Conectar
by Min Jung Kim, Eun-Gee Park, Changyoung Kim, Dong Yoon Kang, Borim Ryu, Kichul Shin
BackgroundA treat-to-target strategy involving treatment modification improves outcomes in gout, but evidence remains limited regarding the optimal approach when initial urate-lowering therapy (ULT) fails. This study aimed to investigate real-world ULT sequence patterns and evaluate treatment retention based on the initial agent, modification type, and comorbidities.
MethodWe analyzed electronic health record data collected from 2010 to 2022 from the common data model databases of two hospitals. Adults aged 18 years or older diagnosed with gout who initiated ULT and were followed for at least 2 years were included. Outcomes included the frequency and sequence of ULT prescriptions. Treatment modification, defined as switching to another ULT or adding an additional agent, was considered the end of retention for the previous regimen. Subgroup analyses were performed based on comorbidity.
ResultsAmong 2220 patients, febuxostat was the most common first-line agent (51.4%), with 90.9% maintaining therapy. Among those who modified febuxostat therapy, switchers and add-on users continued treatment similarly (91.5% vs. 86.8%, P = 0.33). Of allopurinol initiators, 55.8% changed therapy, mainly switching to febuxostat or benzbromarone rather than adding another agent (51.4% vs. 4.1%, P vs. 86.8%, P = 0.33). Among benzbromarone initiators, 57.2% changed therapy (switchers, 56.7%; add-on users, 0.5%; P P = 1.00). Chronic kidney disease was associated with low variability in ULT sequence.
ConclusionsULT demonstrated durable retention when used as first- or second-line treatment, with switching being more common than add-on therapy and maintaining similar retention rates.
To examine trends and demographic characteristics of syphilis incidence in Japan using a large nationwide claims database with family linkage, with particular focus on differences by sex, age, HIV status and family relationships.
Retrospective cohort study.
JMDC claims database (JMDC Inc, Tokyo, Japan), a nationwide administrative claims database in Japan, using data from 2016 to 2023.
Individuals aged 16–59 years enrolled in the JMDC database, including employees of medium-to-large companies and their dependents (n=12.5 million).
Syphilis cases were defined by International Classification of Diseases, 10th Revision (ICD-10) codes (A50–A53) with concurrent treatment with relevant antibiotics. We determined syphilis incidence rates per 100 000 person-years, stratified by sex, age, HIV status and family relationships. We also investigated within-couple concordance patterns and reinfection rates.
Among 16.4 million individuals, 9357 syphilis infections were identified among 8881 individuals. Incidence increased markedly during the pandemic, reaching 48.2 (men) and 12.9 (women) per 100 000 person-years in 2023. Men showed consistently high incidence in their 20s–50s, whereas female incidence peaked in the 10s–20s. Among 2 294 184 married couples, dependent women (ie, housewives) showed comparably high incidence to age-matched men (10–20 per 100 000 person-years). In 1286 couples with at least one syphilis case, 12.4% of wives in their 20s were also diagnosed, compared with 2%–3% in older groups. In 20s couples, the proportion of syphilis among wives only and husbands only was similar. Subgroup analysis revealed notably high incidence among unmarried female dependent youths (2022: 66.7 per 100 000 person-years). Individuals living with HIV had substantially elevated incidence (3000–15 000 per 100 000 person-years) and reinfection rates.
Using a large claims database with family linkage, we found that while male syphilis incidence remained dominant, high rates were also observed among dependent women and youths. These findings suggest that syphilis risk may extend beyond traditionally recognised high-risk populations and emphasise the need for targeted screening and preventive strategies in broader demographic groups.
Diabetes is a chronic disease characterised by elevated blood sugar levels, which can lead to damage across various body systems. Bangladesh has the second highest number of adults with diabetes in South Asia and faces a significant economic burden from this condition. The objective of this study was to investigate the economic burden of diabetes and its associated factors among patients with diabetes registered at a tertiary-level diabetes hospital in the Rajshahi region of Bangladesh.
This was a cross-sectional hospital-based study.
Primary data were collected from patients with diabetes at a tertiary-level diabetes hospital in Bangladesh.
