Nevin Manimala

Biom J. 2026 Aug;68(4):e70153. doi: 10.1002/bimj.70153.

ABSTRACT

Beyersmann et al. propose a functional interpretation of hazards, viewing them as evolving quantities describing the entire event process rather than as pointwise causal contrasts. In this commentary, we elaborate on the implications of this view for causal inference in modern clinical trials with survival outcomes. We emphasize how censoring, competing events, and multistate structures shape not only identifiability but also the definition and transportability of hazard-based estimands. We highlight that, even within a functional framework, censoring mechanisms may implicitly determine the statistical estimand through time-dependent weighting, with direct implications for generalizability across studies and populations. We further discuss how these issues are amplified in competing-risks and multistate settings, where causal interpretation requires careful consideration of intercurrent events and selection induced by post-randomization state occupancy.

PMID:42444496 | DOI:10.1002/bimj.70153

Int Health. 2026 Jul 14:ihag070. doi: 10.1093/inthealth/ihag070. Online ahead of print.

ABSTRACT

Corporate social responsibility has received substantial attention from researchers in the business and organizational literature. However, this concept is equally desirable in nursing care, as nurses must realize their responsibility towards society in the effective delivery of healthcare services. Employing the concept analysis method of Walker and Avant, 128 journal articles published in the PubMed journal during 2000 to 2025 were selected based on the inclusion criteria. Based on this model, the study proposes a framework for nurses’ social responsibility (NSR), especially in the context of developing countries. This framework coins three important dimensions of social responsibility that include NSR towards their profession, community, and patients. Based on the three dimensions of the NSR, this study proposes six major principles that govern this framework. It also presents four strategies for successful implementation of this framework. This framework also outlines certain challenges and mitigation strategies to effectively counter these challenges. Potential outcomes of the proposed framework are discussed, followed by a call for action to nurses, nursing organizations, governments, and the community at large.

PMID:42444477 | DOI:10.1093/inthealth/ihag070

Circ Heart Fail. 2026 Jul 14:e013935. doi: 10.1161/CIRCHEARTFAILURE.125.013935. Online ahead of print.

ABSTRACT

BACKGROUND: There is a growing consensus that screening for subclinical preheart failure (HF) may reduce the burden of symptomatic HF by allowing for timely preventive interventions. However, validated screening algorithms are currently lacking. The aim of this study was to evaluate a fully mobile telemedically supervised cardiac magnetic resonance, as a simple standardized, and ubiquitously applicable screening algorithm for subclinical pre-HF in rural and underresourced regions.

METHODS: HERZCHECK was a cross-sectional cohort study conducted at 12 sites across rural and underresourced regions of Germany. Asymptomatic participants (40-69 years) with ≥1 cardiovascular risk factor-obesity, smoking, arterial hypertension, diabetes, hypercholesterolemia, or chronic kidney disease-were enrolled and underwent telemedically supervised contrast-free short cardiac magnetic resonance in mobile screening units. Subclinical pre-HF was diagnosed using a predefined cutoff of global longitudinal strain ≥-15%. A matched and entropy-balanced control cohort constructed from claims data was used to determine the time difference between detection of subclinical pre-HF in HERZCHECK and the first symptom-based diagnosis of HF within the standard of care.

RESULTS: Between June 2021 and April 2023, 4666 participants were enrolled in the study, of which 4509 participants were included in the final analysis. The prevalence of subclinical pre-HF in the studied at-risk population was 22.7% (95% CI, 21.5%-23.9%). Global longitudinal strain-based screening identified subclinical pre-HF 6.7 years before the average onset of symptomatic HF within the standard of care (n=8420).

CONCLUSIONS: Subclinical pre-HF affects approximately one-fourth of the at-risk population in rural and underresourced regions. The HERZCHECK approach identifies patients suitable for targeted preventive interventions ≈7 years earlier than the standard of care.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05122793.

PMID:42444474 | DOI:10.1161/CIRCHEARTFAILURE.125.013935

Circ Cardiovasc Imaging. 2026 Jul 14:e019755. doi: 10.1161/CIRCIMAGING.126.019755. Online ahead of print.

