Category: Statistics

JAMA Netw Open. 2026 Feb 2;9(2):e2559670. doi: 10.1001/jamanetworkopen.2025.59670.

ABSTRACT

IMPORTANCE: Despite recommendations to begin human papillomavirus (HPV) vaccination as early as 9 years of age, uptake remains low.

OBJECTIVES: To compare early HPV vaccine initiation between 2 interventions, compare vaccine completion rates between youths initiating HPV vaccination at 9 to 10 vs 11 to 14 years of age, and identify factors associated with early HPV vaccination initiation and series completion.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective quality improvement study was conducted from January 1, 2019, to December 31, 2023. The study analyzed a quality improvement project using descriptive statistics and survival analyses. Youths aged 9 to 14 years with no prior HPV vaccination, who had at least 1 in-person visit, and who had complete electronic health record (EHR) data were included. The study took place at 21 US outpatient primary care sites within a large health system. Site assignments were based on patient volume and geographic location (urban and rural).

EXPOSURES: An EHR best practice alert (BPA) recommending HPV vaccination beginning at 9 years of age implemented with or without an added clinician education component.

MAIN OUTCOMES AND MEASURES: The primary outcome was HPV vaccine initiation at 9 to 10 years of age. Secondary outcomes included vaccine series completion within 2 years after initiation and factors associated with early initiation and completion. Outcomes were measured using EHR-recorded vaccination status and timing.

RESULTS: A total of 15 743 eligible patients (mean [IQR] age, 9.9 [9.0-11.0] years; 7946 [50.5%] male; 1260 [8.0%] Asian, 5082 [32.3%] Black or African American, 7621 [48.4%] White, 420 [2.7%] unknown race, and 1360 [8.6%] other race, including American Indian or Alaska Native, Guamanian or Chamorro, and Native Hawaiian or Other Pacific Islander) participated in the study. Overall, 10 102 (64.2%) initiated and 5198 (33.0%) completed the vaccine series. In the group aged 9 to 10 years, the BPA plus education arm had a significantly higher likelihood of initiating vaccination than the BPA-only arm (adjusted hazard ratio, 1.39; 95% CI, 1.17-1.65; P < .001) compared with the group aged 11 to 14 years. Completion increased from 16 (2.2%) to 464 (19.6%) among youths aged 9 to 10 years and from 183 (13.9%) to 323 (66.6%) among youths age 11 to 14 years. By year 3, the group aged 9 to 10 years had a higher cumulative completion rate than the group aged 11 to 14 years (3899 [33.9%] vs 1299 [30.7%], P < .001). Black or African American race and public insurance were associated with HPV vaccine initiation and completion.

CONCLUSIONS AND RELEVANCE: In this quality improvement study of early HPV vaccine initiation, an EHR BPA combined with education was associated with a higher likelihood of early HPV vaccination. Delayed but meaningful improvements in series completion were observed among early initiators.

PMID:41697698 | DOI:10.1001/jamanetworkopen.2025.59670

JAMA Netw Open. 2026 Feb 2;9(2):e2559883. doi: 10.1001/jamanetworkopen.2025.59883.

ABSTRACT

IMPORTANCE: Racial, ethnic, and income disparities in perinatal depression prevalence and treatment are partially driven by social determinants of health. Effective treatments addressing these determinants are needed.

OBJECTIVE: To determine whether enhanced group prenatal care (eGPC) outperforms enhanced individual prenatal care (eIPC) for reducing perinatal depressive symptoms.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conduced in 10 Medicaid-serving clinics in California’s San Joaquin Valley, enrolling English- or Spanish-speaking Medicaid-eligible pregnant individuals at less than 25 weeks’ gestation, from November 2019 to January 2024, with 2 follow-up surveys through 12 weeks postpartum. Analyses were conducted as intention-to-treat. Data were analyzed from December 2024 to December 2025.

INTERVENTIONS: Participants were randomized to eIPC or eGPC. eIPC enhancements included assessments tailored to individual psychosocial, clinical, oral health, and substance use needs. eGPC enhancements included childcare, perinatal mental health screening and referral, transportation stipends, free groceries, and information on community resources.

MAIN OUTCOMES AND MEASURES: The primary outcome was depression, operationalized as change in Patient Health Questionnaire-9 scores from baseline to 3 months postpartum. Outcomes were assessed by masked assessors.

