PDF(Pubmed)
Abstract：
BACKGROUND: Medication non-adherence is a significant problem in patients with Chronic Obstructive Pulmonary Disease (COPD). Efforts to address this issue are receiving increased attention. Simplifying treatment by prescribing single-inhaler triple therapy (SITT) as an alternative to multi-inhaler triple therapy (MITT) or with smart inhalers are often considered potential solutions. However, the actual impact of these innovations on adherence and clinical outcomes is unclear.
METHODS: To address this knowledge gap we first conducted a literature review focusing on two research questions: 1) the difference in adherence between SITT and MITT users in COPD, and 2) the effect of smart inhalers on adherence in COPD. Separate searches were conducted in PubMed and two authors independently assessed the articles. In addition, we present a protocol for a study to acquire knowledge for the gaps identified.
RESULTS: To address the first research question, 8 trials were selected for further review. All trials were observational, i.e. randomized controlled trials were lacking. Seven of these trials showed higher adherence and/or persistence in patients on SITT compared with patients on MITT. In addition, four studies showed a positive effect of SITT on various clinical outcomes. For the second research question, 11 trials were selected for review. While most of the studies showed a positive effect of smart inhalers on adherence, there was considerable variation in the results regarding their effect on other clinical outcomes. The TRICOLON (TRIple therapy COnvenience by the use of one or multipLe Inhalers and digital support in ChrONic Obstructive Pulmonary Disease) trial aims to improve understanding regarding the effectiveness of SITT and smart inhalers in enhancing adherence. This open-label, randomized, multi-center study will enroll COPD patients requiring triple therapy at ten participating hospitals. In total, 300 patients will be randomized into three groups: 1) MITT; 2) SITT; 3) SITT with digital support through a smart inhaler and an e-health platform. The follow-up period will be one year, during which three methods of measuring adherence will be used: smart inhaler data, self-reported data using the Test of Adherence to Inhalers (TAI) questionnaire, and drug analysis in scalp hair samples. Finally, differences in clinical outcomes between the study groups will be compared.
CONCLUSIONS: Our review suggests promising results concerning the effect of SITT, as opposed to MITT, and smart inhalers on adherence. However, the quality of evidence is limited due to the absence of randomized controlled trials and/or the short duration of follow-up in many studies. Moreover, its impact on clinical outcomes shows considerable variation. The TRICOLON trial aims to provide solid data on these frequently mentioned solutions to non-adherence in COPD. Collecting data in a well-designed randomized controlled trial is challenging, but the design of this trial addresses both the usefulness of SITT and smart inhalers while ensuring minimal interference in participants\' daily lives.
BACKGROUND: NCT05495698 (Clinicaltrials.gov), registered at 08-08-2022. Protocol version: version 5, date 27-02-2023.
METHODS: To address this knowledge gap we first conducted a literature review focusing on two research questions: 1) the difference in adherence between SITT and MITT users in COPD, and 2) the effect of smart inhalers on adherence in COPD. Separate searches were conducted in PubMed and two authors independently assessed the articles. In addition, we present a protocol for a study to acquire knowledge for the gaps identified.
RESULTS: To address the first research question, 8 trials were selected for further review. All trials were observational, i.e. randomized controlled trials were lacking. Seven of these trials showed higher adherence and/or persistence in patients on SITT compared with patients on MITT. In addition, four studies showed a positive effect of SITT on various clinical outcomes. For the second research question, 11 trials were selected for review. While most of the studies showed a positive effect of smart inhalers on adherence, there was considerable variation in the results regarding their effect on other clinical outcomes. The TRICOLON (TRIple therapy COnvenience by the use of one or multipLe Inhalers and digital support in ChrONic Obstructive Pulmonary Disease) trial aims to improve understanding regarding the effectiveness of SITT and smart inhalers in enhancing adherence. This open-label, randomized, multi-center study will enroll COPD patients requiring triple therapy at ten participating hospitals. In total, 300 patients will be randomized into three groups: 1) MITT; 2) SITT; 3) SITT with digital support through a smart inhaler and an e-health platform. The follow-up period will be one year, during which three methods of measuring adherence will be used: smart inhaler data, self-reported data using the Test of Adherence to Inhalers (TAI) questionnaire, and drug analysis in scalp hair samples. Finally, differences in clinical outcomes between the study groups will be compared.
CONCLUSIONS: Our review suggests promising results concerning the effect of SITT, as opposed to MITT, and smart inhalers on adherence. However, the quality of evidence is limited due to the absence of randomized controlled trials and/or the short duration of follow-up in many studies. Moreover, its impact on clinical outcomes shows considerable variation. The TRICOLON trial aims to provide solid data on these frequently mentioned solutions to non-adherence in COPD. Collecting data in a well-designed randomized controlled trial is challenging, but the design of this trial addresses both the usefulness of SITT and smart inhalers while ensuring minimal interference in participants\' daily lives.
