Category: Statistics

JMIR Med Inform. 2025 Jun 4;13:e78151. doi: 10.2196/78151.

ABSTRACT

[This corrects the article DOI: 10.2196/63906.].

PMID:40466103 | DOI:10.2196/78151

J Med Internet Res. 2025 Jun 4;27:e67489. doi: 10.2196/67489.

ABSTRACT

BACKGROUND: Wasp stings are a significant public health concern in many parts of the world, particularly in tropical and subtropical regions. The venom of wasps contains a variety of bioactive compounds that can lead to a wide range of clinical effects, from mild localized pain and swelling to severe, life-threatening allergic reactions, such as anaphylaxis. With the rapid development of artificial intelligence (AI) technologies, large language models (LLMs) are increasingly being used in health care, including emergency medicine and toxicology. These models have the potential to assist health care professionals in making fast and informed clinical decisions. This study aimed to assess the performance of 4 leading LLMs-ERNIE Bot 3.5 (Baidu), ERNIE Bot 4.0 (Baidu), Claude Pro (Anthropic), and ChatGPT 4.0-in managing wasp sting cases, with a focus on their accuracy, comprehensiveness, and decision-making abilities.

OBJECTIVE: The objective of this research was to systematically evaluate and compare the capabilities of the 4 LLMs in the context of wasp sting management. This involved analyzing their responses to a series of standardized questions and real-world clinical scenarios. The study aimed to determine which LLMs provided the most accurate, complete, and clinically relevant information for the management of wasp stings.

METHODS: This study used a cross-sectional design, creating 50 standardized questions that covered 10 key domains in the management of wasp stings, along with 20 real-world clinical case scenarios. Responses from the 4 LLMs were independently evaluated by 8 domain experts, who rated them on a 5-point Likert scale based on accuracy, completeness, and usefulness in clinical decision-making. Statistical comparisons between the models were made using the Wilcoxon signed-rank test, and the consistency of expert ratings was assessed using the Kendall coefficient of concordance.

RESULTS: Claude Pro achieved the highest average score of 4.7 (SD 0.603) out of 5, followed closely by ChatGPT 4.0 with a score of 4.5. ERNIE Bot 4.0 and ERNIE Bot 3.5 received average scores of 4 (SD 0.600) and 3.8, respectively. In analyzing the 20 complex clinical cases, Claude Pro significantly outperformed ERNIE Bot 3.5, particularly in areas such as managing complications and assessing the severity of reactions (P<.001). The expert ratings showed moderate agreement (Kendall W=0.67), indicating that the assessments were consistently reliable.

CONCLUSIONS: The results of this study suggest that Claude Pro and ChatGPT 4.0 are highly capable of providing accurate and comprehensive support for the clinical management of wasp stings, particularly in complex decision-making scenarios. These findings support the increasing role of AI in emergency and toxicological medicine and suggest that the choice of AI tool should be based on the specific needs of the clinical situation, ensuring that the most appropriate model is selected for different health care applications.

PMID:40466102 | DOI:10.2196/67489

JMIR Res Protoc. 2025 Jun 4;14:e68677. doi: 10.2196/68677.

ABSTRACT

BACKGROUND: Autism spectrum disorder (ASD) is a complex, incurable condition requiring lifelong care, often placing significant psychological strain on parents and emerging as a public health concern. While various interventions exist to enhance the psychological health of parents, the role of digital health interventions (DHIs) in this context remains underexplored.

OBJECTIVE: This scoping review aims to systematically assess the availability of DHIs targeting the psychological health of parents of children with ASD and evaluate the effectiveness of these interventions in improving parental psychological health.

METHODS: The review will include English-language studies published from inception to June 25, 2024, focusing on DHIs aimed at improving the psychological health of parents of children with ASD. Eligible studies will involve parents of children with ASD less than the age of 18 years, across various settings, and assess psychological health outcomes. A comprehensive search will be conducted across six databases: (1) CINAHL, (2) Ovid EMBASE, (3) Ovid Global Health, (4) Ovid MEDLINE, (5) Ovid PsycINFO, and (6) Web of Science. Studies will be screened and selected based on predefined eligibility criteria. Data extraction will include publication details, study design, participants’ characteristics, intervention specifics, comparisons, psychological outcomes, and key findings. Results will be synthesized using descriptive statistics, charts, and narrative analysis.

