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首页> 外文期刊>Resuscitation. >Design and implementation of resuscitation research: special challenges and potential solutions.
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Design and implementation of resuscitation research: special challenges and potential solutions.

机译：复苏研究的设计和实施：特殊挑战和潜在解决方案。

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Evaluation of the effectiveness of resuscitation interventions is challenging. We describe these challenges, which include design, enrolment and analysis issues. Randomized trials establish if interventions work in predefined populations. "Efficacy" trials determine whether interventions work under ideal conditions. "Effectiveness" trials determine whether interventions work under usual practice conditions. These trials represent a trade-off between internal validity versus external validity. Randomized trials use random allocation of participants to interventions to produce study groups that are similar with respect to known and unknown risk factors, reduce bias in the allocation of participants, and assure that statistical tests have valid significance levels. In the emergency setting, there is a risk that treatment offered to control patients will be contaminated by providers' experiences of applying the intervention to patients receiving the experimental intervention. Frequently there is not time to obtain consent from a patient in an emergency setting. Exception from consent can be applied if certain conditions are met. Enrolment in a research study must be initiated quickly in an emergency setting or the patient will die or become disabled. In any trial, data can be used to explore different aspects of response to treatment: multiple treatments, subgroups, events; and interim analyses. We propose solutions to these challenges to help potential investigators through the myriad of difficulties in initiating trials in a complex environment. Design of simple trials that have adequate power enhances their external validity. Allocating groups of episodes to interventions by randomizing by clusters, rather than by individual patients reduces provider noncompliance. Waiver from consent for emergency research and use of novel technologies could facilitate enrolment despite time constraints. Rigorous statistical methods can be used to analyze multiple data without an excessive increase in the chance of a false-positive result.
机译：对复苏干预措施的有效性进行评估具有挑战性。我们描述了这些挑战，其中包括设计，注册和分析问题。随机试验确定干预措施是否在预定人群中起作用。 “功效”试验确定干预措施是否在理想条件下起作用。 “效果”试验确定干预措施是否在通常的实践条件下起作用。这些试验代表了内部有效性与外部有效性之间的权衡。随机试验使用参与者的随机分配进行干预，以产生与已知和未知风险因素相似的研究组，减少参与者分配的偏倚，并确保统计检验具有有效的显着性水平。在紧急情况下，提供者控制患者的治疗方法可能会受到提供者将干预措施应用于接受实验性干预措施的患者的经验所污染。在紧急情况下，通常没有时间获得患者的同意。如果满足某些条件，则可以适用同意的例外情况。必须在紧急情况下迅速开始研究研究，否则患者会死亡或致残。在任何试验中，数据都可用于探索对治疗反应的不同方面：多种治疗，亚组，事件;以及中期分析。我们提出了应对这些挑战的解决方案，以帮助潜在的研究人员克服在复杂环境中进行试验的各种困难。设计具有足够功能的简单试验可以增强其外部有效性。通过按组而不是按个别患者随机分配发作的组来进行干预，可以减少提供者的不依从情况。尽管有时间限制，放弃对紧急研究的同意和使用新技术可以促进入学率。可以使用严格的统计方法来分析多个数据，而不会过度增加假阳性结果的机会。

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