Categories
Nevin Manimala Statistics

Effect of Problem-Based Learning Combined With Rational Emotive Behavior Therapy on Psychological Outcomes, Self-Efficacy, Adverse Events, Quality of Life, and Treatment Compliance in Breast Cancer Care: A Non-Randomized Study

Nurs Health Sci. 2026 Mar;28(1):e70299. doi: 10.1111/nhs.70299.

ABSTRACT

To evaluate the effectiveness of combined problem-based learning (PBL) and rational emotive behavior therapy (REBT) on Psychological Outcomes, Self-Efficacy, Adverse Events, Quality of Life, and Treatment Compliance in breast cancer care. In this non-randomized study conducted at a tertiary hospital in China, 180 patients with breast cancer treated between October 2021 and August 2022 were divided into a control group (n = 90) receiving conventional education and a study group (n = 90) receiving PBL combined with REBT. Outcomes were assessed using validated scales including the Hamilton Anxiety/Depression Rating Scales, EORTC QLQ-C30, General Self-Efficacy Scale, a hospital-designed compliance questionnaire, and adverse event follow-up. After intervention, the study group demonstrated significantly greater improvements in psychological outcomes (p < 0.05), self-efficacy (p < 0.05), lower adverse event rates (13.33% vs. 31.11%; p < 0.01), quality of life domains (p < 0.05), treatment compliance (p < 0.05), compared to the control group. The combined PBL and REBT approach enhances postoperative care for patients with breast cancer by improving psychological outcomes (e.g., reducing anxiety), enhancing self-efficacy, minimizing adverse events, improving quality of life, and promoting treatment compliance.

PMID:41707047 | DOI:10.1111/nhs.70299

Categories
Nevin Manimala Statistics

A Framework to Quantify Disparities in Pharmacogenomic Treatment Concordance and Drug Response Outcomes

Clin Transl Sci. 2026 Feb;19(2):e70501. doi: 10.1111/cts.70501.

ABSTRACT

Clinical PGx practice guidelines (PGx guidelines) may have limited generalizability for “marginalized” groups. We proposed the five-step Real-World Data for Genome-Guided Prescribing (ReGGRx) framework and, using All of Us research program (AoU) data, examined its ability to estimate disparities in concordance with and benefit from PGx guidelines for CYP2C19 testing when choosing antiplatelet and antidepressant drugs. The selected measures were intended to identify disparities in avoiding drug failure independent of following PGx guidelines, the odds of avoiding drug failure with PGx concordant treatment, and the degree to which “marginalized” groups (i.e., groups underrepresented in biomedical research [UBR] and with indeterminate CYP2C19 phenotypes) benefit from PGx concordant treatment, when compared with “non-marginalized” groups (i.e., non-UBR and known CYP2C19 phenotypes). Our findings identified disparities in the antidepressant cohort with UBRs (32% of cohort) having a lower odds of avoiding drug failure. For both cohorts, a lower probability of avoiding drug failure was observed in the indeterminate phenotype group (1% of cohorts) than in the known phenotype group, indicating a need to better characterize rare or ancestry-specific risk alleles. With PGx concordant treatment, negative equal opportunity difference values suggested that the UBR group was less likely to avoid drug failure than the non-UBR group. Overall, our findings illustrate the promise of the ReGGRx framework to assess PGx guideline generalizability and produce evidence for use in drug policy decisions.

PMID:41707036 | DOI:10.1111/cts.70501

Categories
Nevin Manimala Statistics

Asian Immigrant Parents’ Language Use and Perceptions of Parent-Child Relationship Quality

Fam Process. 2026 Mar;65(1):e70130. doi: 10.1111/famp.70130.

ABSTRACT

Research on Asian immigrant families has primarily focused on the influence of cultural factors, such as acculturation, on parent-child relationships, yet emerging research suggests that language use may play a critical role, especially when multiple languages (e.g., English and/or a heritage language; HL) may be used in the parent-child communication context. This exploratory study investigated the associations between parent language use and perceived parent-child relationship quality (i.e., positive relationship, parent-child conflict) among Asian immigrant parents (N = 90) of early adolescents ages 9-13. A MANCOVA was conducted to examine these associations, controlling for parent and child sociodemographic factors. Results indicated that parent-reported language use was significantly associated with perceived parent-child conflict: English-speaking parents reported higher levels of parent-child conflict (M = 1.65, SE = 0.29) than their HL-speaking (M = 0.61, SE = 0.30) and bilingual counterparts (M = 0.81, SE = 0.19; F(2, 80) = 4.04, p = 0.021, partial η2 = 0.09). When comparing the English language group against the bilingual language group, perceived parent-child conflict was statistically significant (p = 0.048). Parent-reported language use was not associated with perceived positive relationships. Findings highlight language use as an important mechanism in shaping parent-child relationships in Asian immigrant families, above and beyond the effects of acculturation. Greater attention to language use may strengthen future research and family interventions aimed at improving parent-child relationships in Asian immigrant families.

