Category: Statistics

BMC Pediatr. 2025 May 27;25(1):424. doi: 10.1186/s12887-025-05730-5.

ABSTRACT

BACKGROUND: Depressive symptoms in the perinatal period as well as difficulties developing an emotional bond towards the child have been described as potential risk factors for poor child development. Few studies have investigated the mediating role of parent-child bonding for the association between prenatal depressive symptoms and child outcomes. Research on this association is especially scarce regarding the paternal perspective. This study investigated the prospective association between both parents’ prenatal depressive symptoms and child development, taking the mediating role of parent-child bonding into account.

METHODS: Data of 1,178 mothers and 743 fathers were drawn from the prospective longitudinal cohort study “Dresden Study on Parenting, Work, and Mental Health” (DREAM). To investigate the prospective association between depressive symptoms during pregnancy and eight weeks postpartum (self-report, Edinburgh Postnatal Depression Scale), parent-child bonding at eight weeks postpartum (self-report, Postpartum Bonding Questionnaire), and child development at 14 months postpartum (parent-report, Ages and Stages Questionnaire-3), multiple regression and mediation analyses were conducted individually for both parents, including the confounders parental age, education, child’s sex assigned at birth, prematurity, and perceived social support.

RESULTS: In both parents, a statistically significant small-sized mediating effect of parent-child bonding for the association between prenatal depressive symptoms and child development was found, with higher depressive symptoms being associated with more parent-child bonding impairment, which was associated with poorer child development. Paternal depressive symptoms were not directly associated with child development, whereas higher levels of maternal prenatal depressive symptoms were directly associated with better child development at 14 months postpartum. After additionally controlling for postpartum depressive symptoms, the association between prenatal depressive symptoms and parent-child bonding was no longer significant, and a positive association between paternal prenatal depressive symptoms and child development emerged.

CONCLUSIONS: Our results underline the importance of addressing depressive symptoms in the context of perinatal care to support parents experiencing mental health problems or struggles with the adjustment to parenthood early on. Future research on the complex dynamics of mental health, parent-child bonding, and child development is needed to replicate our findings. Our study highlights the relevance of including the perspective of both parents into research and clinical practice.

PMID:40426107 | DOI:10.1186/s12887-025-05730-5

BMC Womens Health. 2025 May 27;25(1):259. doi: 10.1186/s12905-025-03803-2.

ABSTRACT

BACKGROUND: Respectful maternity care (RMC) is an essential strategy to scale up mothers’ positive experiences during childbirth. However, few studies have been conducted to quantify the practice in Rwanda. The main objective of this study was to determine the proportion of the RMC approach in health facilities and associated factors in Musanze District in Rwanda.

METHODS: This is a health facility-based cross-sectional study conducted among 335 women who delivered at eight healthcare facilities including hospital and health centers in Musanze District between March to May 2024. We used simple random sampling to select health centers and included all participants who satisfied the inclusion criteria until the predetermined sample size was reached. The proportion of RMC as an outcome variable was calculated from the 30-item PCMC Scale, and RMC was considered to have been received if a woman responded “2 = yes, most of the time” and “3 = yes, all the time” to all the 30 items. We used multivariate logistic regression to identify factors associated with the provision of RMC such as employment status, parity, and place of delivery. The results were reported using odds ratios with the 95% CI. Variables were proved statistically significant based on p < 0.05.

RESULTS: 335 participants were enrolled in this study. The majority of respondents were between 25-34 years (54.0%) and married (74.3%). The proportion of respectful maternity care was 65.1% (95% CI: 59.7-70.2). Being employed was associated with receiving RMC [AOR = 17.75, 95%CI:8.06-39.06, p < 0.001]. Primiparous women compared to multiparous had higher odds of receiving RMC [AOR = 5.15, 95%CI:2.07-12.79, p < 0.001]. Cesarean deliveries were associated with a greater likelihood of RMC compared to those who delivered vaginally [AOR = 6.00, 95%CI:2.40-15.03, p-value = 0.003]. Women who delivered at health centers were more likely to receive RMC than those who delivered in hospitals [AOR = 3.72, 95% CI: 1.41-9.83, p = 0.008]. Daytime deliveries were more likely to receive RMC than nighttime deliveries (AOR = 3.11, 95% CI: 1.52-6.37, p = 0.002). Additionally, women with insurance other than Rwanda’s Community Based Health Insurance had higher odds of receiving RMC (AOR = 4.46, 95% CI: 1.88-10.61, p < 0.001).

