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Nevin Manimala Statistics

Evaluating and Optimizing Just-in-Time Adaptive Interventions in a Digital Mental Health Intervention (Wysa for Chronic Pain) for Middle-Aged and Older Adults With Chronic Pain: Protocol for a Series of Randomized Trials

JMIR Res Protoc. 2025 Sep 17;14:e77532. doi: 10.2196/77532.

ABSTRACT

BACKGROUND: On a population level, digital mental health interventions effectively reduce depression and anxiety symptoms. However, middle-aged and older adults with chronic pain and coexisting depression or anxiety have not been adequately represented in digital mental health studies.

OBJECTIVE: The goal of this study is to refine an existing mobile, digital mental health intervention (Wysa for Chronic Pain) that addresses symptoms of depression, anxiety, and coexisting chronic pain for the unique challenges and technology use patterns of middle-aged and older adults.

METHODS: Using a mixed methods, human-centered design approach and a series of randomized trials, we will test and iteratively refine just-in-time adaptive interventions (JITAIs) that are designed to increase engagement with a digital mental health intervention. Participants will be aged 45 years or older, endorse at least moderately severe depression or anxiety symptoms (Patient Health Questionnaire-9 or Generalized Anxiety Disorder-7 score ≥10), and have coexisting chronic pain (ie, pain on most days or every day in the past 3 months), and live in the United States. In this open, web-based trial, participants will all receive Wysa for Chronic Pain (by Wysa), which uses a behavioral activation framework and encourages users to work toward pain acceptance. The fully automated intervention also includes cognitive behavioral therapy, mindfulness, and sleep tools, among others. In each trial, participants will be randomized during a maximum 12-week study period to receive versus not receive novel JITAIs that are intended to reduce navigation burden and improve usability (and subsequent engagement and clinical effectiveness). The JITAIs are being designed with iterative user feedback, guided by the Discover, Design/Build, and Test framework and the Behavioral Intervention Technology model. The proximal outcome for each JITAI is related to engagement with Wysa for Chronic Pain after JITAI delivery (compared to when no JITAI is delivered). The primary distal clinical outcome is the Patient Health Questionnaire Anxiety and Depression Scale. Based on statistical analysis that is triangulated with qualitative feedback from a subsample of trial participants, the JITAIs will be iteratively refined and retested in subsequent microrandomized trials until retesting of refined adaptations no longer yields meaningful improvement in immediate engagement or a maximum of 5 total trials have been completed.

RESULTS: Institutional review board approval was obtained on April 11, 2025. The first participant was enrolled on June 2, 2025, and recruitment is expected to conclude in 2026.

CONCLUSIONS: Completion of this project will result in iteratively refined JITAIs that are designed to improve usability and engagement with a digital mental health intervention by middle-aged and older adults with depression or anxiety and coexisting chronic pain.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06978166; https://clinicaltrials.gov/study/NCT06978166.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/77532.

PMID:40961490 | DOI:10.2196/77532

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Nevin Manimala Statistics

Online Yoga Pilot Intervention for Black Women at High Cardiovascular Risk: Internet-Based Recruitment and Engagement

JMIR Form Res. 2025 Sep 17;9:e41221. doi: 10.2196/41221.

ABSTRACT

BACKGROUND: Disproportionately adverse heart health outcomes in Black women, characterized by high metabolic syndrome prevalence, underscore the need for innovative, accessible interventions. Digital health strategies, particularly web-based yoga videos, show promise for engaging this high-risk group in health-promoting behaviors.

OBJECTIVE: This study aimed to evaluate the feasibility and acceptability of a web-based yoga intervention for community-dwelling Black women, providing preliminary data to inform a larger, mixed methods study on reducing cardiometabolic risks.

METHODS: In this 4-week pilot study, grounded in Pender’s Health Promotion Model, 28 participants engaged in daily online health education and yoga activities through YouTube videos. Using Fitbit trackers, electronic blood pressure monitors, and web-based logs, the study measured metabolic syndrome risk factors and sedentary behavior. Participant experiences were further explored through postintervention focus groups aiming to contextualize the intervention’s impact.