PMID:41707033 | DOI:10.1111/famp.70130

Categories
Nevin Manimala Statistics

Informing Dose for Pediatric Rare Diseases-A Survey of Recent Orphan Drugs Approvals

Clin Transl Sci. 2026 Feb;19(2):e70503. doi: 10.1111/cts.70503.

ABSTRACT

Collectively, pediatric rare diseases affect millions of children worldwide. Yet, treatment options are limited. Dose selection presents unique challenges in pediatric rare disease drug development. Traditional dose-finding approaches are impractical for these populations, and conventional pediatric dosing methods like exposure matching face limitations when insufficient adult data exists. Herein, we analyzed dosing strategies and study design characteristics used for new molecular entities (NMEs) for orphan indications approved between 2013 and 2022 that included a pediatric indication at initial approval. Among 63 evaluable products included in this analysis, initial pediatric dose selection was supported by adult data in the same indication (37%), adult healthy volunteer data (33%), nonclinical data only (14%), adult data from different indications (10%), and pediatric data from different indications (5%). The use of modeling and simulation to support initial dose selection was explicitly mentioned for 21% of products. Nearly half (48%) utilized multiple data sources for dose selection. Study design characteristics included multiple dose level evaluation (49%), intra-patient dose escalation (33%), interim pharmacokinetic evaluation (10%), pharmacokinetic/biomarker-driven dosing (5%), and age group staggering (5%). Multiple design features were incorporated in 17% of drugs. This analysis reveals diverse approaches to pediatric dose selection in rare diseases and the use of adaptive study design elements suggests recognition of the need for flexible approaches in these challenging populations. Utility of modeling and simulation, ability to leverage all available data sources, and increased implementation of adaptive trial designs could improve dose selection and optimization in pediatric rare disease drug development.

PMID:41707029 | DOI:10.1111/cts.70503

Categories
Nevin Manimala Statistics

Should I Stay, or Should I Go? Experiences of Newly Licensed Nurses in Clinical Practice

J Nurs Adm. 2026 Mar 1;56(3):148-154. doi: 10.1097/NNA.0000000000001699. Epub 2026 Feb 3.

ABSTRACT

OBJECTIVE: Describe qualitative factors explaining why newly licensed nurses (NLNs) intend to stay or leave clinical practice.

BACKGROUND: One in 3 NLNs will leave nursing within 1 year of entry into practice. Understanding factors related to NLN retention is imperative to address workforce shortages.

METHODS: Descriptive statistical analysis of demographics and qualitative analysis of 3 open-ended survey questions, from a larger study, distributed via email through Listservs for NLNs licensed ≤5 years.

RESULTS: One hundred twenty NLNs responded. Themes for intent to stay are cultural fit, schedule, and being a part of a healthy work environment. Reasons for intent to leave include work environment, current treatment of nurses, and personal well-being.

CONCLUSIONS: Flexibility, appreciation, and healthy work environments are factors valued by NLNs when determining their intent to stay or leave nursing. Younger NLNs place greater emphasis on work-life balance, salary, and support. Nurse administrators play a pivotal role in influencing factors that have been identified to enhance NLN retention.

PMID:41706517 | DOI:10.1097/NNA.0000000000001699

Categories
Nevin Manimala Statistics

Predicting Adolescent Response to School-Based Mindfulness: A Secondary Analysis of the MYRIAD Trial

JAMA Psychiatry. 2026 Feb 18. doi: 10.1001/jamapsychiatry.2025.4638. Online ahead of print.

ABSTRACT

IMPORTANCE: Depression most commonly first emerges during adolescence, making early prevention critical. While school-based mindfulness training (SBMT) offers a scalable prevention approach with broad reach, evidence of its effectiveness is mixed, and there is a compelling case for a more personalized approach to prevention.

OBJECTIVE: To develop a data-driven algorithm from baseline characteristics to predict which adolescents are most likely to benefit from SBMT.

DESIGN, SETTING, AND PARTICIPANTS: The My Resilience in Adolescence (MYRIAD) cluster randomized clinical trial was conducted from October 2016 to July 2018. In this secondary analysis, school-level nested cross-validation was used to train and evaluate machine learning models for predicting individualized benefit from SBMT. Participants were students aged 11 to 13 years at baseline from broadly representative secondary schools across England, Scotland, Wales, and Northern Ireland. Data analysis was performed from April 2023 to October 2025.

