RESEARCH DESIGN

研究设计
  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    重症监护试验评估了干预措施对具有不同个人病史和疾病原因的患者的影响。通常在异质性临床综合征的保护伞下,如败血症或急性呼吸窘迫综合征。鉴于这种变化,对于具有不同特征的个体,治疗对结局的影响可能有所不同是合理的.然而,在随机对照试验中,疗效通常通过平均治疗效果(ATE)来评估,量化干预对研究人群结局的平均影响。重要的是,ATE可能会隐藏患者特征水平之间的治疗对临床结果的影响的变化,这可能会错误地得出这样的结论:当干预实际上可能使某些患者受益时,干预并不能整体起作用。在这次审查中,我们描述了评估治疗效果异质性(HTE)的方法学方法,包括专家派生的分组,数据驱动的分组,基线风险建模,治疗效果建模,和个体治疗规则估计。接下来,我们概述了如何将HTE分析的见解纳入临床试验的设计。最后,我们提出了一个研究议程,以推进该领域并将HTE方法带到床边。
    Critical care trials evaluate the effect of interventions in patients with diverse personal histories and causes of illness, often under the umbrella of heterogeneous clinical syndromes, such as sepsis or acute respiratory distress syndrome. Given this variation, it is reasonable to expect that the effect of treatment on outcomes may differ for individuals with variable characteristics. However, in randomized controlled trials, efficacy is typically assessed by the average treatment effect (ATE), which quantifies the average effect of the intervention on the outcome in the study population. Importantly, the ATE may hide variations of the treatment\'s effect on a clinical outcome across levels of patient characteristics, which may erroneously lead to the conclusion that an intervention does not work overall when it may in fact benefit certain patients. In this review, we describe methodological approaches for assessing heterogeneity of treatment effect (HTE), including expert-derived subgrouping, data-driven subgrouping, baseline risk modeling, treatment effect modeling, and individual treatment rule estimation. Next, we outline how insights from HTE analyses can be incorporated into the design of clinical trials. Finally, we propose a research agenda for advancing the field and bringing HTE approaches to the bedside.
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  • 文章类型: Journal Article
    在初级卫生保健(PHC)中使用数字医疗有助于降低成本和旅行时间,实现全球发展目标,改善访问,护理的质量和纵向,管理健康危机。其评估必须超越技术操作方面,包括患者满意度,评估护理质量的关键因素。
    识别和绘制患者满意度(期望,欲望,文化价值观)关于采用数字健康策略并评估其对PHC护理质量的影响。
    审查将遵循乔安娜·布里格斯研究所(JBI)手册提出的建议,系统审查和Meta分析扩展的首选报告项目(PRISMA-ScR)以及Arksey和O\'Malley和Levac等人提出的方法。将分九个阶段进行。搜索将在健康研究数据库中进行(MEDLINE通过PubMed,EMBASE,CINAHL,WebofScience,和BVS),灰色文学,和预印存储库(谷歌学者和MedRxiv)。两名评审员将选择这些研究,第三个将分析可能的冲突。纳入标准包括已全部提供的研究,无论是初级研究还是短期交流,以及从灰色文献中提取的以下材料:预印本,手册,政府文件,书籍,指导方针,论文和论文。排除标准包括文献综述,摘要,书籍,会议档案,给编辑的信,重复和意见文章。数据将通过内容分析和推理统计进行分析。该协议在开放科学框架(OSF)的DOI10.17605/OSF下注册。IO/PUJDB。
    该研究旨在了解与期望相关的方面,欲望,以及不同国家患者的文化价值观,以及使用数字健康对PHC护理质量的优势和关键节点。
    UNASSIGNED: Using digital health in primary health care (PHC) contributes to reducing costs and travel time, achieving global development goals, improving access, quality and longitudinality of care, and managing health crises. Its evaluation must go beyond the technical-operational aspects to include patient satisfaction, a key element in assessing the quality of care.