ABSTRACT

Fetal ultrasound is the primary screening modality for routine prenatal examinations, but its effectiveness can be influenced by factors such as maternal body habitus, polyhydramnios, or fetal position. Although magnetic resonance imaging (MRI) is well established for fetal brain and body imaging, cardiac assessment has been restricted by the absence of reliable cardiac gating and motion compensation strategies. Only recently have advances in fetal cardiac rhythm monitoring within the MRI scanner enabled retrospective gating, paving the way for clinical use of fetal cardiac MRI. However, a reproducible and standardized imaging protocol for systematic cardiac assessment on cine sequences has not yet been universally adopted. This article proposes a practical framework for fetal cardiac cine MRI acquisition and interpretation based on a segmental approach consistent with standard fetal echocardiographic orientations, while also incorporating ungated T2-weighted imaging with slice-to-volume reconstruction for the assessment of extracardiac vascular anatomy. Representative cases with annotated anatomic landmarks illustrate how MRI can be integrated into a multimodality prenatal imaging strategy. The development of a standardized protocol may facilitate reproducibility across centers and support the incorporation of fetal cardiac MRI as a complementary tool within comprehensive prenatal cardiac evaluation.

PMID:42444472 | DOI:10.1161/CIRCIMAGING.126.019755

Circ Heart Fail. 2026 Jul 14:e014449. doi: 10.1161/CIRCHEARTFAILURE.126.014449. Online ahead of print.

ABSTRACT

BACKGROUND: Skilled nursing facilities (SNFs) play a critical role in postacute recovery for older adults with heart failure (HF), yet the transition from SNF to home remains a vulnerable and understudied phase of care. Although discharge guidelines emphasize clear communication, HF-specific self-care education, medication management, and follow-up coordination, little is known about how these practices are implemented during SNF-to-home transitions.

METHODS: We conducted a convergent mixed-methods study across 4 nonprofit SNFs, integrating data from postdischarge patient and caregiver surveys, structured medical record abstraction of discharge instructions, and semi-structured staff interviews. Eligible patients were Medicare beneficiaries aged ≥65 years discharged from SNF to home following HF hospitalization, with SNF stays ≤60 days. Quantitative data were analyzed using descriptive statistics, while qualitative data underwent thematic and directed content analysis. Findings were triangulated across data sources to identify key challenges and actionable strategies.

RESULTS: Among 150 respondents, 59% reported receiving written discharge instructions; however, HF-specific self-care elements (eg, daily weight monitoring, low salt diet) were documented in only 15% to 41% of instructions. Although 87% reported receiving a medication list, only 53% had it reflected in the discharge instructions, and adherence support was infrequently addressed (24%). Follow-up coordination was similarly discordant: 37% of respondents reported a scheduled primary care appointment, compared with 13% documented in discharge instructions. Staff interviews revealed nonstandardized discharge workflows, workforce constraints, and reliance on verbal education, contributing to variability in patient preparation and communication across care settings.

CONCLUSIONS: SNF-to-home transitions after HF hospitalization are marked by discordance between patient-reported education and written documentation, as well as inconsistent medication and follow-up coordination. These gaps represent modifiable vulnerabilities during a high-risk recovery period. Standardized HF-focused discharge workflows and strengthened cross-setting communication may improve transitional care, while long-term solutions must address structural and workforce constraints.

PMID:42444467 | DOI:10.1161/CIRCHEARTFAILURE.126.014449

Bioanalysis. 2026 Jul 14:1-12. doi: 10.1080/17576180.2026.2698615. Online ahead of print.

ABSTRACT

BACKGROUND: The identification of anti-drug antibodies (ADA) raised against biologic drugs is important for understanding and ensuring efficacy and safety. Because the immunogenicity of novel biologics is unknown before clinical trials, ADA assays are often developed with positivity thresholds assigned based on statistically determined cut-points defined by testing of samples from treatment-naïve donors.

RESEARCH DESIGN AND METHODS: While the standard approaches are based on reasonable theoretical models, we aimed to identify the impact of alternative analytical pipelines on assignment of ADA positivity by analysis of Tier 1 screening and Tier 2 confirmatory ADA bridging assay data for up to 138 mAbs across up to hundreds of serum samples. We evaluate the utility of data augmentation through bootstrapping and the impact of outlier removal approaches on the consistency of ADA status determinations.

