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Clinical performance of monolithic and veneered zirconia three-unit posterior FDPs: A five-year multicenter randomized controlled trial.

AIM: This randomized controlled clinical study compared monolithic, partially veneered, and fully veneered zirconia FDPs over a 5-year period with respect to survival, technical and biological complications, and patient-reported outcome measures (PROMs). MATERIALS AND METHODS: Sixty-four patients requiring three-unit posterior FDPs were randomly allocated to monolithic (MONO-FDP), partially veneered (PV-FDP), or fully veneered (FV-FDP) groups. All FDPs were fabricated from 4 mol% Y₂O₃ partially stabilized zirconia (4Y-TZP). Follow-up examinations were conducted at baseline, 1, 3, and 5 years. Technical parameters were evaluated using modified USPHS criteria. Periodontal measurements (PPD, BOP, PI) and patient satisfaction were assessed at all time points. RESULTS: A total of 63 FDPs were evaluated at baseline, 57 at 3 years, and 54 at 5 years. Survival at 5 years was 94.7% for MONO-FDPs, 100% for FV-FDPs and 100% for PV-FDPs. Technical complications occurred exclusively in PV-FDP (33%) and FV-FDP (38%) groups and consisted of minor, polishable chipping; no chipping or fractures were recorded in MONO-FDPs (0%) with statistically significant difference between MONO-FDP and the other two groups (p ≤ 0.014). Biological parameters remained stable across all groups, with no significant differences in PPD, BOP, or PI. PV-FDPs and FV-FDPs tended to receive more favorable professional color ratings, whereas PROMs were similar among the groups. CONCLUSIONS: All three FDP designs-monolithic, partially veneered, and fully veneered-fabricated from 4Y-TZP zirconia demonstrated excellent 5-year clinical performance. Technical complications were limited to PV- and FV-FDPs and consisted of minor chipping. Biological outcomes and patient satisfaction were similar across groups. CLINICAL SIGNIFICANCE: The five-year outcomes suggest that veneered, partially veneered, and monolithic FDPs can be used with high clinical reliability; however, restorations incorporating veneering ceramic may present an elevated risk of ceramic chipping.

Humans

Effectiveness of a blended care intervention in physiotherapy with exercise and education for patients with hip or knee osteoarthritis (SmArt-E): A multicentre pragmatic randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of a twelve-month smartphone-assisted physiotherapy (SmArt-E) intervention versus usual care in hip and/or knee osteoarthritis (OA), and to assess usability and patient satisfaction with the digital support. METHOD: We conducted a multicentre, pragmatic, parallel-group randomized controlled trial in 27 physiotherapy practices in Germany. Patients with physician-diagnosed hip and/or knee OA aged ≥50 (hip) or ≥38 years (knee) were randomly allocated to SmArt-E (IG; n=166) or usual care (CG; n=164). The twelve-month intervention combined supervised and smartphone-assisted training and education (blended care). Primary outcomes were pain (NRS, 0-10) and physical function (HOOS/KOOS-ADL, 0-100) at twelve months. Secondary outcomes followed OARSI domains; usability and patient satisfaction were also assessed. RESULTS: Among 330 participants (mean age 64±8 years), baseline NRS was 3.2±2.3 in the CG and 3.5±2.4 in the IG; HOOS/KOOS-ADL was 71.6±17.7 and 69.4±17.5, respectively. No significant between-group differences were found for pain (-0.36; 95% CI: -0.84 to 0.12; p=0.14) or physical function (2.66; 95% CI: -0.46 to 5.77; p=0.09). Among 13 secondary outcomes, significant differences favouring the IG emerged at three and twelve months for several domains; however, effect sizes were small and unlikely to be clinically meaningful. CONCLUSION: SmArt-E did not demonstrate superior effectiveness over usual care in mild hip and/or knee OA. Both groups improved over time, with slightly more favourable but clinically inconclusive outcomes in the IG. Findings highlight the need to refine the intervention, better identify eligible patients, and optimize digital and in-person components.

Humans

Toward personalized interventions for preventing depression in primary care: Qualitative and quantitative findings from the e-predictD pilot study.

