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Streptococcus pneumoniae serotype 3 (SPN3) remains a significant contributor to invasive pneumococcal disease globally, despite its inclusion in widely administered vaccines. The next generation of pneumococcal vaccines may confer better protection against this serotype, reducing disease burden. We describe an ethically approved protocol for a double-blind randomised controlled trial assessing the impact of VAXNEUVANCE (15-valent pneumococcal conjugated vaccine (PCV15)) and 0.9% saline (placebo) on the acquisition, density and duration of SPN3 carriage using a controlled human infection model.
Healthy adults aged 18–50 years will be randomised 1:1 to receive PCV15 or placebo. Participants will be considered enrolled on the trial at vaccination. One month following vaccination, all participants will be intranasally inoculated with SPN3. Following inoculation, participants will be followed up on days 2, 7, 14 and 28 to monitor safety, SPN3 colonisation status, density and duration, as well as immune responses. The primary endpoint of the study is to assess the rate of SPN3 acquisition between vaccinated and unvaccinated participants defined by classical microbiological methods. Secondary endpoints will determine the density and duration of SPN3 colonisation and compare the immune responses between study groups. An exploratory cohort of 5 participants will be asked to consent to a nasal biopsy procedure during a screening visit and a second nasal biopsy 28 days after PCV15 vaccination. This cohort will only receive PCV15 and will not be challenged. Through this exploratory cohort, we will explore gene expression changes induced by PCV15 vaccination and their visualisation (spatial location) within the nasal tissue.
This protocol has been reviewed by the sponsor, funder and external peer reviewers. The study is approved by the NHS Research and Ethics Committee (Reference: 24/SC/0388) and by the Medicines and Healthcare Products Regulatory Agency (Reference: CTA 21584/0485/001-0001).
Individuals with Down syndrome (DS) are predisposed to obstructive sleep apnoea (OSA) due to craniofacial features (eg, midface hypoplasia, glossoptosis) and studies have shown that the prevalence of OSA in this population is markedly increased compared with that of typically developing children. Adenotonsillectomy is considered the first-line treatment for childhood OSA. However, persistent OSA is common, thus many children with DS are referred for positive airway pressure (PAP) therapy initiation; PAP appears to be an important aspect of living with DS. PAP has been shown to be highly effective in the general population for treating OSA and improving OSA-associated neurobehavioural symptoms, such as quality of life, behaviour, mood, daytime sleepiness and school performance. However, PAP as a treatment for OSA has not been well-studied in children with DS. Therefore, we designed a multicentre randomised controlled trial recruiting children with DS and OSA at three academic institutions, aged 6–18 years, referred for PAP initiation to treat OSA.
86 participants will be randomised to a 6-month intensive behavioural intervention (INT) to improve PAP adherence versus standard clinical care and underwent standardised evaluations of quality of life, behaviour, attention, PAP adherence and healthcare utilisation at baseline, 6 months and 12 months.
This study has been approved by the institutional review board at Children’s Hospital of Philadelphia (IRB of record, IRB # 20–0 17 512). Cincinnati Children’s Medical Center and University of Miami delegated IRB review and approval responsibility to Children’s Hospital of Philadelphia through reliance agreements as mandated by National Institutes of Health (NIH). All participants will be minors; consent will be obtained from parents and assent from participants will be obtained when possible. The intervention tested in this trial is considered not greater than minimal risk, and no identifiable data will be reported. As required by the NIH, a data safety monitoring board (DSMB) has been formed, who will review and approve the protocol and any protocol changes prior to implementation. The study team will send biannual reports and hold a biannual meeting with the DSMB to review any safety and protocol concerns. Findings will be presented at national conferences pertinent to this topic and published in peer-reviewed medical journals. In addition, findings will be shared in the lay format with DS associations around the world and used for training of healthcare providers and trainees (R25HD118212). Further, data collected will be deposited in a repository (National Sleep Research Resource; sleepdata.org) after completion of the study to maximise use by scientific community.
by Adela Klezlova, Petr Bulir, Alexandr Stepanov, Andrea Sidova, Magdalena Netukova, Jana Vranova, Katarina Urbaniova, Martina Grajciarova, Lenka Vankova, Zbynek Tonar, Pavel Studeny
PurposeThe purpose of the study is to evaluate the effectiveness, surgical preoperative and postoperative complications, histopathological findings, and optimize surgical technique after implantation of the new nanofiber glaucoma drainage implant (GDI).
