reporting checklist

报告清单
  • 文章类型: Journal Article
    目的:最近的一项适用性研究强调,使用模拟患者方法学(CRiSP)报告研究的现有清单需要更清晰和用户友好。这项研究的目的是更新清单以解决这些问题。
    方法:第四轮德尔菲共识研究,在原始检查表开发工作中使用,进行了。以前的参与者,他们在SP方法论方面有专业知识,被邀请填写一份问卷,其中包括在先前研究中开发并在适用性测试后修订的13个清单项目。对封闭的问题进行了频率分析。共识被预先定义为>80%的协议。所有项目都在圆桌会议上进行了讨论,并视需要进一步修改。对开放性问题的回答进行了内容分析。
    结果:21位作者参与。在13个修改的核对表项目中,有12个在统计上达成共识。
    结论:已使用共识方法为使用SP方法的健康研究中的研究制定了最终报告清单。可能需要进一步改进以增加清单在不同上下文中的可泛化性。
    OBJECTIVE: A recent applicability study highlighted the need for the existing checklist for reporting research using a simulated patient methodology (CRiSP) to be clearer and user-friendly. The aim of this study was to update the checklist to address these concerns.
    METHODS: A fourth round of the Delphi consensus study, used in the original checklist development work, was conducted. Previous participants, who had expertise in SP methodology, were invited to complete a questionnaire including a list of 13 checklist items developed in the previous study and revised following applicability testing. Closed questions were analysed for frequency. Consensus was predefined as >80% agreement. All items were discussed in a roundtable meeting and further modified as necessary. Responses to open questions were content analysed.
    RESULTS: Twenty-one authors participated. There was a statistical consensus in 12 out of 13 modified checklist items.
    CONCLUSIONS: A final reporting checklist for studies in health research using SP methodology has been developed using a consensus approach. Further refinements may be needed to increase the generalizability of the checklist in different contexts.
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  • 文章类型: Journal Article
    现有的报告指南对手术技术的详细和全面报告重视不够。外科技术报告清单和标准(SUPER)旨在通过定义外科技术的报告标准来解决这一差距。SUPER指南旨在适用于任何研究设计中包含手术技术的文章,外科学科,和外科创新阶段。
    遵循EQUATOR(增强卫生研究的质量和透明度)网络方法,16位外科医生,期刊编辑,方法学家审查了与手术技术有关的现有报告指南,审查了15种顶级期刊的论文,集思广益,为SUPER起草初始项目。最初的项目是通过来自13个国家和地区的21名多学科德尔福小组专家进行的三轮德尔福调查进行的。最终的SUPER项目是在在线共识会议之后形成的,该会议旨在解决所有16名SUPER工作组成员和5名SUPER顾问的三轮措辞完善。
    SUPER报告指南包括22个项目,这些项目被认为对于良好和信息丰富的外科技术报告至关重要。项目分为六个部分:背景,理由,术前准备和要求(第6至9项);手术技术细节(第10至15项);术后考虑和任务(第16至19项);总结和展望(第20和21项);和其他信息(第22项)。
    SUPER报告指南有可能指导详细的,全面,和外科医生透明的手术技术报告。它也可以帮助期刊编辑,同行审稿人,系统审稿人,并指导开发人员评估手术技术文件,并帮助从业者更好地理解和再现手术技术。
    https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/#SUPER.
    UNASSIGNED: Existing reporting guidelines pay insufficient attention to the detail and comprehensiveness reporting of surgical technique. The Surgical techniqUe rePorting chEcklist and standaRds (SUPER) aims to address this gap by defining reporting standards for surgical technique. The SUPER guideline intends to apply to articles that encompass surgical technique in any study design, surgical discipline, and stage of surgical innovation.
