Best practices

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    文章类型: Journal Article
    国际运动科学杂志(IJES)机遇工作组,Representation,不同视角的任务是制定立场立场,在关键的包容领域提供指导。我们向作者介绍,审稿人,和所有读者IJES理想在实践中利用。重点介绍,然后是对包容性语言领域的更深入的了解和更多的解释,研究的多样性和包容性,和可访问性。同样的方法也适用于年龄领域,残疾状况,性别认同和性取向,种族,和种族,关注土著社区,宗教,社会经济地位,神经多样性。鼓励人的第一语言,承认不同社区成员的偏好可能会有所不同。IJES致力于维护一个欢迎所有身份的环境,让他们感到有价值,尊敬的,并包括在内。
    The International Journal of Exercise Science (IJES) Working Group for Opportunity, Representation, and Diverse Perspectives was tasked with developing a position stand to provide guidance in critical areas of inclusion. We present to authors, reviewers, and all readership IJES ideals to utilize in practice. Key points are presented, followed by a deeper look with greater explanation into the areas of inclusive language, diversity and inclusion in research, and accessibility. The same approach is presented for the areas of age, disability status, gender identity and sexual orientation, race, and ethnicity with attention to Indigenous Communities, religion, socioeconomic status, and neurodiversity. Person-first language is encouraged, with the acknowledgment that the preference of different community members may vary. IJES is committed to maintaining an environment that is welcoming to all identities so that they feel valued, respected, and included.
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  • 文章类型: Journal Article
    组合产品,合并药物,生物制剂,和医疗设备,以其创新疗法的潜力彻底改变了医疗保健领域。然而,这些产品中不同组件的交叉带来了复杂的监管环境,要求严格注意安全性和有效性。本文深入探讨了监管考虑因素的错综复杂的局面,安全,以及与组合产品相关的功效评估-药物交叉的类别,设备,和生物制品。监管框架,主要由美国食品和药物管理局(FDA)管理,需要细致入微的分类来确定调节途径。不同监管中心之间的合作,如药物评估和研究中心(CDER)和设备和放射健康中心(CDRH),强调了这些创新医疗解决方案所需的综合方法。安全考虑因素揭示了与组合不同组件相关的潜在风险和不良事件。强调需要强有力的风险评估和缓解战略。疗效评估涉及复杂的方法,临床试验,和上市后的监督,结合数字技术的最新进展。这一全面的探索旨在促进监管和科学领域不断发展的理解和最佳实践,在组合产品的开发和评估中促进协作和创新。
    Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products-a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.
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  • 文章类型: Journal Article
    东南亚地区的国家在控制传染病方面面临着类似的挑战。邻国的经验和知识有限。印度医学研究理事会(ICMR)为东南亚区域(SEAR)国家建立了东南亚健康研究合作(SEARCH)平台的区域促进者,以解决上述问题。本文讨论了当前的实践,八个SEAR国家结核病预防治疗(TPT)的实施挑战和运营研究重点。
    为期三天的研讨会,主题是“计划设置下的结核病研究能力建设”。在该研究平台的主持下,ICMR和由八个SEAR国家参加的联盟共同进行。数据是从研讨会之前的半结构化问卷和研讨会期间的公开讨论中收集的。
    TPT实施所面临的各种挑战大致分为需求不足和受益人接受度低,提供商提供TPT的接受度较低,排除活动性结核病的挑战,诊断测试和药物的供应和供应链管理问题。许多运筹学的优先事项,如以人为中心的TPT驱动模型,能力建设,以改善潜伏结核感染的级联护理,加强卫生系统和有效的风险沟通。
    全面实施TPT指南需要该国所有利益攸关方的集中关注和协调行动,以实现结核病预防性治疗的全部益处和最终消除结核病的目标。
    UNASSIGNED: Countries in the South East Asian region face similar challenges in control of infectious diseases. There is limited access to experiences and learnings of neighboring countries. The Indian Council - of Medical Research (ICMR) has established a Regional Enabler for the South-East Asia Research Collaboration for Health (RESEARCH) Platform for South East Asian Region (SEAR) countries to address the above issues. This paper discusses about current practices, implementation challenges and operations research priorities of Tuberculosis Preventive therapy (TPT) in eight SEAR countries.
