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Nevin Manimala Statistics

Minimizing bias in a diabetic foot ulcer clinical evaluation: analysis of the HIFLO Trial

Wounds. 2023 Feb;35(3):36-40.

ABSTRACT

INTRODUCTION: Publications aimed at improving the quality of evidence in wound care clinical research have stressed the importance of minimizing study bias. In particular, lack of a universal definition of healing in wound studies leads to detection bias, resulting in noncomparable healing rates.

OBJECTIVE: This report analyzes the steps taken to reduce the main sources of bias in a particular RCT (the HIFLO Trial) that evaluated healing in DFUs using microvascular tissue.

MATERIALS AND METHODS: To address “definition of healing”-induced detection bias, 3 blinded adjudicators independently assessed each DFU using a rigorous 4-part definition of healing. Adjudicator responses were analyzed to assess reproducibility. Predefined criteria were also included to avoid bias owing to selection, performance, attrition, and reporting.

RESULTS: Rigor and comparability across sites were ensured through investigator training, consistent SOC, data monitoring, and independent statistical and ITT-only analysis. The level of agreement among adjudicators was greater than or equal to 90% for each of the 4-part healing criteria.

CONCLUSIONS: High-level agreement by blinded adjudicators confirmed that DFUs in the HIFLO Trial were consistently assessed for healing without bias, validating the most rigorous assessment criteria to date. The findings reported herein may prove beneficial for others seeking to minimize bias in wound studies.

PMID:36877939

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Safety and Efficacy of Carbon Nanoparticle-Labeled Lymph Node Dissection in Radical Resection of Gastric Cancer: A Systematic Review and Meta-Analysis

Technol Cancer Res Treat. 2023 Jan-Dec;22:15330338231154094. doi: 10.1177/15330338231154094.

ABSTRACT

Objective: In this meta-analysis, we investigated the safety and efficacy of carbon nanoparticle (CNP) trace-guided lymph node (LN) dissection during radical gastrectomy. Methods: Literature on CNP tracing compared with non-CNP tracing in radical gastric cancer (GC) surgery was searched from PubMed, EMBASE (Ovid platform), Web of Science, and the Cochrane Library from the establishment of the library until October 2022. This meta-analysis was performed according to the preferred reporting items for systematic reviews and meta-analysis guidelines. Available data regarding the number of LNs dissected, number of metastatic LNs dissected, other surgical outcomes, and postoperative complications were analyzed in a pooled manner. Stata software (version 12.0) was used for the present meta-analysis. Results: This analysis included 7 studies with a total of 1827 GC patients (551 and 1276 in the CNP and non-CNP groups, respectively). The results of the meta-analysis showed that the CNP group had more intraoperative LNs detected [weighted mean difference (WMD) = 6.67, 95% confidence interval (CI): 3.71-9.62], more LN metastases (WMD = 1.60, 95% CI: 0.09-3.12), and less intraoperative bleeding (WMD = 11.33, 95% CI: 6.30-16.37) than the non-CNP group, all with statistically significant differences (P < .05). For postoperative complications (odds ratio [OR] = 0.88, 95% CI: 0.52-1.48) and operative time (WMD = -11.60, 95% CI: -40.53-17.34), there was no statistically significant difference between the 2 groups (P > 0.05). Conclusions: CNP was a significant tracer for the LNs of GC. It increased the number of LNs harvested while reducing intraoperative blood loss, without increasing the operative time or postoperative complications. CNP tracer-guided lymphadenectomy is considered safe and effective for gastrectomy.

PMID:36877933 | DOI:10.1177/15330338231154094

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Patient Preference for Calcipotriene and Betamethasone Dipropionate Cream vs Foam for the Topical Treatment of Psoriasis: A Pilot Study

J Drugs Dermatol. 2023 Mar 1;22(3):271-273. doi: 10.36849/JDD.7165.

