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Development of a CORe outcome set for clinical trials of RECTal cancer treatment: protocol for the CORRECT initiative

Por: Garfinkle · R. · George · M. · Jethwa · K. · Johansen · P. · Lakaszawski · M. · Nagarajan · A. · Smart · N. · Sylla · P. · Vuong · T. · Boutros · M. · Fergusson · D. A.
Introduction

With the rapidly changing landscape of rectal cancer treatment, it is becoming increasingly challenging for clinicians to interpret and synthesise the vast amount of high-quality evidence being generated. A core outcome set (COS) for clinical trials in rectal cancer would help address issues surrounding outcome selection and reporting. The purpose of this research project is to develop a COS to be used in research comparing different treatment paradigms in the management of rectal cancer.

Methods and analysis

This will be a mixed-methods project, including a systematic review, semi-structured interviews and a Delphi consensus process. The project was designed in accordance with the COMET (Core Outcome Measures in Effectiveness Trials) Handbook, which provides a framework for COS development based on existing evidence. A multidisciplinary Study Advisory Group, composed of rectal cancer providers, methodologists and patients, will oversee the project. A systematic review will be performed to identify an inclusive list of outcomes reported by researchers in previous rectal cancer trials. Outcomes will be collapsed into various core areas and domains according to the OMERACT Filter V.2.0. Semi-structured interviews with rectal cancer survivors and their partners/caregivers will help identify additional patient-centric outcomes not captured in the systematic review. Finally, after a final list of outcomes is generated, patients and healthcare professionals will be invited to participate in a Delphi process to develop the final COS.

Ethics and dissemination

The study has received full approval with the Research Ethics Committee at the Integrated Health and Social Services Network for West-Central Montreal (health network responsible for the Jewish General Hospital) (REC: 2025-4377) and the Institutional Review Board of the Mount Sinai School of Medicine (IRB: STUDY-25-00515). The results of this study will be presented at national and international meetings and a manuscript will be submitted for publication in a high-impact surgery and/or oncology peer-reviewed journal.

Trial registration number

The study was registered in the COMET database in December 2023 (https://www.comet-initiative.org/Studies/Details/2941). The full systematic review protocol, along with the search strategy and inclusion/exclusion criteria, was registered online in September 2023 (researchregistry.com; reviewregistry1705).

Prevalence of presbyopia among social safety net beneficiaries with the cognitive, numeracy and dexterity skills required for smartphone use: a cross-sectional analysis of THRIFT RCT screening data from Kurigram, Bangladesh

Por: Aftab · I. B. · Chakma · T. · Pant · S. · Sigwadhi · L. N. · Shitol · S. A. · Rahman · H. M. M. · Alam · J. · Haque · E. · Chadalavada · H. P. · Murtaza · F. · Chan · V. F. · Little · J.-A. · Khanna · R. C. · MacKenzie · G. · Gudwin · E. · Lohfeld · L. · Clarke · M. · Shonchoy · A. · Congd
Objectives

To determine the prevalence of presbyopia and associated risk factors among Bangladeshi recipients of elderly social safety net payments who were not currently using mobile financial services (MFS) and demonstrated numeracy, dexterity and cognitive prerequisites for smartphone use during eligibility screening for the Transforming Households with Refraction and Innovative Financial Technology (THRIFT) trial. Accessing these payments requires use of online banking, as with a smartphone.

Design

Cross-sectional analysis of trial eligibility screening data.

Setting

Community-based screening conducted in two rural subdistricts in Kurigram District, Bangladesh.

Participants

Among 13 944 Old Age Allowance and Widows’ Allowance (WA) beneficiaries screened, 953 met trial eligibility criteria, including passing a smartphone readiness assessment and completing near vision examinations.

Primary and secondary outcome measures

Presbyopia, defined as binocular presenting near visual acuity of N6.3 or worse, correctable to at least N5 with near vision glasses and with distance vision of ≥6/12 in both eyes.

Results

Among 953 participants (mean age 61.4±7.2 years, 62.6% women), presbyopia prevalence was 62.6% (95% CI 59.5 to 65.7). Presbyopia was significantly positively associated with female gender (adjusted prevalence ratio (APR)=1.19, 95% CI 1.02 to 1.41) and receiving WA (APR=1.20, 95% CI 1.04 to 1.38) in multivariable analyses.