RESULTS: We enrolled 28 women, with a completion rate of 79% (22/28), demonstrating successful recruitment and retention. Participants were an average age of 43.3 years with a mean BMI of 40.9 kg/m2, indicating a high-risk group for metabolic syndrome. Engagement with 2 or more intervention components were significantly correlated with study completion (χ21=7.14, P=.008). Specifically, viewing over one-half of the instructional videos (χ21=4.39, P=.04) and daily blood pressure monitoring (χ21=5.67, P=.02) were key to participant adherence. The intervention was well-received, with 95% (19/20) of survey respondents finding it satisfactory and suitable. Technology use was high, with all participants having access to the internet, 96% (27/28) owning smartphones, and 53% (15/28) having a YouTube account prior to the study. Recruitment was effectively conducted online, primarily via Facebook and a university newsletter, each accounting for 39.3% (11/28) of participants. The qualitative focus group data unveiled 4 major themes: (1) accountability, emphasizing the shift toward self-prioritization and collective health responsibility; (2) increased awareness, highlighting enhanced understanding of health behaviors and metabolic syndrome risks; (3) health benefits, noting observed improvements in blood pressure and stress levels; and (4) unanticipated stressors, identifying external factors that challenged engagement. These insights underscore the intervention’s multifaceted impact, from fostering health awareness to navigating external stressors.

CONCLUSIONS: This pilot study demonstrated the feasibility and acceptability of a culturally tailored, online yoga intervention among community-based, Black women at high risk for metabolic syndrome, showing promising engagement and potential health benefits. The high rates of participation and completion highlight the intervention’s acceptability and the potential for digital platforms to facilitate health behavior changes in high-risk populations. The qualitative findings reveal critical insights into the psychological and social dynamics influencing health behavior change, suggesting the importance of addressing both individual and communal barriers to improve intervention efficacy. Future research should further explore these dynamics in larger, more diverse cohorts to substantiate the intervention’s potential in reducing cardiometabolic risks.

PMID:40961483 | DOI:10.2196/41221

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Nevin Manimala Statistics

Effectiveness and Safety of Tuina Therapy Combined With Yijinjing Exercise for Neck Pain: Protocol for a Systematic Review and Meta-Analysis

JMIR Res Protoc. 2025 Sep 17;14:e77864. doi: 10.2196/77864.

ABSTRACT

BACKGROUND: Neck pain with high incidence and recurrence rates significantly impairs patients’ quality of life and imposes a considerable economic burden. Traditional Chinese medicine therapies such as Yijinjing exercise and Tuina have shown promising efficacy in alleviating the local symptoms of neck pain. However, there is currently insufficient high-level evidence to robustly support these findings.

OBJECTIVE: This study aims to evaluate the efficacy and safety of combining Yijinjing exercise with Tuina for the treatment of neck pain.

METHODS: PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, Chinese Biomedical Database, VIP Chinese Science and Technology Periodicals Full-Text database, and Wanfang database will be systematically searched for all relevant randomized controlled trials (RCTs) from their inception to September 2025, without language or publication status restrictions. The Cochrane Risk of Bias 2 assessment tool will be used to evaluate the risk of bias in the included studies, and the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system will be employed to grade the quality of evidence. Heterogeneity will be evaluated through I2 statistics and Cochran’s Q test: a fixed-effect model will be used when I2<50% and P≥.01. If I2≥50% or P<.01, subgroup analysis will be conducted. When heterogeneity still exists, sensitivity analysis or exploratory subgroup analysis will be performed. If it cannot be explained ultimately, the random-effects model will be adopted and the GRADE evidence level will be reduced.

