基于风险矩阵的临床路径风险等级评估

医疗风险是指存在于临床路径中,可能对患者造成伤害以及导致患者利益损失的不确定性因素,主要包括医疗事故、并发症及不良反应等[1].然而,医疗行业的高风险属性以及医疗纠纷逐年增多等问题的存在,使得医疗风险管理成为医院长期以来的管理难题.针对如何降低医疗风险、保障患者就诊医疗安全、提高医疗卫生服务质量这一问题,国内外学者做了大量研究.Pasternak[2]通过对高风险手术研究发现,风险评估及管理标准化等不确定性因素会增加手术风险因素数据的收集难度,并提出应以关键风险因素为重点进行手术风险等级评估;Dimick[3]等指出医院进行质量改进工作可以降低高风险人群术后并发症风险;国内学者在如何建立医疗风险预警系统方面进行了大量研究,部分学者运用自组织神经网络、诊断相关组等方法对医疗保险费用、医疗质量安全及风险等级评分等方面也进行了应用探索[4-9].目前国内医疗风险研究主要集中在医疗风险理念提出及基本方法应用层面,缺乏从临床路径风险角度对医疗风险等级进行预测.现在研究国内外医疗风险及其他领域风险的基础上,采用风险矩阵对临床路径风险等级进行预测[10-13].首先,采用事故树分析法(fault tree analysis,FTA)分析临床路径关键风险因素.然后,设计风险矩阵(risk matrix)对关键风险因素进行排序.最后,通过层次分析法确定关键风险因素的权重,预测临床路径风险等级.     

风险调整及其在卫生领域中的应用

风险调整方法在许多发达国家的医疗管理和支付系统改革中得到广泛应用,并引起了国内学者的一些关注,但系统性的介绍和研究还没有真正开始。文中简单介绍了风险调整的概念、目的,风险调整模型的构建及其在卫生领域的应用研究。希望借此能够促进该模型在国内的发展和应用,帮助管理者进行财政规划、医药管理,风险控制、疾病管理等决策。     

贵州省基层卫生人员医疗风险知识测评及影响因素分析

目的 :分析贵州省基层卫生人员医疗风险知识的测评结果,并探讨其影响因素,为基层医疗机构医疗风险管理提供参考。方法 :采用分层抽样选取贵州省9个地(市,州)基层卫生人员共1 266人进行问卷调查。内容包括一般特征和医疗风险知识测试。对基层卫生人员医疗风险知识测评进行评分和统计描述,对不同特征对象医疗风险知识测评结果差异对比分析,采用logistic回归分析探讨影响卫生人员医疗风险知识测试的因素。结果:基层卫生人员医疗风险知识测试平均得分为(47.44±15.96)分,及格率为21.07%。不同经济水平地区、工作年限、性别、年龄段对象医疗风险知识测试得分差异有统计学意义(P0.01)。多因素logistic回归分析显示性别和工作年限是医疗风险知识测评是否合格的影响因素(P0.01)。结论 :基层卫生人员医疗风险知识认识不足;基层卫生人员医疗风险知识认识与经济水平发展、工作年限及年龄有密切联系;性别和工作年限是基层卫生人员医疗风险知识认识的重要影响因素。需进一步加强卫生人员相关医疗风险法律知识的学习和认识。     

构建医疗风险预警机制的研究

目前我国的病人安全监测体系还不健全,医师对病人安全问题缺乏足够的认识,病人自身保护意识不强。通过对医疗风险预警机制的研究,为具体开展实际医疗风险预警操作提供参考方案,从而为卫生行政部门根据医疗风险状况进行干预提供依据。     

大学生整形美容现状与对策

目前大学生整形美容已成为一种普遍的社会现象。针对大学生存在的对整形美容缺乏医疗常识、医疗风险认识和足够的应对医疗风险的心理承受能力等问题进行分析研究,并给出相应对策。认为大学生进行整形美容是可行的,通过整形美容可以增加获得理想职业的机会,但在整形美容时必须选择正规的医疗机构,并需具备一定的医疗常识、医疗风险认识和应对医疗风险的心理承受能力。     

香港医院的医疗风险管理

介绍了香港医院对医疗风险的认识,医疗风险的成因,香港医疗风险管理机构,以及香港医院管理局防范医疗风险的主要制度。     

我国医疗风险及其影响因素研究现状综述

医疗风险是医疗卫生行业不可回避的一个问题,近年来国内关于这个范畴的研究及文献亦有许多的报道。文章系统检索了核心数据库中公开发表的有关我国医疗风险及其影响因素的相关研究结果,进行了综合概述,以利总结归纳,为今后研究医疗风险管理指明方向。     

三级综合医院医疗过程质量实时监控指标体系探讨

依据科学性、系统性、实用性和可操作性原则,分析国内卫生管理部门质量监管需求和医疗机构质量管理需求,调查现有医院信息系统及信息公司相关产品中医疗质量实时监控功能,研究确立医疗服务流程关键监控点,并构建医疗质量实时监控指标共685个,以便对医疗过程质量进行实时监控.     

