关键词： Monitoring   Complementary and alternative medicine   CAM   Quality assurance   Quality control   Clinical study  

摘要： Background: Clinical trial monitoring is an essential activity for quality assurance (QA) to ensure the protection of human rights and the reliability and transparency of the data collection process. The purpose of this article is to enhance the understanding of monitoring process and major findings in clinical trials of complementary and alternative medicine (CAM). Methods: Based on International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use (ICH-GCP), we summarized main concept of monitoring process. Personal experiences on monitoring for CAM studies were also narratively described. Results: In this brief article, the basic concept of QA and quality control (QC), various monitoring activities during the study process, and major findings regarding clinical trials of CAM are suggested in an effort to improve understanding of monitoring in clinical research on CAM. Conclusion: When performing clinical trials for CAM-related interventions, the monitoring recommended in GCP is needed to be recognized as a mandatory element in the course of CAM research. (C) 2020 Korea Institute of Oriental Medicine. Publishing services by Elsevier B.V.

关键词： cost-effectiveness   cures   economic surplus   cost offsets  

摘要： Objectives: To evaluate alternative methods to calculate and/or attribute economic surplus in the cost-effectiveness analysis of single or short-term therapies. Methods: We performed a systematic literature review of articles describing alternative methods for cost-effectiveness analysis of potentially curative therapies whose assessment using traditional methods may suggest unaffordable valuations owing to the magnitude of estimated long-term quality-adjusted life-year (QALY) gains or cost offsets. Through internal deliberation and discussion with staff at the Health Technology Assessment bodies in England and Canada, we developed the following 3 alternative methods for further evaluation: (1) capping annual costs in the comparator arm at $150 000 per year;(2) "sharing" the economic surplus with the health sector by apportioning only 50% of cost offsets or 50% of cost offsets and QALY gains to the value of the therapy;and (3) crediting the therapy with only 12 years of the average annual cost offsets or cost offsets and QALY gains over the lifetime horizon. The impact of each alternative method was evaluated by applying it in an economic model of 3 hypothetical condition-treatment scenarios meant to reflect a diversity of chronicity and background healthcare costs. Results: The alternative with greatest impact on threshold price for the fatal pediatric condition spinal muscular atrophy type 1 was the 12-year cutoff scenario. For a hypothetical one-time treatment for hemophilia A, capping cost offsets at $150 000 per year had the greatest impact. For chimeric antigen receptor T-cell treatment of non-Hodgkin's lymphoma, capping cost offsets or using 12-year threshold had little impact, whereas 50% sharing of surplus including QALY gains and cost offsets greatly reduced threshold pricing. Conclusions: Health Technology Assessment bodies and policy makers will wrestle with how to evaluate single or short-term potentially curative therapies and establish pricing and pay

摘要： BACKGROUND The effect of different methods for data sampling and data processing on the results of comparative statistical analyses in method comparison studies of continuous arterial blood pressure (AP) monitoring systems remains unknown. OBJECTIVE We sought to investigate the effect of different methods for data sampling and data processing on the results of statistical analyses in method comparison studies of continuous AP monitoring systems. DESIGN Prospective observational study. SETTING University Medical Center Hamburg-Eppendorf, Hamburg, Germany, from April to October 2019. PATIENTS 49 patients scheduled for neurosurgery with AP measurement using a radial artery catheter. MAIN OUTCOME MEASURES We assessed the agreement between continuous noninvasive finger cuff-derived (CNAP Monitor 500;CNSystems Medizintechnik, Graz, Austria) and invasive AP measurements in a prospective method comparison study in patients having neurosurgery using all beat-to-beat AP measurements (Method(all)), 10-s averages (Method(avg)), one 30-min period of 10-s averages (Method(30)), Method(30) with additional offset subtraction (Method(30off)), and 10 30-s periods without (Method(iso)) or with (Method(iso-zero)) application of the zero zone. The agreement was analysed using Bland-Altman and error grid analysis. RESULTS For mean AP, the mean of the differences (95% limits of agreement) was 9.0 (-12.9 to 30.9) mmHg for Method(all), 9.2 (-12.5 to 30.9) mmHg for Method(avg), 6.5 (-9.3 to 22.2) mmHg for Method(30), 0.5 (-9.5 to 10.5) mmHg for Method(30off), 4.9 (-6.0 to 15.7) mmHg for Method(iso), and 3.4 (-5.9 to 12.7) mmHg for Method(iso-zero). Similar trends were found for systolic and diastolic AP. Results of error grid analysis were also influenced by using different methods for data sampling and data processing. CONCLUSION Data sampling and data processing substantially impact the results of comparative statistics in method comparison studies of continuous AP monitoring systems. Depe

