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Nevin Manimala Statistics

Efficacy and safety of low-dose spironolactone for chronic kidney disease in type 2 diabetes

J Clin Endocrinol Metab. 2023 Mar 14:dgad144. doi: 10.1210/clinem/dgad144. Online ahead of print.

ABSTRACT

CONTEXT: Although adding spironolactone to renin-angiotensin system blockers reduces albuminuria in adults with chronic kidney disease and type 2 diabetes, it increases the risk of hyperkalemia.

OBJECTIVE: To assess whether a lower dose of spironolactone (12.5 mg/day) reduces the risk of hyperkalemia while maintaining its effect on reducing albuminemia.

DESIGN: Multicenter, open-label, randomized controlled trial.

SETTING: This study was conducted from July 2016 to November 2020 in ambulatory care at three diabetes medical institutions in Japan.

PATIENTS: We enrolled 130 Japanese adults with type 2 diabetes and albuminuria (≥30 mg/gCre), estimated glomerular filtration rate ≥30 mL/min/1.73 m2, and serum potassium level <5.0 mEq/L.

INTERVENTIONS: The participants were randomly assigned to the spironolactone-administered and control groups.

MAIN OUTCOME MEASURES: Changes in urine albumin-to-creatinine ratio (UACR) from baseline over the 24-week interventional period.

RESULTS: The spironolactone group showed a significant reduction in UACR from baseline (mean decrease: 103.47 ± 340.80 mg/gCre) compared with the control group which showed an increased UACR (mean increase: 63.93 ± 310.14 mg/gCre; p = 0.0007, Wilcoxon rank-sum test and t-test). Although the spironolactone group had a statistically significant increase in serum potassium levels, none of the participants had a potassium level ≥5.5 mEq/L at 24 weeks. Further, participants with a higher initial serum potassium level tended to have a smaller increase (estimate -0.37, analysis of covariance).

CONCLUSIONS: Low-dose spironolactone administration reduced albuminuria without causing hyperkalemia. Spironolactone administration, the oldest known and most cost-effective mineralocorticoid receptor antagonist, at lower doses should be reconsidered.

PMID:36916985 | DOI:10.1210/clinem/dgad144

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Nevin Manimala Statistics

Safety and Efficacy of Topical Calcineurin Inhibitors in the Treatment of Facial and Genital Psoriasis: A Systematic Review

Acta Derm Venereol. 2023 Mar 14;103:adv00890. doi: 10.2340/actadv.v103.6525.

ABSTRACT

Facial and genital psoriasis impairs quality of life and is challenging to treat because of increased percutaneous penetration and, consequently, increased risk of adverse effects. Topical calcineurin inhibitors are recognized as a valid off-label treatment for these sensitive skin areas, but data on safety and efficacy are limited. This systematic review of the literature included 24 of 3,322 studies (5 randomized controlled trials, 9 open-label studies, 2 case series and 8 case reports). All studies demonstrated positive efficacy; 11 studies found statistically significant reductions in psoriasis severity. Local stinging, burning and itching were the most common short-term adverse effects and were reported in 18 studies. Topical calcineurin inhibitors appear to have an important role in the treatment of facial and genital psoriasis. The drugs are effective and generally well-tolerated with few adverse effects.

PMID:36916954 | DOI:10.2340/actadv.v103.6525

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Nevin Manimala Statistics

Emergence of time persistence in a data-driven neural network model

Elife. 2023 Mar 14;12:e79541. doi: 10.7554/eLife.79541. Online ahead of print.

ABSTRACT

Establishing accurate as well as interpretable models of network activity is an open challenge in systems neuroscience. Here we infer an energy-based model of the ARTR, a circuit that controls zebrafish swimming statistics, using functional recordings of the spontaneous activity of hundreds of neurons. Although our model is trained to reproduce the low-order statistics of the network activity at short time-scales, its simulated dynamics quantitatively captures the slowly alternating activity of the ARTR. It further reproduces the modulation of this persistent dynamics by the water temperature and visual stimulation. Mathematical analysis of the model unveils a low-dimensional landscape-based representation of the ARTR activity, where the slow network dynamics reflects Arrhenius-like barriers crossings between metastable states. Our work thus shows how data-driven models built from large neural populations recordings can be reduced to low-dimensional functional models in order to reveal the fundamental mechanisms controlling the collective neuronal dynamics.

PMID:36916902 | DOI:10.7554/eLife.79541

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Nevin Manimala Statistics

A model of hippocampal replay driven by experience and environmental structure facilitates spatial learning

Elife. 2023 Mar 14;12:e82301. doi: 10.7554/eLife.82301. Online ahead of print.

