guidance

指导
  • 文章类型: Journal Article
    背景:近年来,利用常规收集的医疗保健数据(RCD)的观察性研究的使用趋势越来越明显.这些研究依赖于算法来识别用于统计分析的特定健康状况(例如糖尿病或败血症)。然而,算法的开发和验证有很大的差异,导致性能经常欠佳,并对研究结果的有效性构成重大威胁。不幸的是,这些问题经常被忽视。
    方法:我们系统地制定了开发指南,验证,和评估旨在识别健康状况的算法(DEVELOP-RCD)。我们最初的努力包括对与算法开发相关的概念和方法论问题的已发表研究进行叙述性审查和系统审查。验证,和评价。随后,我们对脓毒症的识别算法进行了实证研究.基于这些发现,我们为算法开发制定了具体的工作流程和建议,验证,和指导内的评估。最后,该指南经过了一个由20名外部专家组成的小组的独立审查,然后召开了一次共识会议以最终确定该指南。
    结果:算法开发的标准化工作流程,验证,并建立了评价。在特定健康状况考虑的指导下,该工作流程包括四个综合步骤:评估现有算法对目标健康状态的适用性;使用推荐方法开发新算法;使用规定的性能度量验证算法;评估算法对研究结果的影响。此外,提出了13项良好做法建议,并附有详细解释。此外,本指南的应用纳入了一项关于脓毒症鉴别的实际研究.
    结论:指南的建立旨在帮助研究人员和临床医生适当和准确地开发和应用从RCD中识别健康状况的算法。本指南有可能提高涉及刚果民盟的观察性研究结果的可信度。
    BACKGROUND: In recent years, there has been a growing trend in the utilization of observational studies that make use of routinely collected healthcare data (RCD). These studies rely on algorithms to identify specific health conditions (e.g. diabetes or sepsis) for statistical analyses. However, there has been substantial variation in the algorithm development and validation, leading to frequently suboptimal performance and posing a significant threat to the validity of study findings. Unfortunately, these issues are often overlooked.
    METHODS: We systematically developed guidance for the development, validation, and evaluation of algorithms designed to identify health status (DEVELOP-RCD). Our initial efforts involved conducting both a narrative review and a systematic review of published studies on the concepts and methodological issues related to algorithm development, validation, and evaluation. Subsequently, we conducted an empirical study on an algorithm for identifying sepsis. Based on these findings, we formulated specific workflow and recommendations for algorithm development, validation, and evaluation within the guidance. Finally, the guidance underwent independent review by a panel of 20 external experts who then convened a consensus meeting to finalize it.
    RESULTS: A standardized workflow for algorithm development, validation, and evaluation was established. Guided by specific health status considerations, the workflow comprises four integrated steps: assessing an existing algorithm\'s suitability for the target health status; developing a new algorithm using recommended methods; validating the algorithm using prescribed performance measures; and evaluating the impact of the algorithm on study results. Additionally, 13 good practice recommendations were formulated with detailed explanations. Furthermore, a practical study on sepsis identification was included to demonstrate the application of this guidance.
