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Nevin Manimala Statistics

A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions

PLoS One. 2021 Oct 29;16(10):e0259106. doi: 10.1371/journal.pone.0259106. eCollection 2021.

ABSTRACT

BACKGROUND: Drug coated balloons (DCB) with paclitaxel (Ptx) dose of 2-3.5 μg/mm2 balloon surface inhibit restenosis with different effectiveness and duration of success. A clinical dose finding study is not known for any of the currently marketed products. The aim of the present preclinical trial was to investigate a novel DCB coated with 6 μg Ptx/mm2 in a porcine model.

METHODS AND RESULTS: The current study investigated a DCB with a novel, modified iopromide based matrix with 6 μg Ptx/mm2. Drug transfer to the vessel wall of peripheral arteries was compared with a dose of 3 μg Ptx/mm2 and two fully overlapping DCB with 3 μg Ptx/mm2, each. Ptx concentration in the vessel wall after drug transfer was about twice as high for balloons with 6 μg/mm2 (1957±1472 μg/g) and two overlapping DCB with 3 μg Ptx/mm2, each (1287±619 μg/g) compared to a single balloon with 3 μg Ptx/mm2, (787±738 μg/g), with statistical significant differences for 1×6 μg/mm2 vs. 1×3 μg/mm2 (p = 0.017) but not for 2×3 μg/mm2 vs. 1×3 μg/mm2 (p = 0.184) and 1×6 μg/mm2 vs. 2×3 μg/mm2 (p = 0.178). The proportion of residual Ptx on balloon after treatment was similar for all groups between 6±1% and 10±3% of dose on balloon.

CONCLUSION: The dose of 6 μg Ptx/mm2 was successfully as well as reproducibly coated on conventional balloon catheters. Increased Ptx on balloons resulted in increased drug concentration in the vessel wall. A single balloon with 6 μg Ptx/mm2 seems to provide double dose compared to 3 μg Ptx/mm2, facilitates the procedure, and may reduce medico-economic cost compared to the use of two standard DCB.

PMID:34714843 | DOI:10.1371/journal.pone.0259106

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Burnout and associated factors among nurses working in public hospitals of Harari region and Dire Dawa administration, eastern Ethiopia. A cross sectional study

PLoS One. 2021 Oct 29;16(10):e0258224. doi: 10.1371/journal.pone.0258224. eCollection 2021.

ABSTRACT

BACKGROUND: Burnout is a syndrome of emotional exhaustion, low personal accomplishment and depersonalization experienced by a health professional and it is more common in nurses due to high workload and job stress that is mostly caused by working proximity to patients and taking care of them. Burnout compromises the provision of quality health care. Despite this, there is no information in Ethiopia on burnout among nurses in study area.

OBJECTIVES: To determine the magnitude of burnout and associated factors among nurses working in public hospitals of Harari regional state and Dire Dawa administration, eastern Ethiopia, February 1-29, 2020.

METHODS: Institutional based quantitative cross-sectional study was employed from February 1-29 among 412 randomly selected nurses who have been working in hospitals for the last 6 months. Simple random sampling method was employed and data was collected by self-administered, standardized, reliable and valid, questionnaire (Maslachs Burnout Inventory- Human Services Survey). Data was entered into EpiData Version 3.1 and exported to statistical package for social science version 20 for analysis. All covariate with P-value less than 0.25 in bivariable analysis were candidate for multivariable analysis. Level of statistical significance was declared at p-value < 0.05.

RESULTS: Among 412 nurses taking part in this study, 183(44.4%) of nurses with 95% CI, had experienced burnout. Married marital status [AOR:2.3,95%CI:(1.2-4.3)], poor current health status [AOR:4.8, 95% CI:(1.1-21.4)] and fair current health status [AOR:12, 95% CI:(4.5-32)], working greater than eight hour per-day[AOR:0.52, 95%CI:(0.29-0.92)], intention to leave a job [AOR:0.48,95%CI:(0.2-0.88), being working in emergency room [AOR:0.3,95%CI:(0.1-0.98)] and using a different medication related to work related health problems were factors associated with nurses’ burnout.