CONCLUSION: The level of respectful maternity care in Musanze District was found to be 65.1%. Interventions to improve respectful maternity care should focus on training healthcare providers about its components, including dignity and respect, autonomy and communication, and social support, in addition to educating the community to request quality care. These findings call upon policy makers to involve different stakeholders to come up with interventions to improve quality of care during childbirth.

PMID:40426106 | DOI:10.1186/s12905-025-03803-2

Burns. 2025 May 19;51(6):107549. doi: 10.1016/j.burns.2025.107549. Online ahead of print.

ABSTRACT

BACKGROUND: Tranexamic acid (TXA) has gained increasing recognition for its efficacy in minimizing blood loss, ecchymosis, and edema.

METHODS: This study investigates whether local infiltration of TXA during tissue expander insertion safely reduces postoperative drainage. A single-surgeon retrospective cohort study was performed to analyze patients undergoing tissue expander insertion between 2021 and 2023. Following expander insertion, patients in the intervention group received 5 mL of TXA (0.25 g in NaCl 0.9 %) infiltrated into the dissection area, whereas the historical controls did not. Patient demographics, drainage volume and duration, surgical complications, and adverse events were examined. The impact of various factors on the drainage volume and duration was evaluated by multiple linear regression analysis. Using inverse probability weighting (IPW), a statistical method that applies weights to account for confounding factors in observational studies, the drainage volume and duration between the two groups were compared.

RESULTS: A total of 127 expander insertion procedures were reviewed, with 42 receiving TXA and 85 not. Complications were similar between the groups, and no severe adverse effects of TXA were observed. Regression analysis indicated that the use of TXA and limb location were negatively correlated with postoperative drainage duration and drainage volume unit area of the first postoperative day. Due to the imbalance in the layer of expander insertion between the two groups, IPW was applied. After IPW, the TXA group had significantly reduced drainage duration (P = 0.002) and drainage volume on the first postoperative day (P = 0.008) compared to the no-TXA group.

CONCLUSIONS: Local infiltration of TXA during expander insertion is associated with reduced drainage.

PMID:40424669 | DOI:10.1016/j.burns.2025.107549

EBioMedicine. 2025 May 26;116:105744. doi: 10.1016/j.ebiom.2025.105744. Online ahead of print.

ABSTRACT

BACKGROUND: Despite decades of research on the influenza virus, we still lack a predictive understanding of how vaccination reshapes each person’s antibody response, which impedes efforts to design better vaccines. Models using pre-vaccination antibody haemagglutination inhibition (HAI) titres against the vaccine strain alone poorly predict post-vaccination responses.

METHODS: We combined fifteen prior H3N2 influenza vaccine studies from 1997 to 2021, collectively containing 20,000 data points, and develop of a machine learning model that uses pre-vaccination HAI titres against multiple influenza variants to predict post-vaccination responses. To further test the model, four new vaccine studies were conducted in 2022-2023 spanning two geographic locations and three influenza vaccine types.

FINDINGS: The most predictive pre-vaccination features were HAI titres against the vaccine strain and against historical influenza variants, with smaller predictive power derived from age, sex, vaccine dose, and geographic location. The resulting model predicted future responses even when the vaccine strain or vaccine formulation changed. A pre-vaccination feature-the time between peak HAI across recent variants-distinguished large versus small post-vaccination responses with 73% accuracy. Model predictions against prior vaccine studies had 2.4-fold error (95% CI: 2.34-2.40x, no large outliers with >4-fold error), yielding more accurate and robust predictions than a null model with 3.2-fold error (95% CI: 3.12-3.21x, 12% large outliers). The four new vaccine studies presented here were predicted with comparable accuracy to the intrinsic 2-fold error of the experimental assay.

INTERPRETATION: A person’s pre-vaccination influenza HAI titres using multiple variants are highly predictive of their post-vaccination response. Many individuals exhibited little-to-no vaccine response, as exhibited by the null model’s accuracy, yet the machine learning model identified and accurately predicted both weak and strong responses with statistical superiority. Taken together, this approach paves the way to better utilise current influenza vaccines, especially for individuals that exhibit the weakest responses.

FUNDING: NIAID, UCSD PREPARE Institute, LJI & Kyowa Kirin, Inc. (KKNA-Kyowa Kirin North America), UGA, Cleveland Clinic, the Georgia Research Alliance, and the Bodman family.

