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Nevin Manimala Statistics

Pilot Evaluation of the TissueStat-A Novel Device for Minimally Invasive Spine Surgery Fascial Closure

Clin Spine Surg. 2025 Aug 28. doi: 10.1097/BSD.0000000000001923. Online ahead of print.

ABSTRACT

STUDY DESIGN: Pilot Evaluation Study.

OBJECTIVE: To assess the ease-of-use and performance of TissueStat, a novel minimally invasive spine surgery (MIS) fascial closure device, compared with conventional suturing techniques.

SUMMARY OF BACKGROUND DATA: Wound issues in spine surgery can be a major source of morbidity and decreased patient satisfaction. A robust, multilayered closure can lead to decreased complications and need for revision surgery. However, the development of technology to assist in MIS fascial closures has lagged.

METHODS: Participants completed a fascial suturing trial using a benchtop model with both conventional suture and TissueStat. Time to completion and accuracy of each suture pass with were compared using the Student t test. After the trial, participants filled out a survey to quantify the ease of use and accuracy of conventional suture versus TissueStat. Survey responses were compared using descriptive statistics.

RESULTS: Eight participants were recruited (5 orthopaedic surgery residents and 3 orthopaedic spine surgery fellows). This group performed 16 attempts with the conventional suturing technique and 16 attempts with TissueStat. The average time to knot completion of the conventional suturing technique was slower than TissueStat [3 min and 22 s (range: 1:27-5:19) vs. 2 min and 1 s (range: 1:22-3:15), P=0.001]. The average distance from the suture location to the target dot was larger for the conventional suturing compared with TissueStat (1.25 vs. 0.22 mm, P=0.007). Participants reported a higher average ease of use score for TissueStat compared with conventional suture (9.4 vs. 3.9). Participants reported a higher average accuracy rating for TissueStat compared with the conventional suture (9.3 vs. 6.1). All participants answered that TissueStat offered the higher quality closure and allowed better suture targeting.

CONCLUSION: TissueStat may be a useful tool to decrease operative time, improve closure accuracy/quality, and assist with meticulous fascial soft-tissue handling.

PMID:40874621 | DOI:10.1097/BSD.0000000000001923

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Nevin Manimala Statistics

Semiparametric Efficient Inference for the Probability of Necessary and Sufficient Causation

Stat Med. 2025 Aug;44(18-19):e70242. doi: 10.1002/sim.70242.

ABSTRACT

Causal attribution, which seeks to explain the reasons behind events or behaviors, plays a critical role in causal inference and deepens our understanding of cause-and-effect relationships in scientific research. The probabilities of necessary causation (PN) and sufficient causation (PS) are two of the most common quantities for attribution in causal inference. While several works have explored the identification or bounds of PN and PS, efficient estimation remains unaddressed. To fill this gap, this paper focuses on obtaining semiparametric efficient estimators of PN and PS under two sets of identifiability assumptions: strong ignorability and monotonicity, and strong ignorability and conditional independence. We derive efficient influence functions and semiparametric efficiency bounds for PN and PS under the two sets of identifiability assumptions, respectively. Based on this, we propose efficient estimators for PN and PS and show their large sample properties. Extensive simulations validate the superiority of our estimators compared to competing methods. We apply our methods to a real-world dataset to assess various risk factors affecting stroke.

PMID:40874599 | DOI:10.1002/sim.70242

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Nevin Manimala Statistics

The relationship between rotator cuff disorders and abdominal muscles: Biomechanical and clinical findings

J Back Musculoskelet Rehabil. 2025 Aug 28:10538127251370048. doi: 10.1177/10538127251370048. Online ahead of print.

ABSTRACT

BackgroundRotator cuff (RC) disorders are common musculoskeletal conditions causing shoulder pain and functional loss. While abdominal muscles aid in core stabilization and force transmission, their strength, endurance, and thickness in RC disorders remain underexplored.ObjectivesThis study aimed to examine the differences in abdominal muscle performance between individuals with RC pathology and healthy controls and to evaluate the relationship of these parameters with pain, disability and quality of life.Materials and MethodThis cross-sectional study evaluated 128 individuals (RC group: 64; control group: 64). The strength of the abdominal muscles was evaluated, and the McGill endurance test was performed. Muscle thickness was measured using ultrasound imaging. Shoulder-related pain, symptoms and functionality were assessed with Shoulder Pain and Disability Index and Western Ontario Rotator Cuff Index.ResultsThe RC group exhibited significantly lower abdominal muscle strength and endurance compared to controls (p < 0.001). A moderate negative correlation was observed between abdominal muscle performance and clinical scores. According to ultrasound evaluations, patients with right-sided shoulder pathology (RSSP) had thinner EO (p < 0.001) and TrA (p = 0.016) muscles on the affected side, while left-sided shoulder pathology (LSSP) showed similar reductions in RA (p = 0.001), EO (p = 0.012), and TrA (p = 0.006) thickness. The RC group showed significantly greater percentage asymmetry in RA muscle thickness compared with controls (p = 0.02), while no statistically significant differences were found for EO, IO, or TrA muscles.ConclusionThis study demonstrates that decreased abdominal muscle function and thickness are associated with RC disorders. We emphasize that core stability exercises should be included in rotator cuff rehabilitation.

