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Nevin Manimala Statistics

Phase II Trials in Radiation Oncology: When Success Fails to Translate

JCO Oncol Pract. 2026 Apr 13:OP2600018. doi: 10.1200/OP-26-00018. Online ahead of print.

ABSTRACT

PURPOSE: Phase II trials are intended to identify promising treatment paradigms for definitive phase III testing, but how effectively they serve this role in radiation oncology is unknown. We evaluated whether phase II cooperative group studies of radiation therapy function as effective gateways to phase III testing and identified factors associated with downstream progression.

METHODS: Using ClinicalTrials.gov, we identified completed phase II radiation therapy trials conducted through the National Clinical Trials Network cooperative groups. We assessed whether trials met their prespecified primary end point and whether successful trials progressed to phase III evaluation. Logistic regression evaluated associations between trial characteristics and phase III transition. Decision concordance between phase II outcomes and subsequent development decisions was examined.

RESULTS: Among 92 completed phase II trials (2003-2019), 54% met their primary end point, yet only 17% progressed to phase III testing. Among trials that met their end point, fewer than one third advanced, with 71% representing discordant successes (positive phase II trial without phase III progression). Toxicity-based end points most frequently met phase II criteria (67%) but were least likely to translate to phase III (8% of successful trials). Larger enrollment number (odds ratio [OR], 1.68 per 50 patients [95% CI, 1.21 to 2.31]) and longer duration (OR, 1.20 per year [95% CI, 1.00 to 1.44]) were associated with phase III transition. Trials that advanced to phase III were not completed more rapidly (median duration 132 v 108 months).

CONCLUSION: Most phase II radiation oncology trials that meet prespecified end points do not progress to definitive phase III testing. This phenomenon appears driven less by statistical futility than by structural and decisional barriers. Greater prespecification of advancement intent and selection of decision-relevant end points may improve the efficiency and impact of radiotherapy cooperative group trials.

PMID:41973969 | DOI:10.1200/OP-26-00018

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Nevin Manimala Statistics

An Open-Label Study of Single-Dose Psilocybin for Borderline Personality Disorder With Co-Occurring Major Depressive Disorder

Clin Neuropharmacol. 2026 Apr 1. doi: 10.1097/WNF.0000000000000683. Online ahead of print.

ABSTRACT

OBJECTIVES: Borderline personality disorder (BPD) is often comorbid with major depressive disorder (MDD), and there has been a suggestion in the literature that this comorbidity may interfere with MDD treatment response. Our objective was to conduct a pilot study of psilocybin in adults with BPD and MDD.

METHODS: Adults aged 18 to 65 years with a DSM-5 diagnosis of MDD and BPD were enrolled in an open-label pilot study of a single dose of psilocybin. Assessments were conducted 1 week before dosing (baseline), on the dosing day (visit 2), and at 1, 2, and 4 weeks postdosing. The co-primary outcome measures were changes in depressive and BPD symptoms from baseline to study endpoint, and we used a paired-samples t test to examine changes in symptoms.

RESULTS: Nine participants (4 males; mean age=31.3 y) with MDD and BPD were enrolled. MDD symptoms significantly changed from baseline to visit 5: baseline (M=28.56, SD=4.53) and final visit (M=17.22, SD=10.39); t(8)=-4.217, P=0.003; Cohen d=1.41. BPD scores did not significantly change from baseline to study endpoint.

CONCLUSIONS: This small open-label study resulted in statistically significant improvement in MDD symptoms but not for BPD symptoms. These findings, which await larger clinical trials, suggest that BPD does not appear to interfere with response to depressive symptoms.

PMID:41973961 | DOI:10.1097/WNF.0000000000000683

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Nevin Manimala Statistics

Using Machine Learning to Improve Screening for Oropharyngeal Dysphagia in Hospitalized Versus Primary Care Adult Patients With COVID-19 Disease: Retrospective Observational Study

JMIR AI. 2026 Apr 13;5:e81028. doi: 10.2196/81028.

ABSTRACT

BACKGROUND: Oropharyngeal dysphagia (OD) commonly occurs in patients with COVID-19 disease, posing diagnostic challenges due to isolation protocols.

OBJECTIVE: This study aimed at evaluating Artificial Intelligence Massive Screening for Oropharyngeal Dysphagia (AIMS-OD), a machine learning software for real-time OD screening, comparing OD prevalence and clinical outcomes using OD ICD-10 (International Statistical Classification of Diseases, Tenth Revision) R13 codes (R13-OD) and high-risk AIMS-OD (H-AIMS-OD) scores (>0.5), in hospital and primary care patients with COVID-19 disease. It explored clinical characteristics, OD risk factors, and clinical outcomes.