CONCLUSION: The nurses’ burnout in this study is high and it is attributed by marriage, perceiving health status as poor and fair, whereas, having the intention to leave job, being working in emergency room and using a medication in relation to work related health problems reduced risk of developing burnout. So, the concerned bodies should provide trainings which focus on stress copying mechanisms and assertiveness program.

PMID:34714836 | DOI:10.1371/journal.pone.0258224

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Invasive EEG for temporal lobe epilepsy: selection of technique

Zh Vopr Neirokhir Im N N Burdenko. 2021;85(5):23-29. doi: 10.17116/neiro20218505123.

ABSTRACT

BACKGROUND: Non-invasive EEG reveals epileptogenic zone in 70% of patients. In other cases, invasive EEG monitoring is indicated. Various implantation strategies and techniques of intracranial EEG (icEEG) potentially provide different outcomes. Choosing the optimal icEEG technique may be challenging.

OBJECTIVE: To analyze the results of icEEG in adults with temporal lobe epilepsy and to determine the algorithm for selection of optimal invasive EEG technique.

MATERIAL AND METHODS: The study included 82 patients with temporal lobe epilepsy who underwent invasive EEG. Effectiveness of invasive EEG was determined by detection of epileptogenic zone and post-resection outcomes. Postoperative results were analyzed throughout more than 6-month follow-up period using the Engel grading system. Statistical analysis was conducted using the Fisher’s exact test.

RESULTS: Epileptogenic zone was revealed in 72 (88%) cases. Invasive EEG was supplemented by another modality in 3 (4%) patients. Mean follow-up period after resection was 17 months in 45 patients. Favorable outcomes were achieved in 31 (69%) cases. Statistical analysis showed that identification of epileptogenic zone depends existing of lesion and symptoms of seizures. Selection algorithm for optimal technique of invasive EEG was determined considering own results and literature data.

CONCLUSION: Invasive EEG results and post-resection outcomes demonstrated favorable efficacy of original algorithm. The last one may be used in decision-making on optimal technique of invasive EEG in adults with temporal lobe epilepsy.

PMID:34714000 | DOI:10.17116/neiro20218505123

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Peri-implantitis, systemic inflammation, and dyslipidemia: a cross-sectional biochemical study

J Periodontal Implant Sci. 2021 Oct;51(5):342-351. doi: 10.5051/jpis.2100920046.

ABSTRACT

PURPOSE: The aim of this study was to compare the inflammatory and lipid profile of patients with and without peri-implantitis.

METHODS: A cross-sectional biochemical study was carried out in which blood samples were collected from 16 patients with peri-implantitis and from 31 subjects with healthy implants. Clinical peri-implant parameters were obtained from all subjects. Levels of tumor necrosis factor-alpha and interleukin-10 (IL-10) were measured in serum. Lipid fractions, glucose and creatinine levels, and complete blood count were also assessed.

RESULTS: After controlling for a history of periodontitis, statistically significant differences between peri-implantitis patients and controls were found for total cholesterol (estimated adjusted mean difference, 76.4 mg/dL; 95% confidence interval [CI], 39.6, 113.2 mg/dL; P<0.001), low-density lipoprotein (LDL) cholesterol (estimated adjusted mean difference, 57.7 mg/dL; 95% CI, 23.8, 91.6 mg/dL; P<0.001), white blood cells (WBC) (estimated adjusted mean difference, 2.8×103/μL; 95% CI, 1.6, 4.0×103/μL; P<0.001) and IL-10 (estimated adjusted mean difference, -10.4 pg/mL; 95% CI, -15.8, -5.0 pg/mL; P<0.001). The peri-implant probing pocket depth (PPD) was modestly positively correlated with total cholesterol (r=0.512; P<0.001), LDL cholesterol (r=0.463; P=0.001), and WBC (r=0.519; P<0.001). A moderate negative correlation was observed between IL-10 and PPD (r=0.609; P<0.001).

