Category: Statistics

Diagn Interv Radiol. 2026 Jul 17. doi: 10.4274/dir.2026.263984. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the real-world multimetric performance of four commercially available computed tomography (CT)-based artificial intelligence (AI) solutions for acute intracranial hemorrhage (AIH).

METHODS: Patients who underwent non-contrast brain CT for suspected AIH in our emergency room between February and March 2024 were screened. After applying the inclusion and exclusion criteria, 436 CT scans were included in the final analysis. Three neuroradiologists established the ground truth for AIH and hemorrhage volume. For detection performance, the area under the receiver operating characteristic curve (AUROC), area under the precision-recall curve (AUPRC), and Brier score were calculated based on the available probability score, whereas sensitivity, specificity, precision, and F1 score were calculated based on binary classification. Bland-Altman analysis was performed to assess volumetric agreement for AIH between each algorithm’s calculations and the neuroradiologists’ measurements.

RESULTS: A total of 436 patients (mean age, 62 years ± 20; male patients, 209) were enrolled. The AUROC (0.96 to 0.99) and sensitivity (0.85 to 0.92) were high across all solutions, with no statistically significant differences in pairwise comparisons (P > 0.05). However, solution B demonstrated the highest AUPRC [0.98, 95% confidence interval (CI): 0.94, 1.00] and the lowest Brier score [0.02 (95% CI: 0.02, 0.03)]. In binary performance, both solutions B and D exhibited significantly higher specificity (1.00 and 0.99), precision (0.90 to 0.98), and F1 score (0.87 to 0.94) than the other solutions (P < 0.05). For volumetric agreement of AIH, solution D showed the lowest mean difference [-0.87 mm³ (95% CI: -1.47, -0.27)] and the narrowest limits of agreement (-13.4 to 11.6) relative to the neuroradiologists’ measurements.

CONCLUSION: In a real-world emergency setting, all four commercially available CT-based AI solutions for AIH demonstrated uniformly excellent performance; however, meaningful differences emerged in confirmatory performance and volumetric agreement. These distinct, algorithm-specific trade-offs provide practical guidance for selecting and integrating appropriate AI solutions to improve AIH diagnosis and management workflows.

CLINICAL SIGNIFICANCE: The algorithm-specific performance trade-offs identified in this study suggest that no single AI solution is universally optimal; solutions with superior confirmatory performance may reduce unnecessary notifications in high-volume emergency settings, whereas those with more consistent volumetric agreement may better support treatment planning and longitudinal monitoring. A structured, multimetric evaluation aligned with institutional priorities is essential for evidence-based AI procurement in acute stroke imaging.

PMID:42464524 | DOI:10.4274/dir.2026.263984

Arthritis Rheumatol. 2026 Jul 16. doi: 10.1002/art.70277. Online ahead of print.

ABSTRACT

OBJECTIVE: To characterize the long-term clinical course of children with hematologic non-criteria manifestations and persistent antiphospholipid antibodies (aPL), and to identify predictors of progression to antiphospholipid syndrome (APS) and/or systemic lupus erythematosus (SLE).

METHODS: We conducted a prospective cohort study of children (<18 years) with persistent aPL positivity and hematologic involvement (thrombocytopenia, autoimmune hemolytic anemia [AIHA], or Evans syndrome) followed at a tertiary pediatric rheumatology center between 1995 and 2024, with follow-up extending into adulthood. Progression to clinically classifiable APS and/or SLE was the primary endpoint. Kaplan-Meier and Cox proportional hazards models evaluated predictors at presentation and in complementary time-dependent analyses.

RESULTS: Among 42 enrolled children, 40 were evaluable, of whom 11 (27.5%) progressed to APS and/or SLE. Evans syndrome at presentation was associated with the highest hazard of progression compared with isolated thrombocytopenia (HR 6.21, 95% CI 1.46-26.41). In time-dependent analyses, Evans syndrome emerging during follow-up remained associated with progression. Isolated thrombocytopenia showed the lowest risk, whereas AIHA represented an intermediate state that did not independently predict progression. Lupus anticoagulant was nearly universal, and broader high-risk aPL profiles were more common among progressors but were not statistically significant.

CONCLUSION: In children with persistent aPL positivity, Evans syndrome was the hematologic phenotype most strongly associated with progression to APS and/or SLE, whereas isolated thrombocytopenia followed a largely indolent course. Evolving hematologic phenotypes may improve risk stratification and inform long-term monitoring strategies within the APS-SLE spectrum.

PMID:42463986 | DOI:10.1002/art.70277

Ophthalmol Ther. 2026 Jul 16. doi: 10.1007/s40123-026-01435-9. Online ahead of print.

