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Nevin Manimala Statistics

Evaluation of the efficacy and safety of intralesional vitamin D3 injection in the treatment of acanthosis nigricans: A split-neck comparative study

Clin Exp Dermatol. 2025 Feb 5:llaf067. doi: 10.1093/ced/llaf067. Online ahead of print.

ABSTRACT

BACKGROUND: Acanthosis nigricans (AN) is a prevalent dermatological issue with numerous treatment options that are not entirely sufficient. Topical vitamin D analogs were found to be effective and safe in treating AN; however, other preparations of vitamin D have not been studied yet.

OBJECTIVES: To evaluate the safety and efficacy of intralesional vitamin D3 injection in treating pseudo-acanthosis nigricans.

METHODS: We enrolled thirty subjects who had bilateral pseudo-acanthosis nigricans of the neck. Every patient received intralesional vitamin D3 therapy on the right side of the neck and intralesional saline as a control on the left side over the course of four sessions, each spaced one week apart. Cases were assessed clinically one month after the last treatment session by Acanthosis Nigricans Area and Severity Index (ANASI) score in addition to dermoscopic examination.

RESULTS: A statistically significant decrease in ANASI score was seen between the treated and control sides both before and after treatment, with the intralesional vitamin D treated side exhibiting a larger percentage of reduction than the control side. Intralesional vitamin D3 treatment significantly improved dermoscopic features such as cristae cutis, sulci cutis, and pigmented dots compared to the placebo treatment.

CONCLUSIONS: Intralesional vitamin D3 is a safe and effective modality for treating pseudo-acanthosis nigricans.

PMID:39908337 | DOI:10.1093/ced/llaf067

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Nevin Manimala Statistics

Building support for children and families affected by stroke (BUILD CARE): Study protocol

PLoS One. 2025 Feb 5;20(2):e0308765. doi: 10.1371/journal.pone.0308765. eCollection 2025.

ABSTRACT

Childhood stroke is a rare condition that significantly impacts affected children and their families due to children’s frequently persisting cognitive, physical, and behavioural problems. Existing research on adult stroke shows that the built environment plays a major role in their (partial or possible) recovery and everyday life, but its role has been overlooked in children population. This multidisciplinary research study aims to investigate (1) the role of informal (i.e., home, neighbourhood, school) and formal (i.e., hospital, rehabilitation clinic, outpatient clinic) care environments in the everyday life of children and families confronted with childhood stroke; (2) the families’ financial burden resulting from this rare disease and their economic situation likely affecting the access to care, informal care provision and ability to carry out home modifications.; as well as (3) children’s stroke-related cognitive impairments affecting their experiences of the built environment and their care. The research consists of the preparatory research phase, where existing materials are explored, and three main research phases, each related to one or multiple project objectives. A multi-method approach is adopted, including qualitative (in-depth interviews and participatory creative methods) and quantitative (online questionnaire and cognitive assessments) research methods. Participants are children affected by stroke and their families in Austria, Belgium and Germany. This is a 3-year project that will continue until the end of August 2025. Ethical approvals in all countries were obtained at the time of protocol submission, and data collection for all three research phases started in the second half of 2023 and is currently ongoing. This project will offer first insights into the role of built (care) environments in the experiences of families affected by childhood stroke. Findings are expected to deliver information on their design to improve the life of children affected by this rare disease and their families.

PMID:39908335 | DOI:10.1371/journal.pone.0308765

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Nevin Manimala Statistics

Prevalence, influencing factors, and prediction model construction of anemia in ankylosing spondylitis based on real-world data: An exploratory study

PLoS One. 2025 Feb 5;20(2):e0318332. doi: 10.1371/journal.pone.0318332. eCollection 2025.

ABSTRACT

OBJECTIVE: This study aimed to explore the prevalence and influencing factors of anemia in patients with ankylosing spondylitis (AS) using real-world data and to construct a predictive model for anemia in AS.

