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Nevin Manimala Statistics

Routine coronary procedures via distal transradial access in male versus female patients: insights from the DISTRACTION registry

J Invasive Cardiol. 2025 Aug 5. doi: 10.25270/jic/25.00130. Online ahead of print.

ABSTRACT

OBJECTIVES: Systematic reviews and meta-analyses have highlighted the benefits of distal over proximal transradial access, including lower rates of radial artery occlusion and faster hemostasis. Despite the increasing adoption of distal transradial access by interventionalists, there is a lack of data addressing gender-specific differences. This study aimed to assess those differences in routine coronary procedures via distal transradial access.

METHODS: The authors conducted a retrospective analysis of a large, real-world sample of 6871 consecutive all-comers who underwent coronary procedures via distal transradial access using data from the DISTRACTION registry.

RESULTS: The mean patient ages were 63.8 ± 15.7 years, 63.5 ± 17.7, and 64.4 ± 11.1 years for total, male, and female groups, respectively; 65% of the patients were male. In the female group, there was statistically significant predominance of hypertension (82.2% vs 74%), diabetes (46.8% vs 37%), obesity (29.3% vs 22.2%), severe mitral valve disease (3.1% vs 1.1%), coronary angiography-only (48.7% vs 36%), and access-site crossovers (3.1% vs 1.5%). In the male group, there were more rates of former or current smoking (54.2% vs 40.8%), previous percutaneous coronary intervention (PCI) (29.8% vs 19.7%), previous coronary artery bypass grafting (4.5% vs 1.9%), ST-segment elevation myocardial infarction (24.2% vs 18.5%), PCI (66.1% vs 52.5%), left main PCI (2.6% vs 1.7%), redo right distal transradial access (15.3% vs 9.9%), and 7F sheath size (2.6% vs 0.9%). No major adverse cerebrovascular and cardiac events directly related to distal transradial access, no hand/thumb dysfunction or ischemia after any procedure, and no relevant access-site-related bleeding were recorded.

CONCLUSIONS: The adoption of distal transradial access by proficient operators as the default approach for routine coronary procedures appears to be safe and feasible in both male and female patients, with very low rates of access site crossovers and complications.

PMID:40773706 | DOI:10.25270/jic/25.00130

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Nevin Manimala Statistics

The Lifecycle of Electronic Health Record Data in HIV-Related Big Data Studies: Qualitative Study of Bias Instances and Potential Opportunities for Minimization

J Med Internet Res. 2025 Aug 7;27:e71388. doi: 10.2196/71388.

ABSTRACT

BACKGROUND: Electronic health record (EHR) data are widely used in public health research, including in HIV-related studies, but are limited by potential bias due to incomplete and inaccurate information, lack of generalizability, and lack of representativeness.

OBJECTIVE: This study explores how workflow processes among HIV health care providers (HCPs), data scientists, and state health department professionals may potentially introduce or minimize bias within EHR data.

METHODS: One focus group with 3 health department professionals working in HIV surveillance and 16 in-depth interviews (ie, 5 people with HIV, 5 HCPs, 5 data scientists, and 1 health department professional providing retention-in-care services) were conducted with participants purposively sampled in South Carolina from August 2023 to April 2024. All interviews were transcribed verbatim and analyzed using a constructivist grounded theory approach, where transcripts were first coded and then focused, axial, and theoretically coded.

RESULTS: The EHR data lifecycle originates with people with HIV and HCPs in the clinical setting. Data scientists then curate EHR data and health department professionals manage and use the data for surveillance and policy decision-making. Throughout this lifecycle, the three primary stakeholders (ie, HCPs, data scientists, and health department professionals) identified challenges with EHR processes and provided their recommendations and accommodations in addressing the related challenges. HCPs reported the influence of socio-structural biases on their inquiry, interpretation, and documentation of social determinants of health (SDOH) information of people living with HIV, the influence of which is proposed to be mitigated through people living with HIV access to their EHRs. Data scientists identified limited data availability and representativeness as biasing the data they manage. Health department professionals face challenges with delayed and incomplete data, which may be addressed statistically but require consideration of the data’s limitations. Overall, bias within the EHR data lifecycle persists because workflows are not intentionally structured to minimize bias and there is a diffusion of responsibility for data quality between the various stakeholders.

