Lifespan and Population Health, School of Medicine, University of Nottingham, Nottingham, UK.
Nottingham University Hospitals NHS Trust, Nottingham, UK.
Cochrane Database Syst Rev. 2023 Feb 3;2(2):CD013733. doi: 10.1002/14651858.CD013733.pub2.
Improved understanding and treatment of cystic fibrosis (CF) has led to longer life expectancy, which is accompanied by an increasingly complex regimen of treatments. Suboptimal adherence to the treatment plan, in the context of respiratory disease, has been found to be associated with poorer health outcomes. With digital technology being more accessible, it can be used to monitor adherence to inhaled therapies via chipped nebulisers, mobile phone apps and web-based platforms. This technology can allow monitoring of adherence as well as clinical outcomes, and allow feedback to both the person with CF and their healthcare team.
To assess the effects of using digital technology to monitor adherence to inhaled therapies and health status in adults and children with CF.
We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 28 October 2021. We also searched Embase and three clinical trial registries and checked references of included studies. Date of last search: 9 November 2021.
We searched for randomised controlled trials (RCTs) looking at the effects of a digital technology for monitoring adherence of children and adults with CF to inhaled therapies.
Two review authors screened the search results for studies eligible for inclusion in the review and extracted their data. We used Risk of Bias 2 for assessing study quality. We assessed the overall certainty of the evidence using GRADE.
We included two studies in our review, with 628 participants aged five to 41 years. There was one study each for two different comparisons. Nebuliser target inhalation mode versus standard inhalation mode The included parallel study was carried out over 10 weeks after a run-in period of four to six weeks. The study compared the effects of a digitally enhanced inhalation mode (target inhalation mode) for nebulised antibiotics compared to standard mode in children attending a regional CF clinic in the United Kingdom. The study's primary outcome was the time taken to complete the inhaled treatment, but investigators also reported on adherence to therapy. The results showed that there may be an improvement in adherence with the target inhalation mode when this intervention is used (mean difference (MD) 24.0%, 95% confidence interval (CI) 2.95 to 45.05; low-certainty evidence). The target inhalation mode may make little or no difference to forced expiratory volume in one second (FEV) % predicted (MD 1.00 % predicted, 95% CI -9.37 to 11.37; low-certainty evidence). The study did not report on treatment burden, quality of life (QoL) or pulmonary exacerbations. eNebuliser with digital support versus eNebuliser without support One large multicentre RCT monitored adherence via data-tracking nebulisers. The intervention group also receiving access to an online web-based platform, CFHealthHub, which offered tailored, flexible support from the study interventionist as well as access to their adherence data, educational and problem-solving information throughout the 12-month trial period. We graded all evidence as moderate certainty. Compared to usual care, the digital intervention probably improves adherence to inhaled therapy (MD 18%, 95% CI 12.90 to 23.10); probably leads to slightly reduced treatment burden (MD 5.1, 95% CI 1.79 to 8.41); and may lead to slightly improved FEV % predicted (MD 3.70, 95% CI -0.23 to 7.63). There is probably little or no difference in the incidence of pulmonary exacerbations or QoL between the two groups.
AUTHORS' CONCLUSIONS: Digital monitoring plus tailored support via an online platform probably improves adherence to inhaled therapies and reduces treatment burden (but without a corresponding change in QoL) in the medium term (low- and moderate-certainty evidence). In a shorter time frame, technological enhancement of inhaling antibiotics may improve adherence to treatment (low-certainty evidence). There may be little or no effect on lung function with either intervention, and online monitoring probably makes no difference to pulmonary exacerbations. Future research should assess the effect of digital technology on adherence in both children and adults. Consideration of adherence to the total treatment regimen is also important, as an improvement in adherence to inhaled therapies could come at the cost of adherence to other parts of the treatment regimen.
囊性纤维化（CF）的理解和治疗方法的改进导致了预期寿命的延长，同时也带来了越来越复杂的治疗方案。在呼吸系统疾病中，治疗计划的不依从与健康结果较差有关。随着数字技术的普及，它可以用于通过带芯片的喷雾器、手机应用程序和基于网络的平台来监测吸入疗法的依从性。这种技术可以监测依从性和临床结果，并为 CF 患者及其医疗团队提供反馈。
评估使用数字技术监测 CF 成人和儿童吸入治疗依从性和健康状况的效果。
我们检索了 Cochrane 囊性纤维化试验注册库，该注册库是通过电子数据库搜索以及期刊和会议摘要书籍的手工搜索编制而成。检索日期：2021 年 10 月 28 日。我们还检索了 Embase 和三个临床试验注册库，并检查了纳入研究的参考文献。检索日期：2021 年 11 月 9 日。
我们搜索了随机对照试验（RCT），以评估数字技术监测 CF 儿童和成人吸入治疗依从性的效果。
两名综述作者筛选了符合纳入标准的研究的检索结果，并提取了数据。我们使用风险偏倚 2 评估了研究质量。我们使用 GRADE 评估了证据的总体确定性。
我们的综述纳入了两项研究，共有 628 名年龄在 5 至 41 岁的参与者。每项研究都有一个比较。喷雾器目标吸入模式与标准吸入模式：这项平行研究在为期 10 周的入组期后进行，为期 4 至 6 周。该研究比较了数字化增强吸入模式（目标吸入模式）与英国区域 CF 诊所中标准模式相比，对接受抗生素雾化吸入治疗的儿童的影响。该研究的主要结果是完成吸入治疗所需的时间，但研究人员还报告了治疗的依从性。结果表明，当使用这种干预措施时，目标吸入模式可能会提高依从性（MD 24.0%，95%CI 2.95 至 45.05；低确定性证据）。目标吸入模式对用力呼气量第一秒百分比预测值（FEV）可能没有影响（MD 1.00%预测值，95%CI -9.37 至 11.37；低确定性证据）。该研究没有报告治疗负担、生活质量（QoL）或肺部恶化的情况。eNebuliser 与数字支持对比 eNebuliser 无支持：一项大型多中心 RCT 通过数据跟踪喷雾器监测依从性。干预组还可以访问在线网络平台 CFHealthHub，该平台为研究干预者提供了个性化、灵活的支持，以及在整个 12 个月的试验期间访问他们的依从性数据、教育和解决问题的信息。我们将所有证据都评为中度确定性。与常规护理相比，数字干预可能会提高吸入治疗的依从性（MD 18%，95%CI 12.90 至 23.10）；可能会稍微减轻治疗负担（MD 5.1，95%CI 1.79 至 8.41）；并可能稍微改善 FEV%预测值（MD 3.70，95%CI -0.23 至 7.63）。两组之间肺部恶化或 QoL 的发生率可能没有差异。
在中期（低和中度确定性证据），数字监测加上通过在线平台提供的个性化支持可能会提高吸入治疗的依从性，并减轻治疗负担，但对 QoL 没有影响。在较短的时间范围内，吸入抗生素的技术增强可能会提高治疗的依从性（低确定性证据）。两种干预措施都可能对肺功能没有影响，在线监测可能对肺部恶化没有影响。未来的研究应该评估数字技术对儿童和成人依从性的影响。考虑到对整个治疗方案的依从性也很重要，因为吸入治疗的依从性提高可能是以其他治疗方案的依从性为代价的。