Conclusions

This study highlights a substantial burden of uncorrected presbyopia among a prescreened, randomised control trial-eligible subgroup of social safety net beneficiaries in rural Bangladesh, who were not currently using MFS but demonstrated cognitive and functional capacity to use mobile phones, potentially hampering their ability to carry out online banking. Delivery of reading glasses may improve digital financial access and facilitate broader financial inclusion, a hypothesis currently being tested in the parent THRIFT trial.

Trial registration number

NCT05510687.

Adverse events in different administration routes of Edaravone: A pharmacovigilance study based on the FDA adverse event reporting system

by Deye Ge, Liyan Wu, Jingrong Yang, Jingxian Sun, Jinying Wang, Jingxin Wang, Huihui Song, Ran Wei, Zecheng Xu, Binbin Zhao, Rongfei Sun, Yifei Wang

The U.S. Food and Drug Administration (FDA) approved intravenous edaravone for the treatment of amyotrophic lateral sclerosis (ALS) in 2017, followed by the approval of the oral formulation in 2022. This study aims to utilize the FDA#39;s Adverse Event Reporting System (FAERS) to investigate the spectrum and timing of adverse events (AEs) associated with edaravone administration, employing repeatability analysis, the Reporting Odds Ratio (ROR) approach, Weibull distribution, and stratification methods. The investigation focuses on data collected from the first quarter of 2017 through the fourth quarter of 2024, aiming to identify adverse event signals and their temporal patterns related to both intravenous and oral edaravone administration. In total, 3,262 records of edaravone-related adverse reactions were identified; among these, 1,534 incidents were associated with intravenous administration, while 453 incidents pertained to oral administration. The analysis revealed distinct adverse reaction profiles for the two routes of administration. Notably, the spectrum of adverse reactions resulting from oral administration predominantly involved the respiratory system, digestive system, and skin damage. In contrast, intravenous administration was more frequently linked to complications associated with invasive procedures and local tissue damage. Furthermore, the timing of adverse reactions exhibited significant variability between the two routes. Weibull distribution analysis indicated that the median onset time for adverse reactions following intravenous administration was 35 days, whereas for oral administration, it was 27 days. Both analytical approaches identified early failure signals, suggesting that the risk of adverse events diminishes over time.

Effect of intravenous vitamin C administration on chemotherapy-induced adverse events in patients with nasopharyngeal cancer

by Peesit Leelasawatsuk, Pasawat Supanimitjaroenporn, Nattida Rodsom, Theepat Wongkittithaworn, Manupol Tangthongkum

Nasopharyngeal carcinoma is prevalent in Thailand, with a substantial proportion of cases diagnosed at advanced stages. The standard treatment, concurrent chemoradiotherapy, is associated with considerable adverse effects, which may compromise therapeutic efficacy and diminish patients’ quality of life. While vitamin C has shown potential in reducing chemotherapy-induced toxicities in some cancers, its effects in nasopharyngeal carcinoma remain unclear. In this randomized, double-blind, placebo-controlled trial, patients with nasopharyngeal carcinoma undergoing concurrent chemoradiotherapy were assigned to receive either 2 g of intravenous vitamin C or placebo prior to chemotherapy. The incidence of gastrointestinal adverse effects—including nausea, anorexia, mucositis, diarrhea, and dysphagia—did not differ significantly between groups. However, longitudinal analysis demonstrated a significantly attenuated decline in platelet counts in the vitamin C group compared with placebo. Although intravenous vitamin C did not reduce gastrointestinal toxicities, the observed platelet preservation suggests a potential supportive effect that warrants further investigation. Trial registration The study was registered with the Thai Clinical Trial Registry (TCTR20190316003) on March 16, 2019.

Research on fire scenario analysis and emergency response strategies for L-shaped buildings using FDS

