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Post-trial 12-month follow-up of TRACE (targeted research on addictive and compulsive eating) randomised controlled trial participants: A brief report.

Few treatment interventions for addictive eating have evaluated long-term effectiveness. This post-trial follow-up study evaluates secondary changes in addictive eating symptoms and quality of life at 12-months in a sample of individuals who participated in the TRACE (Targeted Research for Addictive and Compulsive Eating) RCT. Thirty-three adults out of possible 144 (82% female), median age 53 years, randomised to either the active intervention (five telehealth sessions delivered over 3-months), passive intervention (self-guided workbook) or control group completed an online post-trial survey. Pre- and immediate post-intervention (3-months) outcomes were compared to 12-months post-trial outcomes. Positive effects reported in the short term showed a rebound effect at post-trial follow-up in ∼50% of participants. The findings suggest that longer term support is needed to maintain changes in addictive eating behaviours and improve quality of life. Future research is needed to identify optimal intervention durations and support options for sustained change. Australian New Zealand Clinical Trials Registry (ACTRN12621001079831).

Humans

Nerve injury in revision total elbow arthroplasty: a systematic review and meta-analysis.

BACKGROUND: Revision total elbow arthroplasty (TEA) is technically demanding and carries a substantial risk of postoperative neurological complications because of scarring, altered anatomy, implant removal, and repeated humeral and ulnar exposure. The incidence, nerve distribution, and recovery profile of nerve injury after revision TEA remain incompletely defined. This study aimed to systematically review the literature to define the incidence, recovery profile, and risk factors for nerve injury after revision TEA. METHODS: A systematic review of the literature was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. Thirteen retrospective case series were included, comprising 282 revision TEAs in 271 patients. Random-effects meta-analysis of proportions was undertaken where the data permitted. The primary outcome was postoperative nerve injury following revision TEA. Secondary outcomes included nerve type, recovery, secondary nerve-related procedures, infection, triceps insufficiency, metallosis, periprosthetic fracture, and re-revision. RESULTS: The pooled incidence of postoperative nerve injury was 22.3% (95% confidence interval [CI] 16.3 to 29.6; I2 = 34.6%). The crude incidence was 60 of 282 revisions (21.3%, 95% CI 16.6 to 26.5). The ulnar nerve was involved in 66.7% of all nerve injuries, the radial nerve in 31.7%, and the median nerve in 1.7%. No significant difference in pooled nerve-injury incidence was identified between studies published before 2010 and those published from 2010 onwards (22.9% vs. 21.4%, P = .837). Recovery reporting was heterogeneous; among injuries with numerically extractable outcomes, 85.4% improved partially or completely (95% CI 72.2 to 93.9). Secondary nerve-related procedures were reported in 7 studies. Pooled complication estimates were 10.2% for infection, 13.6% for triceps insufficiency, 25.5% for metallosis, 15.9% for periprosthetic fracture, and 14.0% for re-revision. CONCLUSIONS: Postoperative nerve injury is a common and clinically important complication of revision TEA, affecting approximately 1 in 5 cases. The ulnar nerve is most frequently involved, although radial nerve injury accounts for a substantial proportion of cases. Many neuropathies improve during follow-up, but persistent deficits and the need for secondary nerve-related procedures are not uncommon. Future studies should adopt standardized neurological definitions and reporting to improve comparability and guide preventive surgical strategies.

Humans

Ketamine Plus Midazolam versus Fentanyl Plus Midazolam for Sedation and Analgesia during Image-guided Procedures in Interventional Radiology: Randomized Clinical Trial.