RESULTS: As of June 2025, we have completed the preliminary screening of titles and abstracts for 573 studies. The full-text screening is expected to be completed by September 2025, and data analysis is planned to be completed by December 2025. About two-thirds of the studies were published after 2015. Geographically, the samples in the studies were highly concentrated in Asia. The results were comprehensively developed around the core outcomes. The primary outcome was presented by changes in the visual analog scale. The secondary outcomes were evaluated by the neck disability index, self-rating anxiety scale score, mean vertebral artery blood flow velocity, and Cobb angle.

CONCLUSIONS: If the results of this study confirm the effectiveness of massage combined with Yijinjing, it can provide a direction for the nonpharmaceutical treatment of neck pain. However, some studies have risks of bias such as insufficient standardization of massage operations and difficulty in implementing blinding methods. The expected heterogeneity is significant due to differences in intervention plans and patients’ cultural backgrounds, and the original RCTs are few and regionally concentrated, with limited extrapolation of conclusions. In the future, it is necessary to optimize the plan and supplement data through high-quality multicenter research to enhance reliability.

TRIAL REGISTRATION: PROSPERO CRD420251026508; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251026508.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77864.

PMID:40961482 | DOI:10.2196/77864

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Nevin Manimala Statistics

Coronary Artery Disease Prevalence in an Executive Population at a Tertiary Medical Center: Protocol for a Retrospective Cohort Study

JMIR Res Protoc. 2025 Sep 17;14:e72451. doi: 10.2196/72451.

ABSTRACT

BACKGROUND: Coronary artery disease (CAD) is a leading cause of global morbidity and mortality. Although CAD prevalence in the general population is well-documented, its occurrence among executive patients remains largely unexplored. An executive is an individual in a major leadership role, such as a C-suite officer, senior manager, board member, trustee, founder, or business owner, responsible for high-level decision-making and strategic direction. These roles often involve demanding schedules and significant stress. Despite their influence and better access to health care, this demographic faces unique challenges such as demanding work schedules, chronic stress, frequent travel, and reduced control over lifestyle. To address executives’ unique health needs, many health care organizations offer specialized programs emphasizing preventive cardiovascular care, using advanced tools such as lipid panels, stress tests, and coronary calcium scans not typically included in primary care, to detect risks early and to promote long-term wellness.

OBJECTIVE: This protocol aims to design a study to determine the prevalence of CAD in executive patients and compare it to the established prevalence in the US general population with the overarching goal of improving screening and care of CAD among executive patients.

METHODS: This protocol proposes a retrospective review of medical records for patients with CAD seen at the Mayo Clinic’s Executive Health Program from January 1, 2020, to December 31, 2023, with the aim of determining the prevalence of CAD in executive patients. The primary outcome is CAD prevalence, which will be identified through clinical diagnoses in the electronic medical records. Secondary outcomes include demographics, cardiovascular medications, social determinants of health, laboratory and diagnostic results, coronary calcium scores, and treatment interventions. The prevalence of CAD will be calculated as the proportion of patients with a documented CAD diagnosis relative to the total number of patients in the study cohort.

RESULTS: A total of 24,272 patients were seen in the executive health clinic between January 1, 2020, and December 31, 2023. After applying the inclusion criteria, 6466 executive patients were eligible, with 3290 identified as having a potential CAD diagnosis pending confirmation through a detailed chart review.

CONCLUSIONS: In this protocol, we outline a research design and methodology to address a critical gap in understanding the prevalence of CAD among executive patients. This demographic is often overlooked despite their unique risk factors such as high stress and lifestyle choices.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/72451.

PMID:40961480 | DOI:10.2196/72451

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Nevin Manimala Statistics

An innovative X-RAG technique combined with GPT-4o for summarizing medical information from EHR and EMR to assist doctors in clinical decision-making effectively and efficiently

Health Informatics J. 2025 Jul-Sep;31(3):14604582251381233. doi: 10.1177/14604582251381233. Epub 2025 Sep 17.

