中医住院医师规范化培训的人文教育路径探索

<正>住院医师规范化培训是医学生向临床医师“角色转换”的重要桥梁。2013年，北京市启动新模式的中医住院医师（全科医师）规范化培训（以下简称住培），中医住培基地严格按照国家政策文件要求，积极推进基地建设，包括加强制度落地实施、规范过程管理、建设功能完善的临床技能培训中心、开展规范化技能培训、推动师资队伍建设等。     

基于文件连续体理论的医院合同文档管理

医院合同文档是维护医院合法权益的凭证和依据,但传统的合同文档分类归档模式已经不能满足日益多样的利用需求。文件连续体理论为信息化背景下的医院合同文档管理提供了一个新的管理模式,即运用全程管理原则和文档一体化思想,通过建立健全医院文档管理组织机构、加强顶层设计和制度建设、构建合同管理系统等具体措施,突破了医院合同文档管理和利用过程中时间和空间的限制,最终达到提升合同文档管理质量、效率和服务水平的目的。     

医院文档一体化管理的应用研究

文档一体化理论在档案管理中已经逐渐被接受，但把理论用于档案管理的实践，却是近些年的事，随着人类对获取信息渴求程度越来越高，人们开始越来越重视对文件信息和档案信息的管理，本文正是从这个视角出发，着重阐述了文档一体化管理的基本内涵，分析了在传统的文档管理中部门职能分工刚性过大、管理方法落后和管理对象的改变等方面．是直接造成文档一体化工作难以顺利开展的主要原因，指出文档一体化管理中值得注意的几个问题，以及解决之道。本文以南京市第一医院文档一体化管理的实践作为实际案例．对文档一体化管理进行了实证研究，本文指出文档一体化管理是提高档案管理质量和工作效率有效方法。     

《药物临床试验质量管理规范》在疫苗临床试验中的应用

目的说明在疫苗临床试验中严格执行《药物临床试验质量管理规范》(GCP)的重要意义。方法对临床试验过程中发现的问题依据GCP进行分析,探讨解决办法,说明疫苗临床试验严格执行GCP的必要性。结果疫苗临床试验中不遵循GCP的行为是导致临床试验不能顺利开展甚至失败的重要原因。结论 GCP是适用于疫苗临床试验的规范文件,严格遵循GCP和相关法规是保证临床试验数据和结果的质量及科学性、准确性、可靠性和完整性的关键。     

医学实验文档管理系统的数据库设计与实现

目的提高对医学实验文档、原始数据尤其是大文件的管理效率,增强安全性和保密性。方法在数据库管理软件(SQL server 2008)平台下遵循数据库规范化设计方法,利用跨平台的面向对象的程序设计语言(Java)开发医学实验文档管理系统数据库。结果利用该系统实现了对医学实验文档及原始数据进行上传、下载及权限管理和自动备份等管理功能。结论本研究所采用的方法是将实验研究过程中的原始数据和文件直接以二进制的形式保存到数据库,有效地保证了数据的安全性和保密性。     

提高护士书写护理记录水平的方法和体会

护理记录是患者病历的重要组成部分，是护士根据医嘱和病情变化对患者在住院期问护理过程进行客观记录，也是医生观察诊疗效果和调整治疗方案的重要依据之一，又是护士“举证责任倒置”重要的法律判定依据，如何书写符合要求的护理文件已成为护理管理人员和临床护理人员的重点和难点。我院在护理记录书写方面给予高度重视，护理记录实行病历质控院科两级管理，     

FOCUS-PDCA助力提高临床科室文档合格率

临床科室文档对医院评审评价具有重要支撑作用。为做好文档管理工作,将FOCUS-PDCA引入临床科室文档管理,成立质量控制小组,针对缺乏制度规范及监管机制等问题,从修订医院制度管理规定,制定临床科室文档管理规范,建立示范科室,加强督导检查等方面进行改进,建立了科学、合理、规范的临床科室文档管理体系,实现了临床科室文档管理的精细化、标准化。     

利用OFFICE软件编制医院局域网自动备份程序

本文介绍利用OFFICE办公软件的VBA功能，编制出局域网上文档自动备份程序，并配有相应的文件自动加密功能。使文档的备份管理更加轻松自如。     

实施及强化药物临床试验管理规范

实施及强化药物临床试验管理规范费秀瑛，单渊东，顾文英药物临床试验是医院科研管理的重要组成部分，本文将在简单总结我院以往工作的基础上，提出已经实施或将要实施的强化举措。一、医院药物临床试验概况我国在８０年代中期开始执行药品评审法，即国内研制的新药及国外...     