Background Opioid-benzodiazepine regimens remain common for radiologist-administered procedural sedation despite respiratory and analgesic effectiveness concerns. Purpose To compare intraprocedural pain and patient-reported experience between ketamine/midazolam and fentanyl/midazolam during image-guided procedural sedation. Materials and Methods This randomized clinical trial was conducted at a single academic center between June 2025 and February 2026. Adults undergoing image-guided lung or bone biopsy or abscess drainage were randomized to fentanyl/midazolam or ketamine/midazolam administered by interventional radiologists. Procedures were performed using US, CT, CT fluoroscopy, or combined CT and US guidance. The primary outcome was maximum intraprocedural pain (0-10 on the Numeric Rating Scale). Secondary outcomes included sedation depth, physiologic parameters, oxygen desaturation, patient-reported experience assessed using a modified Heidelberg questionnaire, and complications. Results Among 264 randomized procedures (132 procedures per group) in 260 participants (median age, 68 years [IQR, 61-75 years]; 135 [52%] female), ketamine/midazolam resulted in lower maximum intraprocedural pain than fentanyl/midazolam (mean difference, -1.4 points [95% CI: -2.0, -0.8]; P < .001). Pain scores greater than 4 occurred less frequently with ketamine/midazolam (2.3% vs 17%; absolute difference, 14 percentage points [95% CI: 8, 21]; P < .001). Ketamine/midazolam was associated with higher nadir oxygen saturation (mean difference, +1.4% [95% CI: 0.6, 2.2]; P = .001) and fewer oxygen desaturation events below 90% (three [2.3%] vs 13 [9.8%]; absolute difference, 7.6 percentage points [95% CI: 1.9, 13.3]; P = .02). Ketamine/midazolam produced deeper sedation and higher intraprocedural systolic blood pressure. Hallucinations occurred more frequently with ketamine/midazolam (15 [11.4%] vs five [3.8%]; absolute difference, 7.6 percentage points [95% CI: 1.3, 13.9]; P = .03), though overall procedural comfort, reduced recall, and perceived adequacy of sedation were improved. Procedure-related and sedation-related complications did not differ between groups. Conclusion Radiologist-administered ketamine/midazolam during image-guided procedural sedation improved analgesia and patient-reported experience with fewer hypoxemic events and no increase in complications compared with fentanyl/midazolam. Clinical trial registration no. NCT07040163

Aged

Assessment and CommuniCation ExcelLEnce foR sAfe paTient outcomEs (ACCELERATE): A stepped-wedge cluster randomised trial evaluating the effectiveness of a nurse-led assessment and handover communication intervention on patient adverse events.

BACKGROUND: Patients continue to experience harm from undetected deterioration, falls and pressure injuries. We aimed to implement and evaluate an organisational, ward-level nurse-led assessment and communication intervention to proactively reduce patient adverse events. METHODS: A stepped-wedge cluster randomised Trial over 12-months was conducted at three metropolitan hospitals. Our intervention comprised a comprehensive, systematic patient assessment at shift commencement; a structured patient-centred bedside nurse-to-nurse clinical handover; and multidisciplinary communication consisting of nurse participation in medical ward rounds. Evidence-based implementation strategies informed intervention delivery to nine clusters (20-35 bed-wards with &#x2265;70% permanent nurses) over three sequential 14-week steps. Routinely collected patient-level data were used to measure intervention effect. The primary outcome was a composite measure of medical emergency team calls, unplanned intensive care unit admissions, in-hospital falls; and stage 2-4 pressure injuries. Secondary outcomes were: individual measures of the primary outcome; nurse-reported perceptions of safety culture; organisational readiness to change; barriers to physical assessment; staff engagement; and patient-reported experience measures of safety and overall hospital experience. Analyses were adjusted for age, sex, hospital, pre/post intervention, and Trial step (fortnight), with random effects for ward and patient. RESULTS: There were 13,753 eligible admissions. No change was observed in the primary composite outcome measure (odds ratio (OR) [95% confidence interval (CI)]: 0.99 [0.77, 1.28]; p&#xa0;=&#xa0;0.95). There was no significant difference in medical emergency team calls (OR [95% CI]: 1.02 [0.75, 1.39]; p&#xa0;=&#xa0;0.91); unplanned intensive care unit admissions (OR [95% CI]: 1.35 [0.57, 3.20]; p&#xa0;=&#xa0;0.50) and falls (OR [95% CI]: 1.53 [0.96, 2.45]; p&#xa0;=&#xa0;0.07). However, stage 2-4 pressure injuries significantly decreased by 41% (OR [95% CI]: 0.59 [0.38, 0.93]; p&#xa0;=&#xa0;0.02); a significant absolute effect improvement of 0.8% ([95% CI: 0.3%-1.3%], p&#xa0;<&#xa0;0.01). There were statistically significant improvements in nurses' overall perceptions of Safety Attitudes (Pre: 74.6, Post: 79.7; p&#xa0;=&#xa0;0.02), and the Organisational Readiness to Change subscales of, leader culture (Pre: 3.73, Post 3.91; p&#xa0;=&#xa0;0.02), leadership behaviour (Pre: 3.85, Post: 4.11; p&#xa0;=&#xa0;0.03), and general resources (Pre: 3.06, Post: 3.30; p&#xa0;=&#xa0;0.03). A statistically significant decrease in Barriers to Physical Assessment (Pre: 2.48, Post: 2.24; p&#xa0;<0.001) and in six of seven sub-scales was observed. Patients' overall Measure of Safety remained high, but unchanged (Pre: 3.94 Post: 3.92; p&#xa0;=&#xa0;0.07). CONCLUSION: The ACCELERATE Trial demonstrated that nurse-driven initiatives, emphasising structured physical assessments by nurses, patient-centred clinical handovers, and multidisciplinary communication, significantly: reduced pressure injuries; decreased nurses' perceived barriers to performing physical assessments; and improved leadership behaviour, communication, and ward safety culture perceptions. Results highlight the transformative potential of this approach, which now warrants testing at scale for broader implementation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ID: ACTRN12621000265875.