The study recruited 400 patientswith diabetes, who were randomly selected. The economic burden was assessed using the Catastrophic Health Expenditure (CHE) threshold of ≥10% of household income. Descriptive statistics, 2 tests, t-tests, linear regression and binary logistic regression were employed for analysis, with statistical significance set at p
The proportion of diabetes-related burden among patients with diabetes was 50.7%. 95.8% of patients had type 2 diabetes, and over half (52.5%) were overweight or obese. Treatment costs were significantly associated with diabetes duration, insulin use and age (35–55 vs ≥56 years). The economic burden was strongly associated with lower income levels (poor income and middle income vs high income) and longer diabetes duration. Participants not adhering to a healthy diet had 43% lower odds of experiencing economic burden than those following a healthy diet.
Approximately half of the patients experienced catastrophic health expenditure due to diabetes, indicating a substantial economic burden in the Rajshahi region of Bangladesh. This burden was significantly higher among lower-income and middle-income groups and patients with longer disease duration, and treatment-related factors such as insulin use were associated with greater financial strain. These findings emphasise the need for targeted financial protection strategies, including subsidised care and preventive interventions.
To examine a model of the caregiving adaptation process among family caregivers supporting care recipients at home.
Global demand for the support of adults with long-term care needs and family caregivers is increasing. Caregivers' quality of life is affected by positive and negative appraisals of care; however, few studies have simultaneously investigated these factors.
A cross-sectional study.
The STROBE checklist for cross-sectional studies was followed. Seventy-four randomly selected home-visit nursing stations in Japan participated in this study from June 2023 to June 2024. A self-administered anonymous questionnaire was provided to family caregivers with care recipients at home. A total of 168 questionnaires were analysed. The variables included in the model were the European Quality of Life five-dimension five-level (EQ-5D-5L) instrument, positive and negative appraisals of care scale, four external resources and three internal resources, and six characteristics of caregivers and care recipients. Descriptive statistics and correlations between variables were analysed. The model was tested using structural equation modelling.
Family caregivers' negative appraisal of care directly and negatively affected quality of life, and positive appraisal of care had no statistically significant association with quality of life. Positive appraisal of care had a direct negative association with negative appraisal of care. External resources such as support from nurses directly affected the positive appraisal of care. Internal resources such as caregivers' coping strategies had a significant negative effect on negative appraisal of care.
The findings suggest that improving caregivers' quality of life requires support to decrease negative appraisal of care by increasing internal resources and increase positive appraisal of care by providing external resources. Understanding the caregivers' adaptation process model is essential to prevent the deterioration of their quality of life.
STROBE guidelines.
Seventy-four home visit nursing stations and participants who care for family members through home visit nursing were involved in the survey investigation and answering the questionnaires.
For supporting family caregivers' QoL, a reduction in negative appraisals of care is essential, increasing internal resources such as caregivers' coping and positive appraisal of care directly reduces negative appraisal of care.
by Mi Hwa Won, Sun-Hwa Shin
Sedentary behavior is a well-established independent risk factor for numerous chronic diseases. However, validated tools to assess the psychological and behavioral regulation of sedentary time remain limited. This study aimed to develop and validate a self-report scale for assessing sedentary behavior regulation in Korean adults. This scale was developed using a comprehensive multiphase process. First, items were generated based on a comprehensive literature review and expert consultation, followed by a content validity assessment. In total, 600 Korean adults were recruited. Construct validity was examined using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). Criterion validity was evaluated by assessing the correlation between the new scale and the Global Physical Activity Questionnaire (GPAQ). Finally, reliability was assessed through internal consistency and test-retest reliability. The final instrument, the Sedentary Behavior Regulation Scale (SBRS), consisted of 12 items across two distinct sub-factors: sedentary behavior management and environmental support and active movement in sedentary contexts. Criterion-related validity was supported by a small but significant positive correlation with physical activity (r = .19, pby 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 (DEFHyperbaric 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.
Despite the availability of curative treatments, hepatitis C diagnosis and treatment coverage is suboptimal globally with few countries on track to achieve the WHO’s 2030 elimination targets. In 2022, an estimated 50 million people were living with hepatitis C, with 1 million new infections annually. Most people living with hepatitis C reside in low- and middle-income countries, and people who inject drugs are disproportionately affected by hepatitis C.
Continuing simplification of diagnostic pathways and treatment care models is required to improve linkage to care and reduce costs associated with hepatitis C treatment and cure.
This study is a multi-country non-randomised, quasi-experimental, prospective comparative two-arm trial. It aims to assess the feasibility of implementation, retention in hepatitis C care and achievement of cure and cost-effectiveness outcomes, comparing two simplified hepatitis C testing and treatment pathways.