    UNASSIGNED: To identify and map patient satisfaction (expectations, desires, cultural values) about the adoption of digital health strategies and assess their impact on the quality of care in PHC.
    UNASSIGNED: The review will follow the recommendations proposed by the Joanna\'s Briggs Institute (JBI) manual, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) and the methodology proposed by Arksey and O\'Malley and Levac et al. and will be conducted in nine stages. The search will be conducted in health studies databases (MEDLINE via PubMed, EMBASE, CINAHL, Web of Science, and BVS), gray literature, and preprint repositories (Google Scholar and MedRxiv). Two reviewers will select the studies, and the third will analyze possible conflicts. The inclusion criteria comprise studies that have been made available in their entirety, whether they are primary studies or short communications, as well as the following materials extracted from the gray literature: preprints, manuals, government documents, books, guidelines, theses and dissertations. Exclusion criteria include literature reviews, abstracts, books, conference archives, letters to the editor, duplicates and opinion articles. Data will be analyzed by content analysis and inferential statistics. This protocol is registered on the Open Science Framework (OSF) under DOI 10.17605/OSF.IO/PUJDB.
    UNASSIGNED: The study aims to understand aspects related to the expectations, desires, and cultural values of patients from different countries, as well as the strengths and critical nodes of the use of digital health on the quality of care in PHC.
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  • 文章类型: Journal Article
    背景:促进心理健康,预防和治疗精神障碍在公共卫生中至关重要,和许多随机对照试验(RCT)评估这些目标的干预策略。然而,区分推广与预防和治疗RCT是具有挑战性的。在心理健康研究中,不存在将研究沿着促进到治疗的连续体进行研究的工具,让研究人员和政策制定者来决定如何对各个RCT进行分类,这阻碍了证据的综合。
    方法:我们提出了一种新工具的开发方案,以帮助研究人员在促进到治疗的连续过程中区分RCT。我们将成立一个工具开发小组,利用人口,干预,定义结构的比较和结果框架。我们会产生,定义,使用定性方法对工具中的项目进行分类和减少,包括认知访谈和德尔福练习。心理测量评估-包括单维度,地方独立,单调性和项目同质性-将包括数据收集,得分,对可用RCT的工具指标进行内部一致性检查和因子分析。我们将使用标准Cohen的kappa统计数据来评估该工具的可靠性。
    背景:本研究涉及从已经发表的文献中收集数据。然而,本协议已由意大利大学伦理委员会批准(CE202404)。本项目的结果将在同行评审的期刊以及国际和国家科学会议上传播。还将编写应用该工具的培训材料,并分发给科学界。该工具和所有相关执行材料将在网站上发布,并向公众免费提供。
    BACKGROUND: Promoting mental health, preventing and treating mental disorders are critically important in public health, and many randomised controlled trials (RCTs) evaluate intervention strategies for these objectives. However, distinguishing promotion from prevention and from treatment RCTs is challenging. A tool to place studies along the promotion-to-treatment continuum in mental health research does not exist, leaving it to researchers and policymakers to decide on how to classify individual RCTs, which hinders evidence synthesis.
    METHODS: We present a protocol for the development of a new tool to assist researchers in distinguishing RCTs along the promotion-to-treatment continuum. We will establish a Tool Development Group, and use the Population, Intervention, Comparison and Outcome framework to define constructs. We will generate, define, categorise and reduce the items in the tool using qualitative methods, including cognitive interviews and a Delphi exercise. Psychometric evaluation-including unidimensionality, local independence, monotonicity and item homogeneity-will include data collection, scoring, internal consistency checks and factor analysis of the tool\'s indicators for available RCTs. We will use standard Cohen\'s kappa statistics to assess the reliability of the tool.
    BACKGROUND: This study involves data collection from the already published literature. However, this protocol has been approved by the ethics committee of the Università della Svizzera Italiana (CE 2024 04). The results of the present project will be disseminated in peer-reviewed journals and at international and national scientific meetings. Training materials for the application of the tool will also be developed and disseminated to the scientific community. The tool and all related implementation materials will be published on a website and will be freely accessible to the public.
