Category: Statistics

Perfusion. 2025 Dec 22:2676591251409381. doi: 10.1177/02676591251409381. Online ahead of print.

ABSTRACT

BackgroundExtracorporeal membrane oxygenation (ECMO) is a life-saving intervention for neonates with severe respiratory or circulatory failure. Due to its complexity, ECMO is often performed in specialized centers, necessitating the transport of eligible patients from non-ECMO centers. While ECMO transport has been deemed safe, limited data exist comparing outcomes between in-house and transported neonates. This study aimed to evaluate the survival and long-term outcomes of neonates requiring ECMO support based on the cannulation location.MethodsA single-center study was conducted at the largest tertiary center in Israel (2009-2025). Patients were categorized based on cannulation site: in-house ECMO (performed at the tertiary center) or on-site ECMO (cannulated at the referring center and transported on ECMO support). Primary endpoints were in-hospital and long-term survival. Secondary outcomes included ECMO-related complications and long-term sequelae.ResultsA total of 53 neonates received ECMO support, with 26 (49.1%) in the in-house group and 27 (50.9%) in the on-site group. Despite pre-cannulation differences, including higher vasoactive-inotropic scores in the in-house group, lower pH and higher pCO2 in the on-site group, there were no statistically significant differences between the groups (53.8% vs 77.8%, p = 0.12). ECMO-related adverse events and long-term sequelae showed no statistically significant differences between groups, though the study was underpowered to detect clinically meaningful differences.ConclusionAlthough survival rates of critically ill neonates requiring on-site ECMO initiation and transport and those connected to ECMO in the in-house setting, did not differ significantly, the study was underpowered to detect potentially meaningful differences. Nonetheless, the findings reinforce the viability of neonatal ECMO transport.

PMID:41424306 | DOI:10.1177/02676591251409381

Health Technol Assess. 2025 Dec;29(67):1-29. doi: 10.3310/RBGD4741.

ABSTRACT

BACKGROUND: Proximal femoral (hip) fracture is common, serious and costly. An enhanced community rehabilitation intervention (Fracture in the Elderly Multidisciplinary Rehabilitation) was codeveloped with patients, carers and therapists. Trial methods have been tested previously in a feasibility study.

OBJECTIVE: To determine the effectiveness and cost-effectiveness of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention compared with usual NHS rehabilitation care. To determine the mechanisms and processes that explain the implementation and impacts of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention.

DESIGN AND METHODS: Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1 : 1 allocation ratio. Concurrent economic and process evaluations.

SETTING: Participant recruitment in 13 hospitals across England and Wales, with the Fracture in the Elderly Multidisciplinary Rehabilitation intervention delivered in the community.

PARTICIPANTS: Patients aged over 60 years, with mental capacity, recovering from surgical treatment for proximal femoral fracture, and living in their own home prior to fracture.

INTERVENTIONS: Usual rehabilitation care (control) was compared with usual rehabilitation care plus the Fracture in the Elderly Multidisciplinary Rehabilitation intervention, which comprised a patient-held workbook and goal-setting diary aimed at improving self-efficacy, and six additional therapy sessions delivered in the community (intervention), to increase the practice of exercise and activities of daily living.

PRIMARY AND SECONDARY OUTCOME MEASURES: Primary effectiveness outcome was the Nottingham Extended Activities of Daily Living scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy – International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Economic outcomes were EuroQol EQ-5D-3L and Client Service Receipt Inventory.

RESULTS: In total, 205 participants were randomised (n = 104 experimental; n = 101 control). Trial processes were adversely affected by the coronavirus disease discovered in 2019 pandemic and the target sample of 446 was not met. By 52 weeks, the intervention group had worse Nottingham Extended Activities of Daily Living scores than the control group (mean difference: -1.9; 95% confidence interval: -3.7 to -0.1), which was not clinically important. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values, removed the apparent inferiority of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention with a mean difference of 0.1 (95% confidence interval: -1.1 to 1.3). There was no statistical or clinically significant difference in secondary outcomes between groups. A median of 4.5 extra rehabilitation sessions were delivered to the intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events including 11 deaths in the control group: 41 serious adverse events including nine deaths in the intervention group. The mean cost of delivering the Fracture in the Elderly Multidisciplinary Rehabilitation intervention was £444 per participant. The intervention group gained 0.02 (95% confidence interval: -0.036 to 0.076) more quality-adjusted life-years than the control group. This was not clinically or statistically significant. Mean health service use costs were higher in the intervention group.

LIMITATIONS: The trial was severely impacted by coronavirus disease discovered in 2019. Possible reasons for lack of detected effect included limited intervention fidelity (number and remote mode of delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.