RESULTS: The initial keyword-based search, completed in June 2024, identified 5825 records, which were subsequently screened and analyzed. Screening and evidence synthesis were finalized in winter 2024, and the completed scoping review was submitted in December 2024.

CONCLUSIONS: This study will provide a comprehensive overview of commonly used DHIs for supporting the psychological health of parents of children with ASD and their effectiveness. The findings will help identify research gaps, inform future studies and funding priorities, and contribute to the development of practice guidelines to enhance parental psychological health.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/68677.

PMID:40466097 | DOI:10.2196/68677

JMIR Mhealth Uhealth. 2025 Jun 4;13:e60855. doi: 10.2196/60855.

ABSTRACT

BACKGROUND: Gestational diabetes is a type of diabetes that develops during pregnancy and increases the risk of developing type 2 diabetes later in life. The rising prevalence of gestational diabetes mellitus (GDM) highlights the need for more comprehensive treatment strategies, with a particular emphasis on supporting maternal self-management. We showed recently that a mobile app, eMOM, where glucose, nutrition, and physical activity are combined within a single app, significantly improves multiple clinical outcomes among persons with gestational diabetes.

OBJECTIVE: This study aims to explore the effects of the eMOM on maternal self-discovery and learning, autonomous motivation to manage GDM, and psychological well-being. Additionally, we examine the correlation between improved maternal clinical outcomes and change in autonomous motivation. We also assess the acceptance and usability of the eMOM app.

METHODS: Building upon the original randomized controlled trial (RCT), in which the intervention arm used a mobile app (eMOM), we conducted a mixed methods study that included an investigation of eMOM log files, semistructured interviews on self-discovery, and an examination of questionnaires assessing motivation (Treatment Self-Regulation Questionnaire and Perceived Competence Scale), depression (Edinburgh Postnatal Depression Scale), technology use and acceptance (Unified Theory of Acceptance of Use of Technology questionnaire), and usability (modified Software Usability Measurement Inventory). Additionally, we monitored participants’ stress levels using wearable electrocardiographic devices (FirstBeat Bodyguard 2). A total of 148 individuals participated in the original RCTs, with 76 in the intervention arm and 72 in the control arm. From the intervention arm, 18 participants were randomly selected for interviews in this study.

RESULTS: Results show that the use rate of eMOM was high, and novel visualization supported self-discovery in persons with GDM. Most participants (17/18, 94%) indicated that the eMOM app helped to find the associations between their daily activities and glucose levels. Especially having nutrition visualized together with glucose was highly appreciated. Participants also reported learning about the associations between physical activity and glucose levels. No differences were observed between the intervention and control arms in autonomous motivation, depression, or stress. Furthermore, there were no correlations between improved clinical outcomes and changes in motivation. Accessibility and usability ratings were consistently high throughout the intervention.

CONCLUSIONS: The eMOM mobile app combining data from continuous glucose monitor, food diary, and physical activity tracker supports maternal self-discovery related to GDM without contributing to depression or adding extra stress. This encourages the use of such mobile apps in maternity care. Notably, motivational factors did not correlate with the positive outcomes observed in our prior RCT, suggesting that self-discovery has a greater impact on clinical results.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04714762; https://www.clinicaltrials.gov/study/NCT04714762.

PMID:40466096 | DOI:10.2196/60855

JMIR Res Protoc. 2025 Jun 4;14:e67875. doi: 10.2196/67875.

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) after radiotherapy (RT) in patients with breast cancer (BC) is a relatively new and understudied topic. AF can increase the risk of stroke and other serious cardiovascular complications, compromising patients’ quality of life and survival. Screening of AF, both asymptomatic and symptomatic forms, is therefore essential for optimal management.

OBJECTIVE: The aim of the Watch Your Heart After Radiotherapy for Breast Cancer (WATCH) study is to assess the incidence of AF (symptomatic or asymptomatic) occurring throughout a 5-year follow-up after RT and to investigate whether cardiac radiation exposure is associated with the occurrence of such events.