BACKGROUND: The predictD intervention, delivered by family physicians (FPs), has demonstrated effectiveness and cost-efficiency in preventing depression and anxiety. The e-predictD study aims to design, develop, and evaluate a novel personalized intervention for depression prevention by integrating information and communication technologies (ICTs), risk prediction algorithms, and decision support systems (DSS) for both patients and FPs. OBJECTIVE: To evaluate the satisfaction, usability, and acceptability, of a beta version of the e-predictD intervention in primary care settings. METHODS: The e-predictD intervention follows a biopsychosocial approach, including an initial patient-FP interview, specific FP training, and an app. A β-version was tested in a pilot study without a control group over three months. The app integrates a validated depression risk prediction algorithm, decision algorithms, and a monitoring system supporting the DSS. The DSS generates a personalized prevention plan (PPP) from eight intervention modules: physical exercise, social relationships, problem-solving, communication skills, decision-making, assertiveness, sleep improvement, and cognitive restructuring. Patients and FPs discussed the PPP in a 15-minute baseline interview, selecting modules for implementation over three months. Semi-structured interviews gathered feedback. Assessments included depression (PHQ-9), anxiety (GAD-7), quality of life (SF-12), and major depression risk (predictD algorithm). RESULTS: Six FPs from six Spanish cities enrolled 56 non-depressed patients at moderate-to-high risk of depression; 47 (84%) completed follow-up. The app was used for a median of six days (interquartile range: 1-30). Both FPs and patients expressed satisfaction, leading to incorporated improvements. After three months, significant reductions in major depression risk and anxiety symptoms were observed, alongside improved mental quality of life. However, no significant changes were found in depressive symptoms or physical quality of life. CONCLUSION: This pilot study supports the feasibility and acceptability of the e-predictD β-version, despite lower-than-expected app usability. Health improvements were observed, warranting confirmation in a randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT03990792.

Adult

Current Concepts and Emerging Technologies in Aesthetic Outcome Assessment of Breast Reconstruction.

Aesthetic outcomes are a crucial determinant of the overall success of breast reconstruction. Recently, aesthetic assessment has evolved from relying mainly on subjective impressions to incorporating more quantitative methods. This systematic review summarizes current concepts and emerging technologies in aesthetic outcome assessment after breast reconstruction. A comprehensive search of studies evaluating aesthetic outcomes following implant-based, autologous or hybrid breast reconstruction was performed between 2000 and 2025. Assessments were classified as subjective or objective. Extracted variables included assessment characteristics, aesthetic outcome domains, and patient-centered outcomes. Risk of bias was assessed using the Joanna Briggs Institute Critical Appraisal Checklist. Levels of evidence were classified according to the Oxford Centre for Evidence-Based Medicine. A total of 51 studies involving 7711 participants from 16 countries were included. Subjective tools were most frequently employed, led by the BREAST-Q (35/51, 69%), followed by expert- or panel-based evaluations (17/51, 33%) and the visual analog scale (2/51, 4%). Objective methods were applied in 19 studies and included 3-dimensional surface imaging (8/51, 16%), BCCT.core (7/51, 14%), eye tracking (3/51, 6%), and artificial intelligence-based analyses (3/51, 6%). Although subjective tools captured satisfaction with breast appearance, objective tools quantified morphological parameters and positional landmarks. BREAST-Q remains the cornerstone of outcome evaluation after breast reconstruction, providing patient-centered perspectives, including, but not limited to, aesthetic perception. A progressive shift toward multimodal evaluation was noticed, as no single modality comprehensively addressed all aesthetic domains. Future research should focus on integrating subjective and objective assessment methods within a unified framework. Level of Evidence: 3 (Therapeutic) For image description, please refer to the figure legend and surrounding text.

Humans

Acceptability of capillary point-of-care testing: a systematic review.

OBJECTIVE: To identify and synthesise evidence on the acceptability and perceived experience of finger-prick point-of-care testing (POCT) among patients and clinicians across healthcare settings. DESIGN: Systematic review conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020) guidelines. DATA SOURCES: Medline, Embase, PsycInfo, CINAHL, Cochrane and Web of Science were searched from inception to January 2024 and re-run in July 2025, supplemented by citation tracking of relevant studies. ELIGIBILITY CRITERIA: Studies reporting patient and clinicians' experiences, perceptions, satisfaction or acceptability relating to finger-prick POCT for any health condition or blood parameter were eligible. Quantitative, qualitative and mixed-methods designs were included. DATA EXTRACTION AND SYNTHESIS: Data were extracted independently by two reviewers and synthesised using thematic analysis and narrative synthesis. Methodological quality was appraised using the Mixed-Methods Appraisal Tool. RESULTS: 21 studies met the inclusion criteria, encompassing 9128 participants (17 quantitative, 3 qualitative, 1 mixed methods). Across diverse clinical contexts, finger-prick POCT was reported as generally acceptable, less distressing and perceived as a convenient alternative to venous sampling in comparative studies. Thematic synthesis identified two major themes: (1) enhancing the patient-clinician relationship through improved engagement, communication and understanding of care and (2) clinical implications of finger-prick POCT on clinicians' workflow, confidence and skill acquisition. Finger-prick POCT was perceived to promote personalised consultations, enable immediate discussion of results and streamline decision-making. Clinicians highlighted its potential to expand task sharing, improve efficiency and strengthen continuity of care, although concerns regarding training, reliability and quality assurance were identified. CONCLUSIONS: Finger-prick POCT is generally acceptable to patients and clinicians, improving comfort, convenience, engagement and perceived efficiency. Implementation should prioritise training, infrastructure and quality assurance frameworks to maximise clinical and experiential benefits. PROSPERO REGISTRATION NUMBER: CRD42024512130.