INTERVENTIONS: SBMT teaching core mindfulness skills through psychoeducation, class discussion, and practices, compared with standard social-emotional learning (teaching as usual).

MAIN OUTCOMES AND MEASURES: Change in depressive symptoms from preintervention to postintervention measured by the Center for Epidemiologic Studies Depression scale. Causal forest (CF) and elastic net regression (ENR) models computed personalized advantage index scores quantifying individual expected benefit from SBMT vs teaching as usual.

RESULTS: Among 8376 adolescents from 84 UK secondary schools, the mean (SD) age at baseline was 12.2 (0.6) years; there were 4509 (54.9%) female participants and 3547 (43.2%) male participants. CF showed acceptable calibration (mean [SE] best linear predictor slope = 0.78 [0.15]), while ENR demonstrated modest predictive performance (r = 0.29; R2 = 0.09; root mean square error = 10.3). Both the CF and ENR models identified a subset of adolescents predicted to benefit from SBMT, but group differences in outcomes were negligible (CF: d = 0.07; 95% CI, 0.02-0.12; P = .007; ENR: d = 0.08; 95% CI, 0.02-0.13; P = .004). Top predictive features from the CF model were symptom severity (eg, low-to-moderate depression and anxiety predicted greater SBMT benefit) and several school factors with nonlinear patterns. ENR emphasized school-level characteristics with minimal differentiation.

CONCLUSIONS AND RELEVANCE: This study found that machine learning identified a subgroup with statistically detectable but clinically trivial differential intervention response. These findings highlight the substantial challenges in achieving clinically useful personalization in universal school-based prevention programs.

TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN86619085.

PMID:41706471 | DOI:10.1001/jamapsychiatry.2025.4638

Categories
Nevin Manimala Statistics

Emergency Medical Individual Clinician Volume and Mortality in Trauma Patients

JAMA Surg. 2026 Feb 18. doi: 10.1001/jamasurg.2025.6741. Online ahead of print.

ABSTRACT

IMPORTANCE: The initial treatment by emergency medical services (EMS) significantly affects the outcomes for severely injured patients. Effective control of hemorrhage, proper administration of blood products, and adherence to traumatic brain injury guidelines can reduce morbidity and mortality after trauma. Additionally, the experience of prehospital clinicians in high-acuity nontrauma conditions is associated with improved outcomes.

OBJECTIVE: To evaluate the association of annual trauma patient volume and outcomes at the individual EMS clinician level.

DESIGN, SETTING, AND PARTICIPANTS: A secondary subset analysis was performed of the Linking Investigations in Trauma and Emergency Services (LITES) Task Order 1 study, a prospective observational cohort from 2017 to 2021. It includes severely injured patients, identified by an Injury Severity Score of 9 or higher, who were transported to a trauma center by 1 air and 1 ground agency. Data were analyzed from February 2023 to June 2024.

EXPOSURES: EMS crew mean 3-year adult trauma volume and 6-hour mortality and several EMS industry quality metrics.

MAIN OUTCOMES AND MEASURES: Patient-level risk-adjusted regression models were constructed to determine the association between EMS crew mean 3-year adult trauma volume and 6-hour mortality and several EMS industry quality metrics. The association of airway success metrics and procedural intubation volume was also assessed.

RESULTS: A total of 6769 patient-clinician interactions involving 359 clinicians and 3649 patients (median [IQR] age, 54 [33-70] years; 2490 male [68.2%]) were included in this study. For every increase of 5 adult trauma patients annually per crew, there was a 10% decrease in 6-hour mortality (adjusted odds ratio [aOR], 0.899; 95% CI, 0.811-0.996) and a 2.6% decrease in in-hospital mortality (aOR, 0.974; 95% CI, 949-0.999). In subgroup analyses including traumatic brain injury (aOR, 0.974; 95% CI, 0.949-0.999) and prehospital shock (aOR, 0.974; 95% CI, 0.949-0.999), volume was associated with reduced 6-hour mortality. Highest trauma volume among treating EMS crew members, nontrauma volume, and years of experience were not significantly associated with differences in mortality. Among EMS industry quality metrics, decreasing scene time (regression coefficient, -0.134; 95% CI, -0.191 to -0.077) was significantly associated with higher clinician volume. Intubation procedural volume was associated with greater odds of success without hypotension or hypoxia (aOR, 1.110; 95% CI, 1.040-1.190).

CONCLUSIONS AND RELEVANCE: Results of this cohort study suggest that higher patient volumes per EMS clinician were associated with lower early mortality rates after trauma. Exploring this association further is essential to optimize staffing, education strategies, and performance benchmarks.

