations of intervention components, with follow-ups scheduled at 1 week, 1 month, 2 months and 3 months after discharge. In the confirmation phase, we will assess the optimised TEEM through a standard RCT, comparing it to usual care. An additional 320 patients with mental disorders will be recruited for this phase, and the follow-up schedule is the same as in the optimisation phase. Psychiatric patients and family members, clinical and community mental health service providers will be recruited as the community team to help develop and evaluate the TEEM. Quantitative data will be analysed using the intention-to-treat approach and generalised estimating equations, and qualitative data will be coded and categorised to identify key themes.

Ethics/dissemination
The Ethics Committee Review Board of Shenzhen Kangning Hospital has approved this study. All participants will provide written informed consent prior to enrolment. The findings will be disseminated through peer-reviewed scientific journals and conference presentations, and a report will be submitted to the National Natural Science Foundation of China and the mental health authorities in the Shenzhen Municipal Health Commission.

Trial registration number
ClinicalTrials.gov, ID: NCT06358339

Introduction
Cardiac surgery is frequently associated with vasoplegia and vasopressor treatment. Both may be associated with postoperative complications and prolonged length of stay. The most frequently used vasopressor is norepinephrine. However, in a pilot, double-blind, randomised controlled trial (RCT) in cardiac surgery patients, angiotensin II was effective in maintaining blood pressure and was associated with a shorter duration of hospital stay than norepinephrine. Furthermore, hyperreninaemic patients were more sensitive to angiotensin II. These findings support the need for a larger RCT to determine whether angiotensin II is superior to norepinephrine as a first-line treatment for low blood pressure after cardiac surgery.

Methods and analysis
We will conduct a double-blind RCT comparing an infusion of either angiotensin II or norepinephrine intraoperatively and for up to 48 hours after the start of surgery. We will randomly allocate 400 cardiac surgery patients at multiple centres in two countries to either an equipotent angiotensin II or norepinephrine infusion, titrated to a mean arterial pressure of 70–80 mm Hg. The primary outcome will be length of hospital stay. Secondary outcomes will include a composite of renal, cardiovascular and neurological events. A subgroup analysis of patients with elevated baseline renin levels will be undertaken.

Ethics and dissemination
Ethical approval has been granted by the Alfred Human Research Ethics Committee on 14 July 2023 (HREC/97814/Alfred-2023). Results will be published on completion of the trial.

Trial registration number
Australian and New Zealand Clinical Trials Registry: ACTRN12623000848606.

Introduction
Identifying individuals at risk of suicide remains an ongoing challenge. Previous research investigating risk factors for suicidal thoughts and behaviours (STB) has been informative for assessing suicide risk. However, the complex biological, psychological and sociocultural factors underlying STB have not been comprehensively captured to date, which has limited our understanding of how these factors interact to influence STB. Moreover, acute care settings, such as emergency departments (EDs), are often first points of contact for individuals with STB, highlighting a need for more research in these settings.

Methods and analysis
We aim to (1) characterize a cohort seeking care for STB and their clinical trajectories; (2) situate the cohort by comparing its characteristics and outcomes to other groups seeking emergency care; (3) explore their experiences of seeking care; and (4) examine blood-based biomarkers modulating risk for STB. Using a multimethod, prospective cohort design, we will follow up to 500 people aged 16 or older presenting to the ED with STB at a psychiatric hospital over 1 year. Analyses will involve descriptive statistics and latent profile analysis to characterize the cohort, hypothesis tests and regression models to situate the cohort, qualitative analysis based on a realist research framework to understand experiences, and within-participant comparisons of proteins, mRNA and epigenetic DNA modifications to examine biomarkers of contrasting states of STB.

Ethics and dissemination
This study was approved by the hospital’s Research Ethics Board with safeguards in place to ensure the well-being of participants and research team. An integrated knowledge translation approach will be used for dissemination, wherein patient and family advisors are engaged throughout each study phase. Findings will enhance our understanding of the multifactorial nature of suicide risk, inform strategies for prevention and provide important insights into characteristics, experiences and outcomes of individuals with STB, who are under-represented in mental health research.

Introduction
Osteoarthritis (OA) is a multifactorial disease in which low-grade inflammation is considered to play a pivotal role. Although colchicine is a widely used anti-inflammatory drug in the treatment of gout, its effect in OA is still disputed due to inconsistent results of short-term clinical trials. Therefore, we aim to evaluate the effect of long-term colchicine 0.5 mg once daily on the incidence of knee or hip replacements in patients with knee or hip OA.

Methods and analysis
The ECHO trial is a prospective, multicentre, randomised, double-blind, placebo-controlled, phase III trial in which 1200 participants with knee or hip OA tolerant to colchicine during a 30-day run-in period will be 1:1 randomised to colchicine 0.5 mg once daily or matching placebo using concealed allocation. The primary endpoint is the time from randomisation to the first knee or hip replacement assessed up to 4.5 years. Secondary endpoints include course of pain, physical function, joint space narrowing, low-grade inflammation, quality of life, clinical or radiological onset of OA in a new joint group other than present at baseline, number of participants using pain medication during the study, onset of new cardiovascular events (ie, myocardial infarction, ischaemia-driven coronary revascularisation, ischaemic stroke, peripheral artery disease or cardiovascular death) and direct and indirect costs related to treatment and disease burden due to OA. Harm-related endpoints include the number of (serious) adverse events, the number of withdrawals due to (serious) adverse events and changes in laboratory data (ie, serum creatinine, estimated glomerular filtration rate and alanine transferase) throughout the study. The primary analysis will be performed according to the intention-to-treat principle.