Arm 1 is a standard simplified test and treat model of care following global guidance, and arm 2 is an innovative rapid, same-day treatment initiation model of care using a presumptive treatment approach based on shortened read-time of the point-of-care OraQuick hepatitis C antibody test result. Secondary outcomes include assessing the accuracy of the OraQuick hepatitis C antibody test in predicting viraemia and the acceptability of each pathway.
This study will be implemented in Armenia, Georgia and Tanzania. Treatment-naïve people who inject drugs aged over 18 years in each country will be eligible for enrolment.
Recruitment commenced in October 2024 in Armenia, June 2025 in Georgia and August 2025 in Tanzania and is anticipated to close by December 2026.
This trial has been reviewed by WHO Ethics Review Committee (ERC), Alfred Hospital Ethics Committee (Australia) and local country ERCs. Alongside journal publications and conferences, the results from this study will be disseminated through summary reports and workshops with key stakeholders and with communities of people affected by HCV through relevant organisations/networks, including the global Community Advisory Board (CAB). The study results will inform national scale-up of simplified care models and inform potential pathways for further simplification of care models, including the potential for one-step diagnostic pathways and same-day treatment in particular scenarios for the three study countries, and other low- and middle-income countries globally.
To address the gap in existing postpartum care literature by gaining an in-depth understanding of Australian child and family health nurses' experiences of providing postpartum contraceptive care.
A qualitative exploratory study design, using semi-structured interviews.
Convenience and snowballing sampling methods were employed to recruit child and family health nurses currently practising in Australia. Semi-structured interviews were conducted with 15 nurses in July 2023, and data were analysed using reflexive thematic analysis as outlined by Braun and Clarke. The consolidated criteria for Reporting Qualitative research checklist were used to support the research process.
Despite their frequent contact with postpartum women and acknowledging the importance of postpartum contraceptive care, most participants did not commonly discuss contraception or family planning with mothers and did not feel it was part of their role to do so. Participants cited role ambiguity, limited knowledge of postpartum contraception, lack of clinical practice guidance, time constraints, and competing priorities as contributing to inconsistencies in postpartum contraceptive care provision.
This study highlights critical gaps in the provision of postpartum contraceptive care by child and family health nurses in Australia and underscores the need for systemic changes to promote postpartum contraceptive care as a key component of routine maternal health services.
This study provides actionable evidence for improving the delivery of postpartum contraceptive care, ensuring women are provided with accurate information about their options, and supporting contraceptive uptake to reduce the incidence of short interpregnancy intervals.
Our findings provide practical guidance relevant for healthcare policy and practice, emphasising the need to enhance child and family health nurses training in reproductive health, develop clear clinical practice guidelines, and address systemic barriers such as time constraints to improve the provision of postpartum contraceptive care and support women's reproductive health needs.
Standards for reporting qualitative research (SRQR).
No patient or public contribution.
This study aimed to address two objectives: (1) To analyse the meal support behaviours of direct care workers in long-term care facilities in South Korea and (2) to explore associations between mealtime support behaviours and caregiver characteristics.
Secondary analysis of behavioural coding of cross-sectional video recordings.
Positive and negative staff behaviours at mealtimes were coded using the Mealtime Engagement Scale and Cue Utilization and Engagement in Dementia tool, respectively. Statistical analyses, including t-tests and analysis of variance, were used to examine differences in mealtime support behaviours based on caregiver characteristics.
The average mealtime duration of residents was 19.03 ± 5.30 min. Positive meal support behaviours accounted for 91.1% of the observed interactions, whereas negative interactions accounted for 8.9%. The most frequent positive behaviour observed was ‘providing one-on-one assistance’, whereas the most frequent negative behaviour was ‘leaving the resident alone’. Positive meal support behaviours were observed at significant higher frequencies among caregivers working during day shifts than those working during rotating shifts. Additionally, positive behaviours were associated with a higher carer-resident ratio.
Positive mealtime support behaviours were frequently observed but were concentrated in a few specific actions. Negative behaviours, such as leaving the resident alone, were still observed in a considerable portion of mealtime interactions. Training programmes focusing on diverse positive mealtime support behaviours should be developed to improve the quality of dementia care in long-term care facilities.
