Nevin Manimala

Int J Epidemiol. 2025 Apr 12;54(3):dyaf046. doi: 10.1093/ije/dyaf046.

ABSTRACT

BACKGROUND: Maternal pre-pregnancy diabetes is associated with a higher risk of adverse pregnancy outcomes. Few large, cohort studies have assessed associations with a wide large range of causes of infant death.

METHODS: This retrospective cohort study included all singleton live births to women aged 18-49 years in the US National Vital Statistics System from 2011 to 2020. Multivariable Poisson regression models were used to estimate adjusted relative risks (RRs) with 95% confidence intervals (CIs) for all-cause and cause-specific infant mortality.

RESULTS: Of 34 918 803 pregnant women with singleton live births, 302 823 had pre-pregnancy diabetes with 3585 corresponding infant deaths [estimated mortality rate per 10 000 infants with 95% CI was 78.60 (75.96-81.25)] compared with 34 615 980 without pre-pregnancy diabetes and 171 989 corresponding infant deaths [42.63 (42.41-42.86)]. The adjusted RR (95% CI) of pre-pregnancy diabetes compared with no pre-pregnancy diabetes was 1.84 (1.78-1.91) for infant death, 1.89 (1.81-1.97) for neonatal death, 1.85 (1.77-1.94) for early neonatal death, 2.04 (1.87-2.23) for late neonatal death, and 1.75 (1.65-1.86) for postneonatal deaths. The association was stronger (RR: 2.03, 95% CI: 1.88-2.20) with lower maternal age (<25 years) than with higher maternal age (≥40 years) (RR: 1.44, 95% CI: 1.28-1.63). Associations varied across maternal race, smoking, and body mass index. Significantly increased risk was observed for 48 out of 73 specific causes of death.

CONCLUSION: Our findings confirm that maternal pre-pregnancy diabetes is an important risk factor for infant death, encompassing a wide range of causes of death, and suggest that these effects may be systemic given the large number of specific causes of death affected.

PMID:40391520 | DOI:10.1093/ije/dyaf046

Neurogastroenterol Motil. 2025 May 20:e70086. doi: 10.1111/nmo.70086. Online ahead of print.

ABSTRACT

BACKGROUND: Dysphagia and reflux are frequently experienced by individuals with hiatus hernia (HH), but the underlying mechanisms are not fully defined in radiological or manometric studies. This study explores the impact of HH on propulsive esophageal peristalsis and investigates the biomechanical underpinnings of HH-concurrent-related dysphagia in affected individuals.

METHODS: High-resolution manometry with impedance (HRM-I) studies compared the biomechanics of 195 gastroesophageal reflux disease (GERD) patients (excluding large HH and motility disorders) and 20 normal healthy volunteers. Assessments included dysphagia severity, esophageal pH monitoring, and HRM-I with 5-mL liquid and viscous swallows. Bolus distension pressures during bolus transport and esophageal emptying parameters were assessed in conjunction with standard pressure topography metrics. Data grouped by EGJ morphology type were analyzed by a mixed-effects statistical model.

KEY RESULTS: Patients with unequivocal HH exhibited altered bolus transport through the mid-distal esophageal body, indicated by increased intrabolus distension pressure during bolus transport (p < 0.01 for liquid and viscous swallows) and shorter bolus flow time through the EGJ (p ≤ 0.005 for liquid and viscous swallows). Increased HH size during swallows also correlated with increased intrabolus distension pressure (liquid r 0.243, p < 0.001) and shorter EGJ flow time (liquid r – 0.191, p < 0.005). Patients with confirmed GERD without HH showed a different pattern of altered bolus transport in the more proximal esophagus.

CONCLUSION: In the presence of a HH, esophageal biomechanics are altered, with elevated bolus distension pressure revealing resistance to bolus transport occurring in the mid-lower esophageal body for liquid and viscous boluses, contributing to dysphagia symptoms.

PMID:40391512 | DOI:10.1111/nmo.70086

Climacteric. 2025 May 20:1-6. doi: 10.1080/13697137.2025.2496692. Online ahead of print.

ABSTRACT

OBJECTIVE: Obesity is a known risk factor for the development of cardiometabolic diseases (CMD) globally. The study focus was finding the best predictor of CMD among the four anthropometric indices of obesity studied: body mass index (BMI), waist to hip ratio (WHR), waist to height ratio (WHtR) and visceral adiposity index (VAI).