    UNASSIGNED: Following the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach, 16 surgeons, journal editors, and methodologists reviewed existing reporting guidelines relating to surgical technique, reviewed papers from 15 top journals, and brainstormed to draft initial items for the SUPER. The initial items were revised through a three-round Delphi survey from 21 multidisciplinary Delphi panel experts from 13 countries and regions. The final SUPER items were formed after an online consensus meeting to resolve disagreements and a three-round wording refinement by all 16 SUPER working group members and five SUPER consultants.
    UNASSIGNED: The SUPER reporting guideline includes 22 items that are considered essential for good and informative surgical technique reporting. The items are divided into six sections: background, rationale, and objectives (items 1 to 5); preoperative preparations and requirements (items 6 to 9); surgical technique details (items 10 to 15); postoperative considerations and tasks (items 16 to 19); summary and prospect (items 20 and 21); and other information (item 22).
    UNASSIGNED: The SUPER reporting guideline has the potential to guide detailed, comprehensive, and transparent surgical technique reporting for surgeons. It may also assist journal editors, peer reviewers, systematic reviewers, and guideline developers in the evaluation of surgical technique papers and help practitioners to better understand and reproduce surgical technique.
    UNASSIGNED: https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/#SUPER.
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  • 文章类型: Journal Article
    手术技术在实现良好的健康结果方面起着至关重要的作用。然而,手术技术报告的质量仍然不均匀。报告清单可以帮助作者更透明和有效地描述手术技术,以及协助审稿人和编辑对其进行更多的信息评估,并促进读者更好地理解该技术。我们以前开发了SUPER(手术技术报告清单和标准),以帮助作者报告他们的研究,其中包含更透明的手术技术。然而,需要进一步解释和阐述每个项目,以便更好地理解和报告实践。
    我们在PubMed,截至2023年1月,Google学者和期刊网站发布,以查找每个SUPER项目的各种文章类型的多学科示例。
    我们解释了SUPER的22个项目,并逐项提供了理由。我们提供了来自53个文献的69个例子,这些例子提供了22个项目的最佳报告。文章类型的例子包括纯手术技术,和病例报告,包含手术技术的观察性研究和临床试验。例子是多学科,包括普外科,骨科手术,心脏手术,胸外科,胃肠手术,神经外科手术,致癌手术,紧急手术等。
    与SUPER文章一起,这个解释和阐述文件可以促进对SUPER项目的更深入的理解。我们希望这篇文章可以进一步指导外科医生和研究人员的报道,并协助编辑和同行评审员审查与外科技术有关的手稿。
    UNASSIGNED: Surgical technique plays an essential role in achieving good health outcomes. However, the quality of surgical technique reporting remains heterogeneous. Reporting checklists could help authors to describe the surgical technique more transparently and effectively, as well as to assist reviewers and editors evaluate it more informatively, and promote readers to better understand the technique. We previously developed SUPER (surgical technique reporting checklist and standards) to assist authors in reporting their research that contains surgical technique more transparently. However, further explanation and elaboration of each item are needed for better understanding and reporting practice.
    UNASSIGNED: We searched surgical literature in PubMed, Google Scholar and journal websites published up to January 2023 to find multidiscipline examples in various article types for each SUPER item.
    UNASSIGNED: We explain the 22 items of the SUPER and provide rationales item by item alongside. We provide 69 examples from 53 literature that present optimal reporting of the 22 items. Article types of examples include pure surgical technique, and case reports, observational studies and clinical trials that contain surgical technique. Examples are multidisciplinary, including general surgery, orthopaedical surgery, cardiac surgery, thoracic surgery, gastrointestinal surgery, neurological surgery, oncogenic surgery, and emergency surgery etc.
    UNASSIGNED: Along with SUPER article, this explanation and elaboration file can promote deeper understanding on the SUPER items. We hope that the article could further guide surgeons and researchers in reporting, and assist editors and peer reviewers in reviewing manuscripts related to surgical technique.
