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Nevin Manimala Statistics

Randomized investigation of heart failure therapy in patients with advanced cancer at risk of cardiac wasting: Rationale and design of the EMPATICC trial

Eur J Heart Fail. 2025 Aug 26. doi: 10.1002/ejhf.3799. Online ahead of print.

ABSTRACT

AIMS: End-stage cancer may resemble a heart failure (HF)-like phenotype marked by cardiac wasting, dysfunction, and symptoms such as dyspnoea, congestion, and impaired physical function. The EMPATICC (EMPower the heArt of patients with TermInal Cancer using Cardiac medicines) trial evaluates the safety and efficacy of optimized HF therapy in patients with advanced cancer to improve self-care ability.

METHODS: EMPATICC is a multicentre, investigator-initiated, randomized, double-blind, controlled, proof-of-concept trial employing a joint cardio-oncology care approach. Patients were randomized 1:1 to optimized HF therapy (sacubitril/valsartan, empagliflozin, ivabradine, ferric carboxymaltose) plus usual care, or usual care alone, for 30 days, followed by a 30-day open-label extension. Eligible patients had stage IV solid tumours (per Union for International Cancer Control), were receiving palliative care, had a 1-6 month life expectancy, and were on optimized analgesia. At baseline, first patients had to meet ≥2 criteria of the following indicating cardiovascular risk: heart rate ≥70 bpm, N-terminal pro-B-type natriuretic peptide ≥600 pg/ml, elevated high-sensitivity troponin, left ventricular ejection fraction <55%, left ventricular mass loss >15%, transferrin saturation <20%, or moderate/high likelihood of HF with preserved ejection fraction (based on the HFA-PEFF score); and they had to meet at least one criterion of the following indicating functional limitation: ≥6 s to walk 4 m, inability to wash ≥3 days of the last 7 days, or symptoms of dyspnoea at rest. Enrolment ended 30 January 2025; 93 patients completed randomization. The primary endpoint is a hierarchical composite (analysed by win ratio): (1) days alive and able to wash, (2) 4 m walking ability, and (3) patient global assessment of well-being.

CONCLUSIONS: EMPATICC evaluates whether HF therapy can improve function and well-being in advanced cancer, potentially reshaping care in this population.

PMID:40857084 | DOI:10.1002/ejhf.3799

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Nevin Manimala Statistics

Depression improves the predictive accuracy of the VACS Index 2.0 for all-cause mortality among sexual minority men living with HIV in the Multicenter AIDS Cohort Study

J Acquir Immune Defic Syndr. 2025 Aug 26. doi: 10.1097/QAI.0000000000003752. Online ahead of print.

ABSTRACT

BACKGROUND: The Veterans Aging Cohort Study (VACS) Index 2.0 accurately predicts mortality using age and clinical biomarkers, but adding behavioral and psychosocial factors that are common among sexual minority men (SMM) may improve its predictive accuracy. We examined whether adding these factors would improve mortality prediction among SMM living with HIV.

METHODS: We included 1,438 SMM in the Multicenter AIDS Cohort Study (MACS) who initiated highly active antiretroviral therapy (HAART) for at least one year between January 1996 and September 2022. We divided the sample into development (70%) and validation (30%) sets. We used Cox proportional hazards models to develop new indices in the development set by adding binary behavioral and psychosocial factors (depression, cigarette smoking, heavy alcohol use, polydrug use) or the total number of these factors in the VACS Index 2.0 and estimated mortality using Weibull survival models. We compared accuracy using C-statistics and calibration curves in the validation set and within subgroups (age, race, CD4 count, and viral suppression).

RESULTS: Among the 1,438 SMM, 83 (5.8%) died within 5 years of follow-up. Depression significantly predicted 5-year mortality after adjusting for the VACS Index 2.0 and resulted in a 70% increased risk of death (aHR=1.70, 95% CI=1.10-2.63) compared to men without depression. The addition of depression improved C-statistics from 0.818 to 0.851 in the development set. Results were robust in all subgroups.