METHOD: A total of 310 postmenopausal women participated in the study. Sociodemographic data, anthropometric measurements, serum high-density lipoprotein and serum triglycerides were taken for all participants. The receiver operating characteristic curve was used to detect the valid cut-off point for the VAI.

RESULTS: The VAI cut-off point for diagnosing visceral adiposity dysfunction (VAD) in the study was >1.92. The prevalence of peripheral obesity in the study was 18.1%, while that of truncal obesity was 76.5% using the WHR and 81.9% using the WHtR. The prevalence of CMD in the study was 51.6% while that for VAD was 60.3%. The WHtR (p = 0.041) and the VAI (p < 0.001) had statistically significant associations with the presence of CMD among the participants but only the VAI was found to be a significant predictor of CMD.

CONCLUSION: We recommend use of the VAI for CMD screening among postmenopausal women.

PMID:40391498 | DOI:10.1080/13697137.2025.2496692

Headache. 2025 May 20. doi: 10.1111/head.14951. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aimed to evaluate the effects of different types and combinations of exercise on migraine attacks and accompanying comorbidities.

BACKGROUND: Combining aerobic and resistance exercises may yield more significant improvements in patients with migraine.

METHODS: This parallel-group randomized controlled study included 24 participants, who were then divided equally into three groups: an aerobic exercise group, a combined exercise group (aerobic and resistance exercises), and a control group. It was conducted at Ege University Hospital between September 2022 and March 2024. Following a 1-month baseline headache diary period, both intervention groups participated in the same aerobic exercises 3 days a week for 12 weeks. The combined exercise group performed five resistance exercises targeting the neck, upper back, and shoulder muscles alongside the aerobic exercises 3 days a week for 12 weeks. Measurements were taken at baseline, after the 3-month intervention period, and after a 2-month follow-up period. The primary outcome was the number of migraine headache days per month. Secondary outcomes included anxiety and depression levels, aerobic capacity, physical activity status, and migraine-related quality of life.

RESULTS: The number of migraine days per month significantly decreased in both the aerobic and combined exercise groups during the post-intervention period, while no significant change was observed in the control group (p < 0.001 for aerobic and combined exercise groups, p = 0.166 for control group). Migraine headache frequency showed a statistically significant decrease in the combined exercise group compared to the aerobic exercise group (p = 0.027). Additionally, both exercise groups showed significant improvements in aerobic capacity (p < 0.001 for both) and physical activity levels (p < 0.001 and p = 0.001, respectively) post-intervention, which were not observed in the control group (p = 0.747 for aerobic capacity, p = 0.05 for physical activity levels). Although no significant effect on depression scores was observed in either exercise group, anxiety scores significantly decreased in the combined exercise group from pre- to post-intervention (p = 0.037). Significant improvements in migraine-related quality of life were observed in both intervention groups (p = 0.018 and p = 0.001, respectively), with no significant difference (p = 0.934). Neither significant change was observed in depression and anxiety scores nor migraine-related quality of life in the control group (p = 0.593, p = 0.438 and 0.081 respectively).

CONCLUSIONS: Aerobic and combined exercise groups showed a reduction in monthly migraine headache frequency without any side effects, with the reduction being statistically more significant in the combined exercise group.

PMID:40391488 | DOI:10.1111/head.14951

Regen Med. 2025 May 20:1-9. doi: 10.1080/17460751.2025.2507504. Online ahead of print.

ABSTRACT

AIM: To evaluate the effectiveness of a bioregenerative scaffold created from bone marrow aspirate, cancellous bone autograft, platelet-rich plasma, and autologous fibrin in treating complicated non-unions of the supracondylar femur, humeral shaft, and radius and ulna.

METHODS & MATERIALS: Three patients with non-unions resulting from multiple surgical failures underwent bone stabilization along with the application of a novel bioregenerative scaffold. X-rays and subjective assessments were collected prior to surgery and at 6- and 12-months post-surgery.

RESULTS: All non-unions demonstrated healing with adequate callus formation, as confirmed by radiological assessments. By 12 months, all patients were able to resume full weight-bearing activities or regain full range of motion and physical strength without pain. Statistical analysis revealed improvements across all assessment scales compared to pre-surgical values.

