Training and teaching of vagus nerve stimulation surgery: Worldwide survey and future perspectives

ObjectiveVagus nerve stimulation (VNS) therapy has been used for more than two decades to treat drug resistant epilepsy and depression and most recently received FDA approval for stroke rehabilitation. Expanding indications will renew the interest in the technique and increase the number of surgeons to be trained. The aim of this study was to survey surgeons with substantial expertise on optimal teaching and training approaches.MethodsAnonymous forms comprising 16 questions were sent by e-mail to surgeons with substantial expertise. Statistical analyses were used to compare the answers of the most experienced surgeons (>5 years) with the less experienced ones (<5 years).ResultsFully-completed forms were collected from 57 experts from 20 countries. The placement of the helical coils was deemed to be the most difficult step by 36 (63.2%) experts, and the use of optical magnification during this step was deemed necessary by 39 (68.4%) experts. Vocal cord palsy should be largely avoidable with proper surgical technique according to 44 (77.2%) experts. The teaching tool considered the most useful was mentoring (38, 66.7%). The future of VNS surgery teaching was deemed to be in anatomical workshops (29, 50.9%) and surgical simulation (26, 45.6%). Overall, answers did not vary significantly according to experience.ConclusionsVNS surgery should be mastered by actively participating in dedicated practical training courses and by individual mentoring during actual surgery, which is still the best way to learn. This study highlights the need for a formal training course and possible specific accreditation.     

皮肤鳞状细胞癌诊疗专家共识（2021）

【摘要】 皮肤鳞状细胞癌是非黑素瘤皮肤癌中最常见的肿瘤之一。近年来随着对其发病机制研究的深入以及诊断技术、Mohs显微描记手术、靶向治疗、免疫治疗的发展，皮肤鳞状细胞癌的诊疗取得了较大进展。该共识在国内外近期文献及诊疗指南的基础上，结合我国的诊疗现状，重点阐述皮肤鳞状细胞癌的临床表现及分型、病理活检及报告规范、风险等级评估、分级分期以及规范化治疗等，为临床医生的诊疗工作提供参考依据。     

Review of a forensic pseudoscience: Identification of criminals from bitemark patterns

The forensic sciences are a combination of laboratory procedures and physical comparisons of objects associated with victims, perpetrators, and crime scenes. The former is largely university-based protocols adopted by crime labs. The latter is predominantly pattern-matching tools originally developed by police examiners or experts deemed by courts to be relevant to forensic matters. These Court accepted experts bring their reasoning and conclusions into the legal arena. This subgroup of forensics has undergone significant scrutiny in regards to its history of exaggerated claims and weak scientific foundations. This paper addresses the rise and fall of bitemark pattern analysis (i.e. “matching” bitemarks in human flesh to human teeth) in the environment of opposing interests and agendas.     

Developmental validation of the ANDE™ rapid DNA system with FlexPlex™ assay for arrestee and reference buccal swab processing and database searching

A developmental validation was performed to demonstrate reliability, reproducibility and robustness of the ANDE System with the FlexPlex assay, including an integrated Expert System, across a number of laboratories and buccal sample variations. Previously, the related DNAscan™/ANDE 4C Rapid DNA System using the PowerPlex^®16 assay and integrated Expert System Software received NDIS approval in March 2016. The enhanced ANDE instrument, referred to as ANDE 6C, and the accompanying 6-dye, 27-locus STR assay, referred to as FlexPlex, have been developed to be compatible with all widely used global loci, including the expanded set of the CODIS core 20 loci.Six forensic and research laboratories participated in the FlexPlex Rapid DNA developmental validation experiments, testing a total of 2045 swabs, including those obtained from 1387 unique individuals. The goal of this extensive and comprehensive validation was to thoroughly evaluate and document the ANDE System and its internal Expert System to reliably genotype reference buccal swab samples in a manner compliant with the FBI’s Quality Assurance Standards and the NDIS Operational Procedures.The ANDE System, including automated Expert System analysis, generated reproducible and concordant results for buccal swabs when testing various instruments at different laboratories by a number of different operators. When testing a number of non-human DNAs, including oral bacteria, the ANDE System and FlexPlex assay demonstrated limited cross-reactivity. Potential PCR inhibitors were evaluated as part of the validation and no inhibition was detected. Reproducible and concordant profiles were generated from buccal swab samples collected with a limit of detection appropriate for buccal swab collections from arrestees. The precision and resolution of the System met industry standards for detection of microvariants and single base resolution.The integrated Expert System appropriately demonstrated the ability to correctly pass or fail profiles for CODIS upload without human review. During this comprehensive developmental validation, the ANDE System successfully interpreted over 2000 samples tested with over 99.99% concordant alleles. The data package described herein led to the ANDE System with the FlexPlex assay receiving NDIS approval in June 2018.     