ABSTRACT

Background: Large language models (LLM) still face challenges in accurately extracting and summarizing medical information from EHR and EMR. The variability in EHR and EMR formats across institutions further complicates information integration. Moreover, doctors need to spend a lot of time reviewing patient information, which affects the efficiency and effectiveness of clinical decision-making. Objective: This study aims to develop a medical record summarization system that uses the innovative X-RAG technique with GPT-4o to extract medical information from EHR and EMR and convert them into structured FHIR format. The system ultimately generates a doctor-friendly report to improve the efficiency and effectiveness of clinical decision-making. Methods: We propose an innovative X-RAG, which adds page-based chunking, chunk filtering, and guided extraction prompting to the basic framework of RAG and combines it with GPT-4o to extract medical measurement data, diagnostic reports, and medication history records from EHR and EMR with high accuracy. Results: The system achieved 96.5% accuracy in medical data extraction and reduced approximately 40% of the time doctors spend reviewing patient information in clinical applications. Conclusion: The proposed system improves the efficiency and effectiveness of clinical decision-making and provides a valuable tool to optimize medical information management and clinical workflows.

PMID:40961463 | DOI:10.1177/14604582251381233

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Nevin Manimala Statistics

Trends in Births and Deaths: United States, 2010-2023

Natl Vital Stat Rep. 2025 Aug 27;(11):1. doi: 10.15620/cdc/174614.

ABSTRACT

OBJECTIVES: This report presents and compares trends in U.S. births and deaths from 2010 through 2023. Births and deaths are shown by race and Hispanic origin and urbanicity of county of residence.

METHODS: Descriptive tabulations of trends in the numbers, rates, and ratios of births and deaths for the United States from 2010 through 2023 are presented and interpreted.

RESULTS: From 2010 through 2023, the number of births for the United States declined by a total of 10%. Births were essentially stable from 2010 through 2016, declined from 2016 through 2019, and then fluctuated from 2019 through 2023. In contrast, the number of deaths generally increased from 2010 through 2023, by a total of 25%. Deaths increased from 2010 through 2019 and fluctuated from 2019 through 2023. The crude birth rate decreased 18% from 2010 through 2023, declining 0.8% per year from 2010 through 2015 and 2.0% per year from 2015 through 2019; the rate then fluctuated from 2019 through 2023. In contrast, the crude death rate increased 15% from 2010 through 2023, rising 1.0% on average from 2010 through 2019, and then fluctuating from 2019 through 2023. The birth-to-death ratio declined from 2010 through 2023, by a total of 28%, with the ratio decreasing 1.6% per year from 2010 through 2014 and 2.8% per year from 2014 through 2019; the ratio then fluctuated from 2019 through 2023. The ratio generally declined for the three largest race and Hispanic-origin groups from 2010 through 2023, fluctuating but increasing from 2019 through 2023. The differences in the ratios among the groups narrowed from 2010 through 2023. The birth-to-death ratio declined for both urban and rural counties from 2010 through 2023, with differences between ratios narrowing.

PMID:40961445 | DOI:10.15620/cdc/174614

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Nevin Manimala Statistics

Obesity is an independent poor prognostic factor in lupus nephritis

Lupus. 2025 Sep 17:9612033251375856. doi: 10.1177/09612033251375856. Online ahead of print.

ABSTRACT

ObjectiveTo investigate whether obesity is a risk factor for chronic kidney disease G3 (CKD G3; eGFR <60 mL/min/1.73 m2) in lupus nephritis (LN).MethodsWe retrospectively reviewed 132 cases of biopsy-proven class III, IV or V incident LN for which quarterly data were available during a long follow-up period (median 140 months). Rates of complete renal remission, renal flare and CKD G3 were compared between obese (body mass index ≥30 kg/m2) and non-obese patients. Complete renal remission was defined as a urine protein to creatinine ratio (uPCR) < 0.5 g/g and a serum creatinine value <120 % of baseline. Renal flare was defined as the reappearance of an uPCR >1 g/g, leading to a repeat kidney biopsy and/or treatment change.ResultsBaseline characteristics of obese patients did not differ from non-obese patients. By contrast, time to CKD G3 and time to renal flare were statistically shorter in obese patients. Obesity significantly increased long-term risk for the progression of CKD [HR = 2.72 (CI95% 1.11-6.64), p = .028]. In a multivariate analysis, obesity was an independent risk factor for CKD G3 (p = .029).ConclusionA BMI ≥30 kg/m2 is an independent poor prognostic factor for the progression of CKD in LN. More attention should therefore be paid to weight control in LN patients.