CONCLUSION: This approach offers a viable option for treating complex long bone non-unions after multiple surgical interventions.

PMID:40391486 | DOI:10.1080/17460751.2025.2507504

Circ Cardiovasc Interv. 2025 May 20:e015194. doi: 10.1161/CIRCINTERVENTIONS.125.015194. Online ahead of print.

ABSTRACT

BACKGROUND: Six-month results from the SPYRAL HTN-ON MED trial demonstrated that renal denervation (RDN) reduced office blood pressure (BP), and not 24-hour ambulatory systolic BP, compared with sham control in hypertensive patients. In this prespecified analysis of the ON MED trial, long-term changes in BP, antihypertensive drug use, and safety outcomes through 24 months are compared between RDN and sham control groups.

METHODS: SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, blinded trial enrolling 337 patients globally from 56 clinical centers. Eligible patients had an office systolic BP of 150 to 180 mm Hg, a diastolic BP ≥90 mm Hg, and a 24-hour ambulatory systolic BP of 140 to 170 mm Hg. Patients were randomized to RDN or a sham control procedure and were prescribed a stable regimen of 1 to 3 antihypertensive medications through 6 months. After 6 months, patients and physicians were unblinded with permitted changes to antihypertensive therapy, and control patients were permitted to crossover. Crossover patients had their last observations carried forward as part of the control group. Statistical analyses were conducted on the population as a randomized.

RESULTS: At 24 months, the RDN group experienced significantly greater mean reductions in ambulatory systolic BP (-12.1±15.3 mm Hg [n=176] versus -7.0±13.1 mm Hg [n=33]; difference: -5.7 mm Hg; P=0.039) and office systolic BP (-17.4±16.1 mm Hg [n=187] versus -9.0±19.4 mm Hg [n=35]; difference: -8.7 mm Hg; P=0.0034) compared with sham controls. At 24 months, antihypertensive medications increased significantly more in the sham group (1.7-2.7) compared with the RDN group (1.8 versus 2.4; P=0.046). Sensitivity analyses accounting for missing sham patient BP values due to crossover yielded consistent results in favor of RDN for 24-hour ambulatory (P=0.023) and office systolic BP (P<0.0001). Clinically adverse events were rare, with no instances of renal artery stenosis through 24 months.

CONCLUSIONS: RDN produced significantly greater ambulatory and office systolic BP reductions at 24 months compared with sham control, despite higher antihypertensive medication use in the control group.

REGISTRATION: URL: https://clinicaltrials.gov/study; unique identifier: NCT02439775.

PMID:40391448 | DOI:10.1161/CIRCINTERVENTIONS.125.015194

Circ Arrhythm Electrophysiol. 2025 May 20:e013647. doi: 10.1161/CIRCEP.124.013647. Online ahead of print.

ABSTRACT

BACKGROUND: We have previously reported a novel clinical risk score (risk prediction score for shockable sudden cardiac arrest [VFRisk]) for the prediction of shockable sudden cardiac arrest, discovered and validated in 2 US west coast communities. We hypothesized that VFRisk predicts sudden cardiac death (SCD) risk in the geographically distinct FHS (Framingham Heart Study).

METHODS: We performed a nested case-referents study in the FHS to test VFRisk. Cases were participants who experienced SCD among the original and offspring FHS cohorts. Referents were randomly selected from FHS participants frequency-matched (ratio of 1:3) to cases on age, sex, cohort, and exam. VFRisk was the sum of 12 risk factors, each multiplied by its respective points.

RESULTS: Among 312 cases and 935 referents, mean ages were 69.5 and 69.7 years with 70.8% male in both groups. SCD cases had significantly higher prevalence of diabetes, heart failure, stroke, atrial fibrillation, and myocardial infarction compared with the referents group. The VFRisk score was validated with good discrimination (C-statistic, 0.71 [95% CI, 0.66-0.77]) for SCD. Cases had higher VFRisk scores than referents (3.8±2.8 versus 1.8±1.7; P<0.001). A 1-unit increase in VFRisk score was associated with a 48% increase in odds of SCD (odds ratio, 1.48 [95% CI, 1.34-1.64]). The highest VFRisk quartile had 7.8-fold higher odds of SCD than the lowest quartile.

CONCLUSIONS: The VFRisk score successfully predicted SCD in the FHS. The differences in discrimination between the 2 studies could partially be explained by the inability to distinguish shockable versus nonshockable events in the FHS.

