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Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.
MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.
This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.
Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.
by Yasutaka Yanagita, Kosuke Ishizuka, Daiki Yokokawa, Kiyoshi Shikino
BackgroundWith the growing volume of medical information, proficiency in utilizing clinical decision support systems (CDSSs) is increasingly important for physicians. Further, research has primarily focused on CDSSs’ accuracy for specific symptoms, diseases, and treatments, but the extent to which CDSSs contribute to the clinical reasoning process and evaluation of their output remains unclear. While Google is not a traditional CDSS, previous studies have evaluated its role as a diagnostic support tool, demonstrating its ability to assist physicians in retrieving relevant medical information and influencing diagnostic decision-making.
ObjectiveThis study aimed to assess whether using Google search can enhance diagnostic accuracy and confidence among medical students, and to evaluate how the interpretation of search results influences their diagnostic confidence.
MethodsForty-eight fifth-year medical students in clinical clerkship at Chiba University Hospital were presented with ten clinical scenarios in text format. Initially, they provided the most likely diagnosis without assistance and recorded their confidence levels. Subsequently, they used Google search to revisit their diagnoses and confidence levels, using a 7-point Likert Scale. Focus group interviews were conducted to discuss changes in confidence, and the interviews were analyzed qualitatively using content analysis. A mixed-methods analysis compared the average number of correct diagnoses and confidence levels before and after using Google search.
ResultsIn total, 470 responses from 48 fifth-year medical students were evaluated after excluding 10 inappropriate responses. Correct diagnoses increased from an average of 63.6% without assistance to 76.2% using Google search (P P Conclusions
This study underscores the value of using Google search in medical education to enhance diagnostic skills and confidence. The improvement in accuracy and confidence among students demonstrates the supportive role of Google search in clinical reasoning and education. This highlights the need for educators to teach discernment in information analysis to ensure optimal use of CDSS in medical training. Proper integration of these tools is crucial for developing future physicians capable of effectively navigating vast amounts of medical data.
Conducting bias assessments in systematic reviews is a time-consuming process that involves subjective judgments. The use of artificial intelligence (AI) technologies to perform these assessments can potentially save time and enhance consistency. Nevertheless, the efficacy of AI technologies in conducting bias assessments remains inadequately explored.
This study aims to evaluate the efficacy of ChatGPT-4o in assessing bias using the revised Cochrane RoB2 tool, focusing on randomized controlled trials in nursing.
ChatGPT-4o was provided with the RoB2 assessment guide in the form of a PDF document and instructed to perform bias assessments for the 80 open-access RCTs included in the study. The results of the bias assessments conducted by ChatGPT-4o for each domain were then compared with those of the meta-analysis authors using Cohen's weighted kappa analysis.
Weighted Cohen's kappa values showed better agreement in bias in the measurement of the outcome (D4, 0.22) and bias arising from the randomization process (D1, 0.20), while negative values in bias due to missing outcome data (D3, −0.12) and bias in the selection of the reported result (D5, −0.09) indicated poor agreement. The highest accuracy was observed in D5 (0.81), and the lowest in D1 (0.60). F1 scores were highest in bias due to deviations from intended interventions (D2, 0.74) and lowest in D3 (0.00) and D5 (0.00). Specificity was higher in D5 (0.93) and D3 (0.82), while sensitivity and precision were low in these domains.
The agreement between ChatGPT-4o and the meta-analysis studies in the same RCT assessments is generally low. This indicates that ChatGPT-4o requires substantial enhancements before it can be used as a reliable tool for bias risk assessments.
The AI–based tools have the potential to expedite bias assessment in systematic reviews. However, this study demonstrates that ChatGPT-4o, in its current form, lacks sufficient consistency, indicating that such tools should be integrated cautiously and used under continuous human oversight, particularly in evidence-based evaluations that inform clinical decision-making.
Referrals for gender-affirming healthcare services have surged in recent decades, presumably driven by increased visibility, acceptance and reduced barriers to care. Despite these advances, transgender and gender-diverse individuals continue to face significant mental health challenges, including elevated rates of anxiety, depression as well as high prevalence of autistic traits. Gender-affirming hormonal treatment (GAHT) has been suggested to improve mental health and quality of life (QoL) among transgender individuals; however, the short- and long-term treatment effects of GAHT are not yet fully understood. Therefore, this study aims to establish a comprehensive cohort of transgender individuals at the Centre for Gender Identity (CGI), Aalborg University Hospital, Denmark, to enhance understanding and treatment outcomes.