PMID:40874575 | DOI:10.1177/10538127251370048

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Nevin Manimala Statistics

Price-Responsiveness of Cigarette Smoking Behaviors across Income Groups in the United States

Nicotine Tob Res. 2025 Aug 28:ntaf177. doi: 10.1093/ntr/ntaf177. Online ahead of print.

ABSTRACT

INTRODUCTION: To compare price-responsiveness of smoking participation and intensity across U.S. income groups.

METHODS: We pooled the 2015-2016, 2018-2019, and 2022 Tobacco Use Supplement to the Current Population Survey data (n = 337 974 aged 18+), classifying respondents into poor, low-income, middle-income, and high-income groups (<100%, 100-199%, 200-399%, and ≥ 400% of the Federal Poverty Level (FPL), respectively). Using a two-part econometric model of cigarette demand, we estimated the price elasticities of smoking participation and intensity for each income group. State-level cigarette price data came from the Tax Burden on Tobacco Report. Additional covariates included sociodemographic characteristics, secular variation, and state-level smoke-free air law coverage, tobacco control program funding, and unemployment rate.

RESULTS: Price elasticity of smoking participation was significant for the poor (-0.32), low-income (-0.27), and middle-income (-0.24) groups but not for the high-income group. Price elasticity of smoking intensity was statistically significant for middle-income (-0.33) and high-income (-0.42) smokers but not for poor and middle-income smokers. Total price elasticity of cigarette demand was statistically significant for all groups; total elasticity estimates were highest among the middle-income group (-0.56), followed by the low-income (-0.48), and were lowest among the poorest (-0.40) and highest income (-0.40) groups.

CONCLUSIONS: Our results indicate that the lower-income (<200% FPL) groups were significantly more price-responsive than the high-income group in reducing smoking participation but smokers in these lower-income groups were not price-responsive in reducing smoking intensity. Earmarking cigarette taxation revenues for cessation assistance to help smokers in the lower-income groups who could not quit smoking is warranted.

IMPLICATIONS: This study adds to the rich but inconclusive literature, comparing the price-responsiveness of smoking behaviors across U.S. income groups. Our results also indicate that the lower-income (<200% FPL) groups were significantly more price-responsive than the high-income group in quitting cigarette smoking but smokers in the lower-income groups were not price-responsive in reducing smoking intensity. Earmarking cigarette taxation revenues for cessation assistance to help smokers in the lower-income groups who could not quit smoking is warranted.

PMID:40874571 | DOI:10.1093/ntr/ntaf177

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Nevin Manimala Statistics

Glycaemic control after connected insulin pen initiation in people living with diabetes: Results from a real-world setting

Diabetes Obes Metab. 2025 Aug 28. doi: 10.1111/dom.70051. Online ahead of print.

ABSTRACT

AIMS: This observational study investigated changes in glycaemic control in people living with diabetes after initiating a connected insulin pen to administer their bolus insulin in routine clinical practice.

MATERIALS AND METHODS: Data were collected from adults (≥18 years) with insulin-treated diabetes who were using a continuous glucose monitoring (CGM) device and started administering bolus insulin using a connected insulin pen. Key glycaemic outcomes were time in range (TIR; 3.9-10.0 mmol/L), time above range (TAR; >10.0 mmol/L), and time below range (TBR; <3.9 and <3.0 mmol/L) in the overall population and for subgroups by country and by baseline TIR for individuals with 3 months of baseline CGM data.

RESULTS: Data were included from 86 133 individuals with a mean (standard deviation) age of 43.7 (15.7) years. There were small but statistically significant increases from baseline in TIR at month 3 (1.5%-points), month 6 (1.4%-points) and month 12 (1.1%-points), and statistically significant decreases from baseline in TAR and TBR (<3.9 and <3.0 mmol/L) at month 3, month 6 and month 12. Increases in TIR were largest for those with the lowest baseline TIR (3-month baseline average of <40% TIR). Increases in TIR were largest in Austria, with an increase in TIR of 4.7% at month 3.

CONCLUSIONS: These real-world data show that glycaemic outcomes improved after connected insulin pen initiation, especially in individuals with the highest unmet need (i.e., lowest baseline TIR). Combining a connected insulin pen with additional support, such as app-based training or education, may further improve glycaemic control.