Humans

Implementation of a Face-To-Face Vs Virtual Peer-Integrated Collaborative Care Intervention for Mental Health Treatment of Physical Trauma Survivors: A Qualitative Study of Lessons from the COVID-19 Pandemic.

OBJECTIVE: We assessed the impact of the COVID-19 pandemic on the implementation of a peer-integrated enhancement of integrated clinical care intervention to address the mental health needs of 450 patients undergoing treatment for a physical injury. METHODS: Qualitative data were collected by 7 clinician investigators of a randomized controlled trial acting as participant observers in a trauma care setting of a major U.S. metropolitan hospital and analyzed in collaboration with an external mixed methods specialist. RESULTS: The pandemic created or exacerbated several implementation barriers, including increased risk of infection, homelessness, hospitalizations and comorbid conditions such as fentanyl overdoses that increased demand on emergency department and Trauma Center services, imposition of safety measures to reduce risk of infection in clinical settings, transition from face-to-face to virtual interactions with study patients, shortages of specialty mental health providers, suspension of recruitment of patients into the study, scheduling calls with patients, and an increased workload for the study clinical interventionists. Peer specialists perceived the transition to virtual interactions with patients reduced their effectiveness; however, this was not reflected in assessments of patient satisfaction with services received and may have inadvertently increased adoption by Trauma Center staff. Reduction in reach of the intervention to target population was temporary. CONCLUSIONS: The COVID-19 pandemic exacerbated existing barriers and created new barriers to successfully implementing evidence-based practices in trauma care settings, resulting in an attenuation of their effectiveness. However, the shift from face-to-face to virtual services delivery may have actually led to improved implementation outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03569878. Registered June 15, 2018.

Humans

The Impact of Nurse-to-Patient Ratios on Nurses' Burnout, Job Dissatisfaction, and Intention-to-Leave: A Systematic Review and Meta-Analysis.

BACKGROUND: Adequate nurse staffing is essential for ensuring workforce well-being and patient safety. Imbalanced nurse-to-patient ratios contribute to burnout, job dissatisfaction, and turnover, which compromise care quality. OBJECTIVE: This systematic review and meta-analysis evaluated the impact of nurse-to-patient ratios on nurse burnout, job dissatisfaction, intention-to-leave, and patient outcomes. METHODS: A systematic search of PubMed, Scopus, and Web of Science identified cross-sectional studies examining nurse-to-patient ratios and related outcomes. RESULTS: Eighteen studies involving 183 876 nurses from 4085 hospitals were included. Higher nurse-to-patient ratios increased the odds of burnout (OR: 1.08), job dissatisfaction (OR: 1.10), and intention-to-leave (OR: 1.09). Each additional patient per nurse increased mortality and readmission risks by 7% to 8%, with decreased perceived care quality. CONCLUSION: Higher nurse-to-patient ratios adversely affect nurses and patients. Ensuring adequate staffing is critical to prevent burnout and maintain safe, high-quality care.

Humans

The Impact of Baseline Negative Emotions on Postoperative Quality of Life in Adolescent Idiopathic Scoliosis Patients: A 2-Year Follow-Up Study.

