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Nevin Manimala Statistics

The impact of socioeconomic determinants on the access to care and survival in patients with spinal chordomas- a national cancer database analysis

J Neurooncol. 2024 Aug 5. doi: 10.1007/s11060-024-04745-9. Online ahead of print.

ABSTRACT

PURPOSE: Chordomas are rare malignant neoplasms primarily treated surgically. Disparities related to race and socioeconomic status, may affect patient outcomes. This study aims to identify prognostic factors for access to care and survival in patients with spinal chordomas.

METHODS: The NCDB database was queried between the years 2004 and 2017. Kaplan-Meier curves were constructed to compare survival probabilities among different groups, based on race and socioeconomic determinents.

RESULTS: 1769 patients were identified, with 87% being White, 5% Hispanic, 4% Black, and Asian each. The mean age was 61.3 years. Most patients received care at academic/research centers and lived in a large metropolitan area, with no difference between races. A significantly higher percentage of Black patients did not undergo surgery (p < 0.001), with no statistically significant difference in survival between races (p = 0.97). A higher survival probability was seen in patients with other government insurances (p < 0.0001), in higher income quartiles (p < 0.0001), in metropolitan areas (p = 0.023), and at an academic/research center (p < 0.0001). A lower survival probability was seen in patients who are uninsured, in rural areas, and at community cancer programs (p < 0.0001).

CONCLUSION: This study highlights disparities in access to surgical intervention for patients with spinal chordomas, especially among Black individuals. It emphasizes the significant impact of insurance status and income on access to surgical care and highlights geographical and institutional variations in survival rates. Addressing socioeconomic differences is crucial for fostering equity in neurosurgical outcomes.

PMID:39102119 | DOI:10.1007/s11060-024-04745-9

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Flash Glucose Monitoring is Associated with HbA1c Improvement in Type 2 Diabetes Managed with Multiple Daily Injections of Insulin in the UK: A Retrospective Observational Study

Diabetes Ther. 2024 Aug 5. doi: 10.1007/s13300-024-01629-z. Online ahead of print.

ABSTRACT

INTRODUCTION: There is a growing body of evidence demonstrating the benefit of flash glucose monitoring in people living with type 2 diabetes mellitus (T2DM). This real-world study aimed to evaluate the effect of initiating flash glucose monitoring on change in HbA1c after 3-6 months in adults living with T2DM treated with multiple daily injections of insulin.

METHODS: A retrospective observational study using data from ten clinical centres in the UK for adults with T2DM treated with multiple daily injections of insulin for at least 1 year was conducted. Patients who had been using the FreeStyle Libre/Libre 2 Flash Glucose Monitoring System for at least 3 months with baseline HbA1c 64-108 mmol/mol (8.0-12.0%) recorded up to 3 months prior to system use were included. Pregnant patients and those on dialysis were excluded. Patients with an HbA1c value measured 3-6 months after commencing flash glucose monitoring were included in the final analysis for evaluation of change.

RESULTS: In total, 87 patients were included in the final analysis (mean age, 60.0 ± 11.8 years, 60.9% male, mean body mass index (BMI), 31.6 ± 5.4 [mean ± SD]). From a mean baseline HbA1c of 80 ± 11 mmol/mol (9.5% ± 1.0%), HbA1c lowered by 11 ± 14 mmol/mol (1.0% ± 1.3%) at 3-6 months (p < 0.0001). A decrease was observed independent of age, baseline HbA1c, sex, duration of insulin use and BMI subgroups.

CONCLUSIONS: Initiation of flash glucose monitoring was associated with a clinically and statistically significant improvement in HbA1c in a real-world setting at 3-6 months.

PMID:39102115 | DOI:10.1007/s13300-024-01629-z

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Role of ultrasound-guided vacuum-assisted breast biopsy in the management of radiologic-pathologic discordance: a retrospective single-centre study

Radiol Med. 2024 Aug 5. doi: 10.1007/s11547-024-01864-1. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the efficacy of US-guided vacuum-assisted biopsy (US-VAB) in radiologic-pathologic (rad-path) discordance in women with suspicious breast lesions.