MethodImplantation of the GDI, a unique nanofiber drainage device fabricated from polyvinylidene fluoride (PVDF) using the well-established electrospinning technology on the Nanospider™ platform, was first optimized in vitro on cadaver porcine bulbs before the initial in vivo implantations. PVDF was selected due to its favorable properties, including biocompatibility, anti-adhesive behavior, and mechanical stability, which are particularly advantageous in minimizing fibroblast colonization and fibrotic encapsulation. The Nanospider™ technology allows for reproducible, large-scale fabrication of nanofiber materials with controlled fiber morphology, which ensures uniformity and precision of implant dimensions.An in vivo study on 28 normotensive eyes from 14 laboratory New Zealand White rabbits was conducted. There were two groups of animals: the study group (14 eyes) and the control group (14 contralateral eyes). The study group underwent implantation of the new nanofiber GDI; the control group did not undergo any surgical procedure. Intraocular pressure (IOP) was measured preoperatively and at regular times postoperatively (Tono-Pen AVIA®). Preoperative and immediate postoperative complications were monitored. Histological quantification was performed using unbiased sampling and stereological methods to assess leukocyte infiltration, type I and type III collagen fractions, and both absolute and relative levels of inflammation.
ResultsBased on the previous results and in vitro surgical experiences, the implant was narrowed to 2.0 mm, a thickness of 100 µm was chosen, and the implant was fixed with two scleral stitches to maintain its position. No serious preoperative complications occurred during in vivo experiments. There was one extrusion of the glaucoma implant noted after surgery, likely due to insufficient conjunctival fixation. This animal was excluded from both the study and the control groups. No serious instances of intraocular hypotension were observed after surgery. All animals tolerated the surgical procedure well, and the postoperative period was without any serious issues. In the study group, the average preoperative IOP was 13.6 mmHg (±4.1, n = 13). The average postoperative IOP on the first day, one, two, and three weeks, and one month after surgery decreased to 8.8 mmHg (±3.3, n = 13), 9.8 mmHg (±2.0, n = 13), 10.3 mmHg (±3.6, n = 13), 10.2 mmHg (±2.6, n = 13), and 9.7 mmHg (±2.0, n = 13), respectively. In the control group of contralateral eyes, the average preoperative IOP was 11.42 mmHg (±4.2, n = 13). The average postoperative IOP was 11.8 mmHg (±5.4, n = 13), 14.2 mmHg (±4.6, n = 13), 14.5 mmHg (±3.4, n = 13), 14.0 mmHg (±3.8, n = 13), and 14.2 mmHg (±2.4, n = 13), respectively, at the same follow-ups. In the study group, the IOP was statistically significantly lower by 29% at the end of the follow-up compared to the preoperative measurements (p = 0.009). Eyes with the implant showed greater leukocyte infiltration and less type I collagen compared to the group without implants. The ratio of type I to type III collagen was lower in the implant group, indicating delayed maturation and weaker connective tissue during early healing.
ConclusionFor easier implantation, minor technical adjustments such as implant narrowing and scleral fixation of the GDI were developed and tested using in vitro experiments. In vivo implantation of unique nanofiber GDI appeared safe and technically well-suited for our study. No serious perioperative or postoperative complications were observed. There was one scleral extrusion of the device, which was, in our opinion, caused by insufficient conjunctival fixation. A statistically significant IOP reduction was achieved at the end of the follow-up in the study group with implanted GDIs. Further studies on the effectiveness of the implant with longer monitoring periods, together with other surgical options such as combined cataract surgery and nanofibers GDI, are needed.
