我国医疗质量安全不良事件分类的思考

患者安全问题已经成为世界各国医疗质量管理关注的焦点,从国家层面对医疗质量安全不良事件进行统一定义和分类具有重要意义。通过总结世界卫生组织、美国、英国以及我国目前不良事件分类及严重程度分级情况,结合我国相关上报数据,分析存在问题,建议国家及各级卫生行政部门发挥引导推动作用,医疗机构利用现有国家医疗质量安全相关平台,参考借鉴相关分类,开展同质化医疗质量安全管理工作。     

上海市预防接种工作人员疑似预防接种异常反应监测认知和报告影响因素

目的了解上海市预防接种工作人员疑似预防接种异常反应(Adverse events following immunization,AEFI)监测的知识和态度以及影响AEFI报告的因素。方法采用方便抽样在上海市所有459个预防接种门诊选择预防接种工作人员开展问卷调查,分析AEFI监测知识得分(满分6分)和态度,采用多因素Logistic回归分析AEFI报告的影响因素。结果1379名调查对象的AEFI监测知识平均得分为3.30±1.31分;认为开展AEFI监测有必要、报告AEFI是自身职责、AEFI监测是额外工作负担的调查对象分别占98.84%、92.75%、30.38%。69.62%的调查对象近1年报告过AEFI;社区接种门诊、免疫规划专职人员、近1年接受过AEFI培训、AEFI监测知识得分高的调查对象报告AEFI的比例高[OR(95%CI):19.55(14.16-26.98)、1.95(1.45-2.64)、3.14(1.76-5.59)、1.91(1.38-2.63)]。结论上海市预防接种工作人员AEFI监测知识水平不高,对AEFI监测存在一定认识误区;需加强AEFI监测培训,进一步提高其AEFI报告意识。     

Adverse Childhood Experiences and Suicidal Behaviors Among Youth: The Buffering Influence of Family Communication and School Connectedness

PurposeThe main objectives of this study were to determine (1) whether family communication and school connectedness offer protection against suicidal behaviors in the presence of adverse childhood experiences (ACEs; direct protective effect) and (2) whether family communication or school connectedness buffer the association between ACEs and suicidal behaviors (interacting protective effect) on the multiplicative and additive scales.MethodsData were obtained from a western state's 2019 Youth Risk Behavior Survey that included 5,341 middle school and 4,980 high school participants. Generalized linear models were used to estimate whether family communication and school connectedness offered direct protection against suicidal behaviors or buffered the association between ACEs and suicidal behaviors using adjusted prevalence ratios and corresponding 95% confidence intervals.ResultsFamily communication and school connectedness offered direct protection against suicidal behaviors in the presence of ACEs (a 1-unit higher score was associated with a 32%–42% lower prevalence of suicidal behaviors for middle school youth and a 27%–39% lower prevalence of suicidal behaviors for high school youth). There was evidence that family communication and school connectedness buffered the association between ACEs and suicidal behaviors on the multiplicative scale.ConclusionsThe findings provide support for the development and implementation of interventions that build family communication and school connectedness to reduce suicidal behaviors. Furthermore, screening for trauma and suicidal behaviors is warranted.     

强化护理在儿童急性白血病鞘内注射中的应用效果

目的探讨强化护理在儿童急性白血病鞘内注射治疗中的应用效果。方法选取2019年5月至2020年6月于中国科学技术大学附属第一医院西区行鞘内注射治疗的90例急性白血病患儿作为研究对象,按照入院时间将其分为A组(45例)与B组(45例)。A组采用常规护理方法,B组采用强化护理方法。比较两组的不良反应发生情况、家长满意度、护理质量。结果B组不良反应发生率低于A组,差异有统计学意义(P<0.05);B组家长总满意度高于A组,差异有统计学意义(P<0.05);B组护理质量高于A组,差异有统计学意义(P<0.05)。结论采用强化护理模式可缓解患儿鞘内注射治疗不良反应,减轻患儿痛苦,促进治疗顺利完成,提高家长满意度,改善护理质量,应用效果较好。     

9种试点食药物质的安全性评价及试点风险监测现况

按照传统既是食品又是中药材的物质简称为食药物质,传统中医药常使用食药物质来防治疾病或养生保健。随着我国大健康产业的迅速发展,食药物质成为健康领域关注的热点。近年来,随着食药物质品种的增加,研发产品的创新种类和应用增多,拟新增食药物质的安全性问题成为关注重点。现综述国家卫生健康委员会和市场监督管理总局开展的按照传统既是食品又是中药材物质管理试点工作的9种试点食药物质的食用与药用价值、安全性和不良反应、国内部分省份风险监测内容和方案,以期为9种试点食药物质的食品安全风险监测工作的开展提供参考,为食药物质的合理应用和资源开发提供一定的依据。     