METHODS: In November 2023, we accessed the database from China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN). Clinical data of AS collected from the CERTAIN between March 2022 and September 2023 were analyzed. Demographic information, clinical assessment scales, and laboratory test results of the patients were collected. According to the anemia diagnostic criteria established by the World Health Organization (WHO) in 2018, patients were divided into anemia group and non-anemia group. Statistical analyses were performed using SPSS 25.0 software, including χ2 tests, independent sample t-tests to compare differences between the two groups, and multivariate stepwise logistic regression analysis to explore the influencing factors of anemia in AS. The predictive efficacy of the model was evaluated by plotting receiver operating characteristic (ROC) curves. Calibration was assessed through the Hosmer-Lemeshow goodness-of-fit test, and a calibration curve was plotted to comprehensively evaluate the predictive capability of the model.

RESULTS: A total of 251 patients were included in this study, among which 58 cases had anemia (23.1%). There were significant differences in gender, ossification, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) indicators, and clinical assessment scale results between the two groups (P < 0.05). The results of multivariate stepwise logistic regression analysis showed that female gender, underweight, ossification, abnormal CRP and ESR were independent risk factors for anemia in AS (P < 0.05). Based on the results of multivariate stepwise logistic regression analysis, a predictive model for anemia in AS was established as Logit(P) = -5.02 + 2.041 × gender -1.11 × BMI(body mass index) category + 1.103 × ossification category + 0.942 × CRP category + 1.476 × ESR category. The ROC curve analysis showed that the area under the curve of the model for predicting anemia in AS was 0.857 (95% CI: 0.808 ~ 0.906). The Omnibus test of model coefficients yielded χ2 = 85.265, P < 0.001. The Hosmer-Lemeshow test showed χ2 = 7.005, P = 0.536 (P > 0.05).

CONCLUSION: Analysis of real-world AS diagnosis and treatment data showed that the prevalence of anemia in Chinese AS was 23.1%. The occurrence of anemia was closely related to female gender, underweight, ossification, and abnormal CRP and ESR. The logistic model constructed based on these indicators for predicting the risk of anemia in AS demonstrated good efficacy.

PMID:39908327 | DOI:10.1371/journal.pone.0318332

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Nurses’ Perspectives and Experiences of Using a Bed-Exit Information System in an Acute Hospital Setting: Mixed Methods Study

JMIR Form Res. 2025 Feb 5;9:e64444. doi: 10.2196/64444.

ABSTRACT

BACKGROUND: Technology that detects early when a patient at risk of falling leaves the bed can support nurses in acute care hospitals.

OBJECTIVE: To develop a better understanding of nurses’ perspectives and experiences with a bed-exit information system (BES) in an acute care hospital setting.

METHODS: BES was implemented on 3 wards of a university medical center. Nurses completed 2 online surveys at each time point (P0 and P1) and participated in focus groups before (P0) and after (P1) implementation. Additional patient data were collected. Descriptive statistics summarized the survey results, while content analysis was applied to focus group data. Patient rates and adverse events in both phases were compared using negative binomial models. Reporting of this study adhered to the GRAMMS checklist.

RESULTS: A total of 30 questionnaires were completed at P0 (30/72, 42%) and 24 at P1 (24/71, 33%). Of the participants, 15 completed both questionnaires (complete cases). At P1, 64% (9/14) of participants agreed that their perceived workload and strain in caring for patients with cognitive impairment was reduced by the use of the BES. The adverse event rate per patient per day was reduced by a factor of 0.61 (95% CI 0.393-0.955; P=.03). In addition, 11 nurses participated in 4 focus groups before and after the intervention. Participants found it challenging to operationalize the use of the BES due to the heterogeneity of care settings, but certain behaviors of patients with cognitive impairment were recognized as indicating a need for intervention. Negative experiences included information overload and alarm fatigue, leading to occasional removal of the system.

