Category: Nevin Manimala

JMIR Hum Factors. 2025 Jan 22;12:e56521. doi: 10.2196/56521.

ABSTRACT

BACKGROUND: Patients with cerebrovascular accident (CVA) should be involved in setting their rehabilitation goals. A personalized prediction of CVA outcomes would allow care professionals to better inform patients and informal caregivers. Several accurate prediction models have been created, but acceptance and proper implementation of the models are prerequisites for model adoption.

OBJECTIVE: This study aimed to assess the added value of a prediction model for long-term outcomes of rehabilitation after CVA and evaluate how it can best be displayed, implemented, and integrated into the care process.

METHODS: We designed a mock-up version, including visualizations, based on our recently developed prediction model. We conducted focus groups with CVA patients and informal caregivers, and separate focus groups with health care professionals (HCPs). Their opinions on the current information management and the model were analyzed using a thematic analysis approach. Lastly, a Measurement Instrument for Determinants of Innovations (MIDI) questionnaire was used to collect insights into the prediction model and visualizations with HCPs.

RESULTS: The analysis of 6 focus groups, with 9 patients, 4 informal caregivers, and 8 HCPs, resulted in 10 themes in 3 categories: evaluation of the current care process (information absorption, expectations of rehabilitation, prediction of outcomes, and decision aid), content of the prediction model (reliability, relevance, and influence on the care process), and accessibility of the model (ease of understanding, model type preference, and moment of use). We extracted recommendations for the prediction model and visualizations. The results of the questionnaire survey (9 responses, 56% response rate) underscored the themes of the focus groups.

CONCLUSIONS: There is a need for the use of a prediction model to assess CVA outcomes, as indicated by the general approval of participants in both the focus groups and the questionnaire survey. We recommend that the prediction model be geared toward HCPs, as they can provide the context necessary for patients and informal caregivers. Good reliability and relevance of the prediction model will be essential for its wide adoption.

PMID:39842003 | DOI:10.2196/56521

JMIR Res Protoc. 2025 Jan 22;14:e63583. doi: 10.2196/63583.

ABSTRACT

BACKGROUND: In South Africa, there is no centralized HIV surveillance system where key populations (KPs) data, including gay men and other men who have sex with men, female sex workers, transgender persons, people who use drugs, and incarcerated persons, are stored in South Africa despite being on higher risk of HIV acquisition and transmission than the general population. Data on KPs are being collected on a smaller scale by numerous stakeholders and managed in silos. There exists an opportunity to harness a variety of data, such as empirical, contextual, observational, and programmatic data, for evaluating the potential impact of HIV responses among KPs in South Africa.

OBJECTIVE: This study aimed to leverage and harness big heterogeneous data on HIV among KPs and harmonize and analyze it to inform a targeted HIV response for greater impact in Sub-Saharan Africa.

METHODS: The Boloka data repository initiative has 5 stages. There will be engagement of a wide range of stakeholders to facilitate the acquisition of data (stage 1). Through these engagements, different data types will be collated (stage 2). The data will be filtered and screened to enable high-quality analyses (stage 3). The collated data will be stored in the Boloka data repository (stage 4). The Boloka data repository will be made accessible to stakeholders and authorized users (stage 5).

RESULTS: The protocol was funded by the South African Medical Research Council following external peer reviews (December 2022). The study received initial ethics approval (May 2022), renewal (June 2023), and amendment (July 2024) from the University of Johannesburg (UJ) Research Ethics Committee. The research team has been recruited, onboarded, and received non-web-based internet ethics training (January 2023). A list of current and potential data partners has been compiled (January 2023 to date). Data sharing or user agreements have been signed with several data partners (August 2023 to date). Survey and routine data have been and are being secured (January 5, 2023). In (September 2024) we received Ghana Men Study data. The data transfer agreement between the Pan African Centre for Epidemics Research and the Perinatal HIV Research Unit was finalized (October 2024), and we are anticipating receiving data by (December 2024). In total, 7 abstracts are underway, with 1 abstract completed the analysis and expected to submit the full article to the peer-reviewed journal in early January 2024. As of March 2025, we expect to submit the remaining 6 full articles.

CONCLUSIONS: A truly “complete” data infrastructure that systematically and rigorously integrates diverse data for KPs will not only improve our understanding of local epidemics but will also improve HIV interventions and policies. Furthermore, it will inform future research directions and become an incredible institutional mechanism for epidemiological and public health training in South Africa and Sub-Saharan Africa.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63583.

