Nevin Manimala

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

Matern Child Nutr. 2026 Jan;22(1):e70136. doi: 10.1111/mcn.70136.

ABSTRACT

Child stunting affects 38.3% of children under five in Ethiopia as of 2016. Women’s empowerment, defined through both fundamental capabilities and household decision-making authority, has emerged as a critical determinant of child nutritional outcomes. Drawing on Sen’s capability approach and Kabeer’s empowerment framework, we examined the associations between two distinct dimensions of women’s empowerment and child stunting across Ethiopia’s diverse regions. We analyzed 18,466 mother-child pairs from the 2011 and 2016 Ethiopia Demographic and Health Surveys. Validated empowerment indices were constructed using factor analysis. We employed hierarchical multilevel models as our primary specification to examine the associations between women’s empowerment and child stunting across Ethiopia’s 11 administrative regions. Between 2011 and 2016, stunting declined from 42.3% to 36.4%. Women’s decision-making authority increased (mean score: 0.70-0.78), while capabilities remained stable (0.17- 0.16). Higher capabilities were significantly associated with lower odds of stunting (β = -0.141, aOR = 0.87, 95% CI: 0.83, 0.91), whereas decision-making showed no association (β = 0.013, aOR = 1.01, 95% CI: 0.98, 1.05). A significant interaction between capabilities and decision-making was observed (β = 0.050, aOR = 1.05, 95% CI: 1.01, 1.09). Regional heterogeneity was substantial: Amhara maintained high stunting rates despite empowerment gains, while Somali saw improvements with low capabilities but increased decision-making. The study findings suggest that interventions should prioritize capability development through region-specific strategies reflecting diverse pastoral, agrarian, and urban contexts; promote multi-sectoral programs linking education and nutrition services; and develop monitoring frameworks to track both dimensions of empowerment at the regional level.

PMID:41316894 | DOI:10.1111/mcn.70136

Matern Child Nutr. 2026 Mar;22(1):e70146. doi: 10.1111/mcn.70146.

ABSTRACT

Maternal diet quality and perinatal depression significantly impact maternal and child health, yet their relationship remains underexplored in low-resource settings. This cross-sectional study examined the association between overall diet quality and risk of depression during the third trimester among 296 pregnant women receiving antenatal care at Dhulikhel Hospital, Nepal (August 2023-January 2024). Depression risk was assessed using the Edinburgh Postnatal Depression Scale (EPDS), with scores ≥ 12 indicating elevated symptoms. Diet quality was measured using an adapted Nepali version of the 23-item PrimeScreen questionnaire, generating a Prime Diet Quality Score (PDQS) ranging from 0 to 46. Multivariable logistic regression models were used to estimate the association between PDQS and depression risk, adjusting for age, education, ethnicity, occupation, parity, gestational week, physical activity, and pre-pregnancy BMI. The mean PDQS was 24.7 (SD = 3.1), and 22.3% of participants screened positive for depression. Each 1-point increase in PDQS was associated with 16% lower odds of depression (adjusted OR: 0.84; 95% CI: 0.70-0.90; p = 0.002). These findings suggest that higher overall diet quality is associated with a reduced likelihood of third trimester depression. Further longitudinal studies are warranted to assess causality and inform targeted nutritional interventions. If supported by further studies, incorporating brief dietary assessments like PrimeScreen into antenatal care may potentially offer a feasible strategy to identify women with suboptimal diet quality and co-occurring depressive symptoms in low- and middle-income countries.

PMID:41316875 | DOI:10.1111/mcn.70146

Mov Disord. 2025 Nov 29. doi: 10.1002/mds.70120. Online ahead of print.

ABSTRACT

OBJECTIVE: Investigate the efficacy of immediate-release (IR) amantadine in reducing the risk of peak-dose dyskinesia in early Parkinson’s disease (PD) as add-on to levodopa.

BACKGROUND: While the use of amantadine to manage dyskinesia in PD is well supported by controlled clinical trials, data on its efficacy in patients without motor complications remain limited.

METHODS: This 22-month, multicenter, randomized, placebo-controlled trial (NCT01538329) enrolled early PD patients on stable levodopa (≥150 mg/day for ≤1 year) without motor complications. The study included three double-blind phases: an 18-month treatment phase with adjunct amantadine-IR (200 mg/day) or placebo (Period 1), a 3-month delayed-start phase where all participants received amantadine-IR (Period 2), and a 1-month washout with placebo (Period 3). The primary outcome was dyskinesia incidence at month 18; secondary outcomes included dyskinesia rates at the end of Periods 2 and 3 to assess potential long-lasting mechanisms of the drug. Exploratory outcomes investigated the potential effects of amantadine-IR on motor and non-motor symptoms and quality of life.

RESULTS: A total of 207 patients were randomized to amantadine-IR (N = 99) or placebo (N = 108). Significantly fewer patients in the amantadine-IR group developed dyskinesia versus placebo during Period 1 (11% vs. 22%, P = 0.025), while the mean daily dose of levodopa (95% CI) increased by 70 (21-119) mg less (P = 0.005). The proportion of patients with dyskinesia was less in the amantadine-IR group versus placebo at the end of Periods 2 and 3, but the difference was not statistically significant (12% vs. 20%, P = 0.13 and 16% vs. 22%, P = 0.23, respectively). Mild but significant positive effects on freezing of gait, fatigue, and quality of life were observed during Period 1. The safety profile of amantadine-IR was in line with previous reports.

CONCLUSIONS: Adjunctive amantadine-IR in early PD halved dyskinesia incidence over 18 months. Long-lasting mechanisms could not be demonstrated and merit further investigation. Exploratory positive findings on the potential benefit of amantadine-IR on symptoms like freezing of gait and fatigue also call for further investigation. © 2025 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

PMID:41316871 | DOI:10.1002/mds.70120