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Nevin Manimala Statistics

Relationship of TAPSE Normalized by Right Ventricular Area With Pulmonary Compliance, Exercise Capacity, and Clinical Outcomes

Circ Heart Fail. 2024 May 6:e010826. doi: 10.1161/CIRCHEARTFAILURE.123.010826. Online ahead of print.

ABSTRACT

BACKGROUND: While tricuspid annular plane systolic excursion (TAPSE) captures the predominant longitudinal motion of the right ventricle (RV), it does not account for ventricular morphology and radial motion changes in various forms of pulmonary hypertension. This study aims to account for both longitudinal and radial motions by dividing TAPSE by RV area and to assess its clinical significance.

METHODS: We performed a retrospective analysis of 71 subjects with New York Heart Association class II to III dyspnea who underwent echocardiogram and invasive cardiopulmonary exercise testing (which defined 4 hemodynamic groups: control, isolated postcapillary pulmonary hypertension, combined postcapillary pulmonary hypertension, and pulmonary arterial hypertension). On the echocardiogram, TAPSE was divided by RV area in diastole (TAPSE/RVA-D) and systole (TAPSE/RVA-S). Analyses included correlations (Pearson and linear regression), receiver operating characteristic, and survival curves.

RESULTS: On linear regression analysis, TAPSE/RVA metrics (versus TAPSE) had a stronger correlation with pulmonary artery compliance (r=0.48-0.54 versus 0.38) and peak VO2 percentage predicted (0.23-0.30 versus 0.18). Based on the receiver operating characteristic analysis, pulmonary artery compliance ≥3 mL/mm Hg was identified by TAPSE/RVA-D with an under the curve (AUC) of 0.79 (optimal cutoff ≥1.1) and by TAPSE/RVA-S with an AUC of 0.83 (optimal cutoff ≥1.5), but by TAPSE with only an AUC of 0.67. Similarly, to identify peak VO2 <50% predicted, AUC of 0.66 for TAPSE/RVA-D and AUC of 0.65 for TAPSE/RVA-S. Death or cardiovascular hospitalization at 12 months was associated with TAPSE/RVA-D ≥1.1 (HR, 0.38 [95% CI, 0.11-0.56]) and TAPSE/RVA-S ≥1.5 (HR, 0.44 [95% CI, 0.16-0.78]), while TAPSE was not associated with adverse outcomes (HR, 0.99 [95% CI, 0.53-1.94]). Among 31 subjects with available cardiac magnetic resonance imaging, RV ejection fraction was better correlated with novel metrics (TAPSE/RVA-D r=0.378 and TAPSE/RVA-S r=0.328) than TAPSE (r=0.082).

CONCLUSIONS: In a broad cohort with suspected pulmonary hypertension, TAPSE divided by RV area was superior to TAPSE alone in correlations with pulmonary compliance and exercise capacity. As a prognostic marker of right heart function, TAPSE/RVA-D <1.1 and TAPSE/RVA-S <1.5 predicted adverse cardiovascular outcomes.

PMID:38708598 | DOI:10.1161/CIRCHEARTFAILURE.123.010826

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Nevin Manimala Statistics

Exploring Putative Causal Associations between Diet and Periodontal Disease Susceptibility

JDR Clin Trans Res. 2024 May 6:23800844241247485. doi: 10.1177/23800844241247485. Online ahead of print.

ABSTRACT

INTRODUCTION: Dietary factors may play an important role in periodontal health. However, current evidence from observational studies remains inconclusive.

OBJECTIVE: This study aimed to investigate the causal relationships between dietary exposures and periodontal disease risks using Mendelian randomization analysis.

METHODS: Large-scale genome-wide association study summary statistics for 20 dietary factors were obtained from the MRC-IEU consortium. Multivariable and univariable 2-sample Mendelian randomization analyses were performed to assess the causal effects of each dietary exposure on 6 periodontal outcomes, including gingivitis and periodontitis.