企业编制质量手册的几个问题

企业编制质量手册的几个问题中国医疗器械质量认证中心陈志刚企业在实施质量认证建立健全质量体系过程中，必须要按照要求编制质量体系文件。质量体系文件是开展质量管理和质量保证的基础，它既是质量体系运行的规范性依据，也是质量体系审核和质量体系认证的主要依据，同...     

Using documents to investigate links between implementation and sustainability in a complex community intervention: the PRISM study

The increasing imperative to find what works in health services has meant a rise in research trialing interventions deemed 'complex'. While the strength of these interventions comes from taking a 'whole of problem' approach using multiple and inter-linking strategies, ways of examining implementation are under-explored. Building sustainability is an important part of implementing complex intervention research, but this too has received little exploration in the implementation literature. This paper explores issues of implementation and sustainability by examining the case of PRISM (Program of Resources, Information and Support for Mothers), a community randomised trial in Victoria, Australia aimed at improving maternal health and wellbeing. It examines documents placed on the project website. Three groups of documents relating to implementation of the intervention were examined - implementation reports, media reports and community newsletters. Analysing these documents allowed a focus on the 'work' of the intervention - who does the work and what activities comprise the work - in order to examine implementation as it relates to sustainability. Document analysis provides a useful way of considering implementation and sustainability of complex intervention research. It can 'value add' to findings from process evaluation and extend our understanding of an intervention beyond outcome measures. Analysis of the documents in this case provides insights into why sustainability of an intervention may be difficult to achieve during implementation.     

The significance of policy documents in municipal child health promotion

AIMS: To investigate municipal utilization of policy documents in child health-promoting activities with reference to document types, substance in the documents and timing in the policy process. METHODS: Fifty semi-structured interviews were performed using the snowball method, and content analyses of written documentation were made. Data were categorized by means of a policy process matrix, and nine case studies were written. Triangulation was used as a validating method, and the coding reliability was assessed. Statements related to various policy documents were categorized according to document types, substance in the documents, and timing in the policy process. RESULTS: Various policy documents were spontaneously mentioned by 33 of 50 interviewees, in eight of nine case studies, and in all stages of the policy process. Well-defined statements concerning which content in the policy documents that actually impacted on the policy process development were uncommon. CONCLUSIONS: This study shows that policy documents are present in policy processes related to child health-promoting activities in Swedish municipalities. As Swedish municipalities are autonomous and not forced to pursue governmental recommendations, this probably demonstrates that policy documents are significant in the development of such processes.     

An online decision tree for vaccine efficacy trial design during infectious disease epidemics: The InterVax-Tool

BackgroundLicensed vaccines are urgently needed for emerging infectious diseases, but the nature of these epidemics causes challenges for the design of phase III trials to evaluate vaccine efficacy. Designing and executing rigorous, fast, and ethical, vaccine efficacy trials is difficult, and the decisions and limitations in the design of these trials encompass epidemiological, logistical, regulatory, statistical, and ethical dimensions.ResultsTrial design decisions are complex and interrelated, but current guidance documents do not lend themselves to efficient decision-making. We created InterVax-Tool (http://vaxeval.com), an online, interactive decision-support tool, to help diverse stakeholders navigate the decisions in the design of phase III vaccine trials.InterVax-Tool offers high-level visual and interactive assistance through a set of four decision trees, guiding users through selection of the: (1) Primary Endpoint, (2) Target Population, (3) Randomization Scheme, and, (4) Comparator. We provide guidance on how key considerations – grouped as Epidemiological, Vaccine-related, Infrastructural, or Sociocultural – inform each decision in the trial design process.ConclusionsInterVax-Tool facilitates structured, transparent, and collaborative discussion of trial design, while recording the decision-making process. Users can save and share their decisions, which is useful both for comparing proposed trial designs, and for justifying particular design choices.Here, we describe the goals and features of InterVax-Tool as well as its application to the design of a Zika vaccine efficacy trial.     

