Clinical standards

  • 文章类型: Journal Article
    模式视网膜电图(PERG)是由对比度反转模式引起的局部视网膜反应,通常是黑白棋盘,它提供了有关黄斑和视网膜神经节细胞功能的信息。这份文件,来自国际临床视觉电生理学学会(ISCEV;www.iscev.org)提出了更新和修订的临床PERG测试标准。这将替换2013和所有早期版本。基本PERG刺激的最低方案,规定了记录方法和报告,为了促进诊断和监测目的方法的一致性,同时应对不断发展的临床实践和技术。更新后的ISCEV临床PERG标准的主要变化包括对大型刺激场的扩展指导,同时记录PERG和模式视觉诱发电位的刺激参数,基线漂移校正,和使用一致的环境房间照明。这些更改旨在提供有关当前实践的临床相关文件,这将有助于高质量的记录和实验室间的比较。
    The pattern electroretinogram (PERG) is a localized retinal response evoked by a contrast-reversing pattern, usually a black and white checkerboard, which provides information about macular and retinal ganglion cell function. This document, from the International Society for Clinical Electrophysiology of Vision (ISCEV; www.iscev.org ) presents an updated and revised Standard for clinical PERG testing. This replaces the 2013 and all earlier versions. Minimum protocols for basic PERG stimuli, recording methods and reporting are specified, to promote consistency of methods for diagnosis and monitoring purposes, while responding to evolving clinical practices and technology. The main changes in the updated ISCEV Standard for clinical PERG include expanded guidance about large stimulus fields, stimulus parameters for simultaneous PERG and pattern visual evoked potential recording, baseline drift correction, and use of consistent ambient room lighting. These changes aim to provide a clinically relevant document about current practice which will facilitate good quality recordings and inter-laboratory comparisons.
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  • 文章类型: Journal Article
    全场刺激测试(FST)是一种心理物理技术,旨在测量低视力下的视觉功能。该方法涉及使用ganzfeld刺激器,用于常规全场视网膜电描记术,发出全场闪光。本指南由国际临床视觉电生理学学会(ISCEV)和成像和视野学会(IPS)联合开发,以提供技术信息。促进测试和报告的一致性,并鼓励FST方法的趋同。它旨在帮助从业人员并指导FST协议的制定,为了未来的标准化。
    The full-field stimulus test (FST) is a psychophysical technique designed for the measurement of visual function in low vision. The method involves the use of a ganzfeld stimulator, as used in routine full-field electroretinography, to deliver full-field flashes of light. This guideline was developed jointly by the International Society for Clinical Electrophysiology of Vision (ISCEV) and Imaging and Perimetry Society (IPS) in order to provide technical information, promote consistency of testing and reporting, and encourage convergence of methods for FST. It is intended to aid practitioners and guide the formulation of FST protocols, with a view to future standardisation.
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  • 文章类型: Journal Article
    医师是临终关怀跨学科团队(IDT)的不可或缺的成员。本声明描述了临终关怀医疗主任(HMD)和临终关怀医生的核心角色和职责,他们由临终关怀计划指定,以履行HMD的核心职责。此外,我们描述了临终关怀计划的基本要素\'的结构和功能所需的临终关怀医生履行其角色和责任。最后,我们呼吁关注临终关怀项目的特点和工作环境的情况,这应该引起临终关怀医生的担忧,即临终关怀患者和家属有接受低质量护理的风险。这些因素包括缺乏有效的IDT,最少的医生参与直接患者护理和临床IDT会议,对患者家中的症状紧急情况反应不充分,没有或有限地获得普通住院和持续的家庭临终关怀。我们以个人医生的身份撰写,他们担心美国临终关怀服务的获取和质量的麻烦变化。这种说法源于需要保护脆弱的重病人及其家人的安全和福祉,使其免受低质量的临终关怀。此声明主要旨在成为临终关怀医生在谈判就业协议和证明必要的人员配备和方案资源,以履行他们的工作。该声明还可以作为患者倡导团体的资源和参考,临终关怀行业领导者,卫生服务监督组织,问责机构,和立法机构努力确保安全,质量,以及美国临终关怀的可靠性。
    Physicians are integral members of hospice interdisciplinary teams (IDTs). This statement delineates the core roles and responsibilities of hospice medical directors (HMDs) and hospice physicians who are designated by the hospice program to fulfill core HMD responsibilities. In addition, we describe the basic elements of hospice programs\' structure and function required for hospice physicians to fulfill their roles and responsibilities. Finally, we call attention to hospice program characteristics and circumstances of the work environment that should raise a hospice physician\'s concerns that hospice patients and families are at risk of receiving low-quality care. Such factors include lack of a functioning IDT, minimal physician involvement in direct patient care and clinical IDT meetings, inadequate responses to symptom emergencies in patients\' homes, and no or limited access to general inpatient and continuous home hospice care. We write as individual physicians who are concerned about troubling variability in access to and quality of U.S. hospice care. This statement arises from the need to protect the safety and well-being of vulnerable seriously ill people with their families from low-quality hospice care. This statement is primarily intended to be a resource to hospice physicians in negotiating employment agreements and justifying staffing and programmatic resources necessary to perform their jobs well. This statement may also serve as a resource and reference for patient advocacy groups, hospice industry leaders, health services oversight organizations, accountability agencies, and legislatures in efforts to ensure the safety, quality, and reliability of hospice care in the United States.
