Tag: nevin manimala

Eur J Orthop Surg Traumatol. 2025 Nov 29;36(1):28. doi: 10.1007/s00590-025-04584-y.

ABSTRACT

INTRODUCTION: We investigated outcomes of patients treated with either locked plating or retrograde intramedullary nailing (IMN) at a single institution and compared outcomes of retrograde IMN to locked plating for periprosthetic distal femur fractures.

METHODS: We reviewed 241 subjects with distal femur fractures around total knee arthroplasty (TKA) treated with locked plating (197) or retrograde IMN (44). Mean age was 77 years, 78% were female, and mean BMI was 32 kg/m². There were 27% Su I, 41% Su II, and 32% Su III fractures. There were 87% primary TKAs and 13% revision TKAs. Mean follow-up was 3 years.

RESULTS: Overall nonunion rate was 10% and 5-year survivorship free of any revision was 81%, with the most common reasons being nonunion (49%), infection (19%), and aseptic TKA loosening (11%). Patients with prior TKA infection (HR 3; p = 0.02), revision TKA (HR 2; p = 0.03), Su III fractures (HR 2.5; p = 0.04) were at increased risk of revision. There was a trend toward higher non-union rate in the locked plating group (11% vs. 2%; p = 0.07). Those with locked plating had higher rates of osteoporosis (70% vs. 52%; p = 0.02), prior revision TKA (16% vs. 2%; p = 0.02), and Su Type III fractures (36% vs.16%, p = 0.047). Five-year survivorship free of any revision for locked plating and retrograde IMN were 80% and 84%, respectively, with no significant difference in revision, reoperation, or non-operative complications.

CONCLUSIONS: Both locked plating and retrograde IMN are viable fixation options for periprosthetic distal femur fractures after TKA. Those treated with locked plating had higher rates of osteoporosis, prior revision TKA, and more distal fractures, but did not demonstrate a significant increased risk for reoperation or revision.

LEVEL OF EVIDENCE: Level III, Retrospective comparative cohort study.

PMID:41317180 | DOI:10.1007/s00590-025-04584-y

Eur J Pediatr. 2025 Nov 29;184(12):807. doi: 10.1007/s00431-025-06660-1.

ABSTRACT

Off-label prescribing in pediatric care is common due to the lack of age-specific drug formulations, posing risks to safety and efficacy. Understanding how Italian hospitals manage and regulate this practice is essential to improving oversight and promoting safer prescribing. A multicenter, cross-sectional survey was conducted from November 13, 2024, to January 31, 2025, under the Italian Network for Pediatric Clinical Trials (INCiPiT). Fifty facilities participated; 64% of those with < 5000 pediatric admissions had Neonatal Intensive Care Units (NICUs) and birth centers. Off-label prescribing was strongly associated with NICUs, increasing up to 50% following compassionate use refusal. Notably, 25% of centers were unaware of prescribing frequency. Facilities with digital tracking and dedicated research units had better regulatory compliance and higher compassionate use approval rates.

CONCLUSION: The present analysis revealed that off-label prescribing is pervasive and predominantly driven by institutional specialization rather than hospital size. The implementation of structured oversight, digital infrastructure, and cost monitoring has been demonstrated to enhance regulatory compliance. The findings of this study support the need for standardized procedures and policy alignment to ensure safe pediatric pharmacotherapy.

WHAT IS KNOWN: • Off-label drug prescribing in pediatric care is a prevalent practice, primarily attributable to the paucity of age-appropriate formulations and clinical trial data for children.This practice entails potential risks associated with drug safety, efficacy, and dosing accuracy, particularly in vulnerable populations such as neonates and infants. • Regulatory oversight and institutional awareness of off-label use vary significantly across healthcare systems, with limited data available on how hospitals manage these prescriptions at the organizational level.

