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International Journal of Evidence-Based Healthcare最新文献

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Transparency in Reporting Results From Randomized Clinical Trials 随机临床试验报告结果的透明度
Q3 Medicine Pub Date : 2019-06-13 DOI: 10.17267/2675-021XEVIDENCE.V1I1.2254
R. Kaplan, V. Irvin
Submitted 01/31/2019, Accepted 04/17/2019, Published 06/13/2019 J. Évid-Based Healthc., Salvador, 2019 June;1(1):50-51 Designated editor: Luís Cláudio Lemos Correia Doi: 10.17267/2675-021Xevidence.v1i1.2254 | ISSN: 2675-021X How to cite this article: Kaplan R, Irvin V. Transparency in Reporting Results From Randomized Clinical Trials. J Évid-Based Healthc.. 2019;1(1):50-51. doi: 10.17267/2675-021Xevidence.v1i1.2254
2019年1月31日提交,2019年4月17日接受,2019年6月13日发布。中国医学进展,2019年6月;1(1):50-51指定编辑:Luís Cláudio Lemos Correia Doi: 10.17267/2675-021Xevidence.v1i1.2254 | ISSN: 2675-021X本文引用方式:Kaplan R, Irvin V.随机临床试验结果报告的透明度。J Évid-Based health ..1(1): 50-51。2019;2675 - 021 - xevidence.v1i1.2254 doi: 10.17267 /
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引用次数: 0
Why Unbox Evidence-based Medicine? 为什么要拆封循证医学?
Q3 Medicine Pub Date : 2019-06-13 DOI: 10.17267/2675-021XEVIDENCE.V1I1.2364
Luis Cláudio Lemos Correia
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引用次数: 0
Science must speak truth to power 科学必须对权力说真话
Q3 Medicine Pub Date : 2019-06-13 DOI: 10.17267/2675-021XEVIDENCE.V1I1.2366
J. D. D. Barreto Segundo, A. Villalobos, Luis Cláudio Lemos Correia
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引用次数: 1
On presenting Evidence and unboxing science 论呈现证据和开箱科学
Q3 Medicine Pub Date : 2019-06-04 DOI: 10.17267/2675-021XEVIDENCE.V1I1.2362
Luis Cláudio Lemos Correia, J. D. D. Barreto Segundo
The first question we faced as we gathered to discuss the possibility of launching Evidence (then just called the new journal on evidencebased medicine, still no caps) was why (and if) we did need another medical journal in a highly competitive environment already full of those. Douglas Altman stated that we needed “less research, better research and research done for the right reasons” in his famous 1994 article “The Scandal of Poor Medical Research”1. Adding to that, the predictive value of research in general probably lies below 50%2, due to imprecision (low sample size), methodological bias (low quality of research design) and allegiance bias (conclusions being crafted in a manner that reconciles best with the investigator’s or researcher’s perspectives and preferences), not to mention P-hacking3, withholding datasets and publication bias, that is, publishing only or mostly papers that disprove the null hypothesis.
当我们聚集在一起讨论推出《证据》(Evidence)杂志的可能性时,我们面临的第一个问题是,在一个竞争激烈的环境中,我们为什么(以及是否)需要另一份医学杂志,因为这样的杂志已经很多了。道格拉斯·奥特曼(Douglas Altman)在他1994年的著名文章《拙劣医学研究的丑闻》中指出,我们需要“更少的研究,更好的研究,为了正确的理由而进行的研究”。除此之外,由于不精确(样本量小)、方法偏差(研究设计质量低)和忠诚偏差(以最符合研究者或研究人员的观点和偏好的方式制定结论),研究的预测价值一般可能低于50%2,更不用说P-hacking3、隐瞒数据集和发表偏差(即只发表或大部分发表反驳原假设的论文)。
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引用次数: 1
Empaglifozin cardiovascular benefit: can we separate fact from fiction? 恩帕列净对心血管的益处:我们能区分事实与虚构吗?
Q3 Medicine Pub Date : 2019-06-04 DOI: 10.17267/2675-021XEVIDENCE.V1I1.2095
Robson Brandão Silva
Após recente repercussão no meio médico científico a despeito dos resultados promissores relacionado o uso de empaglifozina, um inibidor do SGLT-2, diversas estratégias foram implementadas para a divulgação desses resultados com posterior estimulação da prescrição dessa medicação. Logo após o lançamento da Diretriz Brasileira Baseada em Evidências de Doenças Cardiovasculares em Pacientes com Diabetes, publicada pela Sociedade Brasileira de Cardiologia e Endocrinologia, tivemos recentemente (agosto de 2018) uma nova audiência pública para a implantação desse medicamento no sistema único de saúde do Brasil (SUS), devido aos resultados encontrados com o uso da empaglifozina no EMPA REG Outcomes Trial, pedido esse que já havia sido negado pela CONITEC (Comissão Nacional de Incorporação de Tecnologias no SUS) em sua última decisão. Tomando este gatilho relatado acima como um momento para rediscutir esta questão interessante, meu objetivo será voltar ao seguinte questionamento: O resultado da redução da mortalidade cardiovascular no estudo EMPA REG realmente confirma o quê, eles (investigadores), encontraram ou ainda estamos no campo de resultados exploratórios?, onde precisamos de evidências mais robustas para garantir esse benefício para a população. Vale lembrar que o custo dessa nova medicação, a empaglifozina, terá um importante impacto no orçamento do SUS e o objetivo deste artigo será de reavaliar esse ensaio clínico que mostrou um benefício, porém com foco na prova de conceito.
尽管empaglifozin(一种SGLT-2抑制剂)的使用取得了有希望的结果,但最近在科学医学环境中引起了反响,并实施了一些策略来传播这些结果,随后刺激了这种药物的处方。循证巴西启动指令后患者的心血管疾病的糖尿病、心血管和内分泌的巴西社会发布,最近(2018年8月)一个新的公开部署的产品在巴西的医疗保健系统(SUS)发现的结果,由于使用的empaglifozina EMPA瑞格试验结果,CONITEC(国家统一卫生系统技术整合委员会)在其最新决定中已经拒绝了这一请求。在触发器中更像一个有趣的时间讨论这个问题,我的目标是回到以下问题:心血管死亡率下降的结果EMPA瑞格真的证实了什么研究,发现(研究人员),还是我们还在探索的结果。在那里,我们需要更有力的证据来确保公众受益。值得记住的是,这种新药empaglifozin的成本将对SUS的预算产生重大影响,本文的目的是重新评估这种显示效益的临床试验,但重点是概念证明。
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引用次数: 0
Implementing research findings into practice: frameworks and guidance. 将研究成果付诸实践:框架和指导。
Q3 Medicine Pub Date : 2019-06-01 DOI: 10.1097/XEB.0000000000000195
Bridie Kent