ABSTRACT

Replay of neuronal sequences in the hippocampus during resting states and sleep play an important role in learning and memory consolidation. Consistent with these functions, replay sequences have been shown to obey current spatial constraints. Nevertheless, replay does not necessarily reflect previous behavior and can construct never-experienced sequences. Here we propose a stochastic replay mechanism that prioritizes experiences based on three variables: 1. Experience strength, 2. experience similarity, and 3. inhibition of return. Using this prioritized replay mechanism to train reinforcement learning agents leads to far better performance than using random replay. Its performance is close to the state-of-the-art, but computationally intensive, algorithm by Mattar & Daw (2018). Importantly, our model reproduces diverse types of replay because of the stochasticity of the replay mechanism and experience-dependent differences between the three variables. In conclusion, a unified replay mechanism generates diverse replay statistics and is efficient in driving spatial learning.

PMID:36916899 | DOI:10.7554/eLife.82301

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Nevin Manimala Statistics

Mammographic Screening in Routine Practice: Multisite Study of Digital Breast Tomosynthesis and Digital Mammography Screenings

Radiology. 2023 Mar 14:221571. doi: 10.1148/radiol.221571. Online ahead of print.

ABSTRACT

Background The use of digital breast tomosynthesis (DBT) is increasing over digital mammography (DM) following studies demonstrating lower recall rates (RRs) and higher cancer detection rates (CDRs). However, inconsistent interpretation of evidence on the risks and benefits of mammography has resulted in varying screening mammography recommendations. Purpose To evaluate screening outcomes among women in the United States who underwent routine DM or DBT mammographic screening. Materials and Methods This retrospective cohort study included women aged 40-79 years who underwent DM or DBT screening mammograms between January 2014 and December 2020. Outcomes of RR, CDR, positive predictive value of recall (PPV1), biopsy rate, and positive predictive value of biopsy (PPV3) were compared between DM and DBT with use of adjusted multivariable logistic regression models. Results A total of 2 528 063 screening mammograms from 1 100 447 women (mean age, 57 years ± 10 [SD]) were included. In crude analyses, DBT (1 693 727 screening mammograms vs 834 336 DM screening mammograms) demonstrated lower RR (10.3% [95% CI: 10.3, 10.4] for DM vs 8.9% [95% CI: 8.9, 9.0] for DBT; P < .001) and higher CDR (4.5 of 1000 screening mammograms [95% CI: 4.3, 4.6] vs 5.3 of 1000 [95% CI: 5.2, 5.5]; P < .001), PPV1 (4.3% [95% CI: 4.2, 4.5] vs 5.9% [95% CI: 5.7, 6.0]; P < .001), and biopsy rates (14.5 of 1000 screening mammograms [95% CI: 14.2, 14.7] vs 17.6 of 1000 [95% CI: 17.4, 17.8]; P < .001). PPV3 was similar between cohorts (30.0% [95% CI: 29.2, 30.9] for DM vs 29.3% [95% CI: 28.7, 29.9] for DBT; P = .16). After adjustment for age, breast density, site, and index year, associations remained stable with respect to statistical significance. Conclusion Women undergoing digital breast tomosynthesis had improved screening mammography outcomes compared with women who underwent digital mammography. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Bae and Seo in this issue.

PMID:36916891 | DOI:10.1148/radiol.221571

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Nevin Manimala Statistics

Cardiac MRI to Predict Sudden Cardiac Death Risk in Dilated Cardiomyopathy

Radiology. 2023 Mar 14:222552. doi: 10.1148/radiol.222552. Online ahead of print.