RESULTS AND CONCLUSION: We find that bootstrapping supports assay development efficiency by improving confidence in threshold setting in the context of limited numbers of test samples and that while outlier exclusion approach led to different apparent levels of ADA positivity, immunogenic drug products were identified by differences in the distribution of sample profiles from naïve and treated participants by each method evaluated.

CLINICAL TRIAL REGISTRATION IDENTIFIERS INCLUDE: NCT02716675 https://clinicaltrials.gov/study/NCT02716675NCT02568215NCT02568215 https://clinicaltrials.gov/study/NCT02568215NCT03875209NCT03875209 https://clinicaltrials.gov/study/NCT03875209NCT04173819NCT04173819 https://clinicaltrials.gov/study/NCT04173819.

PMID:42444466 | DOI:10.1080/17576180.2026.2698615

Epidemiol Prev. 2026 May-Jun;50(3):279-289. doi: 10.19191/EP26.3.A992.059.

ABSTRACT

BACKGROUND: the use of real-world (RW) data has become an integral part of pharmacoepidemiological research and regulatory assessment. However, access to individual-level data, especially for purposes other than the original ones (secondary use), is often restricted by legal and ethical constraints related to privacy protection. In this context, generating synthetic data, defined as artificially generated data that reproduce the statistical properties and relationships of real data without containing information traceable to real individuals, offers an innovative opportunity to balance privacy protection with the need to generate RW evidence to support regulatory decision-making.

OBJECTIVES: to compare two methods of generating tabular synthetic data: synthpop, based on transparent and interpretable inferential methodologies, and Conditional Tabular-Generative Adversarial Networks (CT-GANs), which leverage deep learning approaches to reproduce complex multivariate distributions. The focus is on evaluating the ability of both approaches to preserve the statistical structure of real data and reduce the risk of disclosure/re-identification.

DESIGN: comparative study of two synthetic data generation methods.

SETTING AND PARTICIPANTS: a large anonymized RW dataset including 42,926 patients hospitalized for COVID-19 in Italy during the early phase of the pandemic. The dataset was obtained through record linkage of administrative databases and the COVID-19 registry using the TheShinISS tool.

MAIN OUTCOME MEASURES: synthetic versions of the original dataset were generated using both synthpop and CT-GAN methods. Real and synthetic data were compared using three type of measures: 1. general utility measures (univariate, bivariate, and global), including comparison of variable distributions using plots, descriptive statistics, standardized mean differences (SMD), and Propensity Score Mean Squared Error; 2. specific utility measures, assessing the similarity of associations estimates from univariate and multivariable Cox models by evaluating the overlap of 95% confidence intervals (CI) of hazard ratios (HR), and comparison of Kaplan-Meier curves using the log-rank test; 3. disclosure (re-identification) measures, estimating the risk of identity and attribute disclosure using dedicated metrics (Unique in Original – UiO, replicated Uniques – repU, Disclosive in Original – Dorig, Disclosive in Synthetic Correct Original – DiSCO).

RESULTS: in terms of general utility, results confirmed the superiority of synthpop over CT-GAN, with more than half of the variables exceeding the acceptable SMD threshold. Moreover, synthpop showed higher specific utility than CT-GAN, with a median overlap of 95%CI of HR of 75% (interquartile range, IQR: 66%-95%) compared with 0% (IQR: 0%-6%) for CT-GAN. Concerning disclosure measures, although the original dataset already presented a negligible risk of identity disclosure (UiO=0.23%), making synthesis largely redundant, both methods further reduced this risk (synthpop: repU=0.06%; GAN: repU=0.05%).

CONCLUSIONS: in this study, considering the three evaluated aspects, synthpop performed better in balancing statistical accuracy and privacy protection. It also offered greater methodological transparency based on explicit statistical models and required lower computational time. These findings contribute to the ongoing debate on the potential use of synthetic data in research and regulatory assessments supporting their integration into RW data analysis workflows. The disclosure measures adopted may serve as a practical starting point, however, the definition of shared standards for these measures, as well as acceptable disclosure risk thresholds, would be desirable and should be developed collaboratively by the scientific community and data protection authorities. Future studies should focus on generating synthetic data where non-explicit relationships exist in real data (i.e., relationships that are not directly attributable to additive or multiplicative structures).

