哮喘联盟

   摘要
   背景：许多哮喘儿童的病情并未得到有效控制，导致家长的医疗保健花费和生产力损失不断增加，其原因之一便是依从性问题。因此，针对提高药物治疗依从性的有效干预措施可能有助于改善哮喘控制和减少花费。一个有效的解决方案就是在即将忘记用药时，通过移动电话网络发送实时文本信息。由于实时文本信息对哮喘儿童的影响尚不得而知，因此本研究的主要目的旨在明确通过实时药物监控系统（RTMM）发送文本信息对儿童吸入糖皮质激素（ICS）依从性的影响。次要目的为评估RTMM对哮喘控制、生活质量和治疗成本-效益的影响。
   方法：一项多中心、随机对照研究纳入了220例使用ICS治疗的哮喘儿童（4～11岁）。这些儿童均接受RTMM-设备监测1年，记录ICS的服用时间和日期。当存在漏药风险时，干预组儿童还接受定制文本信息推送服务。主要评价结果为预订时间段内使用ICS的比例。次要评价指标包括哮喘控制（每月1次哮喘控制测试(ACT)）、哮喘急性发作、医疗卫生资源使用情况（收集自医院记录、病人报告和药店记录数据）、和疾病特异性生活质量（PAQLQ问卷）。通过在线讨论小组和病患调查问卷评价家长和儿童对RTMM的接受程度。采用社会角度施行经济评估，包括相关医疗保健费用和家长的生产力损失。另外，所采用的决策分析模型包含了与临床和经济结果相关的不同水平的依从性。同时还对RTMM不同价位水平进行了敏感度分析。
   讨论：如果带有定制文本信息提醒的RTMM经证明是有效的，那么该技术即可用于日常实践，它能帮助那些在哮喘（自我）管理中依从性不佳的患儿，帮助其获得更好的哮喘控制和生活质量。
   试验注册：荷兰试验注册NTR2583(www.trialregister.nl)。

（刘国梁 审校）
BMC Med Inform Decis Mak. 2013 Mar 21;13(1):38. [Epub ahead of print]

 

e-Monitoring of Asthma Therapy to Improve Compliance in children using a real-time medication monitoring system (RTMM): the e-MATIC study protocol.
 

Vasbinder EC, Janssens HM, Rutten-van Mölken MP, van Dijk L, de Winter BC, de Groot RC, Vulto AG, van den Bemt PM.

Abstract
BACKGROUND:Many children with asthma do not have sufficient asthma control, which leads to increased healthcare costs and productivity loss of parents. One of the causative factors are adherence problems. Effective interventions improving medication adherence may therefore improve asthma control and reduce costs. A promising solution is sending real time text-messages via the mobile phone network, when a medicine is about to be forgotten. As the effect of real time text-messages in children with asthma is unknown, the primary aim of this study is to determine the effect of a Real Time Medication Monitoring system (RTMM) with text-messages on adherence to inhaled corticosteroids (ICS). The secondary objective is to study the effects of RTMM on asthma control, quality of life and cost-effectiveness of treatment.
METHODS:A multicenter, randomized controlled trial involving 220 children (4--11 years) using ICS for asthma. All children receive an RTMM-device for one year, which registers time and date of ICS doses. Children in the intervention group also receive tailored text-messages, sent only when a dose is at risk of omission. Primary outcome measure is the proportion of ICS dosages taken within the individually predefined time-interval. Secondary outcome measures include asthma control (monthly Asthma Control Tests), asthmaexacerbations, healthcare use (collected from hospital records, patient reports and pharmacy record data), and disease-specific quality of life (PAQLQ questionnaire). Parental and children's acceptance of RTMM is evaluated with online focus groups and patient questionnaires. An economic evaluation is performed adopting a societal perspective, including relevant healthcare costs and parental productivity loss. Furthermore, a decision-analytic model is developed in which different levels of adherence are associated with clinical and financial outcomes. Also, sensitivity analyses are carried out on different price levels for RTMM.
DISCUSSION:If RTMM with tailored text-message reminders proves to be effective, this technique can be used in daily practice, which would support children with suboptimal adherence in their asthma(self)management and in achieving better asthma control and better quality of life.
TRIAL REGISTRATION: Netherlands Trial Register NTR2583 (www.trialregister.nl).
 

BMC Med Inform Decis Mak. 2013 Mar 21;13(1):38. [Epub ahead of print]