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Breast reconstruction and neoadjuvant radiotherapy (BRENAR) - study protocol for a multicenter, prospective, single-arm pilot study
Background: Over the past decade, post-mastectomy radiotherapy (PMRT) is indicated more frequently in breast cancer treatment, especially in patients with involved axillary lymph nodes. However, PMRT is associated with high complication rates and less satisfactory cosmetic results when combined with immediate breast reconstructions. This has led to ongoing controversy regarding breast reconstruction and radiotherapy, often postponing the reconstruction until long after PMRT has been completed. Preoperative radiotherapy, also known as neoadjuvant radiotherapy (NART), is emerging as a safe and promising alternative with the potential to allow immediate reconstruction without the negative effects of radiotherapy on the reconstructed breast. However, data on the complication rates and patient-reported outcomes (PROs) after NART followed by mastectomy and breast reconstruction are still limited. Methods: This is a multicenter, prospective, single-arm pilot study including breast cancer patients requiring mastectomy and PMRT, who desire immediate breast reconstruction, either implant-based or autologous. The primary objective is to assess complications three months after the last planned reconstructive surgery. The secondary objectives are to evaluate patientreported health-related quality of life (HR-QoL), patient- and physician-reported cosmetic results, and pathological response. Discussion: The primary outcome of this pilot study is to provide further evidence to determine whether NART is a viable alternative to PMRT in terms of complication rates when combined with immediate breast reconstruction. The secondary outcomes will enhance our understanding of patients' HR-QoL and cosmetic outcomes. If NART proves to be a safe alternative, this pilot study will lay the foundation for a national multicenter randomized controlled trial to evaluate long-term HR-QoL and oncological outcomes
How Can 'Health in All Policies' Help Maximise the Potential of Microbial Biotechnologies for Health, Equity and Sustainability?
Microbial biotechnologies could affect health through multiple pathways, including impacts on food, nutrition, and the physical, economic, and social environment. Health in All Policies is an approach to ensure that plans and policies in all sectors maximise health gains and minimise any health risks. This approach often uses health impact assessment as a structured process to identify and assess positive and negative health impacts and make recommendations to improve these. There are very few examples where HIA has been applied to the implementation of microbial biotechnologies. As more biotechnologies are developed and implemented, more routine use of HIA could help to avoid adverse effects and realise their potential to improve health and reduce health inequalities. This will require greater awareness and understanding of the breadth of links to health, research to build the evidence base for these links, and governance mechanisms to oversee the development and implementation of microbial biotechnologies that prioritise health, equity and sustainability
[<SUP>18</SUP>F]FDG PET/CT to reduce the need for sentinel lymph node biopsy in early-stage oral cancer:PETN0-study protocol
Using reliable techniques for detecting lymph node metastases (LNM) in oral squamous cell carcinoma (OSCC) is crucial for adequate neck treatment. Currently, palpation of the neck, computed tomography, magnetic resonance imaging, ultrasound-guided fine needle aspiration cytology and/or sentinel lymph node biopsy (SLNB) are used to stage the neck in early-stage OSCC. SLNB is a reliable diagnostic technique to detect occult LNM. However, management of the neck with SLNB has its limitations. First of all, SLNB is an invasive procedure with associated morbidity and approximately 20-30% of patients require a subsequent neck dissection. Moreover, performing a subsequent neck dissection is more complex than elective neck dissection, and carries a higher risk of complications. Therefore, it is important to improve patient selection for SLNB. Fluor-18-fluorodeoxyglucose ([18F]FDG) positron emission tomography/computed tomography (PET/CT) has shown promising results for LNM detection. The aim of the PETN0 study, a prospective Dutch multicenter cohort study (registration number NL83442.041.22), is to reduce the need for SLNB by developing scoring criteria for [18F]FDG PET/CT with a high positive predictive value (PPV) in patients with early-stage OSCC. Developing scoring criteria for a high PPV can reduce SLNBs and second-stage neck dissections by performing a neck dissection together with resection of the primary tumor in patients with predicted LNM. When focused on high PPV the sensitivity will probably be lower, but missed LNM will be detected by SLNB when performed after negative [18F]FDG PET/CT. Patients (n = 159) with cT1-3N0 OSCC (8th TNM edition; only when T3 is assessed based on tumor dimensions of >2 and <= 4 cm, with DOI > 10 mm), candidate for transoral excision and SLNB, are included in the study. [18F]FDG PET/CT will be conducted within a maximum of three weeks before SLNB. A cost-effectiveness analysis will also be performed, together with quality of life assessment using questionnaires