基于预防接种异常反应补偿的山东省卡介苗淋巴结炎经济负担测算

目的了解山东省卡介苗(BCG)淋巴结炎经济负担情况。方法以2011年5月至2019年12月山东省304例申请省级补偿的BCG淋巴结炎病例为对象,收集患者基本情况、预防接种相关情况、门诊(住院)病历和收费票据等相关资料,对其直接经济负担(包括直接医疗费用和直接非医疗费用)、间接经济负担和总经济负担进行测算,比较不同特征病例经济负担的差异。结果304例BCG淋巴结炎患者月龄的M(Q1,Q3)为3(2,4)月,其中男性239例(78.6%),淋巴结破溃71例(23.4%),手术227例(74.7%)。单纯门诊、单纯住院和门诊后住院病例分别占25.7%(78例)、7.2%(22例)和67.1%(204例)。贴现后单例直接、间接和总经济负担的M(Q1,Q3)分别为9910(5713,16074)、2081(1547,3122)和12262(7694,18571)元。直接医疗费用占直接经济负担的89.4%,直接经济负担占总经济负担的84.9%,80.0%病例的总经济负担仅占其补偿金额的20.0%左右,只有2.3%的病例总经济负担占补偿金额的60.0%以上。单纯住院和门诊后住院病例的直接、间接和总经济负担高于单纯门诊病例,手术病例的直接、间接和总经济负担高于非手术病例,淋巴结未破溃病例的直接和总经济负担高于破溃病例(均P<0.05)。结论山东省BCG淋巴结炎病例经济负担受诊疗方式的影响,且以直接医疗费用为主。     

Personal protective equipment related skin reactions in healthcare professionals during COVID‐19

Since the outbreak of COVID‐19 pandemic, clinicians have had to use personal protective equipment (PPE) for prolonged periods. This has been associated with detrimental effects, especially in relation to the skin health. The present study describes a comprehensive survey of healthcare workers (HCWs) to describe their experiences using PPE in managing COVID‐19 patients, with a particular focus on adverse skin reactions. A 24‐hour prevalence study and multi‐centre prospective survey were designed to capture the impact of PPE on skin health of hospital staff. Questionnaires incorporated demographics of participants, PPE type, usage time, and removal frequency. Participants reported the nature and location of any corresponding adverse skin reactions. The prevalence study included all staff in intensive care from a single centre, while the prospective study used a convenience sample of staff from three acute care providers in the United Kingdom. A total of 108 staff were recruited into the prevalence study, while 307 HCWs from a variety of professional backgrounds and demographics participated in the prospective study. Various skin adverse reactions were reported for the prevalence study, with the bridge of the nose (69%) and ears (30%) being the most affected. Of the six adverse skin reactions recorded for the prospective study, the most common were redness blanching (33%), itchiness (22%), and pressure damage (12%). These occurred predominantly at the bridge of the nose and the ears. There were significant associations (P < .05) between the adverse skin reactions with both the average daily time of PPE usage and the frequency of PPE relief. The comprehensive study revealed that the use of PPE leads to an array of skin reactions at various facial locations of HCWs. Improvements in guidelines are required for PPE usage to protect skin health. In addition, modifications to PPE designs are required to accommodate a range of face shapes and appropriate materials to improve device safety.     

Efficacy of m-Health for the detection of adverse events following immunization – The stimulated telephone assisted rapid safety surveillance (STARSS) randomised control trial

IntroductionPassive surveillance is recommended globally for the detection of adverse events following immunisation (AEFI) but this has significant challenges. Use of Mobile health for vaccine safety surveillance enables a consumer-centred approach to reporting. The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) a randomised control trial (RCT) sought to evaluate the efficacy and acceptability of SMS for AEFI surveillance.MethodsMulti-centre RCT, participants were adult vaccinees or parents of children receiving any vaccine at a trial site. At enrolment randomisation occurred to one of two SMS groups or a control group. Prompts on days 2, 7 and 14 post-immunisation, were sent to the SMS group, to ascertain if a medical event following immunisation (MEFI) had occurred. No SMS’s were sent to the control participants. Those in the SMS who notified an MEFI were pre-randomised to complete a computer assisted telephone interview or a web based report to determine if an AEFI had occurred whilst an AEFI in the controls was determined by a search for passive reports. The primary outcome was the AEFI detection rate in the SMS group compared to controls.ResultsWe enrolled 6,338 participants, who were equally distributed across groups and who received 11,675 vaccines. The SMS group (4,225) received 12,675 surveillance prompts with 9.8% being non-compliant and not responding. In those that responded 90% indicated that no MEFI had been experienced and 184 had a verified AEFI. 6 control subjects had a reported AEFI. The AEFI detection rate was 13 fold greater in the SMS group when compared with controls (4.3 vs 0.3%).ConclusionWe have demonstrated that the STARSS methodology improves AEFI detection. Our findings should inform the wider use of SMS-based surveillance which is particularly relevant since establishing robust and novel pharmacovigilance systems is critical to monitoring novel vaccines which includes potential COVID vaccines.     

The safety of BCG revaccination: A systematic review

IntroductionRevaccination with Bacillus Calmette-Guérin (BCG) vaccine is not generally recommended due to a lack of proven efficacy of repeat doses for protection against tuberculosis. However, there is a growing interest in the use of BCG vaccine for its ‘off-target’ effects which might involve revaccination. We did a systematic review of the safety of BCG revaccination.MethodsMEDLINE (1946 to March 2020) and the BCG World Atlas (updated 2017) were searched, limiting to studies of BCG administration by the intradermal or percutaneous route. Adverse events as well as patient and vaccine characteristics were reviewed.ResultsThe search identified 388 articles, of which 24 met the inclusion criteria. These reported 22 studies comprising eight randomised trials, four case-control studies, four observational studies and six case series or reports. Overall, there was evidence for a small increase in the rate of mild local and systemic reactions. No serious adverse events were reported in immunocompetent individuals.ConclusionsEvidence to date suggests that revaccination with BCG vaccine carries minimal risk. Future studies of BCG vaccine for novel applications should report adverse event data stratified by prior BCG vaccination status.