生物样本库知情同意书规范化设计

知情同意书的签署是生物样本库伦理建设的核心, 其结构包括"知情告知"和"自主同意"两部分主体内容。本文依据现阶段生物样本库的特点, 提出生物样本库知情同意书的规范化设计, 具体描述从"生物样本库完备告知"到"捐赠者充分知情"两部分核心内容和要求, 以供生物样本库实践者参考和借鉴。     

我国临床生物样本库平台化建设

医学研究迫切需要大量有价值的生物样本和数据资源集成共享来破解重大疾病难题。在医疗实践和医学研究过程中，临床生物样本库发挥了科研服务支撑平台作用，通过整合有限的生物样本与数据资源，为探索疾病发生、发展、转归、诊断、治疗及药物研发和健康预防等提供资源保障。本文着重阐述我国临床生物样本库平台标准化建设特点与发展、公共管理平台运行模式、信息化平台与资源平台运行管理及质量控制，以期推动我国临床生物样本库平台化、标准化建设。     

建设特勤人员生物样本库的思考

随着精准医疗和转化医学的发展进步,生物样本库作为链接临床工作和实验室研究的重要环节,在国内外医学研究领域越来越受到重视。本文从生物样本库的国内外发展现状、特勤人员生物样本库建设要点、建设特勤人员生物样本库的意义这三个方面进行阐述,分析探讨建设特勤人员生物样本库的重要性,加强未来对特勤人员的精准化、个性化医疗保障工作。     

多中心结直肠癌临床研究生物样本库信息系统的建设与管理

近年来,我国结直肠癌的发病率显著升高。随着对结直肠癌复发、转移机制的深入探索,可提供全面生物医学信息的生物样本库信息系统显得尤为重要。本文阐述了采用微服务架构构建包含临床电子数据采集系统、生物样本管理系统和生物信息数据平台三个子系统的多中心结直肠癌临床研究生物样本库信息系统,同时介绍各子系统在多中心临床研究中的管理模式和特色功能;并通过统一化编码规则、结构化临床信息、标准化样本流转信息和规范化数据存储等数据标准化管理方案,保障数据质量和互联互通,从而为推进转化医学研究和精准医疗发展提供全方位生物医学信息。     

2019细胞产业大会、第四届(上海)细胞与肿瘤精准医疗高峰论坛(9月26-27日)

<正>2019细胞产业大会、2019第四届(上海)细胞与肿瘤精准医疗高峰论坛将于2019年9月26-27日在中国上海举行,此次论坛致力于发展成为中国细胞储存、细胞治疗与精准医疗领域全产业链一站式采购、交流合作、学习平台。会议议题涵盖细胞储存、细胞治疗、细胞培养、细胞工程、细胞银行、细胞能量与代谢、细胞免疫学、细胞生理学、细胞衰老、细胞病理学、再生医学、生物冷链、生物样本库、精准医疗等。论坛特邀国内外细     

2019细胞产业大会、第四届(上海)细胞与肿瘤精准医疗高峰论坛(9月26-27日)

<正>2019细胞产业大会、2019第四届(上海)细胞与肿瘤精准医疗高峰论坛将于2019年9月26-27日在中国上海举行,此次论坛致力于发展成为中国细胞储存、细胞治疗与精准医疗领域全产业链一站式采购、交流合作、学习平台。会议议题涵盖细胞储存、细胞治疗、细胞培养、细胞工程、细胞银行、细胞能量与代谢、细胞免疫学、细胞生理学、细胞衰老、细胞病理学、再生医学、生物冷链、生物样本库、精准医疗等。论坛特邀国内外细胞学新进展相关领域内的学者专家前来参会,并做出精彩的报告。     