PMID:40874386 | DOI:10.1111/dom.70051

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Nevin Manimala Statistics

Barriers and opportunities in biobank utilization: insights from a 3-year repeated cross-sectional survey of the Female Breast and Genital Disease with Microbiome Biobank Network in South Korea

J Yeungnam Med Sci. 2025;42:46. doi: 10.12701/jyms.2025.42.46. Epub 2025 Aug 27.

ABSTRACT

BACKGROUND: This study aimed to document the patterns, challenges, and opportunities for biobank utilization within the Female Breast and Genital Disease with Microbiome Biobank Network (FDMNet) in South Korea. Annual surveys (2022-2024) assessed researcher awareness, utilization patterns, barriers to access, research requirements, and interest in microbiome research.

METHODS: Online questionnaires were distributed to staff members at five university hospitals participating in FDMNet. Data from 155 respondents across 3 years were analyzed using descriptive statistics for quantitative data. Qualitative feedback was examined using Uniform Manifold Approximation and Projection and natural language processing to identify the thematic clusters of user challenges.

RESULTS: Despite high engagement with biobank resources (76% of the respondents), declining participation rates and interinstitutional collaborations were observed, particularly in 2024, amid the nationwide healthcare crisis. The major barriers to utilization included complex access procedures (31.0%), lack of process knowledge (23.9%), and concerns about Institutional Review Board approval (11.6%). Breast neoplasms (12.3%) and female genital neoplasms (11.0%) were the primary research interests, with blood (24.5%) and tissue (23.9%) samples being the most requested specimens. Most respondents (66.5%) expressed interest in microbiome research but reported insufficient knowledge.

CONCLUSION: These findings highlight the need for streamlined access procedures, improved researcher education, enhanced clinical data integration, and stronger governance structures to overcome existing barriers to biobank utilization. These insights can guide strategic improvements in biobank operations and resource allocation to serve the evolving needs of the research community better.

PMID:40874384 | DOI:10.12701/jyms.2025.42.46

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Nevin Manimala Statistics

Evaluation of Validity and Reliability of YouTube and Vimeo Contents About the Management of Tooth Fracture in Permanent Dentition: A Cross-Sectional Study

Dent Traumatol. 2025 Aug 28. doi: 10.1111/edt.70014. Online ahead of print.

ABSTRACT

AIM: Tooth fracture is one of the most common complications of dental trauma, which needs to be addressed on an emergency basis. The pressing demand for reliable information has prompted both professionals and laypersons to turn to video-sharing platforms like YouTube and Vimeo for guidance regarding the management of tooth fractures among local users. These platforms have emerged as significant sources for advice on dental emergencies; however, the trustworthiness and precision of the information provided have not been thoroughly examined. This research sought to evaluate the quality, accuracy, and reliability of videos on YouTube and Vimeo that address the management of tooth fractures.

MATERIALS AND METHODS: A search was conducted on YouTube and Vimeo between November 11, 2024, and February 27, 2025, using terms related to the management of tooth or dental fractures, and 92 videos were included for analysis. Demographic information for the videos, including platform, length, category, upload date, number of likes, and comments, was documented. The assessment of video content quality, reliability, and accuracy was conducted utilizing the Global Quality Scale (GQS), benchmarks from the Journal of the American Medical Association (JAMA), and the Video Information and Quality Index (VIQI).

RESULTS: In total, 92 videos were examined. The average scores were JAMA: 3 ± 1, modified DISCERN: 53 ± 11, GQS: 3 ± 1, and VIQI: 5 ± 1. Statistically significant differences were observed across video types in key parameters such as the DISCERN score (YouTube: p = 0.002; Vimeo: p < 0.001), JAMA benchmark (YouTube: p = 0.045; Vimeo: p = 0.002), GQS, VIQI, and overall video evaluation (p < 0.001), emphasizing that video format, video posted, target audience, and platform influence educational impact. With the highest mean views (983,441) and significantly elevated DISCERN (63 ± 9) and JAMA scores (3 ± 1), actual procedure videos exemplify strong informational reliability and public trust.

CONCLUSION: The research indicates that, although the majority of the videos on managing tooth fractures are produced by dental professionals, their overall quality is subpar. This highlights the potential dangers of relying on misleading or insufficient information in these important circumstances.

PMID:40874374 | DOI:10.1111/edt.70014

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Nevin Manimala Statistics

A monotone single index model for spatially referenced multistate current status data

Biometrics. 2025 Jul 3;81(3):ujaf105. doi: 10.1093/biomtc/ujaf105.