ABSTRACT

INTRODUCTION: This prospective randomized controlled trial aims to evaluate the effectiveness and safety of a 180° nuclear flip technique in phacoemulsification cataract surgery, comparing it with the traditional endocapsular approach for cataracts of Emery-Little grade III and below.

METHODS: A total of 142 patients were randomly assigned to either the 180° nuclear flip group (n = 71) or the conventional endocapsular phacoemulsification group (n = 71). The primary outcomes measured were total phacoemulsification time (TPT) and effective phacoemulsification time (EPT). Secondary outcomes were the incidence of postoperative corneal endothelial cell loss (ECL) at 7 and 28 days, as well as intraoperative complications including posterior capsule rupture (PCR).

RESULTS: The mean TPT was substantially shorter in the flip group (43.75 ± 17.16 s) compared to the conventional group (58.45 ± 22.27 s) (P < 0.0001). Similarly, the mean EPT was also significantly reduced in the flip group (11.08 ± 5.25 s vs. 14.87 ± 8.54 s, P = 0.0046). There were no PCR cases in the flip group, whereas there was one case (1.4%) in the traditional group. At 28 days postoperatively, the mean ECL rate of the flip group (3.7%) was lower than that of the conventional group (4.9%), although this difference did not reach statistical significance.

CONCLUSION: The 180° nuclear flip technique is a safe, efficient, and effective method for managing cataracts of grade III hardness and below. It may help reduce the risk of complications, improves intraoperative stability by creating a more spacious operating field, and significantly reduces phacoemulsification time. Video available for this article.

TRIAL REGISTRATION: chictr.org.cn identifier, ChiCTR2500105241.

PMID:42463970 | DOI:10.1007/s40123-026-01435-9

Npj Ment Health Res. 2026 Jul 16;5(1):35. doi: 10.1038/s44184-026-00231-4.

ABSTRACT

The causal role of established risk factors for premenstrual disorders (PMDs) remains unclear. We used Mendelian randomization (MR) to assess causality for eight known-risk factors identified through a literature review. Summary statistics for these risk factors were from genome-wide association studies (GWAS) with sample size ranging from 129,017 to 1.2 million, and for PMDs from a GWAS of 72,297 participants. Findings were validated using one-sample MR in LifeGene cohort (n = 5674-5937). In two-sample MR, genetic liability to smoking initiation (OR = 1.25 (1.10-1.43)), earlier menarche (OR = 0.94 (0.89-0.98) per year), and higher BMI (OR = 1.19 (1.05-1.34) per kg/m²) were associated with PMD risk. No causal association was indicated for anemia, childhood abuse, childhood asthma, diabetes, and endometriosis. In one-sample MR, point estimates for BMI (OR = 1.10 (0.88-1.38) per kg/m²) and earlier menarche (OR = 0.98 (0.83-1.15) per year) were directionally consistent with the two-sample MR findings, but the confidence intervals included null effects. However, a null association was observed for smoking (OR = 0.94 (0.77-1.16)). The two-sample MR supports causal role of earlier menarche, higher BMI, and smoking in risk of PMDs. The lack of replication in one-sample MR highlights the need for triangulating evidence from future well-powered and methodologically comparable studies to strengthen these findings.

PMID:42463960 | DOI:10.1038/s44184-026-00231-4

Heredity (Edinb). 2026 Jul 16. doi: 10.1038/s41437-026-00861-6. Online ahead of print.

ABSTRACT

A Bayesian hybrid inference method is developed which infers hybrids and backcrosses across two generations using sampled genomes from two populations. The method improves on that of Chakraborty and Rannala (2023) by accounting for uncertainty of population haplotype frequencies and correctly marginalizing over haplotypes while still modeling linkage and recombination across the genome. In analyses of simulated data the new method produced posterior probabilities nearly identical to the method of Chakraborty and Rannala (2023) when sample sizes were large. For small sample sizes, posterior probabilities produced by the new method tended to be lower as expected since it accounts for additional uncertainties of population haplotype frequencies. Statistical performance of the new method as measured by the ROC (Receiver Operating Characteristic) curve appears equivalent to that of Chakraborty and Rannala (2023). The new method is applied to three recently published datasets for populations of kiwifruit (genus Actinidia), plateau fence lizard (Sceloporus tristichus) and puma (Puma concolor).

PMID:42463958 | DOI:10.1038/s41437-026-00861-6

Arch Gynecol Obstet. 2026 Jul 16. doi: 10.1007/s00404-026-08491-3. Online ahead of print.