The findings emphasise the need for targeted training programmes to improve mealtime support and overall care quality in long-term care facilities. This approach signals a transformative shift in caregiver training, fostering more personalised and effective care for older adults with dementia.
This study quantified positive and negative mealtime support behaviours. These findings contribute to understanding caregiver behaviours during mealtimes in dementia care, offering evidence-based insights for developing targeted training programmes and improving quality of care in long-term care facilities.
We adhered to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines.
No patient or public contribution.
To explore the prescribing practices and behaviours of Advanced Practice Nurses (APN) and pharmacist prescribers in Singapore, assess their confidence in key prescribing competencies, examine their use of information sources, and understand their views on the consequences of prescribing errors.
Cross-sectional national survey.
A census survey of all registered APN and pharmacist prescribers in Singapore was conducted from February to May 2024 using a validated 96-item instrument. The survey assessed prescribing practices, confidence in prescribing competencies, use of information sources, and prescribing safety. Descriptive statistics were used for analysis.
Ninety-one prescribers (54 APNs, 37 pharmacists) responded (32% response rate), most of whom worked in public medical/surgical settings. Prescribing comprised a median of 75% of their practice. Most time was spent prescribing continued medications, with less on initiating new medicines. Participants reported high confidence in communication, therapeutic partnerships, and working within professional standards. Greatest confidence was seen in educating patients, legal prescribing, and monitoring treatment response. Lower confidence was noted in complementary medicine-related tasks. Professional literature and colleagues were the most valued information sources. Most participants acknowledged the serious consequences of prescribing errors, though many believed such errors would likely be intercepted.
APNs and pharmacists demonstrate strong competencies in safe, holistic prescribing. However, cultural factors may limit patient engagement, highlighting the need to strengthen shared decision-making and collaborative practice.
Refining governance structures, adopting tiered prescriber autonomy, and enhancing training in complex prescribing are essential. Standardising deprescribing, improving access to decision-support tools, and promoting interprofessional collaboration and patient involvement can strengthen care quality and team-based delivery.
This study offers the first national insight into Singapore's Collaborative Prescribing Framework and informs training, policy, and workforce development for non-physician prescribers locally and in similar international contexts.
STROBE checklist.
This study did not include patient or public involvement in its design, conduct, or reporting.
Negative-pressure wound therapy (NPWT) is widely used in clinical practise to enhance wound healing; however, its biological effects on intact skin remain poorly understood. Given the expanding applications of NPWT, understanding its impact beyond open wounds is increasingly important. This study aimed to evaluate the biological responses of intact skin to negative-pressure, specifically focusing on epithelial-mesenchymal transition (EMT). The effects of negative-pressure loading were assessed using an in vitro model of non-diabetic human keratinocytes and an in vivo model of intact diabetic mouse skin. Human keratinocytes exposed to negative-pressure exhibited increased expression of thrombospondin-1 (THBS1), transforming growth factor-beta 1 (TGF-β1), plasminogen activator inhibitor-1 (PAI-1), and hypoxia-inducible factor 1-alpha (HIF-1α), alongside decreased epithelial markers and increased mesenchymal markers. These EMT-related changes were mitigated by inhibiting the THBS1-TGF-β1 interaction. Similarly, in diabetic mice, intermittent negative-pressure loading applied to intact dorsal skin significantly increased THBS1 and TGF-β1 levels, resulting in epidermal and dermal thickening, and promoted hypoxic, prothrombotic and angiogenic responses, as evidenced by increased HIF-1α, PAI-1, fibrinogen and vascular endothelial growth factor expression. These findings suggest that negative-pressure loading can induce EMT-like responses and tissue remodelling in intact skin primarily via mechanisms involving the THBS1-TGF-β1 signalling axis. This study expands the understanding of the biological influence of NPWT beyond traditional wound treatment applications, potentially informing future therapeutic considerations and safety guidelines.
Eisenmenger syndrome and pulmonary arterial hypertension (PAH) due to unrepaired congenital shunts, including atrial septal defect (ASD), ventricular septal defect (VSD) and patent ductus arteriosus (PDA), remain life-threatening conditions despite advances in congenital heart disease (CHD) care. In this population, vasodilator-based therapies effective in other forms of PAH have shown limited benefit, and no disease-modifying treatment has been established. Sotatercept, an activin-signalling inhibitor, improved exercise capacity and haemodynamics in phase 2/3 PAH trials; however, patients with unrepaired CHD, including Eisenmenger syndrome, were excluded. The efficacy and safety of sotatercept in this population remain unknown.
