Category: Statistics

Respir Res. 2026 Apr 28. doi: 10.1186/s12931-026-03656-9. Online ahead of print.

NO ABSTRACT

PMID:42045892 | DOI:10.1186/s12931-026-03656-9

Clin Transl Sci. 2026 May;19(5):e70531. doi: 10.1111/cts.70531.

ABSTRACT

Chronic kidney disease (CKD) is closely associated with systemic inflammation. This randomized controlled trial aimed to evaluate the effects of omega-3 fatty acids supplementation on inflammatory markers in patients with CKD undergoing hemodialysis. Eligible participants with CKD receiving hemodialysis were randomly assigned to either an intervention group or a control group. The intervention group received three capsules of omega-3 fatty acids (3 g/day) for two months, while the control group received placebo capsules containing medium-chain triglyceride (MCT) oil. Inflammatory markers, including C-reactive protein (CRP) and interleukin-6 (IL-6), were measured both before and after the interventions. The results showed that CRP levels increased from 9.86 ± 12.64 to 11.46 ± 22.23 mg/L in the intervention group and from 5.24 ± 9.01 to 5.61 ± 7.93 mg/L in the control group (p = 0.11). Similarly, IL-6 levels increased from 17.84 ± 14.08 to 81.82 ± 66.22 pg/mL in the intervention group and from 14.96 ± 18.41 to 56.73 ± 115.45 pg/mL in the control group (p = 0.53). No statistically significant group differences were observed after adjusting for confounders such as age, sex, body mass index (BMI), smoking, dietary intake, and pre-existing diseases. The study findings showed that a two-month intake of omega-3 fatty acids supplements did not have a significant impact on reducing the levels of inflammatory markers in CKD patients undergoing hemodialysis. Larger trials with longer durations are warranted. Study Highlights What is the Current Knowledge on the Topic? ○ Omega-3 fatty acids have anti-inflammatory properties and are reported to be potentially beneficial in reducing inflammation associated with CKD, but the evidence regarding the effectiveness of omega-3 supplements in reducing inflammatory markers in this population remains inconsistent. What Question did this Study Address? ○ What is the effect of omega-3 fatty acids supplementation for 2 months on CRP and IL-6 levels in patients with CKD undergoing hemodialysis? What Does This Study Add to Our Knowledge? ○ Contrary to previous studies, this study found that omega-3 fatty acids supplementation did not significantly reduce CRP or IL-6 levels compared with placebo over 2 months and that short-term supplementation is not sufficient to reduce systemic inflammation in hemodialysis patients. How Might this Change Clinical Pharmacology or Translational Science? ○ These findings suggest that short-term omega-3 fatty acids supplementation may not be sufficient in reducing inflammatory markers in CKD patients undergoing hemodialysis and highlight the need for larger-scale clinical trials with different doses and longer durations to investigate nutritional or pharmacological strategies.

PMID:42045798 | DOI:10.1111/cts.70531

Eur J Dent Educ. 2026 Apr 27. doi: 10.1111/eje.70175. Online ahead of print.

ABSTRACT

INTRODUCTION: Dental caries remains a major public health issue worldwide, particularly among children. Pit and fissure sealants represent a high-quality, evidence-based preventive measure. However, ensuring the reliability of their application by newly graduated intern dental students trained through tele-education remains an emerging area of growing interest. Thus, the current study aimed to assess the clinical success of pit and fissure sealants placed by intern dental students following tele-demonstration training compared to traditional training approaches.

MATERIALS AND METHODS: This randomized controlled trial involved 100 mandibular first permanent molars in 50 children aged 7 to 9 years, treated by 20 dental interns assigned to two groups using a split-mouth design. One group received direct clinical demonstration, while the other received tele-education via a pre-recorded video. Sealant retention and marginal discolouration were assessed after a 3-month period.

RESULTS: There was no statistically significant difference in sealant retention (p = 0.766) or marginal discolouration (p = 1.000) between the two studied groups. The tele-education group had a slightly higher relative risk, but this was not clinically significant.