PMID:39841994 | DOI:10.2196/63583

JMIR Mhealth Uhealth. 2025 Jan 22;13:e50014. doi: 10.2196/50014.

ABSTRACT

BACKGROUND: The use of telemonitoring to manage renal function in patients with chronic kidney disease (CKD) is recommended by health authorities. However, despite these recommendations, the adoption of telemonitoring by both health care professionals and patients faces numerous challenges.

OBJECTIVE: This study aims to identify barriers and facilitators in the implementation of a telemonitoring program for patients with CKD, as perceived by health care professionals and patients, and to explore factors associated with the adoption of the program. This study serves as a process evaluation conducted alongside the cost-effectiveness NeLLY (New Health e-Link in the Lyon Region) trial.

METHODS: A mixed methods approach combining a quantitative questionnaire and semistructured interviews was conducted among nurses, nephrologists, and patients with stages 3 and 4 CKD across 10 renal care centers in France that have implemented telemonitoring. The Technology Acceptance Model (TAM) and the Consolidated Framework for Implementation Research (CFIR) were used to design the questionnaires and interview guides. The dimensions investigated included ease of use, perceived usefulness, and intention to use (TAM), as well as characteristics of the intervention, local and general context, individual factors, and processes (CFIR). The adoption of telemonitoring was assessed based on the frequency with which patients connected to the telemonitoring device. Determinants of telemonitoring use were analyzed using nonparametric tests, specifically the Wilcoxon-Mann-Whitney and Kruskal-Wallis tests. Thematic analysis was conducted on the transcriptions of semistructured interviews. Both quantitative and qualitative results, including data from patients and professionals, were integrated to provide a comprehensive understanding of the factors associated with the use of remote monitoring in CKD.

RESULTS: A total of 42 professionals and 128 patients with CKD responded to our questionnaire. Among these, 11 professionals and 13 patients participated in interviews. Nurses, who were responsible for patient follow-up, regularly used telemonitoring (8/13, 62%, at least once a month), while nephrologists, who were responsible for prescribing it, were primarily occasional users (5/8, 63%, using it less than once a month). Among professionals, the main obstacles identified were the heavy workload generated by telemonitoring, lack of training, and insufficient support for nurses. Among the 128 patients, 46 (35.9%) reported using the application at least once a week. The main barriers for patients were issues related to computer use, as well as the lack of feedback and communication with health care professionals. The main facilitators identified by both professionals and patients for using telemonitoring were the empowerment of patients in managing their health and the reduction of the burden associated with CKD.

CONCLUSIONS: Improving adherence to telemonitoring in the context of CKD requires collaborative efforts from both professionals and patients. Our results provide insights that can inform the design of effective, theory-driven interventions aimed at improving telemonitoring adoption and usage.

PMID:39841992 | DOI:10.2196/50014

J Med Internet Res. 2025 Jan 22;27:e54148. doi: 10.2196/54148.

ABSTRACT

BACKGROUND: Medication-related adverse events are common in pregnant women, and most are due to misunderstanding medication information. The identification of appropriate medication information sources requires adequate medical information literacy (MIL). It is important for pregnant women to comprehensively evaluate the risk of medication treatment, self-monitor their medication response, and actively participate in decision-making to reduce medication-related adverse events.

OBJECTIVE: This study aims to examine the effectiveness of a medication education course on a web-based platform in improving pregnant women’s MIL and decision self-efficacy.

METHODS: A randomized controlled trial was conducted. Pregnant women were recruited from January to June 2021 in the Department of Obstetrics and Gynecology of a large hospital in a major city in central China. A total of 108 participants were randomly divided into a control group (CG), which received routine prenatal care from nurses and physicians, and an intervention group (IG), which received an additional 3-week web-based medication education course based on the theory of planned behavior as part of routine prenatal care. Participants completed a Medication Information Literacy Scale and a decision self-efficacy questionnaire at baseline, upon completion of the intervention, and at a 4-week follow-up. Generalized estimation equations (GEE) were used to analyze the main effect (time and grouping) and interaction effect (grouping×time) of the 2 outcomes. The CONSORT-EHEALTH (V 1.6.1) checklist was used to guide the reporting of this randomized controlled trial.