CONCLUSIONS: From the perspective of various stakeholders, this study describes the EHR data lifecycle and its associated challenges as well as stakeholders’ accommodations and recommendations for mitigating and eliminating bias in EHR data. Based upon these findings, studies reliant on EHR data should adequately consider its challenges and limitations. Throughout the EHR data lifecycle, bias could be reduced through an inclusive, supportive health care environment, people living with HIV verification of SDOH information, the customization of data collection systems, and EHR data inspection for completeness, accuracy, and timeliness. Future research is needed to further identify instances where bias is introduced and how it can best be mitigated and eliminated across the EHR data lifecycle. Systematic changes are necessary to reduce instances of bias between data workflows and stakeholders.

PMID:40773672 | DOI:10.2196/71388

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Machine Learning-Based Analysis of Lifestyle Risk Factors for Atherosclerotic Cardiovascular Disease: Retrospective Case-Control Study

JMIR Med Inform. 2025 Aug 7;13:e74415. doi: 10.2196/74415.

ABSTRACT

BACKGROUND: The risk of developing atherosclerotic cardiovascular disease (ASCVD) varies among individuals and is related to a variety of lifestyle factors in addition to the presence of chronic diseases.

OBJECTIVE: We aimed to assess the predictive accuracy of machine learning (ML) models incorporating lifestyle risk behaviors for ASCVD risk using the Korean nationwide database.

METHODS: Using data from the Korea National Health and Nutrition Examination Survey, 5 ML algorithms were used for the prediction of high ASCVD risk: logistic regression (LR), support vector machine, random forest, extreme gradient boosting, and light gradient boosting models. ASCVD risk was assessed using the pooled cohort equations, with a high-risk threshold of ≥7.5% over 10 years. Among the 8573 participants aged 40-79 years, propensity score matching (PSM) was used to adjust for demographic confounders. We divided the dataset into a training and a test dataset in an 8:2 ratio. We also used bootstrapping to train the ML model with the area under the receiver operating characteristics curve score. Shapley additive explanations were used to identify the models’ important variables in assessing high ASCVD risks. In sensitivity analysis, we additionally performed binary LR analysis, in which the ML model’s results were consistent with the conventional statistical model.

RESULTS: Of the 8573 participants, 41.7% (n=3578) had high ASCVD risk. Before PSM, age and sex differed significantly between groups. PSM (1:1) yielded 1976 patients with balanced demographics. After PSM, the high ASCVD risk group had higher alcohol or tobacco use, lower omega-3 intake, higher BMI, less physical activity, and spent less time sitting. In 5 ML models, the extreme gradient boosting model showed the highest area under the receiver operating characteristics curve, indicating superior overall discrimination between high and low ASCVD risk groups. However, the light gradient boosting model demonstrated better performance in accuracy, recall, and F1-score. Variable importance analysis using Shapley additive explanations identified smoking and age as the strongest predictors, while BMI, sodium or omega-3 intake, and low-density lipoprotein cholesterol also had significant variables. Sensitivity analysis using multivariable LR analysis also confirmed these findings, showing that smoking, BMI, and low-density lipoprotein cholesterol increased ASCVD risk, whereas omega-3 intake and physical activity were associated with lower risk.

CONCLUSIONS: Analyzing lifestyle behavioral factors in ASCVD risk with an ML model improves the predictive performance compared to traditional models. Personalized prevention strategies tailored to an individual’s lifestyle can effectively reduce ASCVD risk.

PMID:40773657 | DOI:10.2196/74415

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Promising Outcomes of Ultrasound-Guided Pulsed Radiofrequency for the Treatment of Morton’s Neuromas – A Prospective Study

Pain Physician. 2025 Jul;28(4):E385-E391.

ABSTRACT

BACKGROUND: Morton’s neuroma is a compressive neuropathy of the common plantar digital nerve, causing significant pain and limiting patients’ activities.