CONCLUSION: Tele-demonstration can be used as a supplementary instructional modality for training dental interns in preventive procedures, reinforcing the use of innovative teaching tools while ensuring safe and high-quality patient care.

PMID:42045787 | DOI:10.1111/eje.70175

Clin Transl Sci. 2026 May;19(5):e70562. doi: 10.1111/cts.70562.

ABSTRACT

Reliable biomarkers that enable noninvasive, longitudinal assessment of disease activity and therapeutic response remain a major unmet need in inflammatory bowel disease (IBD). While colonic biopsies are the gold standard for evaluating mucosal inflammation, their invasive nature and limited spatial and temporal resolution constrain their utility in routine monitoring and clinical trials. Blood-based biomarkers offer a complementary approach, providing minimally invasive, readily accessible measures that can be repeatedly sampled over time. Emerging blood-derived signatures, including gene expression profiles and circulating molecular inflammation scores, capture systemic immune activity and have shown promise in predicting treatment response, disease flares, and pharmacodynamic (PD) effects of therapies. Recent advances utilizing multi-omics technologies and machine learning methods have further improved the predictive performance of blood-based biomarkers, particularly in the context of biologic therapies such as anti-tumor necrosis factor agents. Despite these advances and growing promises, challenges related to validation, standardization, and clinical integration persist. This review focused on recent advances in blood-based biomarkers for IBD, with an emphasis on their use in predicting treatment response and assessing pharmacodynamic effects in clinical trials.

PMID:42045784 | DOI:10.1111/cts.70562

Zhonghua Fu Chan Ke Za Zhi. 2026 Apr 25;61(4):305-315. doi: 10.3760/cma.j.cn112141-20250930-00466.

ABSTRACT

Objective: To explore the baseline demographic characteristics of women seeking induced abortion, the proportion of repeat induced abortion, the trend from 2019 through 2021 and risk factors of repeat induced abortions within the framework of the Prospective Cohort of Induced Abortion and Future Pregnancy Outcomes. Methods: Based on the Prospective Cohort of Induced Abortion and Future Pregnancy Outcomes, women seeking abortion due to unwanted pregnancy were recruited from 10 clinical research centers across the country, and a structured questionnaire was used to collect information on age, marital status, pregnancy and childbirth status, and induced abortion and so on. Baseline data of subjects recruited from the beginning of the cohort in 2019 to the end of 2021 were extracted for this study, and were statistically analyzed using the SPSS 22.0 software. χ² test was used to compare the differences between years and characteristics associated with repeat induced abortion, linear by linear association test was used for the trend test, and logistic regression analysis was performed to identify risk factors of repeat induced abortion. Results: A total of 8 990 women with complete key baseline information from the beginning of the cohort in 2019 to the end of 2021 were included in this study. (1) The average age at the time of induced abortion was (28.9±5.1) years (range: 16-49 years); among all these women, 64.2% (5 776/8 990) were aged 25-34 years, 27.8% (2 496/8 990) were unmarried, 70.9% (6 378/8 990) had junior college or above educational background, and 48.8% (4 391/8 990) were clerks (including teachers, doctors, civil servants, etc.). (2) The proportion of repeat induced abortion was 43.3% (3 897/8 990), with no statistical significance between different years (P>0.05). (3) Age, marital status, education, occupation, smoking, alcohol consumption, number of children and reason for current unintended pregnancy were independent risk factors for repeat induced abortion (all P<0.05). The strongest factors associated significantly with repeat induced abortion were: age≥40 years (OR=17.249, 95%CI: 9.535-31.203), remarried, divorced or widowed (OR=2.209, 95%CI: 1.595-3.059), frequency of alcohol consumption>1 drink/week (OR=2.098, 95%CI: 1.239-3.550), frequency of smoking≥5 cigarettes/day (OR=1.938, 95%CI: 1.267-2.966), number of children≥2 (OR=1.643, 95%CI: 1.356-1.992), master’s degree or higher education level (OR=0.351, 95%CI: 0.267-0.460). Conclusions: The 2019 to 2021 baseline information of the cohort reveals the characteristics of women seeking abortions, with the situation of repeated induced abortion still serious. Women who are with advanced maternal age, low educational level, unstable marital status, unemployed, smoking, drinking, with high frequency of sexual exposure, having more children, and using contraception but contraceptive failure in current unintended pregnancy carry an increased risk of repeat induced abortions. There is an urgent need for effective tertiary prevention interventions for unintended pregnancy and subsequent induced abortion, including early and universal access to sexual and reproductive health education, contraceptive delivery services, postpartum contraceptive services and emergency contraceptive services, and sustaining and strengthening post abortion care services. Promoting consistent and correct use of highly effective contraception is critical.