OBJECTIVE: Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that develops during puberty without a clear etiology. Beyond physical manifestations, AIS severely impacts adolescents' psychological and social well-being, leading to anxiety, depression, and low self-esteem. While advancements in surgical techniques have enhanced objective outcomes, existing studies on AIS have primarily focused on objective indices, with limited attention to the long-term impact of preoperative negative emotions on patient-reported subjective quality of life. METHODS: This was a retrospective cohort study. A total of 112 eligible AIS patients who underwent posterior spinal correction surgery between April and August 2023 were enrolled. Inclusion criteria included confirmed AIS, completion of 2-year follow-up, and informed consent; exclusion criteria included missing imaging/questionnaire data, comorbid psychiatric/neurological diseases, or prior spinal surgery. Patients were grouped using the Hospital Anxiety and Depression Scale (HADS) administered on admission. Quality of life was assessed preoperatively and 2&#x2009;years postoperatively using the Scoliosis Research Society-22 (SRS-22, evaluating self-image, mental health, pain, function, treatment satisfaction) and Short Form 36 Health Survey (SF-36, assessing 8 physical and mental health dimensions). Statistical analysis was performed via SPSS, using independent t-tests, paired t-tests, Mann-Whitney U test, and chi-square test. p&#x2009;<&#x2009;0.05 was considered significant. RESULTS: There were no significant differences in baseline characteristics (age, gender, BMI, surgical parameters, scoliosis type, preoperative/postoperative Cobb angles) between the two groups (all p&#x2009;>&#x2009;0.05). Preoperatively, SRS-22 and SF-36 scores showed no inter-group differences (all p&#x2009;>&#x2009;0.05). Postoperatively, the Negative Emotion Group had significantly lower scores in SRS-22 mental health (3.9&#x2009;&#xb1;&#x2009;0.3 vs. 4.5&#x2009;&#xb1;&#x2009;0.2) and treatment satisfaction (4.0&#x2009;&#xb1;&#x2009;0.3 vs. 4.6&#x2009;&#xb1;&#x2009;0.7), as well as SF-36 general health (68.6&#x2009;&#xb1;&#x2009;6.4 vs. 79.7&#x2009;&#xb1;&#x2009;13.3), role-emotional (61.3&#x2009;&#xb1;&#x2009;9.3 vs. 70.8&#x2009;&#xb1;&#x2009;9.7), and mental health (61.8&#x2009;&#xb1;&#x2009;14.3 vs. 68.9&#x2009;&#xb1;&#x2009;10.7) (all p&#x2009;<&#x2009;0.05); no inter-group differences were observed in physical function-related dimensions. Both groups showed significant improvements in physical function-related dimensions postoperatively. The Non-Negative Emotion Group also exhibited significant improvements in SRS-22 self-image/pain and SF-36 bodily pain (all p&#x2009;<&#x2009;0.05), while the Negative Emotion Group showed no significant improvements in these dimensions. CONCLUSIONS: Preoperative anxiety and depression do not affect the recovery of physical function in AIS patients after spinal correction surgery but significantly impede improvements in subjective quality of life dimensions, including mental health and treatment satisfaction. These findings highlight the need to integrate psychological assessment and targeted interventions into the perioperative management of AIS. Such a patient-centered approach will help optimize both physical and psychological outcomes, ultimately achieving comprehensive rehabilitation for AIS adolescents.

Humans

Comfort and Usability of Digital Versus Conventional Custom-Fit Mouthguards: A Randomized Clinical Trial.

BACKGROUND/OBJECTIVES: The use of mouthguards protects teeth and the supporting tissues against impacts. Digital impressions and 3D-printed models can reduce manufacturing steps and minimize discomfort. This study evaluated the fit, comfort, and usability of custom-made mouthguards, obtained by conventional and digital workflow, in amateur athletes. MATERIALS AND METHODS: Amateur athletes were recruited for this randomized, double-blind, crossover clinical study. Each participant received two 4-mm-thick custom-fit mouthguards made of ethylene vinyl acetate (EVA) sheets using two protocols: conventional impression using alginate to produce dental stone cast (CMP) and intraoral digital scanning to produce 3D-printed resin models (DMP). Each mouthguard was worn during all training and matches over 3&#x2009;months. The order of mouthguard use was randomly assigned. Patient satisfaction with the impression protocol and mouthguard use, model accuracy, and mouthguard fit were assessed. RESULTS: Overall, 46 participants completed the study. The DMP protocol required less execution time (p&#x2009;=&#x2009;0.023), caused less discomfort (p&#x2009;=&#x2009;0.018), anxiety (p&#x2009;=&#x2009;0.008), nausea (p&#x2009;=&#x2009;0.027), difficulty breathing (p&#x2009;<&#x2009;0.001), and unpleasant taste (p&#x2009;=&#x2009;0.006) compared to the CMP protocol. The pain (p&#x2009;=&#x2009;0.971) perceived by the participants was similar in both impression protocols. The CMP-mouthguards were considered to be better fitting by the majority of participants (p&#x2009;=&#x2009;0.027). Between-group comparisons revealed that DMP-mouthguard caused less discomfort immediately postadaptation (p&#x2009;=&#x2009;0.034), with no significant differences observed at 30 or 90&#x2009;days. CONCLUSIONS: The digital workflow demonstrated to be efficient in the fabrication of mouthguards. Digital impression was more comfortable, requiring less execution time, with more accurate printed models and produced mouthguards with reported comfort and fit levels similar to those manufactured conventionally.

Humans

Esketamine vs. sufentanil for quality of recovery after outpatient gynecological surgery: a randomized clinical trial.