    UNASSIGNED: A three day workshop on \"Capacity Building for TB Research under Programmatic Settings\". was conducted under the aegis of this RESEARCH platform jointly ICMR and the Union which was participated by eight SEAR countries. Data were collected from a semi-structured questionnaire prior to the workshop and open discussions during the workshop.
    UNASSIGNED: The various challenges faced for TPT implementation were broadly categorized as poor demand and low level of acceptance by the beneficiary, low level of acceptance to provide TPT among the providers, challenges in ruling out active TB, issues with supply and supply chain management of diagnostic tests and drugs. Many operations research priorities like person centric TPT driven models, capacity building for improving cascade of care for latent TB infection, health system strengthening and effective risk communication were identified.
    UNASSIGNED: Full implementation of the TPT guidelines requires focused attention and coordinated action from all stakeholders of the country to attain the full benefit of TB preventive therapy and the ultimate TB elimination goal.
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  • 文章类型: Journal Article
    对于医疗保健数据集,由于道德原因,通常不可能合并来自多个站点的数据样本,隐私,或后勤问题。联合学习允许使用强大的机器学习算法,而无需合并数据。医疗保健数据同时面临许多挑战,比如高度孤立的数据,阶级不平衡,缺少数据,分配转移,和非标准化变量,这需要新的方法来解决。联合学习给传统的集中式机器学习增加了显著的方法复杂性。需要分布式优化,节点之间的通信,模型的聚合,和模型的重新分配。在这次系统审查中,我们考虑2015年1月至2023年2月期间发表的所有关于Scopus的论文,这些论文描述了应对医疗保健数据挑战的新联合学习方法.我们审查了89篇符合这些标准的论文。在整个文献中都发现了重大的系统性问题,损害了许多已审查的方法。我们提供了详细的建议,以帮助改善医疗保健中联合学习的方法开发。
    For healthcare datasets, it is often impossible to combine data samples from multiple sites due to ethical, privacy, or logistical concerns. Federated learning allows for the utilization of powerful machine learning algorithms without requiring the pooling of data. Healthcare data have many simultaneous challenges, such as highly siloed data, class imbalance, missing data, distribution shifts, and non-standardized variables, that require new methodologies to address. Federated learning adds significant methodological complexity to conventional centralized machine learning, requiring distributed optimization, communication between nodes, aggregation of models, and redistribution of models. In this systematic review, we consider all papers on Scopus published between January 2015 and February 2023 that describe new federated learning methodologies for addressing challenges with healthcare data. We reviewed 89 papers meeting these criteria. Significant systemic issues were identified throughout the literature, compromising many methodologies reviewed. We give detailed recommendations to help improve methodology development for federated learning in healthcare.
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  • 文章类型: Journal Article
    2023年9月,美国食品和药物管理局(FDA)发布了指南草案,以就如何获得伴侣动物临床试验的知情客户同意发表评论。本指南有可能大幅改变兽医社区知情同意书的编写和提交给客户的方式。它不仅提供了有关如何获得所有者的知情同意的细节,而且还提供了应获得同意的时间表,同意书中的格式和语言,以及这些同意书中所需要素的详细信息。这些变化将涉及调查人员的额外努力,以确保合规性,但可能导致所有者依从性增加,并增加临床研究的入学率,并为所有人带来后续益处。
    In September 2023 the United States Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained. This guidance has the potential to substantially change how informed consent documents are written and presented to clients in the veterinary community. It provides specifics not only about how to obtain informed consent from owners but also the timeframe within which consent should be obtained, the formatting and language in the consent forms, and details on elements that are required to be in these consent forms. These changes will involve additional efforts by investigators to ensure compliance yet might lead to increased owner compliance and higher enrollment in clinical studies with subsequent benefits for all.