Background: Health services across the world are constantly introducing changes into their workplaces and these affect many people. As new robust and reliable evidence becomes available, it is important that changes to practice are made. As health professionals, we have to be flexible and accommodate this change; for some this means disruption, challenge and having to learn new ways of doing things. Barriers exist that prevent or delay changes being made to established practice in all organizations, whatever the culture. This is a world-wide problem. It is important to understand the barriers to change so that solutions can be found. Some changes that are needed don't occur, because clinicians are unaware of the new evidence, while for others there needs to be something introduced to drive forward the change. This process is not a passive one; active involvement is needed for the change to be successful. Individual attitudes and beliefs play a significant part in change, and their influences are often underestimated, so these also need to be explored. Practice change may require new skills to be learnt - another obstacle for change.

Aim: In this short communication, the science behind evidence implementation is introduced and then some of the factors that impact on change are explored, drawing on three useful models and frameworks.

Conclusion: Ultimately there remains a gap between interventions that research has shown to be effective and their translation into practice; this has to be closed.

背景:世界各地的卫生服务机构不断在其工作场所引入变革,这些变革影响到许多人。随着新的有力和可靠的证据的出现,对实践进行改变是很重要的。作为卫生专业人员,我们必须灵活适应这种变化;对一些人来说,这意味着颠覆、挑战和必须学习新的做事方式。在所有组织中,无论文化如何,都存在阻碍或延迟对既定实践进行更改的障碍。这是一个世界性的问题。了解变革的障碍是很重要的,这样才能找到解决方案。一些必要的改变没有发生,因为临床医生没有意识到新的证据,而对其他人来说,需要引入一些东西来推动改变。这个过程不是被动的;积极参与是变革成功的必要条件。个人的态度和信念在变革中发挥着重要作用,它们的影响往往被低估,因此这些也需要探索。实践变革可能需要学习新的技能——这是变革的另一个障碍。目的:在这个简短的交流中,介绍了证据实施背后的科学,然后探讨了影响变化的一些因素,借鉴了三个有用的模型和框架。结论:最终,在研究表明有效的干预措施与其转化为实践之间仍然存在差距;这件事必须了结。
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引用次数: 6
Implementing evidence in local and global contexts. 在当地和全球范围内实施证据。
Q3 Medicine Pub Date : 2019-06-01 DOI: 10.1097/XEB.0000000000000182
Judith Carrier