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  • 文章类型: Journal Article
    目的:按摩是非药物治疗的常用疗法,特别是在推拿(中国按摩)作为其最常见的风格,干预措施的评估和复制需要详细的报告指导.根据CONSORT(合并报告试验标准),我们的目标是开发推拿/按摩的延伸,即“推拿/按摩临床试验中报告干预措施的标准”(STRICTOTM)。\"
    方法:一组专业临床医生,审判人员,方法学家,报告指南的开发者,流行病学家,统计学家,编辑通过EQUATOR(增强健康研究的质量和透明度)网络推荐的标准方法流程开发了此STRICTOTM清单,包括预期注册,文献综述,初始项目的草案,德尔福调查的三轮,共识会议,试点测试,并最终确定指导方针。
    结果:七个项目的清单(即推拿/按摩理由,推拿/按摩的细节,干预方案,干预的其他组成部分,推拿/按摩提供者背景,控制或比较干预措施,和预防措施),并制定了16个子项目。还提供了每个项目的说明和示例(E&E)。
    结论:工作组希望STRICTOTM,结合CONSORT声明和非药物治疗的扩展,可以提高推拿按摩临床研究的报告质量和透明度。
    OBJECTIVE: Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely \"The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM).\"
    METHODS: A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline.
    RESULTS: A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided.
    CONCLUSIONS: The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research.
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  • 文章类型: Review
    营养研究的透明报告促进了严谨,再现性,以及与人类营养的相关性。我们对最近报道小鼠饮食叶酸干预的文章进行了范围审查,作为案例研究,以确定通用研究设计项目的报告频率(即,性别,应变,和年龄)和营养特定项目(即,基本饮食组成,干预剂量,持续时间,和暴露验证)在基础营养研究中。我们在EMBASE中确定了798篇原始研究文章,Medline,食品科学与技术文摘(FSTA)全球卫生,以及2009年1月至2021年7月之间发布的国际药物文摘(IPA)数据库,其中在小鼠中使用了饮食叶酸(FA)干预措施。我们确定了312篇原始同行评审的文章,包括191篇非妊娠小鼠研究和126篇妊娠小鼠研究。大多数研究报告性别(99%),菌株(99%),年龄(83%)。大多数研究使用3-9周的C57BL/6(53%)或BALB/c(11%)小鼠。非妊娠研究更可能仅使用雄性小鼠(57%)。膳食FA干预措施变化很大且重叠:缺乏(0-3mg/kg),对照(0-16mg/kg),并补充(0-50mg/kg)。只有63%的研究使用具有声明的FA含量的开放式配方基础饮食,60%的研究使用叶酸状态生物标志物验证了FA暴露。非妊娠研究的干预持续时间为1至104周。妊娠研究的干预持续时间为1-19周,发生在怀孕前和/或怀孕和/或哺乳期间。总的来说,17%的研究未报告≥1个通用研究设计项目,40%的研究未报告≥1个营养特异性研究设计项目。营养研究中重要的通用和营养特定研究设计细节的可变性和频繁缺乏报告限制了它们的普遍性。再现性,和解释。在动物研究中使用报告清单将提高关键研究设计的报告质量,并在基于动物的营养研究中实施因素。
    Transparent reporting of nutrition research promotes rigor, reproducibility, and relevance to human nutrition. We performed a scoping review of recent articles reporting dietary folate interventions in mice as a case study to determine the reporting frequency of generic study design items (i.e., sex, strain, and age) and nutrition-specific items (i.e., base diet composition, intervention doses, duration, and exposure verification) in basic nutrition research. We identified 798 original research articles in the EMBASE, Medline, Food Science and Technology Abstracts (FSTA), Global Health, and International Pharmaceutical Abstracts (IPA) databases published between January 2009 and July 2021 in which a dietary folic acid (FA) intervention was used in mice. We identified 312 original peer-reviewed articles including 191 studies in nonpregnant and 126 in pregnant mice. Most studies reported sex (99%), strain (99%), and age (83%). The majority of studies used C57BL/6 (53%) or BALB/c (11%) mice aged 3-9 wk. Nonpregnancy studies were more likely to use only male mice (57%). Dietary FA interventions varied considerably and overlapped: deficiency (0-3 mg/kg), control (0-16 mg/kg), and supplemented (0-50 mg/kg). Only 63% of studies used an open-formula base diet with a declared FA content and 60% of studies verified FA exposure using folate status biomarkers. The duration of intervention ranged from 1 to 104 wk for nonpregnancy studies. The duration of intervention for pregnancy studies was 1-19 wk, occurring variably before pregnancy and/or during pregnancy and/or lactation. Overall, 17% of studies did not report ≥1 generic study design item(s) and 40% did not report ≥1 nutrition-specific study design item(s). The variability and frequent lack of reporting of important generic and nutrition-specific study design details in nutrition studies limit their generalizability, reproducibility, and interpretation. The use of reporting checklists for animal research would enhance reporting quality of key study design and conduct factors in animal-based nutrition research.
