Clinical research methodology

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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    In the view of the controversy that there is no efficacy difference between true and sham acupuncture in acupuncture randomized controlled trials (RCTs), it is analyzed that one of the reasons is that many clinical studies do not properly understand the design of RCT research and interpret the research results. Starting from the concept and coverage of explanatory RCT and pragmatic RCT, this study lists the application examples of two types of RCTs in the field of acupuncture from five aspects: research purpose and trial environment, subject selection, intervention measures, control measures and outcome evaluation, so as to provide some ideas for their application in clinical trials.
    针对针刺随机对照试验(RCT)中真假针刺疗效无差异的结论引发的争议,分析其原因之一是很多临床研究对RCT研究设计理解与研究结果解读的不恰当。本文从解释性RCT与实用性RCT的概念与涵盖范畴出发,从研究目的与试验环境、受试者选择、干预措施、对照措施及结局评价5个方面列举两种RCT在针刺领域的应用实例,为其在临床试验中的应用提供一定的思路。.
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  • 文章类型: Letter
    当前医学研究和护理之间的分离是良好医学实践的基本方面的障碍:验证护理干预措施实际上提供了他们承诺的良好结果,以及使用科学方法优化不确定性下的护理。已经设计了务实护理试验来解决这些问题。护理试验是纳入护理的包罗万象的随机试验。每个试验设计项目的选择都符合参与患者的最佳医疗利益。护理试验最终可以显示基于患者结果的良好医疗实践。同时,当没有人真正知道该怎么做时,护理试验为临床医生和患者提供了优化医疗护理所需的科学方法。我们报告了9项随机护理试验的进展,这些试验用于指导1212例急性卒中患者的血管内或外科治疗。颅内动脉瘤,在选择性或急性护理背景下,单中心的动静脉畸形。护理试验被用来解决关于竞争对手医疗的长期困境,外科,或血管内管理选择或提供创新而不是标准的治疗。审判方法,通过在没有可靠知识的情况下用1:1的随机分配代替不可重复的治疗决策,产生了立竿见影的影响,将无法验证的教条式医疗实践转变为可验证的基于结果的医疗服务。我们相信该方法适用于所有医疗或外科领域,但广泛采用可能需要修订许多目前流行的关于研究在临床实践中的作用的观点.
    The current separation between medical research and care is an obstacle to essential aspects of good medical practice: the verification that care interventions actually deliver the good outcomes they promise, and the use of scientific methods to optimize care under uncertainty. Pragmatic care trials have been designed to address these problems. Care trials are all-inclusive randomized trials integrated into care. Every item of trial design is selected in the best medical interest of participating patients. Care trials can eventually show what constitutes good medical practice based on patient outcomes. In the meantime, care trials give clinicians and patients the scientific methods necessary for optimization of medical care when no one really knows what to do.We report the progress of 9 randomized care trials that were used to guide the endovascular or surgical management of 1212 patients with acute stroke, intracranial aneurysms, and arteriovenous malformations in a single center in an elective or acute care context. Care trials were used to address long-standing dilemmas regarding rival medical, surgical, or endovascular management options or to offer innovative instead of standard treatments. The trial methodology, by replacing unrepeatable treatment decisions by 1:1 randomized allocation whenever reliable knowledge was not available, had an immediate impact, transforming unverifiable dogmatic medical practice into verifiable outcome-based medical care. We believe the approach is applicable to all medical or surgical domains, but widespread adoption may require the revision of many currently prevalent views regarding the role of research in clinical practice.
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  • 文章类型: Journal Article
    BACKGROUND: Pragmatic care trials have been designed to provide optimal neurovascular care in the presence of uncertainty. The feasibility, benefits, and drawbacks of using this novel approach remain unknown.
    METHODS: We report the progress of 9 randomized trials integrated into routine practice to guide the endovascular or surgical treatment of intracranial aneurysms, arteriovenous malformations, and acute stroke. We review the criticisms and commentaries we have received and discuss the corresponding ethical and scientific concepts that need to be revised to practice outcome-based neurovascular care.
    RESULTS: Pragmatic care trials were used to address long standing dilemmas regarding rival management options or to offer innovative treatments for 1212 neurovascular patients recruited in an elective or acute care context. Adopting care trial methodology had an immediate impact on clinical practice, replacing unrepeatable treatment decisions by 1:1 randomized allocation whenever reliable knowledge about best management was not available. The care trial approach transformed unfounded medical practice into verifiable outcome-based medical care and reserved authoritative recommendations for care options that had previously been validated. Criticisms we have encountered include mainly the pragmatic trial design choices, with insufficient selection of patients and clinicians, too-flexible protocols, lack of funding and feasibility.