The notion of context, while underpinning everything that we do in health care, remains something that is difficult to define; however, it determines the success or failure of everything that we do, particularly in the global healthcare arena. Whether we consider context as an objective or subjective construct, it should influence every evidence-based decision we make as healthcare professionals. Methods developed as part of the implementation science movement, including realist synthesis and 'mindlines', emphasize the important of addressing social, cultural and environmental context-specific influences when considering the implementation of complex interventions, particularly in diverse populations. The Joanna Briggs Institute evidence-based clinical fellowship program empowers practitioners, through education, to implement evidence into their own practice areas, taking into account the key variables that impact on successful adoption.

背景的概念虽然支撑着我们在医疗保健领域所做的一切,但仍然很难定义;然而,它决定了我们所做的一切的成功或失败,特别是在全球医疗保健领域。无论我们认为环境是客观的还是主观的,它都应该影响我们作为医疗保健专业人员做出的每一个基于证据的决定。作为实施科学运动的一部分而发展起来的方法,包括现实主义综合和“思维线”,强调在考虑实施复杂的干预措施时,特别是在不同的人群中,处理社会、文化和环境具体背景影响的重要性。乔安娜布里格斯研究所的循证临床奖学金项目通过教育授权从业人员将证据应用到他们自己的实践领域,并考虑到影响成功采用的关键变量。
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引用次数: 0
Feasibility, appropriateness and meaningfulness analysis of the Sunfrail Tool to the European Portuguese population during cross-cultural adaptation process. sun脆弱工具在欧洲葡萄牙人跨文化适应过程中的可行性、适宜性和意义分析。
Q3 Medicine Pub Date : 2019-06-01 DOI: 10.1097/XEB.0000000000000194
Ana F Cardoso, Elzbieta Bobrowicz-Campos, Filipa Couto, Daniela Cardoso, Alberto Barata, João Apóstolo

Frailty is an age-related condition characterized by increased vulnerability to negative outcomes. To enable informed decision-making and implementation of individually tailored practices for frailty management, it is necessary to develop screening tools that cover different domains of individual functioning, reliably predict future adverse outcomes and are generalizable to healthcare settings other than primary care. The Sunfrail Tool, an easy-to-use nine-item instrument, seems to meet all these requirements. The current study aimed to perform a cross-cultural adaptation of the Sunfrail Tool for the European Portuguese population and to perform the feasibility, appropriateness and meaningfulness analyses of the Sunfrail Tool Portuguese version.

Methods: The process of cross-cultural adaptation was conducted in four-phases (translation, synthesis, back translation and creation of consensual version). To reinforce the content validity, the additional analysis on feasibility, appropriateness and meaningfulness were conducted with end-users (older adults, informal caregivers and health and social care professionals).

Results: The frailty concept was considered suitable for the European Portuguese population. A consensus version was reached by an expert panel after considering the results of two forward and two back-translations. This prefinal version was endorsed to the first author of the original version of the instrument, as recommended by international guidelines. The content validation performed by healthcare professionals (n = 7), patients (n = 18) and informal caregivers (n = 3) showed that the Sunfrail Tool was moderately comprehensible and ambiguous. Five items required changes for cultural adaptation.

Conclusion: The Sunfrail Tool seems to be a promising instrument for the early identification of frailty to be used in the European Portuguese context to inform clinical decisions on preventive responses. However, to enable identification of frail and nonfrail individuals with this tool and ensure effectiveness on pathways activation for frailty management, there is a need to define cut-off points. Guidelines supporting the interview process are also desirable.

