Assessing the applicability of obstetrical randomized controlled trials in real-world practices.

IF 1.7 4区 医学 Q3 OBSTETRICS & GYNECOLOGY
Anthony M Vintzileos, Cande V Ananth
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引用次数: 0

Abstract

This article examines the applicability of obstetrical randomized controlled trials (RCTs) in the real-world and proposes a classification of the value of these trials based on their potential for achieving sustainable practices. In the context of this discussion, real-world results pertain to the potential impact of the RCT on sustainable interventions and practices, and its implications for healthcare practice or policy, in the country (or countries) that was conducted. While RCTs are generally regarded as the gold standard of medical evidence, their effectiveness in producing meaningful real-world results depends, among various other factors, on the clarity and specificity of the trial definitions used for diagnosis (characteristics of the study group or enrollment criteria) and treatment (intervention). The definitions used for diagnosis and treatment, especially in pragmatic trials, can influence the likelihood for real-world implementation. By analyzing notable obstetrical RCTs, the authors find that trials with well-defined diagnoses and treatments that can be implemented without specialized expertise are more likely to generate results that are relevant to general practice, indicating higher value. In contrast, RCTs with ambiguous or undefined diagnoses and treatments often lead to variations in practice and produce unreliable real-world outcomes and practices suggesting lower value. Recognizing this variability can offer valuable guidance for the design and evaluation of RCTs in obstetrics.

评估产科随机对照试验在实际工作中的适用性。
本文探讨了产科随机对照试验(RCT)在现实世界中的适用性,并根据其实现可持续实践的潜力对这些试验的价值进行了分类。在本讨论中,现实世界的结果涉及 RCT 对可持续干预和实践的潜在影响,及其对所开展国家(或多个国家)医疗实践或政策的影响。虽然 RCT 通常被视为医学证据的黄金标准,但其在产生有意义的真实世界结果方面的有效性,除其他各种因素外,还取决于用于诊断(研究组的特征或入组标准)和治疗(干预措施)的试验定义是否明确和具体。用于诊断和治疗的定义,尤其是在实用性试验中,会影响在现实世界中实施的可能性。通过分析著名的产科 RCT,作者发现,诊断和治疗定义明确、无需专业知识即可实施的试验更有可能产生与一般实践相关的结果,这表明试验具有更高的价值。相比之下,诊断和治疗方法不明确或未定义的临床试验往往会导致实践中的变化,产生不可靠的真实世界结果和实践,表明价值较低。认识到这种变异性可为产科 RCT 的设计和评估提供有价值的指导。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.40
自引率
0.00%
发文量
217
审稿时长
2-3 weeks
期刊介绍: The official journal of The European Association of Perinatal Medicine, The Federation of Asia and Oceania Perinatal Societies and The International Society of Perinatal Obstetricians. The journal publishes a wide range of peer-reviewed research on the obstetric, medical, genetic, mental health and surgical complications of pregnancy and their effects on the mother, fetus and neonate. Research on audit, evaluation and clinical care in maternal-fetal and perinatal medicine is also featured.
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