RESULTS: A total of 91 pregnant women (48 in the IG and 43 in the CG) completed the questionnaires at the 3 time points. The results of GEE indicated that there was no statistically significant difference in time×group interactions of MIL between the 2 groups (F₂=3.12; P=.21). The results of the main effect analysis showed that there were statistically significant differences in MIL between the 2 groups at T1 and T2 (F₁=17.79; P<.001). Moreover, the results of GEE indicated that there was a significant difference in decision self-efficacy regarding the time factor, grouping factor, and time×group interactions (F₂=21.98; P<.001). The results of the simple effect analysis indicated a statistically significant difference in decision self-efficacy between the 2 groups at T1 (F₁=36.29; P<.001) and T2 (F₁=36.27; P<.001) compared to T0. Results showed that MIL and decision self-efficacy in the IG were found to be significantly higher than those in the CG (d=0.81; P<.001 and d=1.26; P<.001, respectively), and they remained significantly improved at the 4-week follow-up (d=0.59; P<.001 and d=1.27; P<.001, respectively).

CONCLUSIONS: Web-based medication education courses based on the theory of planned behavior can effectively improve pregnant women’s MIL and decision self-efficacy, and they can be used as supplementary education during routine prenatal care.

TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100041817; https://www.chictr.org.cn/showproj.html?proj=66685.

PMID:39841986 | DOI:10.2196/54148

J Med Internet Res. 2025 Jan 22;27:e57636. doi: 10.2196/57636.

ABSTRACT

BACKGROUND: Parental technoference, the interruption of parent-child interactions by technology, has been associated with negative outcomes in children’s media use. However, the magnitude of this relationship and its moderating factors remain unclear.

OBJECTIVE: This study aims to systematically examine the relationship between parental technoference and child problematic media use, as well as to identify moderating factors such as age, parental technoference group, study design, and type of problematic media use.

METHODS: Following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a comprehensive literature search was conducted up to August 2024 across multiple databases, including Web of Science, EBSCO, ProQuest, PubMed, PsycINFO, and China National Knowledge Infrastructure, using predefined search strings. A total of 53 studies with a total of 60,555 participants (mean age of 13.84, SD 1.18 years) were included. Inclusion criteria comprised studies involving children under the age of 22 years, assessing the association between parental technoference and child problematic media use with valid measures, and reporting necessary statistical data. Exclusion criteria included studies focusing on other child outcomes, having sample sizes <30, or being case reports or review papers. The risk of bias was assessed using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. A random-effects meta-analysis was performed using R (version 4.2.1; R Foundation for Statistical Computing) with the meta and metafor packages to evaluate the association and conduct moderator analyses.

RESULTS: The meta-analysis identified a significant positive association between parental technoference and child problematic media use (r=0.296, 95% CI 0.259-0.331). Moderator analyses revealed that both parental technoference group (P<.001) and study design (P=.008) significantly influenced this relationship. Specifically, the association was stronger when both parents engaged in technoference compared to when only 1 parent did, and in cross-sectional studies compared to longitudinal studies. Age, gender, publication status, and type of problematic media use did not significantly moderate the relationship (all P>.05).

CONCLUSIONS: This meta-analysis provides robust evidence of the association between parental technoference and child problematic media use. The findings highlight the need for family-based interventions and underscore the importance of longitudinal research to understand the temporal dynamics of this relationship better.

TRIAL REGISTRATION: PROSPERO CRD42023471997; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=471997.

PMID:39841982 | DOI:10.2196/57636

Psychol Health Med. 2025 Jan 22:1-17. doi: 10.1080/13548506.2025.2450545. Online ahead of print.

ABSTRACT

Patients with type 2 diabetes mellitus (T2DM) are susceptible to mental health issues, impacting medication adherence and diabetes control. This study aimed to evaluate factors associated with depression and anxiety among T2DM patients in Indonesia and Malaysia. A cross-sectional study was conducted in Indonesia and Malaysia from October 2022 to April 2023 among T2DM patients. The study utilised an instrument with patient and disease data and three validated tools to assess depression, anxiety, and medication adherence. Statistical analysis, including binary logistic regression, was performed using SPSS® version 28 software. A study of 606 T2DM patients revealed that 56.5% were at risk of depression, while 41.6% were at risk of anxiety. Older patients with T2DM had lower rates of depression (AOR = 0.41, 0.25-0.68) and anxiety than younger patients. Normal-weight patients were less likely to experience depression and anxiety (AOR = 0.44, 0.27-0.72) than overweight patients. Patients without diabetic foot ulcers had a lower risk of depression (AOR = 0.34, 0.21-0.55) and anxiety than those with foot ulcers. Patients with a shorter duration of diabetes had a higher risk of depression (AOR = 3.27, 1.70-6.30) and anxiety than those with a longer duration. Patients on insulin-based regimens had higher rates of depression and anxiety (AOR = 2.28, 1.20-4.30) than those on metformin-based regimens. Nonadherent patients were more likely to experience depression and anxiety (AOR = 4.30, 2.22-8.32) than patients who adhered to their medication. The prevalence of depression and anxiety is concerning and influenced by factors such as age, diabetes duration, the presence of diabetic foot ulcers, and the prescribed medication regimen. Further efforts are necessary to enhance the mental health of T2DM patients and improve management outcomes.