WHAT IS NEW: • This nationwide Italian survey reveals that off-label prescribing in Italian pediatric hospitals is primarily driven by institutional specialization-especially NICU presence-rather than hospital size, with digital tracking and research units linked to better regulatory compliance. • A significant portion of facilities lack awareness of their off-label prescribing rates, highlighting the need for standardized oversight and national policy alignment to ensure safer pediatric drug use.

PMID:41317175 | DOI:10.1007/s00431-025-06660-1

Neurosurg Rev. 2025 Nov 29;49(1):35. doi: 10.1007/s10143-025-03980-6.

ABSTRACT

Thirty-day readmission rates are commonly used as quality indicators (QIs) due to their feasibility and financial impact on healthcare systems. However, their validity in neurosurgical oncology remains uncertain. This study evaluates 30-day readmission rates following craniotomies for brain tumor resection, focusing on causes, predictors, and their impact on overall survival (OS). A systematic review and meta-analysis were conducted following PRISMA guidelines. PubMed, Cochrane, Scopus, and Web of Science databases were queried for studies reporting 30-day readmission rates in craniotomies for brain tumors. Meta-analysis with random-effects modeling was performed for pooled readmission rates, causes, predictors, and survival outcomes. Individual patient data (IPD) for overall survival were available for glioblastoma patients from four studies and were reconstructed from Kaplan-Meier curves to assess the association between readmission and survival. Eleven studies involving 132,791 patients yielded a pooled 30-day readmission rate of 13% (95% CI: 11%-16%). Neurological (50%) and infectious (25%) causes were the most common readmission indications. Surgical site infections accounted for 11% (7%-16%) and thromboembolic events for 12% (9%-16%) of all readmissions. Preoperative characteristics, including functional status, were consistent predictors of readmission. Among glioblastoma patients, reconstructed IPD from four studies demonstrated that readmitted patients had significantly shorter median overall survival compared with non-readmitted patients (6.4 vs. 8.7 months, p < 0.0001). Thirty-day readmission rates provide insights into neurosurgical oncology care but have limitations as standalone QIs. A combination of QIs would offer a more comprehensive and accurate assessment of care quality. Efforts to reduce readmissions should address modifiable risk factors, such as preventing SSIs and thromboembolic events, and optimizing perioperative care.

PMID:41317174 | DOI:10.1007/s10143-025-03980-6

J Perianesth Nurs. 2025 Nov 28:S1089-9472(25)00356-9. doi: 10.1016/j.jopan.2025.06.015. Online ahead of print.

ABSTRACT

PURPOSE: Total knee arthroplasty is a common orthopedic surgery that can cause anxiety, shivering, and hemodynamic changes in patients. The study aimed to compare the effects of a combination of valerian and Melissa officinalis (Norogol) with clonidine on anxiety, hemodynamic changes, and shivering in total knee replacement.

DESIGN: A parallel-group randomized controlled trial was used.

METHODS: Ninety-six patients were divided into 3 groups: a combination of valerian and M. officinalis (Norogol), clonidine, and a placebo, with 32 individuals in each group. Patients received one capsule each night, starting two nights before surgery. Anxiety levels were assessed before medication and before surgery using the Spielberger questionnaire. Shivering was evaluated using the Crossley-Mahajan scale during recovery. Hemodynamic changes were monitored before drug administration, during surgery, and after surgery. The analysis of variance test was employed to compare quantitative variables FINDINGS: There were no significant differences in age and gender among the groups. The average shivering score in the Norogol and clonidine groups was significantly lower than that of the placebo group up to 60 minutes after the operation (P < .001). Both obvious and hidden anxiety levels in the intervention groups decreased, while anxiety increased in the control group. Hemodynamic factors, including systolic blood pressure and heart rate, decreased in all three groups; however, there were no significant differences among the groups.

CONCLUSIONS: The results indicated that Norogol was as effective as clonidine in reducing shivering in patients after surgery. Although the intervention groups showed a decrease in both obvious and hidden anxiety, the reduction was not statistically significant.