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  • 文章类型: Journal Article
    背景:在过去十年中,对社会责任(SA)干预措施的评估越来越多,然而,报告差距使总结调查结果变得困难。我们开发了社会责任报告研究(SAR4Research)清单,以支持研究人员改进SA流程的文档,context,研究设计,以及同行评审文献中的结果,并加强研究结果的应用。
    方法:我们使用了一个多步骤的过程,从对SA审查的总括审查开始,以确定报告差距。接下来,我们回顾了现有的行为干预报告指南,以确定是否可以以当前或适应的形式使用.我们收到了从业人员和研究人员的反馈,并使用来自三个SA项目的结果文件通过三个工作示例测试了清单。
    结果:我们对SA研究的综述发现了所有领域的报告差距,包括在报告背景方面的差距,干预组件,和研究方法。因为现有的指南没有要求详细说明SA干预中的背景和复杂过程,我们使用CONSORT-SPI作为SAR4Research检查表的基础,并使用其他现有的清单来填补空白。从业者的反馈,研究人员和工作的例子表明需要消除冗余,为项目添加说明,并澄清定量和定性研究组成部分的报告。
    结论:同行评审文献中的SA评估结果将更有用,促进发现的学习和应用,当研究设计时,干预措施及其背景在一篇或一组论文中得到了充分描述。该清单将帮助作者在同行评审的期刊文章中更好地报告。有足够的信息,读者将更好地了解结果是否可以在自己的背景下为问责策略提供信息。作为一个领域,我们将能够更好地发现新发现和我们对SA的理解差距.
    An increasing number of evaluations of social accountability (SA) interventions have been published in the past decade, however, reporting gaps make it difficult to summarize findings. We developed the Social Accountability Reporting for Research (SAR4Research) checklist to support researchers to improve the documentation of SA processes, context, study designs, and outcomes in the peer reviewed literature and to enhance application of findings.
    We used a multi-step process, starting with an umbrella review of reviews on SA to identify reporting gaps. Next, we reviewed existing guidelines for reporting on behavioral interventions to determine whether one could be used in its current or adapted form. We received feedback from practitioners and researchers and tested the checklist through three worked examples using outcome papers from three SA projects.
    Our umbrella review of SA studies identified reporting gaps in all areas, including gaps in reporting on the context, intervention components, and study methods. Because no existing guidelines called for details on context and the complex processes in SA interventions, we used CONSORT-SPI as the basis for the SAR4Research checklist, and adapted it using other existing checklists to fill gaps. Feedback from practitioners, researchers and the worked examples suggested the need to eliminate redundancies, add explanations for items, and clarify reporting for quantitative and qualitative study components.