PMID:42444462 | DOI:10.19191/EP26.3.A992.059

Cent Eur J Public Health. 2026 Jun;34(2):141-148. doi: 10.21101/cejph.a8978.

ABSTRACT

OBJECTIVES: This study assessed perceptions of health and science students and academic staff regarding the health risks, environmental impact, and regulation of dental amalgam (DA). As DA faces increasing restrictions, understanding the views of students and academic staff is essential for evaluating educational and policy readiness.

METHODS: A cross-sectional survey was distributed to 1,230 participants in the Czech Republic. The questionnaire explored awareness of mercury exposure from DA, health and environmental concerns, and familiarity with regulations. Responses were statistically compared across disciplines.

RESULTS: Overall, 35.8% of respondents did not recognize DA as a mercury source, and 48.5% did not view it as a health risk. Most did not consider DA an occupational hazard for dental professionals. However, 55.3% saw it as an environmental pollutant. While 59.2% supported restricting DA use in pregnant women and 51.0% in children, only 22.0% supported a complete ban. Most respondents preferred composites for aesthetic reasons (88.5%) rather than health concerns. Dental students differed significantly from other groups in several key areas, particularly regarding perceived health risks and support for restrictions on dental amalgam use.

CONCLUSIONS: Perceptions of dental amalgam differed according to educational background. While most participants supported restricting its use in vulnerable populations, dental students were less likely to perceive it as a significant health risk and were less supportive of a complete ban. These findings highlight the importance of evidence-based education and public health communication regarding dental amalgam and mercury-related issues.

PMID:42444434 | DOI:10.21101/cejph.a8978

Cent Eur J Public Health. 2026 Jun;34(2):135-140. doi: 10.21101/cejph.a8731.

ABSTRACT

OBJECTIVES: The main objective of the study was to adapt and verify the psychometric properties of the Illinois Bully Scale (IBS) in Czech adolescents.

METHODS: The analysis utilized quantitative data from 1,321 respondents, aged 12 to 14 years, who were enrolled in 7th grade of lower secondary or grammar school. Descriptive and inferential statistics, including chi-square tests and Mann-Whitney U tests, were used to examine group differences.

RESULTS: The IBS demonstrated strong internal consistency and construct validity across all subscales (Victim: 0.84, Bully: 0.80, Fight: 0.79, total IBS: 0.87). Boys and elementary school students reported significant victim and bully experiences. The supplemental cyberbullying scale showed significant correlations with the IBS subscales, supporting its criterion-related validity.

CONCLUSIONS: Adaptation of the IBS confirmed that it is a useful tool for assessing the frequency and experience of different types and severity of bullying. Its Czech adaptation allows for population screening as well as identification of severe cases and planning of interventions.

PMID:42444433 | DOI:10.21101/cejph.a8731

Cent Eur J Public Health. 2026 Jun;34(2):123-128. doi: 10.21101/cejph.a8708.

ABSTRACT

OBJECTIVES: In Ukraine, accurate HIV mortality data are lacking due to limited information on HIV-related deaths. This study focuses on Kyiv to track HIV-related deaths among undiagnosed individuals living with HIV and evaluate HIV programming for cause-of-death identification.

METHODS: Five mortuaries in Kyiv were selected to participate (July-December 2021) with cadavers from people aged 18+ years. HIV status was determined through serology; patient files were examined for prior diagnosis and treatment. Bivariate analyses were conducted to assess HIV status and select characteristics and chi-square or Fisher’s exact tests were used, as appropriate, to assess statistical significance. Multivariable logistic regression explored correlates of HIV.

RESULTS: Of 1,513 cadavers, 39 (2.6%) tested positive for HIV, among whom, 31 (79.5%) had documentation of an HIV-positive status before death. Overall, medical records for 94% of all 1,513 cadavers did not contain information about HIV status at the time of death.

CONCLUSIONS: HIV testing in cadavers can be used to understand burden of HIV disease; data from clinical record from the deceased can be used to assess morbidity and mortality associated with HIV.

PMID:42444431 | DOI:10.21101/cejph.a8708