Humans

Adjuvant alectinib versus chemotherapy in resected ALK-positive non-small-cell lung cancer (ALINA): health-related quality-of-life and safety outcomes from a randomised, open-label, phase 3 trial.

BACKGROUND: For patients with resected, ALK-positive non-small-cell lung cancer (NSCLC), adjuvant alectinib significantly improved disease-free survival versus platinum-based chemotherapy in the global, phase 3, open-label, randomised ALINA trial. We report safety and health-related quality-of-life (HRQoL) outcomes from the ALINA trial. METHODS: Eligible patients aged 18 years or older with resected, ALK-positive, stage IB (&#x2265;4 cm)-IIIA NSCLC (per the American Joint Committee on Cancer and the Union for International Cancer Control Cancer Staging Manual 7th edition) and an Eastern Cooperative Oncology Group performance status of 0-1 were randomly assigned (1:1) via a block-stratified randomisation method to receive oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy for four 3-week cycles. Randomisation was stratified according to disease stage and race. The primary endpoint, previously reported, was disease-free survival. Safety was a secondary endpoint and HRQoL was an exploratory endpoint. Safety was assessed by the investigator as per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5&#xb7;0 until 28 days after the last alectinib dose or chemotherapy cycle. HRQoL was assessed via the Short-Form 36-item health survey version 2 (SF-36v2) questionnaire at baseline, every 3 weeks to week 12, then every 12 weeks until disease recurrence, consent withdrawal, death, or week 96. Norm-based scoring was applied; clinically meaningful changes were defined using the SF-36v2 manual. Safety was assessed in the safety-evaluable population and HRQoL in the intention-to-treat population. This study is registered with ClinicalTrials.gov (NCT03456076) and is ongoing. FINDINGS: Between Aug 16, 2018, and Dec 8, 2021, 257 patients were assigned to receive alectinib (n=130) or chemotherapy (n=127). 123 (48%) patients were male and 134 (52%) were female; 143 (56%) were Asian. The safety-evaluable population comprised 128 patients who received alectinib and 120 patients who received chemotherapy; median duration of safety follow-up was 24&#xb7;8 months (IQR 22&#xb7;0-24&#xb7;9) in the alectinib group and 3&#xb7;7 months (IQR 3&#xb7;7-3&#xb7;8) in the chemotherapy group. The safety of adjuvant alectinib was generally consistent with its known profile. The most common grade 3-4 adverse events were blood creatine phosphokinase increased (eight [6%] of 128), alanine aminotransferase increased (two [2%] of 128), and blood bilirubin increased (two [2%] of 128) in the alectinib group, and neutrophil count decreased (12 [10%] of 120), neutropenia (ten [8%] of 120), and nausea (five [4%] of 120) in the chemotherapy group. Serious treatment-related adverse events occurred in two (2%; one each with appendicitis and pneumonitis) of 128 patients in the alectinib group and eight (7%) of 120 patients in the chemotherapy group ( most common were gastrointestinal disorders in three [3%] patients). No deaths due to adverse events were reported in either group. There were fewer discontinuations due to adverse events with alectinib (seven [5%]) versus chemotherapy (15 [13%]). A clinically meaningful difference in improvement from baseline was seen at week 12 for bodily pain, role physical, mental health, social functioning, and vitality SF-36v2 domains with alectinib; improvements in physical and mental HRQoL were maintained over 2 years of active treatment (at week 96, mean Mental Component Summary score: 49&#xb7;9 [SD 10&#xb7;4]; mean Physical Component Summary score: 48&#xb7;8 [SD 7&#xb7;2]) and reached levels similar to the general population (population norm: 50). INTERPRETATION: For patients with resected ALK-positive NSCLC, adjuvant alectinib had a manageable safety profile; HRQoL improved and was maintained over 2 years of active treatment. Together with the disease-free survival benefit seen in ALINA, these data support adjuvant alectinib as an important new standard-of-care for patients with resected ALK-positive NSCLC. FUNDING: F&#x2008;Hoffmann-La Roche.

Adult

Recurrent myocardial infarction identified by centralized troponin review: Insights from the MINT trial.