生物样本库发展的现状、机遇与挑战

生物样本库是实现转化医学与精准医学的重要源头与关键环节之一,随着精准医学计划和“健康中国2030”战略规划的提出,生物样本库迎来了难得的发展机遇。同时我国生物样本库存在的问题也日益凸显,包括相关国家标准尚未出台、标准化流程实施与质量控制有待推进、共享应用机制尚待完善、低层次重复建设较为严重、自身造血能力普遍较弱及可持续发展机制有待探索等。在过去十年,生物样本库在标准化、共享应用、集约化和可持续发展等方面取得了一定发展,促进了生物样本资源在生物医药产业链各环节的充分应用,开启了中国生物样本库标准化建设的新时代。     

临床生物样本库信息系统建设与发展

随着转化医学的快速发展, 临床生物样本库的作用日益凸显, 其建设和应用日益受到关注和重视。信息管理系统是样本库的核心部分, 其建设应立足于支撑样本库的运营、管理和服务全过程, 通过建立样本信息数据采集流程、数据集成与交换系统及安全系统, 形成一体化整合数据库和公共门户网站, 实现生物样本、临床资料和分子数据等各种资源的高效管理和全面共享。     

基于"四主题理论"的临床实践教学伦理问题分析——以患者拒绝医学生操作为例

临床实践教学过程中经常遇到棘手的伦理问题,如医学生的受教育权与患者"最佳利益"之间的冲突。正确认识这一临床伦理问题,并制定恰当的应对方案,有助于临床带教医师、医学生从容应对该矛盾,并提高患者满意度。本文以"患者拒绝医学生操作"为例,从临床伦理学角度,基于医疗适用性、患者偏好、生命质量及情境特征"四主题理论"模式进行评估,提炼核心伦理问题,并结合国内外文献及自身经验提出应对策略和建议,以期为临床教学提供参考和帮助。     

HIV感染真的被“治愈”了吗？

人类免疫缺陷病毒(human immunodeficiency virus, HIV)感染靶细胞需要识别细胞表面CD4分子及其辅助受体, C-C趋化因子受体5(C-C chemokine receptor type 5, CCR5)和C-X-C趋化因子受体4(C-X-C-motif receptor 4, CXCR4)是HIV识别靶细胞的两种重要辅助受体。CCR5Δ32基因突变使得HIV无法识别CCR5受体, 从而阻止嗜CCR5的HIV病毒株入侵靶细胞。"柏林病人"和"伦敦病人"正是利用这一原理, 通过移植携带纯合子CCR5Δ32突变基因的异基因骨髓, 实现了停用抗病毒药物后病毒无反弹的目标, 故而被誉为HIV感染"治愈"案例。然而, 这一成功是否存在偶然性?事实上, 人群中携带CCR5Δ32纯合子基因突变概率极低、异基因骨髓配型十分困难、骨髓移植医疗费用昂贵、移植后HIV病毒株嗜性迁移等客观因素的存在, 使得通过携带纯合子CCR5Δ32基因突变异基因骨髓移植法实现HIV感染者停用抗病毒药物且保持病毒不反弹的目标困难重重。因此, "柏林病人"和"伦敦病人"的成功经验为治疗HIV感染提供了新的方向和希望, 但如认为HIV感染已被"治愈"为时尚早, 需进一步研究证实。     

The functional structure of Taiwan's Pilot Telecare Project

In order to respond to the growth of the elderly population, to achieve the goal of "aging in place," and to promote the vital development of the healthcare industry, the Department of Health, under Taiwan's Executive Yuan, commissioned a Telecare project in 2007 to manage long-term care needs by utilizing information technologies to support healthcare. With the collaboration of medical institutions, information and communications technology laboratories, and home security providers, and in order to establish comprehensive health service provision, the project team has planned and established not only community-based care services, home-based care services, and institution-based care services, but also a Telecare information integration platform to support care management, exchange of information, and information security. The Telecare project pilot study is expected to prove the efficacy of this innovative service model and bring long-term care services in Taiwan into a new era.     