CONCLUSIONS: Including depression improved the VACS Index 2.0 in predicting mortality. Screening and treating depression could improve health and reduce mortality among SMM living with HIV.

PMID:40857055 | DOI:10.1097/QAI.0000000000003752

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Nevin Manimala Statistics

Surgical Treatment of Fingertip Defects Associated With Nail Bed Injuries: A Dual-Flap Reconstruction Protocol

Ann Plast Surg. 2025 Sep 1;95(3):268-272. doi: 10.1097/SAP.0000000000004477.

ABSTRACT

PURPOSE: To analyze the aesthetic and functional results of a dual-flap reconstruction protocol for nail expansion by recessing the nail fold to increase the exposed nail matrix after repair of finger pulp defect.

METHODS: A total of 18 patients who underwent a dual-flap reconstruction protocol were retrospectively reviewed. We increased nail bed exposure by recessing a Y-V flap of eponychium and reconstructed the pulp with volar V-Y advancement flaps or homodigital island flaps depending on the injury geometry. A controllable 0.3- to 0.45-cm-wide recession of eponychium was feasible. The eponychial Y-V recession flap was separated from the nail matrix and slid proximally to expose more nail matrix, thereby effectively lengthening the exposed nail bed.

RESULTS: The flaps survived in all patients. The exposed nail beds were lengthened 0.3 to 0.45 cm. The fingertips had smooth and natural nail plates with inconspicuous scars on both the eponychium and pulp and no deformities. The mobility of injured and uninjured contralateral fingers did not differ statistically. All patients and observers were satisfied with the appearance and function of the reconstructed fingertips.

CONCLUSIONS: The eponychial Y-V recession flap combined with volar soft tissue reconstruction provided for the aesthetic and functional restoration of the fingertip defects with partial nail bed defect.

PMID:40857042 | DOI:10.1097/SAP.0000000000004477

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Nevin Manimala Statistics

Circulating fatty acid binding protein 4 (FABP-4) concentrations and mortality in individuals with colorectal cancer in the European Prospective Investigation into Cancer and Nutrition study

Int J Cancer. 2025 Aug 26. doi: 10.1002/ijc.70090. Online ahead of print.

ABSTRACT

Human fatty acid binding protein-4 (FABP-4), a protein elevated in obesity that promotes colon cancer cell invasiveness and metastasis, may be associated with higher mortality in individuals with colorectal cancer (CRC) and may serve as a mediator of the obesity-mortality association in these individuals. We used a causal diagram to inform covariate selection and applied Cox proportional hazards models to estimate hazard ratios (HRs) for CRC-specific, non-CRC-specific, and all-cause mortality by FABP-4 levels measured in baseline blood samples from 1371 incident CRC cases from the European Prospective Investigation into Cancer and Nutrition cohort. Competing risk analyses were adapted for CRC and non-CRC deaths. Mediation analyses were conducted to estimate total effects (TEs), direct effects (DEs), and mediation proportions (MPs) by FABP-4 of pre-diagnostic body mass index (BMI) on mortality. In the fully adjusted model including BMI, higher circulating FABP-4 concentrations were associated with higher CRC mortality (HRQ4vsQ1 = 1.49; 95% CI: 1.11-2.00) and all-cause mortality (HRQ4vsQ1 = 1.49; 95% CI: 1.15-1.93), but not statistically associated with non-CRC mortality (HRQ4vsQ1 = 1.51; 95% CI: 0.82-2.76). The TE and DE per 5 kg/m2 of BMI on all-cause mortality were 1.21; 95% CI: 1.10-1.34, and 1.13; 95% CI: 1.02-1.26, respectively, with a MP of 34.5% (p = .002) by FABP-4. For CRC-specific and non-CRC-specific mortality, MPs by FABP-4 were 33.7% (p = .03) and 36.1% (p = .02), respectively. In conclusion, higher concentrations of FABP-4 were associated with higher CRC-specific and all-cause mortality in individuals with CRC. FABP-4 was a significant partial mediator of the adiposity-mortality relationship in individuals with CRC.