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  • 文章类型: Journal Article
    物质使用与亲密伴侣暴力(IPV)密切相关,并且是IPV的可修改风险因素。然而,缺乏对同时发生的IPV和物质使用的全面筛查和转诊,以及他们的精神后遗症,限制了与物质相关的IPV的有效干预措施的识别和实施。这篇叙述性综述(1)调查了IPV筛查和转诊实践的文献,如果这些包括筛查物质使用或其他精神病合并症,(2)为当前的最佳实践提供建议,(3)提出了旨在识别和减少与物质相关的IPV的研究和实践的未来方向。
    一篇叙述性文献综述审查了在诊所中调查IPV筛查和转诊计划的研究。部分研究进行了回顾:(1)有效性,(2)实施和可持续性的障碍,和(3)对精神病共病的反应,包括物质使用和物质使用障碍(SUD)。
    研究结果表明,已经制定了有效的IPV筛查和转诊计划,但是IPV筛查存在差异,许多程序仅筛查IPV受害情况。IPV筛查计划的实施和可持续性的障碍包括缺乏持续的提供者培训,资金或机构支持,并直接连接到转介服务。Further,许多IPV筛查计划缺乏共患精神病的评估和转诊,包括物质使用,并且往往不在SUD诊所常规实施。
    需要开展额外的系统性工作,以制定与物质相关的IPV的普遍和全面的筛查和转诊计划,并解决长期可持续性问题。特别是在SUD治疗设置内。
    UNASSIGNED: Substance use is strongly associated with intimate partner violence (IPV) and is a modifiable risk factor for IPV. However, lack of comprehensive screening and referral for co-occurring IPV and substance use, along with their psychiatric sequalae, limits the identification and implementation of effective interventions for substance-related IPV. This narrative review (1) investigates the literature on screening and referral practices for IPV, and if these include screening for substance use or other psychiatric comorbidities, (2) provides recommendations for current best practices, and (3) suggests future directions for research and practice aimed at identifying and reducing substance-related IPV.
    UNASSIGNED: A narrative literature review examined studies investigating IPV screening and referral programs in clinics. Selected studies were reviewed for: (1) effectiveness, (2) barriers to implementation and sustainability, and (3) responsivity to psychiatric comorbidity, including substance use and substance use disorders (SUD).
    UNASSIGNED: Findings suggest that effective IPV screening and referral programs have been developed, but disparities in IPV screening exist and many programs only screen for IPV victimization. Barriers to the implementation and sustainability of IPV screening programs include lack of ongoing provider training, funding or institutional support, and direct connection to referral services. Further, many IPV screening programs lack assessment of and referral for comorbid psychiatric conditions, including substance use, and tend not to be routinely implemented in SUD clinics.
    UNASSIGNED: Additional systematic work is needed to develop universal and comprehensive screening and referral programs for substance-related IPV and address issues of long-term sustainability, particularly within SUD treatment settings.
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  • 文章类型: Journal Article
    背景:尊重生育储备,正如世界卫生组织在2018年所强调的那样,以及对积极需求的关注,有尊严的分娩体验已成为尊重产妇护理(RMC)的一个组成部分。众所周知,RMC对于良好的分娩结果至关重要,并有助于提高产妇护理的满意度。缺乏RMC会对妇女和新生儿的权利产生负面影响。该研究旨在探索医疗保健提供者对母亲先前报道的维持RMC行动的看法。
    方法:这项研究是在东部卢旺达省的五家医院进行的,涉及与助产士和护士的5次焦点小组讨论(FGD)。对于采访,我们有目的地选择了5个部门的经理和5名医生.此外,FGD招募了40名助产士和护士。这项研究利用了欣赏调查(AI)的梦想阶段进行访谈和焦点小组。数据收集旨在深入了解医疗保健提供者对如何提供RMC以及如何在卢旺达医疗机构中建立和维持RMC的看法。Nvivo12用于组织代码并创建码本,并应用了专题分析。
    结果:出现了四个带有子主题的主题。即,1)以妇女为中心的护理,在同情的关怀下,隐私和保密维护,决策中的信息提供和自由,有效沟通,家庭参与,清洁度,平等关怀。2)对激励员工的专业遵守,团队合作,持续发展,质量工作规定,社区信任。3)RMC遇到4)RMC寄托。
    结论:卢旺达不断追求高RMC标准涉及通过利用现有资源改善分娩体验,持续改进,和持续的成就。本研究中关于维持RMC的主要建议行动包括促进以妇女为中心的护理,加强医疗保健提供者的态度,确保专业性,建立社区信任,维持有利的卫生设施环境,涉及领导。
    BACKGROUND: Childbirth reserves respect, as emphasized by the World Health Organization in 2018, and the focus towards the need for positive, dignified delivery experiences has become an integral aspect of Respectful Maternity Care (RMC). It is a known fact that RMC is pivotal for favourable birth outcomes and contributes to the satisfaction of maternity care. The absence of RMC negatively affects women\'s and newborns\' rights. The study aimed to explore healthcare providers\' perspectives on sustaining RMC actions that mothers previously reported.