PMID:41706461 | DOI:10.1001/jamasurg.2025.6741

Categories
Nevin Manimala Statistics

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD: A Randomized Clinical Trial

JAMA Psychiatry. 2026 Feb 18. doi: 10.1001/jamapsychiatry.2025.4625. Online ahead of print.

ABSTRACT

IMPORTANCE: The phase 2 data presented here support the development of TSND-201 for posttraumatic stress disorder (PTSD), a disorder for which there is a significant unmet need for rapid-acting and effective treatments. TSND-201 (methylone) is a highly selective, rapid-acting neuroplastogen that releases serotonin, norepinephrine, and dopamine without direct activity at 5-hydroxytryptamine (5-HT) 2A receptors that has shown rapid, robust, and long-lasting benefit for preclinical PTSD-related behaviors and has been well tolerated in phase 1 studies of healthy volunteers.

OBJECTIVE: To evaluate the efficacy and safety of TSND-201 vs placebo in adults with PTSD.

DESIGN, SETTING, PARTICIPANTS: A Study to Assess the Use of Methylone in the Treatment of PTSD (IMPACT-1) part B was a phase 2, multicenter, double-blind, placebo-controlled, 10-week randomized clinical trial of TSND-201 in people with PTSD conducted between November 29, 2023, and February 19, 2025, across 16 sites in the US, UK, and Ireland. Adults aged 18 to 65 years who met DSM-5 criteria for current PTSD and 6 months or more of symptoms (Clinician-Administered PTSD Scales for DSM-5 [CAPS-5] ≥35) were eligible.

INTERVENTIONS: Participants were randomized 1:1 to receive TSND-201 or placebo. There were 4 once-weekly oral dosing sessions (150 mg followed by 100 mg or placebo). No psychotherapy was provided; however, dosing sessions were monitored by mental health professionals using a nondirective approach. Participants were followed up for 6 weeks after the last dose.

MAIN OUTCOMES AND MEASURES: The primary end point was change from baseline to day 64 in the CAPS-5 total severity score. Secondary end points included changes in PTSD Checklist for DSM-5 (PCL-5), Sheehan Disability Scale (SDS), and Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Other measures included response (≥50% improvement from baseline), remission (≤11 total severity score), loss of PTSD diagnosis, changes in CAPS-5 symptom clusters, and incidence of treatment-emergent adverse events (TEAEs). Safety was assessed by monitoring adverse events, vital signs, and Columbia-Suicide Severity Rating Scale.

RESULTS: Among the 65 participants (mean [SD] age, 43.7 [10.5] years; 39 female [60.0%]), TSND-201 demonstrated significantly greater improvement in CAPS-5 total score than placebo (least-squares mean difference, 9.64; 90% CI, -16.48 to -2.80; P = .01). PCL-5 (-28.46 vs -19.47; LS mean treatment difference, -8.99; 90% CI, -17.81 to -0.17), SDS (-8.29 vs -3.57; LS mean treatment difference, -4.72; 90% CI, -8.84 to -0.61), and MADRS (-13.94 vs -7.73; LS mean treatment difference, -6.21; 90% CI, -12.41 to -0.27) scores were also improved. Common TEAEs in the TSND-201 group included headache, decreased appetite, nausea, dizziness, blood pressure increased, dry mouth, insomnia.

CONCLUSIONS AND RELEVANCE: Results of this randomized clinical trial reveal that TSND-201 demonstrated statistically significant efficacy and was well tolerated, supporting its potential as a rapid-acting, durable treatment for PTSD.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05741710.

PMID:41706459 | DOI:10.1001/jamapsychiatry.2025.4625

Categories
Nevin Manimala Statistics

Joint and Independent Associations of Gestational Diabetes and Depression With Childhood Obesity

JAMA Netw Open. 2026 Feb 2;9(2):e2559344. doi: 10.1001/jamanetworkopen.2025.59344.

ABSTRACT

IMPORTANCE: Childhood obesity has been independently associated with exposure to gestational diabetes and prenatal depression. Although these conditions frequently co-occur and may share biological pathways, their combined association with childhood obesity remains unknown.

OBJECTIVE: To examine whether exposure to prenatal depression and gestational diabetes is separately and jointly associated with childhood obesity.

DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study of births from 2011 to 2021 used data from Kaiser Permanente Northern California, an integrated health care system. Individuals receiving prenatal care were universally screened for depression and gestational diabetes and their children’s height and weight were monitored until age 10 years. Data analysis was performed from June 2024 to December 2025.