    CONCLUSIONS: The establishment of guidance is intended to aid researchers and clinicians in the appropriate and accurate development and application of algorithms for identifying health status from RCD. This guidance has the potential to enhance the credibility of findings from observational studies involving RCD.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    飞行动物必须制定强大而有效的指导策略来应对栖息地的混乱。鸟类和昆虫使用光流扩展线索来感知和避开障碍物,但是兰花蜜蜂也被证明在间隙协商期间使用亮度提示。因此,这种亮度提示在构造视觉引导的飞行行为中可能具有普遍的重要性。为了检验亮度线索也会影响鸟类间隙协商行为的假设,我们在隧道的另一侧展示了圈养斑马雀Taeniopygiaguttata,背景亮度分布对称或不对称。背景亮度条件影响了鸟类进入隧道孔径的决定,和他们离开时的飞行方向。如果斑马雀能看到明亮的背景,它们更有可能在隧道中飞行;它们也更有可能在离开时飞向光明的一面。我们没有发现任何证据表明,如果在间隙谈判过程中双向平衡光流线索,则可以预期集中响应。相反,鸟类通过瞄准距隧道近边缘约一个机翼长度的间隙进入隧道。因此,亮度提示会影响斑马雀在封闭环境中协商间隙时的飞行结构。
    Flying animals have had to evolve robust and effective guidance strategies for dealing with habitat clutter. Birds and insects use optic flow expansion cues to sense and avoid obstacles, but orchid bees have also been shown to use brightness cues during gap negotiation. Such brightness cues might therefore be of general importance in structuring visually guided flight behaviours. To test the hypothesis that brightness cues also affect gap negotiation behaviours in birds, we presented captive zebra finches Taeniopygia guttata with a symmetric or asymmetric background brightness distribution on the other side of a tunnel. The background brightness conditions influenced both the birds\' decision to enter the tunnel aperture, and their flight direction upon exit. Zebra finches were more likely to initiate flight through the tunnel if they could see a bright background through it; they were also more likely to fly to the bright side upon exiting. We found no evidence of the centring response that would be expected if optic flow cues were balanced bilaterally during gap negotiation. Instead, the birds entered the tunnel by targeting a clearance of approximately one wing length from its near edge. Brightness cues therefore affect how zebra finches structure their flight when negotiating gaps in enclosed environments.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    在法规(EU)2022/1616生效的背景下,EFSA更新了科学指南,以协助申请人准备授权或修改现有授权的“消费后机械PET”回收过程(如法规(EU)2022/1616的附件I所定义),旨在用于制造与食品接触的材料和物品。本指南描述了EFSA将用于评估回收过程的去污能力的评估标准和科学评估方法,以及申请档案中需要包含的信息。科学评估方法的原则是应用回收过程的去污效率,从具有替代污染物的挑战测试中获得,到消费后PET的参考污染水平,对于可能误用造成的污染物,将PET设定为3mg/kg。然后,将回收PET中每种替代物的最终残留浓度与使用公认的保守迁移模型计算的PET中的建模浓度进行比较。因此,相关的迁移不会导致饮食暴露超过每天0.0025μg/kg体重(bw)。这是毒理学关注(TTC)值的最低阈值,即潜在的遗传毒性,在此之下,对人类健康的风险可以忽略不计。在应用程序中提供的信息涉及:回收过程(即输入的收集和预处理,净化过程,后处理和预期用途);通过挑战测试确定去污效率;回收过程的自我评估。根据提交的数据,EFSA将评估机械PET回收工艺的安全性。
    In the context of entry into force of Regulation (EU) 2022/1616, EFSA updated the scientific guidance to assist applicants in the preparation of applications for the authorisation or for the modification of an existing authorisation of a \'post-consumer mechanical PET\' recycling process (as defined in Annex I of Regulation (EU) 2022/1616) intended to be used for manufacturing materials and articles intended to come into contact with food. This Guidance describes the evaluation criteria and the scientific evaluation approach that EFSA will apply to assess the decontamination capability of recycling processes, as well as the information required to be included in an application dossier. The