CONCLUSIONS: Otherwise healthy individuals with peri-implantitis showed increased low-grade systemic inflammation and dyslipidemia.

PMID:34713995 | DOI:10.5051/jpis.2100920046

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Effects of ibuprofen-loaded TiO₂ nanotube dental implants in alloxan-induced diabetic rabbits

J Periodontal Implant Sci. 2021 Oct;51(5):352-363. doi: 10.5051/jpis.2007520376.

ABSTRACT

PURPOSE: Some systemic conditions, especially diabetes mellitus (DM), adversely affect dental implant success. This study aimed to investigate the effects of ibuprofen-loaded TiO2 nanotube (ILTN) dental implants in alloxan-induced diabetic rabbits.

METHODS: Twenty-six New Zealand white rabbits were treated with alloxan monohydrate to induce DM. At 2 weeks following DM induction, 3 types of implants (sandblasted, large-grit, and acid-etched [SLA], ILTN, and machined) were placed into the proximal tibia in the 10 rabbits that survived following DM induction. Each type of implant was fitted randomly in 1 of the holes (round-robin method). The animals were administered alizarin (at 3 weeks) and calcein (at 6 weeks) as fluorescent bone markers, and were sacrificed at 8 weeks for radiographic and histomorphometric analyses.

RESULTS: TiO2 nanotube arrays of ~70 nm in diameter and ~17 μm in thickness were obtained, and ibuprofen was loaded into the TiO2 nanotube arrays. A total of 26 rabbits were treated with alloxan monohydrate and only 10 rabbits survived. The 10 surviving rabbits showed a blood glucose level of 300 mg/dL or higher, and the implants were placed in these diabetic rabbits. The implant stability quotient (ISQ) and bone-to-implant contact (BIC) values were significantly higher in the ILTN group (ISQ: 61.8, BIC: 41.3%) and SLA group (ISQ: 62.6, BIC: 46.3%) than in the machined group (ISQ: 53.4, BIC: 20.2%), but the difference in the BIC percentage between the SLA and ILTN groups was not statistically significant (P=0.628). However, the bone area percentage was significantly higher in the ILTN group (78.0%) than in the SLA group (52.1%; P=0.000).

CONCLUSIONS: The ILTN dental implants showed better stability (ISQ) and BIC than the machined implants; however, these values were similar to the commercially used SLA implants in the 2-week diabetic rabbit model.

PMID:34713996 | DOI:10.5051/jpis.2007520376

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Shear Wave Elastography and Quantitative Ultrasound as Biomarkers to Characterize Deep Vein Thrombosis In Vivo

J Ultrasound Med. 2021 Oct 29. doi: 10.1002/jum.15863. Online ahead of print.

ABSTRACT

OBJECTIVE: Investigate shear wave elastography (SWE) and quantitative ultrasound (QUS) parameters in patients hospitalized for lower limb deep vein thrombosis (DVT).

METHOD: Sixteen patients with DVT were recruited and underwent SWE and radiofrequency data acquisitions for QUS on day 0, day 7, and day 30 after the beginning of symptoms, in both proximal and distal zones of the clot identified on B-mode scan. SWE and QUS features were computed to differentiate between thrombi at day 0, day 7, and day 30 following treatment with heparin or oral anticoagulant. The Young’s modulus from SWE was computed, as well as QUS homodyned K-distribution (HKD) parameters reflecting blood clot structure. Median and interquartile range of SWE and QUS parameters within clot were taken as features.

RESULTS: In the proximal zone of the clot, the HKD ratio of coherent-to-diffuse backscatter median showed a significant decrease from day 7 to day 30 (P = .036), while the HKD ratio of diffuse-to-total backscatter median presented a significant increase from day 7 to day 30 (P = .0491). In the distal zone of the clot, the HKD normalized intensity of the echo envelope median showed a significant increase from day 0 to day 30 (P = .0062). No SWE features showed statistically significant differences over time. Nonetheless, a trend of lower median of Young’s modulus within clot for patients who developed a pulmonary embolism was observed.

