Adherence & Treatment Outcome in Adolescents in CAMPCS

CAMP/CAMPCS是迄今为止进行的最大的儿童哮喘研究，因此提供了一个独特的机会来检验该临床试验中的依从性是高度可变的，并介导治疗和结果之间的剂量-反应关系。最近来自儿童哮喘管理项目（CAMP）的分析数据显示，布地奈德的平均依从性在第一年为77%，但在这个多中心儿童哮喘临床试验的第四年下降到55%，依从性下降最明显的是非洲裔美国儿童。CAMP延续研究（CAMPCS）是一项为期4.5年的观察性随访研究，907名儿童参加了CAMP，其中许多人仍在服用抗炎药物。这项具有里程碑意义的研究计划于2004年4月30日完成，目的是进一步了解炎症及其治疗在儿童哮喘进展中的作用。本建议寻求对CAMPCS进行辅助研究，这将有助于实现这一目标。在评估持续抗炎治疗对肺功能、气道反应性、身体生长、呼吸系统症状、医疗保健利用、晶状体混浊和生活质量的影响时，药物依从性评估将用于阐明剂量-反应关系。拟议的研究将通过为期六个月的每月电话访谈来评估这些儿童对控制性药物的依从性，并在前一天询问依从性。在涉及其他慢性疾病的研究中，基于外部人员通过电话采访进行的短期回忆的依从性评估已被证明可以提供准确的依从性估计。我们的小组最近进行了关于儿童使用哮喘药物的24小时电话访谈，发现这些结果是相关的。通过使用儿童计量吸入器上的电子依从性监测仪获得的信息。电话访谈方法非常经济有效，不会给8个CAMPCS站点的工作人员带来负担，并且与电子监视器不同，不限于ICS吸入器的子集。在最后的电话访谈中，参与者将被问及一系列关于他们的哮喘及其治疗的问题，以确定不依从是否与护理者-患者关系的强度、药物的感知有效性、心理困扰、家庭支持、疾病严重程度或应对能力有关。

CAMP/CAMPCS is the largest study of childhood asthma ever conducted, and hence presents a unique opportunity to examine the hypothesis that adherence in this clinical trial is highly variable and mediates the dose-response relationship between treatment and outcomes. Recently analyzed data from the Childhood Asthma Management Program (CAMP) has revealed that average budesonide adherence was 77 percent in the first year but dropped to 55 percent in year four of this multicenter pediatric asthma clinical trial, with the most dramatic drop in adherence occurring among African-American children. The CAMP Continuation Study (CAMPCS) is a 4.5 year observational followup study of 907 children who were enrolled in CAMP, many of whom remain on anti- inflammatory medication. Scheduled for completion on April 30, 2004, the objective of this landmark study is to further understand the role of inflammation and its' treatment in the progression of childhood asthma. This proposal seeks to conduct an ancillary study to CAMPCS which will help achieve this objective. Medication adherence estimations will be used to clarify dose-response relationships in the evaluation of the effect of ongoing anti-inflammatory treatment upon lung function, airway responsiveness, physical growth, respiratory symptoms, health care utilization, lens opacities, and quality of life. The proposed study will evaluate adherence to controller medicine in these children through monthly telephone interviews over a period of six months, which inquire about adherence on the previous day. Adherence assessments based upon short-term recall via telephone interviews by outside personnel have been shown in studies involving other chronic conditions to provide accurate adherence estimates. Our group has recently piloted 24-hour telephone interviews about children's use of asthma medications and found that these results correlated .77 with information obtained with the use of an electronic adherence monitor on the child's metered dose inhaler. The telephone-interview approach is very cost-effective, does not burden staff at the eight CAMPCS sites, and unlike electronic monitors is not limited to a subset of ICS inhalers. In the final telephone interview, participants will be asked a series of questions about their asthma and its' treatment in order to determine whether nonadherence is related to strength of the caregiver-patient relationship, perceived effectiveness of the medication, psychological distress, family support, illness severity, or coping capacity.