Juniper Elizabeth F, Svensson Klas, Mörk Ann-Christin, Ståhl Elisabeth
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada.
Respir Med. 2005 May;99(5):553-8. doi: 10.1016/j.rmed.2004.10.008. Epub 2004 Nov 26.
The Asthma Control Questionnaire (ACQ) measures the adequacy of asthma treatment as identified by international guidelines. It consists of seven items (5 x symptoms, rescue bronchodilator use and FEV1% of predicted normal). A validation study suggested that in clinical studies measurement of FEV1 and bronchodilator use may not be needed but this has never formally been tested in a clinical trial. The aims of this analysis were (1) to examine the measurement properties of three shortened versions of the ACQ (symptoms alone, symptoms plus FEV1 and symptoms plus short-acting beta2-agonist) and (2) to determine whether using the shortened versions would alter the results of a clinical trial. In the randomised trial, 552 adults completed the ACQ at baseline and after 13 and 26 weeks of treatment. The analysis showed that the measurement properties of all four versions of the ACQ are very similar. Agreement between the original ACQ and the reduced versions was high (intraclass correlation coefficients: 0.94-0.99). Mean differences between the ACQ and the shortened versions were less than 0.04 (on the 7-point scale). Clinical trial results using the four versions were almost identical with the mean treatment difference ranging from -0.09 (P=0.17), to -0.13 (P=0.07). For interpretability, the minimal important difference for all four versions was close to 0.5. In conclusion, these three shortened versions of the ACQ can be used in large clinical trials without loss of validity or change in interpretation.
哮喘控制问卷(ACQ)用于衡量国际指南所确定的哮喘治疗的充分性。它由七个项目组成(5项症状、急救支气管扩张剂使用情况以及预测正常FEV1的百分比)。一项验证研究表明,在临床研究中可能无需测量FEV1和支气管扩张剂的使用情况,但这从未在临床试验中得到正式验证。本分析的目的是:(1)检验ACQ三个缩短版本(仅症状、症状加FEV1以及症状加短效β2受体激动剂)的测量特性;(2)确定使用这些缩短版本是否会改变临床试验的结果。在该随机试验中,552名成年人在基线以及治疗13周和26周后完成了ACQ。分析表明,ACQ的所有四个版本的测量特性非常相似。原始ACQ与简化版本之间的一致性很高(组内相关系数:0.94 - 0.99)。ACQ与缩短版本之间的平均差异小于0.04(在7分制量表上)。使用这四个版本的临床试验结果几乎相同,平均治疗差异范围从 -0.09(P = 0.17)到 -0.13(P = 0.07)。为了便于解释,所有四个版本的最小重要差异均接近0.5。总之,ACQ的这三个缩短版本可用于大型临床试验,而不会损失有效性或改变解释。