诊断学信息采集的新格局

随着互联网、云计算和生物组学技术的发展和日趋成熟,人类迎来了医学的大数据、大诊断时代。人体诊断信息的采集也随之发生了重大变化。医学模式的转变、分子诊断技术的发展、精准医学时代的到来以及移动通信平台的迅速发展共同促进了诊断学信息采集新格局的形成。同时这对诊断学教育结构的调整及诊断学教学也提出了新的要求。     

A needs assessment for a palliative care curriculum

To ensure the success of a new curriculum at an institution, information about the educational needs of learners, available resources, and potential obstacles needs to be systematically collected and analyzed prior to the development and implementation of the actual curriculum. This process, known as needs assessment, is important in the development of palliative care training for internal medicine residents, because internal medicine has only recently begun to address these issues in a formalized way and palliative care is a relatively new topic in medical education and clinical medicine. Therefore, institutional issues and resistance, lack of knowledge and appropriate attitudes among trainees and faculty, and a paucity of educational models for individual internal medicine training programs present potential obstacles. Although curricula that have been developed by national organizations can serve as “guideposts,” these documents are unable to address the specific needs and culture of an individual institution. This paper outlines a systematic methodology of needs assessment for palliative care curricula at individual institutions that could be applied to the development and implementation of palliative care training for different groups of learners. An institution-specific needs assessment was developed based upon the findings of a systematic literature review and interviews with experts in palliative medicine and medical education. The following methods were utilized: 1) an anonymous survey; 2) focus groups; 3) topic rankings; and 4) individual interviews. The needs assessment revealed the following educational, clinical, and institutional information: 1) interns had very little exposure to palliative care in medical school; 2) there was no formalized system for formal education and clinical exposure; 3) tremendous interest in palliative care education existed; 4) patients, families, physicians, and nurses perceived a need to improve the quality of palliative care; and 5) there are several political, logistical, and resource (time and financial) obstacles that needed to be addressed. An institution-specific needs assessment is an important part of the successful development and implementation of any new curriculum for medical residents and was specifically necessary for our palliative care program. As a result of the needs assessment process, a curriculum consisting of ten units of case-based and problem-based teaching was successfully implemented.     

Resourcing the clinical complementary medicine information needs of Australian medical students: Results of a grounded theory study

The aim of this study was to identify Australian medical students’ complementary medicine information needs. Thirty medical students from 10 medical education faculties across Australian universities were recruited. Data were generated using in‐depth semi‐structured interviews and constructivist grounded theory method was used to analyze and construct data. Students sought complementary medicine information from a range of inadequate sources, such as pharmacological texts, Internet searches, peer‐reviewed medical journals, and drug databases. The students identified that many complementary medicine resources may not be regarded as objective, reliable, differentiated, or comprehensive, leaving much that medical education needs to address. Most students sought succinct, easily accessible, evidence‐based information to inform safe and appropriate clinical decisions about complementary medicines. A number of preferred resources were identified that can be recommended and actively promoted to medical students. Therefore, specific, evidence‐based complementary medicine databases and secondary resources should be subscribed and recommended to medical schools and students, to assist meeting professional responsibilities regarding complementary medicines. These findings may help inform the development of appropriate medical information resources regarding complementary medicines.     

Policy for therapeutic massage in an academic health center: a model for standard policy development

CONTEXT: Massage is the most common complementary and alternative medicine (CAM) therapy used in hospitals in the United States. As such, it is often the first CAM therapy to be integrated with conventional medicine. However, few academic medical centers have a written standard policy to guide this integration. This lack of standard policy may impede institutions from offering massage therapy as a clinical service, and may put health care professionals and institutions at risk through a failure to clearly address criteria for practice credentials or malpractice liability. OBJECTIVE: To create a clinical policy for therapeutic massage that may be used as a template for development of policy in academic health centers. RESULTS: We present a clinical policy for therapeutic massage, developed by the University of Michigan Health System, that defines therapeutic massage, provides guidelines for the credentialing and professional conduct of massage therapists, lists indications and contraindications for therapeutic massage, and addresses malpractice in accordance with the specific culture and needs of academic health centers. This policy was created by health care professionals after review of existing evidence and consideration of national criteria for massage therapy. This policy is intended to be used as a template for the development of a standard policy for therapeutic massage by health system administrators, medical directors, and massage professionals, to support the integration of therapeutic massage within their institutions. CONCLUSIONS: With minor modifications of this policy by individual institutions, adoption of this policy may facilitate the thoughtful integration of this CAM therapy into academic health care settings, meeting the unique requirements of academic health care institutions while serving the needs of patients.     