ABSTRACT

Background Sudden cardiac death (SCD) is one of the leading causes of death in individuals with nonischemic dilated cardiomyopathy (DCM). However, the risk stratification of SCD events remains challenging in clinical practice. Purpose To determine whether myocardial tissue characterization with cardiac MRI could be used to predict SCD events and to explore a SCD stratification algorithm in nonischemic DCM. Materials and Methods In this prospective single-center study, adults with nonischemic DCM who underwent cardiac MRI between June 2012 and August 2020 were enrolled. SCD-related events included SCD, appropriate implantable cardioverter-defibrillator shock, and resuscitation after cardiac arrest. Competing risk regression analysis and Kaplan-Meier analysis were performed to identify the association of myocardial tissue characterization with outcomes. Results Among the 858 participants (mean age, 48 years; age range, 18-83 years; 603 men), 70 (8%) participants experienced SCD-related events during a median follow-up of 33.0 months. In multivariable competing risk analysis, late gadolinium enhancement (LGE) (hazard ratio [HR], 1.87; 95% CI: 1.07, 3.27; P = .03), native T1 (per 10-msec increase: HR, 1.07; 95% CI: 1.04, 1.11; P < .001), and extracellular volume fraction (per 3% increase: HR, 1.26; 95% CI: 1.11, 1.44; P < .001) were independent predictors of SCD-related events after adjustment of systolic blood pressure, atrial fibrillation, and left ventricular ejection fraction. An SCD risk stratification category was developed with a combination of native T1 and LGE. Participants with a native T1 value 4 or more SDs above the mean (1382 msec) had the highest annual SCD-related events rate of 9.3%, and participants with a native T1 value 2 SDs below the mean (1292 msec) and negative LGE had the lowest rate of 0.6%. This category showed good prediction ability (C statistic = 0.74) and could be used to discriminate SCD risk and competing heart failure risk. Conclusion Myocardial tissue characteristics derived from cardiac MRI were independent predictors of sudden cardiac death (SCD)-related events in individuals with nonischemic dilated cardiomyopathy and could be used to stratify participants according to different SCD risk categories. Clinical trial registration no. ChiCTR1800017058 © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Sakuma in this issue.

PMID:36916890 | DOI:10.1148/radiol.222552

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Nevin Manimala Statistics

Flat-panel detector CT to assess intracranial hemorrhage immediately following mechanical thrombectomy

J Neuroimaging. 2023 Mar 14. doi: 10.1111/jon.13098. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: The risk of symptomatic intracranial hemorrhage (ICH) approaches 5% despite mechanical thrombectomy (MT) efficacy for ischemic stroke secondary to large vessel occlusion. Flat-panel detector CT (FDCT) imaging with Syngo Dyna CT imaging (Siemens Medical Solutions, Malvern, PA) can be used immediately following MT to detect ICH.

PURPOSE: To evaluate the accuracy and reliability of FDCT imaging with Dyna CT compared to conventional post-MT CT and MRI.

METHODS: Head FDCT (20 second, 70 kV) was performed immediately following MT on 26 consecutive patients; postprocedural CT or MRI was obtained ∼24 hours later. Two blinded, independent neuroradiologists evaluated all imaging, identifying ICH, stroke, and presence of subarachnoid contrast. Cohen’s κ statistic was used to assess interrater agreement for each imaging outcome and compared the FDCT to conventional imaging.

RESULTS: FDCT for ICH demonstrated a strong degree of interrater reliability (κ = 0.896; 95% confidence interval [CI], 0.734-1.057). Negligible reliability was seen for ischemia determination on immediate post-MT FDCT (κ = 0.149; 95% CI, -0.243 to 0.541). ICH evaluation between FDCT and post-MT conventional CT revealed modest interrater reliability (κ = 0.432; 95% CI, -0.100 to 0.965), which did not reach statistical significance. There was no substantive reliability in the evaluation of ICH between FDCT and post-MT MRI (κ = 0.118, 95% CI, -0.345 to 0.580).

CONCLUSION: FDCT, such as Dyna CT, immediately post-MT is a promising tool that can expedite the detection of ICH with a high degree of reliability, although the detection of ischemic parenchymal changes is limited.

PMID:36916873 | DOI:10.1111/jon.13098

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Nevin Manimala Statistics

Twelve-Month Outcomes of a Novel Iopromide-Based Paclitaxel-Coated Balloon for the Treatment of Chronic Total Occlusion of Femoropopliteal Arteries

Turk Kardiyol Dern Ars. 2023 Mar;51(2):112-118. doi: 10.5543/tkda.2022.25324.

ABSTRACT

OBJECTIVE: We designed a retrospective study to evaluate the performance and outcomes of a novel iopromide-based paclitaxel-coated balloon for the treatment of chronic total occlusion of femoropopliteal arteries.

METHODS: Patients with femoropopliteal chronic total occlusion (<100 mm) on angiogram were screened from hospital management system and were included in the study. The width and length of the drug-eluting peripheral balloon was chosen to ensure a vessel/balloon ratio of 1: 1 and exceed the lesion by 10 mm on both ends (based on visual estimation).

