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Nevin Manimala Statistics

Evaluation of a Clinical Decision Support System for Imaging Requests: A Cluster Randomized Clinical Trial

JAMA. 2025 Feb 10. doi: 10.1001/jama.2024.27853. Online ahead of print.

ABSTRACT

IMPORTANCE: Given the widespread use of medical imaging, evaluating the effectiveness of interventions to improve appropriateness is crucial for optimizing health care resources and patient outcomes.

OBJECTIVE: To assess the effects of implementing a clinical decision support system (CDSS), the European Society of Radiology iGuide, on the appropriateness of the medical imaging ordering behavior of physicians.

DESIGN AND SETTING: A cluster randomized clinical trial with 26 departments at 3 German university hospitals acting as clusters, incorporating a before and after discontinued design. All imaging requests originating from physicians in the participating departments over a 2.5-year period were included (between December 2021 and June 2024).

INTERVENTIONS: All departments started without a CDSS and required structured clinical indication data entry and tracking of requested imaging. After randomization, 13 clusters (departments at hospitals) received the CDSS intervention (intervention clusters) and 13 clusters did not (control clusters). The CDSS intervention provided ordering physicians with information as to whether their imaging requests were appropriate, appropriate under certain conditions, or inappropriate; in addition, alternative diagnostic tests, including the corresponding appropriateness score, were suggested by the CDSS, after which physicians could choose to modify their imaging requests.

MAIN OUTCOMES AND MEASURES: The primary outcome measure was the proportion of inappropriate imaging requests made per department. A difference-in-differences analysis was used to investigate changes in the proportion of inappropriate imaging requests between departments with vs those without the CDSS.

RESULTS: A total of 65 764 imaging requests were scored using the CDSS; 50.1% of imaging requests were for female patients and the mean patient age was 64 years (SD, 17.1 years). Prior to implementation of the CDSS, there were 21 625 imaging requests from the control clusters, 1367 (6.3%) of which were categorized as inappropriate; and there were 13 338 imaging requests from the intervention clusters, 1007 (7.6%) of which were categorized as inappropriate. After implementation of the CDSS, there were 10 055 imaging requests from the control clusters, 518 (5.2%) of which were categorized as inappropriate; and there were 7206 imaging requests from the intervention clusters, 461 (6.4%) of which were categorized as inappropriate. The intervention clusters showed a similar reduction (mean difference, -0.5% [99% CI, -2.4% to 0.4%]) in inappropriate imaging requests compared with the control clusters (mean difference, -1.8% [99% CI, -4.3% to -0.4%]) and there was a difference-in-differences value of 1.3 percentage points (99% CI, -2.0 to 1.8 percentage points; P = .69), which was not statistically significant.

CONCLUSIONS AND RELEVANCE: The CDSS did not reduce the number of inappropriate imaging requests ordered by physicians in academic hospital settings.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05490290.

PMID:39928308 | DOI:10.1001/jama.2024.27853

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Effectiveness of Patient Navigation During Transition to Adult Care: A Randomized Clinical Trial

JAMA Pediatr. 2025 Feb 10. doi: 10.1001/jamapediatrics.2024.6192. Online ahead of print.

ABSTRACT

IMPORTANCE: Transition to adult care is a challenging and complex process for youth and emerging adults with chronic health and/or mental health conditions. Patient navigation has been proposed to improve care during transition, but previous studies have used single disease cohorts with a nonrandomized design.

OBJECTIVE: To compare the effectiveness of a patient navigator service to reduce emergency department (ED) use among adolescents and emerging adults with chronic health and/or mental health conditions undergoing transition to adult-oriented health care.

DESIGN, SETTING, AND PARTICIPANTS: This was a pragmatic, parallel-group, nonblinded randomized clinical trial design. Patients were followed up for a minimum 12 months and maximum 24 months after enrollment. The setting was the Canadian province of Alberta, with a population of 4.3 million inhabitants, having 3 tertiary care pediatric hospitals serving the entire population with universal health coverage. Participants included youth aged 16 to 21 years, followed up within a diverse array of chronic care clinics, expected to be transferred to adult care within 12 months, residing in Alberta, Canada.

INTERVENTIONS: A 1:1 allocation to either access to a personalized navigator, an experienced social worker within the health services environment, or usual care, for up to 24 months after randomization.

