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The External Validation of a Multivariable Prediction Model for Recurrent Pelvic Organ Prolapse After Native Tissue Repair: A Prospective Cohort Study.
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317646.pdf (Publisher’s version ) (Open Access)Background/Objectives: A prediction model for anatomical cystocele recurrence after native tissue repair was developed and internally validated in 2016. This model estimates a patients' individual risk of recurrence and can be used for counseling. Before implementation in urogynecological clinical practice, external validation is needed. The aim of this study was to assess the external validity of this previously developed prediction model. The secondary aim was to test the performance of this model with a composite and subjective outcome of pelvic organ prolapse (POP) recurrence. Furthermore, the aim was to investigate whether risk factors for POP recurrence were in line with the population in which the original model was developed. Methods: In this prospective multicenter cohort study, 246 patients who underwent anterior colporrhaphy were included. Inclusion criteria were patients scheduled to undergo a primary anterior colporrhaphy (with a POP Quantification (POPQ) stage ≥ 2 cystocele). A combination of a primary anterior colporrhaphy with other POP or incontinence surgery (without the use of vaginal or abdominal mesh material) was permitted. Patients with prolapse or incontinence surgery prior to index surgery could not participate. All patients filled in questionnaires, pelvic floor ultrasound was performed preoperatively, and data from the medical file concerning POPQ stage and obstetric and general history were obtained. Results: Thirty women (12.2%) were lost at follow up. Anatomical cystocele recurrence was present in 107/216 (49.5%), subjective recurrence in 19/208 (9.1%), and 39/219 (17.8%) patients met the criteria for composite outcome. The area under the receiver operating characteristic curves for anatomical, composite, and subjective recurrence were 65.5% (95% CI: 58.7-72.4), 55.8% (95% CI 47.3-64.3%, NS), and 55.1% (95% CI 45.1-65.2%), respectively. In the multivariable analysis, preoperative cystocele stage 3 or 4 and a complete levator defect on ultrasound were independent risk factors for anatomical recurrence. For composite recurrence, younger age and an active employment status were only risk factors in univariable analysis. No significant risk factors for subjective recurrence could be identified. Conclusions: This external validation study showed a moderate performance for a prediction model for anatomical recurrence. The model cannot be used for a composite or subjective outcome prediction because of poor performance. For composite and subjective recurrence, new prediction models need to be developed
Effect of Bacille Calmette-Guérin vaccination on immune responses to SARS-CoV-2 and COVID-19 vaccination.
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315956.pdf (Publisher’s version ) (Open Access)OBJECTIVES: Bacille Calmette-Guérin (BCG) vaccination has off-target effects on disease risk for unrelated infections and immune responses to vaccines. This study aimed to determine the immunomodulatory effects of BCG vaccination on immune responses to vaccines against SARS-CoV-2. METHODS: Blood samples, from a subset of 275 SARS-CoV-2-naïve healthcare workers randomised to BCG vaccination (BCG group) or no BCG vaccination (Control group) in the BRACE trial, were collected before and 28 days after the primary course (two doses) of ChAdOx1-S (Oxford-AstraZeneca) or BNT162b2 (Pfizer-BioNTech) vaccination. SARS-CoV-2-specific antibodies were measured using ELISA and multiplex bead array, whole blood cytokine responses to γ-irradiated SARS-CoV-2 (iSARS) stimulation were measured by multiplex bead array, and SARS-CoV-2-specific T-cell responses were measured by activation-induced marker and intracellular cytokine staining assays. RESULTS: After randomisation (mean 11 months) but prior to COVID-19 vaccination, the BCG group had lower cytokine responses to iSARS stimulation than the Control group. After two doses of ChAdOx1-S, differences in iSARS-induced cytokine responses between the BCG group and Control group were found for three cytokines (CTACK, TRAIL and VEGF). No differences were found between the groups after BNT162b2 vaccination. There were also no differences between the BCG and Control groups in COVID-19 vaccine-induced antigen-specific antibody responses, T-cell activation or T-cell cytokine production. CONCLUSION: BCG vaccination induced a broad and persistent reduction in ex vivo cytokine responses to SARS-CoV-2. Following COVID-19 vaccination, this effect was abrogated, and BCG vaccination did not influence adaptive immune responses to COVID-19 vaccine antigens
Atosiban versus placebo for threatened preterm birth (APOSTEL 8): a multicentre, randomised controlled trial