RESULTS: Genetically predicted higher dried fruit intake was significantly associated with reduced risks of acute gingivitis (odds ratio [OR]: 0.02; 95% confidence interval [CI]: 0.00-0.42; P = 0.01) and bleeding gums (OR: 0.96; 95% CI: 0.93-0.99; P = 0.01). Higher fresh fruit and water intake showed protective effects against chronic gingivitis (OR: 0.18; 95% CI: 0.04-0.91; P = 0.04 and OR: 0.15; 95% CI: 0.04-0.53; P = 0.00) and bleeding gums (OR: 0.95; 95% CI: 0.92-0.981; P = 0.00 and OR: 0.98; 95% CI: 0.96-0.99; P = 0.02). Alcohol intake frequency and processed meat intake were risk factors for bleeding gums (OR: 1.01; 95% CI: 1.00-1.02; P = 0.01 and OR: 1.05; 95% CI: 1.01-1.08; P = 0.00) and painful gums (OR: 1.01; 95% CI: 1.00-1.01; P = 0.00 and OR: 1.02; 95% CI: 1.01-1.03; P = 0.00). Most of the causal relationships between genetic predisposition to the specified dietary factors and periodontal diseases remained statistically significant (P < 0.05) after adjusting for genetic risks associated with dentures, smoking, and type 2 diabetes in multivariable Mendelian randomization models.

CONCLUSIONS: The findings suggest potential protective effects of higher fruit and water intake against gingivitis and other periodontal problems, while alcohol and processed meat intake may increase the risks of periodontal disease. Our study provides preliminary causal evidence on the effects of diet on periodontal health and could inform prevention strategies targeting dietary habits to improve oral health.

KNOWLEDGE TRANSFER STATEMENT: This study suggests that fruit and water intake may protect against periodontal disease, while alcohol and processed meats increase risk, informing dietary guidelines to improve oral health.

PMID:38708597 | DOI:10.1177/23800844241247485

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Nevin Manimala Statistics

Therapeutic apheresis in kidney transplantation: Emerging trends

J Clin Apher. 2024 Jun;39(3):e22119. doi: 10.1002/jca.22119.

ABSTRACT

INTRODUCTION: The use of therapeutic apheresis (TA) either as stand-alone or adjunctive treatment in kidney transplantation has increased over the years to become a leading indication. This study shows recent trends in indications for TA related to kidney transplantation, adverse events, and patient outcome in this cohort.

METHODS: This is a retrospective cohort review of adults who received TA for kidney transplant-related indications from January 1, 2017, to December 31, 2022, at the University of Virginia Medical Centre, Charlottesville, VA, USA. Data extracted include basic demographics, indication for apheresis, number of procedures, procedure characteristics, procedure-related adverse events (complications), and serum ionized calcium and serum creatinine. Data were analyzed using statistical package for social sciences (SPSS 2022 IBM Inc).

RESULTS: Data from a total of 131 patients who received 860 TA procedures were analyzed. Indications for TA were antibody-mediated rejection (65.5%), recurrent focal segmental glomerulosclerosis (15%), thrombotic microangiopathy (5%), desensitization for ABO incompatibility (4.5%) and for HLA-incompatibility (4.5%), and recurrent IgA nephropathy (1%). Some adverse events were encountered in 16.7% of the procedures and include hypocalcemia (7%), vascular access malfunction (0.7%), hypotension (1.2%), arrhythmia (0.6%), and depletion coagulopathy (0.6%). The overall case mortality rate was 8.4% over the 6-year period. There was one death recorded on machine during TA resulting in a procedure-mortality rate of 0.12%.

CONCLUSION: Antibody-mediated rejection was the most common indication for TA related to kidney transplantation. Adverse events were minor and patient survival over the time was within usual limits.

PMID:38708577 | DOI:10.1002/jca.22119

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Interaction between mental disorders and social disconnectedness on mortality: a population-based cohort study

Br J Psychiatry. 2024 May 6:1-8. doi: 10.1192/bjp.2024.68. Online ahead of print.

ABSTRACT

BACKGROUND: Despite the recognised importance of mental disorders and social disconnectedness for mortality, few studies have examined their co-occurrence.

AIMS: To examine the interaction between mental disorders and three distinct aspects of social disconnectedness on mortality, while taking into account sex, age and characteristics of the mental disorder.