关键词： Printed circuit boards   non-metal fraction   alternative fuel   waste-derived fuel   cement industry   calorific value  

摘要： Waste Printed circuit boards (PCBs) are one of the most valuable and recycled components of electronic waste due to the presence of precious metals such as copper, silver, gold and palladium. The rejects of the PCB recycling process, named non-metal fraction (NMF) have continuously been sent to landfills. Several researchers have proposed alternative use of NMF as secondary materials such as fillers in composites or as adsorbent. This study is focused on the potential application of the PCB recycling rejects as waste-derived fuel or alternative fuel in the cement industry. Approximately 2 million metric tonnes (Mt) of this waste was produced in 2014 globally and estimated to reach 6.5 million Mt in 2050. The presence of high organic matter in the NMF renders it useful as an alternative fuel. The organic content of the NMF could also potentially be increased using gravity separation and thus increasing its net calorific value. The study showed that the NMF could provide up to 21 MJ kg(-1)of heating value with low heavy metal and ash concentration. A comparison with other waste-derived fuel sources is also presented in the paper.

关键词： AIPS‐   E   CLL   early stage   prognosis   TTFT  

摘要： Objectives To validate the predictive value on time to first treatment (TTFT) of AIPS-E and IPS-E evaluated in an independent cohort of newly diagnosed and non-referred Binet stage A CLL patients enrolled in the O-CLL1-GISL protocol (*** identifier: NCT00917540). Methods A cohort of 292 newly diagnosed Binet A CLL cases has been enrolled in the study. Patients from several Italian Institutions were prospectively enrolled within 12 months of diagnosis into the O-CLL1-GISL protocol. Results The majority of patients were male (62%);median age was 60.4 years, 102 cases (34.9%) showed unmutated IGHV genes, 8 cases (2.8) the presence of del(11q)/del(17p), 142 cases (48.6%) the presence of palpable lymph nodes and 146 cases (50%) and ALC > 15 x 10(9)/l. After a median follow-up of 7.2 years, 130 patients underwent treatment. According to the AIPS-E, 96 patients were classified as low-risk, 128 as intermediate-risk, and 68 as high-risk. These groups showed significant differences in terms of TTFT. The C-statistic was 0.71 (P < .0001) for predicting TTFT. According to IPS-E, 77 patients were classified as low-risk, 135 as intermediate-risk, and 80 as high-risk. These groups showed significant differences in terms of TTFT. The C-statistic was 0.705 (P < .0001) for predicting TTFT. Conclusions Our data confirm an accurate prognostic utility of both AIPS-E and IPS-E at the individual patient level. These data may be useful for a precise stratification of early-stage patients.

关键词： Multisystem inflammatory syndrome   Therapeutic plasma exchange   Left ventricular dysfunction   COVID-19   Pediatric intensive care  

摘要： This study aimed to evaluate the effectiveness and the role of therapeutic plasma exchange (TPE) in treatment of children with severe MIS-C. In addition, we assessed demographic data, clinical features, laboratory abnormalities, underlying conditions, treatments, and outcomes. Patients with severe MIS-C who were admitted to the pediatric intensive care unit (PICU) between September 01 and October 05, 2020 were included in this observational, descriptive, retrospective study. The data collected included the patients' demographic data, presenting symptoms, clinical features, laboratory parameters, diagnostic investigations, and medications. Of 27 children with MIS-C, 63 % were male. The median age of the patients was nine years. Intravenous immunoglobulin and corticosteroids were used for treatment in 100 % of the patients, anakinra in 51.8 %, vasopressors in 85.1 %, noninvasive mechanical ventilation in 25.9 %, and invasive mechanical ventilation in 18.5 %. Ten of the 27 patients (37 %) underwent TPE. In the patients who underwent TPE, the median PELOD score was 21 (IQR: 11-30.25) before TPE and 10 (IQR: 10-11) after TPE (p < 0.001). Moreover, their median left ventricular ejection fraction (LVEF) was 52 % (IQR: 49.25 %-55 %) before TPE and median LVEF was 66.5 (IQR: 58 %-68.5 %) after TPE (p = 0.012). The median number of TPE sessions was three (IQR: 2-4.75). The mortality rate of the patients with severe MIS-C admitted to the PICU was 7.4 %. We suggest that TPE should be considered as a therapeutic option in children with severe MIS-C. Early initiation of TPE followed by immunomodulatory therapy in critically ill children with MIS-C may help improve clinical and laboratory outcomes.