虚弱是一种与年龄有关的状况,其特征是对负面结果的脆弱性增加。为了做出明智的决策并实施针对虚弱管理的个性化实践,有必要开发涵盖个人功能不同领域的筛查工具,可靠地预测未来的不良后果,并可推广到初级保健以外的医疗保健环境。sun脆弱工具,一个易于使用的九项仪器,似乎满足了所有这些要求。目前的研究旨在为欧洲葡萄牙人口对sunfragile Tool进行跨文化改编,并对sunfragile Tool葡萄牙语版本进行可行性、适当性和意义分析。方法:跨文化适应过程分为翻译、综合、反译和创造共识版本四个阶段。为了加强内容效度,对最终用户(老年人、非正式护理人员以及卫生和社会护理专业人员)进行了可行性、适当性和意义的额外分析。结果:虚弱概念被认为适用于欧洲葡萄牙人。一个专家小组在审议了两个前译和两个后译的结果后,达成了一个协商一致的版本。根据国际准则的建议,这一定稿前的版本得到了文书原始版本第一作者的认可。由医疗保健专业人员(n = 7)、患者(n = 18)和非正式护理人员(n = 3)进行的内容验证表明,sun脆弱工具具有中度可理解性和模糊性。为适应文化需要改变五个项目。结论:sunfragile工具似乎是一种很有前途的工具,可以在欧洲葡萄牙的背景下用于早期识别虚弱,为预防性反应的临床决策提供信息。然而,为了使用该工具识别体弱和非体弱个体,并确保在体弱管理中激活通路的有效性,需要定义分界点。支持面试过程的指导方针也是可取的。
{"title":"Feasibility, appropriateness and meaningfulness analysis of the Sunfrail Tool to the European Portuguese population during cross-cultural adaptation process.","authors":"Ana F Cardoso,&nbsp;Elzbieta Bobrowicz-Campos,&nbsp;Filipa Couto,&nbsp;Daniela Cardoso,&nbsp;Alberto Barata,&nbsp;João Apóstolo","doi":"10.1097/XEB.0000000000000194","DOIUrl":"https://doi.org/10.1097/XEB.0000000000000194","url":null,"abstract":"<p><p>Frailty is an age-related condition characterized by increased vulnerability to negative outcomes. To enable informed decision-making and implementation of individually tailored practices for frailty management, it is necessary to develop screening tools that cover different domains of individual functioning, reliably predict future adverse outcomes and are generalizable to healthcare settings other than primary care. The Sunfrail Tool, an easy-to-use nine-item instrument, seems to meet all these requirements. The current study aimed to perform a cross-cultural adaptation of the Sunfrail Tool for the European Portuguese population and to perform the feasibility, appropriateness and meaningfulness analyses of the Sunfrail Tool Portuguese version.</p><p><strong>Methods: </strong>The process of cross-cultural adaptation was conducted in four-phases (translation, synthesis, back translation and creation of consensual version). To reinforce the content validity, the additional analysis on feasibility, appropriateness and meaningfulness were conducted with end-users (older adults, informal caregivers and health and social care professionals).</p><p><strong>Results: </strong>The frailty concept was considered suitable for the European Portuguese population. A consensus version was reached by an expert panel after considering the results of two forward and two back-translations. This prefinal version was endorsed to the first author of the original version of the instrument, as recommended by international guidelines. The content validation performed by healthcare professionals (n = 7), patients (n = 18) and informal caregivers (n = 3) showed that the Sunfrail Tool was moderately comprehensible and ambiguous. Five items required changes for cultural adaptation.</p><p><strong>Conclusion: </strong>The Sunfrail Tool seems to be a promising instrument for the early identification of frailty to be used in the European Portuguese context to inform clinical decisions on preventive responses. However, to enable identification of frail and nonfrail individuals with this tool and ensure effectiveness on pathways activation for frailty management, there is a need to define cut-off points. Guidelines supporting the interview process are also desirable.</p>","PeriodicalId":55996,"journal":{"name":"International Journal of Evidence-Based Healthcare","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1097/XEB.0000000000000194","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37407153","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Use of epidemiological analyses in Clinical Practice Guideline development focused on the diabetic patients treated with insulin. 流行病学分析在临床实践指南制定中的应用,重点关注胰岛素治疗的糖尿病患者。
Q3 Medicine Pub Date : 2019-06-01 DOI: 10.1097/XEB.0000000000000188
Miloslav Klugar, Jitka Klugarová, Andrea Pokorná, Klára Benešová, Jiří Jarkovský, Dana Dolanová, Jan Mužík, Radim Líčeník, Martin Prázný, Petra Búřilová, Martin Hunčovský, Tomáš Nečas, Zuzana Kelnarová, Ladislav Dušek