METHOD: This cohort study included participants from the Danish National Health Survey in 2013 and 2017 who were followed until 2021. Survey data on social disconnectedness (loneliness, social isolation and low social support) were linked with register data on hospital-diagnosed mental disorders and mortality. Poisson regression was applied to estimate independent and joint associations with mortality, interaction contrasts and attributable proportions.

RESULTS: A total of 162 497 individuals were followed for 886 614 person-years, and 9047 individuals (5.6%) died during follow-up. Among men, interaction between mental disorders and loneliness, social isolation and low social support, respectively, accounted for 47% (95% CI: 21-74%), 24% (95% CI: -15 to 63%) and 61% (95% CI: 35-86%) of the excess mortality after adjustment for demographics, country of birth, somatic morbidity, educational level, income and wealth. In contrast, among women, no excess mortality could be attributed to interaction. No clear trends were identified according to age or characteristics of the mental disorder.

CONCLUSIONS: Mortality among men, but not women, with a co-occurring mental disorder and social disconnectedness was substantially elevated compared with what was expected. Awareness of elevated mortality rates among socially disconnected men with mental disorders could be of importance to qualify and guide prevention efforts in psychiatric services.

PMID:38708564 | DOI:10.1192/bjp.2024.68

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Nevin Manimala Statistics

Working conditions, missed care and patient experience in home care nursing in Italy: An observational study

Public Health Nurs. 2024 May 6. doi: 10.1111/phn.13320. Online ahead of print.

ABSTRACT

INTRODUCTION: The aging of the population requires an appropriate knowledge of the type of care that needs to be provided to inform healthcare policies. In Italy, neither home care nursing, nor the patient experiences have ever been described.

OBJECTIVES: To describe the characteristics of nurses and care recipients involved in home care.

METHODS: A descriptive cross-sectional study conducted in 18 Italian Regions. Between April and October 2023, data from nurses and patients involved in home care were collected through two surveys. Psychosocial conditions in workplaces, missed care, and care experiences were assessed using validated tools. Descriptive statistics and Pearson’s correlations were performed.

RESULTS: A total of 46 local healthcare units were included in this study, with a total of 2549 nurses and 4709 care recipients. Nurses (mean age 46.60; 79.48% female; 44.68% regional nursing diploma as the highest qualification) reported good working conditions (42.37; SD = 12.25; range = 0-100) and a high mean number of missed care activities (5.11; SD = 3.19; range 0-9). Most nurses (83.41%) reported high levels of job satisfaction, while 20.28% intended to leave their job. Patients (mean age 75.18; 57.57% female; 36.95% primary school), on the other hand, rated positively the care they had received (8.23; range = 0-10).

CONCLUSIONS: Despite the perception of critical issues at work and some missed care, satisfaction in nurses and patients was high. These data constitute a preliminary snapshot of the studied phenomena, which will be investigated through more in-depth analyses.

PMID:38708563 | DOI:10.1111/phn.13320

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Nevin Manimala Statistics

A Simulation-Based Assessment of Levetiracetam Concentrations Following Fixed and Weight-Based Loading Doses: A Meta-Regression and Pharmacokinetic Modeling Analysis

J Clin Pharmacol. 2024 May 6. doi: 10.1002/jcph.2449. Online ahead of print.

ABSTRACT

Current recommendations for refractory status epilepticus (SE) unresponsive to benzodiazepines suggest a loading dose of levetiracetam (LEV) of 60 mg/kg to a maximum of 4500 mg. LEV therapeutic drug monitoring can help guide therapy and is garnering increasing attention. The objective of this study is to simulate the probability of target attainment (PTA) of fixed dose and weight-based loading doses of LEV with respect to established therapeutic target concentrations. Meta-regression of the current literature was performed to evaluate the relationship between intravenous LEV loading dose and seizure cessation in refractory SE patients. A previously published pharmacokinetic model was used to simulate the PTA capacity of competing single intravenous dosing schemes (fixed vs weight-based dosing) to achieve maximum (Cpeak) and 12-h (C12h) plasma concentrations that exceed 12 mg/L. The meta-regression indicated that dosage was not a statistically significant modulator of seizure control at dosages between 20 and 60 mg/kg. Stochastic simulations showed all dosing schemes achieved plasma Cpeak >12 mg/L, but C12h levels were <12 mg/L in subjects over 60 kg with a fixed dose ≤2000 mg or in subjects <60 kg with a weight-based dose <30 mg/kg. Dosages of 40 and 60 mg/kg provided ≥90% PTAs across all weights. Using a weight-based loading dose of 40 mg/kg, up to a suggested maximum of 4500 mg, improves the likelihood of achieving a sustained therapeutic drug concentration after the initial LEV dose, whereas fixed <3000 mg may not achieve the desired concentration before maintenance dosing.