PMID:40424667 | DOI:10.1016/j.ebiom.2025.105744

Knee. 2025 May 26;56:94-102. doi: 10.1016/j.knee.2025.05.014. Online ahead of print.

ABSTRACT

BACKGROUND: Patellar resurfacing during total knee arthroplasty (TKA) is debated. The reverse fragility index (RFI¹) assesses study neutrality by determining the minimum number of events needed to change non-significant results, significant. This study determined the RFI for studies showing no difference in reoperation between TKAs with and without resurfacing.

METHODS: A systematic review of PubMed, Embase, and Web of Science databases was conducted to identify randomized controlled trials (RCT) showing no difference in reoperation rates between TKAs with and without patellar resurfacing. The number of reoperations and the number of patients lost to follow-up were included. The RFI was calculated for reoperation rate of each study with a threshold of P < 0.05.

RESULTS: Nineteen RCTs with 3,804 TKAs were included, 1,813 of which resurfaced the patella. The median (interquartile range [IQR²]) reoperation rate was 4.4% (0-9.1%) in resurfaced patellae, and 4.5% (0-8.3%) in retained patellae. The median RFI was five, indicating that only five patients would need the opposite outcome for the difference in reoperation rate to become significant. The median (IQR) loss to follow-up was eight (3-20) patients, and 63.2% (12 of 19) of studies had loss that exceeded their RFI.

CONCLUSION: Most RCTs showing no difference in reoperation rate between TKAs with or without patellar resurfacing are statistically fragile. Difference in rates can become significant with the reversal of only a few outcomes, and this number was less than a study’s loss to follow-up in most studies.

PMID:40424662 | DOI:10.1016/j.knee.2025.05.014

Int Immunopharmacol. 2025 May 26;159:114946. doi: 10.1016/j.intimp.2025.114946. Online ahead of print.

ABSTRACT

BACKGROUND: The role of various antihypertensive drug classes in myocarditis remains unclear. We aimed to investigate the causal effects of antihypertensive medications on myocarditis and identify potential metabolic pathways.

METHODS: We extracted single-nucleotide polymorphisms for systolic blood pressure (SBP) and diastolic BP (DBP) from a genome-wide association study (N = 757,601) and screened single-nucleotide polymorphisms associated with angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, β-blockers (BB), calcium channel blockers (CCB), and thiazides as instrumental variables. Summary-level statistics of myocarditis were sourced from the FinnGen study, encompassing 1847 cases and 231,952 controls. We subsequently performed a drug-targeted Mendelian randomization (MR) and a two-step network MR approach to investigate the causal impact of antihypertensive medications on myocarditis and to uncover metabolic mediators.

RESULTS: Our study revealed that elevated SBP (odds ratio [OR] = 1.05, 95 % confidence interval [CI] = 1.04-1.06, p = 4.75 × 10^-14) and DBP (OR = 1.07, 95 % CI = 1.05-1.10, p = 1.54 × 10^-10) significantly increased myocarditis risk. Conversely, the use of BB (OR = 0.86, 95 % CI = 0.82-0.90, p = 5.14 × 10^-10) and CCB (OR = 0.95, 95 % CI = 0.92-0.99, p = 0.005) to lower BP was associated with a reduced risk of myocarditis. Network MR analyses identified four and seven metabolites mediating BB and CCB associations with myocarditis, respectively. Methyl indole-3-acetate mediated a significant portion of the relationships between BB and myocarditis (mediation proportion = 6.82 %), while phenylalanine to tyrosine ratio was the predominant mediator (mediation proportion = 11.35 %) linking CCB to myocarditis.

CONCLUSIONS: Our findings suggest that reducing BP through antihypertensive drugs, specifically BB and CCB, may hold potential for preventing myocarditis and have identified several metabolic pathways linking these associations.

PMID:40424652 | DOI:10.1016/j.intimp.2025.114946

Biologicals. 2025 May 26;91:101846. doi: 10.1016/j.biologicals.2025.101846. Online ahead of print.