BACKGROUND: Perioperative administration of esketamine has been reported to improve early quality of recovery (QoR). However, data on its effects in outpatient surgery are limited. This study aimed to assess the impact of esketamine on QoR in patients undergoing outpatient gynecological procedures. METHODS: In this investigator-initiated, double-blind, randomized clinical trial, patients aged 18-65&#x2009;years scheduled for outpatient gynecological surgery under sedation were allocated to receive esketamine (0.2&#x2009;mg/kg) or sufentanil (0.1&#x2009;&#x3bc;g/kg) combined with propofol (1.5-3&#x2009;mg/kg). The primary outcome was quality of recovery on postoperative day (POD) 1. Secondary outcomes included quality of recovery on POD2, sedation success rate, length of post-anesthesia care unit (PACU) stay, injection pain, postoperative pain, nausea and vomiting, fatigue, patient and clinician satisfaction, sleep quality, and anxiety and depression. RESULTS: A total of 126 patients were randomized, with 63 assigned to the esketamine group and 63 to the sufentanil group. Of these, 125 patients were included in the final analysis (62 in the esketamine group and 63 in the sufentanil group), as one patient lacked follow-up data. The mean (SD) QoR-15 score on POD1 was 137.9 (14.5) in the esketamine group and 137.8 (10.7) in the sufentanil group, with no significant difference between groups (absolute difference, 0.2; 95% CI, -4.2 to 4.6; p&#x2009;=&#x2009;0.93). For secondary outcomes, the esketamine group had a longer PACU stay (median, 28.0 vs. 23.0&#x2009;min; p&#x2009;<&#x2009;0.001), a lower incidence of severe injection pain (22.6% vs. 50.8%; p&#x2009;=&#x2009;0.002), a higher proportion of patients with pain scores &#x2265; 4 at 30&#x2009;min postoperatively (30.6% vs. 6.3%; p&#x2009;=&#x2009;0.001), and higher fatigue scores (median, 3.0 vs. 2.0; p&#x2009;=&#x2009;0.01). Other secondary outcomes did not differ significantly between groups. CONCLUSION: Among patients undergoing sedation for outpatient gynecological procedures, esketamine did not significantly improve quality of recovery on POD1 compared to sufentanil. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2500098466.

Humans

Comparative Evaluation of Virtual Reality versus Standard Nursing Care in Managing Pain and Fear during Lumbar Puncture Procedures: A Randomised Controlled Trial.

BACKGROUND: Meningitis is a serious infectious disease that can cause significant morbidity and long-term neurological problems. Although a lumbar puncture is a necessary diagnostic procedure, it is often accompanied by discomfort, anxiety, and fear, which can severely impact the patient's experience. Although there is few data on its application prior to lumbar puncture in adult patients with meningitis, immersive virtual reality (VR) has become a promising non-pharmacological technique for lowering procedural distress. Thus, among individuals undergoing lumbar punctures, this randomized controlled research assessed how well pre-procedural VR reduced pain, anxiety, and fear while enhancing patient satisfaction. OBJECTIVE: This study aims to evaluate the effectiveness of virtual reality (VR) in reducing pain and fear among adults undergoing lumbar puncture (LP) compared with standard care protocol. METHODS: A randomised clinical trial was conducted from May to October 2025, using a single-blind, true experimental design. A total of 85 patients were randomly assigned to either the VR intervention group ( n = 41) or the control group receiving standard care ( n = 44). Pain levels were assessed using a visual analogue scale. Fear was assessed using the Multidimensional Fear-of-Injection Scale. Data were analysed using SPSS version 26. RESULTS: According to the study, the findings revealed a significant reduction in pain levels among the study group following the VR intervention, with mean pain scores dropping from 7.54 &#xb1; 1.925 to 2.49 &#xb1; 0.675. In contrast, the control group showed increased pain intensity, with mean scores rising from 6.84 &#xb1; 1.842 to 8.36 &#xb1; 1.348. The VR group showed a significant reduction in fear scores across all domains, whereas no significant changes were observed in the control group. Direct fear decreased from 20.12 &#xb1; 1.71 to 9.44 &#xb1; 2.00, indirect fear from 17.24 &#xb1; 1.46 to 8.66 &#xb1; 2.24, physiological response improved from 0.34 &#xb1; 0.66 to 3.00 &#xb1; 1.00 and avoidance behaviour decreased from 16.71 &#xb1; 1.49 to 7.80 &#xb1; 1.85. CONCLUSIONS: The research shows that the use of VR prior to LP significantly reduces level of pain and fear compared to standard care. These results support VR as a non-pharmacological intervention for fear and pain to improve patient experience during invasive procedures. In contrast, the control group experienced no improvement.Trial Registration: The IRCT code for the trial was IRCT ID 20250803066743N1.