CONCLUSION: QUS features may be relevant to characterize clot’s evolution over time. Further analysis of their clinical interpretation and validation on a larger dataset would deserve to be studied.

PMID:34713918 | DOI:10.1002/jum.15863

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Peri-implant marginal bone loss and systemic statin use: A retrospective cohort pilot study

Clin Exp Dent Res. 2021 Oct 29. doi: 10.1002/cre2.509. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim was to analyze clinical parameters of peri-implantitis in human subjects exposed and non-exposed to use of systemic statins.

MATERIAL AND METHODS: This retrospective cohort pilot study compared patient records of 60 exposed individuals to 196 non-exposed individuals as of 2011 throughout 2017. Source of records were specialist and general dentistry clinics in Public Dental Service, Stockholm County, Sweden. Extent/severity of peri-implantitis and peri-implant bone loss were registered as well as intake of systemic statins. Background variables considered were bleeding on probing, bone-loss, age, gender, earlier periodontitis, prosthetic quality, and smoking. Stepwise linear and logistic regression analysis at the individual level was adopted in order to study the influence of statin use on the severity of peri-implantitis and the incidence of peri-implant bone loss. Results were considered statistically significant at p < 0.05.

RESULTS: Peri-implant bone loss was significantly correlated to use of statin after compensation for age and sex.

CONCLUSIONS: The results render an actual effect of statins on peri-implant bone loss plausible. Further research is warranted.

PMID:34713988 | DOI:10.1002/cre2.509

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Nurse mentored, student research in undergraduate nursing education to support evidence-based practice: A pilot study

Nurs Forum. 2021 Oct 29. doi: 10.1111/nuf.12667. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim was to investigate if an extracurricular research skills development program builds the knowledge, attitudes, and skills (KAS) to support evidence-based practice (EBP).

METHODS: Twenty nursing students and six mentors in four teams completed small, student-led research projects over 1 year. Using a mixed-methods design, the knowledge, attitudes, and practice (KAP) survey was administered at three-time points, followed by qualitative interviews. A linear mixed-effects regression model was used to analyze survey data and thematic analysis for qualitative data.

RESULTS: The change from the KAP survey from the first to the third time point showed a statistically significant difference following engagement in the program. Qualitative data indicated benefits and challenges to participation for both students and mentors. Mentorship provided students with improved relationships, collaboration, and leadership skills. Students believed the program enhanced their understanding of research and reported increased confidence in using EBP.

CONCLUSION: Offering students innovative first-hand experiences with research develops research KAS to support EBP.

PMID:34713907 | DOI:10.1111/nuf.12667

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Development, validation, and relevance of in vivo low-contrast task transfer function to estimate detectability in clinical CT images

Med Phys. 2021 Oct 29. doi: 10.1002/mp.15309. Online ahead of print.

ABSTRACT

PURPOSE: The current state-of-the-art calculation of detectability index (d’) is largely phantom based, with the latest being based on a hybrid phantom NPS combined with patient specific noise magnitude and high-contrast air-skin interface. The purpose of this study was to develop and assess the use of fully-patient-specific measurements of noise and low-contrast resolution, derived entirely from patient images, on d’.

METHODS: This study developed a d’ calculation that is patient- and task-specific, employing newly developed algorithms for estimating patient-specific noise power spectrum (NPS) and low-contrast task transfer function (TTF). The TTF estimation methodology used a trained regression support vector machine (SVM) to estimate a fitted form of the TTF given a variance-normalized estimate of the noise power spectrum (referred to as the TTFNPS ). The regression SVM was trained and tested using five-fold cross validation on 192 scans (4 dose levels x 6 reconstruction kernels x 4 repeats) of a phantom with low-contrast polyethylene insert, and reconstructed with filtered backprojection and iterative reconstructions across 12 clinically-relevant kernels (FBP: B20f, B31f, B45f; SAFIRE: I26f, I31f, J45f with Strengths: 2, 3, 5). To test the low contrast TTF estimation method, the estimated TTFNPS measurements were compared to (1) TTF measurements from the air-phantom interface (referred to as the TTFair , representing the most patient-specific clinical alternative) and (2) TTF measurements from the edge of the low-contrast polyethylene insert (referred to as the TTFpoly ) which represented the gold standard of low-contrast TTF measurement. Patient-specific NPS, patient-specific noise magnitude, and patient-specific low-contrast TTF were further combined with a reference task function to calculate a d’ (according to a non-pre-whitening matched filter model) across 1120 lesions previously evaluated in 2AFC human observer detection of liver lesions. The resulting values were compared to the observer results using a generalized linear mixed-effects statistical model. The correlations between the model and observer results were also compared with previously-reported values (using a hybrid method with phantom-derived NPS and TTFair ).

