{"title":"为心脏外科患者护理提供信息的试验创新设计:第一部分。","authors":"Nikola Anusic, Daniel I Sessler","doi":"10.1097/ACO.0000000000001335","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose of review: </strong>Randomized clinical trials, now commonplace and regarded as top-tier evidence, are actually a recent development. The first randomized trial took place in 1948, just six decades ago. As anticipated from a relatively young field, rapid progress continues in response to an ever-increasing number of medical questions that demand answers. We examine evolving methodologies in cardiac anesthesia clinical trials, focusing on the transition towards larger sample sizes, increasing use of pragmatic trial designs, and the innovative adoption of real-time automated enrollment and randomization. We highlight how these changes enhance the reliability and feasibility of clinical trials.</p><p><strong>Recent findings: </strong>Recent understanding in clinical trial methodology acknowledges the importance of large sample sizes, which increase the reliability of findings. As illustrated by P value fragility, small trials can mislead despite statistical significance. Pragmatic trials have gained prominence, offering real-world insights into the effectiveness of various treatments. Additionally, the use of real-time automated enrollment and randomization, particularly in situations where obtaining prior consent is impractical, is an important methodological advance.</p><p><strong>Summary: </strong>The landscape of cardiac anesthesia clinical trials is rapidly evolving, with a clear trend towards large sample sizes and innovative approaches to enrollment. Recent developments enhance the quality and applicability of research findings, thus providing robust guidance to clinicians.</p>","PeriodicalId":50609,"journal":{"name":"Current Opinion in Anesthesiology","volume":null,"pages":null},"PeriodicalIF":2.3000,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Innovative designs for trials informing the care of cardiac surgical patients: part I.\",\"authors\":\"Nikola Anusic, Daniel I Sessler\",\"doi\":\"10.1097/ACO.0000000000001335\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose of review: </strong>Randomized clinical trials, now commonplace and regarded as top-tier evidence, are actually a recent development. The first randomized trial took place in 1948, just six decades ago. As anticipated from a relatively young field, rapid progress continues in response to an ever-increasing number of medical questions that demand answers. We examine evolving methodologies in cardiac anesthesia clinical trials, focusing on the transition towards larger sample sizes, increasing use of pragmatic trial designs, and the innovative adoption of real-time automated enrollment and randomization. We highlight how these changes enhance the reliability and feasibility of clinical trials.</p><p><strong>Recent findings: </strong>Recent understanding in clinical trial methodology acknowledges the importance of large sample sizes, which increase the reliability of findings. As illustrated by P value fragility, small trials can mislead despite statistical significance. Pragmatic trials have gained prominence, offering real-world insights into the effectiveness of various treatments. Additionally, the use of real-time automated enrollment and randomization, particularly in situations where obtaining prior consent is impractical, is an important methodological advance.</p><p><strong>Summary: </strong>The landscape of cardiac anesthesia clinical trials is rapidly evolving, with a clear trend towards large sample sizes and innovative approaches to enrollment. 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引用次数: 0
摘要
综述的目的:随机临床试验如今已司空见惯,并被视为顶级证据,但它实际上是最近才发展起来的。第一次随机试验发生在 1948 年,距今不过 60 年。正如一个相对年轻的领域所预料的那样,随着越来越多的医学问题需要答案,随机临床试验也在快速发展。我们研究了心脏麻醉临床试验中不断演变的方法,重点关注向更大样本量过渡、越来越多地使用实用性试验设计以及创新性地采用实时自动注册和随机化。我们强调了这些变化如何提高临床试验的可靠性和可行性:最近对临床试验方法学的理解承认了大样本量的重要性,大样本量可提高研究结果的可靠性。正如 P 值的不稳定性所表明的那样,尽管具有统计学意义,但小规模试验可能会产生误导。实用性试验的地位日益突出,它提供了对各种治疗方法有效性的真实洞察。此外,使用实时自动入组和随机化,尤其是在事先征得同意不切实际的情况下,也是一种重要的方法学进步。摘要:心脏麻醉临床试验的格局正在迅速演变,明显的趋势是大样本量和创新的入组方法。最近的发展提高了研究结果的质量和适用性,从而为临床医生提供了有力的指导。
Innovative designs for trials informing the care of cardiac surgical patients: part I.
Purpose of review: Randomized clinical trials, now commonplace and regarded as top-tier evidence, are actually a recent development. The first randomized trial took place in 1948, just six decades ago. As anticipated from a relatively young field, rapid progress continues in response to an ever-increasing number of medical questions that demand answers. We examine evolving methodologies in cardiac anesthesia clinical trials, focusing on the transition towards larger sample sizes, increasing use of pragmatic trial designs, and the innovative adoption of real-time automated enrollment and randomization. We highlight how these changes enhance the reliability and feasibility of clinical trials.
Recent findings: Recent understanding in clinical trial methodology acknowledges the importance of large sample sizes, which increase the reliability of findings. As illustrated by P value fragility, small trials can mislead despite statistical significance. Pragmatic trials have gained prominence, offering real-world insights into the effectiveness of various treatments. Additionally, the use of real-time automated enrollment and randomization, particularly in situations where obtaining prior consent is impractical, is an important methodological advance.
Summary: The landscape of cardiac anesthesia clinical trials is rapidly evolving, with a clear trend towards large sample sizes and innovative approaches to enrollment. Recent developments enhance the quality and applicability of research findings, thus providing robust guidance to clinicians.
期刊介绍:
Published bimonthly and offering a unique and wide ranging perspective on the key developments in the field, each issue of Current Opinion in Anesthesiology features hand-picked review articles from our team of expert editors. With fifteen disciplines published across the year – including cardiovascular anesthesiology, neuroanesthesia and pain medicine – every issue also contains annotated references detailing the merits of the most important papers.