PMID:40857027 | DOI:10.1002/ijc.70090

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Nevin Manimala Statistics

Podoplanin Expression and the Risk of Malignant Transformation of Oral Pre-Malignant Disease: A Systematic Review and Meta-Analysis

Head Neck. 2025 Aug 26. doi: 10.1002/hed.70018. Online ahead of print.

ABSTRACT

BACKGROUND: Podoplanin is a mucin-like transmembrane glycoprotein expressed in oral epithelium with a documented role in cell motility, tumorigenesis, tumor invasion, and metastasis. Podoplanin is a potentially valuable biomarker for determining malignant transformation of oral premalignant disease (OPMD).

METHODS: A systematic search was done in accordance with PRISMA guidelines for articles reporting podoplanin expression in OPMD. The outcomes compared were the presence of podoplanin expression, the grade of podoplanin expression, and the incidence of malignant transformation. Statistical analysis of these outcomes included proportions (%), sensitivity, negative predictive value, and hazard ratio (HR) with 95% confidence intervals (CI).

RESULTS: There were 14 included studies (N = 971) with 78.7% OPMD, 13.9% OSCC, and 7.4% healthy controls. Positive expression of podoplanin had a sensitivity and negative predictive value for malignant transformation of 78.9% [95% CI: 69.7%-86.2%] and 88.8% [84.4%-92.1%], respectively. The hazard ratio was 4.4 for the malignant transformation of podoplanin expressing OPMDs [95% CI: 2.6-7.4].

CONCLUSIONS: Podoplanin expression levels increased in a gradient from normal tissue to OPMD to OSCC, respectively. Furthermore, OPMD with podoplanin expression has higher rates of malignant transformation than OPMDs not expressing podoplanin.

PMID:40857023 | DOI:10.1002/hed.70018

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Nevin Manimala Statistics

Augmenting Treatment Arms With External Data Through Propensity-Score Weighted Power Priors: An Application in Expanded Access

Stat Med. 2025 Aug;44(18-19):e70168. doi: 10.1002/sim.70168.

ABSTRACT

The incorporation of real-world data to supplement the analysis of trials and improve decision-making has spurred the development of statistical techniques to account for introduced confounding. Recently, “hybrid” methods have been developed through which measured confounding is first attenuated via propensity scores and unmeasured confounding is addressed through (Bayesian) dynamic borrowing. Most efforts to date have focused on augmenting control arms with historical controls. Here we consider augmenting treatment arms through “expanded access”, which is a pathway of nontrial access to investigational medicine for patients with seriously debilitating or life-threatening illnesses. Motivated by a case study on expanded access, we developed a novel method (the ProPP) that provides a conceptually simple and easy-to-use combination of propensity score weighting and the modified power prior. Our weighting scheme is based on the estimation of the average treatment effect of the patients in the trial, with the constraint that external patients cannot receive higher weights than trial patients. The causal implications of the weighting scheme and propensity-score integrated approaches in general are discussed. In a simulation study, our method compares favorably with existing (hybrid) borrowing methods in terms of precision and type I error rate. We illustrate our method by jointly analyzing individual patient data from the trial and expanded access program for vemurafenib to treat metastatic melanoma. Our method provides a double safeguard against prior-data conflict and forms a straightforward addition to evidence synthesis methods of trial and real-world (expanded access) data.

PMID:40857021 | DOI:10.1002/sim.70168

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Nevin Manimala Statistics

Factors Influencing Midazolam Dose for Intravenous Sedation in Dental Patients With Anxiety: A Retrospective Observational Study

Oral Health Prev Dent. 2025 Aug 26;23:499-506. doi: 10.3290/j.ohpd.c_2226.

ABSTRACT

PURPOSE: This study aimed to assess factors that impact midazolam dose for intravenous sedation (IVS) in dental patients with anxiety.

MATERIALS AND METHODS: This was a retrospective, observational study for adult, anxious patients (moderate to severe dental anxiety) who had different types of dental procedures under IVS with midazolam and local anaesthesia. A logbook of dental patients who had dental procedures was used to collect data on an Excel sheet (Microsoft Excel Workbook 2024).