ABSTRACT

Assessment of multistate disease progression is commonplace in biomedical research, such as in periodontal disease (PD). However, the presence of multistate current status endpoints, where only a single snapshot of each subject’s progression through disease states is available at a random inspection time after a known starting state, complicates the inferential framework. In addition, these endpoints can be clustered, and spatially associated, where a group of proximally located teeth (within subjects) may experience similar PD status, compared to those distally located. Motivated by a clinical study recording PD progression, we propose a Bayesian semiparametric accelerated failure time model with an inverse-Wishart proposal for accommodating (spatial) random effects, and flexible errors that follow a Dirichlet process mixture of Gaussians. For clinical interpretability, the systematic component of the event times is modeled using a monotone single index model, with the (unknown) link function estimated via a novel integrated basis expansion and basis coefficients endowed with constrained Gaussian process priors. In addition to establishing parameter identifiability, we present scalable computing via a combination of elliptical slice sampling, fast circulant embedding techniques, and smoothing of hard constraints, leading to straightforward estimation of parameters, and state occupation and transition probabilities. Using synthetic data, we study the finite sample properties of our Bayesian estimates and their performance under model misspecification. We also illustrate our method via application to the real clinical PD dataset.

PMID:40874356 | DOI:10.1093/biomtc/ujaf105

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Nevin Manimala Statistics

Model robust designs for dose-response models

Biometrics. 2025 Jul 3;81(3):ujaf112. doi: 10.1093/biomtc/ujaf112.

ABSTRACT

An optimal experimental design is a structured data collection plan aimed at maximizing the amount of information gathered. Determining an optimal experimental design, however, relies on the assumption that a predetermined model structure, relating the response and covariates, is known a priori. In practical scenarios, such as dose-response modeling, the form of the model representing the “true” relationship is frequently unknown, although there exists a finite set or pool of potential alternative models. Designing experiments based on a single model from this set may lead to inefficiency or inadequacy if the “true” model differs from that assumed when calculating the design. One approach to minimize the impact of the uncertainty in the model on the experimental plan is known as model robust design. In this context, we systematically address the challenge of finding approximate optimal model robust experimental designs. Our focus is on locally optimal designs, so allowing some of the models in the pool to be nonlinear. We present three Semidefinite Programming-based formulations, each aligned with one of the classes of model robustness criteria introduced by Läuter. These formulations exploit the semidefinite representability of the robustness criteria, leading to the representation of the robust problem as a semidefinite program. To ensure comparability of information measures across various models, we employ standardized designs. To illustrate the application of our approach, we consider a dose-response study where, initially, seven models were postulated as potential candidates to describe the dose-response relationship.

PMID:40874355 | DOI:10.1093/biomtc/ujaf112

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Nevin Manimala Statistics

Analysis of the Efficacy and Safety of Cabozantinib Monotherapy Versus Its Combination with Atezolizumab in Cancer Patients: A Systematic Review and Meta-Analysis

Cancer Control. 2025 Jan-Dec;32:10732748251371479. doi: 10.1177/10732748251371479. Epub 2025 Aug 28.

ABSTRACT

IntroductionCancer is a significant worldwide health problem, and targeted drugs like Cabozantinib and Atezolizumab offer new therapeutic options. These drugs enhance patient survival by specifically targeting cancer cells while minimizing damage to healthy tissues. The current research investigates the effectiveness of employing the combination of Cabozantinib and Atezolizumab vs single-agent Cabozantinib.MethodsIn this study, we searched databases including PubMed/Medline, Scopus, Embase, Cochrane, and Web of Science up to the end of January 2025. The results were categorized into two groups: the intervention group (Cabozantinib plus Atezolizumab) and the control group (Cabozantinib monotherapy) in cancer patients. We evaluated variables such as efficacy outcomes, including Objective Response Rate (ORR) and Disease Control Rate (DCR), as well as adverse events (safety). Data analysis was performed using random-effects models, and Relative Risk (RR) was reported as the effect size.ResultsThree clinical trials were included in this study. Regarding efficacy outcomes, there was no statistically significant difference in ORR between the intervention group and the control group (RR = 1.11, 95% CI: 0.76-1.61). Similarly, DCR did not differ significantly between groups (RR = 0.98, 95% CI: 0.94-1.03). In terms of safety, the combination therapy was associated with a statistically significant reduction in four treatment-related adverse events: diarrhea (RR = 0.91, 95% CI: 0.83-0.99), nausea (RR = 0.79, 95% CI: 0.65-0.95), vomiting (RR = 0.70, 95% CI: 0.52-0.96), and hypokalemia (RR = 0.28, 95% CI: 0.19-0.40).ConclusionThe findings suggest that the combination of Cabozantinib and Atezolizumab does not offer significant improvement in treatment efficacy compared to Cabozantinib alone. However, the combination may be associated with a lower incidence of certain chemotherapy-related adverse events. These exploratory findings may inform future research on treatment strategies for patients who experience intolerance to Cabozantinib monotherapy.

PMID:40874322 | DOI:10.1177/10732748251371479