PMID:42045781 | DOI:10.3760/cma.j.cn112141-20250930-00466

Zhonghua Fu Chan Ke Za Zhi. 2026 Apr 25;61(4):289-304. doi: 10.3760/cma.j.cn112141-20250905-00411.

ABSTRACT

Objective: To evaluate the screening efficiency of gene DNA methylation testing, p16 staining, human papillomavirus (HPV) genotyping, and liquid-based cytology (LBC), and their combined strategies in self-collected high-risk HPV (HR-HPV) positive individuals. Methods: This study analyzed a subset of data from a free self-sampling cervical cancer screening program conducted in Baise, Guangxi Zhuang Autonomous Region (from May 2023 to April 2024). HR-HPV positive self-collected cases with complete data and quality control were included. Using the triage strategy recommended by the 2019 American Society for Colposcopy and Cervical Pathology (ASCCP) risk-based management guideline and the Chinese cervical cancer screening guideline [ie, HPV16/18 positivity and (or) LBC of atypical squamous cell of undetermined significance (ASCUS) or worse] as reference standard, the sensitivity, specificity, colposcopy referral rate, and the number needed to colposcopy (NNC) of various secondary triage approaches were assessed. Results: (1) A total of 777 HR-HPV positive women with complete data were analyzed. (2) Methylation positivity was significantly higher in high-risk group HPV16/18 (20.5%, 25/122) and high-intermediate-risk group HPV31/33/35/45/52/58 (17.2%, 66/381) than that in the low-risk group HPV39/51/56/59/66/68 (9.6%, 26/371; χ²=8.85 and χ²=7.59, P=0.003 and P=0.006). (3) Methylation positivity of cervical intraepithelial neoplasia (CIN)Ⅲ and cervical cancer cases (67.5%, 27/40) was significantly higher than CINⅠ cases (12.9%, 31/240), and CINⅡ cases (16.4%, 12/73), with statistically significant differences (P<0.05). The p16 positivity increased with lesion severity in all pairwise comparisons (P≤0.005 after correction). (4) When the guideline-recommended triage strategy [HPV16/18 positivity and (or) LBC≥ASCUS] was applied to this study population, using colposcopy-directed biopsy pathology as the reference standard, the sensitivity and specificity for detecting CINⅡ⁺ and CINⅢ⁺ were 69.03%, 65.21%, and 95.00%, 63.23%, respectively; the colposcopy referral rate was 39.77% (309/777), and NNC was 3.96 for CINⅡ⁺ and 8.13 for CINⅢ⁺. (5) Methylation performance: for CINⅡ⁺, sensitivity was 34.51% and specificity was 88.25%; for CINⅢ⁺, sensitivity was 67.50% and specificity was 87.79%. (6) p16 performance: the sensitivity for detecting CINⅡ⁺ and CINⅢ⁺ were 72.57% and 92.50%, respectively, which did not differ significantly from the guideline-recommended strategy (all P>0.05), whereas the specificity for CINⅡ⁺ and CINⅢ⁺ were 68.67% and 65.60%, respectively, similar to the guideline-recommended strategy (all P>0.05). The colposcopy referral rate was lower with p16 testing alone compared with the guideline-recommended strategy [37.32% (290/777) vs 39.77%; P>0.05]. (7) Combined strategy 3a achieved a sensitivity of 63.72% for detecting CINⅡ⁺, which was similar to the guideline-recommended strategy (P=0.109), and a sensitivity of 95.00% for detecting CINⅢ⁺, identical to that of the guideline-recommended strategy. The specificity of strategy 3a for CINⅡ⁺and CINⅢ⁺ were 70.18% and 68.52%, respectively, both significantly higher than those of the guideline-recommended strategy (χ²=9.75 and 12.56, all P<0.01). The colposcopy referral rate for strategy 3a was significantly lower than that of the guideline-recommended strategy [34.75% (270/777) vs 39.77%; P<0.001], with corresponding NNC of 3.75 for CINⅡ⁺ and 7.11 for CINⅢ⁺. Strategy 5a showed a sensitivity of 64.60% for detecting CINⅡ⁺, which was not significantly different from that of the guideline-recommended strategy (64.60% vs 69.03%; χ²=3.20, P=0.074), and a sensitivity of 95.00% for CINⅢ⁺, identical to that of the guideline-recommended strategy. The specificity of strategy 5a for CINⅡ⁺ and CINⅢ⁺ were 75.30% and 73.00%, respectively, both significantly higher than the guideline-recommended strategy (both P<0.001). NNC for strategy 5a was 3.25 for CINⅡ⁺ and 6.24 for CINⅢ⁺, both lower than those of the guideline-recommended strategy (3.96 and 8.13, respectively). The colposcopy referral rate for strategy 5a was also significantly lower than that of the guideline-recommended strategy [30.50% (237/777) vs 39.77%; χ²=70.01, P<0.001]. Conclusions: Among self-collected, high-risk HPV-positive individuals, combined triage strategies that integrate HPV genotyping with cytology, p16 staining and methylation testing, specifically strategy 3a and 5a, offer comparable sensitivity with superior specificity and lower referral rates versus co-testing for detecting CINⅡ⁺ and CINⅢ⁺.