公立医院财务信息化系统发展方向研究

针对公立医院财务信息化系统中医疗相关数据横向财务分析的潜在价值及其应用案例进行了较为深入的探讨。并以美国为例简单说明了在医院财务信息化系统中,对医疗相关数据的分析如医疗政策制定、系统性风险预测与防范等方面所起的重要作用。说明了在我国目前公立医院财务信息化系统较为普及的情况下,相关的财务分析方法可以在我国的医疗及医保政策的制定,医疗行业财务风险控制等方面提供关键性的数据支持。     

论知情同意制度的不足以及术中改变术式的法律责任

知情同意制度贯穿于医疗活动的整个过程,尊重患者的知情同意权是医务人员的法定义务,国内诸多法律法规均对医疗活动中的知情同意做了原则性的规定。但是由于缺乏针对具体医疗行为如何适用知情同意制度的指引或者规范,导致医务人员常常不知如何正确的地履行知情同意程序。而且．当前的知情同意制度存在诸多不足,司法实践也对知情同意缺乏深入的研究．这为医务人员的执业活动带来了潜在的法律风险。     

医疗风险防范调控体系研究

医疗风险的防范在医疗风险管理过程中可有效消除不必要风险的发生。目前我国医疗安全管理的实践主要集中在医疗纠纷和医疗事故的处理上．对如何防范风险没有进行深入系统的探讨。本文通过构建医疗风险防范调控体系的基本框架，从行业管理、医疗机构、医务人员、患者、医疗责任保险等方面进行了简要阐述，并时如何降低医疗风险提出了若干建议。     

某战区军队医院医疗风险管理现状及影响因素研究

目的分析军队医院医疗风险发生的规律、特点、高危因素及深层次原因,为制定科学有效的风险管理措施提供依据。方法采用整群抽样、横断面问卷调查的方法,对11所医院496名医护人员的风险意识及相关因素等40项内容进行调查研究．并建立数据库及风险研究模型,所得资料运用SPSS13．0软件进行统计分析。结果三级甲等医院的风险管理体系较三级乙等医院完善;外科、妇产科医疗纠纷高于其他科室,为医疗风险的高危科室;新职工、进修实习及责任心不强的人员为医疗风险的高危人群;Logistic回归分析显示,管理制度、职务、文化程度、风险教育、检查陪同、设备维护和工作量等7项变量与医疗风险密切相关。结论应加强医疗风险、法律法规、服务意识、质量管理教育。建立军队医院风险预警机制和风险管理组织与风险评价体系。     

Wind turbines and health: An examination of a proposed case definition

Renewable energy demands have increased the need for new wind farms. In turn, concerns have been raised about potential adverse health effects on nearby residents. A case definition has been proposed to diagnose “Adverse Health Effects in the Environs of Industrial Wind Turbines” (AHE/IWT); initially in 2011 and then with an update in 2014. The authors invited commentary and in turn, we assessed its scientific merits by quantitatively evaluating its proposed application. We used binomial coefficients to quantitatively assess the potential of obtaining a diagnosis of AHE/IWT. We also reviewed the methodology and process of the development of the case definition by contrasting it with guidelines on case definition criteria of the USA Institute of Medicine. The case definition allows at least 3,264 and up to 400,000 possibilities for meeting second- and third-order criteria, once the limited first-order criteria are met. IOM guidelines for clinical case definitions were not followed. The case definition has virtually no specificity and lacks scientific support from peer-reviewed literature. If applied as proposed, its application will lead to substantial potential for false-positive assessments and missed diagnoses. Virtually any new illness that develops or any prevalent illness that worsens after the installation of wind turbines within 10 km of a residence could be considered AHE/IWT if the patient feels better away from home. The use of this case definition in the absence of a thorough medical evaluation with appropriate diagnostic studies poses risks to patients in that treatable disorders would be overlooked. The case definition has significant potential to mislead patients and its use cannot be recommended for application in any health-care or decision-making setting.     