RESULTS: The proportion of patients with ankle-brachial index improvement was 89.8% (106 of 118). The mean ankle-brachial index was 0.5 (0.4-0.7) at baseline and 0.8 (0.7-0.9) at 12 months (P < 0.001). Changes in the Rutherford category between baseline and 12 months were statistically significant (P < 0.001), with the majority of patients (77.9%, 92/118) having ≥1 level improvement. The rate of clinically driven target lesion revasculariza-tion at 12 months was 13.5%(16/118). Overall, the 1-year primary patency rate was 86.4% (102 of 118). The major adverse limb event rate was 9.8% (16/162). Acute limb ischemia was detected in 14 patients, and amputation was performed in 2 patients.

CONCLUSION: Our study is a non-randomized clinical study focusing on the use of drug-eluting balloon as a single treatment strategy. There was significant clinical benefit to patients, as clearly demonstrated by the improvement in ankle-brachial index and the reduction in Rutherford class in the short term, and these results may offer clear insights on the revascularization strategy outlook of interventionalists.

PMID:36916806 | DOI:10.5543/tkda.2022.25324

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Nevin Manimala Statistics

Prognostic factors for delayed healing of complex wounds in adults: A scoping review

Int Wound J. 2023 Mar 14. doi: 10.1111/iwj.14128. Online ahead of print.

ABSTRACT

Complex or hard-to-heal wounds continue to be a challenge because of the negative impact they have on patients, caregivers, and all the associated costs. This study aimed to identify prognostic factors for the delayed healing of complex wounds. Five databases and grey literature were the sources used to research adults with pressure ulcers/injuries, venous leg ulcers, critical limb-threatening ischaemia, or diabetic foot ulcers and report the prognostic factors for delayed healing in all care settings. In the last 5 years, a total of 42 original peer-reviewed articles were deemed eligible for this scoping review that followed the JBI recommendations and checklist PRISMA-ScR. The most frequent prognostic factors found with statistical significance coinciding with various wound aetiologies were: gender (male), renal disease, diabetes, peripheral arterial disease, the decline in activities of daily life, wound duration, wound area, wound location, high-stage WIfI classification, gangrene, infection, previous ulcers, and low ankle brachial index. It will be essential to apply critical appraisal tools and assessment risk of bias to the included studies, making it possible to make recommendations for clinical practice and build prognostic models. Future studies are recommended because the potential for healing through identification of prognostic factors can be determined, thus allowing an appropriate therapeutic plan to be developed.

PMID:36916415 | DOI:10.1111/iwj.14128

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Nevin Manimala Statistics

Integrated gene profiling of fine-needle aspiration sample improves lymph node metastasis risk stratification for thyroid cancer

Cancer Med. 2023 Mar 14. doi: 10.1002/cam4.5770. Online ahead of print.

ABSTRACT

BACKGROUND: Lymph node metastasis risk stratification is crucial for the surgical decision-making of thyroid cancer. This study investigated whether the integrated gene profiling (combining expression, SNV, fusion) of Fine-Needle Aspiration (FNA) samples can improve the prediction of lymph node metastasis in patients with papillary thyroid cancer.

METHODS: In this retrospective cohort study, patients with papillary thyroid cancer who went through thyroidectomy and central lymph node dissection were included. Multi-omics data of FNA samples were assessed by an integrated array. To predict lymph node metastasis, we built models using gene expressions or mutations (SNV and fusion) only and an Integrated Risk Stratification (IRS) model combining genetic and clinical information. Blinded histopathology served as the reference standard. ROC curve and decision curve analysis was applied to evaluate the predictive models.

RESULTS: One hundred and thirty two patients with pathologically confirmed papillary thyroid cancer were included between 2016-2017. The IRS model demonstrated greater performance [AUC = 0.87 (0.80-0.94)] than either expression classifier [AUC = 0.67 (0.61-0.74)], mutation classifier [AUC = 0.61 (0.55-0.67)] or TIRADS score [AUC = 0.68 (0.62-0.74)] with statistical significance (p < 0.001), and the IRS model had similar predictive performance in large nodule [>1 cm, AUC = 0.88 (0.79-0.97)] and small nodule [≤1 cm, AUC = 0.84 (0.74-0.93)] subgroups. The genetic risk factor showed independent predictive value (OR = 10.3, 95% CI:1.1-105.3) of lymph node metastasis in addition to the preoperative clinical information, including TIRADS grade, age, and nodule size.

CONCLUSION: The integrated gene profiling of FNA samples and the IRS model developed by the machine-learning method significantly improve the risk stratification of thyroid cancer, thus helping make wise decisions and reducing unnecessary extensive surgeries.

PMID:36916410 | DOI:10.1002/cam4.5770