From the Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Department of Anesthesiology, Robert Wood Johnson - Saint Barnabas Health System, Livingston, New Jersey.
Anesth Analg. 2018 Mar;126(3):956-967. doi: 10.1213/ANE.0000000000002456.
Objective evaluations comparing different techniques and approaches to pediatric procedural sedation studies have been limited by a lack of consistency among the outcome measures used in assessment. This study reviewed those existing measures, which have undergone psychometric analysis in a pediatric procedural sedation setting, to determine to what extent and in what circumstances their use is justified across the spectrum of procedures, age groups, and techniques. The results of our study suggest that a wide range of measures has been used to assess the efficacy and effectiveness of pediatric procedural sedation. Most lack the evidence of validity and reliability that is necessary to facilitate rigorous clinical trial design, as well as the evaluation of new drugs and devices. A set of core pediatric sedation outcome domains and outcome measures can be developed on the basis of our findings. We believe that consensus among all stakeholders regarding appropriate domains and measures to evaluate pediatric procedural sedation is possible and that widespread implementation of such recommendations should be pursued.
目的
比较不同技术和方法在儿科操作镇静研究中的效果的客观评估受到评估中使用的结果测量指标缺乏一致性的限制。本研究回顾了这些现有的指标，这些指标已经在儿科操作镇静环境中进行了心理测量分析，以确定在各种操作、年龄组和技术中使用它们的程度和情况。我们的研究结果表明，已经使用了广泛的措施来评估儿科操作镇静的疗效和效果。大多数措施缺乏必要的有效性和可靠性证据，这对于促进严格的临床试验设计以及新药物和设备的评估是必要的。可以根据我们的发现制定一套核心的儿科镇静效果的领域和措施。我们相信，所有利益相关者之间对于评估儿科操作镇静的适当领域和措施达成共识是可能的，并且应该广泛实施这些建议。