METHODS: WATCH is a cohort study that will include 200 patients over 65 years old, treated with RT for BC 5 years before inclusion and without a history of AF. Cross-sectional screening for AF at the time of the scheduled 5-year post-RT visit will be conducted by recording data from a Withings ScanWatch smartwatch for 1 month, confirmed by an electrocardiogram (ECG), and validated by a physician. In addition, a transthoracic echocardiography (TTE) will be performed, providing a comprehensive assessment of cardiac structures, and allowing us to investigate the underlying etiology and assess the risk of complications. Patients’ medical records will provide retrospective information about the timing and risk factors for the occurrence of AF and other arrhythmias and cardiac diseases during the 5 years following RT. The development of deep learning algorithms for autosegmentation analysis of potentially critical substructures for the occurrence of AF, including cardiac chambers, the sinoatrial node, the atrioventricular node, coronary arteries, and pulmonary veins (PVs), will produce dosimetry linked to previous RT treatment for all contoured structures.

RESULTS: Enrollment started in October 2023 and will continue until mid-2026 to include 200 patients, which will ensure an 80% statistical power to detect a significant difference in AF incidence around 15% for the group of patients moderately exposed (<75th percentile of the mean heart radiation dose) and 25% for the group of patients highly exposed (>75th percentile of the mean heart radiation dose). The results are expected by the end of 2026.

CONCLUSIONS: This study will contribute to generating new knowledge on AF after RT for BC and help considering the inclusion of AF screening into routine clinical practice for these patients. Identifying the dose-risk associations would improve RT delivery protocols to limit the occurrence of different forms of AF and, if necessary, initiate appropriate treatment.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06073509; clinicaltrials.gov/study/NCT06073509?id=NCT06073509&rank=1.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67875.

PMID:40466092 | DOI:10.2196/67875

N Engl J Med. 2025 Jun 5;392(21):2113-2124. doi: 10.1056/NEJMoa2414859.

ABSTRACT

BACKGROUND: The benefit of regional nodal irradiation in the treatment of breast cancer is well established for patients with pathologically positive axillary nodes, but whether it is also beneficial for patients whose nodes become pathologically tumor free (ypN0) after neoadjuvant chemotherapy remains unclear.

METHODS: We evaluated whether regional nodal irradiation improves outcomes in patients with biopsy-proven, node-positive breast cancer who reach ypN0 status after neoadjuvant chemotherapy. Patients with breast cancer with a clinical stage of T1 to T3 (tumor size, ≤2 cm to >5 cm), N1, and M0 (indicating spread to one to three axillary lymph nodes but no distant metastasis) who had ypN0 status after neoadjuvant chemotherapy were randomly assigned to receive regional nodal irradiation or no regional nodal irradiation. The primary end point was the interval of freedom from invasive breast cancer recurrence or death from breast cancer (invasive breast cancer recurrence-free interval). Secondary end points included the locoregional recurrence-free interval, the distant recurrence-free interval, disease-free survival, and overall survival. Safety was also assessed.

RESULTS: A total of 1641 patients were enrolled in the trial; 1556 were included in the primary-event analysis: 772 in the irradiation group and 784 in the no-irradiation group. After a median follow-up of 59.5 months, 109 primary end-point events (50 in the irradiation group and 59 in the no-irradiation group) had occurred. Regional nodal irradiation did not significantly increase the invasive breast cancer recurrence-free interval (hazard ratio, 0.88; 95% confidence interval, 0.60 to 1.28; P = 0.51). Point estimates of survival free from the primary end-point events were 92.7% in the irradiation group and 91.8% in the no-irradiation group. Regional nodal irradiation did not increase the locoregional recurrence-free interval, the distant recurrence-free interval, disease-free survival, or overall survival. No deaths related to the protocol-specified therapy were reported, and no unexpected adverse events were observed. Grade 4 adverse events occurred in 0.5% of patients in the irradiation group and 0.1% of those in the no-irradiation group.

CONCLUSIONS: The addition of adjuvant regional nodal irradiation did not decrease the risk of invasive breast cancer recurrence or death from breast cancer in patients who had negative axillary nodes after neoadjuvant chemotherapy. (Funded by the National Institutes of Health; NSABP B-51-Radiation Therapy Oncology Group 1304 ClinicalTrials.gov number, NCT01872975.).

PMID:40466065 | DOI:10.1056/NEJMoa2414859

JMIR Cancer. 2025 Jun 4;11:e67131. doi: 10.2196/67131.

