Risultati per: Follow-up ottimale dopo embolia polmonare acuta

Circulation, Volume 148, Issue Suppl_1, Page A15223-A15223, November 6, 2023. Introduction:Short-term cardiac monitors (STMs) are increasingly used in the work-up of cryptogenic stroke patients before proceeding to long-term continuous monitoring for atrial fibrillation (AF) with insertable cardiac monitors (ICM). However, the rate of ICM placement after STM is only 4-5% based on large real-world studies. The impact of patient fall-out after STM on clinical/economic outcomes is unknown.Research Question:The objective of this analysis was to project the risk of additional ischemic strokes and stroke-related costs with varying rates of patient loss to follow-up (LTFU) after 48-hour, 14-day or 30-day monitors, compared to an approach of continuous ICM monitoring post-stroke.Methods:A previously published Markov model based on the CRYSTAL-AF trial was utilized to project lifetime ischemic strokes after various monitoring strategies, from a US payer perspective. Patient characteristics and AF detection rates were based on CRYSTAL-AF: diagnostic yield with the initial STMs were 0.8% for 48-hr, 3.1% for 14-day and 6.8% for 30-day monitors. AF detection resulted in a change from aspirin to DOAC, with subsequent risks of ischemic strokes and associated costs (including acute + post-acute care) modeled based on published literature.Results:Increasing rates of patient LTFU after STM were associated with higher projected additional secondary strokes compared to an immediate ICM approach, across all 3 STM types (figure). In the scenario based on real-world data (95% LTFU), a range of 62-68 additional strokes are projected per 1,000 patients, with associated stroke costs of $4,928-$5,449/patient when averaged across the population.Conclusions:Loss of patient follow-up after STM in real-world CS patients is projected to lead to substantial secondary stroke burden due to undetected AF, compared to continuous monitoring with ICM. Future work could focus on optimizing stroke pathways to ensure timely and continued access to monitoring.

Introduction
Efficacious programmes require implementation at scale to maximise their public health impact. TransformUs is an efficacious behavioural and environmental intervention for increasing primary (elementary) school children’s (5–12 years) physical activity and reducing their sedentary behaviour within school and home settings. This paper describes the study protocol of a 5-year effectiveness–implementation trial to assess the scalability and effectiveness of the TransformUs programme.

Methods and analysis
A type II hybrid implementation–effectiveness trial, TransformUs is being disseminated to all primary schools in the state of Victoria, Australia (n=1786). Data are being collected using mixed methods at the system (state government, partner organisations), organisation (school) and individual (teacher, parent and child) levels. Evaluation is based on programme Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. RE-AIM domains are being measured using a quasi-experimental, pre/post, non-equivalent group design, at baseline, 12 and 24 months. Effectiveness will be determined in a subsample of 20 intervention schools (in Victoria) and 20 control schools (in New South Wales (NSW), Australia), at baseline, 12 and 24 months. Primary outcomes include TransformUs Reach, Adoption, Implementation and organisational Maintenance (implementation trial), and children’s physical activity and sedentary time assessed using accelerometers (effectiveness trial). Secondary outcomes include average sedentary time and moderate to vigorous-intensity physical activity on weekdays and during school hours, body mass index z-scores and waist circumference (effectiveness trial). Linear mixed-effects models will be fitted to compare outcomes between intervention and control participants accounting for clustering of children within schools, confounding and random effects.

Ethics and dissemination
The trial was approved by the Deakin University Human Research Ethics Committee (HEAG-H 28_2017), Victorian Department of Education, the NSW Department of Education, Australian Catholic University (2017-145R), Melbourne Archdiocese Catholic Schools and Catholic Schools NSW. Partners, schools/teachers and parents will provide an informed signed consent form prior to participating. Parents will provide consent for their child to participate in the effectiveness trial. Findings will be disseminated via peer-reviewed publications, scientific conferences, summary reports to schools and our partner organisations, and will inform education policy and practice on effective and sustainable ways to promote physical activity and reduce sedentary behaviours population-wide.

Trial registration number
Australian Clinical Trials Registration Registry (ACTRN12617000204347).

Introduction
The Berlin Long-term Observation of Vascular Events is a prospective cohort study that aims to improve prediction and disease-overarching mechanistic understanding of cardiovascular (CV) disease progression by comprehensively investigating a high-risk patient population with different organ manifestations.