PMID:38708556 | DOI:10.1002/jcph.2449

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Nevin Manimala Statistics

Effect of Food, Crushing of Tablets, and Antacid Coadministration on Maribavir Pharmacokinetics in Healthy Adult Participants: Results From 2 Phase 1, Open-Label, Randomized, Crossover Studies

Clin Pharmacol Drug Dev. 2024 May 6. doi: 10.1002/cpdd.1406. Online ahead of print.

ABSTRACT

The effect of food composition, tablet crushing, and antacid coadministration on maribavir pharmacokinetics was assessed in 2 Phase 1 studies in healthy adults. In the first, a single maribavir 400-mg dose was administered under fasting conditions, with a low-fat/low-calorie or a high-fat/high-calorie meal. In the second, a single maribavir 100-mg dose was administered under fasting conditions, as a crushed tablet, or as a whole tablet alone or with an antacid. The 90% confidence intervals of the geometric mean ratios were within 80%-125% for area under the concentration-time curve (AUC), but not for maximum plasma concentration (Cmax) for low-fat/low-calorie and high-fat/high-calorie meals versus fasting or for whole tablet with antacid versus whole tablet alone. The 90% confidence intervals of the geometric mean ratios for AUC and Cmax were within 80%-125% for crushed versus whole tablet. Maribavir median time to Cmax value in plasma under fed conditions was delayed versus fasting conditions, but there was no statistical difference for crushed versus whole tablet or with versus without antacid. As the antiviral efficacy of maribavir is driven by AUC but not Cmax, findings suggest that maribavir can be administered with food or antacids or as a crushed tablet.

PMID:38708555 | DOI:10.1002/cpdd.1406

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Nevin Manimala Statistics

Reducing IV Antibiotic Duration for Neonatal UTI Using a Clinical Standard Pathway

Hosp Pediatr. 2024 May 6:e2023007454. doi: 10.1542/hpeds.2023-007454. Online ahead of print.

ABSTRACT

OBJECTIVES: Urinary tract infections (UTIs) are the most common bacterial infections in young infants and are traditionally treated with longer intravenous (IV) antibiotic courses. A growing body of evidence supports shorter IV antibiotic courses for young infants. Our primary aim was to decrease the IV antibiotic treatment to 3 days over 2 years for neonates aged 0 to 28 days who have been hospitalized with UTIs.

METHODS: Using quality improvement methods, our primary intervention was to implement a revised clinical pathway recommending 3 (previously 7) days of IV antibiotics. Our primary outcome measure was IV antibiotic duration, and the secondary outcomes were length of stay (LOS) and costs. The balancing measure was readmission within 30 days of discharge. Neonates were identified by using International Classification of Diseases diagnosis codes and excluded if they were admitted to the ICU or had a LOS >30 days. We used statistical process control to analyze outcome measures for 4 years before (baseline) and 2 years after the pathway revision (intervention) in February 2020.

RESULTS: A total of 93 neonates were hospitalized with UTIs in the baseline period and 41 were hospitalized in the intervention period. We found special cause variation, with a significant decrease in mean IV antibiotic duration from 4.7 (baseline) to 3.1 days (intervention) and a decrease in mean LOS from 5.4 to 3.6 days. Costs did not differ between the baseline and intervention periods. There were 7 readmissions during the baseline period, and 0 during the intervention period.

CONCLUSIONS: The implementation of a revised clinical pathway significantly reduced IV antibiotic treatment duration and hospital LOS for neonatal UTIs without an increase in hospital readmissions.