OBJECTIVES: This study aimed to investigate the effect of pulsed radiofrequency (PRF) on the pain, functionality, and quality of life experienced by patients with Morton’s neuroma.

STUDY DESIGN: This was a prospective study with pre- and post-intervention assessments after one, 3, and 6 months of treatment.

SETTING: The orthopedics department of an affiliated hospital.

METHODS: Patients with Morton’s neuroma underwent treatment with ultrasound-guided PRF in 2 sites around the neuroma for 8 minutes. Clinical outcomes were assessed using the visual analog scale (VAS), the American Orthopedic Foot and Ankle Society (AOFAS) questionnaire for assessing foot function, and the Short Form-36 (SF-36) for quality of life.

RESULTS: A total of 20 patients (29 feet) completed the 6-month minimum follow-up period. The VAS and face scale values at follow-up were statistically lower than the pre-procedure VAS scores (P < 0.05). The AOFAS and SF-36 values at follow-up were statistically higher than the pre-procedure values (P < 0.05). No significant adverse events were recorded during the follow-up.

LIMITATIONS: The prospective research features a limited follow-up duration and lacks an additional group, whether control or treatment, for result comparisons.

CONCLUSION: Applications of PRF decreased the pain and the improved functionality and quality of life experienced by patients with Morton’s neuroma for a 6-month follow-up at minimum.

PMID:40773643

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Ozone and Hyaluronic Acid, Alone and in Combination: Exploring Temporal Dynamics and Synergies in Intraarticular Therapy for Knee Osteoarthritis

Pain Physician. 2025 Jul;28(4):347-357.

ABSTRACT

BACKGROUND: Knee Osteoarthritis (KOA) is the most common chronic joint disease in old age. Treatment for KOA focuses on symptom relief and improvement of function. Intraarticular hyaluronic acid (HA) is a well-documented treatment for KOA; it provides pain relief and enhances joint function by increasing lubrication and synovial fluid viscosity. Recently, there has been a growing interest toward the medical effects of oxygen-ozone (O3) treatment, especially for musculoskeletal disorders.

OBJECTIVE: We investigated whether a combination of intraarticular O3 and HA could reduce pain and improve functional and clinical outcomes compared with the same treatments administered separately in patients with KOA.

STUDY DESIGN: This is a retrospective, comparative, observational study approved by the institutional review board of the “Sapienza” University of Rome [RS 6599/2021].

SETTING: Physical Medicine and Rehabilitation Unit of Sant’Andrea University Hospital, Rome, Italian Republic.

METHODS: A total of 106 patients with KOA were examined. Of these, 84 patients met the eligibility criteria and were divided into one of 3 treatment groups: intraarticular O3 therapy (n = 28), intraarticular HA injections (n = 26), or a combination of both (n = 30). Outcome measures were assessed using the Numeric Rating Scale (NRS-11) for pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for functional disability, Knee Society Scores (KSS) for knee assessment, and the 12-item Short-Form Health Survey (SF-12) for quality of life.

RESULTS: Significant differences occured between groups at various evaluation points. At the end of treatment (T1), O3 alone and O3 combined with HA showed superior pain relief compared to HA alone; HA alone and O3 combined with HA demonstrated better stiffness alleviation compared to O3 alone. The combination therapy showed advantages in the WOMAC physical function score, total WOMAC score, KSS knee score, KSS functional score, 12-item Physical Component Summary (PCS-12) score and 12-item Mental Component Summary (MCS-12) score compared to O3 alone and HA alone treatments (P < 0.05). At the one-month follow-up (T2), O3 combined with HA showed significant differences in NRS-11 and WOMAC physical function scores compared to O3 alone (P = 0.026 and P = 0.011, respectively). The KSS knee score, KSS functional score, PCS-12 score, and MCS-12 score all showed differences between the O3 combined with HA and both the O3 and HA alone groups (P < 0.05). At the 3-month follow-up (T3), HA alone demonstrated superiority in the WOMAC pain and physical function scores over O3 alone (P < 0.001 and P = 0.023, respectively). Compared to O3 alone, O3 combined with HA showed advantages in WOMAC stiffness, WOMAC physical function, and total WOMAC scores, as well as the KSS knee score, KSS functional score, PCS-12 score, and MCS-12 score (P < 0.05).At the 6-month follow-up (T4), significant differences favored HA in the WOMAC pain, physical function, and total WOMAC scores compared to O3 (P = 0.039, P = 0.029, and P = 0.034, respectively). O3 combined with HA demonstrated advantages in total WOMAC and KSS knee score compared to O3 (P = 0.034 and P = 0.004, respectively). Within each group, all outcome measures exhibited statistically significant improvements at every follow-up (P < 0.05).

