Categories
Nevin Manimala Statistics

Adverse Events After Same-Day COVID-19 and Influenza Vaccination Versus Influenza Vaccination Alone : A Target Trial Emulation

Ann Intern Med. 2026 Jun 30. doi: 10.7326/ANNALS-26-00217. Online ahead of print.

ABSTRACT

BACKGROUND: Safety studies of the COVID-19 vaccine have identified some adverse events. Yet newer variant-updated formulations, along with increased hybrid immunity, may change these risks. Early-era safety data may not reflect experience with updated formulations in more immune-experienced populations.

OBJECTIVE: To evaluate 90-day risks for adverse events after coadministration of COVID-19 and influenza vaccines compared with influenza vaccination alone, across bivalent, XBB-adapted, and KP-adapted COVID-19 vaccine periods.

DESIGN: Target trial emulation using electronic health care data.

SETTING: U.S. Department of Veterans Affairs.

PARTICIPANTS: Participants receiving both COVID-19 and seasonal influenza vaccines (n = 705 124) and those receiving only an influenza vaccine (n = 1 813 205) between 1 September 2022 and 26 August 2025.

INTERVENTION: Receipt of both COVID-19 and seasonal influenza vaccines versus receipt of only an influenza vaccine.

MEASUREMENTS: 90-day risks for 46 prespecified individual adverse events grouped into 3 composite outcomes (tier 1, serious or life-threatening; tier 2, clinically significant; tier 3, less severe or self-limiting), using weighted discrete-time survival models.

RESULTS: For all 3 composite outcomes, risks were similar between groups: tier 1 (risk ratio [RR], 1.03 [95% CI, 0.99 to 1.09]), tier 2 (RR, 0.99 [CI, 0.96 to 1.03]), and tier 3 (RR, 0.99 [CI, 0.96 to 1.02]). Of the 46 individual adverse events, 2 tier-3 risks had nominal statistical significance: syncope (RR, 1.09 [CI, 1.02 to 1.17]) and tinnitus (RR, 0.95 [CI, 0.92 to 0.99]); no risks were statistically significant after correcting for multiple comparisons. For all risks in tier 1 or tier 2, confidence bounds included 1.0 (no effect). In period-stratified analyses, neither composite (tier) nor individual event estimates supported differences in risks between groups.

LIMITATION: Generalizability and potential unmeasured confounding.

CONCLUSION: Same-day coadministration of COVID-19 and influenza vaccines was not associated with an increased risk for adverse events in 3 updated-formulation periods. These findings support the short-term safety of coadministration.

PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.

PMID:42372279 | DOI:10.7326/ANNALS-26-00217

Categories
Nevin Manimala Statistics

Assessment Instruments for Social Anxiety in Oral and Public Communication Among Health Sciences Students: Protocol for a Scoping Review

JMIR Res Protoc. 2026 Jun 29;15:e93700. doi: 10.2196/93700.

ABSTRACT

BACKGROUND: Proficiency in interpersonal communication and social skills is fundamental for health sciences students, but public speaking anxiety and communication apprehension frequently compromise academic performance, emotional well-being, and the acquisition of essential competencies. The postpandemic educational environment has exacerbated student stress, highlighting the urgent need for reliable assessment tools for social anxiety in this population.

OBJECTIVE: This scoping review protocol aims to map instruments used to assess public speaking anxiety and communication apprehension among health sciences students, analyzing their psychometric properties, cultural adaptations, and application contexts.

METHODS: Following the Joanna Briggs Institute framework and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, a systematic search will be conducted across PubMed, Scopus, Embase, LILACS, Web of Science, the Cochrane Library, and the Biblioteca Virtual em Saúde Portal. Eligible studies will include those evaluating social or performance anxiety in undergraduate or postgraduate health sciences students, using validated or culturally adapted instruments. Two independent reviewers will screen studies, with discrepancies resolved by a third reviewer. Data extraction will be conducted systematically, focusing on structural and content variables. Analysis will use a mixed methods approach, combining descriptive statistics with thematic synthesis and incorporating psychometric expertise.

RESULTS: As of May 2026, protocol registration has been completed via the Open Science Framework. Systematic database searches and study selection are scheduled to commence in June 2026, with anticipated completion by December 2026, aligned with a 2-year implementation road map designed to generate comprehensive instrument mapping and secondary analyses for evidence-based health professional training.

CONCLUSIONS: This protocol establishes a transparent and reproducible methodological plan, ensuring scientific rigor through adherence to Joanna Briggs Institute and PRISMA-ScR standards. It will deepen understanding of social anxiety assessment in oral communication among health sciences students and support the development of more effective interventions.