BACKGROUND: The utility of routine troponin testing to identify recurrent myocardial infarction (MI) after an incident MI is unclear. We assessed the incidence and prognosis of recurrent MIs identified from centralized troponin review in patients from the Myocardial Ischemia and Transfusion (MINT) trial. METHODS: The MINT trial randomized patients with acute MI and anemia to a liberal vs restrictive red blood cell transfusion strategy. Suspected recurrent MIs were identified through both site-report and centralized review of troponin levels collected for 3 days following randomization. Differences in cardiac, noncardiac, and all-cause death at 30 and 180 days were compared across patients with any site-reported MI, only centrally identified MI, and no recurrent MI. RESULTS: Among 3,504 patients, 275 (7.8%) had a recurrent MI within 30 days; 119 (43.3%) by site-report, and 156 (56.7%) by central troponin review only. Rates of cardiac and all-cause death at 30 and 180 days were highest for patients with site-reported MI, intermediate for centrally identified MI, and lowest for no recurrent MI; rates of noncardiac death did not vary. Patients with only centrally identified recurrent MI had an increased risk of cardiac death at 30 days (RR 1.9, 95% CI 1.0-3.4) and 180 days (RR 1.7, 95% CI 1.1-2.7) compared to those without recurrent MI. CONCLUSIONS: In patients with acute MI and anemia, centralized troponin review identified more than half of all recurrent MI events. Patients with centrally identified MI had a higher risk of cardiac death than those with no recurrent MI. TRIAL REGISTRATION: ClinicalTrials.gov NCT02981407 https://clinicaltrials.gov/study/NCT02619136.

Humans

Effect of renin-angiotensin system inhibitors on survival in glioma patients: A systematic review and meta-analysis.

PURPOSE: To evaluate the effect of renin-angiotensin system inhibitors (RASIs) on the survival outcomes of glioma patients, determine whether using RASIs correlates with survival benefit, and provide evidence-based guidance for the clinical treatment. METHODS: Studies assessing the effects of using RASIs versus non-use in glioma patients were retrieved from the PubMed, Cochrane Library, Web of Science, and Embase databases from inception to April 17, 2024. The included studies reported hazard ratios (HRs) with 95% confidence intervals (CIs) for overall survival (OS) and/or progression-free survival (PFS), as well as the effect on brain edema and steroid dosing in patients. RESULTS: Seven articles involving 2660 patients were included in this study. Pooled results indicated there was no significant difference in OS (HR&#x202f;=&#x202f;0.89, 95% CI 0.75-1.06, P&#x202f;=&#x202f;0.204) or PFS (HR&#x202f;=&#x202f;0.98, 95% CI 0.82-1.18, P&#x202f;=&#x202f;0.847) between RASIs-treated patients and non-RASIs-treated patients. Sensitivity analysis identified the ACEIs-focused trial reported by Happold et al. as a major contributor to inter-study heterogeneity. Subgroup analyses revealed that in recurrent glioblastoma, pooled OS was significantly longer in RASIs-treated patients than non-RASIs-treated patients (HR&#x202f;=&#x202f;0.70, 95% CI 0.54-0.92, P&#x202f;=&#x202f;0.01). Similarly, compared with bevacizumab monotherapy, bevacizumab combined with RASIs significantly extended OS in glioblastoma patients (HR&#x202f;=&#x202f;0.73, 95% CI 0.63-0.86, P&#x202f;<&#x202f;0.001). CONCLUSION: The results revealed that treatment with RASIs may show a trend toward prolonged overall survival (OS) in patients with glioma. For patients with glioblastoma, RASI therapy could prolong OS in those with recurrent disease. Furthermore, compared with bevacizumab monotherapy, the combination of RASIs and bevacizumab was associated with improved OS in glioblastoma patients.

Humans

Deucravacitinib 5-Year Safety and Efficacy Results in Plaque Psoriasis: A Phase 3 Open-Label Extension of Randomized Clinical Trials.