A personalized approach to classify the degree of liver insulin resistance in children with obesity
AimsThis study aimed to develop a novel approach for quantifying liver insulin resistance (LIR) in children with obesity using personalized glucose and insulin responses from oral glucose tolerance tests (OGTTs).Materials and MethodsA total of 242 OGTTs were performed on paediatric patients with obesity. Blood glucose and insulin levels were determined at six timepoints. Measurements of liver enzymes, plasma lipids, blood pressure and height and weight were obtained concurrently. Associations of LIR with other clinical parameters of obesity and type 2 diabetes were compared between the conventional and novel LIR quantification.ResultsThe study revealed heterogeneous OGTT response dynamics among the population, with substantial variability in peak levels of glucose and insulin. The novel approach to quantify LIR showed stronger associations between glucose and insulin responses and clinical markers of obesity and type 2 diabetes, compared to the conventional method.ConclusionsThe novel LIR quantification method provides a more precise assessment of insulin resistance in paediatric obesity management compared to traditional methods. By considering individual glucose and insulin dynamics, this approach enhances risk stratification and treatment planning tailored to each patient's OGTT response curve
Burden of Disease of Borderline Personality Disorder:A Comprehensive Evaluation of Quality of Life and Societal Cost of Illness
Information on the burden of disease, including quality of life (QoL) and societal costs, of borderline personality disorder (BPD) is crucial, as healthcare policymakers consider the burden of disease when setting priorities for treatment reimbursement. We conducted a comprehensive evaluation of the burden of disease of BPD by estimating annual costs from a societal perspective using a bottom-up approach and distinguishing between costs primarily related to psychological and somatic problems. QoL was determined using a generic QoL measure (EQ-5D five-level version [EQ-5D-5L]) as well as a measure specifically designed for individuals with psychological problems (Mental Health Quality of Life seven-dimensional questionnaire [MHQoL-7D]). Additionally, societal costs and QoL were compared with a comparison group. Data from 204 Dutch treatment-seeking outpatients diagnosed with BPD and 86 individuals without severe psychological problems were analyzed. The results indicated a severely impaired QoL (EQ-5D-5L: 0.51, MHQoL-7D: 0.24) combined with substantial societal costs (average total <euro>35,038 per year) for BPD outpatients, markedly different from the comparison group. Societal costs of BPD were primarily attributable to psychological problems, with costs in other sectors as the main cost driver. The BPD group incurred higher costs for most patient and family cost items and cost items in other sectors, whereas differences in healthcare costs were limited to outpatient psychiatric treatment, consultations with general practitioners, emergency care, and social work. The high economic burden, along with the low QoL, suggests that increased treatment reimbursement for BPD would benefit both patients and society at large.Trial Registration: The BOOTS study was registered in the Overview of Medical Research in the Netherlands (NL-OMON21337), formerly known as the Netherlands Trial Register
Utilising artificial intelligence in prehospital emergency care systems in low- and middle-income countries:a scoping review
Introduction Improvements in prehospital emergency care have the potential to transform patient outcomes globally, but particularly within low-and middle-income countries. Whilst artificial intelligence is being implemented in many healthcare settings, little is known about its use in prehospital emergency care systems. This scoping review aims to uncover how artificial intelligence is currently being used within the prehospital emergency medical services of low-and middle-income countries and assess the implications for future development.Methods A review of peer-reviewed articles using any artificial intelligence models in prehospital emergency care in low-and middle-income countries was carried out. Medline, Global Health, Embase, CINAHL and Web of Science were searched for studies published between January 2014 and July 2024. Data were extracted, collated and presented in table format and as a narrative synthesis. This scoping review is reported using the PRISMA-ScR guidelines.Results Sixteen articles were included in the study. Most studies were conducted in China and deep learning models were used in half of the studies. Articles assessing dispatch forecasting were the most common, although artificial intelligence tools are also utilised in classification and disease prediction. There was significant variation in sample sizes throughout the selected studies. Overall, machine learning algorithms outperformed other comparator methods when they were used in all but two studies.Discussion Limitations included only analysing articles published in English. Additionally, studies that did not identify the model as an artificial intelligence tool, or did not explicitly mention a LMIC in the title or abstract may have been inadvertently excluded. Whilst artificial intelligence can significantly benefit patient care in out-of-hospital settings, the continued development of this technology requires proper consideration for the local sociocultural contexts and challenges in these countries, along with using complete, population-specific datasets. Further research is needed to support advancements in this field and promote the realisation of universal health coverage.Systematic review registration https://doi.org/10.17605/OSF.IO/9VS2M, osf.io/9vs2m