TRIAL REGISTRATION: Open Science Framework 10.17605/OSF.IO/YQ4KM; https://osf.io/yq4km.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/93700.

PMID:42372261 | DOI:10.2196/93700

Categories
Nevin Manimala Statistics

Risk Factors for Noninitiation and Dropout in Blended Therapy in Inpatient Psychiatric Patients: Retrospective Cohort Study

JMIR Hum Factors. 2026 Jun 29;13:e85816. doi: 10.2196/85816.

ABSTRACT

BACKGROUND: Blended therapy (BT) combines digital applications with face-to-face treatment and has become an increasingly important component of psychiatric care. Evidence indicates that BT can achieve outcomes comparable to or even superior to those of traditional face-to-face therapy. Despite certain advantages, routine implementation of BT remains challenging, and clinical practice suggests that while some inpatients engage with BT, many either discontinue early or do not initiate its use at all. To better understand these patterns, this multicentric, retrospective observational study investigates factors associated with noninitiation and dropout among inpatients who are offered BT.

OBJECTIVE: In this study, data from 278 inpatients were analyzed to examine the influence of sociodemographic variables, comorbidities, and symptom severity on the uptake and continued use of BT. The objective was to identify predictors of noninitiation and dropout.

METHODS: Multivariable logistic regression models were conducted to identify significant predictors of noninitiation and dropout among inpatients using the transdiagnostic, cognitive behavioral therapy-based electronic mental health platform Minddistrict, which offers modules targeting psychoeducation, cognitive restructuring, and behavioral activation. Data were collected from 2 psychiatric hospitals between January 2020 and May 2024. The sample consisted predominantly of patients diagnosed with depression (182/278, 65.7%) and posttraumatic stress disorder (61/278, 21.9%), alongside various comorbid conditions.

RESULTS: The findings indicate distinct patterns of association for noninitiation and dropout. Of the 278 patients, only 5 (1.8%) completed all the assigned modules, and one-third of the patients never initiated the platform at all. Specifically, increasing age was linked to a lower risk of noninitiation (odds ratio [per year age difference] 0.98, 95% CI 0.96-1.00; P=.01), while the presence of a comorbid anxiety disorder was associated with a reduced risk of dropout (odds ratio 0.23, 95% CI 0.08-0.66; P=.007). Several variables showed no association with either noninitiation or dropout across all analyses, including sex, overall symptom severity, and certain comorbidities such as personality disorders and depression.

CONCLUSIONS: In this preselected inpatient sample, uptake of BT was very limited. Older age was associated with lower noninitiation, and comorbid anxiety disorders were associated with a lower likelihood of dropout. These findings may help inform future prospective studies on how BT can be introduced and supported more effectively in inpatient psychiatric care. As access to BT was granted selectively by therapists, the results should be interpreted as predictors of engagement within a selected sample rather than general predictors of BT uptake among all psychiatric inpatients.

PMID:42372259 | DOI:10.2196/85816

Categories
Nevin Manimala Statistics

Repetitive Transcranial Magnetic Stimulation as a Cognitive Rehabilitation Approach for Veterans With Parkinson Disease and Mild Cognitive Impairment: Protocol for a Randomized Sham-Controlled Trial

JMIR Res Protoc. 2026 Jun 29;15:e77241. doi: 10.2196/77241.

ABSTRACT

BACKGROUND: Parkinson disease (PD) is characterized by motor symptoms as well as progressive cognitive decline leading to long-term functional impairment and diminished quality of life. Mild cognitive impairment in PD (PD-MCI) is a risk factor for developing PD-related dementia. PD-MCI provides a window to assess interventions that can improve cognition. Repetitive transcranial magnetic stimulation (rTMS) shows promise as an effective treatment to improve cognitive performance.

OBJECTIVE: This study aims to test the safety and feasibility of a 10-session, high-frequency rTMS protocol applied to the left dorsolateral prefrontal cortex and the rTMS efficacy in improving cognitive test performance among veterans with PD-MCI.