BACKGROUND: Deucravacitinib, an oral, selective, tyrosine kinase 2 inhibitor, is approved for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy and for adults with active psoriatic arthritis. OBJECTIVE: We evaluated deucravacitinib safety and efficacy over 5 years in the phase 3 POETYK PSO-1, PSO-2, and long-term extension (LTE) trials in patients with moderate to severe plaque psoriasis. METHODS: PSO-1 and PSO-2 (parent trials) randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. At 52 weeks, patients enrolled in the LTE trial received open-label deucravacitinib. Safety was reported as exposure-adjusted incidence rates (EAIRs) per 100 person-years (PY). Clinician- and patient-reported outcomes were analyzed using modified nonresponder imputation in patients receiving continuous deucravacitinib from day 1 (PSO-1/PSO-2) through 5 years. RESULTS: Overall, 1519 patients received one or more deucravacitinib dose; total exposure was 5046.7 PY through data cutoff (September 2, 2024). EAIRs/100 PY were comparable or decreased from the 1-year to 5-year cumulative period for adverse events (AEs) (229.23, 127.40, respectively), serious AEs (5.68, 5.06), discontinuation due to AEs (4.38, 2.09), deaths (0.20, 0.22), serious infections excluding coronavirus disease 2019 (COVID-19) (1.53, 0.94), malignancies (1.02, 0.92), major adverse cardiovascular events (0.30, 0.34), and venous thromboembolism (0.20, 0.06). Clinical outcomes were well-maintained in patients receiving continuous deucravacitinib (n = 513) from 1 through 5 years, including achievement of a &#x2265;&#xa0;75% reduction from baseline in the Psoriasis Area and Severity Index (1 year, 72.1% [95% CI 68.2-76.1]; 5 years, 67.3% [62.0-72.6]) and a static Physician Global Assessment score of 0 (clear) or 1 (almost clear) (1 year, 57.5% [53.1-61.9]; 5 years, 52.6% [47.0-58.1]). Dermatology Life Quality Index 0 or 1 was well-maintained from 1 year (52.5% [48.0-57.1]) through 5 years (45.4% [40.0-50.8]). CONCLUSIONS: These findings demonstrate a consistent safety profile with no new safety signals and durable clinical response through 5 years of treatment with deucravacitinib. CLINICAL TRIAL REGISTRATION: NCT03624127, NCT03611751, NCT04036435.

Humans

The influence of organizational culture on medication safety practices and associated risk factors in the community setting: A systematic review.

BACKGROUND: Increasing attention has been given to the role of organizational culture in influencing medication safety practices across healthcare settings. The lack of widely accepted standardized instrumentation makes operational measurement of organizational culture and medication safety challenging. The purpose of this systematic review was to examine the impact of organizational culture on medication safety within community healthcare settings. METHODS: MEDLINE, CINAHL, Scopus, and Nursing & Allied Health were searched in August 2025 using keywords, subject terms, field codes, and Boolean operators to identify papers relevant to the review question; bibliographies of included studies were also reviewed. Screening and full-text review were completed independently by two reviewers with a third to adjudicate conflicts. The Critical Appraisal Skills Programme was used for quality assessment. The PRISMA statement guided the development and implementation of the review. RESULTS: Thirteen articles were included representing various community settings. Most studies reported on untoward medication events, but few measured systematically collected safety data before and after an intervention. Organizational culture was seldom defined or operationalized. Most studies were methodologically sound, but the overall level of evidence was weak to moderate. CONCLUSION: Organizational culture influences medication safety through aspects such as communication channels, teamwork, training, and an environment that allows error and near-miss reporting. Few studies explicitly evaluate the causal impact of culture interventions on measurable medication safety outcomes in community healthcare settings. Further research should incorporate standardized measurement tools and intervention-based, pre-post designs to better understand how organizational culture influences medication safety in community healthcare settings.

Organizational Culture

International study of coronary microvascular angina (iCorMicA): A registry-based diagnostic study and nested randomized trial.

BACKGROUND: Angina is a debilitating condition caused by coronary artery disease and microvascular dysfunction. Following coronary angiography angina and no obstructive coronary arteries is a common outcome, and women are disproportionately affected. The objectives are first, to assess causes of angina in patients undergoing invasive management; and second, to assess effects of coronary function test-guided management on clinical outcomes. METHODS: This is an international, multicenter, prospective, registry-based study and nested, randomized, controlled, triple-blind, and endpoint trial. Participants, community care providers, and outcomes assessors are masked. Consented participants enter the registry. Participants without obstructive coronary artery disease (luminal stenosis <50%, or fractional flow reserve >0.80) are eligible for randomization. Index of microcirculatory resistance (IMR; abnormal &#x2265;25) and coronary flow reserve (CFR; abnormal <2.0; gray zone 2.0-2.5) are measured by bolus thermodilution, and results are disclosed (intervention) or not (control group) to the attending cardiologist. RESULTS: The primary outcome of the registry is the Seattle Angina Questionnaire summary score at baseline described by coronary artery disease status. Secondary outcomes include the prevalence of obstructive coronary artery disease, patient reported outcome measures and clinical outcomes. The primary outcome of the randomized trial is the within-individual change in Seattle Angina Questionnaire summary score at 12-months from baseline. Secondary outcomes include safety, diagnostic accuracy, patient reported outcome measures for quality of life, physical and psychological function, cardiovascular risk, clinical outcomes, health economics and mechanistic biomarkers. The first patient was screened on December 18, 2020 and the last patient was enrolled on June 30, 2026. Forty sites were included in the United Kingdom (n = 35), Republic of Ireland (n = 2), Holland (n = 2), and Poland (n = 1). In total, 1,483 participants were enrolled into the registry of whom 1,047 were randomized and 386 were not randomized (registry-only). CONCLUSION: This international, registry-based clinical trial will provide novel evidence on the natural history of angina and stratified therapy for angina with no obstructive coronary arteries. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT04674449. UNIQUE IDENTIFIER: NCT04674449.