    CONCLUSIONS: Care trials can be integrated into neurovascular practice. Although they remain a work in progress, the approach curtails the practice of unverifiable medicine and offers patients optimal care in the presence of uncertainty.
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  • 文章类型: Journal Article
    美国国立卫生研究院行为与社会科学研究办公室(OBSSR)最近发布了2017年至2021年的战略计划。该计划突出三个科学重点:(1)提高基础和应用行为社会科学研究的协同性,(2)加强和促进研究基础设施建设,方法,以及支持对行为和社会科学研究采取更加累积和综合的方法所需的措施,(3)促进在健康研究和实践中采用行为和社会科学研究结果。本评论着重于促进在健康研究和实践中采用研究成果的挑战和机遇。除了正在进行的NIH支持传播和实施(D&I)研究之外,我们必须应对变革性的挑战和机遇,例如更好地传播和实施D&I研究,研究与实践相结合,在D&I和临床试验研究中采用更严格和多样化的方法和措施,评估基于技术的干预措施交付,并从最小适应性干预包过渡到植根于行为改变原则的计划适应。除了转化为实践和政策,OBSSR战略计划还强调了将行为和社会科学研究结果转化为更广泛的生物医学研究企业的必要性。
    The National Institutes of Health\'s Office of Behavioral and Social Sciences Research (OBSSR) recently released its Strategic Plan for 2017 to 2021. This plan highlights three scientific priorities: (1) improve the synergy of basic and applied behavioral and social sciences research, (2) enhance and promote the research infrastructure, methods, and measures needed to support a more cumulative and integrated approach to behavioral and social sciences research, and (3) facilitate the adoption of behavioral and social sciences research findings in health research and in practice. This commentary focuses on the challenges and opportunities to facilitate the adoption of research findings in health research and in practice. In addition to the ongoing NIH support for dissemination and implementation (D&I) research, we must address transformative challenges and opportunities such as better disseminating and implementing D&I research, merging research and practice, adopting more rigorous and diverse methods and measures for both D&I and clinical trials research, evaluating technological-based delivery of interventions, and transitioning from minimally adaptable intervention packages to planned adaptations rooted in behavior change principles. Beyond translation into practice and policy, the OBSSR Strategic Plan also highlights the need for translation of behavioral and social science findings into the broader biomedical research enterprise.
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  • 文章类型: Journal Article
    目的:多重假设检验(或多重检验)是指在一次分析中检验多个假设,并且可以夸大研究中的I型错误率(假阳性)。这篇综述的目的是量化耳鼻喉科文献中最近的大型临床研究中的多项测试,并讨论解决这一潜在问题的策略。
    方法:2012年在四个普通耳鼻咽喉科期刊上发表了超过100名受试者的原始临床研究文章,期刊引文报告了5年的影响因素。
    方法:对文章进行了综述,以确定作者是否在至少一个推论家族中测试了五个以上的假设。对于符合此标准的多次测试的文章,计算了I型错误率,并对报告的结果进行统计校正.
    结果:在回顾的195篇原始临床研究文章中,72%满足多重测试的标准。在这些研究中,平均有41%的机会出现I型错误,平均而言,18%的显著结果可能是假阳性。在应用Bonferroni校正后,文章中报道的显著结果中,只有57%仍然显著.
    结论:在耳鼻喉科的近期大型临床研究中,多重检测是常见的,值得研究人员密切关注。审稿人,和编辑。讨论了多次测试的调整策略。
    OBJECTIVE: Multiple hypothesis testing (or multiple testing) refers to testing more than one hypothesis within a single analysis, and can inflate the type I error rate (false positives) within a study. The aim of this review was to quantify multiple testing in recent large clinical studies in the otolaryngology literature and to discuss strategies to address this potential problem.
    METHODS: Original clinical research articles with >100 subjects published in 2012 in the four general otolaryngology journals with the highest Journal Citation Reports 5-year impact factors.
    METHODS: Articles were reviewed to determine whether the authors tested greater than five hypotheses in at least one family of inferences. For the articles meeting this criterion for multiple testing, type I error rates were calculated, and statistical correction was applied to the reported results.
    RESULTS: Of the 195 original clinical research articles reviewed, 72% met the criterion for multiple testing. Within these studies, there was a mean 41% chance of a type I error and, on average, 18% of significant results were likely to be false positives. After the Bonferroni correction was applied, only 57% of significant results reported within the articles remained significant.
    CONCLUSIONS: Multiple testing is common in recent large clinical studies in otolaryngology and deserves closer attention from researchers, reviewers, and editors. Strategies for adjusting for multiple testing are discussed.
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