Department of Pediatrics, University of Cincinnati College of Medicine, Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Department of Medicine, Division of Allergy and Immunology, University of Wisconsin School of Medicine and Public Health, Madison, Wis.
J Allergy Clin Immunol. 2019 May;143(5):1760-1768. doi: 10.1016/j.jaci.2018.10.060. Epub 2018 Dec 5.
Multicenter randomized controlled trials (RCTs) for asthma management that incorporate usual-care regimens could benefit from standardized application of evidence-based guidelines.
We sought to evaluate performance of a computerized decision support tool, the Asthma Control Evaluation and Treatment (ACET) Program, to standardize usual-care regimens for asthma management in RCTs.
Children and adolescents with persistent uncontrolled asthma living in urban census tracts were recruited into 3 multicenter RCTs (each with a usual-care arm) between 2004 and 2014. A computerized decision support tool scored asthma control and assigned an appropriate treatment step based on published guidelines. Control-level determinants (symptoms, rescue medication use, pulmonary function measure, and adherence estimates) were collected at visits and entered into the ACET Program. Changes in control levels and treatment steps were examined during the trials.
At screening, more than half of the participants were rated as having symptoms that were not controlled or poorly controlled. The proportion of participants who gained good control between screening and randomization increased significantly in all 3 trials. Between 51% and 70% had symptoms that were well controlled by randomization. The proportion of well-controlled participants remained constant or improved slightly from randomization until the last posttreatment visit. Nighttime symptoms were the most common control-level determinant; there were few (<1%) instances of complete overlap of factors. FEV was the driver of control-level assignment in 30% of determinations.
The ACET Program decision support tool facilitated standardized asthma assessment and treatment in multicenter RCTs and was associated with attaining and maintaining good asthma control in most participants.
纳入常规治疗方案的哮喘管理多中心随机对照试验（RCT）可能受益于基于循证指南的标准化应用。
我们旨在评估计算机决策支持工具——哮喘控制评估和治疗（ACET）程序在 RCT 中标准化哮喘管理常规治疗方案的效果。
2004 年至 2014 年，在 3 项多中心 RCT（每个 RCT 都有常规治疗组）中招募了居住在城市普查区的持续性未控制哮喘的儿童和青少年。计算机决策支持工具根据发表的指南对哮喘控制进行评分，并分配适当的治疗步骤。在就诊时收集控制水平决定因素（症状、急救药物使用、肺功能测量和依从性估计），并将其输入到 ACET 程序中。在试验期间检查控制水平和治疗步骤的变化。
在筛选时，超过一半的参与者被评定为存在未控制或控制不佳的症状。在所有 3 项试验中，参与者获得良好控制的比例在筛选和随机化之间显著增加。在随机分组时，有 51%至 70%的参与者症状得到良好控制。从随机化到最后一次治疗后就诊，良好控制的参与者比例保持不变或略有改善。夜间症状是最常见的控制水平决定因素；很少（<1%）出现因素完全重叠的情况。在 30%的决定中，FEV 是控制水平分配的驱动因素。
ACET 程序决策支持工具促进了多中心 RCT 中标准化的哮喘评估和治疗，并且与大多数参与者实现和维持良好的哮喘控制相关。