    METHODS: This study was conducted in five hospitals in the Eastern province of Rwanda, involving 5 Focus Group Discussions (FGDs) with midwives and nurses. For interviews, we purposively selected 5-unit managers and five physicians. Additionally, 40 midwives and nurses were recruited for the FGDs. The research utilized the Dream phase of Appreciative Inquiry (AI) for interviews and Focus Groups. Data collection aimed to gain insights into Healthcare Providers\' perceptions of how RMC is provided and how to establish and sustain RMC in Rwandan health facilities. Nvivo 12 was employed for organizing codes and creating a codebook, and thematic analysis was applied.
    RESULTS: Four themes with sub-themes emerged. Namely, 1) Women-centered care, with Compassionate care, Privacy and confidentiality maintenance, Information provision and Liberty in decision making, Effective communication, Family involvement, Cleanliness, and Equality care. 2) Professionalism compliance with Motivated staff, Teamwork, Continuous development, Quality work provision, and Community trust. 3) RMC encounters 4) RMC sustenance.
    CONCLUSIONS: The continuous pursuit of high RMC standards in Rwanda involves improving childbirth experiences through utilizing existing resources, ongoing improvement, and sustaining achievements. Key recommended actions in this study for sustaining RMC encompass promoting women-centred care, enhancing healthcare provider attitudes, ensuring professionalism, building community trust, maintaining conducive health facility environments, and involving leadership.
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  • 文章类型: Journal Article
    背景:透明度可以在科学过程中建立信任,但是科学发现可能会被不良和晦涩的数据使用和报告实践所破坏。这项工作的目的是报告迄今为止如何使用青少年大脑认知发育(ABCD)研究的数据,并就如何提高调查结果的透明度和可重复性提供切实可行的建议。
    方法:2017年至2023年发表的使用ABCD研究数据的文章使用30多个数据提取项目进行了审查,以收集有关数据使用实践的信息。报告了每个提取项目的总频率,以及表示提取项目总体认可的完整性水平(LOC)分数的计算。使用单变量线性回归模型来检查LOC评分与单个提取项目之间的相关性。事后分析包括检查LOC得分是否与记录的2年期刊影响因子相关。
    结果:主要分析中包含549篇全长文章。分析脚本在30%的完整文章中共享。60%的文章报告了因数据缺失而被排除在外的参与者数量,以及单个变量缺失数据的信息(例如,家庭收入)在38%的文章中提供。83%的文章中包含了描述分析样本的表格。78%的评论文章中包括种族和/或种族变量,而其中只有41%的文章是合理的。LOC评分与缺失数据检查相关的提取项目高度相关。与LOC得分的前10%相比,LOC得分的后10%与较低的日志影响因子显著相关(β=-0.77,95%-1.02,-0.51;p值<0.0001)。
    结论:这些发现强调了在未来的论文中改进的机会,这些论文使用ABCD研究数据来轻松调整分析实践,以实现更好的透明度和可重复性。提供了一系列建议,以促进未来研究的坚持。
    BACKGROUND: Transparency can build trust in the scientific process, but scientific findings can be undermined by poor and obscure data use and reporting practices. The purpose of this work is to report how data from the Adolescent Brain Cognitive Development (ABCD) Study has been used to date, and to provide practical recommendations on how to improve the transparency and reproducibility of findings.
    METHODS: Articles published from 2017 to 2023 that used ABCD Study data were reviewed using more than 30 data extraction items to gather information on data use practices. Total frequencies were reported for each extraction item, along with computation of a Level of Completeness (LOC) score that represented overall endorsement of extraction items. Univariate linear regression models were used to examine the correlation between LOC scores and individual extraction items. Post hoc analysis included examination of whether LOC scores were correlated with the logged 2-year journal impact factor.