RESULTS: Of 1663 individuals assessed, 678 were enrolled and randomized; 4 withdrew consent, yielding an analyzed sample of 674 participants (mean [SD] age, 27.0 [5.8] years), including 50 African American or Black participants (7.4%); 37 biracial, multiracial, or multiethnic participants (5.5%); 485 Latine participants (72.0%); 77 White participants (11.4%); and 24 participants who identified as another race or ethnicity (3.6%). After randomization, there were 294 participants in the eGPC group and 380 participants in the eIPC group. No difference in reductions in depressive symptom severity from baseline to 3 months postpartum by randomization group was observed (Cohen d for between-group change, 0.1; 95% CI, -0.1 to 0.3; P = .45), adjusting for baseline depressive symptom severity, self-reported history of a mental health condition, language, and calendar time at enrollment. Instead, participants in both groups experienced small to moderate reductions in depression symptoms from baseline to 3 months postpartum (eGPC: mean [SD] difference, -2.2 [5.3]; Cohen d = -0.4; 95% CI, -0.6 to -0.3; P < .001; eIPC: mean [SD] difference, -1.6 [4.5]; Cohen d = -0.5; 95% CI, -0.6 to -0.4; P < .001).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of pregnant, low-income, primarily Latine individuals, statistically significant improvements were observed in depressive symptom severity from baseline to postpartum, regardless of prenatal care type. There was no evidence of a difference between enhanced prenatal care types for improving depressive symptoms.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04154423.

PMID:41697697 | DOI:10.1001/jamanetworkopen.2025.59883

JAMA Pediatr. 2026 Feb 16. doi: 10.1001/jamapediatrics.2025.6150. Online ahead of print.

ABSTRACT

IMPORTANCE: Controversies persist about management of the ductus arteriosus by nonsteroidal anti-inflammatory drugs in extremely preterm infants. Acetaminophen (paracetamol) appears to be a promising alternative with possibly fewer adverse effects.

OBJECTIVE: To evaluate whether prophylactic intravenous acetaminophen started within 12 hours of birth increases survival without neonatal severe morbidities at 36 weeks’ postmenstrual age.

DESIGN, SETTING, AND PARTICIPANTS: A double-blind, randomized, placebo-controlled clinical trial was conducted among preterm infants born between 23 weeks 0 days and 28 weeks 6 days of gestation in 43 neonatal intensive care units of 14 European countries between October 2020 (October 2021 for infants born at 23-26 weeks’ gestation, after the phase 2 study identified the optimal dose of acetaminophen) and April 2024. Data analysis was conducted from January to June 2025.

INTERVENTION: In the acetaminophen group, patients born at 27 to 28 weeks’ gestation received a 20-mg/kg loading dose of acetaminophen followed by 7.5 mg/kg every 6 hours for 5 days, and patients born at 23 to 26 weeks’ gestation received a 25-mg/kg loading dose of acetaminophen followed by 10 mg/kg every 6 hours for 5 days. In the placebo group, isotonic sodium chloride was administered.

MAIN OUTCOMES AND MEASURES: The primary outcome was survival without neonatal morbidity evaluated at 36 weeks’ postmenstrual age. The secondary exploratory outcome was ductus arteriosus closure, assessed by echocardiography on day 7.

RESULTS: A total of 778 patients (median [IQR] gestational age, 26 [25-27] weeks; 375 [48.2%] female) were included in the study, with 391 in the acetaminophen group and 387 in the placebo group. Survival without severe morbidities at 36 weeks’ postmenstrual age occurred in 259 infants (66.2%) in the acetaminophen group and 246 (63.6%) in the placebo group (absolute risk difference [ARD], 2.7 [95% CI, -4.0 to 9.3] percentage points; relative risk [RR], 1.04 [95% CI, 0.94 to 1.16]). The ductus arteriosus was considered closed on day 7 in 264 of 371 infants (71.2%) assigned to acetaminophen and 191 of 366 infants (52.2%) assigned to placebo (ARD, 19.0 [95% CI, 12.0 to 25.7] percentage points; RR, 1.36 [95% CI, 1.21 to 1.53]). In the safety analysis, adverse events were not different except for a higher cholestasis rate in the acetaminophen group (25 of 392 infants [6.4%]) vs the placebo group (10 of 386 infants [2.6%]) (ARD, 3.8 [95% CI, 0.9 to 6.9]) percentage points.

CONCLUSIONS AND RELEVANCE: This study found that prophylactic acetaminophen treatment for patent ductus arteriosus did not increase survival without neonatal morbidities.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04459117.