METHODS: Two thousand three hundred and sixty patients with 2385 BI-RADS category 4 and 5 lesions underwent percutaneous US-guided CNB. Thirty-six lesions were classified as discordant benign and underwent second-line US-VAB. A 14-gauge needle was utilized for CNB and 10-gauge for US-VAB. Final pathology was the reference standard for women who underwent surgery, imaging follow-up in other cases. Rates of malignancy for US-VAB and subsequent surgery were evaluated. Lesions with upgrade and no upgrade to second-line VAB were compared in terms of patient’s age, lesion type and characteristics, size and BI-RADS category. Positive predictive value (PPV), negative predictive value (NPV) for BI-RADS categories and diagnostic performance for second-line US-VAB were calculated. p value < 0.05 was considered statistically significant (t-test, Mann-Whitney, χ2).

RESULTS: US-VAB identified 10 B2, 9 B3 and 17 B5 lesions with upgrade to malignancy of 47.2% (17/36). There were 8 invasive no special type, 7 ductal in situ, 1 invasive lobular carcinoma and 1 angiosarcoma, and their distribution among BI-RADS categories was: 2/2 in BI-RADS 5 (100%), 12/18 in BI-RADS 4C (67%) and 3/16 in BI-RADS 4B lesions (19%) (p = 0.006). Of the remaining 19 lesions, 6 underwent surgery and 2 were upgraded to ductal carcinoma in situ; 13 underwent radiological follow-up and one resulted malignant. False-negative rate for US-VAB was 15.8% (3/19) with final upgrade to malignancy of 55% (20/36). The univariate analysis revealed mass shape (p = 0.008) and BI-RADS categories (p = 0.006) to be associated with upgrade to malignancy. Sensitivity, specificity, PPV, NPV and accuracy for US-VAB were 85, 100, 100, 84 and 92%, respectively.

CONCLUSIONS: US-VAB identified almost 50% of cancers missed by CNB, avoiding surgical biopsies and validating as an effective mini-invasive approach in rad-path discordance.

PMID:39102107 | DOI:10.1007/s11547-024-01864-1

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Predictors of spontaneous intracerebral hemorrhage mortality: a community-based study in Brno, Czech Republic

Acta Neurol Belg. 2024 Aug 5. doi: 10.1007/s13760-024-02612-y. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Intracerebral hemorrhage (ICH) is a serious medical condition with high mortality. However, factors leading to long-term mortality after ICH are largely unclear. The aim of this community-based study is to assess predictors of long-term mortality after spontaneous ICH.

METHODS: We identified all patients admitted with spontaneous ICH to hospitals with a certified stroke unit in Brno, the second largest city in the Czech Republic (CR), in 2011, the year of the Czech Population and Housing Census. We reviewed their medical records for risk factors, radiographic parameters, and measures of post-stroke neurological deficit [National Institutes of Health Stroke Scale (NIHSS)]. Using the dates of death from the Czech National Mortality Register, we calculated mortality at 30 days, six months, one year, and three years after the ICH. Multivariate analysis with forward stepwise logistic regression was performed to determine independent predictors of mortality (p < 0.05).

RESULTS: In 2011, 1086 patients with stroke were admitted to the four stroke-certified hospitals in Brno, CR. Of these, 134 had spontaneous ICH, with complete data available in 93 of them entering the final analysis. The mortality at 30 days, 6 months, 1 year, and 3 years post-ICH was 34%, 47%, 51%, and 63%, respectively. The mortality was highest in the first few days post-event, with 50% of patients dying in 255 days and average survival being 884 ± 90 days. Both NIHSS and modified ICH (MICH) score showed to be strong and reliable predictors of short- as well as long-term mortality; the risk of death post-ICH increased with older age and size of ICH. Other risk factors contributing to higher, primarily shorter-term mortality included history of cardiac failure, myocardial infarction, or atrial fibrillation.

CONCLUSIONS: In our community-based study, we found that severity of neurological deficit at admission (NIHSS), combined with age and size of ICH, well predicted short- as well as long-term mortality after spontaneous ICH. A history of cardiac failure, myocardial infarction, or atrial fibrillation at presentation were also predictors of mortality, underscoring the need for optimal cardiac management in patients with ICH.

PMID:39102105 | DOI:10.1007/s13760-024-02612-y

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Effectiveness of a new 3D printed simulator for mitral transcatheter edge-to-edge repair in enhancing the confidence and procedural skills of the operator

3D Print Med. 2024 Aug 5;10(1):26. doi: 10.1186/s41205-024-00230-1.