The Transgender Cohort (TraCK) will recruit participants from February 14, 2024, with recruitment occurring continuously alongside yearly follow-up. This single-centre cohort study will include both retrospective and prospective data collection. Transgender individuals referred to CGI will be invited to participate in the study via the Danish digital mail system called e-Boks. Participants must provide informed consent and complete a baseline questionnaire. Data will be collected from self-reported questionnaires and medical records across multiple specialists. Self-reported questionnaires include WHO-Quality of Life BREF, Eating Disorders Examination Questionnaire, Autism Spectrum Quotient, Transgender Congruence Scale, and Gender Minority Stress and Resilience Measure. Medical records will provide information on demographics, mental health, physical health, and gender-affirming treatment details. Data will be managed using REDCap, ensuring compliance with GDPR and the National Data Protection Act.
While recognising the potential privacy risks associated with data collection, the study considers these outweighed by the benefits of advancing knowledge on gender diversity and the impacts of gender-affirming care. The North Jutland Region Ethics Committee reviewed the project, determining no formal approval was needed, but it was registered and approved (no. F2024-012) by the North Jutland Region. Findings will be disseminated through peer-reviewed journals, conferences, and accessible reports for participants.
This study is registered with the North Jutland Region (no. F2024-012). Recruitment and data collection began on February 14, 2024, and will continue alongside yearly follow-up. Keywords Transgender individuals, transgender and gender-diverse, transgender cohort, transgender health, transgender research, cohort study, gender-affirming care.
by Akiyo Sasaki-Otomaru, Kyoko Saito, Kotaro Yamasue, Osamu Tochikubo, Yuka Kanoya
Wearable devices have the potential to promote a healthy lifestyle; however, studies on the use of wearable devices in monitoring health in older adults are limited. We aimed to investigate the relationship of sleep and activity data with health status among older adults. Fifty-five community-dwelling older adults were asked to wear a wristwatch-type wearable device (the Pulsense [PS]) and measure home blood pressure (HBP) over a period of 5–7 consecutive days. Deep-sleep duration, physical and mental activity duration, and body-movement duration were obtained from PS data using special software. We also collected data on demographics and physical and mental health status. We found that the body-movement duration in women was longer than that in men. Among men, body-movement duration was strongly and negatively correlated with the Kihon Checklist (KCL) score. It also showed moderate correlations with the Geriatric Depression score, physical functioning, bodily pain, vitality, social function, and role emotional scores from the Medical Outcomes Survey Short Form-8 questionnaire, as well as with hand-grip strength. There was no significant correlation between monitoring data and health status in women. In the multiple linear regression analysis, body-movement duration was negatively associated with age and the KCL score. KCL is a common questionnaire for screening frailty in Japan. Our results showed that body-movement duration was negatively associated with age and the KCL score, suggesting the potential of PS in guiding personalized health management of older community-dwelling adults with risks of frailty.
by Mitsuru Mizuno, Daisuke Suda, Chima Matsumura, Ichiro Sekiya
This study evaluated the effectiveness of a biosafety cabinet equipped with an ozone generator, particularly during the transition periods between the production of cell products. As living cell products cannot undergo sterilization, maintaining an aseptic manufacturing environment is paramount. Raw materials, often derived from human tissues, are frequently contaminated with various resident bacteria, necessitating environmental resets after each process. The utility of this device against bacteria, including endotoxins, endospores, and fungi endemic to human tissues, could facilitate safe and reproducible production changeovers through a simplified, one-button operation. This study focused on bacteria resistant to conventional cleaning protocols, specifically targeting endospore-forming bacteria with robust resistance to disinfectants, spore-forming fungi, and included analyses of endotoxins. The effects of ozone exposure on Pseudomonas aeruginosa (an endotoxin-producing bacterium), Bacillus subtilis (an endospore-forming bacterium), and Aspergillus brasiliensis (a spore-forming fungus) were assessed. In the dedicated biosafety cabinet equipped with an ozone generator, the treatment group exposed to ozone showed a significant reduction in both colony-forming units and endotoxin levels in Pseudomonas aeruginosa at 1.0 × 104 colony-forming units (CFUs) compared to the control group. Moreover, the ozone treatment markedly decreased the colony formation of Bacillus subtilis endospores and Aspergillus brasiliensis spores. Given its effectiveness against endospores and endotoxins—among the most challenging bacterial derivatives to eliminate—the device demonstrates potential for enhanced bacterial control in Grade A biosafety cabinets within cell product manufacturing facilities. The system may substantially reduce operator stress by ensuring product safety through straightforward operational procedures and high reproducibility, although further validation is required.
