Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial: Statistical analysis plan.
Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial: Statistical analysis plan.
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DOI：
10.1016/j.conctc.2023.101219
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发表时间：
2023-12
影响因子：
1.5
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中科院分区：
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取消过度使用的卫生干预措施对于最大限度地提高质量和价值，同时最大限度地减少伤害，浪费和效率低下至关重要。三项国家指南不鼓励在未接受辅助供氧的儿童中进行连续脉搏血氧饱和度（SpO 2）监测，但与指南不一致的做法仍然很普遍，使其成为取消的主要目标。本文详细介绍了消除监测器过度使用（EMO）SpO 2试验的统计分析计划，该试验比较了两种竞争性取消实施策略（仅取消学习与取消学习加替代）对室内空气中毛细支气管炎儿童SpO 2监测的持续取消实施的影响。EMO试验是一项混合3型有效性-去实现试验，采用纵向随机分组设计，在住院患者设置网络医院的儿科研究中进行。主要结局是去实施支持，作为研究组之间的纵向差异比较进行分析。该分析将使用广义分层混合效应模型进行纵向聚类结果。次要结局包括住院时间和吸氧持续时间，使用线性混合效应回归建模。使用完善的反事实的方法，我们还将执行一个中介分析的医院层面的机械措施之间的关联的去执行战略和维持的结果。我们预计，EMO审判将通过提供新的见解的过程中，机制和持续的实践变化的可能性，使用严格设计的deimplementation策略，推进deimplementation的科学。该预先规定的统计分析计划将缓解报告偏倚并支持数据驱动方法。ClinicalTrials.gov NCT05132322。于二零二一年十一月二十四日注册。
Deimplementing overused health interventions is essential to maximizing quality and value while minimizing harm, waste, and inefficiencies. Three national guidelines discourage continuous pulse oximetry (SpO2) monitoring in children who are not receiving supplemental oxygen, but the guideline-discordant practice remains prevalent, making it a prime target for deimplementation. This paper details the statistical analysis plan for the Eliminating Monitor Overuse (EMO) SpO2 trial, which compares the effect of two competing deimplementation strategies (unlearning only vs. unlearning plus substitution) on the sustainment of deimplementation of SpO2 monitoring in children with bronchiolitis who are in room air. The EMO Trial is a hybrid type 3 effectiveness-deimplementation trial with a longitudinal cluster-randomized design, conducted in Pediatric Research in Inpatient Settings Network hospitals. The primary outcome is deimplementation sustainment, analyzed as a longitudinal difference-in-differences comparison between study arms. This analysis will use generalized hierarchical mixed-effects models for longitudinal clustering outcomes. Secondary outcomes include the length of hospital stay and oxygen supplementation duration, modeled using linear mixed-effects regressions. Using the well-established counterfactual approach, we will also perform a mediation analysis of hospital-level mechanistic measures on the association between the deimplementation strategy and the sustainment outcome. We anticipate that the EMO Trial will advance the science of deimplementation by providing new insights into the processes, mechanisms, and likelihood of sustained practice change using rigorously designed deimplementation strategies. This pre-specified statistical analysis plan will mitigate reporting bias and support data-driven approaches. ClinicalTrials.gov NCT05132322. Registered on 24 November 2021.