Methods and analysis
A total of 8000 adult patients will be recruited who have either suffered an acute CV event (CVE) requiring hospitalisation or who have not experienced a recent acute CVE but are at high CV risk. An initial study examination is performed during the acute treatment phase of the index CVE or after inclusion into the chronic high risk arm. Deep phenotyping is then performed after ~90 days and includes assessments of the patient’s medical history, health status and behaviour, cardiovascular, nutritional, metabolic, and anthropometric parameters, and patient-related outcome measures. Biospecimens are collected for analyses including ‘OMICs’ technologies (e.g., genomics, metabolomics, proteomics). Subcohorts undergo MRI of the brain, heart, lung and kidney, as well as more comprehensive metabolic, neurological and CV examinations. All participants are followed up for up to 10 years to assess clinical outcomes, primarily major adverse CVEs and patient-reported (value-based) outcomes. State-of-the-art clinical research methods, as well as emerging techniques from systems medicine and artificial intelligence, will be used to identify associations between patient characteristics, longitudinal changes and outcomes.

Ethics and dissemination
The study was approved by the Charité—Universitätsmedizin Berlin ethics committee (EA1/066/17). The results of the study will be disseminated through international peer-reviewed publications and congress presentations.

Study registration
First study phase: Approved WHO primary register: German Clinical Trials Register: https://drks.de/search/de/trial/DRKS00016852; WHO International Clinical Registry Platform: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00016852. Recruitment started on July 18, 2017.
Second study phase: Approved WHO primary register: German Clinical Trials Register DRKS00023323, date of registration: November 4, 2020, URL: http://www.drks.de/ DRKS00023323. Recruitment started on January 1, 2021.

Objective
This study aimed to determine the socio-demographic and clinical characteristics associated with retention in care and reasons for loss to follow-up (LTFU) among people living with HIV (PLWH) with a known diagnosis of severe mental illness (SMI).

Design
We conducted a parallel convergent mixed-methods study. The quantitative study was used to determine the proportion and factors associated with retention in care among PLWH and SMI. The qualitative study explored reasons for LTFU.

Setting
This study was conducted at two the HIV clinics of two tertiary hospitals in Uganda.

Participants
We reviewed records of 608 PLWH who started antiretroviral therapy (ART) and included participants who had a documented diagnosis of SMI.

Outcomes
The primary outcome was retention in care. Age, gender, religion, tuberculosis (TB) status, WHO clinical stage, functional status, cluster of differentiation 4 (CD4) cell count, viral load and SMI diagnosis were among the predictor variables.

Results
We collected data from 328 participants. Retention at 6 months was 43.3% compared with 35.7% at 12 months. Having an unsuppressed viral load (≥1000 copies/mL) (adjusted incidence risk ratio (IRR)=1.54, 95% CI: 1.17 to 2.03), being 36 years and below (adjusted IRR=0.94, 95% CI: 0.94 to 0.95), initial presentation at outpatient department (adjusted IRR=0.74, 95% CI: 0.57 to 0.96), having TB signs and symptoms (adjusted IRR=0.98 95% CI: 0.97 to 0.99) and being in lower WHO stages (I and II) (adjusted IRR=1.08, 95% CI: 1.02 to 1.14) at ART initiation were significantly associated with retention in care at 6 and 12 months. Inadequate social support, long waiting hours at the clinic, perceived stigma and discrimination, competing life activities, low socioeconomic status and poor adherence to psychiatric medication were barriers to retention in care.

Conclusion
Twelve-month retention in care remains low at 35.7% far below the 90% WHO target. There is a need to design and implement targeted interventions to address barriers to retention in care among PLWH and SMI.

New England Journal of Medicine, Ahead of Print.

Introduction
Improving physical activity (PA) and healthy eating is critical for primary and secondary prevention of cardiovascular disease (CVD). Behaviour change programmes delivered in sporting clubs can engage men in health behaviour change, but are rarely sustained or scaled-up post trial. Following the success of pilot studies of the Australian Fans in Training (Aussie-FIT) programme, a hybrid effectiveness–implementation trial protocol was developed. This protocol outlines methods to: (1) establish if Aussie-FIT is effective at supporting men with or at risk of CVD to sustain improvements in moderate-to-vigorous PA (primary outcome), diet and physical and psychological health and (2) examine the feasibility and utility of implementation strategies to support programme adoption, implementation and sustainment.

Methods and analysis
A pragmatic multistate/territory hybrid type 2 effectiveness–implementation parallel group randomised controlled trial with a 6-month wait list control arm in Australia. 320 men aged 35–75 years with or at risk of CVD will be recruited. Aussie-FIT involves 12 weekly face-to-face sessions including coach-led interactive education workshops and PA delivered in Australian Football League (Western Australia, Northern Territory) and rugby (Queensland) sports club settings. Follow-up measures will be at 3 and 6 months (both groups) and at 12 months to assess maintenance (intervention group only). Implementation outcomes will be reported using the Reach, Effectiveness, Adoption, Implementation, Maintenance framework.

