电子监测联合数字智能储雾罐用于支持哮喘患者个体化吸入器使用教育的随机对照研究：OUTERSPACE 试验。
Electronic monitoring with a digital smart spacer to support personalized inhaler use education in patients with asthma: The randomized controlled OUTERSPACE trial.
机构信息
University of Groningen, University Medical Center Groningen, Department of Clinical Pharmacy & Pharmacology, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of General Practice & Elderly Care Medicine, Groningen, the Netherlands.
University of Groningen, University Medical Center Groningen, Department of Clinical Pharmacy & Pharmacology, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, the Netherlands.
出版信息
Respir Med. 2023 Nov;218:107376. doi: 10.1016/j.rmed.2023.107376. Epub 2023 Aug 6.
BACKGROUND
Poor adherence to inhaled medication has been associated with poor outcomes. Smart spacers can monitor inhaler use and technique, yet their feasibility in adults with asthma and their potential benefits are unknown.
OBJECTIVE
Assessing the feasibility of undertaking a definitive randomized controlled trial (RCT) of smart spacer-based inhaler education and explore potential clinical benefits in adults with asthma.
METHODS
Two-month randomized controlled feasibility OUtcomes following Tailored Education and Retraining: Studying Performance and AdherenCE (OUTERSPACE) trial comparing personalized smart spacer-based inhaler education versus usual care. Patients were recruited in four Dutch primary care centres. Outcomes were feasibility (inclusion speed, patient acceptance), medication adherence, inhaler technique, clinical effects (lung function, ACQ, FeNO) and usability (System Usability Scale [SUS]).
RESULTS
42 patients were randomized and all completed the study. The feasibility of performing a larger trial focusing on asthma patient education using a smart spacer was demonstrated with all patients included in four months and a participation rate of 86%. In the intervention group, inhalation errors per day decreased by 26.2% while in the usual care group inhalation errors increased by 14.6% (p = 0.021). Adherence decreased slightly in the intervention group as opposed to improvement in the control group (difference 12%, p = 0.028). No changes in lung function, ACQ or FeNO were observed. Usability was deemed high (SUS patients 71, nurses 89).
CONCLUSION
This RCT showed that smart spacer-driven education in patients with asthma is feasible and in this short-term study reduced inhaler errors. Longer-term and larger studies are required to assess clinical effects.
背景
吸入药物依从性差与不良结局相关。智能喷雾器可以监测吸入器的使用和技术，但它们在哮喘成人中的可行性及其潜在益处尚不清楚。
目的
评估基于智能喷雾器的吸入器教育进行确定性随机对照试验（RCT）的可行性，并探索哮喘成人的潜在临床益处。
方法
为期两个月的随机对照可行性结局研究：根据个性化智能喷雾器为基础的吸入器教育和重新培训进行研究（OUTERSPACE）试验，比较个性化智能喷雾器为基础的吸入器教育与常规护理。患者在荷兰的四个基层医疗中心招募。结局是可行性（纳入速度、患者接受度）、药物依从性、吸入器技术、临床效果（肺功能、ACQ、FeNO）和可用性（系统可用性量表[SUS]）。
结果
42 名患者被随机分配，所有患者均完成了研究。使用智能喷雾器对哮喘患者教育进行更大规模试验的可行性得到了证明，所有患者在四个月内纳入，参与率为 86%。在干预组，每天的吸入错误减少了 26.2%，而在常规护理组，吸入错误增加了 14.6%（p=0.021）。干预组的依从性略有下降，而对照组的依从性有所改善（差异 12%，p=0.028）。未观察到肺功能、ACQ 或 FeNO 的变化。可用性被认为很高（患者 SUS71，护士 89）。
结论
这项 RCT 表明，哮喘患者的智能喷雾器驱动教育是可行的，在这项短期研究中减少了吸入错误。需要进行更长时间和更大规模的研究来评估临床效果。
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