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  • 文章类型: Journal Article
    背景:父母介导的干预是一种治疗方法,它利用父母的培训,使父母能够通过发展必要的技能为孩子提供主要的支持和干预,知识,和资源。父母介导的干预措施可以大致分为两个阶段:(1)临床医生教育,培训和指导父母实施干预措施和有关孩子状况的相关信息,以及(2)父母根据接受的指导和教育调解和实施干预措施。这些干预措施可以作为儿童的主要干预措施或补充临床干预措施。这项审查将包括执行过程的两个阶段以及主要和补充干预措施。父母介导的干预措施的结果包括长期症状减轻,改善了广泛的行为和大脑功能的预后,并增强了亲子二元社交交流。
    方法:本系统综述旨在综合现有证据,并确定针对农村地区神经发育障碍儿童父母的有效父母介导干预的特征。CINAHL的系统搜索,PsycINFO,ProQuest联合健康和护理数据库,EbscohostPsychandBehavioural数据库和SocINDEX进行了两次,最近一次是在2024年3月5日使用预先识别的搜索词完成的。引文将导入EndNoteV.20.6(ClarivateAnalytics,宾夕法尼亚,美国)进行组织和去重复,然后进行Covidence以完成筛选和提取。这些文章将根据JoannaBriggs研究所(JBI)的混合方法系统评价指南进行筛选和审查。用于系统评价的JBI评估工具将用于评估可信度,定性的相关性和结果,定量和混合方法研究。分析的文献范围将包括2013年至2024年之间以英文发表的文章。文献仅限于过去10年,以确保结果的相关性,因为目的是报告当前的证据。该研究的开始日期为2023年3月,计划完成日期为2024年10月。
    背景:这项研究既不涉及人类也不涉及动物受试者,也不需要伦理学批准。结果将在同行评审的期刊以及相关的儿童和家长健康会议或农村会议上传播给相关团体。关键成果也将在社交媒体上分享,以支持非研究受众的访问。
    BACKGROUND: Parent-mediated interventions are therapeutic approaches that use parent training to enable parents to provide primary support and intervention to their child through the development of necessary skills, knowledge, and resources.Parent-mediated interventions can be broadly divided into two stages: (1) Clinicians educating, training and coaching parents in the implementation of an intervention and relevant information regarding their child\'s condition and (2) Parent(s) mediating and implementing the intervention based on the coaching and education received. These interventions can act as the primary intervention for children or supplement clinical interventions. This review will include both stages of the implementation process as well as both primary and supplementary interventions. Outcomes of parent-mediated interventions include long-term symptom reduction, improved prognosis for a wide range of behavioural and brain functions and enhanced parent-child dyadic social communication.
    METHODS: This systematic review aims to synthesise existing evidence and identify the characteristics of effective parent-mediated intervention for parents of children with neurodevelopmental disorders residing in rural areas. Systematic searches of CINAHL, PsycINFO, ProQuest allied health and nursing database, Ebscohost Psych and Behavioural database and SocINDEX were conducted twice with the latest completed on 5 March 2024 using preidentified search terms. Citations will be imported into EndNote V.20.6 (Clarivate Analytics, Pennsylvania, USA) to organise and de-duplicate and then Covidence to complete screening and extraction. The articles will be screened and reviewed following the Joanna Briggs Institute (JBI) guidelines for systematic reviews of Mixed methods. The JBI appraisal tools for systematic reviews will be used to assess the trustworthiness, relevance and results of qualitative, quantitative and mixed-methods studies. The scope of the literature analysed will include articles published between 2013 and 2024 in English. Literature was limited to the last 10 years to ensure the relevance of results as the intention is to report on current evidence. The start date of the study was March 2023 and the planned completion date is October 2024.
    BACKGROUND: This study will neither involve human nor animal subjects and does not require ethics approval. Results will be disseminated to relevant groups in peer-reviewed journal(s) and at relevant children and parent health conferences or rural conferences. The key outcomes will also be shared on social media to support access for non-research audiences.