A genome-wide association study in 10,000 individuals links plasma N-glycome to liver disease and anti-inflammatory proteins
More than a half of plasma proteins are N-glycosylated. Most of them are synthesized, glycosylated, and secreted to the bloodstream by liver and lymphoid tissues. While associations with N-glycosylation are implicated in the rising number of liver, cardiometabolic, and immune diseases, little is known about the genetic regulation of this process. Here, we performed the largest genome-wide association study of N-glycosylation of the blood plasma proteome in 10,000 individuals. We doubled the number of genetic loci known to be associated with blood N-glycosylation by identifying 16 novel loci and prioritizing 13 novel genes contributing to N-glycosylation. Among these were the GCKR, TRIB1, HP, SERPINA1 and CFH genes. These genes are predominantly expressed in the liver and show a previously unknown genetic link between plasma protein N-glycosylation, metabolic and liver diseases, and inflammatory response. By integrating glycomics, proteomics, transcriptomics, and genomics, we provide a resource that facilitates deeper exploration of disease pathogenesis and supports the discovery of glycan-based biomarkers
Addressing individual needs in mindful eating:a latent profile analysis and exploration of demographics and social-cognitive beliefs
Introduction:To promote mindful eating it may be relevant to take different eating profiles into account. This prospective study aimed to (i) identify the existence of potential respondent subgroups regarding mindful eating and (ii) compare these profiles on socio-demographic characteristics and social-cognitive beliefs about mindful eating using the I-Change Model (ICM).Methods:Dutch adults (Mage = 52.6; 53% male) responded to an online survey at baseline (N = 615) and 3-months (n = 513) follow-up asking about social-cognitive beliefs about practicing mindful eating based on the ICM. Following a latent profile analysis of mindful eating facets, profiles at baseline were compared on social-cognitive beliefs at follow-up using a MANOVA with Tukey-adjusted post-hoc tests.Results:Three profiles were identified (1. low awareness, high acceptance; 2. high awareness, low acceptance; 3. moderate awareness, moderate acceptance). These profiles significantly differed in their demographics and social-cognitive beliefs about mindful eating (e.g., knowledge, perceived pros and cons, self-efficacy, intention and planning to adopt mindful eating).Discussion:Findings suggest the limitations of a one-size-fits-all approach to promoting mindful eating. Interventions may need to consider different recruitment and targeted strategies based on socio-demographic characteristics and social-cognitive beliefs to ensure different groups of individuals are represented in and can benefit from interventions in a safe and accessible way
Perspectives of migrant men who have sex with men and professionals on personal, social and structural barriers and facilitators to sexual healthcare access and outreach strategies:A qualitative study
Background: Migrant men who have sex with men (mMSM) carry a disproportionate burden of sexually transmitted infections (STIs) yet encounter unique barriers to accessing sexual healthcare. This qualitative study explored mMSM's and professionals’ perspectives regarding mMSM's personal, social and structural barriers and facilitators to Dutch sexual healthcare access and outreach strategies. Methods: A qualitative study was conducted using semi-structured interviews with 15 mMSM (aged =16) and 10 professionals from various organisations working with mMSM. mMSM were recruited via sexual health nurses at three STI clinics of a Dutch Public Health Service and flyers; professionals via email, flyers, and the project team's network. Transcripts were analysed thematically using deductive and inductive coding by two researchers, ensuring intercoder agreement. Results: Key facilitators for sexual healthcare access included supportive social networks, in-person consultations, and culturally and LGBTQ+-sensitive staff. Main barriers involved fear of stigma rooted in cultural and religious beliefs, limited awareness of available services, and language-related challenges. Suggested outreach strategies included dating app advertisements, short multilingual videos, and translated posters in venues frequented by mMSM (e.g., bars and schools). Notably, most participants accessed services through personal referrals, underlining the importance of including social networks in outreach strategies. Conclusions: Addressing personal, social and structural barriers while enhancing facilitators contributes to more inclusive and equitable sexual healthcare services. Besides, increasing reach of mMSM through the dissemination of tailored information via social networks, digital platforms, and community settings further supports this objective. These findings inform strategies aimed at reducing health disparities and contribute to broader STI, HIV, and hepatitis prevention goals