CONCLUSIONS: While BES provides some support in managing patients with cognitive impairment, its impact remains limited to specific scenarios and does not significantly reduce nurses’ workload or strain. Our findings highlight the need to manage expectations of BES performance to ensure alignment between expected and actual benefits. To improve BES effectiveness and long-term implementation, future research should consider both objective measures of patient care and subjective factors such as nurse experience, structural conditions, and technical specifications. Improving information mechanisms within call systems could help reduce alarm fatigue and increase perceived usefulness. Overall, successful integration of BES in acute care settings will require close collaboration with nursing staff to drive meaningful healthcare innovation and ensure that the technology meets the needs of both patients and nurses.

TRIAL REGISTRATION: German Register for Clinical Studies DRKS00021720; https://drks.de/search/de/trial/DRKS00021720.

PMID:39908092 | DOI:10.2196/64444

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Remote Monitoring of Chemotherapy-Induced Peripheral Neuropathy by the NeuroDetect iOS App: Observational Cohort Study of Patients With Cancer

J Med Internet Res. 2025 Feb 5;27:e65615. doi: 10.2196/65615.

ABSTRACT

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating adverse effect of neurotoxic chemotherapy characterized by symptoms such as numbness, tingling, and weakness. Effective monitoring and detection of CIPN are crucial for avoiding progression to irreversible symptoms. Due to the inconvenience of clinic-based objective assessment, CIPN detection relies primarily on patients’ reporting of subjective symptoms, and patient-reported outcomes are used to facilitate CIPN detection. Our previous study found evidence that objective functional assessments completed within a smartphone app may differentiate patients with and those without CIPN after treatment.

OBJECTIVE: This prospective, longitudinal observational cohort study aimed to determine the feasibility and accuracy of app-based remote monitoring of CIPN in patients with cancer undergoing neurotoxic chemotherapeutic treatment and to conduct exploratory comparisons of app-based functional CIPN monitoring versus patient-reported outcome-only monitoring.

METHODS: The NeuroDetect app (Medable Inc) includes subjective EORTC (European Organization for Research and Treatment of Cancer) Quality of Life Questionnaire (QLQ)-20-item scale (CIPN20) and 6 objective functional assessments that use smartphone sensors to mimic neurological examinations, such as walking, standing, and manual dexterity tests. The functional assessment data were collected from patients with cancer undergoing neurotoxic chemotherapy, and a neurological examination was conducted at the end of treatment to diagnose CIPN in the feet (CIPN-f) or CIPN in the hands (CIPN-h). Various classification models including NeuroDetect features only (NeuroDetect Model) CIPN20-only (CIPN20 Model) or a combination of both (Combined Model) were trained and evaluated for accuracy in predicting CIPN probability.

RESULTS: Of the 45 patients who completed functional assessments and neurological examinations, 24 had CIPN-f, and 29 had CIPN-h. The NeuroDetect Model could discriminate between patients with and those without CIPN-f (area under the curve=83.8%, comparison with no information rate P=.02) but not CIPN-h (area under the curve=67.9%, P=.18). The rolling rotation features from the eyes-closed phase of the Romberg Stance assessment showed the greatest contribution to CIPN-f (40% of total variable importance) and the Finger Tapping assessment showed the greatest contribution to CIPN-h (85% of total variable importance). The NeuroDetect Model had numerically, and at some time points statistically, superior performance to the CIPN20 Model in both CIPN-f and CIPN-h, particularly before and early in treatment. The Combined Model numerically, though not statistically, outperformed either assessment strategy individually, indicating that the combination of functional and patient-reported assessment within a smartphone may be optimal to CIPN detection.

CONCLUSIONS: Our findings demonstrate the feasibility of integrating subjective and objective CIPN assessment into a smartphone app for remote, longitudinal CIPN monitoring. Studies of larger patient cohorts are needed to refine the app-based CIPN detection models and determine whether their use in practice improves CIPN detection.

