哮喘控制的成本-效益随机试验(ACCURATE):哮喘治疗的目标
2011/12/26
摘要
背景:尽管存在着有效的治疗哮喘方法,但仍然具有较高的患病率,哮喘患者的卫生资源使用也较大。ACCURATE试验旨在研究是否需要长期使用最大剂量的联合治疗,以期获得哮喘所有特征的完全控制。另外,该试验需要解释的问题是,患者和社会是否需要评价该治疗方法能使患者获益。我们对患者的偏好和旨在达到不同哮喘控制水平的3种治疗措施(1:哮喘充分控制;2:哮喘严格控制;3:基于呼出气一氧化氮(额外的疾病标志物)的哮喘严格控制)的成本-效益进行了分析。
设计:根据莱顿、奈梅亨、荷兰阿姆斯特丹基层医疗机构患者的注册信息,入选720名轻度至中度持续哮喘患者,年龄为18~50岁,每日采用激素吸入治疗(过去1年中激素吸入治疗超过3个月)。试验设计为为期12个月的聚类-随机平行试验,三组中各组有40个基层医疗机构。患者在基础水平、3、6、9和12个月后就诊。每次计划的或未计划的一般治疗,将采用网络为基础的监测系统进行校正,该过程由中心协调的专业护理人员监督。患者偏好和使用采用问卷调查和访谈评价。收集的数据包括哮喘控制、治疗步骤、治疗的依从、资源利用和费用,每3个月和未计划的就诊时进行收集。社会开支(用药和其他健康护理及劳动力丧失)的差异与活动受限天数差异及质量调整生命年(荷兰 EQ5D、SF6D、e-TTO、VAS)进行比较。本试验为首次评价哮喘患者偏好及基于不同哮喘控制目标的治疗手段的成本-效益。试验注册:荷兰临床试验注册号:NTR1756。
(刘国梁 审校)
BMC Pulm Med. 2011 Nov 24;11(1):53. [Epub ahead of print]
Asthma control cost-utility randomized trial evaluation (ACCURATE): the goals of asthma treatment.
Honkoop PJ, Loymans RJ, Termeer EH, Snoeck-Stroband JB, Bakker MJ, Assendelft WJ, Sterk PJ, Ter Riet G, Schermer TR, Sont JK.
Abstract
BACKGROUND: Despite the availability of effective therapies, asthma remains a source of significant morbidity and use of health care resources. The central research question of the ACCURATE trial is whether maximal doses of (combination) therapy should be used for long periods in an attempt to achieve complete control of all features of asthma. An additional question is whether patients and society value the potential incremental benefit, if any, sufficiently to concur with such a treatment approach. We assessed patient preferences and cost-effectiveness of three treatment strategies aimed at achieving different levels of clinical control: 1. sufficiently controlled asthma 2. strictly controlled asthma 3. strictly controlled asthma based on exhaled nitric oxide as an additional disease marker.
DESIGN: 720 Patients with mild to moderate persistent asthma from general practices with a practice nurse, age 18-50 yr, daily treatment with inhaled corticosteroids (more then 3 months usage of inhaled corticosteroids in the previous year), will be identified via patient registries of general practices in the Leiden, Nijmegen, and Amsterdam areas in The Netherlands. The design is a 12-month cluster-randomised parallel trial with 40 general practices in each of the three arms. The patients will visit the general practice at baseline, 3, 6, 9, and 12 months. At each planned and unplanned visit to the general practice treatment will be adjusted with support of an internet-based asthma monitoring system supervised by a central coordinating specialist nurse. Patient preferences and utilities will be assessed by questionnaire and interview. Data on asthma control, treatment step, adherence to treatment, utilities and costs will be obtained every 3 months and at each unplanned visit. Differences in societal costs (medication, other (health) care and productivity) will be compared to differences in the number of limited activity days and in quality adjusted life years (Dutch EQ5D, SF6D, e-TTO, VAS). This is the first study to assess patient preferences and cost-effectiveness of asthma treatment strategies driven by different target levels of asthma control. Trial registration: Netherlands Trial Registration NTR1756.
BMC Pulm Med. 2011 Nov 24;11(1):53. [Epub ahead of print]
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成人哮喘患者的焦虑敏感性、哮喘控制和生命质量
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哮喘处理项目对住院频率和急诊频率的影响