ABSTRACT

BACKGROUND: . Mitral transcatheter edge-to-edge repair (m-TEER) is a minimally invasive procedure for treating mitral regurgitation (MR). m-TEER is a highly technical procedure, and a steep learning curve needs to be overcome for operators to ensure optimal patient outcomes and minimise procedural complications. Training via online simulation and observation of procedures is not sufficient to establish operator confidence; thus, advanced hands-on training modalities need to be explored and developed.

METHODS: . In this study, a novel anatomical simulator for m-TEER training was evaluated in comparison to a standard model. The proposed simulator resembled the anatomical features of the right and left atrium, left ventricle and mitral valve apparatus. Participants in the questionnaire (n = 18) were recruited across 4 centres in London with (n = 8) and without (n = 10) prior experience in m-TEER. Participants were asked to simulate procedures on both an idealised, routinely used simulator and the newly proposed anatomical model. The questionnaire was designed to assess (i) participants’ confidence before and after training and (ii) the realism of the model in the context of the m-TEER procedure. The results of the questionnaires were collected, and statistical analysis (t-test) was performed.

RESULTS: . Both models were equally beneficial in increasing operator confidence before and after the simulation of the intervention (P = 0.43). However, increased confidence after training with the anatomical model was recorded (P = 0.02). Participants with prior experience with m-TEER therapy were significantly more confident about the procedure after training with the anatomical model than participants who had no prior experience (P = 0.002). On average, all participants thought that the anatomical model was effective as a training simulator (P = 0.013) and should be integrated into routine training (P = 0.015)). Participants with experience thought that the anatomical model was more effective at reproducing the m-TEER procedure than the idealised model (P = 0.03).

CONCLUSIONS: . This study showed how a more realistic simulator can be used to improve the effectiveness of m-TEER procedural training. Such pilot results suggest planning future and large investigations to evaluate improvements in clinical practice.

PMID:39102099 | DOI:10.1186/s41205-024-00230-1

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Safety and efficacy of biologic drugs in children or adolescents with atopic dermatitis: A systematic review and meta-analysis of randomized controlled trials

Australas J Dermatol. 2024 Aug 5. doi: 10.1111/ajd.14358. Online ahead of print.

ABSTRACT

Children and adolescents suffering from moderate-to-severe atopic dermatitis (AD) face a significant disease burden that greatly impacts their quality of life. Treatment options for AD are currently limited. To assess the safety and efficacy of biologic drugs, dupilumab, lebrikizumab, or tralokinumab, in improving outcomes in patients with moderate to severe inadequately controlled AD. We searched PubMed, Embase and Cochrane databases for randomized controlled trials (RCTs) comparing dupilumab, lebrikizumab or tralokinumab to placebo in patients with AD. We computed odds ratios (ORs) for binary endpoints, with 95% confidence intervals (CIs), random effects model was used and a p-value <0.05 was considered as statistically significant. We analysed data into Review Manager 5.4. A total of five RCTs and 973 patients were included, of whom 592 were prescribed a biologic drug. Compared with placebo, patients receiving a biologic drug had a greater improvement, achieved an Investigator Global Assessment (IGA) score of 0 or 1 (OR 5.05; 95% CI 3.08-8.29), Eczema Area and Severity Index (EASI) 75 (OR 6.87; 95% CI 4.71-10.02), EASI 50 (OR 8.89; 95% CI 6.18-12.78) and EASI 90 (8.30; 95% CI 4.81-14.31). The proportion of patients with 3 points or more (OR 6.56; 95% CI 4.34-9.90) or 4 points or more (OR 8.09; 95% CI 5.19-12.59) improvement from baseline in peak pruritus NRS was significantly higher with biologic drugs than placebo. There were no significant differences between groups regarding adverse events (OR 0.79; 95% CI 0.58-1.07), and conjunctivitis (OR 2.08; 95% CI 1.00-4.33). In this meta-analysis, dupilumab, lebrikizumab, and tralokinumab have shown significant improvements in signs, symptoms and quality of life in children or adolescents with moderate to severe AD. Larger studies may be needed to continue evaluating the safety and efficacy of these biologic drugs in this patient population.