CONCLUSION: The Fracture in the Elderly Multidisciplinary Rehabilitation intervention was not more effective and had higher costs than usual rehabilitation care.

FUNDING: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/167/09.

PMID:41424298 | DOI:10.3310/RBGD4741

Stroke. 2025 Dec 22. doi: 10.1161/STROKEAHA.125.052763. Online ahead of print.

ABSTRACT

BACKGROUND: Robot-assisted gait training (RAGT) with wearable exoskeletons has the potential to enhance walking in patients with stroke; however, large-scale evidence is inconclusive. The aim of this study was to determine the effect of overground gait training using a torque-assisted exoskeleton in patients with subacute stroke on the recovery of ambulatory function.

METHODS: This international, multicenter, randomized controlled trial enrolled 151 patients with subacute stroke who presented with severe gait impairment but relatively preserved trunk control. Participants were randomized to the RAGT group (30 minutes of conventional gait training plus 30 minutes of exoskeleton) or the control group (60 minutes of conventional gait training), 5 times per week for 4 weeks. The primary outcome was the change in ambulatory function, assessed by the Functional Ambulation Category (FAC) before and immediately after the 4-week intervention. Secondary outcomes included the lower limb strength, balance function. Independent ambulation was reassessed 3 months after the intervention.

RESULTS: A total of 127 participants (56 female (44.1%), mean age, 60.1±13.6 years) completed the 4-week intervention. There were no serious adverse events related to the interventions, and dropout rates tended to be higher in the RAGT group without statistical significance. Both groups showed significant improvement in FAC after the intervention; however, no significant difference between groups (mean change (range), 3.0 (1-5) and 2.5 (1-4) in the RAGT and control group). Both groups exhibited significant gains in lower limb motor function; however, the RAGT group demonstrated a significantly greater improvement in lower limb strength (mean change, 15.9±14.2 and 11.1±11.2 in the RAGT and control group, P=0.034).

CONCLUSIONS: Overground gait training using an exoskeleton was not superior to conventional rehabilitation for improving ambulatory function in subacute stroke patients; however, it could provide additional lower extremity motor improvement. These findings suggest that the overground gait training with an exoskeleton might be a potential intervention for patients with subacute stroke.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05157347.

PMID:41424275 | DOI:10.1161/STROKEAHA.125.052763

Ann Afr Med. 2025 Dec 15. doi: 10.4103/aam.aam_575_25. Online ahead of print.

ABSTRACT

CONTEXT: Type 2 diabetes mellitus (T2DM) and hypertension are major chronic conditions affecting elderly populations globally, often combined with socioeconomic hardship and comorbidities, which can impair quality of life (QoL).

AIMS: The aim of this study was to assess the health-related QoL among elderly persons with type 2 diabetes and hypertension living in urban slums of Bengaluru and to identify socio-demographic, clinical, lifestyle, and comorbidity factors associated with QoL.

SETTINGS AND DESIGN: A community-based cross-sectional study was conducted among 255 elderly persons (age ≥60 years) with T2DM and hypertension using probability proportional to size sampling from 12 slums in the field practice area of a tertiary care hospital in Bengaluru, India. Methods and Materials: Data were collected on sociodemographic profile, clinical status, disease duration, comorbidities, lifestyle behaviors, and health-related QoL using domain-specific assessments.

STATISTICAL ANALYSIS USED: Statistical analysis included descriptive statistics, ANOVA/Chi-square tests, and Pearson correlation.

RESULTS: Of 255 participants, the mean age was 67.7 years. Almost half (47.1%) the participants reported poor QoL, predominantly in the social and psychological domains. The mean QoL score among the study subjects is 44.92 ± 7.6, which is below average. The highest score was 47.19 ± 14.6, seen in the physical domain, and the lowest mean scores were observed in social (42.96 ± 16.30) and psychological domains (43.92 ± 10.4).

CONCLUSIONS: The elderly with type 2 diabetes and hypertension in urban slums experience poor QOL influenced by sociodemographic, clinical, and lifestyle factors. Interventions emphasizing physical activity, diet adherence, comorbidity management, and social support are needed.

PMID:41424274 | DOI:10.4103/aam.aam_575_25

Glob Health Action. 2025 Dec;18(1):2599567. doi: 10.1080/16549716.2025.2599567. Epub 2025 Dec 22.

ABSTRACT

BACKGROUND: Hypertension is a major risk factor for cardiovascular diseasemorbidity and mortality, affecting 25% of adults in Ghana. Access to adequate care is critical for effective hypertension management.

OBJECTIVE: Evaluate healthcare utilisation among patients with hypertension and identify determinants.