PMID:38708550 | DOI:10.1542/hpeds.2023-007454

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Nevin Manimala Statistics

What patients with cancer think about the dehospitalization. A survey of Cipomo.

Recenti Prog Med. 2024 May;115(5):232-237. doi: 10.1701/4262.42402.

ABSTRACT

BACKGROUND: Ministerial Decrete 77 (DM 77) promotes dehospitalization for chronic patients and defines out-of-hospital health facilities at this purpose. It has never been investigated how much patients with cancer know and judge this decree law.

MATERIAL AND METHODS: The Collegio italiano dei primari oncologi medici ospedalieri (Cipomo) carried out a survey with a dedicated questionnaire on oncological patients attending public hospital to investigate the liking of DM 77.

RESULTS: Anonymous responses were obtained from 1.443 patients. Median age 64ys, 42% males, 21% live alone, 70% have a companion. 19% thinks that oral chemotherapy could be managed outside the hospital, 26.68% carried out follow-up (FU),19.15% parenteral therapy, 32.16% basic examinations. Home is preferred by 21.8%, a health facility close to home by 36.3%, hospital by 37.54%. 59.67% would like FU in hospital by their personal oncologist, 5.47% by GP, 35.41% by both together and 9.45% by oncologist outside the hospital. Asked what they might feel about being followed out of the hospital, 29.94% say of not being treated at its best, 12.68% of not being able to be visited in hospital anymore, 5.27% of being abandoned, 30.7% of being freer and 10.88% of feeling less sick. Regarding the use of new technical tools to favor dehospitalisation, 44.15% answered yes, 15.88% no and 30.07% did not know. About the distance or traveling time from home to the therapy administration side, 20.26% answered this should be no more than 15 km or 30 mins, 9.91% no more than 30 km or 45 mins, 5.47% no more than 50 km or 60 mins but 39.5% say that the distance does not matter to them but only the continuity of care. The question related to the inconveniences with going to hospital for therapy: 40.81% waiting time, 20.47% lack of parking, 17.02% rotation of doctors,12.76% travel time and 5.62% bureaucracy.

CONCLUSIONS: The patients’ answers suggest that dehospitalization could improve their quality of life, but at the condition of being able to maintain a close relationship with the personal oncologist.

PMID:38708534 | DOI:10.1701/4262.42402

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Nevin Manimala Statistics

Semiparametric analysis of nonparametric proportional hazards models with mixed dependent censored data

Nan Fang Yi Ke Da Xue Xue Bao. 2024 Apr 20;44(4):689-696. doi: 10.12122/j.issn.1673-4254.2024.04.10.

ABSTRACT

OBJECTIVE: To construct a nonparametric proportional hazards (PH) model for mixed informative interval-censored failure time data for predicting the risks in heart transplantation surgeries.

METHODS: Based on the complexity of mixed informative interval-censored failure time data, we considered the interdependent relationship between failure time process and observation time process, constructed a nonparametric proportional hazards (PH) model to describe the nonlinear relationship between the risk factors and heart transplant surgery risks and proposed a two-step sieve estimation maximum likelihood algorithm. An estimation equation was established to estimate frailty variables using the observation process model. Ⅰ-spline and B-spline were used to approximate the unknown baseline hazard function and nonparametric function, respectively, to obtain the working likelihood function in the sieve space. The partial derivative of the model parameters was used to obtain the scoring equation. The maximum likelihood estimation of the parameters was obtained by solving the scoring equation, and a function curve of the impact of risk factors on the risk of heart transplantation surgery was drawn.

RESULTS: Simulation experiment suggested that the estimated values obtained by the proposed method were consistent and asymptotically effective under various settings with good fitting effects. Analysis of heart transplant surgery data showed that the donor’s age had a positive linear relationship with the surgical risk. The impact of the recipient’s age at disease onset increased at first and then stabilized, but increased against at an older age. The donor-recipient age difference had a positive linear relationship with the surgical risk of heart transplantation.

CONCLUSION: The nonparametric PH model established in this study can be used for predicting the risks in heart transplantation surgery and exploring the functional relationship between the surgery risks and the risk factors.

PMID:38708502 | DOI:10.12122/j.issn.1673-4254.2024.04.10