principle of the scientific evaluation approach is to apply the decontamination efficiency of a recycling process, obtained from a challenge test with surrogate contaminants, to a reference contamination level for post-consumer PET, set at 3 mg/kg PET for a contaminant resulting from possible misuse. The resulting residual concentration of each surrogate in recycled PET is then compared to a modelled concentration in PET that is calculated using generally recognised conservative migration models, such that the related migration does not give rise to a dietary exposure exceeding 0.0025 μg/kg body weight (bw) per day. This is the lowest threshold for toxicological concern (TTC) value, i.e. for potential genotoxicity, below which the risk to human health would be negligible. The information to be provided in the applications relates to: the recycling process (i.e. collection and pre-processing of the input, decontamination process, post-processing and intended use); the determination of the decontamination efficiency by the challenge test; the self-evaluation of the recycling process. On the basis of the submitted data, EFSA will assess the safety of the mechanical PET recycling process.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    运动障碍是具有可治疗和不可治疗原因的慢性神经综合征。运动障碍的主要原因是帕金森病和相关疾病。单光子发射计算机断层扫描(SPECT)和正电子发射断层扫描(PET)图像的功能成像研究在诊断和鉴别诊断中起着至关重要的作用,以指导疾病管理。自从有了新的先进成像技术和放射性药物发展以来,有必要制定最新的共识准则。因此,泰国核医学学会,泰国神经学会,和泰国医学物理学家协会合作制定了运动障碍核医学研究指南,用于患者护理。我们已经广泛审查了其他相关协会的现行实践指南和高质量的论文,以及我们自己在运动障碍核医学实践中的经验。我们还调整了最适合在泰国和其他发展中国家的应用。
    Movement disorders are chronic neurological syndromes with both treatable and non-treatable causes. The top causes of movement disorders are Parkinson\'s disease and related disorders. Functional imaging investigations with Single Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) images play vital roles in diagnosis and differential diagnosis to guide disease management. Since there have been new advanced imaging technologies and radiopharmaceuticals development, there is a need for up-to-date consensus guidelines. Thus, the Nuclear Medicine Society of Thailand, the Neurological Society of Thailand, and the Thai Medical Physicist Society collaborated to establish the guideline for Nuclear Medicine investigations in movement disorder for practical use in patient care. We have extensively reviewed the current practice guidelines from other related societies and good quality papers as well as our own experience in Nuclear Medicine practice in movement disorders. We also adjust for the most suitability for application in Thailand and other developing countries.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    本指导文件旨在帮助申请人准备和提交申请,如法规(EC)No1831/2003第7.6条所述,授权用于动物营养的添加剂。它特别涵盖了对饲料添加剂功效的评估。
    This guidance document is intended to assist the applicant in preparing and presenting an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the efficacy of feed additives.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    在患有复发性疼痛的全髋关节置换术(THA)患者中,症状可能是由几种情况引起的,不仅涉及关节,还有周围的软组织,包括肌腱,肌肉,法氏囊,和周围神经。US和US指导的介入程序是诊断THA疼痛患者的重要工具,因为可以直接识别假体周围结构的病理变化并间接评估反应和疼痛缓解在US监测下局部注射麻醉药。然后,US引导可用于从关节或关节周围集合中抽吸液体,或者,在怀疑人工关节感染的情况下,跟随活检针收集样本进行培养分析。此外,美国指导的经皮介入治疗可用于治疗多种疾病,包括注射皮质类固醇的完善的微创手术。局部麻醉药,和富含血小板的血浆或其他自体产品。在这次审查中,我们将讨论US引导经皮介入手术在疼痛性THA中的临床和技术应用,这些手术可用于常规的日常诊断和治疗.