PMID:42045780 | DOI:10.3760/cma.j.cn112141-20250905-00411

BioDrugs. 2026 Apr 27. doi: 10.1007/s40259-026-00779-9. Online ahead of print.

ABSTRACT

BACKGROUND: Only a minority of patients with advanced gastric cancer (GC) or esophagogastric junction (EGJ) adenocarcinoma derive durable benefit from anti-programmed cell death 1 (PD-1) therapy. However, reliable biomarkers for real-world clinical decision-making remain limited.

OBJECTIVE: To identify tumor site-specific genomic alterations associated with outcomes of nivolumab monotherapy in a nationwide real-world cohort.

METHODS: We conducted a retrospective nationwide analysis using Japan’s Center for Cancer Genomics and Advanced Therapeutics (C-CAT) registry, including patients with GC and EGJ cancer adenocarcinoma treated with nivolumab monotherapy (July 2019-April 2024). Primary endpoints were time to treatment failure (TTF) and overall survival (OS), defined as the interval from nivolumab initiation to death from any cause; objective response rate (ORR) was secondary. Gene-level alteration indicators were derived from vendor-reported tumor-only panel calls across multiple platforms and filtered for clonal hematopoiesis of indeterminate potential (CHIP)-like variants (variant allele frequency < 0.05). Multivariable models adjusted for age and sex were fitted separately for GC and EGJ cancer. Variant pathogenicity was based on available panel annotations; therefore, gene-level results should be interpreted as exploratory findings.