ABSTRACT

BACKGROUND: The well-established sequential use of topical calcipotriene and topical betamethasone dipropionate in combination has been shown to provide greater benefit than either monotherapy. A newer topical fixed combination formulation of calcipotriene 0.005% and betamethasone dipropionate 0.064% in a cream base (Cal/BD cream) is effective with high patient ratings for convenience and tolerability. The current study compares patient satisfaction between Cal/BD foam and Cal/BD cream formulations. Study Design and Patient Demographics: This is a single-use, split body, open label study involving 20 subjects. Ten subjects additionally had scalp psoriasis. Study treatments were applied by the investigator in a randomized manner and patients completed questionnaires to assess treatment preferences.

FINDINGS: Both Cal/BD formulations provided rapid and significant improvement in symptoms of pruritus, stinging, burning, and pain; with no statistically significant difference in response between the 2 treatments. Overall, Cal/BD cream outperformed Cal/BD foam on several key measures for vehicle features and patient satisfaction. For non-scalp application, 55% of subjects preferred Cal/BD cream over Cal/BD foam. For the scalp, 60% of subjects preferred Cal/BD cream over Cal/BD foam. No adverse events were reported during the study.

CONCLUSION: Results of this current study indicate high levels of patient satisfaction with Cal/BD cream and a preference for the cream base over foam for the treatment of body and scalp psoriasis. &nbsp; J Drugs Dermatol. 2023;22(3): doi:10.36849/JDD.7165.

PMID:36877880 | DOI:10.36849/JDD.7165

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Characterization and treatment of thoracic duct obstruction in patients with lymphatic flow disorders

Catheter Cardiovasc Interv. 2023 Mar 6. doi: 10.1002/ccd.30613. Online ahead of print.

ABSTRACT

PURPOSE: The contribution of thoracic duct obstruction to lymphatic flow disorders has not been well-characterized. We describe imaging findings, interventions, and outcomes in patients with suspected duct obstruction by imaging or a lympho-venous pressure gradient (LVPG).

MATERIALS AND METHODS: Clinical, imaging, and interventional data, including the LVPG, of patients with flow disorders and imaging features of duct obstruction who underwent lymphatic intervention were retrospectively reviewed, collated, and analyzed with descriptive statistics.

RESULTS: Eleven patients were found to have obstruction, median age 10.4 years (interquartile range: 8-14.9 years). Pleural effusions were seen in 8/11 (72%), ascites in 8/11 (72%), both in 5/11 (45%), and protein-losing enteropathy in 5 (45%). Eight patients (72%) had congenital heart disease. The most common site of obstruction was at the duct outlet in 7/11 patients (64%). Obstruction was secondary to extrinsic compression or ligation 4 patients (36%). Nine patients (82%) underwent interventions, with balloon dilation in 7/9 (78%), massive lymphatic malformation drainage and sclerotherapy in 1, and lympho-venous anastomosis in 1. There was resolution of symptoms in 7/9 (78% who underwent intervention, with worsening in 1 patient and no change in 1. In these patients, preprocedure mean LVPG was 7.9 ± 5.7 mmHg and postprocedure gradient was 1.6 ± 1.9 mmHg (p = 0.014). Five patients in this series underwent intervention solely to alleviate duct obstruction and in 4/5 (80%) this led to resolution of symptoms (p = 0.05).

CONCLUSION: Duct obstruction may be seen in lymphatic flow disorders and can occur from intrinsic and extrinsic causes. Stenosis at the outlet was most common. Obstruction can be demonstrated by an elevated LVPG, and interventions to alleviate the obstruction can be beneficial.

PMID:36877806 | DOI:10.1002/ccd.30613

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Effects of COVID-19 Acute Respiratory Distress Syndrome ICU Survivor Telemedicine Clinic on Patient Readmission, Pain Perception and Self-Assessed Health Scores: A Randomized, Prospective, Single-Center Exploratory Study

JMIR Form Res. 2023 Feb 28. doi: 10.2196/43759. Online ahead of print.