PMID:41697673 | DOI:10.1001/jamapediatrics.2025.6150

Eur Arch Paediatr Dent. 2026 Feb 16. doi: 10.1007/s40368-026-01184-0. Online ahead of print.

ABSTRACT

PURPOSE: To compare the 24 month outcomes of a newer version of conventional glass ionomer cements (GIC; Equia Forte; GC Corp., Tokyo, Japan) and a standard resin-modified glass ionomer cement (RMGIC; Fuji II LC; GC Corp.) in Class II primary molar restorations and investigate reasons for failures.

METHODS: Healthy and cooperative 4- to 9-year-old children with proximal surface caries lesions in all four primary molars of the same jaw, following clinical and/or radiographic examination, received Class II restorations with GIC or RMGIC, allocated randomly per quadrant. These were assessed semi-annually for 2 years using modified USPHS criteria. The radiographic examination was conducted annually, and assessed the presence of furcation/periapical radiolucencies, pathological root resorption and secondary caries lesion formation. Cox regression analyses were used to determine restoration survival between the two materials; Mc Nemar’s test was used to compare proportions of failure between the two restorative materials. The level of statistical significance was set at p < 0.05.

RESULTS: Of the 63 children initially included in the study, 55 attended all four recalls, with a total of 120 restorations per material. There was a statistically significantly higher success rate in the RMGIC group compared to GIC (90.8% and 66.7%, respectively, p < 0.001). Most failures of GIC were attributed to partial or total loss of restoration (31.7%).

CONCLUSION: RMGIC Class II primary molar restorations had statistically significantly greater success compared to GIC restorations in the 24 month observation period.

PMID:41697648 | DOI:10.1007/s40368-026-01184-0

Ther Innov Regul Sci. 2026 Feb 16. doi: 10.1007/s43441-026-00927-x. Online ahead of print.

ABSTRACT

BACKGROUND: Rare diseases present urgent public health challenges requiring coordinated global efforts. This study analyzes China’s orphan drug innovation landscape through patent applications (1995-2023) to identify R&D patterns and policy implications.

METHODS: We analyzed 323 Patent Cooperation Treaty applications from Chinese entities using IPC classification and bipartite network modeling. Data from World Intellectual Property Organization were retrieved via PatSnap, with diseases mapped to China’s Rare Disease Catalogues (207 conditions). Network metrics quantified disease-technology linkages.

RESULTS: Three key findings emerged: (1) Patent filings surged 58.2% (188 patents) during 2018-2023, coinciding with China’s regulatory reforms; (2) Innovation concentrated in oncology/neurology (34.3% patents cover 2 diseases), with 66.2% of catalogued diseases lacking patents; (3) Dominant technologies are small molecules and genetic therapies. Network analysis revealed an R&D ecosystem without a single dominant entity, alongside robust collaborative ties between Chinese and U.S. organizations.

CONCLUSIONS: China’s orphan drug innovation is expanding rapidly but remains uneven, concentrated in specific diseases and technological platforms. Policy interventions are needed to address therapeutic neglect through tiered incentives, dedicated funding for neglected diseases, and global partnerships to accelerate equitable treatment access.

PMID:41697637 | DOI:10.1007/s43441-026-00927-x

J Relig Health. 2026 Feb 16. doi: 10.1007/s10943-026-02583-9. Online ahead of print.

ABSTRACT

This randomized controlled trial was conducted to determine the effect of spiritual support provided through the Virgin Mary’s Hand Plant and Surah Maryam during labor on labour worries, labor pain, and maternal satisfaction. The study is conducted with 120 primiparous in a province in eastern Türkiye. Advanced analysis showed that there was no statistically significant difference in pain levels between women who listened to Surah Maryam and those who used the Virgin Mary’s Hand Plant; however, both groups showed statistically significant differences compared to the control group (F = 192.368, p = 0.00). Regarding labour worries and satisfaction, no significant differences were found between the experimental groups, yet both were statistically significant compared to the control group (F = 445.976, p = 0.00; F = 224.775, p = 0.00). It is recommended that women be allowed to use spiritual practices and non-pharmacological methods of their own choice during labor, thereby contributing to a more positive experience of labor pain, reducing labour worries, and enhancing birth satisfaction.

PMID:41697564 | DOI:10.1007/s10943-026-02583-9

Eat Weight Disord. 2026 Feb 16. doi: 10.1007/s40519-026-01824-w. Online ahead of print.