BACKGROUND: NCT05495698 (Clinicaltrials.gov), registered at 08-08-2022. Protocol version: version 5, date 27-02-2023.
摘要：
背景：在慢性阻塞性肺疾病（COPD）患者中，药物治疗不依从性是一个重要问题。解决这一问题的努力越来越受到重视。通过处方单吸入器三联疗法（SITT）作为多吸入器三联疗法（MITT）或智能吸入器来简化治疗通常被认为是潜在的解决方案。然而,这些创新对依从性和临床结局的实际影响尚不清楚.
方法：为了解决这一知识差距，我们首先进行了文献综述，重点关注两个研究问题：1）COPD患者SITT和MITT患者的依从性差异，和2）智能吸入器对COPD依从性的影响。在PubMed中进行了单独的搜索，两名作者独立评估了文章。此外,我们提出了一项研究方案,以获取所发现差距的知识.
结果：为了解决第一个研究问题，选择8项试验作进一步审查。所有试验都是观察性的,即缺乏随机对照试验。这些试验中有7项显示，与接受MITT的患者相比，接受SITT的患者的依从性和/或持久性更高。此外,4项研究显示SITT对各种临床结局有积极作用.对于第二个研究问题，选择11项试验进行审查。虽然大多数研究表明智能吸入器对依从性有积极影响，关于它们对其他临床结局的影响,结果存在相当大的差异.TRICOLON（在慢性阻塞性肺疾病中使用一种或多种吸入器和数字支持的三联疗法）试验旨在提高对SITT和智能吸入器在增强依从性方面的有效性的理解。这个开放标签，随机化，多中心研究将纳入10家参与医院需要三联疗法的COPD患者.总的来说,300名患者将被随机分为三组：1）MITT;2）SITT;3）SITT通过智能吸入器和电子健康平台提供数字支持。后续期为一年,在此期间，将使用三种测量依从性的方法：智能吸入器数据，使用吸入器依从性测试(TAI)问卷的自我报告数据，和头皮头发样本中的药物分析。最后,将比较研究组之间临床结局的差异.
结论：我们的综述表明，关于SITT的作用，而不是MITT,和智能吸入器坚持。然而,由于缺乏随机对照试验和/或许多研究的随访时间较短,证据质量有限.此外，其对临床结局的影响显示出相当大的差异.TRICOLON试验旨在提供有关这些经常提及的COPD非依从性解决方案的可靠数据。在精心设计的随机对照试验中收集数据是具有挑战性的，但是本试验的设计同时解决了SITT和智能吸入器的实用性,同时确保对参与者日常生活的干扰最小.
背景：NCT05495698（Clinicaltrials.gov），注册时间为08-08-2022。协议版本：版本5，日期27-02-2023。
方法：为了解决这一知识差距，我们首先进行了文献综述，重点关注两个研究问题：1）COPD患者SITT和MITT患者的依从性差异，和2）智能吸入器对COPD依从性的影响。在PubMed中进行了单独的搜索，两名作者独立评估了文章。此外,我们提出了一项研究方案,以获取所发现差距的知识.
结果：为了解决第一个研究问题，选择8项试验作进一步审查。所有试验都是观察性的,即缺乏随机对照试验。这些试验中有7项显示，与接受MITT的患者相比，接受SITT的患者的依从性和/或持久性更高。此外,4项研究显示SITT对各种临床结局有积极作用.对于第二个研究问题，选择11项试验进行审查。虽然大多数研究表明智能吸入器对依从性有积极影响，关于它们对其他临床结局的影响,结果存在相当大的差异.TRICOLON（在慢性阻塞性肺疾病中使用一种或多种吸入器和数字支持的三联疗法）试验旨在提高对SITT和智能吸入器在增强依从性方面的有效性的理解。这个开放标签，随机化，多中心研究将纳入10家参与医院需要三联疗法的COPD患者.总的来说,300名患者将被随机分为三组：1）MITT;2）SITT;3）SITT通过智能吸入器和电子健康平台提供数字支持。后续期为一年,在此期间，将使用三种测量依从性的方法：智能吸入器数据，使用吸入器依从性测试(TAI)问卷的自我报告数据，和头皮头发样本中的药物分析。最后,将比较研究组之间临床结局的差异.
结论：我们的综述表明，关于SITT的作用，而不是MITT,和智能吸入器坚持。然而,由于缺乏随机对照试验和/或许多研究的随访时间较短,证据质量有限.此外，其对临床结局的影响显示出相当大的差异.TRICOLON试验旨在提供有关这些经常提及的COPD非依从性解决方案的可靠数据。在精心设计的随机对照试验中收集数据是具有挑战性的，但是本试验的设计同时解决了SITT和智能吸入器的实用性,同时确保对参与者日常生活的干扰最小.
背景：NCT05495698（Clinicaltrials.gov），注册时间为08-08-2022。协议版本：版本5，日期27-02-2023。
