Category: Statistics

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

JMIR Pediatr Parent. 2025 May 27;8:e64831. doi: 10.2196/64831.

ABSTRACT

BACKGROUND: The COVID-19 pandemic significantly impacted primary health care-seeking behavior of the general population. The extent to which health care-seeking behavior of pregnant women in general practitioner (GP) care was affected remains largely unknown. The unique health care needs of pregnant women necessitate regular monitoring and care to ensure the well-being of expectant mothers, fetuses, and neonates, as timely interventions and screenings can profoundly influence the long-term health outcomes. Understanding how pandemic-related changes have influenced pregnant women’s primary health care-seeking behavior is essential for developing targeted interventions and informing policy decisions to improve health outcomes for expectant mothers, fetuses, and neonates, both during public health emergencies and in routine health care settings.

OBJECTIVE: This study aims to examine the impact of different COVID-19 pandemic phases on health care-seeking behavior among pregnant women in Dutch GP practices throughout 2020 and 2021. By analyzing clinical electronic health record (EHR) GP data, we aim to evaluate the health care consumption, occurrence of pregnancy-relevant symptoms and diagnoses, and types of contact (ie, regular consultations, phone consultations, home visits, and digital consultations) during different pandemic phases.

METHODS: Using a retrospective cohort design, EHRs of selected pregnant women from 3 Dutch GP networks between 2019 and 2021 were analyzed, comparing 6 pandemic phases divided into 13 subphases with a prepandemic phase. Contact rates were analyzed by interrupted time-series analyses, pregnancy-relevant symptoms, and diagnoses by comparing the frequency of pregnancy-relevant International Classification of Primary Care (ICPC) code registrations and type of contact by descriptive statistics.

RESULTS: In total, 10,985 pregnant women were included, yielding 39,023 patient-GP contacts. Contact rates fluctuated significantly across pandemic phases, with the sharpest declines at the onset and the end of the pandemic. Pregnancy-relevant symptoms and diagnosis in the category related to pregnancy showed the highest variability across the pandemic phases, such as an increase in the frequency of health care consumption concerning gestational diabetes mellitus and nausea or vomiting of pregnancy. Detailed statistical results are reported in the main text. Contacts for symptoms and diagnosis like digestive or urinary tract problems did not fluctuate across the pandemic phases. The number of physical contacts decreased, while telephone contacts increased.

CONCLUSIONS: By analyzing EHR data from over 10,000 pregnant women, this study highlights the pandemic’s impact on pregnant women’s GP health care-seeking behavior, including declining health care consumption trends during the initial and end phases of the pandemic (2020-2021). The observed increase in GDM and its potential long-term effects underscore the need for enhanced public health strategies within GP practices, ensuring continuous access to prenatal care and striving for improved outcomes of expectant mothers, their fetuses, and neonates during times of pandemics and in routine health care settings.

PMID:40424580 | DOI:10.2196/64831

JMIR Diabetes. 2025 May 27;10:e62926. doi: 10.2196/62926.

ABSTRACT

BACKGROUND: Diabetes management involves a large degree of data collection and self-care in order to accurately administer insulin. Several mobile apps are available that allow people to track and record various factors that influence their blood sugar levels. Existing diabetes apps offer features that enable integrations with various devices that streamline diabetes management, such as continuous glucose monitors, insulin pumps, or regular activity trackers. While this reduces the tracking burden on the users, the research highlighted several issues with diabetes apps, including issues with reliability and trustworthiness. As pumps and continuous glucose monitors are safety-critical systems-where issues can result in serious harm or fatalities-it is important to understand what issues and vulnerabilities could be introduced by relying on popular diabetes apps as an interface for interacting with such devices.

OBJECTIVE: As there is a lack of research examining in detail the integrations and potential suitability of apps as part of a wider self-management ecosystem, our goal was 2-fold. First, we aimed to understand the current landscape of device integrations within diabetes apps and how well they meet users’ needs. Second, we identified the key issues users of the most popular apps face currently and what features are the source of these issues.

METHODS: Through searches in Android and iPhone app stores, we systematically identified 21 diabetes apps that offer integrations. We conducted a detailed analysis of 602 user reviews. For each review, we recorded its sentiment, features and issues, and additional contextual information provided by the review writers. We used descriptive statistics to analyze the features and issues. We also analyzed the reviews thematically to identify additional trends related to the context of use and the consequences of issues reported by the users.

RESULTS: The reviews focused on key features that users found the most important, including device integrations (n=259, 43%), tracking (n=194, 32.2%), data logging (n=86, 14.3%), and notifications (n=70, 11.6%). We found that 327 (54.3%) of the reviews were negative versus 187 (31.1%) positive and 88 (14.6%) neutral or mixed, and the majority of reviews (n=378, 62.8%) mentioned issues. The biggest issues related to device integrations included inability to connect with external devices (n=95, 25.1%), inability to store, manage, or access data (n=49, 22%), unreliable notifications and alerts (n=35, 9.2%), issues caused by or related to software updates (n=31, 8.5%), hardware issues (n=24, 6.4%), and issues with accessing the app, related services, or associated hardware (n=12, 3.2%).

CONCLUSIONS: Apps for diabetes management are a useful part of self-care only if they are reliable and trustworthy, reduce burden, and increase health benefits. Our results provide a useful overview of desired features for diabetes apps alongside key issues for existing integrations and highlight the future challenges for artificial pancreas system development.

