The management of patients with atrial fibrillation (AF) is often inadequate due to deficient adherence to the guidelines. A nurse-led AF clinic providing integrated chronic care to improve guideline ...adherence and activate patients in their role, may effectively reduce morbidity and mortality but such care has not been tested in a large randomized trial. Therefore, we performed a randomized clinical trial to compare the AF clinic with routine clinical care in patients with AF.
We randomly assigned 712 patients with AF to nurse-led care and usual care. Nurse-led care consisted of guidelines based, software supported integrated chronic care supervised by a cardiologist. The primary endpoint was a composite of cardiovascular hospitalization and cardiovascular death. Duration of follow-up was at least 12 months. Adherence to guideline recommendations was significantly better in the nurse-led care group. After a mean of 22 months, the primary endpoint occurred in 14.3% of 356 patients of the nurse-led care group compared with 20.8% of 356 patients receiving usual care hazard ratio: 0.65; 95% confidence interval (CI) 0.45-0.93; P= 0.017. Cardiovascular death occurred in 1.1% in the nurse-led care vs. 3.9% in the usual care group (hazard ratio: 0.28; 95% CI: 0.09-0.85; P= 0.025). Cardiovascular hospitalization amounted (13.5 vs. 19.1%, respectively, hazard ratio: 0.66; 95% CI: 0.46-0.96, P= 0.029).
Nurse-led care of patients with AF is superior to usual care provided by a cardiologist in terms of cardiovascular hospitalizations and cardiovascular mortality. Trial registration information: Clinicaltrials.gov identifier number: NCT00391872.
Objective
This individual patient data (IPD) meta‐analysis aimed to evaluate the effects of psychosocial interventions (PSI) on quality of life (QoL), emotional function (EF), and social function ...(SF) in patients with cancer, and to study moderator effects of demographic, clinical, personal, and intervention‐related characteristics.
Methods
Relevant studies were identified via literature searches in 4 databases. We pooled IPD from 22 (n = 4217) of 61 eligible randomized controlled trials. Linear mixed‐effect model analyses were used to study intervention effects on the post‐intervention values of QoL, EF, and SF (z‐scores), adjusting for baseline values, age, and cancer type. We studied moderator effects by testing interactions with the intervention for demographic, clinical, personal, and intervention‐related characteristics, and conducted subsequent stratified analyses for significant moderator variables.Results: PSI significantly improved QoL (β = 0.14,95%CI = 0.06;0.21), EF (β = 0.13,95%CI = 0.05;0.20), and SF (β = 0.10,95%CI = 0.03;0.18). Significant differences in effects of different types of PSI were found, with largest effects of psychotherapy. The effects of coping skills training were moderated by age, treatment type, and targeted interventions. Effects of psychotherapy on EF may be moderated by cancer type, but these analyses were based on 2 randomized controlled trials with small sample sizes of some cancer types.
Conclusions
PSI significantly improved QoL, EF, and SF, with small overall effects. However, the effects differed by several demographic, clinical, personal, and intervention‐related characteristics. Our study highlights the beneficial effects of coping skills training in patients treated with chemotherapy, the importance of targeted interventions, and the need of developing interventions tailored to the specific needs of elderly patients.
This study aimed to evaluate rib fracture rate as well as rib fracture characteristics after thoracic trauma in patients with normal versus diminished bone mineral density (BMD). A retrospective ...cohort study of persons aged 50 years or older presenting to the Emergency Department after sustaining blunt thoracic trauma between July 1, 2014, and December 31, 2017, was performed. Patient and trauma characteristics and DXA scan results were collected. Rib fracture rate and characteristics were evaluated on a radiograph and/or CT scan of the thorax. In total, 119 patients were included for analysis. Fifty-eight of them (49%) had a diminished BMD. In the remaining 61, the BMD was normal. The diminished BMD group experienced rib fractures more often than the normal BMD group (
n
= 43 (74%) versus
n
= 31 (51%);
p
= 0.014). Patients with diminished BMD suffered low-energy trauma more frequently than the normal BMD group (21 (36%) versus 11 patients (15%), respectively (
p
= 0.011)). Rib fracture characteristics such as the median number of rib fractures, concomitant intrathoracic injury rate, and rib fracture type distribution were not different between the groups. The rate of rib fractures after blunt thoracic trauma was significantly higher in patients with diminished BMD than in patients with a normal BMD. Differences in number and location of rib fractures between groups could not be proven. When assessing patients aged 50 years or older presenting to the hospital after substantial blunt thoracic trauma, the presence of diminished BMD should be taken into account and the presence of rib fractures should be investigated with appropriate diagnostic procedures. Diminished bone mineral density (i.e., osteopenia or osteoporosis) is associated with increased fracture risk. This study evaluated if diminished BMD increases the rib fracture risk. Patients with diminished BMD have a higher risk of sustaining rib fractures after substantial blunt thoracic trauma, which implicates a lower threshold for CT imaging of the chest.