RESULTS: Data of 233 patients were recorded. The average dose of IVS with midazolam delivered was 6.62 mg (SD = 3.24). Multivariable logistic regression found that two variables were statistically significant predictors for the IVS with midazolam dose, which are age (B = 1.30, S.E = 0.47, Exp(B) = 3.68, 95% CI = 1.45-9.33, P = 0.006) and non-surgical periodontal therapy with root planing (B = 0.85, SE = 0.39, Exp(B) = 2.35, 95% CI = 1.08-5.12, P = 0.031).

CONCLUSIONS: Younger patients and non-surgical periodontal therapy with root planing appear to be predictors for higher doses of IVS with midazolam. Other variables that were not predictors to affect IVS with midazolam dose, such as medical history, American Society of Anesthesiologists (ASA) classification, medications, and others, are crucial, and they should not be neglected when designing the treatment plan to deliver dental treatment under IVS with midazolam.

PMID:40857015 | DOI:10.3290/j.ohpd.c_2226

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Nevin Manimala Statistics

The Impact of Instagram on Dental Professionals in Saudi Arabia: A Cross-Sectional Investigation

Oral Health Prev Dent. 2025 Aug 26;23:489-498. doi: 10.3290/j.ohpd.c_2231.

ABSTRACT

PURPOSE: This study aimed to assess the utilisation of Instagram primarily as a marketing tool among dentists in Saudi Arabia and its perceived impact on patient engagement.

MATERIALS AND METHODS: A cross-sectional survey was conducted among 385 dentists using a convenience sampling method. The questionnaire collected data on demographics, Instagram usage patterns, perception of marketing strategies on the platform, and factors influencing the selection of a dentist or dental clinic. Data were analysed using IBM SPSS Statistics and presented as descriptive statistics and bivariate analyses.

RESULTS: A total of 385 responses were received, yielding a response rate of 64.2%. Approximately 77.1% of participants reported regular Instagram use, with nearly half accessing the platform more than three times per day. Most respondents indicated using Instagram for personal purposes (42.9%) and marketing (39%). The most effective marketing strategies identified were paid promotional advertisements (75%), Instagram searches (55%), and patient recommendations (50.1%). Key content-related factors enhancing account appeal included clinical case photos (84.9%) and high-quality images (99%). Dentists working in the private sector were more likely to utilise Instagram for marketing and reported a significant increase in patient flow (60%) as a result.

CONCLUSION: Instagram serves as a valuable marketing platform for Saudi dental professionals, particularly in the private sector. The platform enhances patient outreach, practice visibility, and brand building. Further research is recommended to explore ethical guidelines, content strategies, and potential applications in professional and patient education.

PMID:40857014 | DOI:10.3290/j.ohpd.c_2231

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Nevin Manimala Statistics

Association Between Periodontitis and SARS-CoV-2 Infection Severity: A Cross-Sectional Study in a Turkish Population

Oral Health Prev Dent. 2025 Aug 26;23:479-487. doi: 10.3290/j.ohpd.c_2234.

ABSTRACT

PURPOSE: The aim of the present study was to evaluate the association between periodontitis and SARS-CoV-2 infection severity in a Turkish population.

METHODS: Adult patients attending hospital consultation and testing positive for SARS-CoV-2 infection were consecutively enrolled in this study. Demographic variables, smoking status, COVID-19 symptoms, SpO2 levels, and markers of inflammation (D-Dimer, lymphocytes and white blood cells count, CRP) were recorded. Patients suspected of periodontal disease were evaluated using self-reported questionnaires (OHIP-14, modified CDC/AAP questionnaire). Periodontal screening score (PESS) was calculated from the questionnaire. Univariate and multivariate logistic regression analyses were performed to evaluate the association between COVID-19-associated parameters and periodontitis.