Ethics and dissemination
This trial has been approved by the Medical Ethics Review Committee East-Netherlands. Findings will be presented at scientific meetings and published in a peer-reviewed scientific journal.

Trial registration number
NCT06578182.

Introduction
Myocardial protection against ischaemia–reperfusion injury is a key determinant of heart function and outcome following cardiac surgery in children. However, myocardial injury still occurs routinely following aortic cross-clamping, as demonstrated by the ubiquitous rise in circulating troponin. del Nido cardioplegia was designed to protect the immature myocardium and is widely used in the USA but has not previously been available in the UK, where St. Thomas’ blood cardioplegia is most common. The del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial will evaluate whether one solution is better than the other at improving myocardial protection by reducing myocardial injury, shortening ischaemic time and improving clinical outcomes.

Methods and analysis
The DESTINY trial is a multicentre, patient-blinded and assessor-blinded, parallel-group, individually randomised controlled trial recruiting up to 220 children undergoing surgery for congenital heart disease. Participants will be randomised in a 1:1 ratio to either del Nido cardioplegia or St. Thomas’ blood cardioplegia, with follow-up until 30 days following surgery. The primary outcome is area under the time–concentration curve for plasma high-sensitivity troponin I in the first 24 hours after aortic cross-clamp release. Secondary outcome measures include the incidence of low cardiac output syndrome and Vasoactive-Inotropic Score in the first 48 hours, total aortic cross-clamp time, duration of mechanical ventilation and lengths of stay in the paediatric intensive care unit and the hospital.

Ethics and dissemination
The trial was approved by the West Midlands—Coventry and Warwickshire National Health Service Research Ethics Committee (21/WM/0149) on 30 June 2021. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Parents will be informed of the results through a newsletter in conjunction with a national charity.

Trial registration number
ISRCTN13638147; Pre-results.

Objectives
The aim is to evaluate the effects of a motivational interviewing-based intervention, Supporting Patient Activation in Transition to Home, on rehospitalisation and patient activation among patients with heart failure or chronic obstructive pulmonary disease.

Design
A randomised, controlled, analysis-blinded trial was conducted.

Setting
Participants were recruited from two hospitals in mid-Sweden and the intervention and interviews were conducted post-discharge.

Participants
207 participants with heart failure or chronic obstructive pulmonary disease were recruited. Participants were randomised to receive five motivational interviewing sessions post-discharge (n=103) or a control group (n=104).

Outcome measures
Rehospitalisation within 180 days post-discharge was retrieved, and patient activation was assessed using the Patient Activation Measure at baseline, 30, 90 and 180 days post-discharge. We used a generalised estimating equation to assess the difference in the secondary outcome, patient activation, between the intervention group and the control group during the 180-day follow-up.

Results
No statistically significant differences between the groups were found for rehospitalisation (p=0.33 to 0.41) or patient activation over time (B=–1.67, –0.71 and –0.83 (95% CI –5.45 to 2.10, –4.06 to 2.64 and –4.28 to 2.62), respectively).

Conclusion
Post-discharge motivational interviewing to decrease rehospitalisation or support patient activation does not seem beneficial for patients with heart failure or chronic obstructive pulmonary disease. The high disease burden may have limited patient participation in the intervention.

Trial registration number
NCT02823795.

Objectives
To investigate how doctors and self-managing older patients with heart failure (HF) discuss the patients’ potential or ongoing medication adherence problems, and how such discussions evolve as patients transition from hospital to home, with particular focus on: (1) doctors’ communicative actions aimed at addressing patient disclosures of adherence problems and (2) patients’ feedback indicating whether their doctor’s supportive actions were acceptable to them.

Design
Exploratory interaction-based observational cohort study. Inductive microanalysis of authentic patient–doctor consultations, audio recorded for each patient at: (1) first ward visit in hospital, (2) discharge visit from hospital and (3) follow-up visit with general practitioner (GP).

Setting
Hospital and primary care, Norway (2022–2023).

Participants
25 patients with HF (+65 years) and their attending doctors (23 hospital doctors, 25 GPs).

Results
Analysis of 74 consultations revealed that 25 HF patients disclosed 23 practical adherence problems indicating risks of unintentional non-adherence (eg, limited resources to manage medications) and 39 perceptual problems indicating risks of intentional non-adherence (eg, worries, negative experience or stance). Doctors addressed 79% of patients’ disclosures by: (1) exploring the scope of the problem or (2) providing supportive actions to improve patients’ ability or motivation to adhere. We calculated nearly five times higher odds for doctors to address patients’ practical problems to their perceptual problems (OR 4.79, 95% CI 1.25 to 25.83). Unresolved problems included: (1) doctors addressed patients’ disclosures, but patients signalled the supportive actions were unsuitable (37%) and (2) doctors left disclosures unaddressed (21%).

Conclusions
In this explorative study, the doctors were more likely to address the patients’ adherence problems associated with unintentional non-adherence risks than those associated with intentional non-adherence risks. Even when doctors attempted to address HF patients’ medication adherence problems, half of the problems remained unresolved, usually because patients indicated that the doctor’s suggestion to improve their situation was against their preference.

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