ABSTRACT

OBJECTIVE: Poor responders pose a significant challenge in fertility treatment, leading to decreased oocyte quality and fertilization rates. Assisted oocyte activation (AOA) has emerged as a method to improve fertilization rates. This study aims to evaluate the effect of AOA on fertilization, pregnancy, and live birth rates in patients with diminished ovarian reserve.

MATERIALS AND METHODS: This prospective non-randomized comparative study included a cohort of infertility patients with diminished ovarian reserve, divided into three groups: the control group receiving standard treatment (Group I/Conventional ICSI), the electrical activation group undergoing piezoelectric stimulation (Group II/ICSI + Piezoelectric), and the chemical activation group treated with calcium ionophore (Group III/ICSI + Calcium Ionophore). Each group consisted of 50 patients. The effects of electrical and chemical activation applied after ICSI on fertilization, pregnancy, and live birth rates were evaluated.

RESULTS: There were no statistically significant differences among the groups in hormone levels (FSH, LH, E2, PRL, and AMH), number of oocytes, or number of MII oocytes. Fertilization rates were significantly higher in the piezoelectric group compared to the control group (p = 0.007). Although the fertilization rate in the calcium ionophore group was higher than that in the control group, this difference did not reach statistical significance (p = 1.000). There was no statistically significant difference in fertilization rates between the piezoelectric and calcium ionophore groups (p = 0.071). Regarding pregnancy rates, the highest implantation rate was observed in the calcium ionophore group (37%), but this difference does not reach statistical significance (p = 0.224). No significant differences were observed among the groups in embryo quality, clinical pregnancy, ongoing pregnancy, and live birth rates.

CONCLUSION: In patients classified as diminished ovarian reserve, artificial oocyte activation (AOA) was associated with higher fertilization rates for increasing fertilization rates, potentially resulting in a greater number of fertilized oocytes and transferable embryos. However, this apparent benefit does not translate into improved biochemical pregnancy outcomes. Moreover, no significant differences were observed between groups in terms of embryo quality, clinical pregnancy, ongoing pregnancy, and live birth rates. These findings suggest that while AOA may enhance early laboratory outcomes, its impact on clinically meaningful reproductive endpoints remains limited. Therefore, further adequately powered randomized studies are required to clarify the efficacy and safety of AOA.

PMID:42463955 | DOI:10.1007/s00404-026-08491-3

Discov Nano. 2026 Jul 17;21(1):348. doi: 10.1186/s11671-026-04808-y.

ABSTRACT

Nanobiomaterials have emerged as critical platforms for modern therapeutics, offering targeted delivery, controlled release, and improved performance. Among these, polymeric PLGA nanoparticles (PLGA-NPs) are widely studied due to their tailorability, biocompatibility, biodegradability, and regulatory acceptance. However, their clinical translation depends on robust manufacturing approaches that support scalability, reproducibility, and continuous manufacturing. Conventional methods, such as high-shear homogenization, suffer from limitations, including high energy input, process sensitivity, and contamination risk. This study presents a comprehensive experimental and statistical approach to systematically compare three PLGA-NPs preparation methods: high-shear homogenization (HSH), dual centrifugation (DC), and high-pressure homogenization (HPH). A full factorial Design of Experiments (DoE) combined with Response Surface Methodology (RSM) evaluated the effects of formulation and process parameters, including PVA and PLGA concentrations, homogenization speed, bead diameter, and pressure on Critical Quality Attributes (CQAs; particle size, polydispersity index, and zeta potential). HSH produced uniform nanoparticles with narrow size distribution but was highly process-sensitive. DC showed more variability in results, while HPH achieved consistent results. PVA concentration was the dominant factor across all methods. In conclusion, DC and HPH emerged as viable candidates for scalable nanoparticles manufacturing.

PMID:42463954 | DOI:10.1186/s11671-026-04808-y

Behav Res Methods. 2026 Jul 16;58(8):240. doi: 10.3758/s13428-026-03112-y.

ABSTRACT

Experience sampling via mobile devices enables unprecedented insights into daily life. However, individual studies often cannot answer research questions conclusively, and open data are scattered across repositories in different formats. This impedes research into robustness, generalizability, and heterogeneity. We address this issue by introducing openESM, an open-source database of openly available experience sampling datasets in a harmonized format. The growing database currently comprises 60 datasets with more than 16,000 participants and more than 740,000 observations. Metadata can be searched via our website ( openesmdata.org ) to select and download datasets via packages in R and Python. We demonstrate the potential of openESM through an analysis of within-person correlations of positive and negative affect in 39 datasets, providing evidence for a large negative momentary correlation ( $–0.49$ , 95% CI: [ $–0.54$ , $–0.42$ ]). We end by discussing the design principles that will allow openESM to become a continuously evolving community resource for cumulative experience sampling research.