Ethics and dissemination
This multisite study has been approved by the lead ethics committees in the lead site’s jurisdiction, the South Metropolitan Health Service Human Research Ethics Committee (Reference RGS4254) and the West Australian Aboriginal Health Ethics Committee (HREC1221). Findings will be disseminated at academic conferences, peer-reviewed journals and via presentations and reports to stakeholders, including consumers. Findings will inform a blueprint to support the sustainment and scale-up of Aussie-FIT across diverse Australian settings and populations to benefit men’s health.

Trial registration number
This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000437662).

Annals of Internal Medicine, Volume 176, Issue 10, Page 1349-1357, October 2023.

Annals of Internal Medicine, Volume 176, Issue 10, Page 1349-1357, October 2023.

Introduction
Colorectal cancer (CRC) is the third most common type of cancer in the Netherlands. Approximately 90% of patients can be treated with surgery, which is considered potentially curative. Postoperative surveillance during the first 5 years after surgery pursues to detect metastases in an early, asymptomatic and treatable stage. Multiple large randomised controlled trials have failed to show any (cancer-specific) survival benefit of intensive postoperative surveillance compared with a minimalistic approach in patients with CRC. This raises the question whether an (intensive) in-hospital postoperative surveillance strategy is still warranted from both a patient well-being and societal perspective. A more modern, home-based surveillance strategy could be beneficial in terms of patients’ quality of life and healthcare costs.

Methods and analysis
The multicentre, prospective FUTURE-primary study implements a patient-led home-based surveillance after curative CRC treatment. Here, patients are involved in the choice regarding three fundamental aspects of their postoperative surveillance. First regarding frequency, patients can opt for additional follow-up moments to the minimal requirement as outlined by the current Dutch national guidelines. Second regarding the setting, both in-hospital or predominantly home-based options are available. And third, concerning patient–doctor communication choices ranging from in-person to video chat, and even silent check-ups. The aim of the FUTURE-primary study is to evaluate if such a patient-led home-based follow-up approach is successful in terms of quality of life, satisfaction and anxiety compared with historic data. A successful implementation of the patient-led aspect will be assessed by the degree in which the additional, optional follow-up moments are actually utilised. Secondary objectives are to evaluate quality of life, anxiety, fear of cancer recurrence and cost-effectiveness.

Ethics and dissemination
Ethical approval was given by the Medical Ethics Review Committee of Erasmus Medical Centre, The Netherlands (2021-0499). Results will be presented in peer-reviewed journals.

Trial registration number
NCT05656326.

Irccs Meldola coordina progetto internazionale. Fondo di 6 mln da Ue

This cluster randomized trial compares the effects of electronic health record reminders and patient outreach with or without patient navigation on overdue follow-up of abnormal cancer screening test results for colorectal, cervical, breast, or lung cancer among primary care patients.

A reported preference for staying up later at night was associated with a 54% higher risk of having an unhealthful lifestyle, including lower engagement in physical activity and greater alcohol intake, according to a study involving 63 676 nurses aged 45 to 62 years.

Circulation, Volume 148, Issue 15, Page 1179-1181, October 10, 2023.

Objective
To examine the association between midlife tobacco smoking and late-life brain atrophy and white matter lesions.

Methods
The study includes 369 women from the Prospective Population Study of Women in Gothenburg, Sweden. Cigarette smoking was reported at baseline 1968 (mean age=44 years) and at follow-up in 1974–1975 and 1980–1981. CT of the brain was conducted 32 years after baseline examination (mean age=76 years) to evaluate cortical atrophy and white matter lesions. Multiple logistic regressions estimated associations between midlife smoking and late-life brain lesions. The final analyses were adjusted for alcohol consumption and several other covariates.

Results
Smoking in 1968–1969 (adjusted OR 1.85; 95% CI 1.12 to 3.04), in 1974–1975 (OR 2.37; 95% CI 1.39 to 4.04) and in 1980–1981 (OR 2.47; 95% CI 1.41 to 4.33) were associated with late-life frontal lobe atrophy (2000–2001). The strongest association was observed in women who reported smoking at all three midlife examinations (OR 2.63; 95% CI 1.44 to 4.78) and in those with more frequent alcohol consumption (OR 6.02; 95% CI 1.74 to 20.84). Smoking in 1980–1981 was also associated with late-life parietal lobe atrophy (OR 1.99; 95% CI 1.10 to 3.58). There were no associations between smoking and atrophy in the temporal or occipital lobe, or with white matter lesions.