MAIN OUTCOMES AND MEASURES: All-cause ED visit rate while under observation.

RESULTS: A total of 335 participants were randomized over a period of 45 months, 164 (49.0%) to the intervention arm and 171 (51.0%) to usual care. After 1 patient withdrew, 334 participants (usual care: mean [SD] age, 17.8 [0.7] years; 99 female [57.9%]; intervention: mean [SD] age, 17.7 [0.6] years; 81 male [49.7%]) were included in the final data analysis. Among the participants, 131 (39.2%) resided in a rural location, and 126 (37.7%) had a self-reported mental health comorbidity during baseline assessment. We observed significant effect modification in the relationship between intervention and ED visits based on mental health comorbidity. Among those with a self-reported mental health condition, ED visit rates were lower in those with access to the navigator, but the association was not significant (adjusted incidence rate ratio [IRR] 0.75; 95% CI, 0.47-1.19). Among those with no mental health comorbidity, the corresponding adjusted IRR was 1.45 (95% CI, 0.95-2.20).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the navigator intervention was not associated with a significant reduction in ED visits among youth with chronic health conditions transitioning to adult care. The study did not accrue sufficient sample size to demonstrate a significant difference between groups should it exist.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03342495.

PMID:39928304 | DOI:10.1001/jamapediatrics.2024.6192

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Association Between Intestinal Diseases and Periodontitis: A Systematic Review and Meta-Analysis

Oral Dis. 2025 Feb 10. doi: 10.1111/odi.15260. Online ahead of print.

ABSTRACT

BACKGROUND: Despite evidence suggesting a potential correlation between intestinal diseases such as inflammatory bowel diseases (IBD) and colorectal cancer (CRC) with periodontitis (PD), there is a lack of comprehensive systematic reviews and meta-analyses to consolidate these findings.

METHODS: This study investigates studies published until December 31, 2023, in reputable databases such as PubMed, Embase, Cochrane Library, and Web of Science. The statistical analysis was conducted using Review Manager Version 5.4, calculating odds ratios (OR) and 95% confidence intervals (CI) based on the selected research papers, utilizing a fixed-effects model.

RESULTS: It demonstrates a significant increase in the risk of PD among patients with IBD, as indicated by an OR of 2.11 (95% CI: 1.80-2.49). Further analysis revealed elevated risks of PD for both Crohn’s disease (CD) and ulcerative colitis (UC), with respective ORs of 1.96 (95% CI: 1.69-2.26) and 2.14 (95% CI: 1.85-2.47). A direct association was observed between CRC and PD, suggesting a 20% higher risk of PD in patients with CRC (OR = 1.20, 95% CI: 1.06-1.36).

CONCLUSION: Our meta-analysis highlights the potential role of PD in managing systemic conditions like IBD and CRC.

PMID:39928298 | DOI:10.1111/odi.15260

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Impact of Predictive Hemodynamic Monitoring on Intraoperative Hypotension and Postoperative Complications in Multi-level Spinal Fusion Surgery

Spine (Phila Pa 1976). 2025 Mar 1;50(5):333-338. doi: 10.1097/BRS.0000000000005121. Epub 2024 Aug 13.

ABSTRACT

STUDY DESIGN: Prospective longitudinal comparative cohort.

OBJECTIVES: To determine if the use of predictive hemodynamic monitoring (PHM) during elective multi-level posterior instrumented spine fusions decreases episodes of intraoperative hypotension (IOH) and complications.

BACKGROUND: A recent study showed an association between complications and duration of IOH in patients undergoing multi-level spine fusions. Whether the use of PHM to maintain hemodynamic stability intraoperatively decreases postoperative complications has not been evaluated.

METHODS: Adults undergoing elective multi-level posterior thoracolumbar fusion with arterial line blood pressure monitoring were identified and stratified into those in which predictive hemodynamic monitoring (PHM) was used and those in which it was not. Number of minutes of hypotension (MAP <65 mm Hg) and hypertension (MAP ≥100 mm Hg), volume of fluids, blood products and vasopressors administered intraoperatively and within the first 4 hours postoperatively as well as the number and type of postoperative complications were collected.