Humans

Educational Effects of Electronic Documents and Videos on Parents' Responses to Acute Illness in Young Children: A Randomized Controlled Trial.

AIM: This study compared changes associated with electronic document-based and video-based education for parents responding to acute illness in young children, focusing on self-reported knowledge, anxiety, and satisfaction. METHODS: A randomized controlled trial with pre- and post-intervention measurements was conducted among 140 adults in Japan who self-reported raising a child under 3&#x2009;years of age and having experienced their child's acute illness. Participants were assigned to an electronic document group or a video group (n&#x2009;=&#x2009;70 each). Self-reported knowledge was assessed using a researcher-developed questionnaire, and anxiety was measured using the State-Trait Anxiety Inventory. Pre-post changes and between-group differences in change scores were examined. RESULTS: Total self-reported knowledge scores increased significantly in both groups (p&#x2009;<&#x2009;0.01), with no significant between-group difference. The video group showed significant improvements in items related to symptoms requiring attention at home and information sources, whereas the electronic document group improved in items related to symptoms requiring medical consultation and emergency calls. State and trait anxiety did not change significantly in either group. Satisfaction was high in both groups. CONCLUSIONS: Both educational formats may support parents' learning about responses to acute illness in young children, although appropriate formats may differ according to the educational content. Information provision alone may have limited effects on anxiety; therefore, future parent education should incorporate interactive and reassurance-focused approaches. TRIAL REGISTRATION: UMIN-CTR: UMIN000056457.

Humans

Haemodialysis Nurses' Self-Reported Cultural Competence and Responsiveness: A Cross-Sectional Survey.

BACKGROUND: People receiving in-centre haemodialysis have distinct cultural care needs and preferences, and nurses are expected to respond to these. However, haemodialysis nurses' cultural competence and responsiveness are unknown. OBJECTIVES: To examine nurses' cultural competence and responsiveness when caring for people with diverse cultural characteristics. DESIGN: An online cross-sectional survey. PARTICIPANTS: Haemodialysis nurses from Australia and New Zealand (n&#x2009;=&#x2009;123), recruited through the Renal Society of Australasia and professional networks. MEASUREMENTS: The 25-item Cultural Competence Assessment instrument measured cultural awareness and sensitivity, and culturally responsive behaviours. Demographic characteristics were also collected. RESULTS: Of 123 complete responses, overall cultural competence was high (M&#x2009;=&#x2009;5.09, SD&#x2009;=&#x2009;0.76), particularly awareness and sensitivity (M&#x2009;=&#x2009;5.76, SD&#x2009;=&#x2009;0.53), with significantly higher scores among those who had completed cultural awareness training (p&#x2009;=&#x2009;0.009). In contrast, culturally responsive behaviours were moderate (M&#x2009;=&#x2009;4.53, SD&#x2009;=&#x2009;1.23), highlighting the gap between cultural competence and responsiveness. The lowest scoring areas were documentation of patients' cultural needs (M&#x2009;=&#x2009;3.88, SD&#x2009;=&#x2009;2.02) and access to cultural learning resources (M&#x2009;=&#x2009;3.02, SD&#x2009;=&#x2009;1.75), indicating limited supports. Qualitative findings reflected practices of culture care preservation and accommodation, with themes of cultural awareness and language differences highlighting barriers related to language and resources. CONCLUSIONS: High cultural competence does not necessarily translate into culturally responsive behaviour. Organisational supports, including guidance for documenting cultural needs, cultural assessment tools and accessible learning resources, may help strengthen culturally responsive haemodialysis care.

Humans

Effectiveness of digital health technologies for post-discharge follow-up and management in older adults: a systematic review.