ABSTRACT

Foot-and-mouth disease (FMD) serosurveillance is used as one of the disease control instruments. For this goal, it is necessary to differentiate infected animals from the vaccinated ones using non-structural protein (NSP) enzyme-linked immunoassays (ELISA). Various NSP ELISA have been developed. However, their sensitivity and specificity have shown variable results. Therefore, a meta-analysis was conducted to re-evaluate the sensitivity and specificity of these ELISAs. Experimental data were analyzed using R version 4.2.1, employing the rma.mv function in {metafor} package, and the impute covariance_matrix function from the {clubSandwich} package. Commercial kits, the highest sensitivity (0.82, 0.83) and specificity (0.97) were observed in Kit 1 and 3 groups. Differences in performance measures due to animal profiles were not statistically justified. In-house kits, performance measures varied by animal species and NSP protein. Specifically, sensitivity and specificity were lower in pigs (0.62 and 0.81) compared to cattle (0.93 and 0.97) and sheep (0.94 and 0.98) with 3ABC protein. No significant differences were found between sheep and cattle. Additionally, assays using protein 2C showed significantly lower sensitivity and specificity compared to those using protein 3ABC. The highest diagnostic measures were observed in cattle and sheep tested with the 3AB protein, followed by 3B and 3ABC proteins.

PMID:40424643 | DOI:10.1016/j.biologicals.2025.101846

Int J Oral Maxillofac Implants. 2025 May 27;0(0):1-28. doi: 10.11607/jomi.11118. Online ahead of print.

ABSTRACT

PURPOSE: The aim of the study was to compare the patient’s quality of life (QoL) after Free gingival graft (FGG) application around teeth and implants and to evaluate the factors affecting it.

MATERIALS AND METHODS: Thirty-two participants were included in the study, with FGG performed on 27 natural teeth in 16 participants (T-FGG group) and 24 implants in 16 participants (I-FGG group). QoL was assessed using the General Oral Health Assessment Index (GOHAI) at preoperatively (T0), seven days (T7) and first month (T30) postoperatively. Patient satisfaction was evaluated at T30. Graft dimensions (height, width, thickness), and operation time were recorded. Keratinized tissue width (KTW) was measured baseline and at T30. Graft volume (GV) and vertical collapse rate (VCR) were also calculated for analysis.

RESULTS: The GOHAI-total scores were found higher for the T7 and T30 in the I-FGG compared to the T-FGG. Behavioral impact (GOHAI-BI) and Functional limitation (GOHAI-FL) subscores were found to be significantly higher in I-FGG than T-FGG on T6 and T7. According to multiple linear regression analysis, GOHAI score of female patients were 8.749 points higher than male patients at T7. Patients in the I-FGG had a GOHAI score of 5.488 points higher than T FGG at T30 (p <0.05). The VCR for T-FGG and I-FGG groups was found 23.57% and 28.92%, respectively, and there was no statistically significant differences (p>0.05). VCR was positively correlated with BI for T-FGG and negatively correlated with FL for I-FGG, at T30 (p<0.05).

CONCLUSIONS: The negative effect of implant experience and female gender on QoL after FGG seems to be more effective than other clinical and intraoperative variables for first month and relationship with VCR and confound factors need to be clarified. Clinical trial number is NCT04813081/24.03.2021, retrospectively registered.

PMID:40424626 | DOI:10.11607/jomi.11118

J Med Internet Res. 2025 May 27;27:e70955. doi: 10.2196/70955.

ABSTRACT

BACKGROUND: Digital therapeutics (DTx) are software-driven interventions that provide personalized, evidence-based treatments for various medical conditions. China’s rapid technological adoption, large population, and supportive government policies position it as a potential global leader in DTx. However, challenges remain in clinical trial standardization, regulatory approval, product development, and reimbursement models. A comprehensive assessment of clinical evidence, commercialization trends, and regulatory frameworks is essential for understanding China’s evolving DTx ecosystem and its global implications.

OBJECTIVE: This study systematically reviews and analyzes the DTx landscape in China, focusing on clinical trials, commercial products, regulatory frameworks, and pricing and reimbursement models. The findings provide insights for countries aiming to develop, regulate, and integrate DTx solutions into health care systems.

METHODS: This comprehensive review integrates multiple methodological approaches to examine different aspects of the DTx ecosystem in China. We conducted a systematic review and meta-analysis to evaluate clinical trials, searching PubMed, Google Scholar, IEEE, Web of Science, and ScienceDirect until July 2024. Meta-analyses used random-effects models, reporting results as standardized mean differences (SMDs) and 95% CIs. For commercial products, a scoping review using the National Medical Products Administration database was performed. Regulatory policies were systematically identified through a manual review of official government sources, while pricing and reimbursement models were analyzed through a comprehensive assessment of public and private insurance policies, government initiatives, and commercial pathways.

