What does it mean to involve consumers successfully in NHS research? A consensus study

OBJECTIVE: To obtain consensus on the principles and indicators of successful consumer involvement in NHS research. DESIGN: Consensus methods were used. An expert workshop, employing the nominal group technique was used to generate potential principles and indicators. A two-round postal Delphi process was used to obtain consensus on the principles and indicators. SETTING AND PARTICIPANTS: Participants were drawn from health, social care, universities and consumer organizations. A purposive sampling strategy was used to identify people who had experience and/or knowledge of consumer involvement in NHS research. Six researchers and seven consumers participated in an expert workshop. Ninety-six people completed both rounds of the Delphi process. MAIN OUTCOME MEASURES: Consensus on principles and indicators of successful consumer involvement in NHS research. RESULTS: Eight principles were developed through an expert workshop and Delphi process, and rated as both clear and valid. Consensus was reached on at least one clear and valid indicator by which to measure each principle. CONCLUSIONS: Consensus has been obtained on eight principles of successful consumer involvement in NHS research. They may help commissioners, researchers and consumers to deepen their understanding of this issue, and can be used to guide good practice.     

Utility of published DNA reactivity alerts

The identification of impurities with mutagenic potential is required for any potential pharmaceutical. The ICH M7 guidelines state that two complementary in silico toxicity prediction tools may be used to predict the mutagenic potential of pharmaceutical impurities. An expert review of the resulting in silico predictions is required, and numerous publications have been released to guide the expert review process. One such publication suggests that literature-based structural alerts (LBSAs) may provide a suitable aid in the expert review process. This publication provides a study of the effect of using one such set of LBSAs for the expert review of mutagenicity predictions from two complementary in silico tools. The analysis was performed using an Ames test dataset of 2619 compounds, and required interpretation of the LBSAs which proved to be a subjective process. Globally the LBSAs produced many more false positives than the in silico systems; whilst some exhibited a predictive performance comparable to the in silico systems, the majority were overly sensitive at the cost of accuracy. Use of LBSAs as part of an expert review process, without considering mitigating factors, could result in many more false positives and potentially the need to carry out additional and unnecessary Ames tests.     

基于临床治疗指南及共识的使用华法林住院患者用药分析与评价

目的：对某院使用华法林的住院患者进行用药分析和评价,并对其出院后复诊情况进行追踪,以更好地发挥华法林的治疗作用,减少不良反应的发生。方法：采用回顾性的分析方法,对某院2018年7月-12月使用华法林的住院患者用药进行分析,结合指南、共识对其用药情况进行分析评价。结果：共调取509份病例,华法林的使用主要分布于心血管内科、心血管外科、呼吸内科。华法林应用临床诊断主要为肺栓塞、心房颤动、肺动脉高压、静脉血栓等;住院患者华法林用量范围为0.625~9 mg,平均日剂量（2.99±1.11）mg;全院服用华法林后INR总体测定率为79%,将INR值以"<2.0"、"2.0~3.0"、">3.0"分布进行统计,INR2.0~3.0占比为33.17%,最高的为呼吸内科。26例（5.11%）患者住院期间INR达到4.5~10.0,38.46%使用维生素K进行拮抗;2例（0.39%）患者INR大于10,全部使用维生素K进行拮抗。在院期间合用其他抗凝药中,低分子肝素使用率最高的为骨外科,心血管外科,心血管内科;普通肝素使用率最高的为呼吸内科;阿加曲班使用率最高的为神经内科;利伐沙班使用率最高的为心血管内科,根据相关指南共识分析用药基本合理。患者出院后一周内及总复诊率最高的均为呼吸内科。复诊后INR分布在2.0~3.0占比最高的也为呼吸内科,与呼吸科临床药师药学监护及用药教育相关。结论：目前华法林临床应用仍不够规范,INR达标率偏低,出院后复诊率较低,抗凝药物转换过程中有不规范的问题,积极开展药师药学监护、用药教育及随访具有重要意义。     

