Trinity Centre for Bioengineering, Trinity College Dublin, Dublin, Ireland.
The Department of Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
PLoS One. 2014 Jun 6;9(6):e98701. doi: 10.1371/journal.pone.0098701. eCollection 2014.
Poor adherence to inhaler use can be due to poor temporal and/or technique adherence. Up until now there has been no way of reliably tracking both these factors in everyday inhaler use.
This paper introduces a device developed to create time stamped acoustic recordings of an individual's inhaler use, in which empirical evidence of temporal and technique adherence in inhaler use can be monitored over time. The correlation between clinical outcomes and adherence, as determined by this device, was compared for temporal adherence alone and combined temporal and technique adherence.
The technology was validated by showing that the doses taken matched the number of audio recordings (r2 = 0.94, p<0.01). To demonstrate that audio analysis of inhaler use gives objective information, in vitro studies were performed. These showed that acoustic profiles of inhalations correlated with the peak inspiratory flow rate (r2 = 0.97, p<0.01), and that the acoustic energy of exhalations into the inhaler was related to the amount of drug removed. Despite training, 16% of participants exhaled into the mouthpiece after priming, in >20% of their inhaler events. Repeated training reduced this to 7% of participants (p = 0.03). When time of use was considered, there was no evidence of a relationship between adherence and changes in AQLQ (r2 = 0.2) or PEFR (r2 = 0.2). Combining time and technique the rate of adherence was related to changes in AQLQ (r2 = 0.53, p = 0.01) and PEFR (r2 = 0.29, p = 0.01).
This study presents a novel method to objectively assess how errors in both time and technique of inhaler use impact on clinical outcomes.
EudraCT 2011-004149-42.
吸入器使用依从性差可能是由于时间和/或技术依从性差造成的。到目前为止,还没有一种可靠的方法可以在日常吸入器使用中同时跟踪这两个因素。
本文介绍了一种用于创建个体吸入器使用时间标记声记录的设备,通过该设备可以监测吸入器使用的时间和技术依从性随时间的变化。比较了仅通过时间依从性和同时通过时间和技术依从性确定的设备相关性与临床结果之间的相关性。
通过显示所取剂量与音频记录数量相匹配(r2=0.94,p<0.01),验证了该技术的有效性。为了证明吸入器使用的音频分析提供了客观信息,进行了体外研究。这些研究表明,吸气的声谱与吸气峰流速(r2=0.97,p<0.01)相关,并且吸入器内呼出的声能与去除的药物量相关。尽管经过培训,仍有 16%的参与者在预充后将气从吸嘴呼出,在超过 20%的吸入事件中。重复培训将这一比例降低到 7%的参与者(p=0.03)。当考虑使用时间时,在依从性和 AQLQ 变化之间(r2=0.2)或 PEFR(r2=0.2)之间没有证据表明存在关系。将时间和技术结合起来,依从率与 AQLQ(r2=0.53,p=0.01)和 PEFR(r2=0.29,p=0.01)的变化相关。
本研究提出了一种新的方法来客观评估吸入器使用时间和技术错误如何影响临床结果。
EudraCT 2011-004149-42。