RESULTS: Among 798 patients with GC and 114 patients with EGJ cancer adenocarcinoma, median TTF/OS/ORR were 3.98 months/20.2 months/11.7% in GC and 4.80 months/24.7 months/14.9% in EGJ cancer adenocarcinoma. In GC, ASXL1 mutation remained independently associated with longer TTF (hazard ratio [HR] 0.59, 95% confidence interval [CI] 0.37-0.94) after adjustment and CHIP filtering. For OS, microsatellite instability-high [MSI-H] (HR 0.16, 95% CI 0.04-0.70) and FANCG (HR 0.37, 95% CI 0.16-0.87) were associated with longer OS, whereas CDH1 (HR 1.51, 95% CI 1.10-2.05) was associated with shorter OS. In EGJ cancer adenocarcinoma, NTRK1 mutation correlated with longer TTF (HR 0.31, 95% CI 0.10-0.98) and MUTYH with shorter OS (HR 5.68, 95% CI 2.04-15.81), both exploratory.

CONCLUSIONS: In this large Japanese real-world cohort, genomic associations with nivolumab outcomes differed by tumor site. In gastric cancer, ASXL1 mutation was associated with prolonged treatment benefit under PD-1 blockade, while CDH1 and FANCG showed exploratory associations with OS. These findings warrant further validation in prospective and platform-controlled analyses.

PMID:42045774 | DOI:10.1007/s40259-026-00779-9

J Imaging Inform Med. 2026 Apr 27. doi: 10.1007/s10278-026-01966-4. Online ahead of print.

ABSTRACT

Lumbar intervertebral disc degeneration (LIDD) is a leading cause of low back pain, with subtle and variable imaging features that challenge early diagnosis. This study aimed to develop and validate a rigorous MRI-based radiomics ensemble model for disc-level LIDD discrimination, using the patient as the primary sampling unit, with explicit statistical correction for the non-independence of multiple lumbar discs from the same patient. This retrospective single-center study enrolled 122 subjects (102 LIDD patients and 20 healthy controls), contributing a total of 610 lumbar discs. Regions of interest (ROIs) of intervertebral discs were manually segmented on fat-suppressed T2-weighted imaging (FS-T2WI) sequences, and 1409 Image Biomarker Standardization Initiative (IBSI)-compliant radiomic features were extracted. To account for within-patient clustering of discs, multi-step feature selection was performed in the patient-level split training set, including Generalized Estimating Equations (GEE), Benjamini-Hochberg FDR correction, Spearman correlation-based redundancy removal, and L1-regularized logistic regression. Three base classifiers (logistic regression (LR), random forest (RF), radial basis function SVM) and a soft-voting ensemble model were trained with patient-level fivefold group cross-validation to avoid data leakage. Model performance for disc-level LIDD diagnosis was evaluated via AUC, accuracy, sensitivity, and specificity in an independent patient-level test set, with SHapley Additive exPlanations (SHAP) for model interpretability. A compact, reproducible radiomic signature was derived from the final selected features. All models achieved excellent diagnostic performance in the independent test set: RF (AUC = 0.966, 95% CI: 0.937-0.988), SVM (AUC = 0.974, 95% CI: 0.949-0.992), and LR (AUC = 0.974, 95% CI: 0.949-0.992). The soft-voting ensemble model achieved the best discrimination with an AUC of 0.976 (95% CI: 0.954-0.992), along with balanced sensitivity (88%) and specificity (96%). SHAP analysis identified key intensity- and texture-based radiomic features driving model predictions. The MRI-based radiomics ensemble model, built with rigorous statistical correction for within-patient clustering of discs and patient-level validation, enables accurate and interpretable disc-level LIDD discrimination. This model shows strong promise for assisting the early detection and objective diagnosis of LIDD in clinical practice.

PMID:42045763 | DOI:10.1007/s10278-026-01966-4

Optom Vis Sci. 2026 Apr;103(4):e70049. doi: 10.1002/ovs2.70049.

ABSTRACT

PURPOSE: To analyze trends in malpractice payments made on behalf of U.S. optometrists from 1996 to 2023 using National Practitioner Data Bank (NPDB) data, and to assess whether state-level scope-of-practice expansions are associated with increased liability risk.