The SuMILE trial is a prospective, exploratory, multicentre, open-label, randomised, controlled trial conducted at 11 Japanese tertiary centres. 36 adults with vasodilator-resistant PAH due to unrepaired ASD, VSD or PDA, including Eisenmenger syndrome, will be randomised 2:1 to sotatercept add-on therapy plus vasodilator-based PAH therapy versus vasodilator-based PAH therapy alone. Sotatercept will be administered subcutaneously every 3 weeks in accordance with label-approved dose-modification rules for haemoglobin and platelet changes. The primary endpoint is the change in 6-min walk distance from baseline to week 24. Key clinical events will be independently adjudicated. Secondary endpoints include all-cause mortality or lung transplantation; pulmonary hypertension-related hospitalisation or initiation of parenteral prostacyclin and changes in WHO functional class, N-terminal pro-brain natriuretic peptide and emPHasis-10. Exploratory endpoints include genotype, right heart catheterisation and cardiac MRI parameters. The primary analysis will use ANCOVA, adjusting for baseline 6-min walk distance and randomisation stratum in the intention-to-treat population.
The protocol has been reviewed and approved by the certified central review board (Kyushu University Hospital Clinical Ethics Review Board) and participating institutions. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, scientific conferences and trial registries.
Japan Registry of Clinical Trials no. 1071250069; ClinicalTrials.gov NCT07356778. Protocol version and date: V.1.3; 23 October 2025
by Jingwen Gao, Yasushige Shingu, Ryota Azuma, Satoru Wakasa
BackgroundInflammatory response plays a pivotal role in myocardial injury and post-infarction remodeling after acute myocardial infarction (AMI). Mechanical unloading (UL) of the left ventricle (LV) has been proposed as a potential therapeutic strategy to preserve cardiac function; however, its effects on myocardial inflammation remain incompletely understood.
MethodsWe employed a rat model of partial UL using heterotopic heart-lung transplantation following AMI. RNA sequencing (RNA-seq) was performed to evaluate transcriptomic changes, with a specific focus on inflammatory pathways in the non-infarcted remote area. Immune cell abundance was estimated using deconvolution analysis (QUANTISEQ). Quantitative PCR was performed to analyze some inflammatory cytokines, and macrophage polarization was evaluated by immunohistochemistry.
ResultsAMI significantly impaired cardiac function, which was mitigated by UL. RNA-seq analysis revealed marked activation of inflammatory pathways and identified several hub genes involved in cytokine signaling following AMI, while these transcriptional changes were not significantly altered in UL groups after AMI. Immune cell profiling demonstrated an increase in M2 macrophages after AMI, while UL preserved M2 macrophage levels. Histological analysis further supported UL’s modulatory effect on macrophage polarization. Pro-inflammatory cytokines TNFα and IL1β were upregulated after AMI but showed attenuation with UL.
ConclusionPartial UL potentially attenuates cardiac functional deterioration after AMI while exerting substantial effects on inflammatory gene expression and macrophage polarization. These findings suggest that the cardioprotective effects of UL may be correlated with the modulation of inflammatory pathways in the remote area after AMI.
Selective fetal growth restriction (sFGR) is a major cause of perinatal morbidity and mortality in monochorionic diamniotic (MCDA) twin pregnancies. Current management relies on umbilical artery Doppler patterns in the smaller twin. These patterns are, however, inconsistent and do not represent a reliable severity scale, complicating clinical decision-making and parental counselling. This study aims to improve risk stratification by identifying predictors of adverse outcomes, while also evaluating the pathophysiology and multi-organ impact of sFGR in early childhood.
This is a prospective, international, multicentre cohort study conducted in six tertiary fetal medicine centres with expertise in complicated twin pregnancies. Recruitment began in March 2023 and will continue until December 2026, targeting 274 MCDA twin pairs with complete follow-up to develop a prediction model for adverse perinatal outcomes in sFGR at the time of diagnosis. Standardised data collection includes serial ultrasound examinations, advanced fetal imaging (cardiac, cerebral and 3D volumetric), fetal brain MRI and detailed placental phenotyping. Maternal and parental well-being are assessed during pregnancy and after birth. Neurodevelopmental outcome is evaluated up to 2 years after birth using validated tools. The statistical analysis plan includes predictive modelling with internal validation.