by Qin Zhang, Yuhong Hu, Xiaoju Li

With the rapid development of information and communication technologies, modern fire rescue models are evolving towards informatization, proactivity, and spatialization. Existing fire simulation models primarily focus on the impact of individual building parameters, lacking a systematic analysis of the multi-factor coupling effects on fire spread. As a result, it is difficult to accurately predict the trend of fire spread and meet the demands of dynamic escape routes for three-dimensional rescue systems. In this study, a typical L-shaped building was used as the research object, and a parameterized fire scenario database was constructed using the FDS (Fire Dynamics Simulator) fire simulation software, combined with experimental data for multi-factor coupling analysis. By simulating various factors such as initial fire locations (stairwell or corridor corner), floor height of ignition (low/mid/high area), and wind direction, this study systematically reveals the dynamic evolution process of smoke diffusion and the spatial distribution characteristics and interaction mechanisms of fire smoke in indoor and outdoor three-dimensional spaces. It also focuses on the time-dependent variations of smoke propagation in indoor escape routes, staircases, and external walls. The results indicate that the L-shaped building causes asymmetric smoke diffusion. The fire spread mode is a result of multi-factor coupling effects at the fire scene. Safe evacuation decisions are directly related to fire spread characteristics, smoke diffusion paths, the location of trapped individuals, fire alarm occurrence time, and rescue methods. Minor changes in each parameter can lead to significant differences in evacuation outcomes. Based on the situation at the site, generating real-time, dynamic escape paths is a crucial guarantee for improving rescue efficiency and success rates. The findings provide scientific support for the design and optimization of human-machine collaborative rescue systems and offer a data foundation for fire risk assessment and emergency response planning.

Translation, Validation and Cross‐Cultural Adaptation of the Patient and Observer Scar Assessment Scale Version 3.0 (POSAS 3.0) Into Malay Language for Injury‐Related Scar

ABSTRACT

Patient and Observer Scar Assessment Scale Version 3.0 (POSAS 3.0) is a robust instrument for scar evaluation. Currently, no validated POSAS 3.0 in the Malay language is available. This study aimed to translate, culturally adapt, and psychometrically evaluate POSAS 3.0 for Malay-speaking populations in Malaysia. Malaysian patients were recruited between 31 October 2023, to 31 December 2024. Translation was conducted using a forward and backward translation approach. Reliability was assessed using internal consistency (Cronbach's alpha) and test–retest. Face validity was addressed with 10 patients, and content validity was evaluated by four clinical specialists. Content validity was evaluated using the item-content validity index (I-CVI) and content validity ratio (CVR). Construct validity was assessed using exploratory factor analysis (EFA). Seventy-eight participants with facial (n = 39, 50.0%) and non-facial (n = 39, 50.0%) soft tissue scars were recruited for the EFA. The Malay POSAS-O demonstrated acceptable internal consistency (α = 0.75) and excellent inter-rater reliability, with item-level intraclass correlation coefficient (ICCs) ranging from 0.91 to 1.00 and total score ICC of 0.99. Agreement for categorical scar severity ratings was almost perfect (κ = 0.89). The Malay POSAS-P showed excellent internal consistency (α = 0.89), and test–retest reliability for the total score was good to excellent (ICC = 0.89). Intermittent symptom items (painful, shooting, burning and fragile) exhibited lower stability, reflecting natural symptom variability. Content validity was excellent, with all items achieving I-CVI and CVR values of 1.00. EFA supported construct validity, with adequate Kaiser-Meyer-Olkin (KMO) values (POSAS-O: 0.88; POSAS-P: 0.85), significant Bartlett's tests, strong communalities and factor loadings. The cumulative variance explained was 79.05% for POSAS-O and 68.19% for POSAS-P. The Malay version of the POSAS 3.0 is a reliable, valid, and culturally appropriate instrument for scar assessment. Its strong psychometric properties support its application in clinical practice and research involving Malay-speaking populations.

Clinical Evaluation of a Novel Synthetic Nanofiber Wound Matrix for the Treatment of Chronic Wounds

ABSTRACT

Chronic wounds, including Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs) and Pressure Ulcers (PUs), present significant challenges for the patients, clinicians and healthcare systems. There remains a strong need for novel and effective technologies to accelerate the healing of these wounds. The objective of this prospective, single-arm pilot study was to evaluate the clinical performance of a novel nanofiber wound matrix for the treatment of chronic lower extremity wounds refractory to standard-of-care treatment at a single centre. A total of 15 patients with 15 chronic wounds (5 DFUs, 8 VLUs and 2 PUs) were included in this study. These wounds were non-healing to previous standard-of-care treatments for an average of 4 weeks. They were all treated with the novel nanofiber wound matrix with weekly clinical evaluation and re-application for a total duration of four (4) weeks, per the study protocol. The average wound area reduction (WAR) was 83.6% upon 4 weeks of treatment with the application of the subject wound matrix, as an adjunctive measure to the standard of care. Additionally, seven (7) of the 15 wounds (46.7%) completely healed starting from Week 3, and the average complete healing time was 13.9 days. These results demonstrated accelerated healing effects of the subject wound matrix, when compared to the standard of care reported in literature, where the average WAR was at 62.9% at Week 12, six (6) of the 18 wounds (33.3%) were completely healed within 12 weeks, and the average complete healing time was 49.0 days. These results demonstrated that the subject wound matrix is a safe and effective novel technology in treating chronic wounds, providing significant clinical and economic benefits for patients with various chronic wounds.

