Encounter-based randomization did not result in contamination in a shared decision-making trial: a secondary analysis.
Encounter-based randomization did not result in contamination in a shared decision-making trial: a secondary analysis.
复制标题
基于遭遇的随机化不会导致共同决策试验中的污染：二次分析。
DOI：
10.1016/j.jclinepi.2022.09.017
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发表时间：
2022
影响因子：
7.2
通讯作者：
SharedDecision-MakingforAtrialFibrillation(SDM4AFib)TrialInvestigators
中科院分区：
文献类型：
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作者：
Spencer-Bonilla,Gabriela;Branda,MeganE;Kunneman,Marleen;Bellolio,Fernanda;Burnett,Bruce;Guyatt,Gordon;Montori,VictorM;SharedDecision-MakingforAtrialFibrillation(SDM4AFib)TrialInvestigators
目的评估一项评估共同决策（SDM）工具的随机试验中的污染水平。研究设计和设置我们在三个层面评估污染：(1)工具污染（工具是否在常规护理中实际存在），(2)功能污染（在常规护理中是否在不直接使用工具的情况下重新创建了SDM工具的组件），以及(3)学习污染（临床医生是否在常规护理中“在SDM方面做得更好”，由OPTION-12评分评估）。对于功能性污染和习得性污染，评估了与工具暴露次数的相互作用。结果我们记录并分析了922例随机接触中的830例。在411例随机分配到常规护理的记录就诊中，SDM工具在9例（2.2%）就诊中使用。临床医生在377次常规护理会面中（92%）至少讨论了一个患者重要问题，在214次会面中（52%）讨论了卒中风险。我们发现SDM工具的使用次数与随后的功能性或学习性污染之间没有显著的相互作用。结论：尽管随机分配临床医生在一些接触中使用SDM工具，而不是其他接触，但我们没有发现在常规护理接触中污染的证据。
ObjectivesTo estimate the level of contamination in an encounter-randomized trial evaluating a shared decision-making (SDM) tool.Study Design and SettingWe assessed contamination at three levels: (1) tool contamination (whether the tool was physically present in the usual care encounter), (2) functional contamination (whether components of the SDM tool were recreated in the usual care encounters without directly accessing the tool), and (3) learned contamination (whether clinicians “got better at SDM” in the usual care encounters as assessed by the OPTION-12 score). For functional and learned contamination, the interaction with the number of exposures to the tool was assessed.ResultsWe recorded and analyzed 830 of 922 randomized encounters. Of the 411 recorded encounters randomized to usual care, the SDM tool was used in nine (2.2%) encounters. Clinicians discussed at least one patient-important issue in 377 usual care encounters (92%) and the risk of stroke in 214 encounters (52%). We found no significant interaction between number of times the SDM tool was used and subsequent functional or learned contamination.ConclusionDespite randomly assigning clinicians to use an SDM tool in some and not other encounters, we found no evidence of contamination in usual care encounters.