ABSTRACT

BACKGROUND: Cancer imposes significant physical and emotional distress not only on patients, but also on their caregivers. In recent years, there has been a growing focus on the mental and physical well-being of caregivers. Among various psychological interventions, cognitive behavioral therapy (CBT) is widely recognized as one of the most effective approaches. However, traditional CBT is often limited by time and geographical constraints, resulting in delayed or inefficient support for caregivers. Internet-based cognitive behavioral therapy (ICBT) presents a valuable alternative for alleviating the caregiving burden and the negative emotions experienced by caregivers.

OBJECTIVES: This study aimed to provide a scoping review of ICBT interventions for caregivers of patients with cancer, examining intervention content, outcome measures, and effectiveness and to offer insights and references for the development and clinical applications of ICBT programs tailored to caregivers of patients with cancer in China.

METHODS: Relevant literature was systematically searched in PubMed, Web of Science, Cochrane Library, CINAHL, Embase, China National Knowledge Infrastructure (CNKI), Wanfang Data, and VIP Chinese Journal Database. The search timeframe was from database inception to June 6, 2024. Inclusion criteria encompassed intervention studies that implemented cognitive behavioral therapy for caregivers of patients with cancer via the internet, WeChat (Tencent), or mobile electronic devices. This category includes both randomized and nonrandomized controlled trials.

RESULTS: A total of 12 studies met the criteria and were included in the review. The intervention content included the following components: treatment initiation and brief introduction (5/12, 41%), cognitive education and restructuring (7/12, 58%), emotional expression and coping (6/12, 50%), cognitive restructuring and reinforcement (4/12, 33%), behavioral training and activation (9/12, 75%), problem-solving techniques (4/12, 33%), communication (5/12, 41%), and completion of treatment with follow-up consolidation (3/12, 25%). The intervention duration typically ranged from 6 to 8 weeks. Outcome indicators encompassed feasibility and acceptability, anxiety, depression, caregiver burden, and quality of life. ICBT demonstrated positive effects for caregivers of patients with cancer. Most intervention programs were feasible and acceptable, with 2 out of 5 feasibility studies reporting recruitment rates below 50%. Attrition rates across studies ranged from 3% to 16%, and caregivers expressed satisfaction with the information, quality, and skills provided. ICBT exhibits a moderate effect in diminishing negative emotions among caregivers and alleviating caregiver stress. However, its impact on improving quality of life is not statistically significant, underscoring the need for long-term follow-up.

CONCLUSIONS: The implementation of ICBT for caregivers of patients with cancer has demonstrated beneficial outcomes, attributed to its practicality and flexibility, which contribute to its greater acceptance among caregivers. Nevertheless, there is significant heterogeneity in intervention format, duration, and outcome indicators. It is necessary to develop optimal intervention strategies and secure online platforms based on the cultural background in China to improve the quality of life of caregivers.

PMID:40466058 | DOI:10.2196/67131

JMIR Cancer. 2025 Jun 4;11:e67650. doi: 10.2196/67650.

ABSTRACT

BACKGROUND: Despite its potential to predict and detect early cancer risks, genetic testing remains underused by the public. This study, guided by the health belief model (HBM), examined key factors influencing an individual’s willingness to undergo genetic testing for cancer, with a particular focus on gender, caregiver status, and participation in online social support groups.

OBJECTIVE: This study aimed to explore the factors that can influence the individual’s decision to undergo preventative genetic testing for cancer so that more informed action can be taken to encourage the individuals to engage in preventative health behavior.

METHODS: This study uses data collected from the 2020 Health Information National Trends Survey (HINTS 5 Cycle 4), which included 2947 respondents representing 199,510,996 US adults aged 18 years and older. Multivariable logistic regression and survey-weighted generalized linear models were applied to examine the relationship between cancer genetic testing and caregiver status, participation in online support groups, gender, and constructs associated with the HBM, while controlling for sociodemographic and health-related characteristics.

RESULTS: Our findings show that women are more likely to undergo cancer genetic testing, with gender moderating the influence of perceived susceptibility (β=2.54, P=.03) and severity (β=0.94, P<.050) on testing decisions. In line with the HBM, perceived benefits (β=0.19, P=.03) and cues to action (β=2.86, P<.001) increase the likelihood of testing. Results also show that caregivers of patients with cancer (β=1.25, P=.04) and those actively participating in online health support groups (β=0.47, P=.04) are also more likely to engage in cancer genetic testing.

