Tag: statistics

JAMA Netw Open. 2025 Nov 3;8(11):e2544535. doi: 10.1001/jamanetworkopen.2025.44535.

ABSTRACT

IMPORTANCE: Mobility limitations are common in older adults and impact quality of life and social interaction. Walking aids can improve mobility and prevent falls but require oversight and training. Despite being recommended by geriatric emergency department (ED) guidelines, their effectiveness in this setting has not been studied to date.

OBJECTIVE: To evaluate the effectiveness of training and provision of walking aids, with or without telemonitoring, on mobility, fear of falling, gait, functional capacity, quality of life, cognition, depression, and occurrence of falls in older adults after an ED visit compared with safe ambulation recommendations only.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted at the Geriatric ED of Hospital Sírio-Libanês, São Paulo, Brazil, from July 20 to December 16, 2023, with a 90-day follow-up. Participants were patients 65 years or older who were discharged from the geriatric ED with at least 1 indication for walking aids according to the institutional protocol. Researchers involved in postintervention assessment and statistical analyses were blinded to group allocation.

INTERVENTION: Seventy-five participants were allocated to 1 of 3 groups: control, walking aids (WA), or walking aids with telemonitoring (WAT). All participants received safe ambulation recommendations. Intervention groups (WA and WAT) were assessed and trained in device use by a physiotherapist. The WAT group received telemonitoring follow-up to promote adherence.

MAIN OUTCOMES AND MEASURES: The primary outcomes were improved life-space mobility as assessed by the Life Space Assessment and fear of falling as assessed by the Falls Efficacy Scale International at 90 days follow-up. Secondary outcomes included gait, functional capacity, quality of life, cognition, depression, and occurrence of falls.

RESULTS: A total of 75 older adults were enrolled (mean [SD] age, 81.3 [7.7] years; 40 [53.3%] female). At 90 days, the WA group had significant improvement in life-space mobility (mean difference [MD], 12.77; 95% CI, 1.06-24.54; P = .03), fear of falling (MD, -5.60; 95% CI, -9.06 to -2.14; P = .002), and 1-minute sit-to-stand test (MD, 8.45; 95% CI, 4.34-12.56; P = .001) compared with the control group. No significant improvements were observed in any of these outcomes in the WAT group compared with the WA group.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, training and provision of walking aids for older adults in the ED improved mobility and fear of falling as long as 90 days after discharge. The addition of telemonitoring did not result in additional benefits. This study highlights the role of a specialized physiotherapy intervention to optimize outcomes in older adults in the ED.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05950269.

PMID:41269694 | DOI:10.1001/jamanetworkopen.2025.44535

JAMA Netw Open. 2025 Nov 3;8(11):e2545046. doi: 10.1001/jamanetworkopen.2025.45046.

ABSTRACT

IMPORTANCE: The incidence and prevalence of clinical Alzheimer disease (AD) are higher among Black and Latinx older adults than among White older adults. Past studies that compared plasma AD biomarker concentrations among groups minoritized by their race and ethnicity yielded inconsistent findings; however, these efforts did not include population representative samples or statistical procedures to ensure population representation.

OBJECTIVE: To examine race and ethnicity differences in plasma AD biomarker concentrations and in the association between biomarkers and medical conditions in a US population-representative cohort of middle-aged adults (approximately 58 years of age).

DESIGN, SETTING, AND PARTICIPANTS: Data for this cohort study came from the High School and Beyond sample, a nationally representative cohort of high school sophomores and seniors who were recruited in 1980. In 2021, a subset of participants provided blood samples that were assayed for amyloid-β (Aβ42/Aβ40 ratio), phosphorylated tau-181 (pTau-181), neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP). The analyses for the present study were conducted between July 2, 2024, and August 26, 2025, using data collected during the 2021 follow-up study.

EXPOSURES: Race and ethnicity groups and common medical conditions.

MAIN OUTCOMES AND MEASURES: General linear models with Wald tests were used to compare biomarker concentrations between race and ethnicity groups and to test interactions with common medical conditions using unadjusted biomarker values and models adjusted to ensure population representation with inverse probability weighting and multiple imputation.