ABSTRACT

BACKGROUND: Post-intensive care syndrome (PICS) affects up to 50% of intensive care unit (ICU) survivors leading to long-term neurocognitive, psychosocial, and physical impairments. Approximately 80% of COVID-19 pneumonia patients who require ICU level care are at elevated risk for developing acute respiratory distress syndrome (ARDS). Survivors of COVID-19 ARDS are at high-risk for unanticipated healthcare utilization post discharge. Common to this group of patients are increased readmission rates, long term decreased mobility, and overall poorer outcomes. Multidisciplinary post-ICU clinics for ICU survivors are usually located in large urban academic medical centers providing in-person consultation. Data is lacking on the feasibility of providing telemedicine post-ICU care for COVID-19 ARDS survivors.

OBJECTIVE: We explored the feasibility of instituting a COVID-19 ARDS ICU survivor telemedicine clinic and examined its effect on healthcare utilization post hospital discharge.

METHODS: This randomized, unblinded, single-center, parallel-group exploratory study was conducted at a rural, academic, tertiary-care medical center. Study group (SG) participants underwent a telemedicine visit within 14 days of discharge, during which a six-minute walk test (6MWT), a EuroQoL 5-Dimension (EQ-5D) questionnaire, and vital signs logs (VSL) were reviewed by an intensivist. Additional appointments were arranged as needed based on the outcome of these review and tests. The control group (CG) received a telemedicine visit within six weeks of discharge and completed the EQ-5D questionnaire; additional care was provided as needed based on findings in this telemedicine visit.

RESULTS: Both SG (n=20) and CG (n=20) participants had similar baseline characteristics and dropout rate (10%). Among SG participants, 72.2% agreed to follow up in the pulmonary clinic compared to 50.0% of CG participants (P=.31). Unanticipated visits to the emergency department were 11.1% in the SG compared to 5.6% CG (not sig.). The rate of pain/discomfort was noted to be 66.7% in the SG compared to 61.1% in the CG (P=.72). The anxiety/depression rate was 72.2% vs. 61.1% (P=.59) in the SG compared to the CG. Participants’ self-assessed health rating scores was M=73.9, SD 16.1 in the SG compared to M=70.6, SD 20.9 in the CG (P=.59). Both primary care physicians (PCPs) and participants in the SG perceived the telemedicine clinic as a favorable model for post-discharge critical illness follow-up in an open-ended questionnaire regarding care.

CONCLUSIONS: This exploratory study found no statistically significant results in reducing healthcare utilization post-discharge and health related quality of life. However, PCPs and patients perceived telemedicine as a feasible and favorable model for post-discharge care among COVID-19 ICU survivors to facilitate expedited subspecialty assessment, decrease unanticipated post-discharge healthcare utilization, and reduce PICS. Further investigation is warranted to determine the feasibility of incorporating telemedicine-based post-hospitalization follow-up for all medical ICU survivors which may show improvement in healthcare utilization in a larger population.

PMID:36877802 | DOI:10.2196/43759

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Can Sublingual Nitrate Improve Visualization of Lower Limb Arteries on Computed Tomography Angiography?

J Comput Assist Tomogr. 2023 Mar 4. doi: 10.1097/RCT.0000000000001446. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of the study is to evaluate the role of sublingual nitrate in improving vessel visualization on peripheral computed tomography angiography (CTA).

METHODS: Fifty patients clinically diagnosed with peripheral arterial disease of the lower limb were prospectively included in this study: Twenty-five underwent CTA after sublingual nitrate administration (nitrate group) and 25 without (non-nitrate group). Two blinded observers qualitatively and quantitatively assessed the data thus generated. The mean luminal diameter, intraluminal attenuation, site, and percentage of stenosis were evaluated in all segments. Assessment of collateral visualization at sites of significant stenosis was also done.

RESULTS: Patients in the nitrate and non-nitrate groups were similar in age and sex characteristics (P > 0.05).On subjective evaluation, there was significantly improved visualization of the femoropopliteal and tibioperoneal vasculature of the lower limb in the nitrate group compared with the non-nitrate group (P < 0.05). Quantitative evaluation showed a statistically significant difference in the measured arterial diameters for all evaluated segments in the nitrate group versus the non-nitrate group (P < 0.05). Intra-arterial attenuation was significantly greater for all segments in the nitrate group resulting in better contrast opacification in these studies. Collateral visualization around segments with more than 50% stenosis/occlusion was also better in the nitrate group.