基于云计算的传染病症候群与病原学监测数据分析平台设计与实现

  目的  传染病监测技术平台信息管理系统于“十一五”期间依托项目建设,为传染病监测提供信息化支持。 经过多年运行,系统已不能满足新的信息管理需求,且采集数据敏感、用户类型复杂,系统的安全性面临一定挑战。  方法  从业务需求、架构设计、系统部署等方面,阐述传染病症候群与病原学监测数据分析平台设计与实现,并分析平台应用效果。  结果  通过构建传染病症候群与病原学监测网络信息云平台,实现已建系统同新建设的传染病症候群与病原学监测综合分析平台、病原组学信息共享平台的统一集成与云部署应用,提供可视化统计分析结果展示,提升了数据应用价值。  结论  平台有效控制资源访问,保证用户身份真实可信,促进资源融合,为科学决策探索科技支撑路径。     

Informatics and Knowledge Translation

To ensure that the benefits of knowledge translation synthesis are accessible to care providers at the point of decision-making, fast, efficient, usable clinical information systems are required. Medical informatics appears to hold the greatest promise to be able to create systems with the necessary capacity and functionality. Emergency medicine needs to be actively engaged at all levels of the process. This includes driving the development and filtering of emergency-specific synopses and summaries. It requires advocating for hardware and software that suit the needs of the emergency department environment. It is increasingly important to educate and participate on committees with funders and policy-makers to ensure they support this growing evolution. To determine the outcome of these initiatives, careful evaluation is required to inform the discussion. End-users need to be actively involved in the development and usability testing of clinical information retrieval technology and clinical decision-support systems and make certain relevant best evidence is readily accessible and formatted to meet the needs of the working emergency physician. The integration of knowledge translation into clinical practice, and the impact of delivering electronic clinical decision-support, requires methodologically sound studies to confirm or refute its benefits and guide future development of medical informatics.     

高质量循证医学证据获取与应用研究

随着医疗大数据时代的到来,循证医学的发展迎来了新的变革。本文介绍了数据驱动的循证医学思维定义,并阐释其为循证医学发展带来的变化。从越来越科学的原始证据来源、智能化的循证医学文献信息提取、基于AI的真实世界健康医疗数据分析、创新的临床科研专病数据库、基于AI的临床指南等场景,探讨了智慧化高质量循证医学证据的获取与应用过程,总结了循证医学证据质量的影响因素,包括数据集成、数据质量、技术偏差、数据安全和伦理、人才队伍等。     

Building a data base for monitoring and facilitating health care

Our experience suggests that (1) comprehensive objective information is a valuable medical resource; (2) the systematic acquisition of objective information in a form suitable for computers is a necessary first step to building a useful data base; (3) when appropriately utilized, objective medical information may permit a study of medical practice, cost of care, and operational efficiency; (4) analysis of costs divorced from outcome and rehospitalization experiences may be misleading; (5) for some desired studies, the information required may be obtainable within a single institution. For others, however, community-wide studies may be the only possible way to obtain the information needed; (6) useful computer systems will be developed only if the health professionals become more knowledgeable (and demanding) and administrators are persuaded to provide effective support; and (7) effective hospital support for adequate medical information systems will probably come when criteria evaluating hospital performance are altered to reflect society's needs. Our experience with computer evaluation of care has been a sobering one. Still, it is obvious that the technology offers considerable hope that many inefficiencies in practice can be corrected. Considering all the current jeremiads about what we can afford in health care, it is reassuring to learn that good medicine is cost effective.