RESULTS: The sample included 4340 adults (mean [SD; range] age, 58.1 [1.1; 56-63] years; 2400 [55.3%] women); 630 (14.4%) were Black, 900 (20.7%) were Latinx, and 2610 (60.1%) were White. Black participants had a lower Aβ42/Aβ40 ratio (d = -0.002; 95% CI, -0.004 to -0.000; P = .04) and lower NfL concentrations (d = -1.16; 95% CI, -2.15 to -0.16; P = .02) than White participants, but these differences were attenuated when models were adjusted for population representation (d = 0.000; 95% CI, -0.002 to 0.002; P = .85 for Aβ ratio; d = -0.88; 95% CI, -1.78 to 0.02; P = .05 for NfL). Latinx participants had lower GFAP concentrations than White participants (d = -3.87; 95% CI, -7.30 to -0.45; P = .03), but these differences were also attenuated when models were adjusted for population representation (d = 3.36; 95% CI, -3.13 to 9.86; P = .31). In general, estimated biomarker means were similar between race and ethnicity groups. History of type 2 diabetes was associated with increased NfL concentration (d = 0.19; 95% CI, 0.07 to 0.30; P = .04), and high body mass index was associated with lower Aβ42/Aβ40 ratio (d = -0.13; 95% CI, -0.21 to -0.06; P = .02); whereas high cholesterol was associated with lower pTau-181 concentration (d = -0.18; 95% CI, -0.25 to -0.10; P = .01) and high BMI was associated with lower GFAP concentration (d = -0.30; 95% CI -0.44 to -0.16; P = .01). No differences in associations between morbidities and AD biomarker concentrations were detected across race and ethnicity groups.

CONCLUSIONS AND RELEVANCE: In this cohort of middle-aged adults, the use of appropriate statistical estimation to ensure population representation indicated that blood-based AD biomarker concentrations were not distinguishable among race and ethnicity groups. Common medical conditions were associated with plasma biomarker concentrations similarly across race and ethnicity groups. These results highlight the importance of considering population representation and comorbid conditions in AD research to ensure accurate characterization of disease pathophysiology and improve precision of diagnostic and treatment strategies for populations that experience AD disparities.

PMID:41269690 | DOI:10.1001/jamanetworkopen.2025.45046

Environ Sci Pollut Res Int. 2025 Nov 21. doi: 10.1007/s11356-025-37103-x. Online ahead of print.

ABSTRACT

Microplastics (MPs) are ubiquitous in aquatic environments and closely tied to human activities, yet linking measured concentrations to urban pressures remains challenging. Methodological inconsistencies inflate variance, obscure spatial patterns, and hinder comparability. We therefore implemented fully harmonized sampling and FTIR-verified analysis across ten lakes in Latvia, Lithuania, and Poland, with all field and laboratory work performed by the same team. In parallel, we calculated an urbanization index to relate MP concentrations to shoreline development and urban influences. This design enabled comparisons of MPs in surface waters and sediments with ranges of 0.67-7.68 particles L⁻¹ (water) and 0.09-3.90 particles g⁻¹ dw (sediments). Polyethylene and polypropylene predominated, with fibres and fragments as the most common shapes; particles < 5 mm, and black, blue, or white, were most frequent. Shoreline urbanization, quantified by the shoreline urbanization index, was the only significant predictor of MPs in surface waters, explaining ~ 74% of variance, while nutrient concentrations, lake type, proximity to point sources, and season showed no consistent effect. Seasonal shifts in particle shape and type were observed but not in total abundance. MP concentrations were broadly similar among countries, with modest, statistically inconclusive differences in particle size and colour, indicating limited regional variation once methodological noise is removed. Our findings highlight that harmonized protocols sharpen the detection of environmental drivers and may overturn previously reported geographic differences driven by inconsistent methods. This first fully standardized, multi-lake, cross-country MP survey provides a robust framework for future monitoring and mitigation in inland waters.

PMID:41269591 | DOI:10.1007/s11356-025-37103-x

Dermatol Ther (Heidelb). 2025 Nov 21. doi: 10.1007/s13555-025-01603-y. Online ahead of print.

ABSTRACT

INTRODUCTION: Calcipotriol and betamethasone dipropionate (Cal/BDP) PolyAphron dispersion (PAD) cream and Cal/BDP foam have demonstrated superior efficacy to Cal/BDP gel in patients with plaque psoriasis exhibiting a more severe profile defined by the Rule of Tens in different studies. However, its comparative efficacy in this subgroup of patients needs to be studied.

METHODS: An indirect treatment comparison (ITC) using individual patient data for Cal/BDP PAD cream and available aggregated data for Cal/BDP foam was conducted for three outcome measures: Physician’s Global Assessment (PGA) success, modified Psoriasis Area and Severity Index 75 (mPASI75), and Dermatology Life Quality Index (DLQI) satisfaction. Bucher’s method was used for the ITC base case, and alternative analyses were performed using an anchored matching-adjusted indirect comparison (MAIC). Odds and risk ratios were calculated for each outcome.