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  • 文章类型: Journal Article
    背景:重新对齐截骨术在荷兰整形外科医生中越来越受欢迎。由于缺乏国家注册,有关截骨术的确切数字和临床实践中使用的标准尚不清楚。这项研究的目的是调查进行截骨术的国家统计数据,利用临床检查,外科技术,以及荷兰的术后康复标准。
    方法:荷兰骨科医生,荷兰膝关节协会的所有成员,在2021年1月至3月之间收到了一项基于网络的调查。这项电子调查包含36个问题,细分为:普通外科医生相关信息,进行截骨术的数量,纳入患者,临床检查,外科技术,和术后管理。
    结果:86名骨科医师填写了问卷,其中60人在膝盖周围进行重新对齐截骨术。所有60名响应者(100%)进行胫骨高位截骨术,另外63.3%进行股骨远端截骨术,而30%的人进行双水平截骨术。在纳入标准方面报告了手术标准的差异,临床检查,外科技术,和术后策略。
    结论:结论:这项研究对荷兰整形外科医生应用的膝关节截骨术临床实践有了更深入的了解。然而,仍然存在重要的差异,这些差异要求基于现有证据进行更多的标准化。(国际)国家膝关节截骨登记,更重要的是,联合保存手术的(国家间)注册可能有助于实现更多的标准化和治疗见解。这样的注册可以改善截骨术的各个方面及其与其他关节保留干预措施的组合,以提供个性化治疗的证据。
    BACKGROUND: Realignment osteotomies is gaining popularity amongst Dutch orthopaedic surgeons. Exact numbers and used standards in clinical practice concerning osteotomies are unknown due to the absence of a national registry. The aim of this study was to investigate the national statistics of performed osteotomies, utilized clinical workups, surgical techniques, and post-operative rehabilitation standards in the Netherlands.
    METHODS: Dutch orthopaedic surgeons, all members of the Dutch Knee Society, received a web-based survey between January and March 2021. This electronic survey contained 36 questions, subdivided into: general surgeon-related information, number of performed osteotomies, inclusion of patients, clinical workup, surgical techniques, and post-operative management.
    RESULTS: 86 orthopaedic surgeons filled in the questionnaire, of whom 60 perform realignment osteotomies around the knee. All the 60 responders (100%) perform high tibial osteotomies and 63.3% additionally perform distal femoral osteotomies, while 30% perform double level osteotomies. Discrepancies in surgical standards were reported regarding to inclusion criteria, clinical workup, surgical techniques, and post-operative strategies.
    CONCLUSIONS: In conclusion, this study got more insight in knee osteotomy clinical practices as applied by Dutch orthopaedic surgeons. However, there are still important discrepancies which pleads for more standardization based on available evidence. A (inter)national knee osteotomy registry, and even more so, a (inter)national registry for joint preserving surgeries could be helpful to achieve more standardization and treatment insights. Such a registry could improve all aspects of osteotomies and its combinations with other joint-preserving interventions towards evidence for personalised treatments.