PMID:39101303 | DOI:10.1111/ajd.14358

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Medial-pivot design does not provide superior clinical results compared to posterior-stabilized total knee arthroplasty despite kinematic differences during step-up and lunge activities: A prospective randomized controlled trial under medial tight soft tissue balance

Knee Surg Sports Traumatol Arthrosc. 2024 Aug 5. doi: 10.1002/ksa.12399. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to compare in vivo kinematics during weight-bearing daily activities and determine the relationship with clinical outcomes in patients undergoing total knee arthroplasty (TKA) with a medial-pivot (MP, Evolution™) versus a posterior-stabilized (PS, Persona®) design under constant conditions of intraoperative soft tissue balance.

METHODS: Forty patients undergoing MP or PS-TKA under similar conditions of soft tissue balance were enrolled in this prospective randomized controlled trial. Outcome measures included clinical knee society scores (KSS) and knee injury and osteoarthritis outcome scores (KOOS). A kinematic assessment was conducted while the participants performed lunge and step-up activities under fluoroscopic guidance.

RESULTS: Eighteen patients in each arm completed 1-year follow-up and were included in the analysis. All patients experienced pain relief and satisfactory knee function postoperatively. In kinematics, in the MP arm, the medial femoral condyle remained consistent, whereas the lateral femoral condyle gradually shifted posteriorly with increasing knee flexion. Conversely, in the PS arm, paradoxical anterior movement of the medial femoral condyle accompanied the lateral pivot motion. During lunge and step-up activities, a medial-pivot motion was observed in 83% and 72% of knees in the MP arm, respectively, compared with 22% and 11% in the PS arm. Despite these differences in kinematics, there were no statistically significant differences in the KSS and KOOS between the two groups.

CONCLUSION: Under weight-bearing conditions during flexion, knees that underwent Evolution™ MP-TKA did not show superior clinical results compared to Persona® PS-TKA, despite exhibiting in vivo kinematics closely resembling the normal in vivo pattern.

LEVEL OF EVIDENCE: Therapeutic studies-Level I.

PMID:39101251 | DOI:10.1002/ksa.12399

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Lateral Ankle Ligament Repair Is Not Only for Young Patients: Trends in Incidence and Demographics

Foot Ankle Spec. 2024 Aug 5:19386400241266361. doi: 10.1177/19386400241266361. Online ahead of print.

ABSTRACT

The purpose of this study was to examine the changes in annual incidence and patient population undergoing lateral ankle ligament repair (LALR) for the surgical treatment of chronic ankle instability. The IBM Watson Health MarketScan Database was queried for patients who underwent LALR from January 2009 to December 2019 based on CPT code 27698. Volume and incidence per 100 000 population were determined for annual sums, gender, age, and geographical regions based on population estimates from the United States Census Bureau. Future annual volumes were statistically projected with linear regression modeling to the year 2032. Overall, 160 457 LALR procedures were identified in the database from 2009 to 2019. Annual incidence increased 76.6% from 3.46 to 6.11 cases per 100 000 population, while estimates of annual volumes are projected to increase 61.5% from 19 829 to 32 033 procedures to the year 2032. Interestingly, the greatest increase in incidence was observed among patients above 70 years old, which might suggest older patients are staying active longer and desiring elective procedures to maintain their activity levels. As the incidence of LALR increases in older patients, more research will be needed to understand the unique surgical considerations and risk factors impacting patient-reported outcomes.Level of Evidence: Level IV.

PMID:39101246 | DOI:10.1177/19386400241266361

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Development and initial evaluation of a clinical prediction model for risk of treatment resistance in first-episode psychosis: Schizophrenia Prediction of Resistance to Treatment (SPIRIT)

Br J Psychiatry. 2024 Aug 5:1-10. doi: 10.1192/bjp.2024.101. Online ahead of print.

ABSTRACT

BACKGROUND: A clinical tool to estimate the risk of treatment-resistant schizophrenia (TRS) in people with first-episode psychosis (FEP) would inform early detection of TRS and overcome the delay of up to 5 years in starting TRS medication.

AIMS: To develop and evaluate a model that could predict the risk of TRS in routine clinical practice.