METHODS: This is a double-blind randomized controlled trial. We will enroll US military veterans with PD-MCI. Participants will be randomized to either active or sham rTMS treatment groups, each with 10 treatment sessions (2 sessions/day). Treatment need not be consecutive; rather, they can be spread across approximately 10 days (eg, Monday, Wednesday, Thursday, Monday, Tuesday, and Wednesday). Participants randomized to active rTMS will receive stimulation applied to the left dorsolateral prefrontal cortex at 110% the resting motor threshold, a 15-Hz rate, 5 seconds per train of pulses, a 10-second intertrial interval, and 40 trains of pulses per session. Each patient will receive approximately 3000 pulses per session. Sham stimulation will be administered at the same parameters as real rTMS; however, no magnetic field will be produced on the placebo side of the active or placebo coil. This protocol was approved by the Edward Hines Jr Veterans Administration Hospital and Jesse Brown Department of Veterans Affairs Medical Center institutional review boards. This study includes a Food and Drug Administration investigational device exemption (G190076).

RESULTS: Safety will be assessed using the number of research-related adverse events experienced by the active rTMS group compared to the sham rTMS group. Feasibility will be assessed using protocol completion rates. To examine preliminary effects of rTMS, participants will complete a standardized neurocognitive battery assessment at baseline, end point, and 1-month follow-up. The primary study outcome is the change in score from baseline to end point on the National Institutes of Health-sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research Executive Composite score. This project was funded in June 2019, with additional funding secured in April 2024. As of April 2025, a total of 18 veterans with PD-MCI have completed the randomized controlled trial phase. Data collection is ongoing and will be completed by March 2027. We expect the results of this study to be available by March 2028.

CONCLUSIONS: The knowledge gained on the safety, feasibility, and efficacy of rTMS will set the stage for future research optimizing therapeutic gains for existing cognitive rehabilitation treatments or developing new and adjunct treatments for PD-MCI.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03836950; https://clinicaltrials.gov/study/NCT03836950.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77241.

PMID:42372258 | DOI:10.2196/77241

Categories
Nevin Manimala Statistics

Evaluation of a Digital Intervention for Monitoring and Improving Medication Adherence Among Real-World e-Consumers of HIV Preexposure Prophylaxis in China: Protocol for a Randomized Controlled Trial

JMIR Res Protoc. 2026 Jun 29;15:e92750. doi: 10.2196/92750.

ABSTRACT

BACKGROUND: Preexposure prophylaxis (PrEP) is a key biomedical HIV prevention strategy that relies heavily on adherence for optimal effectiveness. In China, most PrEP users purchase their medication online, making it challenging to monitor and support adherence effectively.

OBJECTIVE: This protocol aims to describe a digital intervention developed to monitor and improve the medication adherence of real-world e-consumers of PrEP and an evaluation plan assessing its acceptability, feasibility, and effectiveness.

METHODS: The Real-Time Monitoring and Precision Intervention for HIV PrEP Adherence (REMOTE) trial is a parallel-group, open-label, online-delivered, active-controlled, and stratified randomized controlled trial conducted among 430 e-consumers of PrEP (320 event-driven regimen users and 110 daily regimen users) in China. People who have purchased PrEP online, have taken PrEP in the previous 3 months, and plan to continue for the next 6 months will be stratified by regimen type and randomized into control and intervention groups at a 1:1 ratio. A WeChat-based digital platform will deliver the REMOTE intervention. The monitoring module follows ecological momentary assessment principles. The intervention design is guided by the stages of change theory, tailoring strategies to different nonadherence risks based on monitoring results. Intervention components include low-risk (health education and an artificial intelligence chatbot), medium-risk (peer forum and admonitory education), and high-risk (customized reminders and physician counseling) strategies. The control group will use a simplified platform with only real-time monitoring. The primary outcome is the proportion of participants achieving optimal adherence for 6 months, assessed via real-time monitoring and validated via surveys at baseline and the 1-, 3-, and 6-month follow-ups. Secondary outcomes include PrEP adherence knowledge, self-efficacy, risk perception, adherence barriers, stigma, and social support, measured via surveys. Intention-to-treat analysis will be conducted.

RESULTS: Funding for the study was approved in March 2024. Ethics approval for the study was granted in July 2024. The pilot trial was completed in November 2025. Baseline data collection commenced in January 2026. By February 5, 2026, recruitment and baseline data collection were completed, with 448 participants enrolled. The data have not been viewed by the research team. The intervention is currently ongoing, and the study is expected to conclude in August 2026. Results are anticipated to be published in early 2027.

CONCLUSIONS: The REMOTE trial pioneers a real-time monitoring and precision intervention for e-consumers of PrEP. Leveraging technology and ecological momentary assessment, it delivers a personalized, real-time intervention that is crucial for adherence. The findings could significantly impact future HIV prevention strategies.

TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2400088278; https://www.chictr.org.cn/showproj.html?proj=236414.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/92750.