    In patients with total hip arthroplasty (THA) with recurrent pain, symptoms may be caused by several conditions involving not just the joint, but also the surrounding soft tissues including tendons, muscles, bursae, and peripheral nerves. US and US-guided interventional procedures are important tools in the diagnostic work-up of patients with painful THA given that it is possible to reach a prompt diagnosis both directly identifying the pathological changes of periprosthetic structures and indirectly evaluating the response and pain relief to local injection of anesthetics under US monitoring. Then, US guidance can be used for the aspiration of fluid from the joint or periarticular collections, or alternatively to follow the biopsy needle to collect samples for culture analysis in the suspicion of prosthetic joint infection. Furthermore, US-guided percutaneous interventions may be used to treat several conditions with well-established minimally invasive procedures that involve injections of corticosteroid, local anesthetics, and platelet-rich plasma or other autologous products. In this review, we will discuss the clinical and technical applications of US-guided percutaneous interventional procedures in painful THA that can be used in routine daily practice for diagnostic and therapeutic purposes.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    背景:口腔疾病是全球主要的公共卫生问题,影响受影响者的生活质量。虽然对高质量的重要性存在共识,循证指南,为医学实践和公共卫生决策提供信息,口腔健康指南的生产者通常不遵守适当的方法和标准。本研究旨在系统地确定在全球范围内制定口腔健康循证指南的组织,并调查制定建议所遵循的方法学过程。
    方法:我们搜索了许多电子数据库,指南库,和指南开发者的网站,科学社会,和国际组织(2012年1月至2023年10月),以确定制定针对任何口腔健康主题的指南并明确宣布在其制定中纳入研究证据的组织。成对的评审员根据预定义的选择标准和提取的有关组织特征的数据,独立评估潜在合格的组织,他们指南的关键特征,以及在制定正式建议时遵循的过程。描述性统计用于分析和总结数据。
    结果:我们纳入了46个制定口腔健康循证指南的组织。这些组织主要是专业协会和科学学会(67%),其次是政府组织(28%)。总的来说,组织制作了55种不同的指导方针文件类型,其中大多数包含临床实践建议(77%)。小组主要由医疗保健专业人员(87%)组成,其次是研究方法学家(40%),决策者(24%),和患者伴侣(18%)。大多数(60%)的指南报告了他们的资金来源,但只有三分之一(33%)包括利益冲突(COI)政策管理。55种准则文件中使用的方法因组织而异,但只有19个(35%)包含正式建议。一半(51%)的准则文件提到了方法论手册,46%的人建议采用结构化的方法或系统来评估证据的确定性和建议的强度,37%的人提到使用框架从证据转向决策,GRADE-EtD是使用最广泛的(27%)。
    结论:我们的发现强调了口腔健康指南中使用的术语和方法与当前国际标准的一致性和标准化的必要性,以制定值得信赖的建议。
    BACKGROUND: Oral diseases are a major global public health problem, impacting the quality of life of those affected. While consensus exists on the importance of high-quality, evidence-informed guidelines to inform practice and public health decisions in medicine, appropriate methodologies and standards are not commonly adhered to among producers of oral health guidelines. This study aimed to systematically identify organizations that develop evidence-informed guidelines in oral health globally and survey the methodological process followed to formulate recommendations.
    METHODS: We searched numerous electronic databases, guideline repositories, and websites of guideline developers, scientific societies, and international organizations (January 2012-October 2023) to identify organizations that develop guidelines addressing any oral health topic and that explicitly declare the inclusion of research evidence in their development. Pairs of reviewers independently evaluated potentially eligible organizations according to predefined selection criteria and extracted data about the organization\'s characteristics, key features of their guidelines, and the process followed when formulating formal recommendations. Descriptive statistics were used to analyze and summarize data.
    RESULTS: We included 46 organizations that developed evidence-informed guidelines in oral health. The organizations were mainly professional associations and scientific societies (67%), followed by governmental organizations (28%). In total, organizations produced 55 different guideline document types, most of them containing recommendations for clinical practice (77%). Panels were primarily composed of healthcare professionals (87%), followed by research methodologists (40%), policymakers (24%), and patient partners (18%). Most (60%) of the guidelines reported their funding source, but only one out of three (33%) included a conflict of interest (COI) policy management. The methodology used in the 55 guideline document types varied across the organizations, but only 19 (35%) contained formal recommendations. Half (51%) of the guideline documents referred to a methodology handbook, 46% suggested a structured approach or system for rating the certainty of the evidence and the strength of recommendations, and 37% mentioned using a framework to move from evidence to decisions, with the GRADE-EtD being the most widely used (27%).
    CONCLUSIONS: Our findings underscore the need for alignment and standardization of both terminology and methodologies used in oral health guidelines with current international standards to formulate trustworthy recommendations.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    背景:患者参与研究的一个组成部分,也被称为耐心和公众参与,通过补偿适当地承认患者伴侣的贡献(例如,共同作者,酬金)。尽管已知补偿患者伴侣的好处,我们之前的工作表明,补偿很少报道,研究人员认为在这个问题上缺乏指导。为了解决这个差距,我们确定并总结了患者合作伙伴补偿的可用指南和政策文件.