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  • 文章类型: Journal Article
    背景:不健康的饮食对欧洲儿童构成重大的公共卫生风险,导致超重和非传染性疾病患病率上升。孩子们每天在学校花费大量时间,包括午餐时间,因此,学校环境对于促进健康饮食和生活习惯至关重要。虽然有大量关于学校食品政策对健康和非健康结果的影响的文献,必须确定哪些政策是有效的,可以建议实施,以确保资源的有效利用。本文提出了一项范围审查方案,旨在绘制当前已发表的有关学校食品政策对健康结果的影响的文献。欧洲中学生的接受度和负担能力。此外,范围审查将绘制用于评估健康结果的测量图,接受和负担能力。
    方法:范围审查方案和审查遵循系统审查的首选报告项目和范围审查的Meta分析扩展。为了确定符合条件的研究,我们将搜索MEDLINE,PsycINFO,CINAHL和WebofScience。将检查所包含文章的参考列表以进行其他研究。此外,欧洲联盟成员国针对具体国家的部报告,英国,挪威,冰岛和瑞士将被确定。世卫组织和欧盟委员会网站也将被搜索相关报告。范围审查将包括2023年9月20日之前发表的文献。对学习设计和语言没有限制。筛选和数据提取将由三名评审员独立进行。分歧将通过讨论解决。预先测试的数据图表表将用于提取关键信息。研究结果将以表格和可视化摘要以及叙述性摘要形式呈现。
    背景:此范围审查不需要道德批准。我们的传播策略包括同行评审的出版物,会议向决策者介绍和建议。
    BACKGROUND: Unhealthy diets pose a significant public health risk among European children, contributing to the increasing prevalence of overweight and non-communicable diseases. Children spend a substantial amount of time at school daily, including lunchtime, so the school setting becomes crucial for promoting healthy diets and lifestyle habits. While there is a large body of literature on the impact of school food policies on health and non-health outcomes, it is essential to identify which policies are effective and can be recommended for implementation to ensure the efficient use of resources. This article presents a protocol for a scoping review that aims to map the current published literature on the effects of school food policies on health outcomes, acceptance and affordability in secondary school children in Europe. Moreover, the scoping review will map the measurements used to assess health outcomes, acceptance and affordability.
    METHODS: The scoping review protocol and review follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review. To identify eligible studies, we will search MEDLINE, PsycINFO, CINAHL and Web of Science. The reference lists of the included articles will be checked for additional studies. In addition, country-specific ministry reports from Member States of the European Union, the UK, Norway, Iceland and Switzerland will be identified. The WHO and European Commission websites will also be searched for relevant reports. The scoping review will include literature published until 20 September 2023. No restrictions to study design and language will be applied. Screening and data extraction will be carried out independently by three reviewers. Disagreements will be resolved by discussion. A pretested data charting table will be used to extract key information. Findings will be presented in tabular and visualised summaries and a narrative summary.
    BACKGROUND: This scoping review does not require ethical approval. Our dissemination strategy comprises peer-reviewed publications, conference presentations and recommendations to policy-makers.
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  • 文章类型: Journal Article
    背景:虽然指南承认在儿茶酚胺能多形性室性心动过速(CPVT)患者中使用植入式心律转复除颤器(ICD)的预期益处。然而,潜在的不良影响受到的关注较少。
    方法:为了全面解决这个问题,我们将探索各种数据库,如Cochrane图书馆,WebofScience,EMBASE和PubMed。我们的研究将包括CPVT患者,有和没有ICD植入。两名研究人员将独立评估符合条件的研究并收集相关数据。纳入研究的质量将使用纽卡斯尔-渥太华量表或Cochrane偏差风险工具进行评估。数据分析将使用RevMan进行。
    背景:因为这项研究完全依赖于现有的研究,获得患者知情同意和伦理批准是不必要的.这项荟萃分析的结果将在会议或同行评审的期刊上分享。
    CRD4202237824。
    BACKGROUND: While the guidelines acknowledge the anticipated benefits of using an implantable cardioverter defibrillator (ICD) in individuals with catecholaminergic polymorphic ventricular tachycardia (CPVT). However, the potential adverse effects have received less attention.