The study has been approved by the ethical review boards of all participating centres. Findings will be disseminated through peer-reviewed publications, international conferences and engagement with clinical guideline committees.
The study evaluated the feasibility and efficacy of a non-immersive virtual reality (VR) system on upper extremity (UE) recovery in ischaemic stroke patients in comparison to a conventional physiotherapy.
An open-label, parallel-group, randomised controlled trial randomly assigned the participants to two groups, VR intervention or conventional physiotherapy.
Two tertiary stroke care centres in South India participated in the study.
Sixty first-ever ischaemic stroke patients (1–6 months of stroke onset) having spasticity grades of 1 or 1+ as per Modified Ashworth scale and Brunnstrom recovery stages of 3, 4 or 5 in the UE were included in the intention-to-treat analysis.
High-intensity non-immersive VR-based comprehensive rehabilitation gaming system with a duration of 12 weeks (3 days/week) was compared with equally intensive conventional physiotherapy.
The feasibility outcome was the compliance with the treatment. The primary efficacy outcome was the improvement in the motor function assessed by the Fugl-Meyer assessment (FMA) and Wolf motor function test (WMFT). The secondary outcomes included the performance in activities of daily living by the Barthel index (BI) and the quality of life by the 36-item short form health survey (SF-36).
The treatment compliance was similar in two groups (p=0.19). Both groups improved in motor performance, activities of daily living and quality of life. However, there were no significant differences in the FMA (p=0.58), WMFT (functional ability scale, p=0.33; performance time, p=0.44), BI (p=0.84) and SF-36 (physical, p=0.87; mental, p=0.99) scores between the groups.
The non-immersive VR system was feasible, effective and safe; however, it was not found to be superior to conventional physiotherapy. The trial was stopped early and did not reach its proposed sample size and hence, the findings are to be interpreted cautiously.
Clinical trial registry India: CTRI/2021/11/038339 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTc1OTI=&Enc=&userName=CTRI/2021/11/038339).
Oxaliplatin, a key drug in the treatment of colorectal cancer (CRC), can cause oxaliplatin-induced peripheral neuropathy (OIPN) in a dose-dependent manner. These symptoms can severely affect daily life, and chronic OIPN often limits treatment continuation because of its correlation with the cumulative dose of oxaliplatin. Currently, effective preventive measures are unavailable. However, surgical glove compression therapy may reduce paclitaxel-induced neuropathy, suggesting its potential in preventing OIPN.
This multicentre, randomised, open-label, phase II/III trial evaluates surgical glove compression therapy to investigate the possible preventive effects of OIPN in patients with CRC receiving adjuvant capecitabine plus oxaliplatin chemotherapy. Patients with stage III CRC undergoing curative surgery will be enrolled and randomised into two groups. The intervention group will wear two layers of tight-fitting surgical gloves from 30 min before to 30 min after oxaliplatin infusion, whereas the control group will receive standard care. The primary endpoint is the incidence of grade ≥2 chemotherapy-induced peripheral neuropathy (CIPN) based on the Common Terminology Criteria for Adverse Events criteria. Secondary endpoints include quality of life assessments (Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item), duration and extent of OIPN as assessed using the Debiopharm Neurologic and Sensory Toxicity Criteria, chemotherapy completion rates, and adverse events. To detect a significant reduction in the incidence of CIPN, 170 patients will be enrolled (36% in the control group vs 15% in the intervention group). The planned case enrolment period is from 1 November 2024 to 31 October 2026.
This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB2024-0008), and has been registered with the Japan Registry of Clinical Trials (jRCTs062240066). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences.
jRCTs062240066
by Achilleas Livieratos, Maria Kudela, Yuxi Zhao, All-shine Chen, Xin Luo, Junjing Lin, Di Zhang, Sai Dharmarajan, Sotirios Tsiodras, Vivek Rudrapatna, Margaret Gamalo
BackgroundNetwork meta-analysis (NMA) can compare several interventions at once by combining head-to-head and indirect trial evidence. However, identifying, extracting, and modelling these often takes months, delaying updates in many therapeutic areas.
ObjectiveTo develop and validate MetaMind, an end-to-end, transformer-driven framework that automates NMA processes—including study retrieval, structured data extraction, and meta-analysis execution—while minimizing human input.