by Koichi Tamura, Yukinori Takenaka, Kiyohito Hosokawa, Takashi Sato, Takeshi Tsuda, Hirotaka Eguchi, Masami Suzuki, Takahito Fukusumi, Motoyuki Suzuki, Hidenori Inohara
Immune checkpoint inhibitors (ICIs) are pharmacological agents indicated for recurrent and metastatic head and neck squamous cell carcinoma (HNCSCC). Immune-related adverse events (irAEs) have been reported as predictors of therapeutic response to ICIs. However, previous studies have not adequately addressed the immortal time bias. Therefore, we aimed to investigate the association between the onset of irAEs and oncological outcomes, accounting for immortal time bias. We conducted a retrospective study involving 130 patients with HNSCC who were treated with ICIs. The objective response, progression-free survival (PFS), and overall survival (OS) were assessed using logistic regression analysis, the Kaplan–Meier method, and the Cox proportional hazard (PH) model. The immortal time bias was considered using a landmark analysis and an extended Cox (EC) model. The odds ratios for response and disease control were smaller in the landmark than in the naïve analyses. In the landmark analysis, the 1-year PFS rates were 47.6% and 27.2% for irAE+ and irAE- patients, respectively (p = 0.049), and the 1-year OS rates were 85.7% and 66.5%, respectively (p = 0.006). Regarding PFS, the adjusted HRs for irAEs were 0.49 (95% confidence interval (CI) 0.28–0.85) in the PH analysis and 0.75 (95% CI 0.40–1.40) in the EC analysis. As for OS, the adjusted HRs for irAEs were 0.36 (95% CI 0.19–0.66) in the PH analysis and 0.51 (95% CI 0.27–0.95) in the EC analysis. IrAEs were an independent prognostic factor for OS but not PFS. Without considering the immortal time bias, the association between irAEs and oncologic outcomes in patients with HNSCC treated with ICIs was overestimated. Therefore, the balance between the benefits and risks of ICI therapy must be carefully weighed in clinical settings.
by Yuki Yokoi, Ryu Nakamura, Shuya Ohira, Shota Takemi, Tokiyoshi Ayabe, Kiminori Nakamura
Live imaging visualizes the structure, dynamics, and function of cells and tissues to reveal the molecular mechanisms, and has contributed to the advancement of life science. In live imaging, it has been well known that there is a trade-off between higher-resolution analysis and cell damage caused by light illumination, i.e., phototoxicity. However, despite the risk of unknowingly distorting experimental results, phototoxicity is an unresolved issue in live imaging because overall consequences occurring inside cells due to phototoxicity remains unknown. Here, we determined the molecular process of phototoxicity-induced cell damage systematically under low- and high-dose light illumination conditions by analyzing differential gene expression using RNA-sequencing in a three-dimensional organoid of small intestinal epithelial cells, enteroid. The low-dose light illumination already induced various abnormalities in functional molecules involved in the response to reactive oxygen species generated by the excitation of fluorescent dyes, intracellular metabolism, mitosis, immune responses, etc., at mRNA expression level. Together with the behavior toward apoptosis caused by high-dose light illumination, the light dose-dependent progression of intracellular damage was revealed. About visible impairment of intestinal epithelial function, failures in both the structure-forming ability of enteroids and Paneth cell granule secretion were observed under high-dose light illumination, while the drug efflux was not disturbed despite abnormal drug efflux transporter mRNA expression. Based on the gene expression profiles, we comprehensively clarified phenomena in the cells at mRNA level that cannot be recognized both morphologically and functionally during live imaging, further providing a new insight into the risk of phototoxicity. This study warns from the aspect of mRNA expression that awareness of phototoxic artifacts is needed when analyzing cellular function and the mechanism in live imaging.
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