PMID:42372256 | DOI:10.2196/92750

Categories
Nevin Manimala Statistics

Economic value analysis and development of economic weights for selection index construction in indigenous chicken genetic improvement

Br Poult Sci. 2026 Jun 29:1-10. doi: 10.1080/00071668.2026.2686308. Online ahead of print.

ABSTRACT

1. The primary aim of this study was to conduct a cost-benefit analysis of Ethiopian indigenous chickens and to estimate the economic weights of key performance traits. Data were collected through structured questionnaires administered to smallholder poultry farmers and subsequently analysed using R statistical software.2. Data were analysed using a bio-economic model integrating biological performance parameters with economic parameters to assess the profitability and efficiency of production systems. It was applied to a standardised flock of 100 indigenous chickens (IC) to evaluate economic performance across systems for egg number (EN), body weight (BW), age at first egg (AFE) and survival rate (SV).3. The study revealed that production in Shambu and Fincha districts was predominantly based on a free-range production system (FRS), whereas production in Shagar City was mainly a semi-intensive system (SIS). The FRS generated a total income of US$1,687.28, while the SIS produced a significantly higher return of US$9,082.85. In both production systems, feed costs accounted for the largest share of production expenses, 61.21% (US$2,709.41) in FRS and 62.94% (US$18,346.63) in SIS followed by fixed costs, which represented 24.04% (US$1,064.28) and 24.27% (US$1,632.88), respectively.4. The major sources of income in both systems were the sale of surplus grower females and cockerels. Specifically, revenues for FRS and SIS were US$46.15 and US$162.80 from eggs; US$2,254.63 and US$3,044.84 from surplus females; US$3,529.42 and US$5,348.27 from surplus cockerels; and US$226.54 and US$236.04 from culled breeding stock, respectively. Under SIS, a 1% improvement in performance through selection and management would increase profits by 6.35 from EN, 54.75 from BW, 20.67 from AFE and 145.42 US$.5. The results suggested that meat-oriented production from indigenous chickens generates higher economic returns than egg production under the two systems. However, economic weights derived from marginal profit and genetic variance, integrating both market values and biological performance indicators, assigned the highest priority to EN (36.46), followed by BW (34.37), AFE (23.91) and SV (5.26).

PMID:42372246 | DOI:10.1080/00071668.2026.2686308

Categories
Nevin Manimala Statistics

Getting It Right the First Time: Improving Antibiotic Stewardship in Febrile Oncology Patients Presenting to the Pediatric Emergency Department

JCO Oncol Pract. 2026 Jun 29:OP2600031. doi: 10.1200/OP-26-00031. Online ahead of print.

ABSTRACT

PURPOSE: Febrile pediatric oncology patients with central lines are at high risk of sepsis. However, emerging evidence fails to support the historic 1-hour window for antibiotic administration in well-appearing patients, suggesting that providers may have more time to tailor antibiotic therapy in these patients. Before this quality improvement project, 92% of febrile oncology patients without severe neutropenia (absolute neutrophil count [ANC] ≥500) in our pediatric emergency department (ED) received empiric intravenous cefepime. The aim of this study was to decrease this percentage to 60% by June 30, 2025.

METHODS: A multidisciplinary team implemented interventions using Plan-Do-Study-Act (PDSA) methodology, including clinical pathways and order set updates, tips for communicating with families, and a risk stratification tool. The outcome measure was the percentage of febrile oncology patients without severe neutropenia who received cefepime. Process measures included order set use, percentage of antibiotics ordered before ANC results were obtained, and the time to ANC result. Balancing measures included readmission of patients within 7 days, admission to the intensive care unit within 24 hours of ED discharge, and percentage of patients with antibiotics administered >3 hours after arrival.

RESULTS: There was an average of 7.9/month febrile oncology patients without severe neutropenia. Following the first PDSA cycle, cefepime use in patients without severe neutropenia decreased from 92% to 26.8%. Patients with antibiotics administered before ANC reporting decreased from 90% to 35.2%. Patients with IV antibiotics administered >3 hours from arrival increased from 2.3% to 29%. Remaining balancing measures did not statistically change.

CONCLUSION: Implementation of a new clinical pathway with order sets, adoption of a risk stratification tool, and patient and family involvement safely improved antibiotic stewardship for febrile oncology patients.

PMID:42372214 | DOI:10.1200/OP-26-00031

Categories
Nevin Manimala Statistics

Survival Heterogeneity in U.S. Hospice Patients: A Retrospective Cohort Study

Am J Hosp Palliat Care. 2026 Jun 29:10499091261462816. doi: 10.1177/10499091261462816. Online ahead of print.

