Kennedy Suzanne, Bailey Ryan, Jaffee Katy, Markus Anne, Gerstein Maya, Stevens David M, Lesch Julie Kennedy, Malveaux Floyd J, Mitchell Herman
Rho, Chapel Hill, North Carolina;
Rho, Chapel Hill, North Carolina.
Pediatrics. 2017 Jun;139(6). doi: 10.1542/peds.2016-4221. Epub 2017 May 9.
Researchers often struggle with the gap between efficacy and effectiveness in clinical research. To bridge this gap, the Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS) study adapted an efficacious, randomized controlled trial that resulted in evidence-based asthma interventions in community health centers.
Children (aged 5-12 years; = 590) with moderate to severe asthma were enrolled from 3 intervention and 3 geographically/capacity-matched control sites in high-risk, low-income communities located in Arizona, Michigan, and Puerto Rico. The asthma intervention was tailored to the participant's allergen sensitivity and exposure, and it comprised 4 visits over the course of 1 year. Study visits were documented and monitored prospectively via electronic data capture. Asthma symptoms and health care utilization were evaluated at baseline, and at 6 and 12 months.
A total of 314 intervention children and 276 control children were enrolled in the study. Allergen sensitivity testing (96%) and home environmental assessments (89%) were performed on the majority of intervention children. Overall study activity completion (eg, intervention visits, clinical assessments) was 70%. Overall and individual site participant symptom days in the previous 4 weeks were significantly reduced compared with control findings (control, change of -2.28; intervention, change of -3.27; difference, -0.99; < .001), and this result was consistent with changes found in the rigorous evidence-based interventions.
Evidence-based interventions can be successfully adapted into primary care settings that serve impoverished, high-risk populations, reducing the morbidity of asthma in these high-need populations.
在临床研究中，研究人员常常在疗效与实际效果之间的差距上遇到困难。为了弥合这一差距，哮喘管理与症状预防社区医疗（CHAMPS）研究采用了一项有效的随机对照试验，该试验在社区卫生中心产生了基于证据的哮喘干预措施。
从亚利桑那州、密歇根州和波多黎各的高危、低收入社区的3个干预点和3个地理/能力匹配的对照点招募了590名5至12岁的中重度哮喘儿童。哮喘干预措施根据参与者的过敏原敏感性和暴露情况进行调整，在1年的时间里包括4次就诊。研究就诊情况通过电子数据捕获进行前瞻性记录和监测。在基线、6个月和12个月时评估哮喘症状和医疗保健利用情况。
共有314名干预组儿童和276名对照组儿童参与研究。大多数干预组儿童进行了过敏原敏感性测试（96%）和家庭环境评估（89%）。总体研究活动完成率（如干预就诊、临床评估）为70%。与对照组结果相比（对照组，变化为-2.28；干预组，变化为-3.27；差异为-0.99；P<0.001），前4周总体及各研究点参与者的症状天数显著减少，这一结果与严格的基于证据的干预措施中的变化一致。
基于证据的干预措施可以成功地应用于为贫困、高危人群服务的初级保健环境中，降低这些高需求人群中哮喘的发病率。