LIMITATIONS: A limited number of patients were retrospectively recruited.

CONCLUSIONS: Our study suggests that intraarticular O3 therapy and HA, alone or combined, provide distinct and complementary benefits for knee osteoarthritis. O3 therapy offers immediate pain relief, while HA contributes to sustained improvements in pain and function. The combination demonstrates a synergistic effect, enhancing joint functionality and quality of life.

PMID:40773642

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Effects of Dexamethasone Administration in Sphenopalatine Ganglion Block for Allergic Rhinitis: A Prospective, Randomized, Single-blind Controlled Trial

Pain Physician. 2025 Jul;28(4):307-320.

ABSTRACT

BACKGROUND: Allergic rhinitis (AR) is a common chronic condition that significantly affects quality of life. Ultrasound-guided sphenopalatine ganglion block (SPGB) is a minimally invasive, safe, and effective treatment gaining clinical attention for symptom relief. Dexamethasone is often used in an SPGB, but its effect on autonomic nerve modulation remains unclear.

OBJECTIVES: This study aimed to assess the therapeutic effect of ultrasound-guided SPGB for treating AR and to compare the clinical efficacy and adverse reactions of dexamethasone used in conjunction with an SPGB.

STUDY DESIGN: A prospective, randomized, single-blind controlled trial.

SETTING: Nanjing Drum Tower Hospital Clinical College of Xuzhou Medical University, People’s Republic of China.

METHODS: This randomized clinical trial, involving 84 patients with AR, was conducted at Nanjing Drum Tower Hospital from February 2024 through May 2024. Patients were randomly assigned to either the experimental group (42 patients) or the control group (42 patients), with blinding applied. A total of 78 patients completed the study (40 in the experimental group, 38 in the control group). Both groups received an ultrasound-guided SPGB once a week for 4 weeks, alternating sides. The experimental group was treated with a combination of bupivacaine and dexamethasone, while the control group received only bupivacaine. Changes in efficacies, Total Nasal Symptom Score (TNSS), nasal symptom Visual Analog Scale (VAS), Rhino-conjunctivitis Quality of Life Questionnaire (RQLQ) scores, Total Nasal Respiratory Volume (TNRV), Total Nasal Volume (TNV), and Total Nasal Resistance (TNR) were measured at pretreatment and at one week, one month, 3 months, and 6 months posttreatment. Additionally, effective rate was calculated as the percentage of patients achieving a clinically meaningful response, defined as a reduction in TNSS of 30% or greater from baseline.

RESULTS: Both groups had significant reductions in TNSS, nasal symptom VAS, and RQLQ scores compared to pretreatment levels at all follow-up points (P < 0.001). At one week, one month, and 3 months posttreatment, the experimental group had higher efficacies, lower TNSS, lower VAS, and lower RQLQ scores than the control group (P < 0.05). At 6 months posttreatment, there were no significant differences between the groups for efficacy rates, VAS, or RQLQ scores (P > 0.05) while the experimental group had lower TNSS scores (P < 0.05). Both groups had significant improvement in nasal ventilation, with increases in TNRV and TNV and reductions in TNR (P < 0.001). At each follow-up, the experimental group had higher TNRV and TNV and lower TNR compared to the control group, with statistical significance observed at most time points (P < 0.05), except for TNRV at 6 months and TNV at 3 and 6 months posttreatment. Safety indicators showed no significant differences between groups (P > 0.05).