PMID:40391444 | DOI:10.1161/CIRCEP.124.013647

Nutr Diet. 2025 May 20. doi: 10.1111/1747-0080.70021. Online ahead of print.

ABSTRACT

AIMS: The aim of this study is to explore the occurrence of food insecurity among pregnant women in Australia.

METHODS: This cross-sectional, self-reported study included two measures of food insecurity (the US Department of Agriculture Household Food Security Survey Module and single item measure), use of emergency and community food assistance, health conditions, eating habits during pregnancy, and professional nutritional advice and health seeking behaviours. Participants were recruited using (1) an advertisement posted on social media and (2) flyers with a QR code linked to the online survey, made available for women to take from clinic rooms at a hospital in Melbourne, Victoria. Data were analysed using basic statistics, spearman’s rho correlation coefficients, and linear regression to identify factors that may be associated with food insecurity among pregnant women in Australia; the study was open between May 2021 and March 2022.

RESULTS: Three hundred and three valid responses were received from pregnant women in Australia. Food insecurity was determined to be 14.5% (US Department of Agriculture Household Food Security Survey Module) and 6.3% (single item used). Food insecurity was significantly associated with income, education level and age.

CONCLUSIONS: Results indicate a high prevalence of food insecurity among pregnant women. Routine screening and referral of food insecure pregnant women should be considered in antenatal care settings.

PMID:40391424 | DOI:10.1111/1747-0080.70021

Nurs Health Sci. 2025 Jun;27(2):e70137. doi: 10.1111/nhs.70137.

ABSTRACT

This cross-sectional study aimed to investigate dyadic effects of micro-level (physical [PCS]/mental [MCS] health) and meso-level (dyadic coping/social support) factors on both subjective and objective social isolation in patient-spousal caregiver dyads with colorectal cancer (CRC), with hypothesized actor-partner interdependence effects. Data from 220 patient-caregiver dyads with CRC collected using validated instruments (General Alienation Scale, Lubben Social Network Scale-6, Medical Outcomes Study 12-item Short-Form version 2, Dyadic Coping Inventory, and Perceived Social Support Scale) were analyzed using the Actor-Partner Interdependence Model. Findings substantiated dyadic interdependence between subjective/objective social isolation and variables within dyads across micro- and meso-levels. Both micro-level (PCS/MCS) and meso-level (dyadic coping/social support) factors demonstrated significant actor effects on both subjective and objective social isolation experienced by patients and their partners. Patients’ both micro-level (PCS/MCS) and meso-level (dyadic coping/social support) factors negatively influenced their partners’ subjective and objective social isolation. No partner effect was identified from variables associated with spousal caregivers on patients’ social isolation. These findings suggest that interventions targeting these variables could be effectively designed for patient-spousal caregiver dyads with CRC to address social isolation.

PMID:40391397 | DOI:10.1111/nhs.70137

Stat Comput. 2025;35(4):97. doi: 10.1007/s11222-025-10624-8. Epub 2025 May 17.

ABSTRACT

Individual treatment effect estimation has gained significant attention in recent data science literature. This work introduces the Double Neural Network (Double-NN) method to address this problem within the framework of extended fiducial inference (EFI). In the proposed method, deep neural networks are used to model the treatment and control effect functions, while an additional neural network is employed to estimate their parameters. The universal approximation capability of deep neural networks ensures the broad applicability of this method. Numerical results highlight the superior performance of the proposed Double-NN method compared to the conformal quantile regression (CQR) method in individual treatment effect estimation. From the perspective of statistical inference, this work advances the theory and methodology for statistical inference of large models. Specifically, it is theoretically proven that the proposed method permits the model size to increase with the sample size n at a rate of $O\left(n^{\zeta }\right)$ for some $0\le \zeta <1$ , while still maintaining proper quantification of uncertainty in the model parameters. This result marks a significant improvement compared to the range $0\le \zeta <\frac{1}{2}$ required by the classical central limit theorem. Furthermore, this work provides a rigorous framework for quantifying the uncertainty of deep neural networks under the neural scaling law, representing a substantial contribution to the statistical understanding of large-scale neural network models.

SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11222-025-10624-8.

PMID:40391382 | PMC:PMC12085359 | DOI:10.1007/s11222-025-10624-8