CONCLUSIONS: Our study suggests that nitrate administration before peripheral vascular CTA can improve visualization, especially in the distal segments by increasing the vessel diameter and intraluminal attenuation along with better delineation of the collateral circulation around stenotic areas. It may also improve the number of evaluable segments of vasculature in these angiographic studies.

PMID:36877793 | DOI:10.1097/RCT.0000000000001446

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Comparison of 3 CT Perfusion Software Packages in Estimation of Ischemic Lesions in Acute Ischemic Stroke Patients

J Comput Assist Tomogr. 2023 Mar 4. doi: 10.1097/RCT.0000000000001421. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study was to compare 3 computed tomography perfusion (CTP) software packages in the estimation of infarct core volumes, hypoperfusion volumes, and mismatch volumes.

METHODS: Forty-three patients with large vessel occlusion in the anterior circulation who underwent CTP imaging were postprocessed by 3 software packages: RAPID, advantage workstation (AW), and NovoStroke Kit (NSK). Infarct core volumes and hypoperfusion volumes were generated by RAPID with default settings. The AW and NSK threshold settings were the following: infarct core (cerebral blood flow [CBF] <8 mL/min/100 g, CBF <10 mL/min/100 g, CBF <12 mL/min/100 g, and cerebral blood volume [CBV] <1 mL/100 g) and hypoperfusion (Tmax >6 seconds). Mismatch volumes were then obtained for all the combinations of the settings. Bland-Altman, intraclass correlation coefficient (ICC), and Spearman ρ or Pearson correlation coefficient were applied for statistical analysis.

RESULTS: In the estimation of infarct core volumes, good agreement was observed between AW and RAPID when CBV <1 mL/100 g (ICC, 0.767; P < 0.001). For hypoperfusion volumes, good agreement (ICC, 0.811; P < 0.001) and strong correlation (r = 0.856; P < 0.001) were observed between NSK and RAPID. For mismatch volumes, the setting of CBF <10 mL/min/100 g combined with hypoperfusion with NSK resulted in moderate agreement (ICC, 0.699; P < 0.001) with RAPID, which was the best among all other settings.

CONCLUSIONS: The estimation results varied among different software packages. Advantage workstation had the best agreement with RAPID in the estimation of infarct core volumes when CBV <1 mL/100 g. NovoStroke Kit had better agreement and correlation with RAPID in the estimation of hypoperfusion volumes. NovoStroke Kit also had moderate agreement with RAPID in estimating mismatch volumes.

PMID:36877792 | DOI:10.1097/RCT.0000000000001421

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What to Do about Plastics? Lessons from a Study of United Kingdom Plastics Flows

Environ Sci Technol. 2023 Mar 6. doi: 10.1021/acs.est.3c00263. Online ahead of print.

ABSTRACT

Plastics are one of the most widely used materials on the planet, owing to their usefulness, durability, and relatively low cost. Yet, making, using, and disposing of plastics create important environmental impacts, most notably greenhouse gas emissions and waste pollution. Reducing these impacts while still enjoying the benefits of plastic use requires an integrated assessment of all of the life cycles of plastics. This has rarely been attempted due to the wide variety of polymers and the lack of knowledge on the final uses and applications of plastics. Using trade statistics for 464 product codes, we have mapped the flows of the 11 most widely used polymers from production into six end-use applications for the United Kingdom (UK) in 2017. With a dynamic material flow analysis, we have anticipated demand and waste generation until 2050. We found that the demand for plastics seems to have saturated in the UK, with an annual demand of 6 Mt, responsible for approximately 26 Mt CO2e/a. Owing to a limited recycling capacity in the UK, only 12% of UK plastic waste is recycled domestically, leading to 21% of the waste being exported, labeled as recycling, but mostly to countries with poor practices of waste management. Increasing recycling capacity in the UK could both reduce GHG emissions and prevent waste pollution. This intervention should be complemented with improved practices in the production of primary plastics, which currently accounts for 80% of UK plastic emissions.