PMID:41317165 | DOI:10.1016/j.jopan.2025.06.015

Health Technol Assess. 2025 Nov 26:1-42. doi: 10.3310/TNGF8545. Online ahead of print.

ABSTRACT

BACKGROUND: There are over 200,000 hospital attendances for self-harm per annum in the United Kingdom at an estimated annual cost of £133-162M. Systematic reviews prior to commencing the study suggested that brief psychological interventions are effective in reducing psychological distress after self-harm and reduce repetition of self-harm.

OBJECTIVE: The SafePIT trial was designed to evaluate the effectiveness and cost-effectiveness of self-harm-focused psychological therapy plus standard care versus standard care alone.

DESIGN: Pragmatic, multicentre individually randomised controlled trial of brief psychodynamic-interpersonal therapy compared with standard care with internal pilot, cost-effectiveness and process evaluation.

SETTING AND PARTICIPANTS: People aged over 18 years who attend hospital after intentional self-harm with a history of ≤ 3 episodes in the last 12 months.

INTERVENTION: Individual psychodynamic-interpersonal therapy, delivered face to face or by video conferencing by liaison mental health nurses, over four (or fewer by mutual agreement) 50-minute weekly sessions with two optional boosters.

MAIN OUTCOME MEASURES: The primary outcome was time from randomisation to first repetition of self-harm leading to hospital attendance. Secondary outcomes (at 6 and 12 months) included rate of repetition of self-harm leading to hospital attendance; self-reported self-harm using questionnaires and Short Message Service; psychological distress and clinically significant improvement (Clinical Outcomes in Routine Evaluation – Outcome Measure); anxiety (Generalised Anxiety Disorder-7); hopelessness (Beck Hopelessness Scale); interpersonal function (Inventory of Interpersonal Problems-32) and quality of life (EuroQol-5 Dimensions, five-level version; Recovering Quality of Life; Clinical Outcomes in Routine Evaluation-6D).

RESULTS: The planned sample size was 770 participants. The trial closed to recruitment early in January 2023 at the end of the 12-month internal pilot, with 22 randomised participants, 12 allocated to psychodynamic-interpersonal therapy and 10 to standard care. Due to the early trial closure, trial follow-up was curtailed to 6 months, and analyses are restricted to descriptive statistics. Seven of 12 participants allocated to psychodynamic-interpersonal therapy started therapy, and four completed therapy. Participant-reported secondary outcomes were completed for nine (40.9%) participants at 6 months. Repetition of self-harm leading to hospital presentation could be assessed for 18 participants and occurred in two participants in the psychodynamic-interpersonal therapy arm (18.2%) and no participants in the standard care arm within 6 months of randomisation. Economic findings indicated no substantive changes in health-related quality of life, or primary and secondary care resource usage across arms or over time. Intervention costs were highly sensitive to assumptions regarding the number of patients that would be treated per therapist in real-world role out of intervention.

LIMITATIONS: The study was unable to recruit the necessary sample size, preventing the trial from progressing. The trial met with several challenges.

CONCLUSIONS: Trial timelines coincided with the start of the second wave of the COVID-19 pandemic, causing substantial delays, difficulties with recruitment and, ultimately, its early closure. Although the trial closed early and with insufficient participants to proceed with full statistical analysis, our experiences and recommendations can inform future trial design and delivery.

FUTURE WORK: Self-harm remains a major risk factor for suicide, and provision of cost-effective interventions for people who self-harm is a key part of the government’s Suicide Prevention Strategy.

FUNDING: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR131334.

PMID:41317150 | DOI:10.3310/TNGF8545

Hosp Pract (1995). 2025 Nov 29:2597730. doi: 10.1080/21548331.2025.2597730. Online ahead of print.

ABSTRACT

INTRODUCTION: Decisions about whether to admit patients with pulmonary embolism (PE) are often guided by risk stratification tools, such as the simplified Pulmonary Embolism Severity Index (sPESI). Patients deemed low-risk are typically treated as outpatients; however, some still experience complications. This study compares characteristics of low-risk PE patients managed as outpatients versus inpatients and evaluates patient-level factors associated with admission decisions.