    Results of SA evaluations in the peer-reviewed literature will be more useful, facilitating learning and application of findings, when study designs, interventions and their context are described fully in one or a set of papers. This checklist will help authors report better in peer-reviewed journal articles. With sufficient information, readers will better understand whether the results can inform accountability strategies in their own contexts. As a field, we will be better able to identify emerging findings and gaps in our understanding of SA.
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  • 文章类型: Review
    营养研究的透明报告促进了严谨,再现性,以及与人类营养的相关性。我们对最近报道小鼠饮食叶酸干预的文章进行了范围审查,作为案例研究,以确定通用研究设计项目的报告频率(即,性别,应变,和年龄)和营养特定项目(即,基本饮食组成,干预剂量,持续时间,和暴露验证)在基础营养研究中。我们在EMBASE中确定了798篇原始研究文章,Medline,食品科学与技术文摘(FSTA)全球卫生,以及2009年1月至2021年7月之间发布的国际药物文摘(IPA)数据库,其中在小鼠中使用了饮食叶酸(FA)干预措施。我们确定了312篇原始同行评审的文章,包括191篇非妊娠小鼠研究和126篇妊娠小鼠研究。大多数研究报告性别(99%),菌株(99%),年龄(83%)。大多数研究使用3-9周的C57BL/6(53%)或BALB/c(11%)小鼠。非妊娠研究更可能仅使用雄性小鼠(57%)。膳食FA干预措施变化很大且重叠:缺乏(0-3mg/kg),对照(0-16mg/kg),并补充(0-50mg/kg)。只有63%的研究使用具有声明的FA含量的开放式配方基础饮食,60%的研究使用叶酸状态生物标志物验证了FA暴露。非妊娠研究的干预持续时间为1至104周。妊娠研究的干预持续时间为1-19周,发生在怀孕前和/或怀孕和/或哺乳期间。总的来说,17%的研究未报告≥1个通用研究设计项目,40%的研究未报告≥1个营养特异性研究设计项目。营养研究中重要的通用和营养特定研究设计细节的可变性和频繁缺乏报告限制了它们的普遍性。再现性,和解释。在动物研究中使用报告清单将提高关键研究设计的报告质量,并在基于动物的营养研究中实施因素。
    Transparent reporting of nutrition research promotes rigor, reproducibility, and relevance to human nutrition. We performed a scoping review of recent articles reporting dietary folate interventions in mice as a case study to determine the reporting frequency of generic study design items (i.e., sex, strain, and age) and nutrition-specific items (i.e., base diet composition, intervention doses, duration, and exposure verification) in basic nutrition research. We identified 798 original research articles in the EMBASE, Medline, Food Science and Technology Abstracts (FSTA), Global Health, and International Pharmaceutical Abstracts (IPA) databases published between January 2009 and July 2021 in which a dietary folic acid (FA) intervention was used in mice. We identified 312 original peer-reviewed articles including 191 studies in nonpregnant and 126 in pregnant mice. Most studies reported sex (99%), strain (99%), and age (83%). The majority of studies used C57BL/6 (53%) or BALB/c (11%) mice aged 3-9 wk. Nonpregnancy studies were more likely to use only male mice (57%). Dietary FA interventions varied considerably and overlapped: deficiency (0-3 mg/kg), control (0-16 mg/kg), and supplemented (0-50 mg/kg). Only 63% of studies used an open-formula base diet with a declared FA content and 60% of studies verified FA exposure using folate status biomarkers. The duration of intervention ranged from 1 to 104 wk for nonpregnancy studies. The duration of intervention for pregnancy studies was 1-19 wk, occurring variably before pregnancy and/or during pregnancy and/or lactation. Overall, 17% of studies did not report ≥1 generic study design item(s) and 40% did not report ≥1 nutrition-specific study design item(s). The variability and frequent lack of reporting of important generic and nutrition-specific study design details in nutrition studies limit their generalizability, reproducibility, and interpretation. The use of reporting checklists for animal research would enhance reporting quality of key study design and conduct factors in animal-based nutrition research.