PMID:39908091 | DOI:10.2196/65615

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Nevin Manimala Statistics

The Effects of MyChoices and LYNX Mobile Apps on HIV Testing and Pre-Exposure Prophylaxis Use by Young US Sexual Minority Men: Results From a National Randomized Controlled Trial

JMIR Public Health Surveill. 2025 Feb 5;11:e63428. doi: 10.2196/63428.

ABSTRACT

BACKGROUND: Young sexual minority men have among the highest rates of HIV in the United States; yet, the use of evidence-based prevention strategies, including routine HIV testing and pre-exposure prophylaxis (PrEP), remains low. Mobile apps have enormous potential to increase HIV testing and PrEP use among young sexual minority men.

OBJECTIVE: This study aims to assess the efficacy of 2 theory- and community-informed mobile apps-LYNX (APT Mobility) and MyChoices (Keymind)-to improve HIV testing and PrEP initiation among young sexual minority men.

METHODS: Between October 2019 and May 2022, we implemented a 3-arm, parallel randomized controlled trial in 9 US cities to test the efficacy of the LYNX and MyChoices apps against standard of care (SOC) among young sexual minority men (aged 15-29 years) reporting anal sex with cisgender male or transgender female in the last 12 months. Randomization was 1:1:1 and was stratified by site and participant age; there was no masking. The co-primary outcomes were self-reported HIV testing and PrEP initiation over 6 months of follow-up.

RESULTS: A total of 381 young sexual minority men were randomized. The mean age was 22 (SD 3.2) years. Nearly one-fifth were Black, non-Hispanic (n=67, 18%), Hispanic or Latino men (n=67, 18%), and 60% identified as gay (n=228). In total, 200 (53%) participants resided in the Southern United States. At baseline, participants self-reported the following: 29% (n=110) had never had an HIV test and 85% (n=324) had never used PrEP. Sociodemographic and behavioral characteristics did not differ by study arm. Compared to SOC (n=72, 59%), participants randomized to MyChoices (n=87, 74%; P=.01) were more likely to have received at least 1 HIV test over 6 months of follow-up; those randomized to LYNX also had a higher proportion of testing (n=80, 70%) but it did not reach the a priori threshold for statistical significance (P=.08). Participants in both MyChoices (n=23, 21%) and LYNX (n=21, 20%) arms had higher rates of starting PrEP compared to SOC (n=19, 16%), yet these differences were not statistically significant (P=.52).

CONCLUSIONS: In addition to facilitating earlier treatment among those who become aware of their HIV status, given the ubiquity of mobile apps and modest resources required to scale this intervention, a 25% relative increase in HIV testing among young sexual minority men, as seen in this study, could meaningfully reduce HIV incidence in the United States.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03965221; https://clinicaltrials.gov/study/NCT03965221.

PMID:39908084 | DOI:10.2196/63428

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Nevin Manimala Statistics

Identification of Clusters in a Population With Obesity Using Machine Learning: Secondary Analysis of The Maastricht Study

JMIR Med Inform. 2025 Feb 5;13:e64479. doi: 10.2196/64479.

ABSTRACT

BACKGROUND: Modern lifestyle risk factors, like physical inactivity and poor nutrition, contribute to rising rates of obesity and chronic diseases like type 2 diabetes and heart disease. Particularly personalized interventions have been shown to be effective for long-term behavior change. Machine learning can be used to uncover insights without predefined hypotheses, revealing complex relationships and distinct population clusters. New data-driven approaches, such as the factor probabilistic distance clustering algorithm, provide opportunities to identify potentially meaningful clusters within large and complex datasets.

OBJECTIVE: This study aimed to identify potential clusters and relevant variables among individuals with obesity using a data-driven and hypothesis-free machine learning approach.