MethodsMetaMind integrates Promptriever, a fine-tuned retrieval model, to semantically retrieve high-impact clinical trials from PubMed; a multi-agent LLM architecture--Mixture of Agents (MoA)-- pipeline to extract PICO-structured (Population, Intervention, Comparison, Outcome) endpoints; and GPT-4o–generated Python and R scripts to perform Bayesian random-effects NMA and other NMA designs within a unified workflow. Validation was conducted by comparing MetaMind’s outputs against manually performed NMAs in ulcerative colitis (UC) and Crohn’s disease (CD).
ResultsPromptriever outperformed baseline SentenceTransformer with higher similarity scores (0.7403 vs. 0.7049 for UC; 0.7142 vs. 0.7049 for CD) and narrower relevance ranges. Promptriever performance achieved 82.1% recall, 91.1% precision and an F1 score of 86.4% when compared to a previously published NMA. MetaMind achieved 100% accuracy on a limited set of remission endpoints regarding PICO (Population, Intervention, Comparator, Outcome) element extraction and produced comparative effect estimates and credible intervals closely matching manual analyses.
ConclusionsIn our validation studies, MetaMind reduced the end-to-end NMA process to less than a week, compared with the several months typically needed for manual workflows, while preserving statistical rigor. This suggests its potential for future scaling of evidence synthesis to additional therapeutic areas.
Cutaneous T cell lymphoma (CTCL) is a group of non-Hodgkin lymphomas that primarily affects the skin and can mimic inflammatory dermatoses. Unlike many skin diseases, CTCL can lead to disabling symptoms, and advanced CTCL can even be fatal. Early studies investigating health-related quality of life (HRQOL) in patients with mycosis fungoides (MF) and Sézary syndrome (SS), common subtypes of CTCL, demonstrated significant impairment across numerous domains. The aim of this current study is to develop a core domain set (CDS) to identify the essential aspects of MF/SS that influence HRQOL that should be measured in therapeutic clinical trials. In the future, this set of core concepts will be used to identify the best patient- reported outcome measure(s) (PROM) for HRQOL for MF/SS clinical research.
Multiple strategies will be used to generate candidate concepts: systematic review of the literature, qualitative study and a survey study of healthcare providers. A Delphi consensus process including a comprehensive group of stakeholders (patients, caregivers/care partners, a multidisciplinary group of healthcare professionals, patient advocacy groups, pharmaceutical industry representatives, methodologists and government agencies) will be used to achieve consensus. Statistical corrections for multiple significance testing and false positive findings will be undertaken.
The study was submitted for and received institutional review board approval at the University of Washington (IRB# STUDY00018890 and STUDY00019407). Informed consent will be obtained from all participants where necessary. We will disseminate our findings through peer-reviewed, open access publications and presentations at national/international conferences. We will provide a plain language summary in lay terms for patients and families to patient advocacy groups for distribution to their network.
The protocol is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database.
Case reports (CRs) are essential in physiotherapy, yet reporting remains heterogeneous and insufficiently standardised. The 2013 CAse REport (CARE) guideline improves transparency but lacks physiotherapy-specific detail. This study aimed to develop a consensus-driven extension of the CARE reporting guideline to support structured reporting of physiotherapy CRs, encompassing physiotherapy-specific assessments and interventions.
An e-Delphi consensus process study following the ACcurate COnsensus Reporting Document (ACCORD) guidelines.
Online.
Forty-four international experts in physiotherapy practice, research and education, along with six core committee members.
Experts objectively scored items for relevance (5-point Likert scale) and provided open-ended responses for each item of the drafts. Scores and responses were analysed to facilitate iterative refinement of the Physiotherapy CAse REport (PhyCARE) reporting guidelines. Consensus was predetermined at over 70% agreement.
Round 1 had the majority of items achieving ≥70% agreement, except two items that did not meet the threshold were revised and replaced with an alternative. Five new items addressing physiotherapy-specific reporting needs were added, and 10 items were relocated. In round 2, all 35 items across 13 domains achieved 84%–100% agreement. The nomenclature of one domain was revised to ‘Outcomes and Follow-up’. Following two e-Delphi rounds, consensus was achieved, and suggestions from online meeting, piloting led to item rephrasing, after which the PhyCARE guidelines were finalised.
The PhyCARE guidelines have the potential to provide a physiotherapy-specific extension of CARE to support structured, transparent and reproducible reporting of physiotherapy CRs.
FreshRSS 