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  • 文章类型: Journal Article
    为了促进监测数据的跨部门整合,有必要改进和协调监测数据报告中提供的元信息。在特定部门报告中跨部门整合监测结果通常很困难,因为侧重于单个部门的报告往往缺乏澄清监测背景所需的相关元信息的方面。这种报告缺陷降低了监测报告对OneHealth社区的价值。一个健康共识报告注释清单(OH-CRAC),本文描述的以及潜在的应用场景,是为了改进当前对监测数据报告中呈现的数据进行注释的做法而开发的。它旨在为研究人员和报告官员提供指导,说明应收集和提供哪些元信息,以提高监测数据报告的完整性和透明度。OH-CRAC可被所有OneHealth相关部门采用,并且由于其跨部门设计,它支持从联邦部门特定监视报告中相互映射监视元信息,国家和国际层面。为了方便检查表的完成,OH-CRAC也可作为在线资源,允许以简单和用户友好的方式收集监视元信息。完整的OH-CRAC检查表可以作为附件附加到相应的监视数据报告,甚至附加到单个数据文件,无论数据源如何。这样,报告和数据变得更易于解释,与其他部门的信息可用且可比,提高其对所有监督行为者的价值,并为风险管理者提供更好的建议基础。
    To facilitate cross-sector integration of surveillance data it is necessary to improve and harmonize the meta-information provided in surveillance data reports. Cross-sector integration of surveillance results in sector-specific reports is frequently difficult as reports with a focus on a single sector often lack aspects of the relevant meta-information necessary to clarify the surveillance context. Such reporting deficiencies reduce the value of surveillance reports to the One Health community. The One Health Consensus Report Annotation Checklist (OH-CRAC), described in this paper along with potential application scenarios, was developed to improve the current practice of annotating data presented in surveillance data reports. It aims to provide guidance to researchers and reporting officers on what meta-information should be collected and provided to improve the completeness and transparency of surveillance data reports. The OH-CRAC can be adopted by all One Health-related sectors and due to its cross-sector design, it supports the mutual mapping of surveillance meta-information from sector-specific surveillance reports on federal, national and international levels. To facilitate the checklist completion, OH-CRAC is also available as an online resource that allows the collection of surveillance meta-information in an easy and user-friendly manner. Completed OH-CRAC checklists can be attached as annexes to the corresponding surveillance data reports or even to individual data files regardless of the data source. In this way, reports and data become better interpretable, usable and comparable to information from other sectors, improving their value for all surveillance actors and providing a better foundation for advice to risk managers.
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  • 文章类型: Journal Article
    背景:批判性评估有助于评估科学文献的质量,这是循证医学实践的核心。有几种工具和指南可用于批评和评估特定研究类型的质量。然而,对于临床药代动力学研究的关键评估,存在有限的指导。
    目的:我们旨在就临床药代动力学研究的质量指标达成专家共识,试图开发一种关键的评估工具。
    方法:与临床药代动力学研究相关的质量标记,来自已发表的文献,并根据手稿报告领域(摘要,介绍/背景,方法论,结果,讨论,和结论)。从这些质量标记中提出了有助于评估药代动力学研究的问题。专家们参与了修改后的德尔菲程序,以就所提出的问题达成共识。所提出的工具在最近发表的30项临床药代动力学研究中进行了初步测试。衡量了观察员之间的协议,以确定所包含项目的可靠性。
    结果:25位专家同意参与。需要进行三轮改良的Delphi调查才能为旨在评估临床药代动力学研究质量的21项工具达成共识。当应用于最近发表的30项临床药代动力学研究时,大多数项目得分中等至中等水平(61.90-95.24%)。
    结论:本研究中开发的临床药代动力学关键评估工具(CACPK)由21个项目组成,旨在帮助最终用户确定药代动力学研究的质量。需要进一步的研究来重申CACPK工具的有效性和可靠性。
    BACKGROUND: Critical appraisal aids in assessing the quality of scientific literature, which is central to the practice of evidence-based medicine. Several tools and guidelines are available for critiquing and assessing the quality of specific study types. However, limited guidance exists for critical appraisal of clinical pharmacokinetic studies.