METHODS: This retrospective, observational study analyzed patients with SARS-CoV-2 aged 18 years and older in Catalonia from January 1 to August 31, 2020, including hospital and primary care data on clinical information, International Classification of Diseases, Tenth Revision (ICD-10) codes, hospital stay, discharge destination, and mortality. AIMS-OD assessed OD risk, stratifying patients by age (aged 18-69 years and 70 years and older).

RESULTS: Among 257,541 patients with COVID-19 disease, 59.3% (152,721/257,541) were aged 18-69 years and 40.7% (104,820/257,541) were aged 70 years and older. Hospital and primary care R13-OD prevalence was 3.5% and 4.3%, respectively; AIMS-OD showed 34.8% and 15.4%, with True prevalence at 16.7% and 7.4%. Patients aged 70 years and older had worse clinical outcomes and worse prognosis. Patients in R13-OD experienced significantly worse clinical outcomes than patients with H-AIMS-OD, who in turn fared worse than those with no R13-OD and with low AIMS-OD risk. Risk factors for patients with COVID-19 R13-OD included age, neuroleptic use, stroke, dementia, and delirium.

CONCLUSIONS: AIMS-OD screening revealed high prevalence and significant underdiagnosis in patients with COVID-19 disease across settings. Early detection and risk stratification using AIMS-OD could improve clinical decision-making, diagnosis, and management, particularly in older patients with comorbidities.

PMID:41973941 | DOI:10.2196/81028

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Nevin Manimala Statistics

Physical Activity Monitoring in Adolescents and Young Adults With Cancer: Observational Feasibility Study

JMIR Cancer. 2026 Apr 13;12:e87591. doi: 10.2196/87591.

ABSTRACT

BACKGROUND: There is a growing interest in characterizing the relationship between long-term physical activity (PA) habits and cancer-related outcomes such as treatment-related toxicities, recurrence, and complications. Wearable devices can provide critical information to achieve this goal; however, inferences are significantly influenced by device wear adherence.

OBJECTIVE: This study aimed to assess the feasibility of using wearable devices to monitor short- and long-term PA in adolescent and young adult (AYA) patients with sarcoma during and after chemotherapy in a free-living environment and evaluate the ability to accurately capture changes in PA over 3 years.

METHODS: A total of 63 AYA patients with sarcoma were provided with a Fitbit Charge 3 to track daily steps, sedentary time, and heart rate for up to 3 years.

RESULTS: On average, during the first 30 days of follow-up, 57.1% (36/63) of patients wore their device at least 10 hours per day, and only 23.8% (15/63) of patients wore their devices thereafter. Patients spent a mean of 80% (SD 11%) of their day in a sedentary state. Despite low adherence, daily step count trends increased over time.

CONCLUSIONS: This study highlights the adherence challenges met with longitudinal PA monitoring in AYA patients with sarcoma. Wearer discomfort, lost devices, and lack of data uploading compliance contributed to data missingness and attrition. Caution is warranted when relying on wearable activity trackers to inform program decisions, accurately assess PA outcomes, and monitor program adherence longitudinally without consideration of wearer bias. Alternative methods that would be more broadly accepted by AYA patients for effective long-term monitoring should be considered.

PMID:41973938 | DOI:10.2196/87591

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Nevin Manimala Statistics

Municipal water fluoridation, adolescent IQ, and cognition across the life course: Evidence from the Wisconsin Longitudinal Study

Proc Natl Acad Sci U S A. 2026 Apr 21;123(16):e2536005123. doi: 10.1073/pnas.2536005123. Epub 2026 Apr 13.

ABSTRACT

We investigate associations between community water fluoridation (CWF), adolescent IQ, and cognition across the life course using representative data from the US state of Wisconsin. Exposure is inferred from historical records on community water fluoridation; adolescent IQ is ascertained from state testing records; and cognition in later life is assessed as part of the Wisconsin Longitudinal Study [P. Herd et al., Int. J. Epidemiol. 43, 34-41 (2014).]. In contrast to studies cited in recent decisions to end CWF in Utah, Florida, and elsewhere, we find no evidence that CWF is negatively associated with adolescent IQ or adult cognitive functioning.

PMID:41973917 | DOI:10.1073/pnas.2536005123

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Nevin Manimala Statistics

Tree growth after a major hurricane reflects predisturbance vigor rather than canopy damage

Proc Natl Acad Sci U S A. 2026 Apr 21;123(16):e2532451123. doi: 10.1073/pnas.2532451123. Epub 2026 Apr 13.