PMID:39841970 | DOI:10.1080/13548506.2025.2450545

Diabetes Care. 2025 Feb 1;48(2):212-219. doi: 10.2337/dc24-1537.

ABSTRACT

OBJECTIVE: The goal of this study was to assess the additive value of considering type 2 diabetes (T2D) polygenic risk score (PRS) in addition to family history for T2D prediction.

RESEARCH DESIGN AND METHODS: Data were obtained from the All of Us (AoU) research database. First-degree T2D family history was self-reported on the personal family history health questionnaire. A PRS was constructed from 1,289 variants identified from a large multiancestry genome-wide association study meta-analysis for T2D. Logistic regression models were run to generate odds ratios (ORs) and 95% CIs for T2D. All models were adjusted for age, sex, and BMI.

RESULTS: A total of 109,958 AoU research participants were included in the analysis. The odds of T2D increased with 1 SD PRS (OR 1.75; 95% CI 1.71-1.79) and positive T2D family history (OR 2.32; 95% CI 2.20-2.43). In the joint model, both 1 SD PRS (OR 1.69; 95% CI 1.65-1.72) and family history (OR 2.06; 95% CI 1.98-2.15) were significantly associated with T2D, although the ORs were slightly attenuated. Predictive models that included both the PRS and family history (area under the curve [AUC] 0.794) performed better than models including only family history (AUC 0.763) or the PRS (AUC 0.785).

CONCLUSIONS: In predicting T2D, inclusion of a T2D PRS in addition to family history of T2D (first-degree relatives) added statistical value. Further study is needed to determine whether consideration of both family history and a PRS would be useful for clinical T2D prediction.

PMID:39841967 | DOI:10.2337/dc24-1537

Diabetes Care. 2025 Feb 1;48(2):292-300. doi: 10.2337/dc24-1678.

ABSTRACT

OBJECTIVE: To provide an updated synthesis on effects of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) on weight, BMI, and waist circumference incorporating newer randomized controlled trials (RCTs), particularly in individuals with overweight or obesity.

RESEARCH DESIGN AND METHODS: We systematically searched PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) for RCTs published from inception to 4 October 2024. The search was limited to RCTs evaluating the use of GLP-1 RAs for mean differences from baseline in weight, BMI, and waist circumference in adults with obesity or overweight with or without diabetes. Two independent reviewers performed the literature search and data extraction, resolving disagreements via consensus or third-reviewer consultation.

RESULTS: Forty-seven RCTs were included, with a combined cohort of 23,244 patients. GLP-1 RAs demonstrated a mean weight reduction of -4.57 kg (95% CI -5.35 to -3.78), mean BMI reduction of -2.07 kg/m2 (95% CI -2.53 to -1.62), and mean waist circumference reduction of -4.55 cm (95% CI -5.72 to -3.38) compared with placebo. This effect was consistent across diabetes status, GLP-1 RA used, and route of administration. The greatest treatment benefit appeared to favor patients who were younger, female, without diabetes, with higher baseline weight and BMI but lower baseline HbA1c, and treated over a longer duration. Limitations include substantial statistical heterogeneity, in part due to broad inclusion criteria. However, this heterogeneity may improve generalizability by reflecting a wide range of study designs and patient populations.

CONCLUSIONS: GLP-1 RAs demonstrated significant weight, BMI, and waist circumference reduction benefits in this meta-analysis.

PMID:39841962 | DOI:10.2337/dc24-1678

JCO Clin Cancer Inform. 2025 Jan;9:e2400042. doi: 10.1200/CCI.24.00042. Epub 2025 Jan 22.