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318267.pdf (Publisher’s version ) (Open Access)BACKGROUND: Tocolytics are recommended in international guidelines as treatment for threatened preterm birth. Atosiban, an oxytocin receptor antagonist, is a registered tocolytic drug specifically indicated for the treatment of threatened preterm birth. Although tocolytics have been shown to delay birth, benefits on neonatal outcomes have not been demonstrated. In the APOSTEL 8 trial we aimed to assess superiority of tocolysis with atosiban compared with placebo in threatened preterm birth from 30 weeks and 0 days (30(+0) weeks) to 33(+6) weeks of gestation in improving neonatal morbidity and mortality. METHODS: This was an international, multicentre, randomised, double-blind, superiority trial conducted in 26 hospitals in the Netherlands, England, and Ireland. After written informed consent, women aged 18 years or older with a singleton or twin pregnancy with threatened preterm birth from 30(+0) to 33(+6) weeks of gestation were randomly assigned (stratified by centre, 1:1 ratio) to intravenous atosiban or placebo. The primary outcome was a composite of perinatal mortality (stillbirth and death until 28 days postpartum) and six severe neonatal morbidities. Analysis was by intention-to-treat. Treatment effect was estimated as relative risk (RR) with 95% CI. This trial was prospectively registered at EudraCT (2017-001007-72) and the Netherlands Trial Registry (NL-OMON54673), and is complete. FINDINGS: Between Dec 4, 2017, and July 24, 2023, a total of 755 participants were randomly assigned, of whom 752 were included in the intention-to-treat analysis (atosiban n=375, placebo n=377). The primary outcome occurred in 37 (8%) of 449 infants in the atosiban group and 40 (9%) of 435 in the placebo group (RR 0·90 [95% CI 0·58-1·40]). There were three (0·7%) and four (0·9%) infants who died, respectively (RR 0·73 [0·16-3·23]); all deaths were deemed unlikely to be related to the study drug. Maternal adverse events did not differ between groups, and there were no maternal deaths. INTERPRETATION: We did not demonstrate superiority of atosiban over placebo in improving neonatal outcomes as treatment for threatened preterm birth from 30(+0) to 33(+6) weeks of gestation. As the primary goal of tocolysis should be improvement of neonatal outcomes, our outcomes question the standardised use of atosiban as treatment for threatened preterm birth from 30(+0) to 33(+6) weeks of gestation. Our findings should reduce practice variation across countries and will contribute to evidence-based treatment for patients with threatened preterm birth. FUNDING: ZonMw
Good Practices for Health Technology Assessment Guideline Development: A Report of the Health Technology Assessment International, HTAsiaLink, and ISPOR Special Task Force.
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315065.pdf (Publisher’s version ) (Open Access)OBJECTIVES: Health technology assessment (HTA) guidelines are intended to support the successful implementation of HTA by enhancing consistency and transparency in concepts, methods, processes, and use, thereby enhancing the legitimacy of the decision-making process. This report lays out good practices and practical recommendations for developing or updating HTA guidelines to ensure successful implementation. METHODS: The task force was established in 2022 and comprised experts and academics from various geographical regions, each with substantial experience in developing HTA guidelines for national health policy making. Literature reviews and key informant interviews were conducted to inform these good practices. Stakeholder consultations, open peer reviews, and expert opinions validated the recommendations. A series of teleconferences among task force members was held to iteratively refine the report. RESULTS: The recommendations cover six key aspects throughout the guideline development cycle: (1) setting objectives, scope, and principles of the guideline, (2) building a team for a quality guideline, (3) defining a stakeholder engagement plan, (4) developing content and utilizing available resources, (5) putting in place appropriate institutional arrangements, and (6) monitoring and evaluating guideline success. CONCLUSION: This report presents a set of resources and context-appropriate practices for developing or updating HTA guidelines. Across all contexts, the recommendations emphasize transparency, building trust among stakeholders, and fostering a culture of ongoing learning and improvement. The report recommends timing development and revision of guidelines according to the HTA landscape and pace of HTA institutionalization. Because HTA is increasingly used to inform different kinds of decision making in a variety of country contexts, it will be important to continue to monitor lessons learned to ensure the recommendations remain relevant and effective
All Optical Switching: a Path to Recording Technology Beyond HAMR
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317986.pdf (Publisher’s version ) (Open Access
Riding the Storm in a Probabilistic Model Checking Landscape
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316741.pdf (Publisher’s version ) (Open Access)Probabilistic model checking is a formal verification technique to check whether stochastic models satisfy properties of interest. Along with a rich theory, the community has developed mature tool support, which in turn has been applied to a set of industrial case studies. This paper demonstrates various abilities of the probabilistic model checker Storm by a set of simple and more accessible examples
Building Resilience: The Stress Response as a Driving Force for Neuroplasticity and Adaptation