ABSTRACT

Tree crown damage from disturbance events strongly influences forest demography, yet its effect on stem growth remains poorly quantified, with both positive and negative impacts reported. Hurricanes provide a powerful natural experiment to examine these dynamics, generating a broad range of structural damage across individuals and forest stands. Here we assess how crown damage from Hurricane María (2017) affected poststorm stem growth in a wet subtropical forest in Puerto Rico by combining airborne LiDAR with field measurements for 1,082 trees. Unlike previous studies, paired pre- and posthurricane LiDAR assessment enabled us to quantify crown damage as a continuous, objective variable across the canopy. Using a causal inference framework, we separated individual- from neighborhood-level effects, defined as the damage that occurred within a 5 m radius of each tree. Repeated stem growth censuses allowed direct comparison of individual growth responses before and after the hurricane. Across the community, posthurricane stem growth rates were similar to prehurricane values. Larger and more heavily damaged trees exhibited moderately reduced growth, while neighborhood crown damage and mortality had no detectable effect. However, these damage effects were smaller than the influence of prehurricane growth rates, indicating that prehurricane individual vigor outweighed biomass loss and competitive release in shaping growth responses. These findings highlight the resilience of surviving trees in sustaining carbon uptake after a severe disturbance and challenge the assumption of strong postdamage growth suppression that is embedded in dynamic vegetation models.

PMID:41973916 | DOI:10.1073/pnas.2532451123

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Nevin Manimala Statistics

Application of the Technology Acceptance Model to Predict Nursing Students’ Intention to Use Informatics: Cross-Sectional Study

JMIR Nurs. 2026 Apr 13;9:e85385. doi: 10.2196/85385.

ABSTRACT

BACKGROUND: Nursing informatics is essential for digital health transformation; however, the technology acceptance of undergraduate nursing students in Saudi Arabia remains underexplored.

OBJECTIVE: This study examined factors influencing nursing students’ intention to use informatics technologies using the technology acceptance model.

METHODS: A cross-sectional survey was conducted with 132 undergraduate nursing students. Data were analyzed using descriptive, correlational, and hierarchical regression analyses.

RESULTS: Perceived usefulness (mean 3.68, SD 1.22) and perceived ease of use (mean 3.64, SD 1.32) were the strongest predictors of acceptance, together explaining 87% of the variance (R²=0.87; β=0.323 for usefulness, P<.001; β=0.195 for ease of use, P=.032). Only 25.8% (n=34) of the students often used electronic health records, while 31.8% (n=42) had no electronic health record experience, indicating a clear gap in practical informatics exposure.

CONCLUSIONS: Nursing students’ acceptance of informatics is primarily driven by its perceived usefulness and perceived ease of use. These findings highlight the urgent need to integrate practical, user-centered informatics training and clinical simulation into undergraduate nursing curricula to better prepare students for technology-based practice.

PMID:41973911 | DOI:10.2196/85385

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Nevin Manimala Statistics

Exploring Metabolic Changes in Children with Congenital Hypothyroidism: A Serum Metabolomic Study Combined by Machine Learning

J Proteome Res. 2026 Apr 13. doi: 10.1021/acs.jproteome.5c01112. Online ahead of print.

ABSTRACT

Congenital hypothyroidism (CH) is a genetic endocrine disorder that can cause developmental delays if it is untreated. In this study, NMR-based metabolomics was employed to analyze serum samples from CH children and healthy controls across different age groups. Multivariate statistical analysis screened for 17, 16, 33, and 21 differential metabolites in the respective age groups and identified seven common metabolites, including lysine, 1-methylhistidine, glycerophosphocholine, phosphocholine, β-glucose, lipids, and creatine. The results indicated that CH children experienced metabolic disturbances in multiple pathways, particularly glycerophospholipid metabolism and glycine, serine, and threonine metabolism. Following recursive feature elimination (RFE) for feature selection, the top five core metabolites were selected to construct an optimized artificial neural network (ANN) model for CH diagnosis, achieving a prediction accuracy of 89.4%. These findings suggest that the identified metabolites can be used as potential diagnostic biomarkers for CH in children. This may help improve the early diagnosis accuracy of CH, serve as a rapid screening tool for newborns, and provide an auxiliary diagnostic method for suspected CH cases to facilitate early clinical intervention.

PMID:41973905 | DOI:10.1021/acs.jproteome.5c01112

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Nevin Manimala Statistics

Leveraging Innovative Electronic Health Record Data to Characterize Social Determinants of Health Among Survivors of Cancer in Persistent Poverty Areas: Cross-Sectional Study

JMIR Cancer. 2026 Apr 13;12:e81054. doi: 10.2196/81054.