METHODS: We used cross-sectional data from individuals with abdominal obesity from The Maastricht Study. Data (2971 variables) included demographics, lifestyle, biomedical aspects, advanced phenotyping, and social factors (cohort 2010). The factor probabilistic distance clustering algorithm was applied in order to detect clusters within this high-dimensional data. To identify a subset of distinct, minimally redundant, predictive variables, we used the statistically equivalent signature algorithm. To describe the clusters, we applied measures of central tendency and variability, and we assessed the distinctiveness of the clusters through the emerged variables using the F test for continuous variables and the chi-square test for categorical variables at a confidence level of α=.001.

RESULTS: We identified 3 distinct clusters (including 4128/9188, 44.93% of all data points) among individuals with obesity (n=4128). The most significant continuous variable for distinguishing cluster 1 (n=1458) from clusters 2 and 3 combined (n=2670) was the lower energy intake (mean 1684, SD 393 kcal/day vs mean 2358, SD 635 kcal/day; P<.001). The most significant categorical variable was occupation (P<.001). A significantly higher proportion (1236/1458, 84.77%) in cluster 1 did not work compared to clusters 2 and 3 combined (1486/2670, 55.66%; P<.001). For cluster 2 (n=1521), the most significant continuous variable was a higher energy intake (mean 2755, SD 506.2 kcal/day vs mean 1749, SD 375 kcal/day; P<.001). The most significant categorical variable was sex (P<.001). A significantly higher proportion (997/1521, 65.55%) in cluster 2 were male compared to the other 2 clusters (885/2607, 33.95%; P<.001). For cluster 3 (n=1149), the most significant continuous variable was overall higher cognitive functioning (mean 0.2349, SD 0.5702 vs mean -0.3088, SD 0.7212; P<.001), and educational level was the most significant categorical variable (P<.001). A significantly higher proportion (475/1149, 41.34%) in cluster 3 received higher vocational or university education in comparison to clusters 1 and 2 combined (729/2979, 24.47%; P<.001).

CONCLUSIONS: This study demonstrates that a hypothesis-free and fully data-driven approach can be used to identify distinguishable participant clusters in large and complex datasets and find relevant variables that differ within populations with obesity.

PMID:39908080 | DOI:10.2196/64479

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Screening for Helicobacter pylori to Prevent Gastric Cancer-Reply

JAMA. 2025 Feb 5. doi: 10.1001/jama.2024.26389. Online ahead of print.

NO ABSTRACT

PMID:39908043 | DOI:10.1001/jama.2024.26389

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Nevin Manimala Statistics

Observational and Genetic Analyses of Traumatic Experiences and Endometriosis

JAMA Psychiatry. 2025 Feb 5. doi: 10.1001/jamapsychiatry.2024.4694. Online ahead of print.

ABSTRACT

IMPORTANCE: Although psychological traumas have been associated with endometriosis, limited information is available regarding the role of trauma type and genetic predisposition.

OBJECTIVE: To examine the relationship between traumatic experiences and endometriosis using observational and genetically informed analyses.

DESIGN, SETTING, AND PARTICIPANTS: For this case-control study, the analyses were performed between May 13, 2023, and September 30, 2024. Genotypic and phenotypic information was combined from UK Biobank individual-level data (up to 8276 patients with endometriosis and 240 117 female controls) with genome-wide information available from a large meta-analysis (European ancestry: 21 779 patients and 449 087 female controls; East Asian ancestry: 1713 patients and 1581 female controls) and the FinnGen cohort (16 588 patients and 111 583 female controls of European descent).

MAIN OUTCOMES AND MEASURES: Phenotypic associations via multiple regression; latent-class analysis (LCA) to investigate the co-occurrence patterns of different traumatic experiences in endometriosis cases and controls; genetic correlation and polygenic risk scoring (PRS) analyses to assess pleiotropy linking traumatic events to endometriosis.