Conclusion
Longstanding tobacco smoking was mainly associated with atrophy in the frontal lobe cortex. A long-term stimulation of nicotine receptors in the frontal neural pathway might be harmful for targeted brain cell.

Introduction
The feasibility and efficacy of surgical resection following systemic therapy for intermediate-stage hepatocellular carcinoma (HCC) beyond the Up-to-7 criteria is unclear. The combination of lenvatinib (LEN) and transcatheter arterial chemoembolisation (TACE), termed LEN–TACE sequential therapy, has shown a high response rate and survival benefit in patients with intermediate-stage HCC. This trial aims to evaluate the efficacy and safety of LEN–TACE sequential therapy and the feasibility of surgical resection for intermediate-stage HCC beyond the Up-to-7 criteria.

Methods and analysis
This is a multicentre, single-arm, prospective clinical trial. Thirty patients with intermediate-stage HCC beyond the Up-to-7 criteria will be enrolled. Patients eligible for this study will undergo LEN–TACE sequential therapy in which LEN is administered for 4 weeks, followed by TACE, and then further LEN for another 4 weeks. Patients will be assessed for efficacy of LEN–TACE sequential therapy and resectability, and surgical resection will be performed if the HCC is considered radically resectable. The primary outcome of this study is the resection rate after LEN–TACE sequential therapy. The secondary outcomes are the objective response rate of LEN–TACE sequential therapy, safety, curative resection rate, overall survival and recurrence-free survival.

Ethics and dissemination
This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB210003), and has been registered with the Japan Registry of Clinical Trials (jRCTs061220007). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences.

Trial registration number
jRCTs061220007 (https://jrct.niph.go.jp/latest-detail/jRCTs061220007).

Circulation, Ahead of Print. OBJECTIVE:In the SVR trial (Single Ventricle Reconstruction), newborns with hypoplastic left heart syndrome were randomly assigned to receive a modified Blalock-Taussig-Thomas shunt (mBTTS) or a right ventricle-to-pulmonary artery shunt (RVPAS) at Norwood operation. Transplant-free survival was superior in the RVPAS group at 1 year, but no longer differed by treatment group at 6 years; both treatment groups had accumulated important morbidities. In the third follow-up of this cohort (SVRIII [Long-Term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type]), we measured longitudinal outcomes and their risk factors through 12 years of age.METHODS:Annual medical history was collected through record review and telephone interviews. Cardiac magnetic resonance imaging (CMR), echocardiogram, and cycle ergometry cardiopulmonary exercise tests were performed at 10 through 14 years of age among participants with Fontan physiology. Differences in transplant-free survival and complication rates (eg, arrhythmias or protein-losing enteropathy) were identified through 12 years of age. The primary study outcome was right ventricular ejection fraction (RVEF) by CMR, and primary analyses were according to shunt type received. Multivariable linear and Cox regression models were created for RVEF by CMR and post-Fontan transplant-free survival.RESULTS:Among 549 participants enrolled in SVR, 237 of 313 (76%; 60.7% male) transplant-free survivors (mBTTS, 105 of 147; RVPAS, 129 of 161; both, 3 of 5) participated in SVRIII. RVEF by CMR was similar in the shunt groups (RVPAS, 51±9.6 [n=90], and mBTTS, 52±7.4 [n=75];P=0.43). The RVPAS and mBTTS groups did not differ in transplant-free survival by 12 years of age (163 of 277 [59%] versus 144 of 267 [54%], respectively;P=0.11), percentage predicted peak Vo2for age and sex (74±18% [n=91] versus 72±18% [n=84];P=0.71), or percentage predicted work rate for size and sex (65±20% versus 64±19%;P=0.65). The RVPAS versus mBTTS group had a higher cumulative incidence of protein-losing enteropathy (5% versus 2%;P=0.04) and of catheter interventions (14 versus 10 per 100 patient-years;P=0.01), but had similar rates of other complications.CONCLUSIONS:By 12 years after the Norwood operation, shunt type has minimal association with RVEF, peak Vo2, complication rates, and transplant-free survival. RVEF is preserved among the subgroup of survivors who underwent CMR assessment. Low transplant-free survival, poor exercise performance, and accruing morbidities highlight the need for innovative strategies to improve long-term outcomes in patients with hypoplastic left heart syndrome.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT00115934.