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315773.pdf (Publisher’s version ) (Open Access)People exhibit an extraordinary capacity to adjust to stressful situations. Here, we argue that the acute stress response is a major driving force behind this adaptive process. In addition to immediately freeing energy reserves, facilitating a rapid and robust neurocognitive response, and helping to reinstate homeostasis, the stress response also critically regulates neuroplasticity. Therefore, understanding the healthy acute stress response is crucial for understanding stress resilience-the maintenance or rapid recovery of mental health during and after times of adversity. Contemporary resilience research differentiates between resilience factors and resilience mechanisms. Resilience factors refer to a broad array of social, psychological, or biological variables that are stable but potentially malleable and predict resilient outcomes. In contrast, resilience mechanisms refer to proximate mechanisms activated during acute stress that enable individuals to effectively navigate immediate challenges. In this article, we review literature related to how neurotransmitter and hormonal changes during acute stress regulate the activation of resilience mechanisms. We integrate literature on the timing-dependent and neuromodulator-specific regulation of neurocognition, episodic memory, and behavioral and motivational control, highlighting the distinct and often synergistic roles of catecholamines (dopamine and norepinephrine) and glucocorticoids. We conclude that stress resilience is bolstered by improved future predictions and the success-based reinforcement of effective coping strategies during acute stress. The resulting generalized memories of success, controllability, and safety constitute beneficial plasticity that lastingly improves self-control under stress. Insight into such mechanisms of resilience is critical for the development of novel interventions focused on prevention rather than treatment of stress-related disorders.9 p
Commentary: Effective communication about pregnancy, birth, lactation, breastfeeding and newborn care: the importance of sexed language.
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315909.pdf (Publisher’s version ) (Open Access
Bias in artificial intelligence for medical imaging: fundamentals, detection, avoidance, mitigation, challenges, ethics, and prospects.
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317281.pdf (Publisher’s version ) (Open Access)Although artificial intelligence (AI) methods hold promise for medical imaging-based prediction tasks, their integration into medical practice may present a double-edged sword due to bias (i.e., systematic errors). AI algorithms have the potential to mitigate cognitive biases in human interpretation, but extensive research has highlighted the tendency of AI systems to internalize biases within their model. This fact, whether intentional or not, may ultimately lead to unintentional consequences in the clinical setting, potentially compromising patient outcomes. This concern is particularly important in medical imaging, where AI has been more progressively and widely embraced than any other medical field. A comprehensive understanding of bias at each stage of the AI pipeline is therefore essential to contribute to developing AI solutions that are not only less biased but also widely applicable. This international collaborative review effort aims to increase awareness within the medical imaging community about the importance of proactively identifying and addressing AI bias to prevent its negative consequences from being realized later. The authors began with the fundamentals of bias by explaining its different definitions and delineating various potential sources. Strategies for detecting and identifying bias were then outlined, followed by a review of techniques for its avoidance and mitigation. Moreover, ethical dimensions, challenges encountered, and prospects were discussed
Transdisciplinariteit als creatieve contingentie
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315710.pdf (Publisher’s version ) (Open Access)Purpose: Co-creation, characterised by artists and patients creating a joint work of art, may support patients with the integration of life events, such as living with cancer, into their life story. In the process of co-creation, resonance relationships between patients, artists and material may evolve that support such integration. Using the framework of resonance theory, we aim to investigate if and how patients move through the three phases of resonance during a process of co-creation and explore the role of uncontrollability in this process. Methods: Ten patients who received cancer treatment with palliative intent completed co-creation processes, which were audio recorded. These recordings were imported in Atlas-Ti and analysed by applying content analysis. We searched for the three phases of resonance, Being affected, touched and moved; Self-efficacy and responding; Adaptive transformation. We additionally searched
for signs of uncontrollability. Results: Patients used 4–8 sessions (median 5 sessions) with a duration 90–240 min per session (median duration 120 min). We found that patients move through the three phases of resonance during co-creation
processes. Uncontrollability both presents a challenge and an invitation to integrate experiences of contingency into one's life narrative. Patients express self-recognition and the experience of contingency in their work of art. Conclusions: Integration of experiences of contingency into a life narrative can be supported by the process of co-creation of art, which invites patients to relate
to their illness, their environment and themselves. The phases of resonance in combination with uncontrollability as a continuously present factor, provide a means to both study and support the integration of experiences of contingency into the life narrative