    METHODS: To address this issue comprehensively, we will explore various databases such as the Cochrane Library, Web of Science, EMBASE and PubMed. Our study will include CPVT patients, both with and without ICD implantation. Two researchers will evaluate the eligible studies independently and gather pertinent data. The quality of the studies included will be assessed using either the Newcastle-Ottawa Scale or the Cochrane Risk of Bias Tool. Data analysis will be conducted using RevMan.
    BACKGROUND: Because this research depends exclusively on existing studies, obtaining patient informed consent and ethics approval is unnecessary. The results of this meta-analysis will be shared at conferences or in peer-reviewed journals.
    UNASSIGNED: CRD42022370824.
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  • 文章类型: Journal Article
    紫外线辐射(UVR)是影响地球生命进化的普遍因素。UVR的环境水平介导关键的生物学功能,但也可以在广泛的生物体中引起严重的致死和亚致死效应。此外,UVR是其他环境因素对机体生理学影响的强大调节剂,如温度,疾病,毒理学和pH,在其他人中。这在全球变化的背景下至关重要,对于实验生物学家来说,理解多种应激源的影响是一个关键的挑战。生态生理学家很少提供UVR讨论或在实验设计中包括UVR,即使它与他们的学习系统直接相关。在这篇评论中,我们为实验生物学家提供了一个指导,以更好地理解,when,以及如何将UVR集成到实验设计中以提高其实验的生态真实感。
    Ultraviolet radiation (UVR) is a pervasive factor that has shaped the evolution of life on Earth. Ambient levels of UVR mediate key biological functions but can also cause severe lethal and sublethal effects in a wide range of organisms. Furthermore, UVR is a powerful modulator of the effects of other environmental factors on organismal physiology, such as temperature, disease, toxicology and pH, among others. This is critically important in the context of global change, where understanding the effects of multiple stressors is a key challenge for experimental biologists. Ecological physiologists rarely afford UVR discussion or include UVR in experimental design, even when it is directly relevant to their study system. In this Commentary, we provide a guide for experimental biologists to better understand if, when, and how UVR can be integrated into experimental designs to improve the ecological realism of their experiments.
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  • 文章类型: Journal Article
    样本量的计算是研究设计的重要组成部分,因为它影响到研究的可靠性和可行性。在这篇文章中,我们看看不同类型研究的样本量计算原则。
    Calculation of sample size is an essential part of research study design since it affects the reliability and feasibility of the research study. In this article, we look at the principles of sample size calculation for different types of research studies.
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    文章类型: Journal Article
    定性研究是进行健康学科研究的一种相对较新的方法。这种研究方法的价值在于探索人们的经历,并更深入地理解他们经历的意义。定性调查回答了关于什么的研究问题,为什么以及如何通过实施各种研究设计,如定性描述性,定性案例研究,民族学,现象学,或扎根理论设计。目的和滚雪球抽样方法通常用于招募参与者,然后进行个人访谈或焦点小组讨论以收集数据。数据分析需要研究人员执行几个编码程序,或者另一种方法是使用编码软件程序。准备一份用于传播结果的手稿可能具有挑战性,虽然可以实现。
    Qualitative research is a relatively new approach for conducting studies in health disciplines. The value of this research approach is to explore peoples\' experiences and gain a deeper understanding of the meaning of their experiences. Qualitative inquiries answer research questions about what, why and how by implementing various research designs such as qualitative descriptive, qualitative case study, ethnological, phenomenology, or grounded theory designs. Purposive and snowball sampling methods are commonly used to recruit participants followed by personal interviews or focus group discussions to collect data. Data analysis requires several coding procedures performed by the researcher or an alternative is using a coding software program. Preparing a manuscript for dissemination of the results can be challenging, although achievable.
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