Older adults (&#x2265;65 years) are a rapidly growing population that are experiencing a higher number of hospitalisation admissions, longer hospital stays, and greater hospitalisation-related costs than younger adults. There is an important gap in post-discharge care for older adults, and digital technologies, such as video visits, mobile health apps, and remote patient monitoring, may support follow-up and management after hospital discharge. This systematic review examined the effectiveness, feasibility, acceptability, and impact (ie, effects on rehospitalisation, quality of life, mental health, adherence, and patient satisfaction) of technology-based interventions used for the follow-up and management of older adults after hospital discharge. MEDLINE (via PubMed), Scopus, and Web of Science were searched from database inception to January, 2026. The search identified 1972 records, of which 46 studies met the inclusion criteria: older adult populations (aged &#x2265;65 years), a technology-based intervention, post-discharge follow-up or management, and empirical data. Overall, digital post-discharge interventions were reported to be feasible, with good engagement, adherence, compliance, and retention; low dropout rates; and positive patient satisfaction. However, mixed findings were reported regarding rehospitalisation rates and mental health outcomes for virtual care compared with those for traditional care. Digital health technologies might represent a promising step towards improving post-discharge health care and continuity of care for older adults.

Journal Article

Assessment of temporomandibular joint space changes after orthognathic surgery in skeletal malocclusion patients: a systematic review.

PURPOSE: To interpret postoperative changes in temporomandibular joint (TMJ) joint space dimensions and condylar position following orthognathic surgery in patients with skeletal malocclusions, and to determine whether reported alterations represent clinically meaningful displacement or physiological adaptive remodeling. MATERIALS AND METHODS: A comprehensive search of PubMed, SCOPUS, Web of Science, EBSCOhost, and Cochrane Library was performed to assess pre- and postoperative TMJ changes using three-dimensional imaging. Joint spaces including anterior (AJS), superior (SJS), and posterior (PJS) and condylar morphology were evaluated. Methodological quality was appraised using the Joanna Briggs Institute (JBI) checklist. Due to methodological and clinical heterogeneity, findings were synthesized narratively with attention to malocclusion type and surgical movement. RESULTS: A total of 16 studies consisting 628 patients undergoing BSSO, Le Fort I osteotomy, vertical ramus osteotomy, or bimaxillary surgery were included. Most studies reported minor, adaptive postoperative changes in AJS, SJS, and PJS. Class II patients showed more consistent increases in AJS/SJS, whereas Class III patients demonstrated variable posterior or anterior remodelling depending on surgical movement. Volumetric analyses revealed region-specific adaptations without significant condylar displacement. Postoperative temporomandibular disorder symptoms were infrequent, and no consistent evidence supported detrimental TMJ effects attributable to surgery. CONCLUSION: Postoperative TMJ joint space changes after orthognathic surgery primarily represent physiological adaptive remodeling rather than pathological condylar displacement, with reported variability driven by malocclusion type, surgical movement, fixation method, and imaging protocol. Recognizing these predictable patterns is essential to prevent overinterpretation of postoperative imaging and to improve clinical assessment through standardized three-dimensional and long-term evaluation strategies.

Humans

Applications of artificial intelligence in robot-assisted surgery: a systematic review.

To characterize applications of artificial intelligence (AI) in robot-assisted surgery, summarize technical and clinical performance, and assess the quality of the available evidence. PubMed, Web of Science Core Collection, and Scopus were searched for English-language journal articles published from 1 January 2020 through 31 October 2025. Randomized, observational, model-development, validation, and feasibility studies evaluating AI in robot-assisted surgery or closely related image-guided minimally invasive workflows were eligible. Two reviewers independently performed study selection, data extraction, and risk-of-bias assessment. Owing to heterogeneity in surgical procedures, AI tasks, analytical units, validation strategies, and outcomes, findings were synthesized descriptively without statistical pooling. The review was registered in the International Prospective Register of Systematic Reviews (CRD420251175699). Seventeen studies were included: seven clinical prediction or decision-support studies, eight intraoperative recognition, segmentation, or image-guided studies, and two training or workflow studies. Five prediction studies reported area-under-the-curve values of 0.74-0.95. Technical studies reported F1 or Dice scores of 0.525-0.995 and task-specific accuracies of 0.840-0.998. Two randomized studies suggested benefits for personalized suturing feedback and automated camera control, but neither established improved patient outcomes. Only one study had low overall risk of bias; the remaining studies were at high or unclear risk or raised some concerns. AI applications in robot-assisted surgery show promise for prediction, intraoperative perception, training, and workflow support. Evidence primarily demonstrates technical feasibility rather than established clinical effectiveness. Independent multicenter validation and prospective evaluation of patient, educational, and workflow outcomes are required before widespread implementation.

Robotic Surgical Procedures

Who Is the Ideal Candidate for High-Definition Liposuction? A Systematic Review and Meta-Analysis.