Prediction Model for Skin Damage Related to Medical Adhesives in Adult Patients Undergoing Degenerative Spine Surgery

ABSTRACT

This study aimed to develop a prediction model for the occurrence of medical adhesive-related skin injuries (MARSIs) based on electronic medical records (EMRs) of adult patients who underwent degenerative spine surgery. This study used the EMR data of adult patients who underwent degenerative spine surgery at a university hospital in Seoul between January 2020 and December 2024. Seven machine learning algorithms and the SuperLearner algorithm were used to evaluate the performance of the SuperLearner model. Performance was focused on the area under the curve (AUC), accuracy, sensitivity, specificity, precision and F1 score. Among the machine learning algorithms, the RuleFit algorithm showed the best performance, with an AUC of 0.723, accuracy of 0.689, sensitivity of 0.959, specificity of 0.276, precision of 0.762 and F1 score of 0.789. In contrast, predicting MARSI using the SuperLearner algorithm had an AUC of 0.951, accuracy of 0.834, sensitivity of 0.635, specificity of 0.964, precision of 0.921 and F1 score of 0.752. This study provides practical evidence for the early identification of high-risk patients and establishment of customized nursing plans by presenting a MARSI prediction model using the SuperLearner ensemble. Future research is recommended to verify the external validity of the model through prospective studies and integration of clinical decision support systems.

Trial Registration: ClinicalTrials.gov Identifier KCT0010601.

Integration of PrEP dispensing with HIV self-testing among heterosexual men in Sub-Saharan Africa: protocol for a scoping review

Por: Hlongwa · M. · Tsai · A. C. · Choko · A.
Background

Sub-Saharan Africa (SSA) continues to be the hub of the global HIV/AIDS pandemic, globally. Despite several attempts to meet their HIV prevention needs, men continue to have high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is an effective treatment that, when taken as prescribed, can be very efficient in preventing and reducing the risk of HIV acquisition. HIV self-testing (HIVST) has been demonstrated to be acceptable among men in SSA. As such, this review aims to explore the existing literature on the integration of PrEP dispensing with HIVST among men in SSA.

Methods

We will systematically search bibliometric databases, including PubMed/MEDLINE, Embase, Scopus, the Cumulative Index to Nursing and Allied Health Literature Plus, Sociological Abstracts, ProQuest Dissertations and Theses global. Our review will be guided by the Arskey and O’Malley framework and Levac et al. The review results will be reported using the preferred reporting items for systematic reviews and meta-analysis: extension for scoping reviews guidelines. To assess the methodological quality of the included articles, the mixed methods appraisal tool version 2018 will be used. We will use NVivo software (V.11) to synthesise data from the included studies using a thematic approach.

Ethics and dissemination

Ethical approval is not required, as this review uses publicly available data. Findings will be disseminated through peer-reviewed publication, conference presentations and engagement with key stakeholders in HIV prevention and treatment across SSA.

Real-world safety of aliskiren in primary hypertension: A cross-database study

by Meirong Shan, Qian Guo, Ruofei Li, Ni Li, Yanhua Fu, Huanyu Qi, Ge Zhang, Qian Wang, Xingli Xu, Jinchuan Lai