    方法:我们按照JBI建议的方法进行了范围审查。我们搜索了灰色文献(谷歌,GoogleScholar)于2022年3月,Overton(国际政策文件数据库)于2022年4月。我们包括文章,关于患者合作伙伴对其研究贡献的补偿的指导或政策文件。两名审阅者独立提取和综合了文档特征和建议。
    结果:我们确定了65个指南或政策文件。大多数文件在加拿大出版(57%,n=37)或英国(26%,n=17)。最常见的推荐非经济补偿方法是为患者伴侣提供培训机会(40%,n=26),并促进患者伴侣出席会议(38%,n=25)。大多数指导文件(95%)建议进行财务补偿(即为他们的研究贡献提供具有货币价值的东西)患者合作伙伴。跨指导文件,经济补偿的建议货币价值相对一致,并且与患者伴侣所扮演的角色和/或具体参与活动相关.例如,获得患者伴侣反馈的中值货币价值(即,咨询)为19美元/小时(美元)(范围为12美元-50美元/小时)。我们确定了一些指导特定人群补偿的文件,包括青年和土著人民。
    结论:存在多种公开可用的资源来指导研究人员,患者合作伙伴和机构制定量身定制的患者合作伙伴补偿策略。我们的发现挑战了缺乏指导会阻碍患者伴侣经济补偿的看法。未来的努力应优先考虑这些补偿策略的有效实施,以确保患者合作伙伴得到适当的认可。
    患者伴侣共同作者告知了方案制定,标识的数据项,和解释的发现。
    BACKGROUND: An integral aspect of patient engagement in research, also known as patient and public involvement, is appropriately recognising patient partners for their contributions through compensation (e.g., coauthorship, honoraria). Despite known benefits to compensating patient partners, our previous work suggested compensation is rarely reported and researchers perceive a lack of guidance on this issue. To address this gap, we identified and summarised available guidance and policy documents for patient partner compensation.
    METHODS: We conducted this scoping review in accordance with methods suggested by the JBI. We searched the grey literature (Google, Google Scholar) in March 2022 and Overton (an international database of policy documents) in April 2022. We included articles, guidance or policy documents regarding the compensation of patient partners for their research contributions. Two reviewers independently extracted and synthesised document characteristics and recommendations.
    RESULTS: We identified 65 guidance or policy documents. Most documents were published in Canada (57%, n = 37) or the United Kingdom (26%, n = 17). The most common recommended methods of nonfinancial compensation were offering training opportunities to patient partners (40%, n = 26) and facilitating patient partner attendance at conferences (38%, n = 25). The majority of guidance documents (95%) suggested financially compensating (i.e., offering something of monetary value) patient partners for their research contributions. Across guidance documents, the recommended monetary value of financial compensation was relatively consistent and associated with the role played by patient partners and/or specific engagement activities. For instance, the median monetary value for obtaining patient partner feedback (i.e., consultation) was $19/h (USD) (range of $12-$50/h). We identified several documents that guide the compensation of specific populations, including youth and Indigenous peoples.
    CONCLUSIONS: Multiple publicly available resources exist to guide researchers, patient partners and institutions in developing tailored patient partner compensation strategies. Our findings challenge the perception that a lack of guidance hinders patient partner financial compensation. Future efforts should prioritise the effective implementation of these compensation strategies to ensure that patient partners are appropriately recognised.