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  • 文章类型: Journal Article
    全场视网膜电图(ERG)是对弥散性闪光的大量电生理反应,被广泛用于评估广义视网膜功能。这份文件,来自国际临床视觉电生理学学会(ISCEV),提供了用于临床ERG测试的更新和修订的ISCEV标准。基本ERG刺激的最低方案,规定了记录方法和报告,为了促进诊断方法的一致性,监测和实验室间比较,同时也应对不断发展的临床实践和技术。此更新的ISCEV临床ERGs标准中的主要变化包括规定ERGs可能符合标准而没有散瞳,提供足够的刺激补偿非扩张的瞳孔。关于暗适应振荡电位(OP)的分析有更多细节,文档格式已更新,补充内容已减少。对主要ERG组件的起源进行了更详细的回顾。先前作为附加ERG协议列表的几项测试现在被引用为已发布的ISCEV扩展协议。描述了非标准缩写ERG协议,当患者年龄较大时使用,符合性或其他情况排除ISCEV标准ERG测试。
    The full-field electroretinogram (ERG) is a mass electrophysiological response to diffuse flashes of light and is used widely to assess generalized retinal function. This document, from the International Society for Clinical Electrophysiology of Vision (ISCEV), presents an updated and revised ISCEV Standard for clinical ERG testing. Minimum protocols for basic ERG stimuli, recording methods and reporting are specified, to promote consistency of methods for diagnosis, monitoring and inter-laboratory comparisons, while also responding to evolving clinical practices and technology. The main changes in this updated ISCEV Standard for clinical ERGs include specifying that ERGs may meet the Standard without mydriasis, providing stimuli adequately compensate for non-dilated pupils. There is more detail about analysis of dark-adapted oscillatory potentials (OPs) and the document format has been updated and supplementary content reduced. There is a more detailed review of the origins of the major ERG components. Several tests previously tabulated as additional ERG protocols are now cited as published ISCEV extended protocols. A non-standard abbreviated ERG protocol is described, for use when patient age, compliance or other circumstances preclude ISCEV Standard ERG testing.
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  • 文章类型: Journal Article
    There is a growing demand in clinical chemistry for analyses to be performed in a manner allowing comparisons of results among laboratories and, from time to time, in the same laboratory. Reliable comparability requires adequate procedures of standardization for spectrophotometric and fluorometric instruments and methods. Problems with chemical and instrumental standardization are discussed. For assays where the substance to be measured is available in suitable form, primary chemical standardization is justifiably popular. Relatively unsophisticated instrumentation can be used to compare measurements of unknown samples with such standards. Because primary standards meeting all necessary criteria are not available for many assays of clinical significance, standardization must depend on precision and accuracy of the instrumentation used, and on accurately compiled values of chemical-optical properties for the materials of interest. The task of compilation is outside the capability of the routine laboratory and should be provided by a reliable central agency. If an individual laboratory is to use the agency\'s compiled values, that laboratory must have available precise, accurate and reasonably inexpensive instrumentation along with reliable absorbance, fluorescence, and wavelength calibration standards.
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  • 文章类型: Journal Article
    人工智能(AI)和其他机器诊断系统的发展,也被称为作为医疗设备的软件,最近将其引入临床实践需要在生物伦理学中根深蒂固的基础,以供监管机构和全球其他利益相关者考虑。
    就在为医学中的人工智能建立生物伦理基础时要考虑的问题展开对话,基于眼睛结构的图像,与所有利益相关者进行讨论。
    眼科成像和算法解释基础原则工作组正在审议的问题和讨论摘要的范围,在2020年9月7日的眼科影像学合作社区成立会议上首次提出,随后在工作组中提出。
    人工智能有可能从根本上改善医疗保健服务和患者预后,同时缩小差距。降低成本,加强护理团队。然而,存在实质性的担忧。生物伦理学家,AI算法专家,以及食品和药物管理局和其他监管机构,工业,患者倡导团体,临床医生和他们的专业协会,其他提供者组,和付款人(即,利益相关者)在协作社区中共同努力,解决非恶意的基本道德问题,自主性,公平对于实现这一潜力至关重要。分辨率影响设计的各个层面,验证,以及人工智能在医学中的实施。设计,验证,人工智能的实施值得一丝不苟的关注。
    如果建立在非恶意行为的基本伦理原则基础上,生物伦理健全的基础是可能的,自主性,以及设计考虑的公平性,验证,以及人工智能系统的实施。在监管机构考虑之前,实现这样的基础将有助于继续成功引入医学。卫生保健的可及性和质量方面的重要改进,减少健康差距,从而可以实现更低的成本。这些考虑应与所有利益攸关方讨论,并作为这一对话的有益启动加以扩大。
    The development of artificial intelligence (AI) and other machine diagnostic systems, also known as software as a medical device, and its recent introduction into clinical practice requires a deeply rooted foundation in bioethics for consideration by regulatory agencies and other stakeholders around the globe.