Hypertension is one of the main causes of cardiovascular diseases worldwide, affecting over one billion people. Although aliskiren offers a valuable option for inhibiting the renin-angiotensin system, its safety profile in the real world remains insufficiently explored, especially for rare or under-recognized adverse events (AEs), which have not been fully clarified. Therefore, leveraging large-scale post-marketing surveillance data is crucial for identifying rare AEs and guiding safer clinical practice. This study aims to elucidate pharmacovigilance signals associated with aliskiren (an antihypertensive drug) by systematically analyzing the characteristics of adverse events (AEs) from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database and WHO-VigiAccess database, which provides a reliable scientific basis for clinical practice and regulatory decision-making. We conducted a retrospective quantitative analysis of aliskiren-related AE reports from the aforementioned two databases, employing the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) algorithms for signal detection. The results indicate that there were 5,596 and 5,549 aliskiren-related reports in the FAERS and WHO-VigiAccess databases, respectively. The median duration of these AEs during the observation period was 62 days, with an interquartile range (IQR) of 7–282 days. In both databases, signals for aliskiren were distributed across 28 System Organ Classes (SOCs), among which investigations, cardiac disorders, renal and urinary disorders, vascular disorders, and metabolism and nutrition disorders exhibited significant signals based on specific criteria applied across the four algorithms. A total of 607 preferred terms (PTs) with significant disproportionality signals were detected using the four algorithms, including potential AEs not previously well-documented, such as palpitations, myalgia, proteinuria, muscular weakness, pulmonary edema, and pollakiuria. This study not only confirms the known adverse reactions of aliskiren but also uncovers new potential risks, highlighting the importance of strengthening drug safety monitoring to enhance therapeutic efficacy and reduce the risk of adverse reactions. It provides valuable safety insights for physicians considering the use of aliskiren in the management of primary hypertension.

Study on the therapeutic effect of eggshell membrane on osteoarthritis in rats

by Mingming Pan, Yanhua Shen, Jiayu Wu, Chaonan Liu, Meihong Zhu, Zhengyu Zhou

This study aimed to investigate the therapeutic effects of ELASEM®Flex and ELASEM®ProFlex, two eggshell membrane (EM) products, on sodium iodoacetate (MIA)-induced osteoarthritis (OA) in rats. An OA model was established by a single intra-articular injection of MIA into the knee joint. After modeling, rats were administered diclofenac sodium, ELASEM®Flex, and ELASEM®ProFlex by gavage daily for 4 consecutive weeks. During the experiment, food intake, water intake, body weight, and plantar mechanical pain threshold (MPT) of rats were measured weekly. Serum levels of TNF-α, COX-2, IL-1β, and CTX-II were assessed at weeks 2 and 4. After 4 weeks, knee joints were harvested for histopathological examination (HE staining and Safranin-O fast green staining). Results indicated that knee joints of OA rats showed significant swelling, which was alleviated to varying degrees in all treatment groups. Both ELASEM®Flex and ELASEM®ProFlex significantly increased the MPT (P ®Flex and ELASEM®ProFlex can exert preventive and reparative effects on knee OA in rats by alleviating arthritis pain, inhibiting inflammatory factor expression, reducing type II collagen degradation, and promoting chondrocyte proliferation.

Trends and factors associated with previous induced abortions among young women in Foshan, China: insights from a retrospective cross-sectional study

Por: Ou · Y. · Chokkakula · S. · Chong · S. · Wang · H. · Liu · S. · Si · A. I.-C. · Pathakumari · B. · Lyu · J. · Yin · C. · Ye · X. · Huang · X.
Objectives

This study aims to explore the history of prior abortions and the factors influencing them among young women seeking abortion services in Foshan, Guangdong, China.

Design

This is a retrospective, cross-sectional study of young women seeking abortion care.

Setting

Gynaecological outpatient clinics at the Department of Gynaecology, Foshan Women and Children Hospital Affiliated to Guangdong Medical University, Foshan, Guangdong, China, between 2013 and 2023.

Participants

A total of 7361 young women aged 12–25 years seeking abortion services.

Measures

Data on abortion history, sociodemographic factors, contraceptive use and postabortion contraceptive choices were collected and analysed, with special emphasis on the incidence of repeat abortions and the factors associated with them.

Results

Of the 7361 participants, 34.2% reported at least one previous abortion, underscoring a notable public health concern. The mean age of the participants was 22.30 years (SD=2.13). Women with a history of abortion were significantly older than those without (22.57 vs 22.08 years, p

Conclusions

This study underscores the need for targeted interventions to address the multifaceted factors leading to repeat abortions among young women in China. The results offer valuable insights for improving reproductive health outcomes in this vulnerable population and highlight the importance of expanding access to contraceptive education and services in China.