LIMITATIONS: We did not assess patient depression and anxiety; how dexamethasone over triamcinolone potentially affected efficacy; and how the absence of 3D navigation would have resulted in a safer, more precise block.

CONCLUSIONS: Ultrasound-guided SPGB is a safe and effective treatment for AR, improving symptoms, quality of life, and nasal airflow. The addition of corticosteroids may enhance short-term efficacy.

PMID:40773638

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Using Artificial Intelligence to Predict Residual Distal Lumbosacral Pain Post Percutaneous Kyphoplasty for Osteoporotic Vertebral Compression Fractures

Pain Physician. 2025 Jul;28(4):E337-E346.

ABSTRACT

BACKGROUND: Percutaneous kyphoplasty (PKP) can restore spinal stability and relieve pain in patients with osteoporotic vertebral compression fractures (OVCF). However, in some cases, distal lumbosacral pain (DLP) persists postoperatively, affecting patients’ expectations of the surgery and their recovery to activities of daily life.

OBJECTIVE: To use artificial intelligence to predict DLP post-PKP for OVCF, thereby providing personalized treatment plans for patients with OVCF.

STUDY DESIGN: Retrospective study.

SETTING: The study was carried out at a university hospital.

METHODS: A univariate analysis was performed to identify the risk factors for DLP post-PKP. A heatmap analysis was conducted to examine the relationships between variables in the dataset. A random forest model was established, and its performance was evaluated using a confusion matrix. After validating and tuning the model, features were ranked based on their contribution to prediction accuracy.

RESULTS: A total of 179 patients completed this study. Patients were divided into 2 groups (Group 0 without DLP; Group 1 with DLP). The univariate analysis indicated statistically significant differences in terms of bone density, intravertebral vacuum cleft, sarcopenia, bone cement distribution, interspinous ligament degeneration, and Hounsfield unit (P < 0.05). The heatmap analysis revealed a moderate correlation between DLP and both sarcopenia and interspinous ligament degeneration. A random forest model was built. The confusion matrix showed that the model exhibited strong performance across all metrics. The random forest model showed that the preoperative Cobb angle and sarcopenia were the most critical features.

LIMITATIONS: This was a retrospective study, which may be prone to selection and recall bias. Single-center noncontrolled studies may also introduce bias.

CONCLUSION: Our random forest model can effectively predict DLP post-PKP for OVCF, assisting in the selection of treatment plans.

PMID:40773631

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Is the Treatment of Coronary Artery Disease Following the Recommendations Set Out in the Proposed Guidelines and in the SYNTAX Study?

Braz J Cardiovasc Surg. 2025 Aug 7;40(5):e20240248. doi: 10.21470/1678-9741-2024-0248.

ABSTRACT

INTRODUCTION: Coronary artery disease (CAD) is the main cause of death among cardiovascular diseases. Current guidelines aim to guide clinical practice in choosing the best treatment, based on the best scientific evidence. The SYnergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) score uses anatomical and clinical factors, helping to assess the complexity of coronary lesions.

OBJECTIVE: To verify whether the treatment used in CAD complied with the recommendations set out in the guidelines and in the SYNTAX study.

METHODS: Single-center, cross-sectional, observational, descriptive, and retrospective study, which analyzed medical records over a three-year period. Patients diagnosed with CAD who had obstructive disease in at least two vessels were selected. The exams were evaluated by a specialist who was unaware of the report and the treatment used for each patient. SYNTAX 1 and 2 scores were calculated, and the recommended treatment was compared to the established treatment.

RESULTS: Two hundred and ten patients were distributed, according to SYNTAX Score 1, into the groups low (Group A), intermediate (Group B), and high risk (Group C). Of 155 patients in Groups B and C, 105 (67.7%) were treated with percutaneous coronary intervention (PCI), vs. 24 (15.5%) with CABG. When calculating the SYNTAX Score 2 of the 101 patients with recommended treatment for CABG, 71 (70.3%) received PCI, compared to 18 (17.8%) treated with CABG. All patients recommended for preferential treatment for PCI had the recommendation respected.