METHOD: We used data from two UK-based FEP cohorts (GAP and AESOP-10) to develop and internally validate a prognostic model that supports identification of patients at high-risk of TRS soon after FEP diagnosis. Using sociodemographic and clinical predictors, a model for predicting risk of TRS was developed based on penalised logistic regression, with missing data handled using multiple imputation. Internal validation was undertaken via bootstrapping, obtaining optimism-adjusted estimates of the model’s performance. Interviews and focus groups with clinicians were conducted to establish clinically relevant risk thresholds and understand the acceptability and perceived utility of the model.

RESULTS: We included seven factors in the prediction model that are predominantly assessed in clinical practice in patients with FEP. The model predicted treatment resistance among the 1081 patients with reasonable accuracy; the model’s C-statistic was 0.727 (95% CI 0.723-0.732) prior to shrinkage and 0.687 after adjustment for optimism. Calibration was good (expected/observed ratio: 0.999; calibration-in-the-large: 0.000584) after adjustment for optimism.

CONCLUSIONS: We developed and internally validated a prediction model with reasonably good predictive metrics. Clinicians, patients and carers were involved in the development process. External validation of the tool is needed followed by co-design methodology to support implementation in early intervention services.

PMID:39101211 | DOI:10.1192/bjp.2024.101

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Dapagliflozin Enhances Arterial and Venous Compliance During Exercise in Heart Failure With Preserved Ejection Fraction: Insights From the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction Trial

Circulation. 2024 Aug 5. doi: 10.1161/CIRCULATIONAHA.124.068788. Online ahead of print.

ABSTRACT

BACKGROUND: Systemic arterial compliance and venous capacitance are typically impaired in patients with heart failure with preserved ejection fraction (HFpEF), contributing to hemodynamic congestion with stress. Sodium-glucose cotransporter-2 inhibitors reduce hemodynamic congestion and improve clinical outcomes in patients with HFpEF, but the mechanisms remain unclear. This study tested the hypothesis that Dapagliflozin would improve systemic arterial compliance and venous capacitance during exercise in patients with HFpEF.

METHODS: In this secondary analysis from the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction Trial, 37 patients with HFpEF (mean age 68 ± 9 years, women 65%) underwent invasive hemodynamic exercise testing with simultaneous echocardiography at baseline and following treatment for 24 weeks with Dapagliflozin or placebo. Radial artery pressure (BP) was measured continuously using a fluid-filled catheter with transformation to aortic pressure, central hemodynamics were measured using high-fidelity micromanometers, and stressed blood volume was estimated from hemodynamic indices fit to a comprehensive cardiovascular model.

RESULTS: There was no statistically significant effect of Dapagliflozin on resting BP, but Dapagliflozin reduced systolic BP during peak exercise (estimated treatment difference [ETD], -18.8 mm Hg [95% CI, -33.9 to -3.7] P=0.016). Reduction in BP was related to improved exertional total arterial compliance (ETD, 0.06 mL/mm Hg/m2 [95% CI, 0.003-0.11] P=0.039) and aortic root characteristic impedance (ETD, -2.6 mm Hg/mL*sec [95% CI: -5.1 to -0.03] P=0.048), with no significant effect on systemic vascular resistance. Dapagliflozin reduced estimated stressed blood volume at rest and during peak exercise (ETD, -292 mm Hg [95% CI, -530 to -53] P=0.018), and improved venous capacitance evidenced by a decline in ratio of estimated stressed blood volume to total blood volume (ETD, -7.3% [95% CI, -13.3 to -1.3] P=0.020). Each of these effects of Dapagliflozin at peak exercise were also observed during matched 20W exercise intensity. Improvements in total arterial compliance and estimated stressed blood volume were correlated with decreases in body weight, and reduction in systolic BP with treatment was correlated with the change in estimated stressed blood volume during exercise (r=0.40, P=0.019). Decreases in BP were correlated with reduction in pulmonary capillary wedge pressure during exercise (r=0.56, P<0.001).

CONCLUSIONS: In patients with HFpEF, treatment with Dapagliflozin improved systemic arterial compliance and venous capacitance during exercise, while reducing aortic characteristic impedance, suggesting a reduction in arterial wall stiffness. These vascular effects may partially explain the clinical benefits with sodium-glucose cotransporter-2 inhibitors in HFpEF.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04730947.

PMID:39101201 | DOI:10.1161/CIRCULATIONAHA.124.068788