摘要： BACKGROUND Augmented renal creatinine clearance (ARC) (>= 130 ml min(-1) 1.73 m(-2)) is frequent in intensive care unit (ICU) patients and may impact patient outcome. OBJECTIVES To compare glomerular filtration rate (GFR) measured with iohexol plasma clearance and creatinine clearance in critically ill patients with augmented renal clearance. DESIGN Single-centre, retrospective study. SETTING French University Hospital ICU from November 2016 to May 2019. PATIENTS Adult patients with augmented renal clearance who had a measurement of iohexol plasma clearance. MAIN OUTCOME MEASURE Agreement between 6 h creatinine clearance (6 h CrCl) and iohexol plasma clearance (GFRio). RESULTS Twenty-nine patients were included. The median 6 h creatinine clearance was 195 [interquartile range (IQR) 162 to 251] ml min(-1) 1.73 m(-2) and iohexol clearance was 133 [117 to 153] ml min(-1) 1.73 m(-2). Sixteen patients (55%) had hyperfiltration (clearance >130 ml min(-1) 1.73 m(-2)) measured with iohexol clearance. Mean bias between iohexol and creatinine clearance was -80 [limits of agreement (LoA) -216 to 56 ml min(-1) 1.73 m(-2)]. For Cockcroft and Gault Modification of Diet in Renal Disease equation (MDRD), Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) formulae, mean biases were, respectively -27 (LoA -99 to 45), -14 (LoA -86 to 59) and 15 (LoA -33 to 64) ml min(-1) 1.73 m(-2). CONCLUSION In the present study, we found that in patients with augmented renal creatinine clearance, half of the patients do not have hyperfiltration using iohexol clearance measurements. We observed an important bias between 6 h CrCl and GFRio with large LoA. In critically patients with ARC, 6 h CrCl does not reliably estimate GFR and 6 h CrCl nearly systematically overestimates renal function. Comparison of creatinine-based GFR estimations and GFRio show acceptable bias but wide LoA.

关键词： Median sternotomy   Superior sulcus tumors   Pediatrics  

摘要： Pediatric tumors in the apex of the thoracic cavity are often diagnosed late due to the absence of symptoms. These tumors can be quite large at presentation with involvement of the chest wall, sympathetic chain, spine, and aortic arch. The tumors can also extend into the thoracic inlet and encircle the brachial plexus. Depending on the diagnosis, treatment may involve chemotherapy with subsequent surgery or require primary resection. Optimal exposure to resect large apical tumors with thoracic inlet extension is a surgical challenge. To date, several surgical techniques have been described to resect these tumors-including both anterior and posterior thoracic approaches. Each of these techniques can be limited by inadequate exposure of the mass. We describe an alternative approach to surgical resection of these masses that employs an extended sternotomy with a lateral neck incision. This report details two successful resections of large left apical masses with thoracic inlet involvement in children using this technique (Level of evidence 4). (c) 2021 Elsevier Inc. All rights reserved.

关键词： 4   4   4-trifluoro-3   3-dihydroxy-2-(hydroxyimino)butan-1-ones   polyfluoroalkyl-2-hydroxyimino-1   3-diketones   1-methyl-4-nitrosopyrazoles   mycostatic activity  

摘要： We studied different approaches to the synthesis of polyfluoroalkyl-containing 1-methyl-4-nitrosopyrazoles, which are based on the cyclization of 4,4,4-trifluoro-3,3-dihydroxy-2-hydroxyimino-1-R-butan-1-ones or 2-hydroxyimino-1,3-diketones with methylhydrazine and on a one-pot sequential treatment of 1,3-diketones with sodium nitrite and methylhydrazine. It was found that the regioselectivity of the formation of 1-methyl-4-nitrosopyrazoles is affected by the steric factors of 1,3-dicarbonyl reagents. The study of the mycostatic effect of 4-nitrosopyrazoles showed that the introduction of a bulky polyfluoroalkyl or tert-butyl substituent leads to a decrease in their activity.