RESULTS: After adjustment to the Rule of Tens, Cal/BDP PAD cream showed no differences vs. Cal/BDP foam in the three outcomes. Similar results were found for the MAIC scenarios after population matching, supporting the validity of the results.

CONCLUSION: In this ITC analysis, no significant differences in the clinical efficacy of Cal/BDP PAD cream and Cal/BDP foam in patients with plaque psoriasis meeting the Rule of Tens were observed considering their recommended treatment durations.

PMID:41269583 | DOI:10.1007/s13555-025-01603-y

BioDrugs. 2025 Nov 21. doi: 10.1007/s40259-025-00747-9. Online ahead of print.

ABSTRACT

Even though the use of biosimilar medicines is increasing across European countries, detailed and regularly published official data on biosimilar uptake are not publicly available except in Italy and Portugal. The main objective of this study was to provide a nationwide assessment of biosimilar consumption and uptake patterns in Spain between 2016 and 2023. Data were provided by the Ministry of Health and included the defined daily dose (DDD) of biosimilars (N = 17) dispensed through both community pharmacies and public hospitals, biosimilar market share, and information on the registration status of both the bio-originator and biosimilars of each active principle. Data were analysed using non-parametric tests and bootstrap analysis with 10,000 replications, considering market share, time since market entry, number of competitors, and indication type (acute vs. chronic). The results show that biosimilar penetration increased from 9% in 2016 to 47% in 2023. In 2023, the biosimilar market share was substantially higher in the hospital setting (68%) compared to community pharmacies (34%). Biosimilars indicated for acute conditions achieved significantly higher market shares than those used for chronic conditions (p < 0.05). A positive correlation was observed between market share and the number of competitors, which was statistically significant only in the hospital setting (p = 0.007), while no significant association was found in the community pharmacy setting. Additionally, no correlation was identified between biosimilar market penetration and the time elapsed since the introduction of the first biosimilar. Other factors, such as prices, tendering, interchangeability, patients’ characteristics, etc., may also influence biosimilar use. We suggest further analysis of policies aimed at promoting biosimilar adoption in Spain.

PMID:41269540 | DOI:10.1007/s40259-025-00747-9

Ultrasound J. 2025 Nov 21;17(1):61. doi: 10.1186/s13089-025-00469-7.

ABSTRACT

BACKGROUND: Focused cardiac ultrasound (FCU) is increasingly used as an extension of physical examination to aid diagnosis and clinical decision-making. Emerging educational technologies such as artificial intelligence (AI)-enabled ultrasound devices and virtual reality (VR) simulators offer novel, cost-effective and self-directed approaches for FCU skill acquisition training. Prior studies suggest that VR-based training may be non-inferior to traditional teaching, while AI offers real-time feedback to enhance learning.

OBJECTIVE: This study aimed to evaluate the effectiveness and non-inferiority of AI and VR-assisted training compared to Traditional in-person instruction in achieving competency in FCU image acquisition. Secondary outcomes included time to acquire an optimal apical 4 chamber (A4C) view and self-reported confidence in image acquisition, assessed immediately post-training and at 3-month follow up.

METHODS: In this single-blind, randomized controlled pilot trial, 66 local medical students with no prior FCU experience were randomised into 3 arms: (1) AI-enabled ultrasound training using the Kosmos system, (2) VR-based stimulator (Vimedix), and (3) Traditional instructor-led teaching. All sessions were 60 min long. Image acquisition of 5 standard FCU views was assessed by blinded evaluators using the Rapid Assessment of Competency in Echocardiography (RACE) score at both time points.

RESULTS: Two participants were lost to follow-up (one each from the AI and VR groups). In the first assessment, the Traditional group achieved the highest mean RACE score (15.77), followed by AI (13.39) and VR (13.23). Non-inferiority testing confirmed that both AI (95% CI -∞ to 3.60; p < 0.001) and VR (95% CI -∞ to 3.58; p < 0.001) methods were non-inferior to Traditional instruction. The AI group achieved the shortest mean time to acquire an optimal A4C view (158 ± 99.1 s), followed by the VR (189 ± 94.7 s), and traditional (199 ± 115.1 s), though differences were not statistically significant (p = 0.591). Confidence levels were initially highest in the Traditional group, while the VR group showed higher confidence at 3-month follow-up, particularly in parasternal long-axis view acquisition.