RESULTS: Up to 8276 women with endometriosis (mean [SD] age, 53.2 [13.0] years) and 240 117 female controls (mean [SD] age, 56.5 [9.6] years) were investigated in the study. Women with endometriosis were more likely to report childhood and adulthood traumatic experiences and stressful events (eg, contact trauma odds ratio [OR], 1.28; 95% CI, 1.02-1.26). Our LCA highlighted the association of endometriosis with emotional and physical trauma (225 [8%] vs 3948 [5%]; P < 2.2 × 10-16) and sexual trauma (414 [5%] vs 3158 [4%]; P = 2.9 × 10-3). Unaffected women (controls) were more likely assigned to the “no trauma” latent class (563 [20%] vs 18 949 [24%]; P = 7.4 × 10-14). Our genetic correlation (rg) analyses linked endometriosis to multiple trauma-related outcomes, including posttraumatic stress disorder (meta-analysis rg = 0.31, P = 7.1 × 10-16; FinnGen rg = 0.26, P = 4.7 × 10-15) and childhood maltreatment (meta-analysis rg = 0.23, P = 1.3 × 10-6; FinnGen rg = 0.16, P = 1 × 10-4). Endometriosis PRS was associated with increased odds of the disease (β = 0.31, P < 2.2 × 10-16), but no interaction was observed with different types of trauma events.

CONCLUSIONS AND RELEVANCE: The present study comprehensively investigated the impact of childhood and adulthood traumatic experiences and stressful events on endometriosis. In particular, our findings highlight the potential association between contact traumas and endometriosis, which appears to be independent of the disease genetic predisposition.

PMID:39908042 | DOI:10.1001/jamapsychiatry.2024.4694

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Return on Investment of Enhanced Behavioral Health Services

JAMA Netw Open. 2025 Feb 3;8(2):e2457834. doi: 10.1001/jamanetworkopen.2024.57834.

ABSTRACT

IMPORTANCE: Employer-sponsored benefit programs aim to increase access to behavioral health care, which may help contain health care costs. However, research has either focused solely on clinical outcomes or demonstrated reductions in medical claims without accounting for the costs of behavioral health services, leaving the financial return on investment unknown.

OBJECTIVE: To determine whether a clinically effective employer-sponsored behavioral health benefit is associated with net medical cost savings.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included participants eligible for an employer-sponsored behavioral health benefit between November 1, 2019, and May 31, 2023. Eligibility criteria included having a behavioral health diagnosis and, in the program group, attending at least 1 behavioral health appointment. Program users were matched to nonusers on medical risk scores, behavioral health diagnoses, date of diagnosis, age, sex, and employer. Participants were followed up for 1 year before and after the benefit launch.

EXPOSURE: A digital platform screened individuals for common behavioral health conditions and provided access to video and in-person psychotherapy, medication management, care navigation, and self-guided digital content.

MAIN OUTCOMES AND MEASURES: Primary outcomes were per member per month (PMPM) medical spending, inclusive of all medical claims and program costs. A difference-in-differences analysis was used to compare changes in net medical spending between groups from the year before and up to 1 year after an index mental health diagnosis.

RESULTS: This study included 13 990 participants: 4907 of 4949 (99.1%) eligible program group members were matched to 9083 control participants. Their mean (SD) age was 37 (13.2) years, and most participants (65.5%) were female. Costs decreased in the program group relative to the control group, with a net difference-in-differences of -$164 PMPM (95% CI, -$228 to -$100 PMPM), corresponding to savings of $1070 per participant in the first program year and a return on investment of 1.9 times the costs (ie, every $100 invested reduced medical claims costs by $190). Behavioral health costs in the program group increased relative to the control group but were more than offset by decreases in physical health care costs. Savings were larger for participants with higher medical risk.

CONCLUSIONS AND RELEVANCE: In this cohort study, every $100 invested in an employer-sponsored behavioral health program with fast access to psychotherapy and medication management was associated with a reduction in medical claims costs by $190. These findings suggest that expanding access to behavioral health care may be a financially viable cost-reduction strategy for health care buyers.

PMID:39908020 | DOI:10.1001/jamanetworkopen.2024.57834