RESULTS: The TTFNPS more accurately represented resolution across the considered reconstruction settings compared with the TTFair . The out-of-fold predictions of the TTFNPS had statistically better RMSE concordance (p < 0.05, one-tailed Wilcoxon ranksum test) to gold standard than the TTFair (the alternative, measured from the air-phantom interface). Detectability indices informed by purely patient-specific NPS and TTF were strongly correlated with 2AFC outcomes (p<0.05). R-squared between human detection accuracy and model-predicted detection accuracy were shown be greater for those measured with patient-specific d’ than for the hybrid d’ but failed to rise to the level of statistical significance (p >= 0.05, bootstrap resampled corrected paired Student’s t-test).

CONCLUSIONS: The results suggest that fully-patient-specific characterization of image quality based on in vivo NPS and low-contrast TTF offer advantages over hybrid methods. The results in terms of detectability index favorably relate to observer detection of liver lesions. The method can potentially be integrated into an automated image quality tracking system to assess image quality across a CT clinical operation without needing phantom scans. This article is protected by copyright. All rights reserved.

PMID:34713908 | DOI:10.1002/mp.15309

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AFP-L3 for the diagnosis of early hepatocellular carcinoma: A meta-analysis

Medicine (Baltimore). 2021 Oct 29;100(43):e27673. doi: 10.1097/MD.0000000000027673.

ABSTRACT

BACKGROUND: The present study aimed to systematically evaluate the diagnostic value of an isoform of alpha-fetoprotein (AFP), AFP-L3, for early hepatocellular carcinoma (HCC) by a meta-analysis.

METHODS: Diagnostic reports of AFP-L3% in early HCC were searched in the PubMed, Web of Science, Cochrane Library, and Embase databases up to December 2019. The retrieved literature was reviewed, and eligible articles were selected. Data were extracted from the eligible articles, and the risk of bias was evaluated according to the Quality Assessment of Diagnostic Accuracy Studies scale. Statistical analyses were conducted by MetaDiSc1.4 and RevMan5.3 software. The sensitivities, specificities, and diagnostic odds ratios were pooled. The summary receiver operating characteristic curve was drawn, and the area under the curve was calculated.

RESULTS: Six studies with acceptable quality were included in the meta-analysis involving 2447 patients. No threshold effect was observed among the 6 studies, but there was obvious heterogeneity. The pooled sensitivity, specificity, and positive and negative likelihood ratios of AFP-L3% for the diagnosis of early HCC were 0.34 (95% CI 0.30-0.39, P < .0001), 0.92 (95% CI 0.91-0.93, P < .0001), 4.46 (95% CI 2.94-6.77, P = .0033), and 0.71 (95% CI 0.61-0.82, P = .0004), respectively. The diagnostic odds ratio was 6.78 (95% CI 4.02-11.44, P = .0074). The the area under the curve of the summary receiver operating characteristic was 0.755 (95% CI 0.57-0.94).

CONCLUSION: AFP-L3% has high specificity but low sensitivity for diagnose early HCC, suggesting that AFP-L3% is more valuable for excluding HCC in conditions with elevated AFP than for diagnosing early HCC. In addition, a hypersensitive detection method can improve the diagnostic accuracy of AFP-L3% for early HCC.

PMID:34713864 | DOI:10.1097/MD.0000000000027673