BACKGROUND: High-definition liposuction (HDL) enhanced muscular definition by selectively removing superficial subcutaneous fat. Despite its growing popularity and high satisfaction rates, no consensus exists regarding the ideal candidate. This systematic review evaluates demographic factors, patient selection criteria, and complication rates associated with HDL. METHODS: A systematic review and meta-analysis were conducted utilizing PRISMA-P guidelines. PubMed, Cochrane Library, Embase, and Web of Science were searched for studies published within the past 10 years. Seventeen studies met inclusion criteria, comprising 9570 patients. Study designs included randomized controlled trials, cohort studies, and observational analyses reporting demographics, procedural details, and complications. Standardized data extraction was performed. Pooled analyses were conducted for hematoma and seroma, and univariable meta-regression assessed associations between mean age, BMI, and proportion of female patients with complication rates. RESULTS: Mean age was 36.0 years and mean BMI was 25.8&#xa0;kg/m 2 (range: 18 to 66); 55% of patients were female. Selection criteria varied; most studies applied BMI thresholds (&#x2264;30 to 34&#xa0;kg/m 2 ) and excluded poorly controlled diabetes, heavy smoking, and thromboembolic history. The abdomen, flanks, and chest were most treated. Mean fat removal was 4268.8&#xa0;mL, with an average operative time of 235 minutes. Complication rates were low; the pooled incidence of seroma was 7% and hematoma was 1%. Meta-regression showed no significant associations between complications and age, BMI, or sex. Patient satisfaction was high. CONCLUSION: HDL is safe and effective across diverse populations; however, variability in selection criteria and reporting limits evidence-based definitions of ideal candidates. Further prospective studies with standardized reporting are needed.

Humans

Nurse-led titration models of care for heart failure reduced ejection fraction: a systematic narrative review of characteristics, patient outcomes, and healthcare resource utilization.

AIMS: Nurse-led titration (NLT) models of care assist with delivery of guideline directed medical therapy for patients with heart failure with reduced ejection fraction (HFrEF). Effectiveness of NLT is established but there is limited information of characteristics of models, patient outcomes and healthcare resource utilization. To build upon the existing evidence by providing a systematic narrative review of the literature of NLT of medications for patients with HFrEF. This review syntheses characteristics of NLT models of care, patient outcomes and healthcare resource utilization. METHODS AND RESULTS: A systematic narrative literature review with systematic search strategy, identification of results, thematic analysis and narrative synthesis. A search was conducted from 2012 to 2025 in Medline, Cinahl complete, Embase and Cochrane. Sixteen studies of NLT models of care were identified from 1944 screened records. Characteristics of models of care were participation of nurses, multidisciplinary teams, follow-up and common features of service delivery. Patient outcomes of mortality were favourable for those that received NLT. There is some evidence of changes in healthcare resource utilization; studies in which the NLT groups received more HF nurse visits and greater HF medication use also reported reduced rehospitalizations. CONCLUSION: Findings reinforce the published benefits of NLT. Additional studies examining adverse events and quality-of-life outcomes are needed to strengthen the evidence base. Several studies suggest a shift in resource use with NLT, highlighting the need for an economic evaluation to inform a cost-effective model of care.

Humans

Multicenter randomized effectiveness/implementation trial of a digital self-management support tool to improve the quality of life during adjuvant hormonal therapy for patients with early breast cancer: The HOPE trial.

BACKGROUND: For patients with hormone receptor (HR) positive early breast cancer (BC), adjuvant endocrine therapy (ET) represents the cornerstone of treatment. However, 75% of patients experience ET-related symptoms that negatively affect their quality of life (QOL). Despite their high prevalence, these symptoms are often underestimated and under-addressed during consultations. As a result, non-adherence to ET is common and remains a major barrier for optimal disease and survival outcomes. METHODS: National, prospective, randomized, open-label hybrid type 1 effectiveness/implementation trial conducted in France comparing a personalized digital health pathway plus standard of care (SoC) vs. SoC alone in patients with HR+ early BC reporting ET-related symptoms. 180 patients will be randomized 1:1 to receive either 12&#xa0;weeks of the digital health pathway or 12&#xa0;weeks of SoC. The intervention is anchored by the Resilience&#xa9; digital companion including remote symptom and needs assessment, an introductory nurse-navigator phone call, and access to personalized, symptom-specific online educational and self-management programs (physical activity, yoga, meditation or cognitive behavioral therapy). In both arms, patients will be invited to wear a wearable device to objectively monitor behavioral parameters. The primary endpoint is the ET symptoms scale of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR45 over 12-weeks. Secondary endpoints include other QOL domains, self-reported ET adherence, eHealth literacy, self-efficacy, and evaluation of the implementation process. DISCUSSION: This study should provide evidence on the effectiveness and real-world implementation of a personalized digital health pathway to improve QOL in patients experiencing ET-related symptoms. TRIAL REGISTRATION: ClinicalTrials.gov NCT06781996; Protocol version 3.0.

Humans