The prevention of treatment discontinuation is crucial in mitigating the adverse consequences of diabetes. This study aimed to identify the psychosocial factors and patient experiences associated with the discontinuation of diabetes treatment.
A cross-sectional study was conducted.
A nationwide online survey with convenience sampling.
Participants, aged 40–79 years, who reported living with diabetes, were included.
Treatment continuation status was the outcome variable. Participants who previously received regular treatment but were not currently under medical care were classified as the treatment discontinuation group. Psychological factors (mood and anxiety disorders, self-esteem, procrastination), social factors (loneliness, economic difficulties, adverse childhood experiences) and patient experiences and opinions regarding diabetes were assessed.
A total of 4715 individuals were included in the analysis. After adjusting for confounders, psychological distress (adjusted OR (AOR)=1.87, 95% CI (1.06 to 3.30), p=0.032) and higher procrastination (AOR=2.64, 95% CI (1.25 to 5.56), p=0.011) were significantly associated with treatment discontinuation. Overall, 9.7% of participants reported financial hardship, and 12.1% reported diabetes burnout during their course of treatment. Financial hardships (p=0.002), difficulty with child or older adult care (p
Psychological distress and higher procrastination levels were significantly associated with diabetes treatment discontinuation, after adjusting for potential confounders. The treatment discontinuation group reported significantly more psychosocial challenges than the continuation group. Healthcare providers and systems should prioritise addressing the psychosocial characteristics, experiences and challenges faced by individuals with diabetes.
Nurse leaders at every level are needed to help organizations achieve strategic goals and deliver safe patient care. Nurse leaders can find fulfillment in their roles; however, they are often prone to poor work-life balance due to the complexity and demands of their jobs. Professional well-being, consisting of an individual's overall health and the perception of good work-related quality of life, is at risk for being compromised in these nurses. Research exploring variables associated with psychosocial well-being in nurse leaders is limited.
To describe variables related to psychological well-being in nurse leaders, explore associations among these variables, and identify potential demographic and psychosocial predictors of resilience and burnout.
Participants were a convenience sample of nurse leaders from two hospitals located in the southwestern United States. We used a prospective observational design to describe the incidence of and relationships between self-compassion, satisfaction with life, resilience, perceived stress, and burnout. We then sought to identify predictors of disengagement and exhaustion (subscales of burnout) and resilience.
Participants (n = 105) were mostly female (82.7%) and white (57.7%), while one-third were charge nurses. Most reported normal to high levels of satisfaction with life (86%), self-compassion (90%), and resilience (93.3%) and 72.4% reported high stress levels. Moderately high levels of disengagement (46.4%) and exhaustion (59.1%) were also present. Higher self-compassion levels predicted higher levels of resilience. Lower satisfaction with life and self-compassion together predicted high disengagement scores, while lower self-compassion scores predicted high exhaustion scores.
When disengagement, exhaustion, and perceived stress are elevated, nurse leaders are at risk for low professional well-being and may be more prone to resignation ideation or turnover. Evidence-based interventions designed specifically for nurse leaders promoting professional well-being and emphasizing self-compassion skills are needed along with high-quality research on program outcomes.
Objetivo principal: Conocer si el estudio realizado en el artículo original está elaborado con una calidad metodológica consistente como para constituir una evidencia fuerte. Metodología: Revisión crítica de un artículo original siguiendo unas pautas aconsejadas por la revista Evidentia. Resultados principales: Los resultados proponen que el uso de fototerapia simple con cortinas reflectantes es tan efectiva para el tratamiento de la hiperbilirrubinemia neonatal severa como el tratamiento con fototerapia doble. Varios estudios controlados aleatorizados han demostrado la mayor eficacia de la fototerapia al añadirle alrededor de la cuna unas cortinas que reflejaran la luz. Conclusión principal: Este artículo añade datos importantes al cuantificar hasta qué punto pueden ser efectivas las cortinas blancas añadidas a la fototerapia convencional ya que iguala la efectividad a la fototerapia doble. Nivel de evidencia: “alta”, según la escala GRADE.
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