药物临床试验伦理审查质量风险的管理研究

目的:为提高我国药物临床试验伦理审查质量、保障受试者权益提供参考。方法:以风险管理理论为指导,运用文献研究法、专家意见法和层次分析法对药物临床试验伦理审查流程进行梳理,提取并确定影响伦理审查质量的风险因素及其权重,并对我国药物临床试验伦理审查工作提出改进建议。结果与结论:构建的药物临床试验伦理审查风险指标体系包括5个方面共31个影响因素,其中影响药物临床试验伦理审查质量的5个方面的重要性(权重)排序依次为医学伦理委员会的自身建设(0.2635)、审查会议的管理(0.2514)、跟踪审查(0.1945)、审查申请的受理与处理(0.1892)、文件档案的管理(0.1014);权重较高的影响因素包括"讨论投票过程利益冲突人员回避(0.0787)""对方案修改、知情同意修改、严重不良事件等情形及时审查或召开会议讨论(0.0705)""明确伦理审查工作流程及时间并对外公示(0.0598)""统一、规范的审查标准与批准标准(0.0521)"等。建议可通过讨论投票环节利益冲突人员予以回避,对方案修改、知情同意修改、严重不良事件等情形及时审查或召开伦理会议讨论,明确伦理审查工作流程及时间,建立统一、规范的审查标准和批准标准等方式提高药物临床试验伦理审查的质量。     

多肽药物专家共识

中国生化制药工业协会多肽分会日前召开多肽药物专家共识研讨会,专家们就中国多肽药物发展现状,发展重点方向及对相关部门的建议达成共识。     

慢性心力衰竭护理结局分类评价表的构建研究

目的本研究以护理结局分类(NOC)为基础,筛选符合慢性心力衰竭患者的相关护理结局,由此构建具有专科专病特点的慢性心力衰竭患者护理结局评价表。方法成立研究核心小组,应用文献回顾法、专家函询法确定护理结局分类指标,并进行统计学分析,最终建立慢性心力衰竭护理结局分类评价表。结果通过研究,确定慢性心力衰竭护理结局中包含4个领域、8个一级指标、68个二级指标。4个领域分别是生理健康、功能健康、健康知识和行为、心理社会健康。一级指标中包含心脏泵血功能、活动耐力、社会支持、抑郁水平等。二级指标中包含心脏指数、血压、呼吸困难、情绪波动大、步行距离、步行速度等68个指标。统计学分析中:第一、二轮函询专家的积极系数分别为90%、100%,专家权威系数为0.895,专家意见协调程度(P<0.05)。结论本研究成功建立慢性心力衰竭护理结局分类评价表,有助于临床护士用于评价护理措施的有效性,也使其成为一种标准化语言,便于应用到护理电子信息系统中进行绩效测算等。但是本研究不足之处是未能将该研究进行临床实证,未能进一步确认其有效性。     

多种微量元素注射液临床应用中国专家共识（2021）

多种微量元素注射液可以提供铁、锌、铜、锰、钴、氟、碘、硒、钼、铬等多种人体微量元素，广泛应用于需要肠外营养 治疗的患者。为了进一步提高临床医师对多种微量元素注射液的认识，更好地指导其临床合理用药，特邀请全国专家组成员， 在系统性文献检索的基础上，参考欧洲临床营养与代谢学会（ESPEN）、美国肠外与肠内营养学会（ASPEN）指南，结合我国临床 实践，经多次交流讨论，达成此共识。本共识基于临床研究证据和专家经验，为多种微量元素注射液临床用于危重症、中重度 烧伤、围手术期、肿瘤、老年、透析、肠瘘及短肠综合征等提供参考。