ABSTRACT

PURPOSE: Undifferentiated pleomorphic sarcomas (UPSs) demonstrate therapy-induced hemosiderin deposition, granulation tissue formation, fibrosis, and calcification. We aimed to determine the treatment-assessment value of morphologic tumoral hemorrhage patterns and first- and high-order radiomic features extracted from contrast-enhanced susceptibility-weighted imaging (CE-SWI).

MATERIALS AND METHODS: This retrospective institutional review board-authorized study included 33 patients with extremity UPS with magnetic resonance imaging and resection performed from February 2021 to May 2023. Volumetric tumor segmentation was obtained at baseline, postsystemic chemotherapy (PC), and postradiation therapy (PRT). The pathology-assessed treatment effect (PATE) in surgical specimens separated patients into responders (R; ≥90%, n = 16), partial responders (PR; 89%-31%, n = 10), and nonresponders (NR; ≤30%, n = 7). RECIST, WHO, and volume were assessed for all time points. CE-SWI T2* morphologic patterns and 107 radiomic features were analyzed.

RESULTS: A Complete-Ring (CR) pattern was observed in PRT in 71.4% of R (P = 7.71 × 10^-6), an Incomplete-Ring pattern in 33.3% of PR (P = .2751), and a Globular pattern in 50% of NR (P = .1562). The first-order radiomic analysis from the CE-SWI intensity histogram outlined the values of the 10th and 90th percentiles and their skewness. R showed a 280% increase in 10th percentile voxels (P = .061) and a 241% increase in skewness (P = .0449) at PC. PR/NR showed a 690% increase in the 90th percentile voxels (P = .03) at PC. Multiple high-order radiomic texture features observed at PRT discriminated better R versus PR/NR than the first-order features.

CONCLUSION: CE-SWI morphologic patterns strongly correlate with PATE. The CR morphology pattern was the most frequent in R and had the highest statistical association predicting response at PRT, easily recognized by a radiologist not requiring postprocessing software. It can potentially outperform size-based metrics, such as RECIST. The first- and high-order radiomic analysis found several features separating R versus PR/NR.

PMID:39841956 | DOI:10.1200/CCI.24.00042

J Clin Oncol. 2025 Jan 22:JCO2401829. doi: 10.1200/JCO-24-01829. Online ahead of print.

ABSTRACT

PURPOSE: Radiotherapy (RT)/cetuximab (C) demonstrated superiority over RT alone for locally advanced squamous head and neck cancer. We tested this in completely resected, intermediate-risk cancer.

METHODS: Patients had squamous cell carcinoma of the head and neck (SCCHN) of the oral cavity, oropharynx, or larynx, with one or more risk factors warranting postoperative RT. Patients were randomly assigned 1:1 to intensity-modulated RT (60-66 Gy) with once-per-week C or RT alone. The primary hypothesis was that RT + C would improve overall survival (OS) in randomly assigned/eligible patients, with a prespecified secondary plan to test this in the human papillomavirus (HPV)-negative subpopulation. Disease-free survival (DFS) and toxicity were secondary end points. OS and DFS were tested via stratified log-rank test; toxicity was compared via Fisher’s exact test.

RESULTS: We enrolled 702 patients from November 2009 to March 2018; 577 were randomly assigned/eligible. Most (63.6%) had oral cavity cancer and most (84.6%) had high epidermal growth factor receptor expression. There were fewer deaths (184) than expected. OS (median follow up, 7.2 years) was not significantly improved (hazard ratio [HR], 0.81; one-sided P = .0747; 5-year OS 76.5% v 68.7%), but DFS was (HR, 0.75; one-sided P = .0168; 5-year DFS 71.7% v 63.6%). Benefit of RT + C was only seen in the HPV-negative subpopulation (80.2% of patients in the trial). Grade 3-4 acute toxicity rates were 70.3% (RT + C) versus 39.7% (RT; two-sided P < .0001), mostly skin and/or mucosal effects. Late grade ≥3 toxicity rate was 33.2% (RT + C) versus 29.0% (RT; two-sided P = .3101). There were no grade 5 toxicities in either arm.

CONCLUSION: RT + C significantly improved DFS, but not OS, with no increase in long-term toxicity, compared with RT alone for resected, intermediate-risk SCCHN. RT + C is an appropriate option for carefully selected patients with HPV-negative disease.

PMID:39841939 | DOI:10.1200/JCO-24-01829