METHODS: Publicly available NPDB data were reviewed for malpractice payments involving optometrists between 1996 and 2023. Variables included number and value of payments, provider age, patient demographics, geographic distribution, and allegation category. Nationwide trends were analyzed using the Mann-Kendall test; pre- and post-scope expansion comparisons in 11 states were evaluated using the Mann-Whitney rank-sum test. All monetary values were inflation adjusted to 2023 U.S. dollars.

RESULTS: A total of 1040 malpractice payments were recorded (mean 38.5 cases/year). Mean payment was $220,918 (SD $311,395; range $300-$2.95 million). The average provider age was 43 years; 56% of patients were >50 years old. ‘Failure to diagnose’ accounted for 40% of primary allegations. Inflation-adjusted total payments demonstrated a significant upward trend (p = 0.008) that became nonsignificant after excluding 2021-2023 (p = 0.15). No significant change in annual case numbers was observed (p = 0.28). Among 11 states with expanded optometric authority, no statistically significant increase in malpractice cases occurred post-expansion except in Indiana (p = 0.049). Expanded-scope states mirrored national trends in both payment frequency and amount.

CONCLUSIONS: Malpractice payments involving optometrists remain infrequent and financially modest compared with other health professions, with most claims arising from diagnostic rather than procedural issues. There is no evidence that expanding optometric privileges, including lasers, injections, or oral medications, has increased malpractice risk. Advances in education, technology, and interprofessional collaboration likely underpin this stability. Ongoing monitoring of NPDB data will help ensure that optometry’s growing clinical role continues to align with patient safety and professional accountability.

PMID:42045747 | DOI:10.1002/ovs2.70049

Insights Imaging. 2026 Apr 27;17(1):122. doi: 10.1186/s13244-026-02291-8.

ABSTRACT

OBJECTIVES: To prospectively evaluate the correlation between the attenuation imaging (ATI) parameter and hepatic steatosis in overweight (OW)/obese (OB) children, and to establish normal ATI reference values from a prospectively enrolled cohort of healthy children.

MATERIALS AND METHODS: A total of 653 prospectively enrolled children were categorized into OW, OB, and normal control groups based on body mass index (BMI). Ultrasonographic hepatic steatosis grading and ATI measurements were independently assessed by two radiologists. Hepatic steatosis was graded visually as none, mild, moderate, or severe.

RESULTS: The final study cohort consisted of 97 OW, 292 OB, and 264 control children. Median attenuation coefficient obtained with ATI for normal control group, OW group, and OB group were 0.51, 0.54, and 0.64 dB/cm/MHz, respectively. Statistically significant differences in ATI values were observed among all three groups (all p < 0.001). In the combined OW/OB subgroup, ATI values demonstrated a significant weak to strong positive correlation with age, height, weight, BMI, skin-to-liver distance, serum alanine aminotransferase, aspartate aminotransferase, triglycerides, and uric acid (all p < 0.05). Additionally, ATI values increased stepwise with the severity of hepatic steatosis and showed a statistically significant positive correlation with steatosis grade, with higher grades corresponding to greater ATI values (η² = 0.626, p < 0.001).

CONCLUSIONS: ATI values exhibit a significant stepwise increase across healthy, OW, and OB pediatric cohorts, and correlate with anthropometric/metabolic profiles and ultrasonographic steatosis severity. This evidence positions ATI as a non-invasive tool to grade severity and monitor treatment response in metabolic-associated steatotic liver disease.

CRITICAL RELEVANCE STATEMENT: ATI shows significant increases across pediatric weight groups, correlating with metabolic profiles and steatosis severity, positioning it as a non-invasive metabolic-associated steatotic liver disease assessment tool.

KEY POINTS: The ATI value increased significantly in a stepwise manner from healthy controls to OW and OB children, confirming its sensitivity to fat-related liver changes. ATI correlates significantly with most metabolic and anthropometric parameters in OW and OB children, suggesting its utility in reflecting metabolic status. ATI values increase progressively with hepatic steatosis severity and show a strong positive correlation with ultrasonographic steatosis grade.

PMID:42045745 | DOI:10.1186/s13244-026-02291-8