ABSTRACT

Hospice has become an important component of End-of-life care in the United States. The use of hospice, however, remains subject to many forces, including the patient, providers, families and cultural beliefs. One consequence of these forces is significant variability of survival of patients in hospice. In a recent study, the authors reported a median survival of approximately 24 days after enrollment. However, a significant minority of patients survive for more than 180 days (the target set by CMS for the Medicare hospice benefit). We examine the factors contributing to the variability of hospice patient survival, including demographics, diagnoses, care setting, and patient drug prescriptions. We apply Cox proportional hazards models to assess the effect of covariates on time-to-event (in this case death in hospice). A high hazard ratio is associated with a shorter life expectancy. In addition to these factors we evaluated medication exposure variables. Medications are strongly associated with the mortality hazard: analgesic use is associated with a nearly three-fold higher hazard (HR = 2.977), and anxiolytic use with a roughly two-fold higher hazard (HR = 1.910) when compared with the group without any anxiolytic use. We provide a detailed understanding of medication use near the end of life that serve as an indicator that medication trajectories can serve as an additional indicator of symptom burden and individualized care planning.

PMID:42372182 | DOI:10.1177/10499091261462816

Categories
Nevin Manimala Statistics

Beyond unit cells: Programmable morphogenetic design of irregular architected materials

Proc Natl Acad Sci U S A. 2026 Jul 7;123(27):e2606412123. doi: 10.1073/pnas.2606412123. Epub 2026 Jun 29.

ABSTRACT

Architected materials derive functionality from geometry, yet conventional unit cell-based design limits functional heterogeneity, geometric adaptability, and robustness to defects. Inspired by natural morphogenesis, we introduce RDGenCAD, a morphogenetic design framework that translates programmable growth rules into reaction-diffusion dynamics to generate self-organized, CAD-ready architectures. A database of 120,000 morphogenetic structures reveals statistically deterministic and continuous tunability of elastic properties across auxetic and conventional regimes, despite pronounced geometric irregularity. These architectures further exhibit emergent flaw insensitivity and crack deflection through stress compartmentalization, leading to synergistic gains in strength and toughness relative to regular lattices. By shifting architected material design from unit-cell tessellation to programmable morphogenetic growth, this work establishes self-organization as a generative principle for designing materials that are irregular yet predictable, heterogeneous yet “coherent,” and directly manufacturable.

PMID:42372167 | DOI:10.1073/pnas.2606412123

Categories
Nevin Manimala Statistics

Dynamic positioning of Rpc34 winged helix in RNA polymerase III elongation complex for its stability with implications for reinitiation

Proc Natl Acad Sci U S A. 2026 Jul 7;123(27):e2601775123. doi: 10.1073/pnas.2601775123. Epub 2026 Jun 29.

ABSTRACT

RNA polymerase III (Pol III) is specialized for the high-throughput synthesis of short RNAs, a capability linked to its unique TFIIE- and TFIIF-like subcomplexes that are stably associated through different stages of transcription. To date, the role of a winged helix domain (WH2) of Rpc34 subunit in the TFIIE-like subcomplex during elongation has remained a conundrum because its density is consistently absent in cryo-EM structures of Pol III elongation complexes (ECs), suggesting its high conformational mobility. In this study, we employed single-molecule Förster resonance energy transfer (smFRET) and nano-positioning triangulation to characterize the dynamics and determine the position of the Rpc34-WH2 domain within transcription-competent but nontranslocating Pol III ECs. To achieve the required site-specific labeling, we developed a chemical biology framework that utilizes azido-carrying unnatural amino acid incorporation and a thiol-capping strategy to eliminate off-target alkyne-thiol cross-reactivity. With the acceptor at Rpc34-WH2 and the donor at a defined position on the DNA template as the reference point, our smFRET results reveal that Rpc34-WH2 dynamically transitions among three discrete states, corresponding to preferred positional sites in downstream, middle, and upstream regions across the DNA-binding cleft. One of these sites coincides with Rpc34-WH2’s position in the preinitiation complex, indicating positional similarity across transcriptional states. Together with prior Pol I and Pol II studies, these findings establish Rpc34-WH2 as a mobile regulatory element that engages the Pol III EC through transient, weak interactions. Additionally, the bio-orthogonal labeling strategy presented here provides a robust, generalizable route for smFRET studies of large, multisubunit protein assemblies.

PMID:42372135 | DOI:10.1073/pnas.2601775123