The tobacco industry's response to the COMMIT Trial: an analysis of legacy tobacco documents

We analyzed internal tobacco industry documents that describe the industry's response to the Community Intervention Trial for Smoking Cessation (COMMIT), a multi-center community-based tobacco intervention project funded by the National Cancer Institute from 1988 to 1992. Our analysis of documents from the Legacy Tobacco Documents Library (www.legacy.library.ucsf.edu) suggests that the tobacco industry reacted to COMMIT by (1) closely monitoring trial activities, (2) confronting COMMIT in communities where it was most active, (3) distorting COMMIT findings on underage smoking data reported in the media, and (4) using COMMIT activities as practice to strengthen their attack against the subsequent ASSIST trial, falsely accusing both studies of illegal political lobbying with taxpayers' money. The tobacco industry closely monitored COMMIT activities and organized local responses to findings and activities perceived as threatening to the industry's public image or interests. Although we could not document a concerted attack by the tobacco industry that impacted the results of the COMMIT trial, data suggest that the industry used COMMIT as a learning opportunity to mount a well orchestrated and potentially damaging response to the larger American Stop Smoking Intervention Study for Cancer Prevention Trial.     

医院档案开发利用在医院卫生志编纂中的价值探讨

目的:探讨医院档案开发利用在医院卫生志编纂中的价值。方法:整理档案室收集的医院工作计划、总结表彰、大事记、会议记录以及统计报表等大量各种门类不同的载体档案,用于医院卫生志编纂工作。结果:完整、详实地医院档案为医院卫生志的编纂提供了准确依据,是卫生志编纂中主要的资料源泉。结论:医院档案是医院建设与发展历史的真实记录,编史修志是档案开发利用的途径之一,编史修志需要并依靠档案,并能促进医院档案工作的发展。     

Are clinical documents optimised for patient safety? A critical analysis of patient safety outcomes using the EDA error model

Iatrogenic errors and patient safety in clinical processes are an increasing concern. The quality of process information in hardcopy or electronic form can heavily influence clinical behaviour and decision making errors. Little work has been undertaken to assess the safety impact of clinical process planning documents guiding the clinical actions and decisions. This paper investigates the clinical process documents used in elective surgery and their impact on latent and active clinical errors. Eight clinicians from a large health trust underwent extensive semi-structured interviews to understand their use of clinical documents, and their perceived impact on errors and patient safety. Samples of the key types of document used were analysed. Theories of latent organisational and active errors from the literature were combined with the EDA semiotics model of behaviour and decision making to propose the EDA Error Model. This model enabled us to identify perceptual, evaluation, knowledge and action error types and approaches to reducing their causes. The EDA error model was then used to analyse sample documents and identify error sources and controls. Types of knowledge artefact structures used in the documents were identified and assessed in terms of safety impact. This approach was combined with analysis of the questionnaire findings using existing error knowledge from the literature. The results identified a number of document and knowledge artefact issues that give rise to latent and active errors and also issues concerning medical culture and teamwork together with recommendations for further work.     

医政执法中医疗文书调查取证初探

医疗文书是医政执法中最典型、最有价值的文书类证据,是进行有效监管处罚的一项重要证据。本文阐释了医疗文书含义,分析其性质,并对其作为医政执法证据的取证要点进行分析,有助于提高获取医疗文书及固定证据效力的能力,推动医政执法工作更规范有序地开展。     

Health Literacy and Informed Consent Materials: Designed for Documentation,Not Comprehension of Health Research

Minority populations with health disparities are underrepresented in research designed to address those disparities. One way to improve minority representation is to use community-based participatory methods to overcome barriers to research participation, beginning with the informed consent process. Relevant barriers to participation include lack of individual or community awareness or acceptance of research processes and purposes. These barriers are associated with limited health literacy. To inform recommendations for an improved consent process, we examined 97 consent documents and 10 associated Institutional Review Board websites to determine their health literacy demands and degree of adherence to principles of community-based research. We assessed the reading level of consent documents and obtained global measures of their health literacy demand by using the Suitability and Comprehensibility Assessment of Materials instrument. Although these documents were deemed suitable as medical forms, their readability levels were inappropriate, and they were unsuitable for educating potential participants about research purposes. We also assessed consent forms and Institutional Review Board policies for endorsement of community-based participatory principles, finding that very few acknowledged or adhered to such principles. To improve comprehension of consent documents, we recommend restructuring them as educational materials that adhere to current health literacy guidelines.     

医院基建档案的重要性及有效管理

医院基建档案作为一个独立的验收项目,已渐渐成为医院工程建设项目的重要依据。基建档案不仅涉及到建设项目在立项、审批、招投标、勘察、设计、施工、监理及竣工验收全过程中形成的文字、图表、声像等形式的全部文件,还涉及交付后使用过程中的改建、装修、设备安装等施工过程和结果的记录等。它不仅是医院领导班子决策成果的证明,也是基建部门工作人员集体智慧的结晶,是医院历史上的一笔精神财富。如何去利用和管理这笔精神财富是一个需要长期摸索和探讨的问题,这笔财富的管理水平也正代表一个医院建设期间的管理水平。