PMID:40424579 | DOI:10.2196/62926

JMIR Hum Factors. 2025 May 27;12:e63841. doi: 10.2196/63841.

ABSTRACT

BACKGROUND: Readmission avoidance initiatives have been a priority for the Centers for Medicare & Medicaid Services for over a decade; however, interventions are often high-intensity, costly, and resource-intensive, and therefore, rarely scalable or sustainable. Large national payers are in a unique position to leverage data to identify members in real-time who are at high risk of readmission to prioritize the scaled delivery of tailored behavior change techniques to provide an educational intervention to modify health behaviors.

OBJECTIVE: This study aims to examine the impact of an informatics-driven, multichannel educational messaging campaign implemented to decrease 30- and 90-day acute inpatient readmissions and emergency department (ED) visits among Medicare Advantage members of a large national payer.

METHODS: A quality improvement initiative was designed and implemented to provide an evidence-based outreach campaign using human-centered design and behavior change principles to deliver multiple intervention functions, including timely, contextual, and relevant delivery of education, enablement, and persuasion, to reinforce health-promoting behaviors related to planned or unplanned inpatient admissions. Outcomes, including 30- and 90-day acute inpatient readmissions and ED visits, were retrospectively evaluated from Medicare Advantage members enrolled in a large national health plan residing across the United States between May 2020 and July 2022. Leveraging utilization management data, rules-based logic identified members (N=368,393) with a planned acute inpatient procedure (ie, preadmission) or discharged from an acute hospital stay (ie, postdischarge) within 15 days. Members were sequentially assigned to a standard (N=141,223) or an enhanced (N=227,470) messaging group, whereby the standard group received usual outreach and the enhanced group received an educational intervention via a messaging campaign deployed through multiple low-intensity communication channels (eg, text message, email, direct mail) in addition to standard outreach.

RESULTS: Members who received enhanced outreach had fewer relative 30-day acute inpatient readmissions (-4.1%, 95% CI -5.5% to -2.7%; P<.001) and ED visits (-3.4%, 95% CI -5.0% to -1.7%; P<.001) compared with members receiving standard outreach. Similarly, these findings persisted for relative 90-day outcomes such that members receiving enhanced outreach experienced fewer acute inpatient readmissions (-5.4%, 95% CI -6.5% to -4.3%; P<.001) and ED visits (-3.8%, 95% CI -5.0% to -2.5%; P<.001) compared with members receiving standard outreach messaging.

CONCLUSIONS: Behavior change techniques deployed via educational interventions as low-intensity multi-channel outreach is an effective strategy to reduce avoidable 30- and 90-day inpatient readmissions and ED visits in recently discharged Medicare Advantage members (primarily >65 years).

PMID:40424576 | DOI:10.2196/63841

JMIR Form Res. 2025 May 27;9:e65489. doi: 10.2196/65489.

ABSTRACT

BACKGROUND: The adult Hispanic population of the United States faces an increased risk of dementia compared to non-Hispanic White adults. Physical activity (PA) can help reduce dementia risk, but culturally adapted interventions for Hispanic populations are lacking. Culturally adapted interventions are needed to increase uptake and adherence to brain health promotion strategies in the Hispanic community.

OBJECTIVE: The De Pie y a Movernos intervention aims to reduce barriers to participation in clinical research by culturally adapting a remotely based PA intervention for middle-aged and older Hispanic adults and establish its feasibility and acceptability through a pre-post pilot study. Findings from the cultural adaptation process will inform a stage II PA randomized controlled trial.

METHODS: The adaptation process followed Barrera and Castro’s 2006 cultural adaptation framework and included a literature review, translation of intervention materials, review by a Hispanic-comprised community advisory board and bilingual staff, and a pre-post pilot study (N=10) with subsequent focus groups to refine the intervention. The pilot intervention included the use of Fitbit activity trackers and 2 individualized goal-setting calls with a health coach over a period of 3 weeks. Feasibility and acceptability were assessed using both quantitative methods and qualitative focus groups. Primary quantitative outcomes included enrollment, recruitment, and completion rates, as well as acceptability (predetermined satisfaction survey scores ≥3). Focus groups were thematically coded to identify themes for participants’ opinions about several aspects of the intervention and explore key barriers and facilitators to PA engagement to improve the planned stage II trial.

RESULTS: Ten Hispanic adults (age: mean 62.7, SD 5.3 years; education: mean 11.8, SD 3.8 years; n=9, 90% female; n=9, 90% Spanish-speaking) participated in the pre-post pilot, with a 100% completion rate, 50% enrollment rate, and a recruitment rate of 5 participants per month. Acceptability was high (mean score 4.6, SD 0.3; range 1-5). Qualitative analyses indicated that participants had high satisfaction with the intervention. They expressed a preference for adding group-based activities and increased interaction with study staff. Key barriers to PA included lack of awareness about the benefits of PA, low self-efficacy, time constraints, health conditions, and weather, while facilitators included awareness of PA’s cognitive benefits, social support from family or friends, accountability, enjoyable activities, self-efficacy, and Fitbit use. Insights from participants and community advisory board recommendations led to modifications for the larger trial, such as incorporating group-based elements for those who want them and adding an option for teleconference coaching calls.

CONCLUSIONS: The cultural adaptation process was essential in refining the intervention to align with the preferences of older Hispanic adults, which resulted in a feasible and acceptable intervention. Findings will inform a planned stage II randomized controlled trial aimed at promoting PA and reducing dementia risk in older Hispanic adults.

PMID:40424571 | DOI:10.2196/65489