PMID:42463898 | DOI:10.3758/s13428-026-03112-y

Commun Med (Lond). 2026 Jul 16. doi: 10.1038/s43856-026-01664-w. Online ahead of print.

ABSTRACT

BACKGROUND: Endophthalmitis is a blinding complication following any invasive ocular procedure, and historical treatment guidelines do exist but only for cataract surgery cases. To the best of our knowledge, no randomised controlled trial evidence exists to answer the question of early vitrectomy surgery for the treatment of endophthalmitis following any eye surgery.

METHODS: We conducted a multicentre, national prospective randomized controlled clinical (RCT) trial aimed to assess the feasibility of randomizing patients to an early vitrectomy (Arm-A) intervention within 48-96 hours compared to current standard patient care of repeated, immediate intravitreal antibiotic injection (Arm-B) and delayed vitrectomy. There was no blinding or masking conducted in the trial. The key inclusion criteria were: over 18 years of age; confirmed diagnosis of POE at any time-point following an ocular surgery, procedure, or injection; symptomatic visual loss attributable to POE; best corrected visual acuity (VA) worse than 35 ETDRS letters, including counting fingers, hand motions and perception of light vision. The key exclusion criteria were: known adverse reaction to intravitreal antibiotics (amikacin/vancomyin/cephalosporins); optic atrophy in study eye; corneal oedema or haze that would prevent visualisation of fundus to perform vitrectomy surgery. The primary outcome measure was, the feasibility and acceptability of carrying out a RCT of early surgical treatment compared to standard treatment for POE.

CLINICALTRIALS: gov NCT04522661 (13/08/2020).

RESULTS: Here we show that the study is feasible and meets the primary endpoint whereby 63 participants are randomized at 79% recruitment rate. Median change in VA (IQR) as per-protocol from baseline-to-week 24 was 40 (28-70) letters in Arm-A (n = 24) versus 13 (0-66) letters in Arm-B (n = 25); corresponding to a between-group difference of 24 letters, adjusted for baseline, in favour of early vitrectomy (p = 0.139). Higher rate of non-serious adverse events observed in Arm-B (68%) compared to Arm-A (47%), with higher incidence of retinal detachment 8 cases (24%) in Arm-B versus 2 cases in Arm-A (6.7%).

CONCLUSIONS: The EVIAN trial meets the primary endpoint demonstrating feasibility in conducting a trial to randomize the target population at multiple eye centres. Although not statistically significant, the effect on VA change indicates a potential meaningful benefit of vitrectomy compared to standard of care treatment, which can now be tested in a definitive phase 3 clinical trial.

PMID:42463897 | DOI:10.1038/s43856-026-01664-w

Commun Med (Lond). 2026 Jul 16;6(1):397. doi: 10.1038/s43856-025-01272-0.

ABSTRACT

BACKGROUND: Data science methods can provide novel and pragmatic approaches for preventing and controlling non-communicable diseases (NCDs) in Africa. This study highlights current efforts, opportunities, and challenges in leveraging data science methods to accelerate and advance the prevention and control of NCDs in Africa.

METHODS: We undertake a systematic review and gap analysis, as registered in PROSPERO (CRD42023406237).

RESULTS: Our findings suggest several data science methods have been used in research across the four leading NCDs in Africa. However, limited information exists on their application to improve disease surveillance, risk factor identification and characterization, prevention, treatment, drug discovery and rehabilitation. Machine learning outperforms traditional statistical methods in improving risk stratification in most studies (80.8%) designed for the prevention and control of NCDs. Notwithstanding, most (76.0%) data science techniques for NCDs prevention and control remain in the exploratory research phase, with limited clinical or public health application and minimal impact on the African population. There are critical gaps along the continuum of data generation, data quality, method development, and validation, which may be attributed to inadequate funding, capacity development, policy shortcomings, and infrastructure deficits. Considerable gaps exist in intra-African collaboration, data sharing, and replication, which hinder the cross-cultural replication and applicability of data science methods for NCDs prevention and control in Africa.

CONCLUSIONS: Multi-sectoral interventions that promote interdisciplinary capacity building, investment, and knowledge linkages, taking into account indigenous epistemologies, are needed to harness the enormous potential of data science to accelerate the prevention and control of NCDs in Africa.

PMID:42463895 | DOI:10.1038/s43856-025-01272-0