Tag: statistics

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

JMIR Med Inform. 2025 May 27;13:e65575. doi: 10.2196/65575.

ABSTRACT

BACKGROUND: In Japan, research on the types of medical data requested by health care workers in health information exchanges (HIEs) is limited. Examining the number of views for each data type is important to quantify its benefits.

OBJECTIVE: This study aimed to identify the types of medical data that are frequently viewed on demand using HIEs in Japan.

METHODS: We analyzed audit log data from two HIEs, Choukai Net and PicaPicaLink, covering the period from April 1, 2017, to March 31, 2022. First, we calculated the cumulative monthly usage days of the HIEs by each institution for the financial year (FY) 2021/22. Second, we calculated the cumulative annual usage days of the HIEs by each user type for FY 2021/22. Third, we calculated the view rate for each output field and content within each HIE, using institution type or year as the aggregation unit. Fourth, we calculated the cumulative annual usage days of the HIEs for days with and without progress note viewing, and for days without any content viewing. Fifth, we calculated the cumulative number of viewed days for content scheduled to be included in the national HIE compared to that which was not.

RESULTS: In 32.6% (47/144) of hospitals connected to Choukai Net and 2.3% (20/875) of hospitals connected to PicaPicaLink, cumulative monthly usage days exceeded 101. Additionally, in 32.4% (56/173) of visiting nursing stations connected to Choukai Net, cumulative monthly usage days were over 51. User types viewing HIEs were heavily biased toward institution types other than hospitals. The overall view rate for progress notes was highest among all content types, at 67.4% (83,476/123,915) for Choukai Net and 32.9% (26,159/79,612) for PicaPicaLink. In both HIEs, when comparing by institution type, the view rate for progress notes was highest for visiting nursing stations, reaching 91.8% (5553/6052) for Choukai Net and 65.3% (126/193) for PicaPicaLink. We also found that 17% (5417/31,944) of Choukai Net usage and 9.6% (1802/18,862) of PicaPicaLink usage involved referencing only progress notes in FY 2021/22. The view rate of content scheduled to be included in the national HIE was 45.6% (56,499/123,791) for Choukai Net and 47.7% (37,972/79,612) for PicaPicaLink. Conversely, the view rate for content not scheduled to be included in the national HIE was higher, at 80.2% (99,234/123,791) for Choukai Net and 56.6% (45,052/79,612) for PicaPicaLink.

CONCLUSIONS: In both HIEs analyzed in this study, progress notes were the most viewed content. As more health care organizations disclose the progress notes they manage to their HIEs, progress notes are likely to be viewed more frequently. The cost-benefit of disclosing progress notes to HIEs remains unclear, and both health care providers and patients have concerns about privacy risks. Future research is needed to quantify and maximize the benefits of disclosure while mitigating the associated privacy risks.

PMID:40424594 | DOI:10.2196/65575

J Med Internet Res. 2025 May 27;27:e69729. doi: 10.2196/69729.

ABSTRACT

BACKGROUND: Human papillomavirus (HPV) is a leading cause of cervical cancer. It has a substantial impact on global public health, with low- and middle-income countries, including India, facing the highest burden. In 2022, India reported 127,526 new cases and 79,906 deaths due to cervical cancer, projected to increase by 61% by 2040. Although the National Technical Advisory Group on Immunization recommended the HPV vaccine for cervical cancer prevention, it is yet to be a part of India’s universal immunization program.

OBJECTIVE: This study aims to examine online interest in the HPV vaccine in India from January 2010 to April 2024 using Google Trends.

METHODS: A cross-sectional analysis of Google Trends data was performed, using the relative search volume to track interest on a scale of 0-100. Trends were analyzed annually using 1-way ANOVA and joinpoint regression to identify significant changes in search behavior related to public health events. Statistical significance was set at P<.05.

RESULTS: The average annual growth in HPV vaccine-related searches was 13.7% (95% CI 7.9%-19.1%), with the highest relative search volume in 2024 (49.5) and the lowest in 2017 (3.38). Spikes in search interest aligned with key events like the 2018 National Technical Advisory Group on Immunization recommendation and the 2022 launch of the indigenous HPV vaccine. The results highlight online search data’s value in tracking public interest, which fluctuates in response to health policy changes or developments on social media. In India, targeted digital strategies will be vital for addressing vaccine hesitancy and increasing HPV vaccine uptake.

CONCLUSIONS: Google Trends data can inform public health strategies by identifying periods of high interest, aiding in the promotion of HPV vaccination in India.

PMID:40424583 | DOI:10.2196/69729