    OBJECTIVE: We aimed to achieve experts\' consensus regarding the quality markers for clinical pharmacokinetic studies in an attempt to develop a critical appraisal tool.
    METHODS: Quality markers related to clinical pharmacokinetic studies, were derived from the published literature and categorized according to manuscript reporting domains (abstract, introduction/background, methodology, results, discussion, and conclusion). Questions that aid in appraising pharmacokinetic studies were formulated from these quality markers. Experts were involved in a modified Delphi process to achieve a consensus regarding the formulated questions. The proposed tool was pilot tested on 30 recently published clinical pharmacokinetic studies. Inter-observer agreement was measured to determine the reliability of the included items.
    RESULTS: Twenty-five experts consented to participate. Three rounds of a modified Delphi survey were required to generate a consensus for a 21-item tool aimed at appraising the quality of clinical pharmacokinetic studies. When applied to 30 recently published clinical pharmacokinetic studies, most items scored fair to moderate levels of agreement (61.90-95.24%).
    CONCLUSIONS: The clinical pharmacokinetic critical appraisal tool (CACPK) developed in this study consisted of 21 items aimed at helping an end-user to determine the quality of a pharmacokinetic study. Further studies are warranted to reaffirm the validity and reliability of the CACPK tool.
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  • 文章类型: Journal Article
    背景:据我们所知,没有设计报告指南,在健康科学中进行和报告有限元研究。我们打算为报告这些研究提出具体和详细的指导方针。
    方法:在认识到在医学和牙科中需要有统一的有限元分析报告指南之后,作为研究领域的5名研究人员于2020年夏季开会,起草了制定此类指南的方法。每位研究人员分别列出了报告这些研究所需的主要标题,并于2020年9月再次开会以最终确定该领域。随后,已绘制了子标题和详细信息。报告准则的项目清单草案已提交给一个由15名专家组成的更大的小组,并根据他们的投入进一步进行了一些修改。
    结果:该指南涉及七个主要领域及其子领域,包括模型结构的参数,分割,网状结构,力施加和模型验证,等。该清单旨在提高FEA研究的报告和一致性。
    结论:我们希望科学界对这些指南的使用和采纳将导致更周到和统一的文档。此外,对结果的信心将通过模型的可重复性得到增强,可重用性和问责制。拟议的指南被命名为“使用医学有限元分析的计算机研究报告”,术语“RIFEM”被用作首字母缩写。
    BACKGROUND: To the best of our knowledge, there are no reporting guidelines for design, conduct and reporting of Finite Element studies in health sciences. We intend to propose specific and detailed guidelines for reporting these studies.
    METHODS: After recognizing the need to have uniform guidelines for reporting of finite element analysis in medicine and dentistry, a group of 5 researchers working on FEA as their research area met in the summer of 2020 and drafted the methodology for the development of such guidelines. Each researcher individually made a list of major headings required for reporting these studies and met again in September 2020 to finalize the domains. Subsequently, sub headings and details were charted. The draft list of items for reporting the guidelines were presented to a larger team of 15 experts and some changes were further made based on their inputs.
    RESULTS: The guidelines entail seven major domains and their sub-domains, including parameters for model structure, segmentation, mesh structure, force application and model validation, etc. This checklist aims to improvise the reporting and consistency of FEA studies.
    CONCLUSIONS: We hope that the usage and adoption of these guidelines by the scientific community would result in more thoughtful and uniform documentation. Also, the confidence in the results would be enhanced through model reproducibility, reusability and accountability. The proposed guidelines were named as \'Reporting of in-silico studies using finite element analysis in medicine\' and the term \'RIFEM\' was used as acronym.
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