    To initiate a dialogue on the issues to consider when developing a bioethically sound foundation for AI in medicine, based on images of eye structures, for discussion with all stakeholders.
    The scope of the issues and summaries of the discussions under consideration by the Foundational Principles of Ophthalmic Imaging and Algorithmic Interpretation Working Group, as first presented during the Collaborative Community on Ophthalmic Imaging inaugural meeting on September 7, 2020, and afterward in the working group.
    Artificial intelligence has the potential to improve health care access and patient outcome fundamentally while decreasing disparities, lowering cost, and enhancing the care team. Nevertheless, substantial concerns exist. Bioethicists, AI algorithm experts, as well as the Food and Drug Administration and other regulatory agencies, industry, patient advocacy groups, clinicians and their professional societies, other provider groups, and payors (i.e., stakeholders) working together in collaborative communities to resolve the fundamental ethical issues of nonmaleficence, autonomy, and equity are essential to attain this potential. Resolution impacts all levels of the design, validation, and implementation of AI in medicine. Design, validation, and implementation of AI warrant meticulous attention.
    The development of a bioethically sound foundation may be possible if it is based in the fundamental ethical principles of nonmaleficence, autonomy, and equity for considerations for the design, validation, and implementation for AI systems. Achieving such a foundation will be helpful for continuing successful introduction into medicine before consideration by regulatory agencies. Important improvements in accessibility and quality of health care, decrease in health disparities, and lower cost thereby can be achieved. These considerations should be discussed with all stakeholders and expanded on as a useful initiation of this dialogue.
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  • 文章类型: Journal Article
    多焦视网膜电图(mfERG)是一种电生理测试,可同时测试视网膜多个离散区域的功能。这份文件,来自国际临床视觉电生理学学会(ISCEV),提供了更新和修订的ISCEV临床mfERG标准,并定义了基本临床mfERG记录和报告的最低方案,以便可以识别和比较来自全球不同实验室的反应。与以前的mfERG标准相比,主要的变化涉及用于记录的m序列的最小长度,报告结果和文件格式的变化,与其他ISCEV标准更加一致。
    The multifocal electroretinogram (mfERG) is an electrophysiological test that allows the function of multiple discrete areas of the retina to be tested simultaneously. This document, from the International Society for Clinical Electrophysiology of Vision (ISCEV), presents an updated and revised ISCEV standard for clinical mfERG and defines minimum protocols for basic clinical mfERG recording and reporting so that responses can be recognized and compared from different laboratories worldwide. The major changes compared with the previous mfERG standard relate to the minimum length of m-sequences used for recording, reporting of results and a change in document format, to be more consistent with other ISCEV standards.
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  • 文章类型: Journal Article
    This article describes the development of a system, the Ethics Network, designed to promote discussion of ethical issues in a human services organization. The system includes several core components, including people (e.g., leaders, ambassadors), tools (e.g., hotline, training modules), and resources (e.g., monthly talking points). Data from 6 years of hotline submissions were analyzed to identify the most common concerns, and the data were compared to the pattern of violation notices submitted to the Behavior Analyst Certification Board. Recommendations are provided for creating similar systems in other organizations.
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  • 文章类型: Journal Article
    国际临床视觉电生理学学会(ISCEV)视觉诱发电位(VEP)标准描述了临床VEP测试的最低程序,并鼓励进行更广泛的测试。该ISCEV扩展协议是VEP标准的扩展。它描述了将多个VEP记录到一定尺寸范围的模式刺激以建立VEP空间频率极限(阈值)并将该极限与视敏度相关联的过程。
    The International Society for Clinical Electrophysiology of Vision (ISCEV) standard for visual evoked potentials (VEPs) describes a minimum procedure for clinical VEP testing and encourages more extensive testing. This ISCEV extended protocol is an extension to the VEP standard. It describes procedures for recording multiple VEPs to a range of sizes of pattern stimuli to establish the VEP spatial frequency limit (threshold) and for relating this limit to visual acuity.
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