EXPOSURES: Gestational diabetes diagnosis and prenatal depression diagnosis and severity obtained from medical records.

MAIN OUTCOMES AND MEASURES: The primary outcome was childhood obesity, defined as Centers for Disease Control and Prevention body mass index z scores greater than or equal to the 95th percentile stratified by child age in years. Modified Poisson regression with robust SEs estimated risk ratios (RRs) for prenatal depression and gestational diabetes separately and jointly, adjusting for the birthing parent’s age, race and ethnicity, neighborhood deprivation, parity, and prenatal alcohol and tobacco use. Effect modification was assessed separately by statistical interactions and stratified models.

RESULTS: In this cohort study of 203 333 birthing parent-child pairs (mean [SD] age of birthing parents at the time of delivery, 30.8 [5.3] years; 104 214 male children [51.3%]), rates of childhood obesity increased with child’s age, from 14.6% (29 198 of 199 329 children) at age 2.0 to 4.9 years, to 16.5% (19 155 of 116 398 children) at age 5.0 to 7.9 years, and 21.8% (9798 of 44 894 children) at age 8.0 to 10.0 years. Prenatal depression was minimally associated with obesity (RR, 1.07 [95% CI, 1.04-1.10] for children aged 2.0-4.9 years; RR, 1.08 [95% CI, 1.04-1.12] for children aged 5.0-7.9 years; RR, 1.05 [95% CI, 1.00-1.11] for children aged 8.0-10.0 years). Gestational diabetes demonstrated larger effect estimates (RR, 1.29 [95% CI, 1.25-1.34] for children aged 2.0-4.9 years; RR, 1.45 [95% CI, 1.40-1.51] for children aged 5.0-7.9 years; RR, 1.39 [95% CI, 1.31-1.46] for children aged 8.0-10.0 years). Joint exposure to gestational diabetes and depression conferred the highest RRs compared with having neither exposure (RR, 1.33 [95% CI, 1.23-1.44] for children aged 2.0-4.9 years; RR, 1.54 [95% CI, 1.41-1.69] for children aged 5.0-7.9 years; RR, 1.43 [95% CI, 1.25-1.64] for children aged 8.0-10.0 years), with no evidence of interaction (P for interaction >0.10). After additionally adjusting for prepregnancy body mass index, joint results were attenuated, although the association for the 5.0 to 7.9 years age group remained especially robust.

CONCLUSIONS AND RELEVANCE: In this cohort study, both prenatal depression and gestational diabetes were associated with childhood obesity risk, with larger effect sizes observed for gestational diabetes. Children exposed to both conditions had the greatest risk, although associations appeared additive rather than synergistic. These findings underscore the need for universal prenatal screening and risk stratification, along with targeted interventions for children exposed to these conditions.

PMID:41706453 | DOI:10.1001/jamanetworkopen.2025.59344

Categories
Nevin Manimala Statistics

Ten-Year Experience Transitioning from MRI-guided Transrectal to Transperineal Prostate Biopsies at a Large Single-Institution Academic Center

Urol Pract. 2026 Feb 18:101097UPJ0000000000000988. doi: 10.1097/UPJ.0000000000000988. Online ahead of print.

ABSTRACT

INTRODUCTION: We share our 10-year experience with transitioning from MRI-fusion transrectal (TR) to MRI-fusion transperineal (TP) prostate biopsy and the increased costs and time associated with this transition, particularly from the pathology perspective.

METHODS: Our prospectively maintained MRI-fusion prostate biopsy database was queried. Demographic and clinical data were captured. The cost difference between processing TR and TP biopsies was calculated. Scenarios to decrease cost and time were explored. R-software was used for statistical analyses.

RESULTS: Over 10 years, 2,370 prostate biopsies were performed (1,719 TR, 651 TP). TP biopsy became the preferred method in 2023. The overall cancer detection rates (CDR) and clinically significant CDR (csCDR) for TR biopsy were 55.4% (952/1,719) and 35.4% (609/1,719), respectively. For TP, it was 62.8% (409/651) and 41.8% (272/651), respectively. This was a significant difference in CDR and csCDR (p<0.01). The estimated increased annual cost for TP biopsy from a pathology processing standpoint was $136,662, and the estimated time increase per year was 1,332.5 hours. We constructed 4 scenarios with cost and time reductions as high as $282,750 and 2730 hours per year, respectively.

CONCLUSION: Transitioning to an MRI-fusion TP prostate biopsy has resulted in higher overall CDR and csCDR rates, but also significantly higher costs and time spent. Possible designs may exist that could yield significant cost and time savings per annum.

PMID:41706435 | DOI:10.1097/UPJ.0000000000000988