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Nevin Manimala Statistics

Impact of Dolutegravir-Based Antiretroviral Therapy on Viral Load Suppression and Uptake of DTG-Based Regimen Among Pediatric HIV Patients in Africa: A Systematic Review and Meta-Analysis

J Int Assoc Provid AIDS Care. 2026 Jan-Dec;25:23259582261467826. doi: 10.1177/23259582261467826. Epub 2026 Jul 14.

ABSTRACT

BackgroundDespite global advances in HIV care, pediatric populations in Africa continue to experience suboptimal treatment outcomes. Dolutegravir (DTG)-based antiretroviral therapy (ART) offers improved efficacy and tolerability, however, its real-world impact on viral load suppression (VLS) and the uptake of DTG-based regimens from older ART to newly recommended DTG-based ART among children and adolescents in Africa has not been systematically quantified.ObjectiveThis systematic review and meta-analysis aimed to estimate the pooled viral load suppression after initiation of dolutegravir-based ART and the uptake of DTG-based regimens from older regimens to dolutegravir-based ART among children and adolescents living with HIV in Africa.MethodsA systematic review and meta-analysis conducted in accordance with PRISMA 2020 guidelines. Comprehensive searches of PubMed, Google Scholar, ScienceDirect, Hinari, CORE, and DOAJ were performed from January 01-10, 2026. Studies reporting VLS after initiation of DTG-based ART and the uptake of DTG-based regimens among pediatric patients with HIV in Africa were included. Pooled estimates were computed using random-effect models. Heterogeneity was assessed using I2 statistics, and subgroup, sensitivity, and publication bias analyses were performed.Resultsout of 7,789 records screened, twenty-four studies comprising 119,292 participants were included. The overall pooled viral load suppression at six months after initiation of DTG-based ART was 82% (95% CI: 79-85%) and 70 (95% CI: 62-77%) among participants who were unsuppressed at baseline. The pooled uptake of DTG-based regimens was 77% (95% CI: 68-86%) based on 23 studies. Substantial heterogeneity was observed across outcomes (I2≥98%). Subgroup analysis indicated regional and study-design variation in the uptake of DTG-based regimens but not in viral suppression. No substantial publication bias was detected among the included studies.ConclusionDTG-based ART effectively suppressed viral load among pediatric patients in Africa, though adoption remains incomplete and below UNAIDS 95-95-95 targets. Significant heterogeneity highlights the influence of contextual and health system factors. Accelerated rollout, strengthened adherence support, and harmonized monitoring are needed to optimize pediatric HIV outcomes.

PMID:42444527 | DOI:10.1177/23259582261467826

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Nevin Manimala Statistics

Psychosocial Predictors of Quality of Life Among Older Women: Implications for AI-Enabled Predictive Healthcare

J Appl Gerontol. 2026 Jul 14:7334648261464234. doi: 10.1177/07334648261464234. Online ahead of print.

ABSTRACT

BackgroundOlder women in India experience high levels of chronic illness, psychosocial distress, and social vulnerability. With the growing interest in predictive healthcare approaches, identifying psychosocial risk patterns among ageing women is critical for early intervention.ObjectiveThis study examined the prevalence of physical and mental health problems, coping strategies across age groups, and the relationship between coping styles and quality of life (QOL), along with implications for geriatric care.MethodsA descriptive analytical design was employed among 420 older women in Aligarh city using stratified random sampling. Data were collected through structured interviews, the WHO Quality of Life Scale (WHO-QOL), and a coping strategies inventory. Data were analysed using descriptive statistics, chi-square tests, ANOVA, correlation, and regression techniques.ResultsArthritis (44%) and hypertension (39%) were the most prevalent conditions, with 49% of respondents reporting multimorbidity. Problem-focused coping was associated with higher QOL, whereas avoidant coping showed a significant negative association. Social protection factors, including pension access and healthcare support, were positively associated with QOL.ConclusionThe findings highlight the importance of psychosocial and structural determinants in shaping quality of life among older women. These results provide empirically grounded indicators that may inform the future development of predictive and preventive geriatric healthcare approaches.

PMID:42444505 | DOI:10.1177/07334648261464234

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Nevin Manimala Statistics

When prima facie duties collide: Ethical responses to refusal of basic nursing care

Nurs Ethics. 2026 Jul 14:9697330261463755. doi: 10.1177/09697330261463755. Online ahead of print.

ABSTRACT

BackgroundWhen patients refuse basic nursing care in the hospital setting, ethical tension arises between promoting patient dignity by providing hygiene and honoring bodily autonomy by respecting patient refusal of interventions.Research AimTo describe patient factors, clinical context, and the role of ethics consultation when basic care is refused to identify implications for future practice and/or policy.Research DesignWe conducted a retrospective qualitative content analysis of adult and pediatric ethics consultation documentation between January 2015 and December 2025 at a quaternary academic medical center, screening 2,381 consultations to identify cases involving refusal of basic nursing care. We collected patient demographics, admission and clinical information, reasons for ethics consultation, and actions taken by the ethics consultation service. Data were summarized via descriptive statistics, and categories were abstracted to develop a framework.Participants and Research ContextPatients receiving inpatient care at an academic medical center in the Midwestern United States.Ethical ConsiderationsUniversity of Michigan IRBMED deemed the study exempt (HUM00256591).Findings34 ethics consultations for 29 unique patients involved refusal of basic nursing care. Patients were adults (100%), with an average LACE score of 12.8; 15 (44%) had decision-making capacity. Care over objection was provided in 16 (47%) of cases, and physical restraints were used in 2 (6%) cases. Refusals involved hygiene (18, 53%), wound care (15, 44%), and repositioning (9, 26%), and occurred across nursing units and clinical services. Refusals were addressed through persuasion (9, 26%), soft paternalism (13, 38%), hard paternalism (3, 9%), or permitted refusal (9, 26%).DiscussionEthics consultation involvement resulted in four approaches to refusal of basic nursing care based on patient agency, decision-making capacity, and clinical context.ConclusionsWhen refusal results in dignitary or physical harm, healthcare teams should address barriers and encourage participation. In rare circumstances, care over objection is ethically permissible with multidisciplinary input.

PMID:42444500 | DOI:10.1177/09697330261463755

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Nevin Manimala Statistics

Censoring, Competing Events, and Multistate Models: Comment on Beyersmann et al. “Hazards Constitute Key Quantities for Analyzing, Interpreting and Understanding Time-to-Event Data”

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

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Nevin Manimala Statistics

Nurses’ social responsibility and health system strengthening for equity in low- and middle-income countries

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

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Nevin Manimala Statistics

HERZCHECK: Early Detection of Subclinical Preheart Failure Using Mobile Cardiac Magnetic Resonance and Telemedicine in Rural and Underressourced Regions

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

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Nevin Manimala Statistics

Standardized Acquisition of Fetal Cardiac Cine MRI: A Practical Guide

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

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Nevin Manimala Statistics

Skilled Nursing Facility-to-Home Transitions After Heart Failure Hospitalization: A Mixed-Methods Study of Communication, Self-Care, Medication, and Follow-Up

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

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Drawing a line in the sand: impact of analytical choices on anti-drug antibody cut-points and testing outcomes

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

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Nevin Manimala Statistics

Comparing synthetic data generation methods in pharmacoepidemiology: reconciling reproducibility with privacy protection

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