CONCLUSIONS: Cancer remains a significant health challenge in the United States, with 1.8 million new cases and 606,520 deaths annually. Early detection is vital for treatment success. This study investigates factors influencing the decision to undergo genetic testing for cancer. The examination of caregiver status and online support groups as influencing factors, along with the HBM, provided a significant theoretical contribution to the health care research domain. Results indicated that caregivers and men should be directly targeted with messaging on genetic cancer screening as a proactive health behavior. Additionally, online support groups can promote early detection and encourage participation in genetic testing. Future research should further explore implementing proactive outreach strategies to encourage wider adoption of genetic testing for cancer.

PMID:40466055 | DOI:10.2196/67650

Crit Care Explor. 2025 Jun 4;7(6):e1270. doi: 10.1097/CCE.0000000000001270. eCollection 2025 Jun 1.

ABSTRACT

IMPORTANCE: Epidemiological studies have highlighted disparities in illnesses and outcomes for critically unwell children.

OBJECTIVES: We aimed to describe social characteristics and explore links with the outcome of postoperative complications with children’s heart surgery.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of a multicenter observational dataset including those under 17 years old undergoing heart surgery from October 2015 to June 2017 at five U.K. children’s cardiac centers.

MAIN OUTCOMES AND MEASURES: Univariate and multivariable multinomial regression analyses were undertaken for the outcome of predefined postoperative complications.

RESULTS: Of 2898 cases meeting criteria, 2708 had complete data. Two thousand one hundred three (77.66%) had no complications, 369 (13.62%) had a single complication, 56 (2.06%) received Extracorporeal Life Support, and 179 (6.61%) had multiple complications. Children residing in low deprivation neighborhoods were under-represented: lowest quintile 361 (13.33%). Minoritized ethnic group was strongly linked to indices of deprivation: residence in neighborhoods with highest deprivation occurred with Bangladeshi, Black African, and Pakistani ethnicity and lowest deprivation with White ethnicities. Adjusted for clinical risk factors compared with the reference group (White), patients from Asian background had a significantly higher risk of developing single vs. no complications (odds ratio [OR], 1.53; 95% CI, 1.00-2.32) and Black patients had a higher risk of developing multiple vs. no complications (OR, 2.19; 95% CI, 1.09-4.41). Among single complications, Asian children had a higher risk of developing feeding issues (OR, 2.07; 95% CI, 1.13-3.28).

CONCLUSIONS AND RELEVANCE: Ethnicity and socioeconomic deprivation may be linked to greater risk of certain complications after pediatric cardiac surgery. Further exploration of inequities is needed in this population.

PMID:40466039 | DOI:10.1097/CCE.0000000000001270

Crit Care Explor. 2025 Jun 4;7(6):e1271. doi: 10.1097/CCE.0000000000001271. eCollection 2025 Jun 1.

ABSTRACT

OBJECTIVES: To evaluate the safety and efficacy of an early chest tube removal protocol in reducing tube duration without increasing complications following pediatric cardiac surgery.

DESIGN: A single-center, randomized controlled trial.

SETTING: Pediatric cardiac ICU.

PATIENTS: Two hundred fifteen pediatric patients with chest tubes after cardiac surgery.

INTERVENTIONS: Patients were randomized to early removal (drainage threshold < 6 mL/kg over 8 hr) or late removal (24-hr assessment) groups. Primary outcomes included chest tube duration, whereas secondary outcomes encompassed ICU stay, ventilation time, hospital stay, and complication rates.

MEASUREMENTS AND MAIN RESULTS: Median chest tube duration was significantly shorter in the early removal group (3 d) compared with the late removal group (4.9 d; p < 0.0001). Rates of fluid reaccumulation and pneumothorax were low and comparable between groups. Notably, no patients in either group required tube reinsertion. ICU and total hospital stay durations were similar across groups.

CONCLUSIONS: An early chest tube removal protocol following pediatric cardiac surgery suggests a reduction in chest tube duration without increasing the risk of complications. These findings support the adoption of an evidence-based early removal approach to enhance patient comfort and optimize ICU resource utilization in pediatric cardiac surgery patients.

PMID:40466038 | DOI:10.1097/CCE.0000000000001271