Humans

Global prevalence and associated factors of turnover intention among intensive care nurses: A systematic review and meta-analysis.

OBJECTIVES: To estimate the global prevalence of two distinct turnover intentions among intensive care unit (ICU) nurses-intention to leave the ICU and intention to leave the nursing profession-identify significant sources of heterogeneity, and synthesise associated psychosocial factors. METHODS: Ten databases were systematically searched from inception to September 28, 2025. Two reviewers independently conducted study selection, data extraction, and quality appraisal using Joanna Briggs Institute checklists. Random-effects meta-analyses were performed to estimate pooled prevalence and associated factors. Subgroup and meta-regression analyses explored potential sources of heterogeneity. Associated factors were pooled as odds ratios (ORs) and interpreted within an integrated Job Demands-Resources and Theory of Planned Behavior framework. RESULTS: Forty-six studies published between 2007 and 2025, involving 39,246 ICU nurses, were included. The pooled prevalence was 30.7% for intention to leave the ICU and 27.5% for intention to leave the nursing profession. Significant sources of heterogeneity included ICU type, geographic region, publication year, study design, measurement tool, and sampling method. Depression, burnout, high workload, and unsafe patient-to-nurse ratios were associated with increased turnover intention, whereas positive work environments, perceived organisational support, and nursing competence were protective factors. No significant publication bias was detected. CONCLUSIONS: Turnover intention affects approximately one-third of ICU nurses globally and varies across clinical and geographical contexts. Excessive workload, inadequate organisational support, and unfavourable work environments appear to be important contributors to turnover intention among ICU nurses. IMPLICATIONS FOR CLINICAL PRACTICE: Strategies to reduce turnover intention among ICU nurses should focus on reducing excessive workload, improving staffing conditions, strengthening organisational support, and fostering positive work environments. Promoting supportive and sustainable ICU work environments may help improve nurse retention and maintain the quality of critical care services.

Humans

Long-term outcomes of surgical correction of ventral penile curvature in children: Patient-reported measures, surgical results, and decisional regret.

INTRODUCTION: There is a dearth of data on long-term outcomes, including patient-reported outcomes (PROMs), decisional regret, and complication rates for surgical correction of isolated ventral penile curvature in childhood. PATIENTS AND METHODS: Twenty-six children treated for ventral curvature between 1993 and 2008 were identified; 24 met inclusion criteria (isolated ventral curvature without hypospadias or need for urethral reconstruction). Surgical correction consisted of degloving alone or degloving with Nesbit-like dorsal plication when residual curvature >20&#xb0; persisted after degloving. PROMs were collected via pre-mailed validated questionnaires after puberty: Danish Prostatic Symptom Score (DAN-PSS) for LUTS, Erection Hardness Score (EHS) for erectile function, Penile Perception Score (PPS) for cosmetic perception, and items assessing decisional regret and perceived appropriateness of surgical timing. RESULTS: Curvature was corrected intraoperatively in all 24 patients. Twelve underwent degloving alone and 12 required additional dorsal plication. During long-term follow-up (median 14.2 years), one patient (4%) underwent re-operation for residual curvature, and three (13%) underwent cosmetic revisions; two (8%) underwent cystoscopy for flow concerns. 71% returned PROMs at a median age of 16.2 years. LUTS were uncommon, with low bother scores. Erectile function was favorable: 87% (13/15) reported EHS 4 and 93% (14/15) reported ejaculation. Cosmetic outcomes were favorable, with PPS dissatisfaction rates comparable to controls. Two patients reported dissatisfaction with overall appearance, and one with residual subjective curvature. No patient expressed decisional regret, and 88% felt timing of surgery was appropriate. CONCLUSION: Early surgical correction of isolated ventral penile curvature using degloving with or without dorsal plication provided durable anatomical correction and favorable long-term functional and cosmetic outcomes. These findings support early intervention as an effective approach with sustained patient-perceived benefits.

Humans

Comparison of Iodinated Contrast Doses Based on Total Body Weight and Lean Body Weight in Pediatric Patients: Impact on Image Quality and Contrast Exposure.