新型冠状病毒肺炎临床合理用药专家共识

新型冠状病毒肺炎（coronavirus disease 2019,COVID-19）疫情发生以来,全国医院药学工作者坚持医药协同,在保障药品供应的前提下,积极参与临床救治工作,加强对患者的用药教育和指导,有效提高药物治疗水平,改善临床救治效果。为更好地发挥药学服务在COVID-19疫情防控中的重要作用,中国药学会医院药学专业委员会特组织临床和药学专家,在《新型冠状病毒感染的肺炎诊疗方案（试行第七版）》的基础上,参考国内外最新的诊疗方案和研究成果,并结合国内各地COVID-19患者的救治经验,制定出新型冠状病毒肺炎临床合理用药专家共识。本共识详细阐述COVID-19临床救治的九类用药,内容涵盖药物治疗作用、遴选原则、用法用量、不良反应及注意事项,以期为COVID-19临床用药提供参考。     

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(0.263 5)、审查会议的管理(0.251 4)、跟踪审查(0.194 5)、审查申请的受理与处理(0.189 2)、文件档案的管理(0.101 4);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(0.078 7)""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(0.070 5)""明确伦理审查工作流程及时间并对外公示(0.059 8)""统一、规范的审查标准与批准标准(0.052 1)"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...     

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。     

ARIMA模型预测甲肝发病

目的探讨ARIMA模型在甲肝预测方面的应用,建立甲肝发病预测模型,并证明模型的适用性。方法利用甘肃省1990-01/2007-12甲肝发病数资料,通过SPSS Expert Modeler拟合ARIMA模型,用Q统计量法对模型适应性进行检验。结果建立ARIMA（0,1,1）（0,1,1）模型,模型统计量Q=20.637,P〉0.05,证实了该模型的适用性。结论ARIMA模型可用于甲肝发病的动态分析和短期预测。     

中药群体药代动力学专家共识(征求意见稿)

中药群体药代动力学(population pharmacokinetics,PPK)研究以治疗窗窄的有毒中药、或目标人群极不均一的中药、或不良反应较多的中药为研究对象,选择中药中有确切治疗作用的已知成分、有毒成分、有毒代谢酶为研究指标,采用完整的PPK采样设计方法制定采样时间点和样本量。利用气相色谱法、高效液相色谱法、色谱-质谱联用法等方法检测目标成份。最终采用总量统计矩分析方法拟合各成份PPK参数,获得能体现中药整体趋势的PPK模型,为临床合理调整给药剂量提供依据。     

Capitalizing on Federal Agencies’ Intentions To Protect Youth Working in Agriculture

ABSTRACT

Nearly 750,000 youth work on farms across the United States. The U.S. Department of Labor’s (U.S. DOL) Fair Labor Standards Act (FLSA) Hazardous Occupations Orders for Agriculture (HOOA) applies to approximately 37% of these youth. The HOOA regulations had not been updated since their inception in the late 1960s and the early 1970s. An attempt by U.S. DOL to update the regulations in 2011 was met with fierce opposition by the agricultural community, and the proposed updated regulations were withdrawn. One impactful outcome of these two events was a rededication by USDA and the farm community to address agricultural youth farm safety through education rather than through regulation. An agriculturally based National Steering Committee has developed consensus Belief Statements and Guiding Principles to proactively influence agricultural youth safety. In this case, USDA was clearly a ‘sphere of influence’ for youth agricultural safety.     

医院参与全员新冠病毒核酸检测样本采集管理专家共识

目的 形成《医院参与新冠病毒核酸检测样本采集管理专家共识》,规范采样管理.方法 在查阅国内外文献,依据相关政策的基础上,综合参与采样工作的操作实践及相关专家意见建议,撰写共识初稿,并通过会议讨论及函询征求专家意见,对共识稿进行修改,形成终版共识稿.结果 专家就采样前准备,采样点、采样台设置及采样人员配置,采样操作管理,...