Perspectives on multimorbidity care provision among public hospital-based healthcare workers in Blantyre and Chiradzulu, Malawi: A qualitative study

by Gift Treighcy Banda-Mtaula, Ibrahim Simiyu, Sangwani Nkhana Salimu, Stephen A. Spencer, Nateiya M. Yongolo, Marlen Chawani, Hendry Sawe, Jamie Rylance, Ben Morton, Adamson S. Muula, Eve Worall, Felix Limbani, Miriam Taegtmeyer, Rhona Mijumbi, on behalf of the Multilink consortium

Multimorbidity, the presence of multiple chronic health conditions, is a leading cause of death globally. In Malawi, chronic noncommunicable and communicable diseases such as HIV frequently co-exist, putting pressure on an under-resourced system. However, the health system is primarily structured around disease-specific [vertical] programs, which hinders person-centred care approaches to multimorbidity. Our study focuses on multimorbidity care and explores the perceptions of healthcare workers on the patient pathways and service organisation throughout the patient’s interaction with the health facilities. This cross-sectional qualitative study took an interpretivist approach. We conducted 13 days of clinical observations at Queen Elizabeth Central Hospital and Chiradzulu District Hospital. We also conducted 13 days of clinical observations and semi-structured in-depth interviews with different cadres of purposively sampled healthcare workers (n = 22) at Queen Elizabeth Central Hospital and Chiradzulu District Hospital. Through thematic analysis, we identified an understanding of the organisation of care and healthcare workers’ perspectives on the delivery of services. Findings showed both hospitals provided services for inpatients and outpatients with multimorbidity, including screening, management, prevention of secondary conditions and rehabilitation. Patient diagnosis and management for multimorbidity were often delayed due to frequent stockouts of medication and consumables necessary for diagnostic testing for NCDs at the hospital level. Some healthcare workers were not equipped with the knowledge, skills, or guidelines to manage multimorbidity. As HIV care is currently better resourced than other chronic conditions, healthcare facilities may strengthen the supply chain, healthcare workers’ training sessions and monitoring and evaluation tools to ensure NCDs are well managed, learning from HIV programmes.

Estimating the velocity and direction of African Swine Fever spread in wild boar populations in South Korea using Trend-Surface Analysis

by Cecilia Aguilar-Vega, Jaime Bosch, Satoshi Ito, Benjamin Ivorra, Hyunkyu Jeong, José Manuel Sánchez-Vizcaíno

African swine fever (ASF) is a lethal disease of swine that has spread across Asia since its introduction in 2018. South Korea first reported the disease in September 2019 in domestic pigs, and since then, more than 4,000 cases have been reported in wild boars during its expansion up to August 2024. Due to the high number of ASF notifications in wild boars in South Korea, contrasted with their scarcity in most Asian countries, analyzing the spatiotemporal spread of the disease in a setting with active surveillance provides valuable insights. In this study, we performed a trend-surface analysis on temporally gridded case data to characterize the overall geographic spread and direction of ASF in wild boars across South Korea, from its emergence to August 2022. Additionally, we propose a novel approach distinct from previous studies, to estimate spread velocity by incorporating an upper threshold to avoid unrealistic values. The model described the spread of ASF in the study area. The disease showed greater expansion in the east of the country. Initially, a south and eastward direction was estimated. The estimated median velocity was 19.53 km/month, with cell-level velocities ranging from 2.45 to 69.99 km/month. Velocity increased notably from autumn 2021 onward and varied substantially across years. Our results show the dynamics of ASF in wild boars of South Korea, providing new evidence of their role in the epidemiology of the disease.

An overlooked source of skin dose perturbation: Commercial tattoo inks in radiotherapy

by Hongjun Park, Beechui Koo, Jungwook Shin, Byoung Hyuck Kim, James J. Sohn

Approximately one-third of US adults have tattoos, yet the dosimetric impact of intradermal tattoo pigments during radiation therapy remains uncharacterized. Commercial tattoo inks contain unregulated metallic impurities including chromium, lead, and nickel, raising concerns about dose perturbations in tattooed skin. This work quantifies radiation dose perturbations induced by high-atomic-number (Z) tattoo pigments under clinically relevant radiotherapy conditions. Monte Carlo simulations (TOPAS) modeled layered skin phantoms with a 0.3-mm intradermal tattoo layer embedded at 1.25–1.55 mm depth. Three commercial inks were evaluated: carbon-based (black) and metal-containing (Fe-rich brown, Al-containing orange) at pigment loadings of 5–100 vol% within the tattoo layer, to establish upper-bound effects. Electron (6, 18 MeV) and photon (6, 18 MV) beams were simulated with standard clinical geometry (1 × 1 cm² field, SSD = 100 cm). Photon irradiation produced pronounced, depth-localized dose enhancement, with peak dose enhancement factor (DEF) reaching 2.5 for brown ink at 18 MV, a 62% mean increase relative to non-tattooed skin driven by high-Z–mediated secondary electron production. Electron beams exhibited energy-dependent behavior: 6 MeV produced modest enhancement (peak DEF ~ 1.07), while 18 MeV unexpectedly generated dose deficits (DEF 