CONCLUSION: The treatment offered was not supported by current guidelines and recommendations. Expanding the sample size may determine the current situation of the treatment of CAD in Brazil.

PMID:40773620 | DOI:10.21470/1678-9741-2024-0248

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Open-Label Study: Over-the-Counter Oat Flour/Oat Oil/ Oat Extract-containing Lotion With Avenanthramides for Sensitive Skin and Psoriasis

J Drugs Dermatol. 2025 Aug 1;24(8):782-786. doi: 10.36849/JDD.9238.

ABSTRACT

BACKGROUND: Psoriasis is a common skin condition that affects the physical and emotional well-being of patients. Moisturizers have been shown to significantly improve skin condition and quality of life in this patient population. Skin afflictions such as atopic dermatitis and pruritis share etiological similarities with psoriasis, and oatmeal (Avena sativa)-containing lotion has proven effective in treating the symptoms of those conditions. However, data on the use of an over-the-counter oatmeal-containing lotion alone to treat the symptoms of psoriasis are limited.

METHODS: An open-label clinical study of 60 adult subjects with sensitive skin and mild to moderate psoriasis was completed. Subjects applied a topical lotion containing oat flour, oat oil, and oat extract with avenanthramides (the oatmeal-containing lotion) on the entire body, with a focus on dry patches, at least once daily for 4 weeks as the sole intervention to manage their symptoms. The primary objective of the study was to assess the efficacy and tolerability of the oatmeal-containing lotion in patients with psoriasis. Product satisfaction was also measured after 4 weeks of use.

RESULTS: After 4 weeks of treatment, subjects reported statistically significant improvements in all self-assessment parameters of skin condition, with no adverse effects reported. Overall, subjects expressed high satisfaction with the product.

CONCLUSIONS: This study provides evidence supporting the efficacy and tolerability of a topical, over-the-counter lotion containing oat flour, oat oil and oat extract with avenanthramides as the sole intervention for managing the symptoms of sensitive skin and mild to moderate psoriasis.

PMID:40773617 | DOI:10.36849/JDD.9238

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Study of Adjuvant Sensitive-Skin Cleansing and Moisturizing Regimen in Plaque Psoriasis

J Drugs Dermatol. 2025 Aug 1;24(8):739-743. doi: 10.36849/JDD.9163.

ABSTRACT

BACKGROUND: Epidermal barrier dysfunction is a key feature of plaque psoriasis. Skincare improves epidermal barrier function and is an increasingly recommended part of psoriasis management.

METHODS: This multicenter, blinded study of adults (N=46) with psoriasis evaluated the use of a gentle skincare regimen (cleanser, moisturizer, and optional moisturizer with SPF 35) as an adjunct to medical therapy during an 8-week period. Efficacy was assessed via clinical grading of body surface area (BSA), target lesion severity score (TLSS), physician global assessment (PGA), and bioinstrumentation for skin hydration and texture. Standard safety and tolerability assessments were performed, and subjects completed satisfaction and the Dermatology Life Quality Index (DLQI) questionnaires.

RESULTS: There was a statistically significant decrease in BSA by week 8 from 9.3 to 5.1 (P&lt;0.05). Significant improvements in TLSS (10.9 to 3.5, P&lt;0.05) and PGA (2.7 to 1.4, P&lt;0.05) occurred by week 8, with improvements noted at each study time point (P&lt;0.05 vs baseline). Bioinstrumentation showed reduced scaling and improved skin smoothness (P&lt;0.05 at all timepoints vs baseline). DLQI results improved from 9.2 at baseline (a moderate effect of disease) to 2.9 at week 8 (small effect, P&lt;0.05). There was a significant reduction in dryness, itching, and burning/stinging throughout the study (P&lt;0.05 at all timepoints). Four adverse events occurred in 4 subjects (itching and burning/stinging) and resolved by the end of the study.

CONCLUSIONS: This study highlighted the benefit of skincare in conjunction with prescription products for plaque psoriasis. The skincare regimen supported the skin barrier and improved patient outcomes.

PMID:40773615 | DOI:10.36849/JDD.9163