CONCLUSIONS: AI and VR-based training methods were non-inferior to traditional instruction for FCU skill acquisition. Both modalities show promise as scalable, technology-enabled alternatives in ultrasound education. Trial registration This trial was registered on Clinicaltrials.gov (NCT06355557).

PMID:41269495 | DOI:10.1186/s13089-025-00469-7

Sports Med Open. 2025 Nov 21;11(1):143. doi: 10.1186/s40798-025-00940-8.

ABSTRACT

BACKGROUND: There is no robust prognostic guides for patellar tendinopathy (PT), hence we do not understand who gets better, when and why. Therefore, we aimed to identify which combination of self-reported factors best predicts PT recovery. A previously validated, reliable online questionnaire battery yielded data from an international sample of professional and recreational jumping athletes with a one-year follow-up. Recovery was defined using Global Rating of Change, alongside full availability for training and competition. Data on > 100 plausible bio-psycho-social, demographic and sporting outcome predictors were collected; and a multivariable cox proportional-hazards model constructed.

RESULTS: 128 athletes with PT (30.9 ± 8.9 years; 77 males (60%); Victorian Institute of Sport Assessment Questionnaire-Patellar Tendon = 61.5 ± 16.2) provided 25,284 days at risk for analysis. Recovery rate was 45%, peaking at 6-month. The multivariable model partially predicted PT recovery with acceptable performance (optimism-corrected C-statistic:0.77, 95%CI:0.74-0.79) and internal validation. Recovery was associated with lower severity (Hazard Ratio (HR) = 1.03, 95%CI 1.02-1.05), a shorter time off sport (HR = 0.93, 95%CI 0.87-0.99), feeling more rested after sleep (HR = 1.93, 95%CI 1.13-3.28), not having multiple concurrent tendon problems (HR = 0.23, 95%CI 0.07-0.69), higher training duration (HR = 1.05, 95%CI 1.01-1.10) and symptoms being modifiable by movement (HR = 2.71, 95%CI 1.21-6.09).

CONCLUSIONS: To the best of our knowledge, this is the first study investigating outcome predictors for PT recovery in a large international cohort of jumping athletes. The exploratory recovery model showed that a combination of self-reported sports-specific and biomedical variables were predictive of PT recovery. These findings can be used to support clinical judgements of prognosis.

PMID:41269475 | DOI:10.1186/s40798-025-00940-8

Sports Med Open. 2025 Nov 21;11(1):134. doi: 10.1186/s40798-025-00908-8.

ABSTRACT

BACKGROUND: Underpowered study designs undermine the reliability of experimental research, with growing concerns regarding randomised controlled trials (RCTs) informing musculoskeletal injury management. We assessed the statistical power and sample size calculations of such RCTs.

METHODS: Electronic searches (MEDLINE and PEDro searched up to March 2024) identified meta-analyses of RCTs comparing conservative interventions for musculoskeletal injury, without restrictions on demographics, injury type, or outcome. Statistical power was estimated using two approaches: (1) meta-analytic-the RCT’s power to detect the summary effect of the meta-analysis it contributed to, and (2) conventional-the RCT’s power to detect Cohen’s small (d = 0.2), medium (d = 0.5), and large (d = 0.8) effect sizes. The RCTs’ manuscripts and registry entries were screened for sample size planning details.

RESULTS: The search identified 4737 articles, with 41 eligible meta-analyses of 266 RCTs. The median power was 42% (54% among RCTs within statistically significant meta-analyses). Less than 1 in 3 RCTs from statistically significant meta-analyses had ≥ 80% power to detect the corresponding summary effect. The number of RCTs with ≥ 80% power to detect small, medium, and large effects was 0%, 7.9%, and 37.6%, respectively. One in four RCTs reported sample size calculations; 80% expected larger effects than they observed. RCTs not reporting sample size calculations were smaller and reported larger effects.

CONCLUSION: Low statistical power permeates musculoskeletal injury research, limiting the clinical utility of many RCTs. The underlying causes of low power in this field are multifactorial and extend beyond sample size calculation alone. Enhancing study power requires methodological improvements, including robust planning, stronger theoretical frameworks, multi-center collaboration, data sharing, and the use of valid, reliable outcome measures.

PMID:41269466 | DOI:10.1186/s40798-025-00908-8

Sports Med Open. 2025 Nov 21;11(1):135. doi: 10.1186/s40798-025-00949-z.