Associations of tumor necrosis factor alpha genetic variants with metabolic syndrome and type 2 diabetes mellitus in a Thai population

by Metha Yaikwawong, Khanittha Kamdee, Kasarnchon Mek-yong, Somlak Chuengsamarn

This work aimed to clarify how polymorphisms in the TNF gene relate to metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM), and a broad spectrum of cardiometabolic characteristics, while also determining their impact on circulating TNF‑α concentrations. A total of 765 participants were genotyped for rs1800629 and rs361525, and serum TNF-α was also measured. To assess these relationships, multivariable logistic regression models—incorporating age, sex, and body mass index (BMI)—were applied to estimate adjusted odds ratios (aORs) and their corresponding 95% confidence intervals (CIs). Both variants were significantly associated with MetS: rs1800629 (crude OR = 2.22, 95% CI: 1.45–3.44, P P P = 0.035; adjusted OR = 2.84, 95% CI: 1.17–7.31, P = 0.025). The rs1800629 variant was also linked to T2DM risk (adjusted OR = 2.61, 95% CI: 1.35–5.24, P = 0.006), whereas rs361525 showed no such association. Carriers of rs1800629 had higher mean TNF-α levels (P

Sick leave and engagement as workforce well-being proxies in hospital departments: a cross-sectional study of routinely collected organisational data in a Dutch academic hospital

Por: Bazuin · T. · Oerbekke · M. S. · Bontjer · S. · Reijmerink · I. M. · Dongelmans · D. A. · Franx · A. · Wietasch · J. K. G. · Hooft · L. · van der Laan · M. J.
Objectives

Well-being of healthcare professionals (HCPs) is vital for care quality, staff retention and overall healthcare system effectiveness. This study aims to identify the organisational and workplace variables associated with sick leave and measures of engagement of HCPs on department level within a single Dutch academic hospital.

Design

Cross-sectional study using routinely collected organisational data.

Setting

A tertiary-care academic hospital in the Netherlands.

Participants

25 clinical departments were included. Department level variables were derived from routinely collected hospital databases. Availability of data varied across variables. Analysis included information on patient population, human resources, care processes, quality of care and employee and patient experiences to assess differences, correlations and predictors for sick leave and engagement.

Primary and secondary outcome measures

Primary outcome measures were (1) sick leave (%) and (2) engagement, assessed through two staff-survey items (vitality and connectedness; 0–10 Numeric Rating Scale). Both outcomes were analysed at department level.

Results

Employee population data showed the most consistent patterns across analyses. Departments with higher staffing capacity had higher sick leave and lower engagement in group comparisons (p=0.009, p=0.030, respectively). In multivariable models, higher staffing capacity remained associated with increased sick leave (B=1.38, 95% CI 0.53 to 2.23, p=0.003). Engagement was positively associated with higher inflow (B=0.92, 95% CI 0.06 to 1.77, p=0.037) and negatively associated with outflow (B = –1.36, 95% CI –2.08 to –0.63, p=0.001). No consistent associations were found with patient population and patient experience measures.

Conclusions

Workforce-related factors, particularly staffing capacity and inflow and outflow, are strongly linked to sick leave and engagement. Routinely collected hospital data can be used to identify at-risk departments and inform targeted strategies for improving workforce sustainability. Future studies should explore more granular, team-level data to better support staff well-being and care quality.

Colchicine and dialysis patients (CAD): protocol for a feasibility study

Por: Wong · Y. T. D. · Hughes · L. D. · Norton · S. · Robson · M. G.
Introduction

Colchicine has been shown to reduce cardiovascular events and may improve outcomes in arteriovenous fistulas used for haemodialysis due to antiproliferative effects. However, it is often avoided in patients receiving dialysis. Therefore, a large trial assessing the potential benefits of colchicine in dialysis patients cannot begin without further data on feasibility. The primary objective of this study is to assess the feasibility of carrying out future trials of colchicine in dialysis patients.