ABSTRACT

PURPOSE: To investigate sex differences in prospective associations between eating disorder (ED) symptoms and changes in body mass index (BMI) percentile in early adolescence.

METHODS: This prospective study used survey data from 7111 participants aged 10-12 years at Year 1 from the Adolescent Brain Cognitive Development (ABCD) Study-a diverse, national sample of adolescents from 21 sites across the United States (US). Multivariable linear regression models were used to assess the prospective associations between ED symptoms at Year 1 and BMI percentile at Year 2, adjusting for covariates and BMI percentile at Year 1. Effect moderation was explored in sex-stratified models.

RESULTS: Sex modified the relationship between ED symptoms and changes in BMI percentile. Having binge eating symptoms (B = 3.65, 95% CI 1.80-5.51, p <0.001), distress related to binge eating (B = 2.79, 95% CI 0.05-5.53, p = 0.046), inappropriate compensatory behaviors (B = 6.39, 95% CI 2.16-10.62, p = 0.005), and fear of weight gain (B = 5.26, 95% CI 3.18-7.33, p < 0.001) at Year 1 were significantly associated with higher BMI percentile at Year 2 among males. In the overall sample, distress related to binge eating (B = 2.09, 95% CI 0.40-3.69, p = 0.017) was significantly associated with a higher BMI percentile 1 year later; the interaction by sex was not statistically significant.

DISCUSSION: ED symptoms were associated with higher BMI percentiles 1 year later in early adolescents, although sex-stratified findings revealed that many associations were significant only for males. Clinicians caring for early adolescents should consider evaluating for ED symptoms as potential risk factors for elevated weight.

LEVEL OF EVIDENCE: Level III: Evidence obtained from well-designed cohort or case-control analytic studies.

PMID:41697562 | DOI:10.1007/s40519-026-01824-w

Infect Dis Ther. 2026 Feb 16. doi: 10.1007/s40121-026-01315-6. Online ahead of print.

ABSTRACT

INTRODUCTION: Neutralizing antibody titers are recognized as an acceptable surrogate efficacy endpoint for immunobridging next-generation monoclonal antibodies (mAbs) to those with demonstrated clinical efficacy for the prevention of COVID-19. However, titers measured at early time points after dosing overestimate levels required for clinical protection. Long-term efficacy data are limited due to continued evolution of SARS-CoV-2 and loss of activity of previously effective mAbs against emerging variants. We aimed to develop a predictive tool for efficacy using neutralizing titers to provide a framework for dose selection, target efficacy, and immunobridging of mAbs for the prevention of COVID-19.

METHODS: Drug concentration and clinical efficacy data collected over 12 months following pemivibart administration in the phase 3 CANOPY trial were used to develop a Cox proportional hazards model with time-varying covariate as a statistical immune correlates of protection model. The time-varying covariate was estimated serum virus neutralizing antibody activity, estimated at 2-week intervals by integrating drug concentration with weighted average IC₅₀ (half-maximal inhibitory concentration) values of the circulating variant population. Clinical efficacy was predicted in immunocompromised and non-immunocompromised populations.

RESULTS: Efficacy increased with antibody titer in a non-linear manner, with smaller incremental gains at higher concentrations. Predicted efficacy was lower at all titer levels in the immunocompromised cohort. Model-derived estimates aligned well with observed infection outcomes and external analyses, supporting model validity. A titer of 1:500 predicted an estimated efficacy of 50% (immunocompromised) and 70% (non-immunocompromised).

CONCLUSION: The Cox model enables evaluation of suitable neutralizing titer targets to guide dosing, predict estimated clinical benefit for related mAbs derived from the same platform, and support immunobridging in both immunocompromised and non-immunocompromised populations.

TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT06039449.

PMID:41697535 | DOI:10.1007/s40121-026-01315-6

J Neurooncol. 2026 Feb 16;177(1):1. doi: 10.1007/s11060-026-05467-w.

ABSTRACT

INTRODUCTION: Tumor Treating Fields (TTFields), as an emerging non-invasive therapeutic approach, has gradually demonstrated its potential as an adjuvant therapy in cancer treatment in recent years. Currently, TTFields has become an important adjunct to the standard treatment of glioblastoma (GBM). Real-world data on its clinical application, outcomes, and prognostic factors hold significant value for optimizing clinical practice. This study aims to evaluate the actual effectiveness of TTFields in treating GBM by providing clinical data and exploring potential clinical factors that may influence its efficacy.