Optimising case definitions of upper limb disorder for aetiological research and prevention: a review

Experts disagree about the optimal classification of upper limb disorders (ULDs). To explore whether differences in associations with occupational risk factors offer a basis for choosing between case definitions in aetiological research and surveillance, we analysed previously published research. Eligible reports (those with estimates of relative risk (RR) for >1 case definition relative to identical exposures were identified from systematic reviews of ULD and occupation and by hand-searching five peer-review journals published between January 1990 and June 2010. We abstracted details by anatomical site of the case and exposure definitions employed and paired estimates of RR, for alternative case definitions with identical occupational exposures. Pairs of case definitions were typically nested, a stricter definition being a subset of a simpler version. Differences in RR between paired definitions were expressed as the ratio of RRs, using that for the simpler definition as the denominator. We found 21 reports, yielding 320 pairs of RRs (82, 75 and 163 respectively at the shoulder, elbow, and distal arm). Ratios of RRs were frequently ≤1 (46%), the median ratio overall and by anatomical site being close to unity. In only 2% of comparisons did ratios reach ≥4. We conclude that complex ULD case definitions (e.g. involving physical signs, more specific symptom patterns, and investigations) yield similar associations with occupational risk factors to those using simpler definitions. Thus, in population-based aetiological research and surveillance, simple case definitions should normally suffice. Data on risk factors can justifiably be pooled in meta-analyses, despite differences in case definition.     

我国药品安全定义和范畴的系统综述和定性访谈

目的：深入探讨药品安全的定义和范畴,为药品安全监管工作提供政策性建议。方法：采用系统综述方法,对近10年来相关中、英文数据库及网站中提及药品安全概念、范畴,或对保障药品安全策略和措施的文章分析、整理和综合,总结出药品安全所包含的主要内容;利用定性访谈了解药品监管人员、医务工作者和专业技术人员对于药品安全概念和范畴的认识,以及当前影响药品安全的重要问题。结果：系统综述纳入290篇文献,其中6篇给出了药品安全的定义,纳入文献对于药品安全的定义侧重于药品不良反应／事件监测、避免用药错误、风险管理以及可及性方面。药品安全的范畴主要包括药品监管、药品不良反应／事件、药品保障、药品研发、药品生产、药品流通、药品使用和药品信息获取;定性访谈结果显示,大部分受访者认为药品安全涵盖所有与药物相关的工作,现阶段质量问题和不合理用药是受访者集中反映的药品安全的主要问题。结论：通过综合分析,我们将药品安全定义为通过对药品研发、生产、流通、使用全环节进行监管所表现出来的消除或控制了外在威胁和内在隐患的综合状态,以及为达到这种状态所必要的供应保障和信息反馈。其范畴可以界定为质量符合标准、不良反应在可接受的范围内、临床无用药差错和可及性四个部分。     

Risk Society - Reconsidered in a drug context

This article attempts to test Ulrich Beck's theoretical concept of risks as presented in his work Risk Society . It questions whether the risks of modern drugs can be explained and understood through the theoretical framework of a Risk Society. Based on a case study of the psychotropic drug fluoxetine, better known as Prozac ®, we show how risks associated with modern drugs are induced by socially constructed technological artefacts and are capable of producing risk on an objective as well as non-objective global level. Here, risks are invisible to individuals and sometimes to social perception as a consequence of their non-objective nature. The transformation of side-effects from a traditional individual level (physical and psychological) to a collective level (economic, societal and ethical) illustrates the new dynamics of risk associated with modern drugs. We conclude that the risks of modern drugs fall within Beck's definition of risks of modernity, and that risk of drugs is expanding beyond control mechanisms and the fixed understandings of relations between medicine and society. As a sociological diagnosis of contemporary society, Risk Society appears to be the theoretical framework which best explains the risk trends of social medicine and pharmacy.     