RESULTS: : A total of 96 clinical trials on DTx in China were identified, with cognitive disorders (n=21, 22%) and diabetes (n=20, 21%) being the most frequently studied, followed by cardiovascular diseases (n=8, 8%), sleeping disorders (n=6, 6%), and smoking cessation (n=6, 6%). Meta-analysis for diabetes DTx showed a trend toward improved hemoglobin A_1c levels in digital intervention groups compared to controls (SMD -0.96, 95% CI -2.03 to 0.11) but did not reach statistical significance (I²=97%). Meta-analysis for cognitive disorder DTx showed significant improvement in global cognitive function in DTx-treated participants (SMD 0.65, 95% CI 0.37-0.94), despite notable heterogeneity (I²=71.7%). The commercial landscape analysis identified 97 active DTx solutions, primarily targeting cognitive impairment (38 companies), ophthalmic diseases (30 companies), and respiratory diseases (5 companies). The regulatory review highlighted China’s reliance on general medical device policies under the National Medical Products Administration rather than DTx-specific regulations, with emerging regional innovation policies supporting industry growth. Pricing analysis revealed diverse reimbursement models, including value-based pricing, private insurance partnerships, and government-facilitated programs.

CONCLUSIONS: China has made substantial progress in DTx development but still faces challenges in clinical trial standardization, regulatory approval, and reimbursement. Key factors driving DTx adoption include targeted indications, standardized clinical trials, streamlined regulation, and diversified pricing models. China’s experience provides valuable lessons for other countries with emerging digital health ecosystems as they develop DTx research, regulations, and integration strategies.

TRIAL REGISTRATION: PROSPERO CRD42024615584; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024615584.

PMID:40424619 | DOI:10.2196/70955

JMIR Public Health Surveill. 2025 May 27;11:e72233. doi: 10.2196/72233.

ABSTRACT

BACKGROUND: Health education could be an effective way to increase knowledge regarding behavioral changes to prevent the recurrence of stroke; however, the evidence is ambiguous. A lack of both knowledge and compliance with treatment to control modifiable risk factors and unhealthy lifestyles increases the risk of stroke recurrence.

OBJECTIVE: This study aimed to evaluate the effectiveness of a health education program among patients with stroke postdischarge and their family caregivers in a tertiary specialized hospital in Bangladesh to reduce stroke recurrence by controlling modifiable risk factors.

METHODS: A parallel (1:1), open-label, prospective randomized controlled trial was conducted in Bangladesh. A total of 432 patients with first-time stroke, aged ≥18 years and a modified Rankin Scale (mRS) score of 0-4, were randomly enrolled at the National Institute of Neuroscience & Hospital. We stratified the patients by age and type of stroke and randomly allocated to an intervention group (IG) and a control group (CG). We collected sociodemographic and clinical data by using a structured questionnaire. The IG received (self) management education, including monitoring blood pressure (BP), medication, diet, and exercise for 12 months, and the CG received usual care. The outcomes were (1) recurrence after 28 days of stroke and (2) all adverse events related to stroke after 12-month follow-up.

RESULTS: Of 432 patients (n=216, 50%, in each group), stroke recurrence was observed 14 (6.5%) patients in the IG and 8 (3.7%) patients in the CG, and the difference was not significant (P=.19). Death was lower in the IG (n=39, 18.1%, vs n=56, 25.9%) compared to the CG. In Cox regression analysis, the unadjusted model showed death was significant (hazard ratio [HR] 1.531, 95% CI 1.017-2.304; P=.04); however, the difference was not significant after adjusting the mRS score at baseline (HR 0.818, 95% CI 0.540-1.238; P=.34). Patients’ medication adherence significantly improved at 6-month (P<.001) and 12-month (P=.002) follow-up after the intervention.

CONCLUSIONS: This study failed to demonstrate the effectiveness of health education in reducing recurrence, death, and stroke-related adverse events. However, health education enhanced medication adherence. Some causes of death could not be diagnosed due to inadequate health care systems. Further research with diagnostic facilities and a long observation period is necessary to explore the underlying cause of recurrence. The results suggest the importance of structuring acute care management for patients with stroke into the health care system of Bangladesh.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05520034; https://clinicaltrials.gov/ct2/show/NCT05520034.

PMID:40424617 | DOI:10.2196/72233