Traumatic brain injury (TBI) has drawn national attention for its high incidence and mechanistic complexity. The majority of TBI cases are “mild” in nature including concussions and mild TBI (mTBI). ...Concussions are a distinct form of mTBI where diagnosis is difficult, quantification of the incidence is challenging and there is greater risk for subsequent injuries. While concussions occur in the general population, it has become a hallmark injury consistently observed among adolescent and young adult athletes and the risks for repeat TBI (rTBI) is significant. Clinical and experimental evidence shows that the magnitude and duration of deficits is dependent on the number and the interval between injuries. Several studies suggest that metabolic vulnerabilities after injury may contribute to the window for cerebral vulnerability from rTBI. In addition to metabolism, this review addresses how age, sex and hormones also play an important role in the response to repeat concussions. Understanding how these factors collectively contribute to concussion and rTBI recovery is critically important in establishing age/sex appropriate return to play guidelines, injury prevention, therapeutic interventions and mitigation of long-term consequences of rTBI.
•This study is the first to describe the safety and immunogenicity of a nanoporous microneedle array for SARS-CoV-2 vaccination with the mRNA-1273 vaccine in healthy participants as a booster ...vaccination.•Nanoporous microneedle array for SARS-CoV-2 vaccination with 20 µg mRNA-1273 was safe but failed to induce an anamnestic antibody response, which is probably due to the used vaccine loading technique resulting in a very low amount of loaded vaccine on the microneedle tips.•As microneedle patch immunisation is a promising vaccination technique; it is worth to evaluate this novel technology further to be better prepared for pandemics in the future.
Nanoporous microneedle arrays (npMNA) are being developed as skin patches for vaccine delivery. As alternative for needle-based immunisation, they may potentially result in higher vaccine acceptance, which is important for future mass vaccination campaigns to control outbreaks, such as COVID-19, and for public vaccination in general. In this study we investigated the safety and immunogenicity of needle-free intradermal delivery of a fractional third or fourth dose of mRNA-1273 vaccine by npMNA.
This study was an open-label, randomised-controlled, proof-of-concept study. Healthy adults were eligible if they had received a primary immunisation series against SARS-CoV-2 with two doses of mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) mRNA vaccine. A history of a COVID-19 infection or booster vaccination with mRNA-1273 or BNT162b2 was allowed if it occurred at least three months before inclusion. Participants were randomised in a 1:1 ratio to receive 20 µg mRNA-1273 vaccine, either through npMNA patch applied on the skin (ID-patch group), or through intramuscular (IM) injection (IM-control group). Primary outcomes were reactogenicity up to two weeks after vaccination, and fold-increase of SARS-CoV-2 spike S1-specific IgG antibodies 14 days post-vaccination.
In April 2022, 20 participants were enroled. The geometric mean concentration (GMC) did not increase in the ID-patch group after vaccination, in contrast to the IM-control group (GMC was 1,006 BAU/mL (95% CI 599–1,689), 3,855 (2,800–5,306), and 3,513 (2,554–4,833) at day 1, 15 and 29, respectively). In addition, SARS-CoV-2-specific T cell responses were lower after ID vaccination through npMNA.
Needle-free delivery of 20 µg mRNA-1273 vaccine by npMNA failed to induce antibody and T cell responses. As this is a potentially very useful vaccination method, it is important to determine which adjustments are needed to make this npMNA successful.
NCT05315362.
Intimate partner violence (IPV) affects almost one in three women worldwide. However, disclosing violence or seeking help is difficult for affected women. eHealth may represent an effective ...alternative to the standard support offers, which often require face-to-face interaction, because of easy accessibility and possibility of anonymous usage. In the Netherlands we are developing SAFE, an eHealth intervention for female victims of IPV, which will be evaluated in a randomized controlled trial and a process evaluation, followed by an open feasibility study to assess real-world user data.
The randomized controlled trial is a two-arm parallel design comparing an intervention arm and a control group. The groups both have access to eHealth but differ in the offer of interactive features compared to static information. Both groups complete questionnaires at three or four time points (baseline, three months, six months, 12 months) with self-efficacy at 6 months as the primary outcome, measured with the General Self-Efficacy (GSE) scale. The process evaluation consists of quantitative data (from the website and from web evaluation questionnaires) and qualitative data (from interviews) on how the website was used and the users' experiences.
eHealth has the potential to reach a large number of women who experience IPV. The internet-based design can lower access barriers and encourage help-seeking behavior ultimately reducing the lag time between subjective awareness and protective action.
Trial registered on 15 August 2017 at the Netherlands Trial Register NL7108 (NTR7313).