    RESULTS: There were 549 full-length articles included in the main analysis. Analytic scripts were shared in 30 % of full-length articles. The number of participants excluded due to missing data was reported in 60 % of articles, and information on missing data for individual variables (e.g., household income) was provided in 38 % of articles. A table describing the analytic sample was included in 83 % of articles. A race and/or ethnicity variable was included in 78 % of reviewed articles, while its inclusion was justified in only 41 % of these articles. LOC scores were highly correlated with extraction items related to examination of missing data. A bottom 10 % of LOC score was significantly correlated with a lower logged journal impact factor when compared to the top 10 % of LOC scores (β=-0.77, 95 % -1.02, -0.51; p-value < 0.0001).
    CONCLUSIONS: These findings highlight opportunities for improvement in future papers using ABCD Study data to readily adapt analytic practices for better transparency and reproducibility efforts. A list of recommendations is provided to facilitate adherence in future research.
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  • 文章类型: Journal Article
    医疗保健相关感染(HAIs)仍然是一个重要的患者安全问题,可能导致疾病和死亡。尽管实施了预防HAIs的临床捆绑措施。管理实践可以支持HAI预防,但是他们在HAI绩效监控和反馈中的作用还没有得到很好的理解。为了解决这个知识差距,我们之前对18家医院的工作人员进行了半结构化访谈,以研究在预防中央管路相关血流感染(CLABSI)和导管相关尿路感染(CAUTIs)方面的管理实践的作用.对访谈记录进行了分析,以确定与HAI绩效监控和反馈相关的主题。当前的分析重点是10家成功预防CLABSI和CAUTI的绩效较高的医院。这些机构有强有力的做法,包括及时的事件分析,领导参与,以及多学科参与HAI审查。在这些网站上,我们发现了共同的目标,包括无缘无故地调查HAIs和确定改进的机会.管理实践,如及时分析HAIs,设施领导和多学科团队成员之间的合作,并专注于识别程序或协议的失败,而不是工作人员的失败,都是可以支持感染预防工作的方法。随着医院试图解决冠状病毒大流行期间可能发生的CLABSI和CAUTI发病率的增加,这些管理实践可能尤为重要。
    Healthcare-associated infections (HAIs) remain a significant patient safety problem that can lead to illness and death, despite the implementation of clinical bundles to prevent HAIs. Management practices can support HAI prevention, but their role in HAI performance monitoring and feedback is not well understood. To address this knowledge gap, we previously conducted semi-structured interviews with staff at 18 hospitals to examine the role of management practices around the prevention of central line-associated bloodstream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs). Interview transcripts were analyzed to identify themes related to HAI performance monitoring and feedback. The current analysis focuses on 10 higher-performing hospitals that were successful in preventing CLABSIs and CAUTIs. These institutions had robust practices including timely event analysis, leadership engagement, and multidisciplinary participation in HAI reviews. Across these sites, we found common goals including investigating HAIs without blame and identifying opportunities for improvement. Management practices such as timely analysis of HAIs, collaboration between facility leadership and multidisciplinary team members, and a focus on identifying the failure of a procedure or protocol, rather than the failure of staff members, are all approaches that can support infection prevention efforts. These management practices may be especially important as hospitals attempt to address increases in CLABSI and CAUTI rates that may have occurred during the coronavirus pandemic.
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  • 文章类型: Journal Article
    从诊断和治疗的角度来看,骶髂疾病的临床管理已被证明具有挑战性。尽管它被广泛认为是下腰痛的常见来源,关于骶髂关节疼痛和功能障碍的适当临床管理几乎没有共识。了解生物力学,神经支配,这种复杂的承载关节的功能对于制定针对SI关节疾病的适当治疗算法至关重要。ASPN制定了这一综合实践指南,以利用现有的最佳证据作为SI关节疾病适当管理的基础参考,并作为美国和全球成人患者治疗的基础指南。
    Clinical management of sacroiliac disease has proven challenging from both diagnostic and therapeutic perspectives. Although it is widely regarded as a common source of low back pain, little consensus exists on the appropriate clinical management of sacroiliac joint pain and dysfunction. Understanding the biomechanics, innervation, and function of this complex load bearing joint is critical to formulating appropriate treatment algorithms for SI joint disorders. ASPN has developed this comprehensive practice guideline to serve as a foundational reference on the appropriate management of SI joint disorders utilizing the best available evidence and serve as a foundational guide for the treatment of adult patients in the United States and globally.
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