METHODS: We conducted a retrospective cohort study of adults (≥18 years) with objectively confirmed acute PE diagnosed between 1 June 2014, and 31 May 2019. Patients classified as low-risk (sPESI = 0) and without right ventricular dysfunction (RVD) were included. Clinical data were abstracted from records, and patients were categorized by initial site of care (inpatient versus outpatient). Data analysis included descriptive statistics as well as multivariate logistic regression to identify factors associated with hospitalization.

RESULTS: Of 229 eligible patients, 140 (61.1%) were admitted, and 89 (38.9%) managed as outpatients. Baseline characteristics were similar between groups; however, hospitalized patients often had heart rates (HR) ≥90 beats per minute (bpm), lower oxygen saturation, and more medical conditions requiring inpatient care. Among low-risk patients, HR 90-109 bpm (OR 1.78, 95% CI: 1.10-3.04), oxygen saturation between 90% and 94% (OR 1.10, 95% CI: 1.01-1.27), and medical indications for hospitalization > 24 hours (OR 33.97, 95% CI: 8.47-236.09) were significantly associated with admission.

CONCLUSIONS: Although classified as low-risk, over half of patients with acute PE were hospitalized. Elevated HR, reduced oxygen saturation, and comorbid conditions significantly influenced site-of-care decisions in this population. Outpatient management was associated with comparable 90-day safety outcomes, reinforcing its viability when patients are appropriately selected.

PMID:41317135 | DOI:10.1080/21548331.2025.2597730

Int J Paediatr Dent. 2025 Nov 29. doi: 10.1111/ipd.70056. Online ahead of print.

ABSTRACT

BACKGROUND: Molar incisor hypomineralization (MIH) often poses challenges in achieving effective anesthesia. The role of neuromodulation as a potential alternative to local anesthesia injections in managing MIH-affected teeth remains unexplored.

AIM: This study evaluated the efficacy of neuromodulation in providing pain relief during vital pulp therapy for MIH-affected permanent molars.

DESIGN: A triple-blind, randomized clinical trial in 35 children (70 M) aged 6-12 assessed pulpotomy pain management. Teeth were randomly assigned to neuromodulation (Synapse Dental Pain Eraser) for 3 min and mock injection (experimental group), or to conventional infiltration of local anesthesia preceded by inactive control probes (control). Pain was evaluated using the Sound, Eye, Motor (SEM) scale, along with anesthesia need, patient satisfaction, and anesthesia duration. Data were analyzed using independent t-tests with significance set at p < 0.05.

RESULTS: The experimental group reported higher no-pain scores (29%) compared to the control group (20%). Supplemental anesthesia was required in 11% of cases in the experimental group and 19% in the control group. Neither showed a statistically significant difference (p = 0.42 for pain scores; p = 0.36 for supplemental anesthesia).

CONCLUSIONS: Neuromodulation demonstrated comparable effectiveness to local anesthesia alone in managing pain during pulpotomy in MIH molars, and its use should be further studied.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: CTRI/2024/06/069004.

PMID:41317129 | DOI:10.1111/ipd.70056

Int J Paediatr Dent. 2025 Nov 29. doi: 10.1111/ipd.70060. Online ahead of print.

ABSTRACT

BACKGROUND: Important psychometric approaches (structural validity, measurement invariance) remain underdeveloped in measuring oral health-related quality of life, particularly for preschool children across diverse contexts.

AIM: This study aimed to evaluate the structural validity of the child’s self-reported version of the Scale of Oral Health Outcomes for 5-year-old children (SOHO-5) and test the measurement invariance from cultural and clinical/non-clinical comparison perspectives.

DESIGN: Three datasets were analysed: two from Brazil and one from the United Kingdom (UK). One Brazilian dataset was derived from clinical data collection (n_br-cl. = 193), while the others were from non-clinical epidemiological school-based studies (n_br-ncl. = 768, n_uk-ncl. = 296). Dimensionality was tested through parallel analysis and confirmed by unidimensional indexes. Measurement invariance across datasets was tested via multi-group Confirmatory Factor Analysis (CFA).