ABSTRACT

BACKGROUND: There is controversy in the literature with regards to the short-term effects of wearing footwear with motion control features on running mechanics and whether commercially available footwear with motion control features has extra benefits compared with non-commercially available motion control footwear. In this systematic review with meta-analysis, we investigated the effects of wearing commercially available and non-commercially available footwear with motion control features versus standard shoes applied during one experimental session on lower limb joint angles and moments during running in adults.

METHODS: Five electronic databases (Scopus, PubMed, EMBASE, PEDro, Cochrane Central Register of Controlled Trials [CENTRAL]) were systematically searched for articles potentially eligible for inclusion from inception until September 2025. Footwear with motion control features were classified into commercially available motion control footwear without additional modifications (shoes with dual midsole material) versus non-commercially available footwear incorporating self-manufactured motion control features (shoes with heel flare or wedge). The main difference between these shoe types is how they control foot pronation. The control condition comprised standard (neutral) shoes. The outcome parameters were lower limb kinematics (e.g., peak rearfoot eversion) and kinetics (e.g., peak ankle inversion moment) during running. The modified version of the Downs and Black checklist was used to assess the methodological quality of the included studies. Within and between-group standardized mean differences (SMDs) with 95% confidence intervals (CI) were computed using a random-effects model to elucidate the effects of (i) wearing footwear with motion control features (both commercially available motion control shoes and non commercially available footwear with motion control features) compared to standard shoes (total effects) and (ii) commercially available motion control footwear without additional modifications versus non-commercially available footwear incorporating self-manufactured motion control features (subgroup analysis).

RESULTS: The systematic search revealed 11,623 hits and finally 18 studies were eligible for inclusion of which 14 were used for quantitative analyses. We observed significant total effects of wearing footwear with motion control features versus standard shoes during running on the peak rearfoot eversion angle (six studies; SMDs = – 0.87, 95% CI – 1.38 to – 0.35, p = 0.001, I² = 66%) and the peak knee internal rotation angle (four studies; small SMDs = – 0.30, 95% CI – 2.58 to – 0.0, p = 0.05, I² = 0%). The subgroup analyses revealed significantly lower peak rearfoot eversion in commercially available motion control footwear versus non-commercially available footwear incorporating self-manufactured motion control features (five studies SMDs = – 0.69, 95% CI – 1.19, – 0.18, p = 0.008, I² = 50%). The included studies were rated as moderate methodological quality.

CONCLUSIONS: This study revealed that wearing footwear with motion control features versus standard shoes has the potential to control rearfoot eversion and proximal segment motion in adults. The findings showed that wearing commercially available footwear with motion control features has extra benefits compared with non-commercially available motion control footwear. The observed findings for peak rearfoot eversion angle were statistically significant and clinically relevant. Nevertheless, more high-quality research is needed to elucidate the effects of footwear with motion control features application on running kinematics and kinetics as well as lower limb muscular activation.

PMID:41269461 | DOI:10.1186/s40798-025-00949-z

Jpn J Ophthalmol. 2025 Nov 21. doi: 10.1007/s10384-025-01306-z. Online ahead of print.

ABSTRACT

PURPOSE: To investigate the association between best-corrected visual acuity (BCVA) and sarcopenia in older adults, while the relationship between low visual acuity and age-related muscle decline remains unclear.

STUDY DESIGN: Cross-sectional study.

METHODS: This cross-sectional study included 874 participants in the Kyotango Longevity Cohort Study from August 2017 to June 2022. We analyzed the association between best-corrected visual acuity (BCVA) and the presence of sarcopenia, grip strength, gait speed, and skeletal muscle index (SMI) in older adults. Logistic regression analyses were performed with sarcopenia as the dependent variable and visual acuity as the independent variable, adjusted for age, sex, body mass index (BMI), HbA1c, smoking, exercise, and alcohol consumption. Decimal BCVA was converted to the logarithm of the minimum angle of resolution (logMAR) for statistical analyses.

RESULTS: This cross-sectional study comprised 356 men and 518 women, with a median age of 72.0 years (range: 65-98 years). The prevalence of sarcopenia was 6.7% (24 cases) in the men and 5.2% (27 cases) in the women. Multivariate logistic regression analysis revealed a significant association between low visual acuity and sarcopenia for both sexes [odds ratio: 1.86, 95% confidence interval (CI): 1.23-2.81, p = 0.002 for men, and odds ratio: 1.45, 95% CI: 1.01-2.02, p = 0.038 for women).

CONCLUSIONS: This study demonstrates a significant relationship between lower visual acuity and sarcopenia. These findings support maintaining visual acuity to prevent age-related decline of physical functions.

PMID:41269445 | DOI:10.1007/s10384-025-01306-z