PMID:40961424 | DOI:10.1177/09612033251375856

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Nevin Manimala Statistics

Genomic Biomarker for Prostate Cancer Focal Therapy: Post Hoc Assessment of a Phase II Clinical Trial

JCO Precis Oncol. 2025 Sep;9:e2500535. doi: 10.1200/PO-25-00535. Epub 2025 Sep 17.

ABSTRACT

PURPOSE: A biomarker to help predict outcomes after prostate cancer (PCa) focal therapy would be of considerable interest. We sought to assess the association between treatment failure after focal therapy and the Decipher score, a tumor-based genomic classifier (GC).

MATERIALS AND METHODS: We performed a post hoc analysis of a single-center phase II trial (ClinicalTrials.gov identifier: NCT03503643) in which patients with unilateral grade group (GG) 2-4 PCa (n = 108) underwent hemigland cryoablation of the prostate (2017-2021; n = 108). Pretreatment biopsy tissue was subjected to transcriptomic profiling to generate GC scores. The primary outcome was the association between GC-low (<0.45) versus GC-high (≥0.45) and in-field recurrence (GG ≥2) on magnetic resonance imaging-guided biopsy 6 months post-treatment, evaluated using multivariable logistic regression.

RESULTS: In the GC-high group (n = 37), treatment failure occurred in 17 patients (46%). In the GC-low group (n = 71), treatment failure occurred in 15 patients (21%). These differences were statistically significant (odds ratio [OR], 2.61 [95% CI, 1.05 to 6.51]; P = .04). Differences at 18 months were also significant (76% v 44%; OR, 3.58 [95% CI, 1.37 to 9.36], P = .009).

CONCLUSION: In patients with PCa otherwise suitable for management with focal therapy, a high GC score (≥0.45) was independently associated with treatment failure. A GC score derived from diagnostic biopsy can be used to help predict focal therapy outcomes.

PMID:40961406 | DOI:10.1200/PO-25-00535

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Nevin Manimala Statistics

Why Adjuvant Treatment With a CDK4/6 Inhibitor Should Be Recommended for Women With High-Risk Breast Cancer: Methodologic Considerations on Available Evidence

J Clin Oncol. 2025 Sep 17:JCO2501148. doi: 10.1200/JCO-25-01148. Online ahead of print.

NO ABSTRACT

PMID:40961402 | DOI:10.1200/JCO-25-01148

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Nevin Manimala Statistics

Comparing COVID-19 Acute And Postacute Medical Spending By Vaccination Status For Child And Adult Medicaid Enrollees

Health Aff (Millwood). 2025 Sep 17:101377hlthaff202500050. doi: 10.1377/hlthaff.2025.00050. Online ahead of print.

ABSTRACT

Although COVID-19 vaccines have been shown to be highly effective in preventing severe illness, hospitalization, and death, information on the economic benefits of COVID-19 vaccination is lacking. Using data from a comprehensive, integrated health system, we linked health plan data and electronic health records to vaccination data to compare the average medical expenditures of vaccinated versus unvaccinated patients diagnosed with COVID-19. We examined expenditures during acute (within thirty days after diagnosis) and postacute (at least thirty days after diagnosis) periods from April 2021 through July 2022. Among children, average acute medical expenditures were $194 less for vaccinated than unvaccinated cases and among adults, $1,743 less for vaccinated than unvaccinated cases. Medical expenditures in the postacute period were not statistically different by vaccination status. The findings suggest that COVID-19 vaccination is associated with lower medical expenditures in the acute period. Vaccination continues to be important for reducing the economic impact of COVID-19.

PMID:40961389 | DOI:10.1377/hlthaff.2025.00050