INTRODUCTION: Iodinated contrast dosing in pediatric computed tomography (CT) traditionally relies on total body weight (TBW), which may result in excessive contrast administration, particularly in patients with higher adiposity. Lean body weight (LBW)-based protocols have shown promise in adults but remain underexplored in children. Therefore, the aim of this study was to compare contrast volume requirements and hepatic enhancement quality among three dosing protocols: LBW-based, TBW-based, and the Control Group (CG), based on the institutional standard for pediatric abdominal CT. METHODS: This prospective study enrolled 66 patients (age 0-16 years) undergoing contrast-enhanced abdominal CT between September 2023 and August 2024. Patients were randomly assigned to receive iodinated contrast (iobitridol 350mg I/mL) dosed by: (1) LBW (0.63 g iodine/kg x LBW, calculated using Peters formula; n = 23), (2) TBW (0.46 g iodine/kg x TBW; n = 20), or (3) institutional control protocol (2 mL/kg x TBW, equivalent to 0.7 g iodine/kg; n = 23). Kruskal-Wallis, ANOVA, Two-way ANOVA, ANCOVA, Scheirer-Ray-Hare, and Cohen's Kappa tests with Likert scale were used. RESULTS: The LBW group received lower median contrast volumes (27 mL; IQR, 10-80 mL) compared to the TBW group (34.5 mL; IQR, 18-78 mL) and the CG group (40 mL; IQR, 13-80 mL), although the differences did not reach statistical significance (P > 0.05). Notably, this reduction did not compromise hepatic enhancement, which remained comparable to the CG (552 &#xb1; 139 HU; P = 0.107). CONCLUSION: Lean body weight may be a useful parameter for estimating contrast dose in pediatric abdominal CT, potentially reducing administered volumes without compromising diagnostic image quality. IMPLICATIONS FOR PRACTICE: These results provide early evidence that LBW-based dosing may support more individualized contrast administration in pediatric CT, potentially reducing exposure-related risks.

Humans

A 12-week, double-blind, quasi-randomized, placebo-controlled study to evaluate the efficacy and safety of Coleus forskohlii (Forcslim) on body weight loss.

BACKGROUND: Overweight and obesity have emerged as a global epidemic, significantly impacting human health. Traditional usage and growing scientific evidence suggest that Coleus forskohlii extract (Forcslim) may aid in reducing excess body weight and fat. This study aimed to evaluate the efficacy and safety of Forcslim supplementation in overweight individuals. METHODS: A quasi-randomized, double-blind, placebo-controlled clinical trial was conducted in 60 overweight subjects aged 20-70&#x2009;years over a period of 12&#x2009;weeks. The participants were assigned to receive either Forcslim or placebo. The key outcome measures included body weight, body mass index (BMI), body composition, and anthropometric parameters. Additionally, lipid profile parameters and safety markers (including metabolic, hepatic, and cardiovascular indicators) were assessed throughout the study duration. RESULTS: Compared to the placebo group, the Forcslim group showed significant reductions in waist circumference (-1.83&#x2009;cm; p&#x2009;<&#x2009;0.01) and body weight (-1.93&#x2009;kg; p&#x2009;<&#x2009;0.001). Significant improvements in anthropometric parameters were observed exclusively in the Forcslim group. Furthermore, triglyceride (TG) levels were significantly reduced (p&#x2009;<&#x2009;0.01), while high-density lipoprotein (HDL) levels showed a significant increase (p&#x2009;=&#x2009;0.001). No clinically significant changes were observed in metabolic markers, liver and muscle enzyme levels, heart rate, blood pressure, or reported adverse effects, indicating a favorable safety profile. CONCLUSIONS: Forcslim demonstrated significant anti-obesity effects, including reductions in body weight, waist circumference, and improvements in the lipid profile. These findings suggest that C. forskohlii extract supplementation may serve as a safe and effective alternative to synthetic anti-obesity drugs.

Humans

Probiotic supplementation improves body composition, lipid profiles, and fatty acid metabolism in combat sports athletes during the weight reduction phase.

PURPOSE: Pre-competition weight control for combat sports athletes may alter body composition and fatty acid metabolism. Probiotics have shown potential to regulate overall metabolism; however, their specific effects on fatty acid metabolism during weight control in athletes remain unclear. METHODS: Thirty-two combat sports athletes participating in the 4-week weight reduction period were assigned to either the probiotic group (Group E) or the placebo group (Group C). Body composition, lipid profiles, and fatty acid metabolism were measured before and after the 4-week weight reduction phase. RESULTS: All the athletes experienced a decrease in body weight, body mass index (BMI), body fat percentage, and muscle mass following the 4-week weight loss intervention. Notably, a more significant reduction in body fat percentage (p&#x2009;<&#x2009;0.05) was observed, along with lower levels of triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C), specifically in Group E. Weight loss intervention resulted in increased levels of short-chain fatty acids (SCFAs), specifically acetic acid, propionic acid, and butyric acid. Notably, Group E exhibited higher mean values for SCFAs compared to Group C (p&#x2009;<&#x2009;0.05). Additionally, the serum levels of &#x3b3;-linolenic acid and 8,11,14-eicosatrienoic acid were significantly reduced in Group E (p&#x2009;<&#x2009;0.05). In contrast, the majority of free fatty acids (FFAs) showed significant increases, with greater magnitudes of change observed in Group C (p&#x2009;<&#x2009;0.05). CONCLUSION: Probiotic supplementation can improve body composition, enhance SCFAs levels, and decrease circulating FFAs in combat sports athletes, suggesting that probiotics may have a beneficial impact on pre-competition weight management. TRIAL REGISTRATION NUMBER: chiCTR2400079908 (Reg Date:2024-01-16).