RESULTS: The study included 134 patients diagnosed with COVID-19. Nearly half of the participants were female (n = 68, 50.7%), and the mean age of the patients was 48.7 ± 18.2 years. A statistically significant majority of individuals (69.2%) were asymptomatic, while 22.3% experienced mild symptoms, and 8.5% reported moderate or severe symptoms. Oxygen saturation was found to be higher in asymptomatic patients (96.4 ± 2.8) compared to mild (90.4 ± 5.1) and moderate/severe patients (86.6 ± 8.9) (P 0.001). There was no statistically significant difference concerning OHIP-14 score (P = 0.316), periodontitis (PESS ≥ 5) (P = 0.130), brushing habits (P = 0.901), and frequency of dental visits (P = 0.975) when considering SARS-CoV-2 infection severity. In multivariate logistic regression analysis, it was concluded that male gender (OR = 2.90, 95% CI: 1.04-8.04, P = 0.040), age 55 and above (OR = 5.94, 95% CI: 1.22-28.76, P = 0.026), and smoking (OR = 0.14, 95% CI: 0.02-0.75, P = 0.022) were statistically significant predictors of SARS-CoV-2 infection severity.

CONCLUSIONS: Even the association between SARS-CoV-2 infection severity and periodontitis, evaluated through self-reported outcome measures, were weak: male gender, age, and smoking were independent risk factors for SARS-CoV-2 infection severity in this patient cohort. Further research is warranted to explore these associations comprehensively.

PMID:40857013 | DOI:10.3290/j.ohpd.c_2234

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Nevin Manimala Statistics

Body Mass Index and Postsurgical Outcomes in Older Adults

JAMA Netw Open. 2025 Aug 1;8(8):e2528875. doi: 10.1001/jamanetworkopen.2025.28875.

ABSTRACT

IMPORTANCE: High body mass index (BMI) has been associated with increased postoperative complications including mortality in the general population, leading many perioperative clinicians to recommend preoperative lifestyle modifications aimed at achieving normal body weight. However, aging introduces physiological changes associated with frailty, such as altered body composition, fat redistribution, and stature reduction due to height loss, all of which may modify the association between BMI and surgical outcomes in older adults.

OBJECTIVE: To determine if a higher BMI in older adults who are undergoing major elective surgery is associated with rates of all-cause mortality.

DESIGN, SETTING, AND PARTICIPANTS: Cohort study of adults aged 65 years or older presenting for surgery from February 2019 to January 2022 at a preoperative clinic before planned major elective surgery at a large academic Center in Southern California.

EXPOSURE: Body mass index.

MAIN OUTCOMES AND MEASURES: Postoperative outcomes included all-cause 30-day and 1-year mortality, postoperative delirium, discharge disposition, and complications classified using the Clavien-Dindo system.

RESULTS: The study included 414 older adults undergoing major elective surgery with a mean (SD) age of 75.9 (7.2) years; 54.8% (95% CI, 50.2%-60.4%) of the cohort were female. The prevalence of frailty was 24.2% (95% CI, 20.3%-28.5%), and 37.0% (95% CI, 32.6%-41.8%) of the cohort was prefrail. The overall 30-day all-cause mortality rate was 11.0% (95% CI, 8.5%-14.5%). Patients categorized as overweight (BMI, 25.0-29.9; calculated as weight in kilograms divided by height in meters squared) had the lowest 30-day all-cause mortality rate, with a significant risk reduction compared with patients with a normal BMI (18.5-24.9) (1 of 128 patients [0.8%] vs 25 of 133 patients [18.8%]; odds ratio [OR], 0.03; 95% CI, 0.01-0.26; P = .001). This association remained significant in the multivariable logistic regression model after adjusting for potential confounders (OR, 0.14; 95% CI, 0.06-0.34; P < .001). Patients categorized as underweight (BMI <18.5) had the highest 30-day all-cause mortality rate (15 of 20 patients [75.0%]; 95% CI, 55.0%-90.0%).

CONCLUSIONS AND RELEVANCE: In this observational cohort study of older adults undergoing major elective surgery, being overweight was associated with lower odds of 30-day all-cause mortality. These findings suggest that traditional weight loss recommendations based on achieving normal BMI may need to be reevaluated for this population.

PMID:40857003 | DOI:10.1001/jamanetworkopen.2025.28875