METHODS: This study is a retrospective cohort study that included 40 newly diagnosed glioblastoma (ndGBM) patients received TTFields treatment based on the Stupp regimen. Additionally, 48 ndGBM patients who did not receive TTFields treatment during the same period were selected as the control group through continuous sampling. Kaplan-Meier curves were employed to estimate the overall survival (OS) and progression-free survival (PFS) in both groups. To identify factors affecting these outcomes and the efficacy of TTFields, a Cox regression analysis was subsequently performed on various clinical variables.

RESULTS: Patients receiving the TTFields demonstrated superior median PFS (12.0 months, 95%CI: 8.97-15.03) and OS (18.0 months, 95%CI: 13.65-22.35), versus 9.0 (95%CI: 7.06-10.94) and 12.0 (95%CI: 9.36-14.64) months in controls. Multivariate analysis showed that the extent of resection (P = 0.032, HR: 0.47, 95%CI: 0.24-0.94), the MGMT promoter methylation status (P = 0.024, HR: 0.51, 95%CI: 0.28-0.91) and whether accepted TTFields therapy (P = 0.022, HR: 0.50, 95%CI: 0.28-0.90) were independent prognostic factors affecting PFS. Additionally, patient compliance with TTFields therapy was significantly associated with their OS and PFS (OS: P = 0.004, HR: 0.12, 95%CI: 0.03-0.51; PFS: P = 0.007, HR: 0.24, 95%CI: 0.09-0.68). Further analysis revealed a certain relationship between the duration of TTFields therapy and survival. Comparative analysis revealed distinct survival outcomes based on treatment duration. The long-term (> 2 months) and short-term (≤ 2 months) TTFields groups had median OS of 21.0 (95%CI: 15.58-26.42) and 16.0 months (95%CI: 10.32-21.68) (P = 0.099), and median PFS of 20.0 (95%CI: 6.99-33.01) and 8.0 months (95%CI: 4.36-11.65) (P = 0.017), respectively, indicating a statistically significant PFS advantage for prolonged therapy.

CONCLUSIONS: The TTFields combined with Stupp regimen was associated with longer Survival outcome in patients with GBM. Additionally, higher patient compliance with TTFields treatment (≥ 0.81) and prolonged use of TTFields (> 2 months) are closely associated with improved prognosis.

PMID:41697534 | DOI:10.1007/s11060-026-05467-w

Acta Parasitol. 2026 Feb 16;71(1):41. doi: 10.1007/s11686-026-01234-z.

ABSTRACT

PURPOSE: Schistosomiasis is a water related parasitic disease with significant public health importance in tropical regions. This study aimed to determine the geographical distributions of Biomphalaria and Bulinus snails and to determine the prevalence of schistosome infection among Biomphalaria snails in Ethiopia.

METHODS: a systematic literature search was conducted in public online databases namely Scopus, PubMed, Google Scholar and Science Direct, which report on Biomphalaria and Bulinus snails in Ethiopia and were published between 2000 and October 2025. Geographical mapping of the snail distribution was performed via AcriGIS online software. The pooled prevalence of schistosome infection was determined via a random effects model, and heterogeneity across studies was assessed using the I² statistic. Data analysis was conducted using Stata software version 14 with the ‘metan’ command.

RESULTS: A total of 19,659 snails were reported in the eligible studies, of which 81.4% (15,997) were Biomphalaria and 18.6% (5,662) were Bulinus snails. The geographical distributions of the two snail genera showed substantial overlap, with most studies conducted in Amhara, Oromia and Sidama regional states. Among the collected snails 8852 Biomphalaria snails and 1538 Bulinus snails were examined for schistosome infections using cercarial shedding techniques. The pooled prevalence of schistosome infection among Biomphalaria snails was 9.25% (95% CI: 5.87-12.64), whereas none of the examined Bulinus shed schistosome cercariae. Although eleven types of cercariae were reported across the eligible studies, schistosome cercariae were the most frequently detected.

CONCLUSION: This systematic review and meta-analysis revealed that Biomphalaria and Bulinus snails were widely distributed across Ethiopia, with considerable geographical overlap. This study revealed that about 9% of the tested Biomphalaria snails were infected with schistosomes. This finding underscores the importance of incorporating snail-targeted control strategies alongside ongoing preventive chemotherapy to effectively reduce schistosomiasis in Ethiopia.

PMID:41697524 | DOI:10.1007/s11686-026-01234-z