Humans

Effects of Lactiplantibacillus plantarum KABP051 Probiotic on Body Composition, Microbiome and Mood in Healthy Overweight Adults.

Obesity and mental health disorders are among the greatest public health challenges of the 21st century. Interestingly, an altered microbiome profile has been associated with both conditions. The aim of this randomized, double-blind, placebo-controlled clinical trial was to evaluate the effects of dietary supplementation with a specific probiotic strain (Lactiplantibacillus plantarum KABP051) on body composition and gut microbiome balance, together with measures of mood state, in a population of healthy overweight subjects. Sixty healthy, moderately stressed, nondepressed and overweight or obese volunteers were supplemented for 12 weeks with probiotic (L. plantarum KABP051; 1 billion colony forming units/day) or placebo (microcrystalline cellulose). The KABP051 group experienced significantly greater improvements compared with placebo on body composition measurements, including a reduction in body weight and waist circumference, which decreased in 1.97 &#xb1; 0.77 (mean &#xb1; SE) kg and 2.15 &#xb1; 0.81 (mean &#xb1; SE) cm versus placebo at the end of the intervention (both P < .05, mixed model for repeated measures [MMRM] and post-hoc analysis). Microbiome composition improved in KABP051 group, with significant increase in the relative abundance of Lactiplantibacillus spp. versus placebo. Body fat percentage, profile of mood states fatigue, and confusion sub-scores showed a global trend toward improvement compared with placebo, with the change at 12 weeks being significant in the three measurements in post-hoc analysis (P = .015, P = .014, and P = .016, respectively). No serious adverse events were registered during the intervention period. These results suggest that a specific strain of probiotic bacteria (L. plantarum KABP051) may have both metabolic and psychobiotic effects and may be beneficial for enhancing weight loss and body composition, improving energy (less fatigue) and mood levels while embarking on a healthy lifestyle regimen. ClinicalTrials.gov identifier: NCT06808061.

Humans

The effect of drysuit diving in warm water on body temperature and post immersion orthostatic hypotension.

INTRODUCTION: Warm-water diving can limit heat dissipation, particularly when performed in fully encapsulating protective gear, leading to substantial thermal and cardiovascular strain that may impair diver safety. Following immersion, removal of hydrostatic support combined with heat-induced vasodilation may reduce central blood volume and increase susceptibility to orthostatic intolerance during egress and recovery. The extent to which this thermal strain impairs post-immersion orthostatic tolerance remains unknown. METHODS: Four randomised, crossover immersion trials were conducted at 28&#xb0;C, 33&#xb0;C, 38&#xb0;C without precooling (38&#xb0;C), and 38&#xb0;C with precooling (38&#xb0;C + Cool), with subjects wearing fully encapsulating dive gear. Subjects walked for up to 60 minutes at approximately 50% of O2max heart rate (HR) or until core temperature (Tc) reached 38.5&#xb0;C, or they voluntarily stopped. Tc, HR, and perceptual measures were recorded every 10 minutes. Orthostatic tolerance was assessed after immersion via a 70&#xb0; head-up tilt test. RESULTS: Eight healthy adults completed all aspects of the study. Tc and HR were higher during both 38&#xb0;C conditions compared with 28&#xb0;C and 33&#xb0;C (all P < 0.01) with no differences between 38&#xb0;C and 38&#xb0;C + Cool. Sweat loss exceeded 1.2 (SD 0.67) L&#x22c5;h-1 in both 38&#xb0;C conditions compared with &#x2264; 0.3 (0.32) L&#x22c5;h-1 at 28&#xb0;C and 33&#xb0;C (P < 0.01). Survival analysis showed orthostatic tolerance decreased with increasing thermal stress (log-rank P = 0.027; trend P = 0.003). Precooling did not reduce peak Tc or HR, nor did it improve tolerance time in 38&#xb0;C water. CONCLUSIONS: Encapsulated warm-water diving causes heat stress and cardiovascular strain that persists after immersion, impairing orthostatic tolerance. Precooling does not significantly reduce these outcomes.

Humans