ABSTRACT

BACKGROUND: Residents in persistent poverty areas experience higher cancer mortality due to social determinants of health that negatively affect multiple factors, including health behaviors.

OBJECTIVE: This study aimed to characterize demographic, clinical, and social determinant of health factors among survivors of cancer in persistent poverty areas using electronic health record (EHR) data-including an embedded social risk screener and natural language processing (NLP) of social work notes-to inform community-engaged adaptation of lifestyle interventions.

METHODS: EHR data from a large multispecialty group practice were extracted for patients with cancer residing in zip codes inclusive of persistent poverty areas targeted for a health behavior intervention and receiving care between January 2018 and November 2023. Self-reported social determinant of health data were obtained using the Protocol for Responding to and Assessing Patients’ Assets, Risks, and Experiences (PRAPARE) and through NLP of social histories from a social work visit.

RESULTS: We identified 2672 unique patients with cancer, of whom 578 (21.6%) had PRAPARE data and 1597 (59.8%) had social history data available for analysis. The most common cancers among survivors (n=1420, 53.1% female; n=1299, 48.6% Black individuals; mean age 65.2, SD 13.7 years) included breast (n=536, 20.1%), prostate (n=400, 15%), and lymphoid or hematopoietic (n=323, 12.1%) cancer. Among survivors in persistent poverty areas (n=509, 19%; all with a high Social Vulnerability Index), 34.6% (176/509) were single, 55.4% (282/509) had Medicare coverage (with only 73/509, 14.3% having private insurance), 36.5% (186/509) had obesity, 63.9% (325/509) had hypertension, and 31.2% (159/509) had diabetes. Of survivors in persistent poverty areas with PRAPARE data, 15.8% (19/120) lacked transportation, 4.2% (5/120) lived with housing insecurity, and 6.7% (8/120) felt unsafe where they lived.

CONCLUSIONS: Innovative EHR and NLP approaches identified several socioeconomic and safety-related challenges along with opportunities for health behavior interventions to leverage Medicare coverage and target multiple comorbidities when adapting interventions for survivors of cancer living in persistent poverty areas.

PMID:41973902 | DOI:10.2196/81054

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Nevin Manimala Statistics

His Pacing vs Biventricular Pacing for Cardiac Resynchronization Therapy: Long-Term Follow-Up From the His-Alternative I Trial

JACC Clin Electrophysiol. 2026 Mar 12:S2405-500X(26)00148-9. doi: 10.1016/j.jacep.2026.02.016. Online ahead of print.

ABSTRACT

BACKGROUND: The His-Alternative I (A Randomized Trial of His Pacing Versus Biventricular Pacing in Symptomatic Heart Failure Patients With Left Bundle Branch Block) trial was the first randomized European trial to compare cardiac resynchronization therapy (CRT) delivered by His bundle pacing (His-CRT) vs CRT delivered by conventional biventricular pacing (BiV-CRT).

OBJECTIVES: The goal of this study was to compare long-term lead performance, survival, and echocardiographic response between His-CRT and BiV-CRT.

METHODS: A total of 50 patients with symptomatic heart failure (HF), left ventricular ejection fraction ≤35%, and left bundle branch block were randomized 1:1 to undergo His-CRT or BiV-CRT. Following crossover at implantation, 19 patients received His-CRT and 31 received BiV-CRT. The primary analyses were conducted by these groups, with 5 years of follow-up. Outcomes included the occurrence of reinterventions, an endpoint of all-cause mortality or hospitalization for HF, and echocardiographic response (≥15% reduction in left ventricular end-systolic volume compared with baseline).

RESULTS: The median follow-up was 5.3 years (Q1-Q3: 4.6-5.7 years). More lead revisions (37% vs 3%; P = 0.003) and generator replacements (47% vs 10%; P = 0.005) occurred in the His-CRT group compared with the BiV-CRT group. However, no statistically significant differences in reinterventions and threshold development over time were observed between the His-CRT patients with implantation thresholds ≤2.5 V/1 millisecond and the BiV-CRT group. The risk of all-cause mortality or hospitalization for HF was similar between groups (HR: 0.32; 95% CI: 0.07-1.49; P = 0.147), and echocardiographic response was comparable between the 2 groups (89% in His-CRT and 90% in BiV-CRT; P = 1.0).

CONCLUSIONS: No statistically significant difference in long-term performance was detected between His-CRT with low implantation thresholds and BiV-CRT, and echocardiographic response was comparable.

PMID:41973899 | DOI:10.1016/j.jacep.2026.02.016