RESULTS: Unidimensionality was empirically confirmed for all three datasets. The multi-group CFA tests reached partial scalar invariance threshold between the Brazilian and UK non-clinical datasets. However, there was no scalar equivalence when comparing non-clinical with clinical datasets, neither within Brazil nor between countries.

CONCLUSION: The child’s self-reported version of the SOHO-5 is a unidimensional oral health-related quality-of-life measure that is psychometrically comparable across different cultures (partial scalar invariance), but not between clinical and non-clinical groups.

PMID:41317126 | DOI:10.1111/ipd.70060

Genet Med. 2025 Nov 25:101654. doi: 10.1016/j.gim.2025.101654. Online ahead of print.

ABSTRACT

PURPOSE: Neurofibromatosis 1 (NF1) is associated with reduced life expectancy due to malignancies; however, the risk of non-neoplastic causes of death is less well characterised.

METHODS: A total of 1622 persons with NF1, identified through either the Danish National Patient Registry or a clinical database, and 15856 matched comparators born 1951-2002 were followed from either age 20 or NF1 diagnosis. Death causes were from the Danish Cause of Death Register. Cumulative risks of different causes of death were compared between persons with and without NF1, and years of life lost (YLL) were calculated.

RESULTS: Overall, 259 persons with NF1 (16.0%) and 578 comparators (3.6%) died during follow-up. The most frequent non-neoplastic causes of death in NF1 were diseases in the circulatory and nervous systems, with the latter showing a statistically significant higher 70-year cumulative risk in NF1. An excess of 6.1 (4.7-7.5) YLL within age 20-60 was seen in NF1 including 2.5 (1.5-3.5) years from non-neoplastic causes, and 3.6 (2.5-4.7) years from neoplasms.

CONCLUSION: Persons with NF1 showed an increased risk of death from nervous system diseases and neoplasms and a reduced life expectancy, with non-neoplastic causes accounting for almost half of the YLL.

PMID:41316922 | DOI:10.1016/j.gim.2025.101654

Br J Clin Pharmacol. 2025 Nov 29. doi: 10.1002/bcp.70348. Online ahead of print.

ABSTRACT

AIM: To evaluate the clinical effectiveness, cost-effectiveness, quality of life (QoL) and patient/caregiver satisfaction associated with VWs/HaH vs. traditional inpatient care in adults with acute or post-acute illness.

METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs), following PRISMA 2020 guidelines, registered with PROSPERO (CRD42024508457). Major databases were searched until October 2024. Primary outcomes were mortality, readmission, emergency attendance and length of stay. Secondary outcomes were quality of life (QoL), cost-effectiveness, patient satisfaction and caregiver burden. Meta-analyses employed random-effects models; heterogeneity was assessed using the I² statistic.

RESULTS: A total of 47 reports of RCTs (9749 patients) were included. Meta-analyses showed no statistically significant differences in mortality over 1 to 12-month periods (OR 0.82-1.11, 95% CI 0.54-1.43), readmission rates (OR 0.93-1.16, 95% CI 0.80-1.67) or emergency attendance rates (3-month OR 0.86, 95% CI: 0.6-1.25). Narrative synthesis indicated VWs/HaH had higher patient satisfaction and potential cost savings. Quality of life outcomes were comparable, with some improvements in pain and emotional well-being noted in home care settings.

CONCLUSION: VWs/HaH models demonstrated non-inferior clinical safety and cost-effectiveness compared to inpatient care for select adult populations. High satisfaction and comparable clinical outcomes were observed. Findings support the continued, regulated integration of virtual care into routine practice. Future research should focus on service standardization, patient/caregiver satisfaction and support and specific economic evaluations.

PMID:41316908 | DOI:10.1002/bcp.70348