METHODS: Guided by the Andersen and Newman model, we examined predisposing, enabling, and need factors affecting HCU. Data were collected from 600 patients with hypertension, 19 in-depth interviews with health workers, and six focus group discussions with patients. Logistic regression was used for quantitative analysis, while qualitative data were analyzed thematically.

RESULTS: In all, 73% of patients with hypertension used health care. Key predisposing factors included age 70+ years (adjusted odds ratio [aOR]: 1.97, 95% CI: 1.06-3.69) and being female (aOR: 2.32, 95% CI: 1.53-3.54). Enabling factors included health insurance (aOR: 4.07, 95% CI: 2.04-8.20), closer proximity to referral facilities (aOR: 2.28, 95% CI: 1.44-3.65), and care at district hospitals (aOR: 3.37, 95% CI: 1.94-6.03). Need factors were not associated with HCU. Barriers included financial difficulties, reliance on alternative medicines, poor health-seeking behavior, delays, erratic medication supplies, and health insurance limitations.

CONCLUSIONS: This study finds high healthcare use (73%) among rural Ghanaian hypertension patients, mainly driven by demographic and structural factors. It highlights ongoing inequalities, especially among men. Interventions should focus on addressing gender issues, enhancing access to insurance, and strengthening district hospital services. Future research should evaluate the quality and consistency of hypertension care to improve health outcomes.

PMID:41424267 | DOI:10.1080/16549716.2025.2599567

J Community Psychol. 2026 Jan;54(1):e70076. doi: 10.1002/jcop.70076.

ABSTRACT

Scholars of youth civic development have assessed agency using a wide range of constructs, including motivation, efficacy, empowerment, and sociopolitical control. We propose a multidimensional framework and describe the development and validation of a measure of civic agency, conceptualized as competence, drive, individual power, and collective power. In Study 1, we developed a set of items and employed exploratory factor analysis with a pilot sample of adolescents (N = 295, M_age = 17.1, 65.4% youth of color, 47.9% female, 15.8% nonbinary), which supported our hypothesized four-factor model of civic agency. In Study 2, we conducted confirmatory factor analysis of our final items with a separate adolescent sample (N = 1120, M_age = 16.2, 73.0% youth of color, 55.7% female, 23.3% nonbinary), which demonstrated measurement invariance on race/ethnicity, gender, and age. In Study 3, we validated our scale in a sample of young activists (N = 342, M_age = 19.1, 57.6% youth of color, 72.6% female, 23.0% nonbinary). Confirmatory factor analysis supported a four-dimensional hierarchical structure and we established measurement invariance between adolescents and young adults. Overall, the 16-item Civic Agency Measure consistently demonstrated validity and reliability. We discuss the utility of our work for advancing sociopolitical development theory and supporting adolescents’ efforts for social change.

PMID:41424263 | DOI:10.1002/jcop.70076

Am J Hosp Palliat Care. 2025 Dec 22:10499091251409748. doi: 10.1177/10499091251409748. Online ahead of print.

ABSTRACT

IntroductionCancer is one of the leading causes of global mortality and imposes high costs on healthcare systems. In Brazil, a significant portion of resources is allocated to oncology, especially in the terminal phase. Palliative care has been associated with reduced hospital expenses and improved quality of life. This study aimed to compare direct medical costs in the last week of life of oncology patients receiving usual care (UC) or palliative care (PC).MethodsA retrospective cohort study conducted at Santa Rita Hospital (Porto Alegre, RS), using data from 2021. Patients over 18 years old, hospitalized for ≥7 days, whose death resulted from cancer progression, were included. The sample comprised 58 individuals: 41 in PC and 17 in UC. Direct medical costs included medications, procedures, laboratory and imaging exams, adjusted for inflation and converted to US dollars.ResultsDespite no statistically significant difference in the median of total cost (P = 0.4493), the median cost was lower in the PC group (USD 67.5) compared to the UC group (USD 91.5). Patients receiving palliative care had reduced costs related to procedures, laboratory tests, and imaging exams.ConclusionThe integration of palliative care was associated with reduced specific expenses and greater multidisciplinary support, indicating potential for resource optimization in oncology. These results reinforce the importance of systematic incorporation of this approach in the Brazilian context.

PMID:41424257 | DOI:10.1177/10499091251409748

Epigenomics. 2025 Dec 22:1-10. doi: 10.1080/17501911.2025.2606041. Online ahead of print.

ABSTRACT

AIMS: Environmental factors can alter DNA methylation (DNAm) levels, influence gene expression, and then change fasting glucose (FG) or hemoglobin A1c (HbA1c).