RESULTS: The 47 cases in the PHM group and 70 in the non-PHM group had similar demographic and operative characteristics. A shorter duration of IOH was seen in the PHM group (8.13 min) compared with the non-PHM group (13.28 min, P=0.029); and a shorter duration of intraoperative hypertension seen in the PHM group (0.46 min) compared with the non-PHM group (1.38 min, P=0.032). There was a smaller number of patients in the PHM group who had a surgical site infection (2.% vs. 13%, P=0.027), postoperative nausea and vomiting (0 vs. 14%, P=0.004) and postoperative cognitive dysfunction (6% vs. 19%, P=0.049) compared with the non-PHM group. There was also a statistically significant shorter length of hospitalization in the PHM (4.62 d) compared with the non-PHM group (5.99 d, P=0.017).

CONCLUSION: Predictive hemodynamic monitoring to manage intraoperative hemodynamic instability is associated with a shorter duration of intraoperative hypotension, a lower prevalence of complications, and a decreased hospital stay in multi-level spinal fusion surgery.

PMID:39928297 | DOI:10.1097/BRS.0000000000005121

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Nevin Manimala Statistics

Towards ultra-low-dose CT for detecting pulmonary nodules using DenseNet

Phys Eng Sci Med. 2025 Feb 10. doi: 10.1007/s13246-025-01520-6. Online ahead of print.

ABSTRACT

Low-radiation techniques should be used to detect and follow lung nodules on CT images, but reducing radiation dose to ultra-low-dose CT with submilliSievert dose level would drastically impede image quality and sensitivity for nodule detection. This study investigated the feasibility of using DenseNet to suppress image noise in ultra-low-dose CT for lung cancer screening. DenseNet was trained using input-label pairs from 1, 2, 4, and 6 patients. After training, the model was tested with chest CT from 14 patients that were not used in training process. Seven patients have solid nodules and 7 patients have subsolid nodules. Root mean square error (RMSE) and peak signal-to-noise ratio (PSNR) were calculated to quantify the difference between reference and test images. The contrast-to-noise ratio (CNR) between lung nodule and lung parenchyma was calculated to evaluate the target detectability of chest CT. Subjective image quality assessment was performed using 4-point ranking scale to evaluate the visual quality of CT images perceived by end user. Substantial improvements in RMSE and PSNR were observed after denoising. The lung nodules in denoised images could be distinguished more easily in comparison with those in the original ultra-low-dose CT, which is supported by the CNRs and subjective image quality scores. The comparison of intensity profiles for lung nodules demonstrated that the image noise in ultra-low-dose CT could be suppressed effectively after denoising without causing edge blurring or variation in Hounsfield unit (HU) values. A two-sample t-test revealed no statistically significant differences between full-dose CT and denoised ultra-low-dose CT in the evaluation of lung nodules, lung parenchyma, paraspinal muscle, or vertebral body. Since the linear no-threshold model suggests that no amount of ionizing radiation is entirely risk-free, the quest for further dose reduction remains a consistently important focus in radiology. Overall, our findings suggest that DenseNet could be a viable approach for reducing image noise in ultra-low-dose CT scans used for lung cancer screening.

PMID:39928290 | DOI:10.1007/s13246-025-01520-6

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Nevin Manimala Statistics

A novel method for early prediction of sudden cardiac death through nonlinear feature extraction from ECG signals

Phys Eng Sci Med. 2025 Feb 10. doi: 10.1007/s13246-025-01517-1. Online ahead of print.

ABSTRACT

Sudden cardiac death (SCD) is a critical cardiovascular issue affecting approximately 3 million individuals globally each year, often occurring without prior noticeable symptoms. While the precise etiology of SCD remains elusive, ventricular fibrillation is believed to play a pivotal role in its pathophysiology. Given that symptoms typically manifest only an hour before the event, timely prediction is crucial for effective cardiac resuscitation. This study aims to predict SCD using time-frequency analysis of ECG signals. We utilized two online datasets: the Sudden Cardiac Death Holter dataset and the MIT-BIH Normal Sinus Rhythm dataset. Our proposed method involves segmenting the 60-min interval preceding ventricular fibrillation into one-minute segments, which are then decomposed into time-frequency sub-bands using empirical mode decomposition (EMD). Nonlinear features are extracted from these decomposed signals, followed by classification using support vector machines (SVM) and K-nearest neighbors (KNN) algorithms. To enhance classification accuracy, we employed two statistical feature selection techniques: T-test and ANOVA. Results indicate that using the ANOVA feature selection method in conjunction with SVM and KNN algorithms achieves high accuracy in predicting SCD. Specifically, the average accuracy rates for the 60 min preceding SCD were 93.51% for ANOVA-SVM and 93% for ANOVA-KNN. With T-test feature selection, the average accuracy rates were 93.29% for SVM and 93.41% for KNN. These findings demonstrate the promising performance of our proposed approach in predicting SCD, potentially contributing to improved early intervention strategies and patient outcomes.