    UNASSIGNED: The patient partner coauthor informed protocol development, identified data items, and interpreted findings.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    患者体验数据(PED),由患者/他们的护理人员提供,没有临床医生的解释,直接捕捉对患者更重要的医疗状况,医疗保健的治疗和影响。PED可以通过不同的方法收集,这些方法需要健壮并验证其预期用途。医药监管机构越来越鼓励利益相关者产生,收集并提交PED,以支持开发计划中的科学建议以及有关批准和使用这些药物的监管决定。本文回顾了PED的现有定义和类型,并展示了在药物生命周期的不同环境中使用的潜力,重点关注患者报告结果(PRO)和患者偏好(PP)。此外,它解决了一些挑战和机遇,暗示已经发布的重要监管指南,方法论和数字化,强调缺乏指导是实现更系统地将PED纳入监管文件的关键障碍。此外,这篇文章讨论了在欧洲和全球层面可以实施的机会,以利用PED的使用。允许患者实时收集PED的新数字工具也可能有助于这些进步,但同样重要的是,不要忽视它们带来的挑战。该领域各利益攸关方正在制定的众多相关举措,包括监管机构,展示他们对PED价值的信心,并创造一个理想的时刻来应对挑战,并在整个药物生命周期中巩固PED的使用。
    Patient experience data (PED), provided by patients/their carers without interpretation by clinicians, directly capture what matters more to patients on their medical condition, treatment and impact of healthcare. PED can be collected through different methodologies and these need to be robust and validated for its intended use. Medicine regulators are increasingly encouraging stakeholders to generate, collect and submit PED to support both scientific advice in development programs and regulatory decisions on the approval and use of these medicines. This article reviews the existing definitions and types of PED and demonstrate the potential for use in different settings of medicines\' life cycle, focusing on Patient-Reported Outcomes (PRO) and Patient Preferences (PP). Furthermore, it addresses some challenges and opportunities, alluding to important regulatory guidance that has been published, methodological aspects and digitalization, highlighting the lack of guidance as a key hurdle to achieve more systematic inclusion of PED in regulatory submissions. In addition, the article discusses opportunities at European and global level that could be implemented to leverage PED use. New digital tools that allow patients to collect PED in real time could also contribute to these advances, but it is equally important not to overlook the challenges they entail. The numerous and relevant initiatives being developed by various stakeholders in this field, including regulators, show their confidence in PED\'s value and create an ideal moment to address challenges and consolidate PED use across medicines\' life cycle.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    高中的初始职业培训(VT)包括短期计划,从而导致在技术贸易中就业。为了更好地调整培训与就业机会,并鼓励学生留在课程中,直到他们毕业,大多数计划包括实习。由于培训涉及直接在工作中获得技能,他们需要更多的主管参与来指导受训者。鉴于在职指导对实现实习目标的重要性,本研究考察了培训主管提供的三个维度指导的潜在影响-计划,支持,和培训-对学生的工作感知(即,职业形象)和实习满意度。总的来说,结果提供了混合的结果,部分支持以前研究结果提出的调解假设。的确,结果表明,主管提供的培训质量会影响后续学生对实习经验的满意度。培训通过学生的职业形象间接影响满意度。然而,主管指导的其他两个维度——学生认为的计划和支持程度——与学生选择的职业形象之间的预期间接联系无法得到证实。结果支持在学习期间为学生提供高质量的在职培训的重要性。
    Initial vocational training (VT) in high school consists of short-term programs leading to employment in a skilled trade. To better align training with employment opportunities and to encourage students to stay in the programs until they graduate, most programs include traineeship. Since traineeships involve acquiring skills directly on the job, they require greater involvement of supervisors to guide the trainees. Given the importance of on-the-job guidance in achieving traineeship objectives, this study examines the potential influence of three dimensions of guidance provided by traineeship supervisors -planning, support, and training- on students\' job perception (i.e., occupational image) and traineeship satisfaction. Overall, the results provide mixed results, partially supporting the mediation hypothesis suggested by the results of previous studies. Indeed, the results reveal that the quality of the training offered by the supervisor affects subsequent students\' satisfaction with traineeship experience. Training has an indirect effect on satisfaction via the occupational image held by students. However, the expected indirect links between the other two dimensions of supervisor guidance -degree of planning and support perceived by the student- and the students\' image of their chosen occupation could not be confirmed. The results support the importance of providing quality on-the-job training to students during their studies.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

公众号