METHODS: Through analyzing DNAm data of 2366 Taiwan Biobank individuals aged between 30 and 70 years, I evaluated the role of DNAm in mediating the associations of seven non-genetic factors (BMI, chronological age, sex, smoking, drinking alcoholic beverages, education, and regular exercise) with FG and HbA1c.

RESULTS: Among 846,232 Cytosine-phosphate-Guanine (CpG) sites, the single-mediator model explored that 21, 15, 10, 3, 3, and 1 CpGs significantly mediated (p < 6.6E-9) the BMI-HbA1c, BMI-FG, sex-FG, age-FG, age-HbA1c, and drinking-HbA1c associations, respectively. The multiple-mediator model considered all significant mediators and selected the model with the smallest Akaike Information Criterion, and identified 8 CpGs that linked exposures (BMI, sex, age, and drinking) to diabetes indicators. Seven out of the 8 CpGs have been reported to be associated with diabetes, FG, HbA1c, or insulin resistance in previous epigenome-wide association studies.

CONCLUSION: Four of the 8 CpGs (cg19693031, cg04816311, cg00574958, and cg11024682) were associated with the expression of genes implicated in diabetes and metabolism, including the TXNIP, GPR146, CPT1A, and SREBF1 genes. These findings highlight the underlying epigenetic mechanism linking non-genetic factors with diabetes.

PMID:41424234 | DOI:10.1080/17501911.2025.2606041

Int J Gynaecol Obstet. 2025 Dec 22. doi: 10.1002/ijgo.70736. Online ahead of print.

ABSTRACT

T. Shokeir, and S. Mousa, “A Randomized, Placebo-Controlled, Double-Blind Study of Hysteroscopic-Guided Pertubal Diluted Bupivacaine Infusion For Endometriosis-Associated Chronic Pelvic Pain,” International Journal of Gynecology & Obstetrics 130, no. 3 (2015): 219-222, 10.1016/j.ijgo.2015.03.043. The above article, published online on 03 June 2015 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the journal Editor-in-Chief, Michael Geary; and John Wiley & Sons Ltd. UK. Concerns were raised by a third party regarding the reproducibility of the results reported in Tables 2 and 3, including the p-values stated Table 3. The authors were asked to provide their raw data. However, they did not provide the requested data. Because of the incompatibility of the statistical results presented in the publication and without an adequate explanation by the authors, the editorial team and publisher consider the data and conclusions as unreliable, therefore the article must be retracted.

PMID:41424228 | DOI:10.1002/ijgo.70736

Vasc Endovascular Surg. 2025 Dec 22:15385744251410004. doi: 10.1177/15385744251410004. Online ahead of print.

ABSTRACT

BackgroundVaricose vein surgery increases the risk of venous thromboembolism (VTE). Although pharmacological thromboprophylaxis is commonly used postoperatively, its efficacy and optimal regimen remain unclear. This study systematically reviews the effectiveness and safety of various anticoagulant strategies.MethodsA comprehensive literature search was conducted across PubMed, Embase, EBSCO, and Web of Science databases to identify relevant studies. Eligible studies were screened and selected based on predefined inclusion and exclusion criteria. A network meta-analysis was performed to compare different anticoagulant agents and prophylaxis durations indirectly. Additionally, a random-effects meta-analysis was conducted to calculate the relative risk (RR) and 95% confidence intervals (CI) for VTE and bleeding outcomes.ResultsA total of 11 studies, including 7359 patients who underwent either endovenous or open surgical procedures for varicose veins, met the inclusion criteria. Meta-analysis results indicated that pharmacological thromboprophylaxis was associated with a lower risk of VTE compared to no prophylaxis (RR = 0.49, 95% CI: 0.12-1.99, P < 0.01); however, this difference was not statistically significant. Similarly, there was no significant difference in bleeding risk between patients who received anticoagulant prophylaxis and those who did not (RR = 2.03, 95% CI: 0.82-5.07, P = 0.81). Furthermore, network meta-analysis revealed no significant differences in the incidence of thromboembolic events or bleeding risk across various prophylaxis durations (3, 5, and 10 days) or among different anticoagulants, including low-molecular-weight heparin (LMWH), rivaroxaban, heparin, apixaban, and sulodexide.ConclusionsPostoperative anticoagulant prophylaxis for VTE following varicose vein surgery appears to be safe; however, its effectiveness in reducing VTE incidence remains uncertain. The lack of significant differences in outcomes across different prophylaxis durations and anticoagulant types highlights the need for further high-quality, large-scale randomized controlled trials to establish the optimal prophylactic strategy, including the appropriate agent, dosage, and duration.

PMID:41424201 | DOI:10.1177/15385744251410004