PMID:39928289 | DOI:10.1007/s13246-025-01517-1

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Exploring miR-34a, miR-449, and ADAM2/ADAM7 Expressions as Potential Biomarkers in Male Infertility: A Combined In Silico and Experimental Approach

Biochem Genet. 2025 Feb 10. doi: 10.1007/s10528-025-11050-1. Online ahead of print.

ABSTRACT

miR-34a and miR-449 are key miRNAs involved in sperm function and male fertility, with their dysregulation potentially contributing to male infertility. ADAM proteins, specifically ADAM2 and ADAM7, are also implicated in sperm function. This study investigates the interactions between miR-34a, miR-449, and ADAM2/ADAM7, exploring their roles in male infertility through both experimental analyses and molecular docking. In this case-control study, 15 infertile males and 15 healthy controls were included. Gene expression levels of miR-34a, miR-449, and SOX30 were measured using real-time PCR, while protein levels of ADAM7 and ADAM2 in sperm were assessed through western blotting. Additionally, molecular docking was performed to analyze the binding affinities between miR-34a/miR-449 and ADAM2/ADAM7, with docking scores and confidence levels evaluated. Expression levels of ADAM7 and ADAM2 proteins in sperm from the infertile group showed significant differences compared with the control group (P ≤ 0.05). A significant difference was observed in the expression of miR-449, miR-34a, and SOX30 genes between the control and infertile groups (P < 0.05). A significant correlation between miR-34a expression, ADAM7 protein expression, and sperm morphology was observed. However, no statistically significant correlation was found between miR-34a expression and sperm motility, sperm count, blastocyst, or embryo rates in ICSI and IVF (P ≥ 0.05). Molecular docking and dynamics studies revealed strong interactions between miR-34a/miR-449 and ADAM proteins. The ADAM7/miR-34a complex showed the highest binding affinity with a docking score of – 372.40 and a confidence score of 0.9884, followed by ADAM7/miR-449. Hydrogen bond analysis indicated stable binding, with 9 bonds for ADAM2/miR-34a and 7 for ADAM7/miR-34a. These interactions suggest a significant role in regulating sperm morphology and function.miR-34a, miR-449, ADAM7, and ADAM2 protein expression appear to be involved in the molecular mechanisms of male infertility. These parameters show potential as biomarkers in assisted reproductive technology techniques, particularly by influencing sperm morphology and function.

PMID:39928278 | DOI:10.1007/s10528-025-11050-1

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Evaluating Financial Incentives as a Tool to Increase Medication Adherence for Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis

Diabetes Ther. 2025 Feb 10. doi: 10.1007/s13300-025-01694-y. Online ahead of print.

ABSTRACT

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a common chronic disease with high rates of complications. Although there are successful treatments, rates of medication non-adherence remain high. This study aims to evaluate the impact of financial incentives on medication adherence in people living with T2DM.

METHODS: PubMed, Scopus, and Embase were searched via the terms “medication adherence,” “diabetes,” and “financial/economic incentive.” Data on study characteristics, incentive type, and impact were extracted. The outcome measures included the proportion of days covered (PDC), mean possession ratio (MPR), percent adherent (PDC/MPR > 80%), and others. Two pooled Bayesian meta-analyses were conducted, analyzing the mean differences in PDC or MPR and the percentage of adherent patients (MPR > 80%).

RESULTS: The search yielded 8244 results with 126 full-text articles reviewed. In total, 22 studies that met the inclusion criteria were included. Among these 22 studies, 16 reported that financial incentives significantly increased medication adherence in all, four reported that they did not lead to significant changes in adherence, and two studies reported differing results per subgroup. For the pooled meta-analyses, the effect of financial incentives on percent adherent was significant in three studies (weighted Cohen’s D: 0.03, P = 0.02) and in the ten studies assessed PDC/MPR, financial incentives significantly increased adherence (weighted Cohen’s D: 0.02, 95%, P < 0.01).