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Burnout is highly prevalent in medical residents. In order to prevent or reduce burnout in medical residents, we should gain a better understanding of contributing and protective factors of burnout. ...Therefore we examined the associations of job demands and resources, home demands and resources, and work–home interferences with burnout in male and female medical residents. This study was conducted on a nation-wide sample of medical residents. In 2005, all Dutch medical residents (n = 5245) received a self-report questionnaire on burnout, job and home demands and resources and work–home interference. Path analysis was used to examine the associations between job and home characteristics and work–home interference and burnout in both males and females. In total, 2115 (41.1 %) residents completed the questionnaire. In both sexes emotional demands at work and the interference between work and home were important contributors to burnout, especially when work interferes with home life. Opportunities for job development appeared to be an important protective factor. Other contributing and protective factors were different for male and female residents. In females, social support from family or partner seemed protective against burnout. In males, social support from colleagues and participation in decision-making at work seemed important. Effectively handling emotional demands at work, dealing with the interference between work and home, and having opportunities for job development are the most essential factors which should be addressed. However it is important to take gender differences into consideration when implementing preventive or therapeutic interventions for burnout in medical residents.
Purpose
To determine thresholds for amyloid beta pathology and evaluate associations with longitudinal memory performance with the aim to identify a grey zone of early amyloid beta accumulation and ...investigate its clinical relevance.
Methods
We included 162 cognitively normal participants with subjective cognitive decline from the SCIENCe cohort (64 ± 8 years, 38% F, MMSE 29 ± 1). Each underwent a dynamic
18
F florbetapir PET scan, a T1-weighted MRI scan and longitudinal memory assessments (RAVLT delayed recall,
n
= 655 examinations). PET scans were visually assessed as amyloid positive/negative. Additionally, we calculated the mean binding potential (BP
ND
) and standardized uptake value ratio (SUVr
50–70
) for an a priori defined composite region of interest. We determined six amyloid positivity thresholds using various data-driven methods (resulting thresholds: BP
ND
0.19/0.23/0.29; SUVr 1.28/1.34/1.43). We used Cohen’s kappa to analyse concordance between thresholds and visual assessment. Next, we used quantiles to divide the sample into two to five subgroups of equal numbers (median, tertiles, quartiles, quintiles), and operationalized a grey zone as the range between the thresholds (0.19–0.29 BP
ND
/1.28–1.43 SUVr). We used linear mixed models to determine associations between thresholds and memory slope.
Results
As determined by visual assessment, 24% of 162 individuals were amyloid positive. Concordance with visual assessment was comparable but slightly higher for BP
ND
thresholds (range kappa 0.65–0.70 versus 0.60–0.63). All thresholds predicted memory decline (range beta − 0.29 to − 0.21, all
p
< 0.05). Analyses in subgroups showed memory slopes gradually became steeper with higher amyloid load (all
p
for trend < 0.05). Participants with a low amyloid burden benefited from a practice effect (i.e. increase in memory), whilst high amyloid burden was associated with memory decline. Memory slopes of individuals in the grey zone were intermediate.
Conclusion
We provide evidence that not only high but also grey zone amyloid burden subtly impacts memory function. Therefore, in case a binary classification is required, we suggest using a relatively low threshold which includes grey zone amyloid pathology.
Aim
To assess viral clearance, pharmacokinetics, tolerability and symptom evolution following ensovibep administration in symptomatic COVID‐19 outpatients.
Methods
In this open‐label, ...first‐in‐patient study a single dose of either 225 mg (n = 6) or 600 mg (n = 6) of ensovibep was administered intravenously in outpatients with mild‐to‐moderate COVID‐19 symptoms. Pharmacokinetic profiles were determined (90‐day period). Pharmacodynamic assessments consisted of viral load (qPCR and cultures) and symptom questionnaires. Immunogenicity against ensovibep and SARS‐CoV‐2‐neutralizing activity were determined. Safety and tolerability were assessed throughout a 13‐week follow‐up.
Results
Both doses showed similar pharmacokinetics (first‐order) with mean half‐lives of 14 (SD 5.0) and 13 days (SD 5.7) for the 225‐ and 600‐mg groups, respectively. Pharmacologically relevant serum concentrations were maintained in all subjects for at least 2 weeks postdose, regardless of possible immunogenicity against ensovibep. Viral load changes from baseline at day 15 were 5.1 (SD 0.86) and 5.3 (SD 2.2) log10 copies/mL for the 225‐ and 600‐mg doses, respectively. COVID‐19 symptom scores decreased from 10.0 (SD 4.1) and 11.3 (SD 4.0) to 1.6 (SD 3.1) and 3.3 (SD 2.4) in the first week for the 225‐ and 600‐mg groups, respectively. No anti‐SARS‐CoV‐2 neutralizing activity was present predose and all patients had SARS‐CoV‐2 antibodies at day 91. Adverse events were of mild‐to‐moderate severity, transient and self‐limiting.
Conclusion
Single‐dose intravenous administration of 225 or 600 mg of ensovibep appeared safe and well tolerated in patients with mild‐to‐moderate COVID‐19. Ensovibep showed favourable pharmacokinetics in patients and the pharmacodynamic results warrant further research in a larger phase 2/3 randomized‐controlled trail.
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