The prevalence of diabetes is on the rise worldwide especially in developed countries. The aim of glucose management in all types of diabetes is to minimize chronic and acute complications associated with diabetes. All patients with type 1 diabetes mellitus (T1DM) require insulin. Main areas of technology advances in diabetes are continuous subcutaneous insulin infusion (CSII) and also continuous glucose monitoring systems for the management of patients with both types of diabetes. It is very important to analyse the epidemiological situation within each country before and during the clinical practice guidelines (CPGs) development and implementation. The analyses will allow us to monitor the effect of the CPG after its implementation.The aim of this short communication is to analyse the epidemiology of prevalence and incidence of diabetes mellitus and use of CSII to inform development of CPGs in the Czech Republic.The analysis is developed based on the data managed by Institute of Health Information and Statistics of the Czech Republic. We used the National Register of Reimbursed Health Services 2015-2017 as primary source, and the annual report type A (Ministry of Health) 1-01: for Diabetology (A MH 004) 2007-2017 was used as validation source. The presented data are related to the year 2016 because we were able to validate them based on the data from 2015 to 2017 for this cohort of patients.The number of patients with T1DM is increasing in the Czech Republic with no significant sex difference. Life expectancy is about 11 years lower in the T1DM population. The majority of the patients are in older age; however, these are not treated with CSII compared with the younger population. From 61 533 patients with T1DM, 81% were reported with acute and chronic complications in 2016. Only 5011 of these patients were reported as using CSII.

糖尿病的患病率在世界范围内呈上升趋势,特别是在发达国家。在所有类型的糖尿病中,血糖管理的目的是尽量减少与糖尿病相关的慢性和急性并发症。所有1型糖尿病(T1DM)患者都需要胰岛素。糖尿病技术进步的主要领域是连续皮下胰岛素输注(CSII)和连续血糖监测系统,用于两种糖尿病患者的管理。在制定和实施临床实践指南之前和期间分析每个国家内部的流行病学情况非常重要。通过这些分析,我们可以在实施CPG后监测其效果。本简短交流的目的是分析糖尿病流行病学和发病率,以及CSII的使用情况,为捷克共和国CPGs的制定提供信息。该分析是根据捷克共和国卫生信息和统计研究所管理的数据编制的。我们使用2015-2017年国家报销卫生服务登记册作为主要来源,并使用2007-2017年年度报告A(卫生部)1-01:糖尿病(A MH 004)作为验证来源。所呈现的数据与2016年有关,因为我们能够根据该队列患者2015年至2017年的数据对其进行验证。捷克共和国T1DM患者数量呈增加趋势,性别差异不显著。T1DM人群的预期寿命要低11年左右。患者以老年患者居多;然而,与年轻人群相比,这些人没有接受CSII治疗。在2016年61533例T1DM患者中,81%报告有急性和慢性并发症。这些患者中只有5011例报告使用CSII。
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引用次数: 1
A unified framework for bias assessment in clinical research. 临床研究偏倚评估的统一框架。
Q3 Medicine Pub Date : 2019-06-01 DOI: 10.1097/XEB.0000000000000165
Jennifer C Stone, Kathryn Glass, Justin Clark, Zachary Munn, Peter Tugwell, Suhail A R Doi

Methodological flaws, limitations, and inadequate practices in research are well known and pose threats to the internal validity of any research study. However, there are ways of safeguarding research conduct to reduce the chance of research producing distorted results. Numerous tools now exist to assess the incorporation of such safeguards into primary research studies (also known as quality and/or risk-of-bias assessment). These tools typically include a variety of items that are then checked against those implemented in the study. Despite a lot of research in this area, no comprehensive generic classification of safeguards across study designs exist, although attempts have been made to clarify aspects of this. We review the developments in this area as well as use preliminary data from 100 methodological studies to illustrate our proposed approach. We conclude by proposing a new framework for identifying research studies at risk of being biased and the information in this article will promote a unification of the diverse approaches to facilitating bias assessment in clinical research.

研究方法上的缺陷、局限和不充分的实践是众所周知的,并对任何研究的内部有效性构成威胁。然而,有一些方法可以保护研究行为,以减少研究产生扭曲结果的机会。现在存在许多工具来评估将这些保障措施纳入初级研究(也称为质量和/或偏倚风险评估)。这些工具通常包括各种各样的项目,然后根据研究中实现的项目进行检查。尽管在这一领域进行了大量研究,但没有对研究设计中的保障措施进行全面的通用分类,尽管已经试图澄清这一问题的各个方面。我们回顾了这一领域的发展,并使用了100项方法学研究的初步数据来说明我们提出的方法。最后,我们提出了一个新的框架来识别有偏倚风险的研究,本文中的信息将促进不同方法的统一,以促进临床研究中的偏倚评估。
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引用次数: 30
期刊
International Journal of Evidence-Based Healthcare
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