PMID:36877788 | DOI:10.1021/acs.est.3c00263

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Osseous-Tissue Tumor Reporting and Data System With Diffusion-Weighted Imaging of Bone Tumors-An Interreader Analysis and Whether It Adds Incremental Value on Tumor Grading Over Conventional Magnetic Resonance Imaging

J Comput Assist Tomogr. 2023 Mar 7. doi: 10.1097/RCT.0000000000001415. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of the study is to determine whether the use of diffusion-weighted imaging (DWI) provides incremental increase in performance in the osseous-tissue tumor reporting and data system (OT-RADS) with the hypothesis that use of DWI improves interreader agreement and diagnostic accuracy.

METHODS: In this multireader cross-sectional validation study, multiple musculoskeletal radiologists reviewed osseous tumors with DW images and apparent diffusion coefficient maps. Four blinded readers categorized each lesion using the OT-RADS categorizations. Intraclass correlation (ICC) and Conger κ were used. Diagnostic performance measures including area under the receiver operating curve were reported. These measures were then compared with the previously published work that validated OT-RADS but did not include incremental value assessment of DWI.

RESULTS: One hundred thirty-three osseous tumors of the upper and lower extremities (76 benign, 57 malignant) were tested. Interreader agreement for OT-RADS with DWI (ICC = 0.69) was slightly lower (not statistically different) from the previously published work that did not incorporate DWI (ICC = 0.78, P > 0.05). The mean sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating curve including DWI of the 4 readers were 0.80, 0.95, 0.96, 0.79, and 0.91, respectively. In the previously published work without DWI, the mean values of the readers were 0.96, 0.79, 0.78, 0.96, and 0.94, respectively.

CONCLUSIONS: The addition of DWI to the OT-RADS system does not allow significantly improved area under the curve diagnostic performance measure. Conventional magnetic resonance imaging can be prudently used for OT-RADS for reliable and accurate characterization of bone tumors.

PMID:36877760 | DOI:10.1097/RCT.0000000000001415

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Quantification of facial fat compartments variations according to gender, age and BMI: a 3-Dimensional morphometric analysis of the cheek

Plast Reconstr Surg. 2023 Mar 8. doi: 10.1097/PRS.0000000000010357. Online ahead of print.

ABSTRACT

OBJECTIVE: The contour of the cheek is the main determinant of facial attractivity. The aim of this study is to evaluate the relationship between age, gender and BMI and cheek fat volume in a large cohort to better understand and treat facial aging.

MATERIALS AND METHODS: This study was performed by a retrospective review of the archives of the Department of Diagnostic and Interventional Radiology, University Hospital of Tübingen. Epidemiological data and medical history were assessed. The patients´ cheek superficial and deep fat compartment volumes were measured on magnetic resonance (MR) images. Statistical analyses were performed using the SPSS (Statistical Package for Social Sciences, version 27) and SAS statistical software package (Version 9.1; SAS Institute, Inc, Cary, NC).

RESULTS: 87 patients with a mean age of 46.0 years (range: 18-81 years) were included. The superficial and deep fat compartment volumes of the cheek increase with BMI (p< 0.001 and p=0.005), but there was no significant relationship between age and volume. The ratio of superficial versus deep fat does not change with age. No significant difference of the superficial or deep fat compartments was found between men and women in a regression analysis (p=0.931 and p=0.057).

CONCLUSION: Cheek fat volume measurements on MRI scans using reconstruction software suggest that the fat volume of the cheek increases with BMI but does not significantly change with age. Further studies will have to elucidate the role of age-related changes of bone structures or sagging of the fat compartments.

LEVEL OF EVIDENCE: II (Exploratory cohort study developing diagnostic criteria (with “gold” standard as reference) in a series of consecutive patients).

PMID:36877747 | DOI:10.1097/PRS.0000000000010357