Risk, life extension and the pursuit of medical possibility

With increasing frequency, the oldest members of US society are undergoing medical interventions aimed at prolonging life. Using cardiac care as a case study, this paper explores how a discourse of risk infuses and legitimates high-tech clinical treatments in late life. In particular, we examine how the diminishing risks associated with biomedical procedures produce a sense of medical possibility regarding life extension, and push the definition of "old age" into a receding future. Simultaneously, physicians, patients and families come to understand the management and reduction of future cardiac risks to be germane for individuals even near the end of life. Driven by the logic and language of risk, decisions to intervene are experienced as incremental and largely unremarkable, and the pursuit of an open-ended future via biomedical means is perceived as an ethical imperative, trumping deliberation or discussion of the utility of intervention and the ultimate ends being pursued. For practitioners and patients alike, the engagement of risk, the preservation of hope it facilitates and the routinisation of intervention it produces all contribute to the emerging mandate to treat at ever-older ages.     

Risking public safety: Experts,the medical profession and ‘acceptable’ drug injury

By locating expertise within an institutional framework, this paper examines the roles of regulators, the pharmaceutical industry and the medical profession in drug risk assessment and in the construction of ‘acceptable’ drug injury in particular. It is suggested that, while public perceptions of risks are important, they may be extremely limited due to relative secrecy surrounding some risk-generating activities, such as pharmaceutical development and regulation. Under these circumstances, a necessary starting point is the investigation of the formation of expert risk assessments. Taking the case of the anaesthetic drug, Althesin, the article explains how drug risks, largely unknown to the public, came to be defined as acceptable by expert and regulatory interpretation for over a decade. The reasons for and drivers of the regulatory route taken, together with alternative regulatory approaches are identified in relation to the salient risk – benefit problems: extrapolation of animal toxicology to humans, construction of therapeutic benefit, comparative risk assessment, unpredictability of risk and risk – benefit evaluation. It is argued that professional closure between expert regulators, the manufacturer and sections of the anaesthesiology profession led to passive decision-making and a regulatory approach towards acceptable drug injury unlikely to have been sustainable if it had been subjected to public accountability. The Althesin experience also suggests that regulators, the medical profession and other stakeholders concerned about drug risks should focus their attention not only on improving the evidence-base of risk assessment, but also on more robust interpretation and informative communication of the evidence already available at any particular time. Finally, the Althesin case demonstrates that, contrary to popular claims, major drug risks have not necessarily only been discovered upon widespread use after marketing approval and that, even after discovery of life-threatening risks, drugs have not necessarily been withdrawn quickly by the UK regulatory authorities despite the availability of safer alternatives.     

A proposed approach may help systematic reviews retain needed expertise while minimizing bias from nonfinancial conflicts of interest

ObjectivesGroups such as the Institute of Medicine emphasize the importance of attention to financial conflicts of interest. Little guidance exists, however, on managing the risk of bias for systematic reviews from nonfinancial conflicts of interest. We sought to create practical guidance on ensuring adequate clinical or content expertise while maintaining independence of judgment on systematic review teams.Study Design and SettingWorkgroup members built on existing guidance from international and domestic institutions on managing conflicts of interest. We then developed practical guidance in the form of an instrument for each potential source of conflict.ResultsWe modified the Institute of Medicine's definition of conflict of interest to arrive at a definition specific to nonfinancial conflicts. We propose questions for funders and systematic review principal investigators to evaluate the risk of nonfinancial conflicts of interest. Once risks have been identified, options for managing conflicts include disclosure followed by no change in the systematic review team or activities, inclusion on the team along with other members with differing viewpoints to ensure diverse perspectives, exclusion from certain activities, and exclusion from the project entirely.ConclusionThe feasibility and utility of this approach to ensuring needed expertise on systematic reviews and minimizing bias from nonfinancial conflicts of interest must be investigated.     

The Interplay Between Early Father Involvement and Neonatal Medical Risk in the Prediction of Infant Neurodevelopment

The current study examines the association between early father involvement and infant neurodevelopment, and whether neonatal medical risk moderates this association. Data from approximately 6000 fathers and their children were obtained from the Early Childhood Longitudinal Study: Birth Cohort (ECLS-B). Hierarchical regression was employed to analyze the data. The findings reveal that the association between early father involvement and infant neurodevelopment is contingent on both the timing of involvement (i.e., prenatal/perinatal or infancy) and offspring medical status at birth. The neurodevelopment of medically at-risk neonates was enhanced when fathers were involved during the gestational period and at the time of their birth. This relationship was not detected, however, in the case of infants who did not experience medical risks as neonates. Neonatal medical risk appears to be an important moderating factor in the link between father involvement during pregnancy and childbirth and infant neurodevelopment. Practitioners should continue to make efforts to involve fathers during gestation and childbirth. The findings of the present study suggest that doing so may protect against neurodevelopmental delays in neonates with medical risks.