CONCLUSION: This systematic review and meta-analysis demonstrated that financial incentives lead to statistically significant but possibly clinically irrelevant increases in medication adherence for patients living with T2DM.

PMID:39928226 | DOI:10.1007/s13300-025-01694-y

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Association Between Serum α-Klotho Levels and Diabetic Kidney Disease Prevalence in Middle-Aged and Elderly US Patients with Diabetes: A Cross-Sectional Study Using NHANES 2007-2016 Data

Diabetes Ther. 2025 Feb 10. doi: 10.1007/s13300-024-01683-7. Online ahead of print.

ABSTRACT

INTRODUCTION: Diabetic kidney disease (DKD) represents a significant microvascular complication associated with diabetes and serves as a major contributor to end-stage renal disease. While many studies have highlighted the renal protective effects of the anti-aging protein Klotho, the potential link between Klotho and DKD within individuals with diabetes remains a subject of debate, and comprehensive studies utilizing large population-based databases are still needed.

METHODS: This cross-sectional study, which is representative of the national population, examined data from US patients with diabetes aged 40-79 years, collected during the 2007-2016 cycles of the National Health and Nutrition Examination Survey (NHANES). Serum α-Klotho levels were determined using enzyme-linked immunosorbent assay (ELISA) techniques. Given that serum Klorho levels are not normally distributed, our analysis is based on values converted from the natural logarithm of Klotho. To assess the association between Klotho levels and the prevalence of DKD, multivariate regression models were utilized, taking into account potential confounding factors. Furthermore, we applied smooth curve fitting and segmented regression analyses to investigate possible threshold effects and identify inflection points. Subgroup analyses and cross-tests were performed to assess the consistency of associations in the general population.

RESULTS: The investigation included 4490 individuals with diabetes, with an median age of 60.0 years and 48.2% of them being male. Among these participants, 1352 (30.1%) were diagnosed with DKD. The fully adjusted model (model 3) indicated a significant inverse relationship between Klotho levels and DKD prevalence. Statistical analysis showed that in fully adjusted model 3, each 1-unit increase in log-transformed Klotho was associated with a 42% reduction in DKD prevalence [OR 0.58, 95% CI (0.42, 0.80), p = 0.002]. Further analysis using smooth curve fitting revealed a U-shaped relationship between Klotho levels and DKD prevalence, with an inflection point at 6.82 (after natural logarithm conversion).

CONCLUSIONS: This study identified a U-shaped relationship between Klotho levels and the prevalence of DKD in middle-aged and older adults with diabetes in the USA, with an inflection point of 6.82 (after natural logarithm conversion). Prior to this threshold, the relationship between Klotho and DKD prevalence was negatively correlated, while after the inflection point, the relationship became positive. Future studies are recommended to investigate the causal relationship behind this relationship.

PMID:39928222 | DOI:10.1007/s13300-024-01683-7

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FrAMBI: A Software Framework for Auditory Modeling Based on Bayesian Inference

Neuroinformatics. 2025 Feb 10;23(2):20. doi: 10.1007/s12021-024-09702-5.

ABSTRACT

Research in hearing science often relies on auditory models to describe listener’s behaviour and its neural underpinning in acoustic environments. These models gather empirical evidence from behavioural data to address research questions on the neural mechanisms underlying sound perception. Despite seemingly similar statistical methods, auditory models are often implemented for each study separately, which hinders reproducibility and across-study comparisons, thus limiting the advancement at a field level. Here, we introduce a framework for studying neural mechanisms of sound perception by employing auditory modeling based on Bayesian inference (FrAMBI), a MATLAB/Octave toolbox. FrAMBI provides a standardized structure to implement an auditory model following the perception-action cycle and enables the automatic application of statistical analysis with behavioural data. We show FrAMBI’s capabilities in several examples with increasing levels of complexity within the context of sound source localisation tasks: a basic implementation for a static scenario, iterating over the perception-action cycle with a moving sound source, the definition of multiple model variants testing different neural mechanisms, and the procedure for parameter estimation and model comparison. Being integrated into the widely used auditory modelling toolbox (AMT), FrAMBI is planned to be maintained in the long term and expanded accordingly, fostering reproducible research in the field of neuroscience.

PMID:39928214 | DOI:10.1007/s12021-024-09702-5