Methods and analysis

This is an open-label, single centre, single arm study with 100 participants. The primary outcome is feasibility and the decision to progress to a full-scale trial. This will be based on the consent rate and the colchicine discontinuation rate. Secondary objectives are testing the feasibility of data collection procedures relating to quality-of-life measures, vascular access interventions and safety. Other secondary objectives are to assess the utility of the electronic health record for collecting trial data and to explore patients’ and healthcare providers’ experiences and attitudes towards colchicine and a feasibility study.

Ethics and dissemination

The study has Research Ethics Committee approval (Wales REC 6; 24/WA/0277). It is intended that the results of the study will be reported in peer-reviewed scientific journals.

Trial registration number

ISRCTN91308625.

Development and Internal Validation of a Gradient Boosting Model for Pressure Injury Risk in the ICU

ABSTRACT

Pressure injury (PI) is common in the ICU and not well captured by single-risk tools such as the Braden scale. We aimed to develop and internally validate a machine-learning model to predict new-onset PI using routinely collected ICU data. This retrospective single-centre cohort included adult ICU patients with length of stay ≥ 48 h (2018–2023). The primary outcome was new-onset PI during ICU stay. Candidate predictors were pre-specified: minimum albumin, maximum lactate, SOFA, APACHE II, first recorded Braden score, age, BMI, a nutrition score and treatment indicators. Missing values were imputed (median/mode). A gradient boosting model (GBM) was evaluated with stratified 3-fold cross-validation; a random forest (RF) served as a benchmark (stratified 70/30 train–test split). Discrimination (AUC) was primary; calibration, Brier score, decision-curve analysis (DCA) and feature importance were secondary. Logistic regression quantified independent associations. Among included ICU stays, 14.6% developed PI. On multivariable analysis, higher lactate, lower albumin, lower Braden scores, older age, CRRT, prone positioning, enteral nutrition and analgesic exposure were associated with increased PI risk, whereas sedatives showed an inverse association. The GBM achieved AUC≈0.69 with acceptable calibration and net clinical benefit across thresholds commonly used in preventive workflows (≈0.10–0.50). Single markers or simple combinations displayed only modest discrimination. A GBM built from routine ICU data provided moderate, well-calibrated discrimination for predicting new-onset PI and demonstrated decision-relevant net benefit. The model can complement Braden-based screening by refining risk stratification and prioritising intensified prevention for patients most likely to benefit. External validation and prospective evaluation are warranted.

Enhanced Wound Healing Through Air‐Break Augmentation of Hyperbaric Oxygen Therapy Combined With Adipose‐Derived Stromal Cell Transplantation in a Murine Model

ABSTRACT

Hyperbaric oxygen therapy (HBOT) enhances wound healing by promoting angiogenesis and reducing hypoxia. However, the role of air-breaks—intermittent exposures to ambient air during HBOT—remains unclear. We investigated the effects of air-breaks on HBOT-mediated wound healing, particularly in combination with adipose-derived stromal cells (ASCs). Full-thickness wounds were created in C57BL/6 mice (n = 36) and assigned to control, HBOT (1 h/day, 2 ATA for 11 days), or HBOT with a 10-min air-break groups. In a second experiment, we evaluated ASC treatment combined with HBOT and air-breaks. Wound healing was assessed via gross examination, histology and gene expression analysis of collagen type 1 alpha 1 (Col1a1), hypoxia-inducible factor 1 alpha (Hif1a) and tumour necrosis factor (Tnf-α). Compared with HBOT alone, air-breaks significantly improved wound closure, epithelial regeneration and collagen deposition (p < 0.05). Gene analysis showed higher Col1a1 expression and lower Hif1a and Tnf-α levels in the air-break group. In ASC-treated wounds, air-breaks further accelerated healing, enhancing collagen synthesis and reducing hypoxia and inflammation. These findings suggest that incorporating air-breaks into HBOT protocols improves wound healing outcomes, both generally and in ASC-based therapies, by modulating collagen production, hypoxia and inflammation, and could optimise HBOT efficacy, particularly in cell-based regenerative therapies.

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